Deputizing institutional review boards to police (audit?) Biomedical research

Journal of Legal Medicine

Volumn 25, Issue 3, 2004, Pages 267-293

  Noah, Lars ^a  

^a UNIVERSITY OF FLORIDA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DECISION MAKING; MEDICAL AUDIT; MEDICAL RESEARCH; ORGANIZATION; REVIEW; RISK ASSESSMENT;

BIOMEDICAL AND BEHAVIORAL RESEARCH; LEGAL APPROACH;

BIOMEDICAL RESEARCH; ETHICS COMMITTEES, RESEARCH; HUMAN EXPERIMENTATION; HUMANS; RISK ASSESSMENT; UNITED STATES;

EID: 4644268458     PISSN: 01947648     EISSN: None     Source Type: Journal    
DOI: 10.1080/01947640490496962     Document Type: Review

References (333)

1. See Carl H. Coleman, Rationalizing Risk Assessment in Human Subject Research, 46 ARIZ. L. REV. 1 (2004).
2. Lars Noah, Informed Consent and the Elusive Dichotomy Between Standard and Experimental Therapy, 28 AM. J.L. & MED. 361, 384 (2002) (footnotes omitted); see also id. ("In many cases, however, the investigators know so little about an experimental therapy that, even if they have fully disclosed all that they know and do so in a way that the subjects can understand, some commentators have wondered whether it even makes sense to speak of 'informed' consent in the research setting.").
3. Lars Noah, Informed Consent and the Elusive Dichotomy Between Standard and Experimental Therapy, 28 AM. J.L. & MED. 361, 384 (2002) (footnotes omitted); see also id. ("In many cases, however, the investigators know so little about an experimental therapy that, even if they have fully disclosed all that they know and do so in a way that the subjects can understand, some commentators have wondered whether it even makes sense to speak of 'informed' consent in the research setting.").
4. See Coleman, supra note 1, at 28-40; id. at 33 (discussing casuistry).
5. See Coleman, supra note 1, at 28-40; id. at 33 (discussing casuistry).
6. See id. at 14 ("[T]he risk assessment process is highly unstructured.... Because the members are not required to state reasons for their decisions, the process encourages reliance on impressionistic judgments, or 'gut reactions.'"); id. at 16 (referring to the "virtually unfettered discretion" exercised by IRBs); id. at 42 ("[A]n obligation to write opinions would force IRBs to develop articulable reasons for their decisions, rather than simply relying on impressionistic judgments or gut reactions.").
7. See id. at 14 ("[T]he risk assessment process is highly unstructured.... Because the members are not required to state reasons for their decisions, the process encourages reliance on impressionistic judgments, or 'gut reactions.'"); id. at 16 (referring to the "virtually unfettered discretion" exercised by IRBs); id. at 42 ("[A]n obligation to write opinions would force IRBs to develop articulable reasons for their decisions, rather than simply relying on impressionistic judgments or gut reactions.").
8. See id. at 14 ("[T]he risk assessment process is highly unstructured.... Because the members are not required to state reasons for their decisions, the process encourages reliance on impressionistic judgments, or 'gut reactions.'"); id. at 16 (referring to the "virtually unfettered discretion" exercised by IRBs); id. at 42 ("[A]n obligation to write opinions would force IRBs to develop articulable reasons for their decisions, rather than simply relying on impressionistic judgments or gut reactions.").
9. See id. at 40-49.
10. Id. at 51. The regulations do refer to the need to include board members who are "able to ascertain the acceptability of proposed research in terms of ... applicable law." 21 C.F.R. § 56.107(a) (2003); 45 C.F.R. § 46.107(a) (2003).
11. Id. at 51. The regulations do refer to the need to include board members who are "able to ascertain the acceptability of proposed research in terms of ... applicable law." 21 C.F.R. § 56.107(a) (2003); 45 C.F.R. § 46.107(a) (2003).
12. Id. at 51. The regulations do refer to the need to include board members who are "able to ascertain the acceptability of proposed research in terms of ... applicable law." 21 C.F.R. § 56.107(a) (2003); 45 C.F.R. § 46.107(a) (2003).
13. In contrast, other commentators have drawn such a parallel before adding that IRBs also undertake tasks that transcend this peer review function. See Jesse A. Goldner, An Overview of Legal Controls on Human Experimentation and the Regulatory Implications of Taking Professor Katz Seriously, 38 ST. LOUIS U. L.J. 63, 105 (1993).
14. See, e.g., Jesse A. Goldner, Dealing with Conflicts of Interest in Biomedical Research: IRB Oversight as the Next Best Solution to the Abolitionist Approach, 28 J.L. MED. & ETHICS 379, 381, 390-91, 397-98 (2000); Dale L. Moore, An IRB Member's Perspective on Access to Innovative Therapy, 57 ALB. L. REV. 559 (1994); Barbara A. Noah, Bioethical Malpractice: Risk and Responsibility in Human Research, 7 J. HEALTH CARE L. & POL'Y 175 (2004). Commentators with first-hand experience may, however, lapse into simple anecdotalism. See, e.g., Bartolo, Tales of Informed Consent: Four Years on an Institutional Review Board, 2 HEALTH MATRIX 193, 193 (1992) (doing so unapologetically though anonymously).
15. See, e.g., Jesse A. Goldner, Dealing with Conflicts of Interest in Biomedical Research: IRB Oversight as the Next Best Solution to the Abolitionist Approach, 28 J.L. MED. & ETHICS 379, 381, 390-91, 397-98 (2000); Dale L. Moore, An IRB Member's Perspective on Access to Innovative Therapy, 57 ALB. L. REV. 559 (1994); Barbara A. Noah, Bioethical Malpractice: Risk and Responsibility in Human Research, 7 J. HEALTH CARE L. & POL'Y 175 (2004). Commentators with first-hand experience may, however, lapse into simple anecdotalism. See, e.g., Bartolo, Tales of Informed Consent: Four Years on an Institutional Review Board, 2 HEALTH MATRIX 193, 193 (1992) (doing so unapologetically though anonymously).
16. See, e.g., Jesse A. Goldner, Dealing with Conflicts of Interest in Biomedical Research: IRB Oversight as the Next Best Solution to the Abolitionist Approach, 28 J.L. MED. & ETHICS 379, 381, 390-91, 397-98 (2000); Dale L. Moore, An IRB Member's Perspective on Access to Innovative Therapy, 57 ALB. L. REV. 559 (1994); Barbara A. Noah, Bioethical Malpractice: Risk and Responsibility in Human Research, 7 J. HEALTH CARE L. & POL'Y 175 (2004). Commentators with first-hand experience may, however, lapse into simple anecdotalism. See, e.g., Bartolo, Tales of Informed Consent: Four Years on an Institutional Review Board, 2 HEALTH MATRIX 193, 193 (1992) (doing so unapologetically though anonymously).
17. See, e.g., Jesse A. Goldner, Dealing with Conflicts of Interest in Biomedical Research: IRB Oversight as the Next Best Solution to the Abolitionist Approach, 28 J.L. MED. & ETHICS 379, 381, 390-91, 397-98 (2000); Dale L. Moore, An IRB Member's Perspective on Access to Innovative Therapy, 57 ALB. L. REV. 559 (1994); Barbara A. Noah, Bioethical Malpractice: Risk and Responsibility in Human Research, 7 J. HEALTH CARE L. & POL'Y 175 (2004). Commentators with first-hand experience may, however, lapse into simple anecdotalism. See, e.g., Bartolo, Tales of Informed Consent: Four Years on an Institutional Review Board, 2 HEALTH MATRIX 193, 193 (1992) (doing so unapologetically though anonymously).
18. See, e.g., John A. Robertson, The Law of Institutional Review Boards, 26 UCLA L. REV. 484 (1979); Robert J. Katerberg, Note, Institutional Review Boards, Research on Children, and Informed Consent of Parents: Walking the Tightrope Between Encouraging Vital Experimentation and Protecting Subjects' Rights, 24 J.C. & U.L. 545 (1998); see also Harold Edgar & David J. Rothman, The Institutional Review Board and Beyond: Future Challenges to the Ethics of Human Experimentation, 73 MILBANK Q. 489 (1995); cf. Sheryl Gay Stolberg, Bioethicists Find Themselves the Ones Being Scrutinized, N.Y. TIMES, Aug. 2, 2001, at A16 (explaining that just about anyone can call themselves a "bioethicist" ).
19. See, e.g., John A. Robertson, The Law of Institutional Review Boards, 26 UCLA L. REV. 484 (1979); Robert J. Katerberg, Note, Institutional Review Boards, Research on Children, and Informed Consent of Parents: Walking the Tightrope Between Encouraging Vital Experimentation and Protecting Subjects' Rights, 24 J.C. & U.L. 545 (1998); see also Harold Edgar & David J. Rothman, The Institutional Review Board and Beyond: Future Challenges to the Ethics of Human Experimentation, 73 MILBANK Q. 489 (1995); cf. Sheryl Gay Stolberg, Bioethicists Find Themselves the Ones Being Scrutinized, N.Y. TIMES, Aug. 2, 2001, at A16 (explaining that just about anyone can call themselves a "bioethicist" ).
20. See, e.g., John A. Robertson, The Law of Institutional Review Boards, 26 UCLA L. REV. 484 (1979); Robert J. Katerberg, Note, Institutional Review Boards, Research on Children, and Informed Consent of Parents: Walking the Tightrope Between Encouraging Vital Experimentation and Protecting Subjects' Rights, 24 J.C. & U.L. 545 (1998); see also Harold Edgar & David J. Rothman, The Institutional Review Board and Beyond: Future Challenges to the Ethics of Human Experimentation, 73 MILBANK Q. 489 (1995); cf. Sheryl Gay Stolberg, Bioethicists Find Themselves the Ones Being Scrutinized, N.Y. TIMES, Aug. 2, 2001, at A16 (explaining that just about anyone can call themselves a "bioethicist" ).
21. See, e.g., John A. Robertson, The Law of Institutional Review Boards, 26 UCLA L. REV. 484 (1979); Robert J. Katerberg, Note, Institutional Review Boards, Research on Children, and Informed Consent of Parents: Walking the Tightrope Between Encouraging Vital Experimentation and Protecting Subjects' Rights, 24 J.C. & U.L. 545 (1998); see also Harold Edgar & David J. Rothman, The Institutional Review Board and Beyond: Future Challenges to the Ethics of Human Experimentation, 73 MILBANK Q. 489 (1995); cf. Sheryl Gay Stolberg, Bioethicists Find Themselves the Ones Being Scrutinized, N.Y. TIMES, Aug. 2, 2001, at A16 (explaining that just about anyone can call themselves a "bioethicist" ).
22. The famous Belmont Report focused on "risk-benefit assessment," which is not the same as risk assessment. See 44 Fed. Reg. 23,192, 23,195-96 (1979); see also NAT'L BIOETHICS ADVISORY COMM'N, ETHICAL AND POLICY ISSUES IN RESEARCH INVOLVING HUMAN PARTICIPANTS 69-80 (2001), available at http://www.georgetown.edu/research/nrcbl/nbac/human/overvol1.pdf (last visited Feb. 14, 2004) [hereinafter NBAC REPORT] (distinguishing between risk assessment and risk-benefit balancing); Charles Weijer, The Ethical Analysis of Risk, 28 J.L. MED. & ETHICS 344 (2000) (focusing on the identification of risks but rarely in isolation from potential benefits).
23. The famous Belmont Report focused on "risk-benefit assessment," which is not the same as risk assessment. See 44 Fed. Reg. 23,192, 23,195-96 (1979); see also NAT'L BIOETHICS ADVISORY COMM'N, ETHICAL AND POLICY ISSUES IN RESEARCH INVOLVING HUMAN PARTICIPANTS 69-80 (2001), available at http://www.georgetown.edu/research/nrcbl/nbac/human/overvol1.pdf (last visited Feb. 14, 2004) [hereinafter NBAC REPORT] (distinguishing between risk assessment and risk-benefit balancing); Charles Weijer, The Ethical Analysis of Risk, 28 J.L. MED. & ETHICS 344 (2000) (focusing on the identification of risks but rarely in isolation from potential benefits).
24. The famous Belmont Report focused on "risk-benefit assessment," which is not the same as risk assessment. See 44 Fed. Reg. 23,192, 23,195-96 (1979); see also NAT'L BIOETHICS ADVISORY COMM'N, ETHICAL AND POLICY ISSUES IN RESEARCH INVOLVING HUMAN PARTICIPANTS 69-80 (2001), available at http://www.georgetown.edu/research/nrcbl/nbac/human/overvol1.pdf (last visited Feb. 14, 2004) [hereinafter NBAC REPORT] (distinguishing between risk assessment and risk-benefit balancing); Charles Weijer, The Ethical Analysis of Risk, 28 J.L. MED. & ETHICS 344 (2000) (focusing on the identification of risks but rarely in isolation from potential benefits).
25. See Coleman, supra note 1, at 23.
26. Cf. Lars Noah, Challenges in the Federal Regulation of Pain Management Technologies, 31 J.L. MED. & ETHICS 55, 64 (2003) ("Traditionally, the FDA has adopted a clinical (or individualistic) mindset [when reviewing the safety and effectiveness of new drugs], leaving most of the difficult risk-benefit judgments in the hands of health care professionals and patients."); id. at 56 ("The FDA usually does not, however, make judgments about comparative efficacy, preferring to leave that task for physicians and patients based on the information supplied in the labeling dictated by agency reviewers.").
27. Cf. Lars Noah, Challenges in the Federal Regulation of Pain Management Technologies, 31 J.L. MED. & ETHICS 55, 64 (2003) ("Traditionally, the FDA has adopted a clinical (or individualistic) mindset [when reviewing the safety and effectiveness of new drugs], leaving most of the difficult risk-benefit judgments in the hands of health care professionals and patients."); id. at 56 ("The FDA usually does not, however, make judgments about comparative efficacy, preferring to leave that task for physicians and patients based on the information supplied in the labeling dictated by agency reviewers.").
28. See NAT'L RESEARCH COUNCIL, RISK ASSESSMENT IN THE FEDERAL GOVERNMENT: MANAGING THE PROCESS 18-20 (1983) [hereinafter NRC REPORT]; see also 61 Fed. Reg. 17,960 (1996) (announcing the Environmental Protection Agency's proposed guidelines for carcinogen risk assessment).
29. See NAT'L RESEARCH COUNCIL, RISK ASSESSMENT IN THE FEDERAL GOVERNMENT: MANAGING THE PROCESS 18-20 (1983) [hereinafter NRC REPORT]; see also 61 Fed. Reg. 17,960 (1996) (announcing the Environmental Protection Agency's proposed guidelines for carcinogen risk assessment).
30. See Albert L. Nichols & Richard J. Zeckhauser, The Perils of Prudence: How Conservative Risk Assessments Distort Regulation, 8 REG. TOXICOL. & PHARMACOL. 61, 67 (1988); Mark Eliot Shere, The Myth of Meaningful Environmental Risk Assessment, 19 HARV. ENVTL. L. REV. 409, 413-14 (1995). For responses to some of these objections, see NAT'L RESEARCH COUNCIL, SCIENCE AND JUDGMENT IN RISK ASSESSMENT (1995).
31. See Albert L. Nichols & Richard J. Zeckhauser, The Perils of Prudence: How Conservative Risk Assessments Distort Regulation, 8 REG. TOXICOL. & PHARMACOL. 61, 67 (1988); Mark Eliot Shere, The Myth of Meaningful Environmental Risk Assessment, 19 HARV. ENVTL. L. REV. 409, 413-14 (1995). For responses to some of these objections, see NAT'L RESEARCH COUNCIL, SCIENCE AND JUDGMENT IN RISK ASSESSMENT (1995).
32. See Albert L. Nichols & Richard J. Zeckhauser, The Perils of Prudence: How Conservative Risk Assessments Distort Regulation, 8 REG. TOXICOL. & PHARMACOL. 61, 67 (1988); Mark Eliot Shere, The Myth of Meaningful Environmental Risk Assessment, 19 HARV. ENVTL. L. REV. 409, 413-14 (1995). For responses to some of these objections, see NAT'L RESEARCH COUNCIL, SCIENCE AND JUDGMENT IN RISK ASSESSMENT (1995).
33. See Celia Campbell-Mohn & John S. Applegate, Learning from NEPA: Guidelines for Responsible Risk Legislation, 23 HARV. ENVTL. L. REV. 93, 93-105 (1999) (canvassing this debate); Lisa Heinzerling, Regulatory Costs of Mythic Proportions, 107 YALE L.J. 1981, 2056-60 (1998); Donald T. Hornstein, Reclaiming Environmental Law: A Normative Critique of Comparative Risk Analysis, 92 COLUM. L. REV. 562, 630 (1992); Howard Latin, Good Science, Bad Regulation, and Toxic Risk Assessment, 5 YALE J. ON REG. 89, 147-48 (1988); Thomas O. McGarity, A Cost-Benefit State, 50 ADMIN. L. REV. 7, 16-32 (1998).
34. See Celia Campbell-Mohn & John S. Applegate, Learning from NEPA: Guidelines for Responsible Risk Legislation, 23 HARV. ENVTL. L. REV. 93, 93-105 (1999) (canvassing this debate); Lisa Heinzerling, Regulatory Costs of Mythic Proportions, 107 YALE L.J. 1981, 2056-60 (1998); Donald T. Hornstein, Reclaiming Environmental Law: A Normative Critique of Comparative Risk Analysis, 92 COLUM. L. REV. 562, 630 (1992); Howard Latin, Good Science, Bad Regulation, and Toxic Risk Assessment, 5 YALE J. ON REG. 89, 147-48 (1988); Thomas O. McGarity, A Cost-Benefit State, 50 ADMIN. L. REV. 7, 16-32 (1998).
35. See Celia Campbell-Mohn & John S. Applegate, Learning from NEPA: Guidelines for Responsible Risk Legislation, 23 HARV. ENVTL. L. REV. 93, 93-105 (1999) (canvassing this debate); Lisa Heinzerling, Regulatory Costs of Mythic Proportions, 107 YALE L.J. 1981, 2056-60 (1998); Donald T. Hornstein, Reclaiming Environmental Law: A Normative Critique of Comparative Risk Analysis, 92 COLUM. L. REV. 562, 630 (1992); Howard Latin, Good Science, Bad Regulation, and Toxic Risk Assessment, 5 YALE J. ON REG. 89, 147-48 (1988); Thomas O. McGarity, A Cost-Benefit State, 50 ADMIN. L. REV. 7, 16-32 (1998).
36. See Celia Campbell-Mohn & John S. Applegate, Learning from NEPA: Guidelines for Responsible Risk Legislation, 23 HARV. ENVTL. L. REV. 93, 93-105 (1999) (canvassing this debate); Lisa Heinzerling, Regulatory Costs of Mythic Proportions, 107 YALE L.J. 1981, 2056-60 (1998); Donald T. Hornstein, Reclaiming Environmental Law: A Normative Critique of Comparative Risk Analysis, 92 COLUM. L. REV. 562, 630 (1992); Howard Latin, Good Science, Bad Regulation, and Toxic Risk Assessment, 5 YALE J. ON REG. 89, 147-48 (1988); Thomas O. McGarity, A Cost-Benefit State, 50 ADMIN. L. REV. 7, 16-32 (1998).
37. See Celia Campbell-Mohn & John S. Applegate, Learning from NEPA: Guidelines for Responsible Risk Legislation, 23 HARV. ENVTL. L. REV. 93, 93-105 (1999) (canvassing this debate); Lisa Heinzerling, Regulatory Costs of Mythic Proportions, 107 YALE L.J. 1981, 2056-60 (1998); Donald T. Hornstein, Reclaiming Environmental Law: A Normative Critique of Comparative Risk Analysis, 92 COLUM. L. REV. 562, 630 (1992); Howard Latin, Good Science, Bad Regulation, and Toxic Risk Assessment, 5 YALE J. ON REG. 89, 147-48 (1988); Thomas O. McGarity, A Cost-Benefit State, 50 ADMIN. L. REV. 7, 16-32 (1998).
38. See DAVID L. FAIGMAN, LEGAL ALCHEMY: THE USE AND MISUSE OF SCIENCE IN THE LAW 178-79 (1999) ("Too often the science is made to appear more certain than it is in order to hide the policy preferences driving the decision."); id. at 182 ("[S]cience cannot establish where the line should be drawn."); John S. Applegate, The Perils of Unreasonable Risk: Information, Regulatory Policy, and Toxic Substances Control, 91 COLUM. L. REV. 261, 277-98 (1991) (explaining that risk assessment magnifies rather than reduces the gaps in existing data); Nicholas A. Ashford et al., A Hard Look at Federal Regulation of Formaldehyde: A Departure from Reasoned Decisionmaking, 7 HARV. ENVTL. L. REV. 297, 315 (1983) (explaining two levels of risk assessment, the first focusing on genuinely scientific questions and the second posing trans-scientific policy questions); Wendy E. Wagner, The Science Charade in Toxic Risk Regulation, 95 COLUM. L. REV. 1613, 1618-28, 1720-21 (1995).
39. See DAVID L. FAIGMAN, LEGAL ALCHEMY: THE USE AND MISUSE OF SCIENCE IN THE LAW 178-79 (1999) ("Too often the science is made to appear more certain than it is in order to hide the policy preferences driving the decision."); id. at 182 ("[S]cience cannot establish where the line should be drawn."); John S. Applegate, The Perils of Unreasonable Risk: Information, Regulatory Policy, and Toxic Substances Control, 91 COLUM. L. REV. 261, 277-98 (1991) (explaining that risk assessment magnifies rather than reduces the gaps in existing data); Nicholas A. Ashford et al., A Hard Look at Federal Regulation of Formaldehyde: A Departure from Reasoned Decisionmaking, 7 HARV. ENVTL. L. REV. 297, 315 (1983) (explaining two levels of risk assessment, the first focusing on genuinely scientific questions and the second posing trans-scientific policy questions); Wendy E. Wagner, The Science Charade in Toxic Risk Regulation, 95 COLUM. L. REV. 1613, 1618-28, 1720-21 (1995).
40. See DAVID L. FAIGMAN, LEGAL ALCHEMY: THE USE AND MISUSE OF SCIENCE IN THE LAW 178-79 (1999) ("Too often the science is made to appear more certain than it is in order to hide the policy preferences driving the decision."); id. at 182 ("[S]cience cannot establish where the line should be drawn."); John S. Applegate, The Perils of Unreasonable Risk: Information, Regulatory Policy, and Toxic Substances Control, 91 COLUM. L. REV. 261, 277-98 (1991) (explaining that risk assessment magnifies rather than reduces the gaps in existing data); Nicholas A. Ashford et al., A Hard Look at Federal Regulation of Formaldehyde: A Departure from Reasoned Decisionmaking, 7 HARV. ENVTL. L. REV. 297, 315 (1983) (explaining two levels of risk assessment, the first focusing on genuinely scientific questions and the second posing trans-scientific policy questions); Wendy E. Wagner, The Science Charade in Toxic Risk Regulation, 95 COLUM. L. REV. 1613, 1618-28, 1720-21 (1995).
41. See DAVID L. FAIGMAN, LEGAL ALCHEMY: THE USE AND MISUSE OF SCIENCE IN THE LAW 178-79 (1999) ("Too often the science is made to appear more certain than it is in order to hide the policy preferences driving the decision."); id. at 182 ("[S]cience cannot establish where the line should be drawn."); John S. Applegate, The Perils of Unreasonable Risk: Information, Regulatory Policy, and Toxic Substances Control, 91 COLUM. L. REV. 261, 277-98 (1991) (explaining that risk assessment magnifies rather than reduces the gaps in existing data); Nicholas A. Ashford et al., A Hard Look at Federal Regulation of Formaldehyde: A Departure from Reasoned Decisionmaking, 7 HARV. ENVTL. L. REV. 297, 315 (1983) (explaining two levels of risk assessment, the first focusing on genuinely scientific questions and the second posing trans-scientific policy questions); Wendy E. Wagner, The Science Charade in Toxic Risk Regulation, 95 COLUM. L. REV. 1613, 1618-28, 1720-21 (1995).
42. See DAVID L. FAIGMAN, LEGAL ALCHEMY: THE USE AND MISUSE OF SCIENCE IN THE LAW 178-79 (1999) ("Too often the science is made to appear more certain than it is in order to hide the policy preferences driving the decision."); id. at 182 ("[S]cience cannot establish where the line should be drawn."); John S. Applegate, The Perils of Unreasonable Risk: Information, Regulatory Policy, and Toxic Substances Control, 91 COLUM. L. REV. 261, 277-98 (1991) (explaining that risk assessment magnifies rather than reduces the gaps in existing data); Nicholas A. Ashford et al., A Hard Look at Federal Regulation of Formaldehyde: A Departure from Reasoned Decisionmaking, 7 HARV. ENVTL. L. REV. 297, 315 (1983) (explaining two levels of risk assessment, the first focusing on genuinely scientific questions and the second posing trans-scientific policy questions); Wendy E. Wagner, The Science Charade in Toxic Risk Regulation, 95 COLUM. L. REV. 1613, 1618-28, 1720-21 (1995).
43. See Lars Noah, Civil Jury Nullification, 86 IOWA L. REV. 1601, 1609, 1643-58 (2001); Lars Noah, Rewarding Regulatory Compliance: The Pursuit of Symmetry in Products Liability, 88 GEO. L.J. 2147, 2150-51, 2153, 2163 (2000).
44. See Lars Noah, Civil Jury Nullification, 86 IOWA L. REV. 1601, 1609, 1643-58 (2001); Lars Noah, Rewarding Regulatory Compliance: The Pursuit of Symmetry in Products Liability, 88 GEO. L.J. 2147, 2150-51, 2153, 2163 (2000).
45. Coleman, supra note 1, at 19.
46. See id. at 22 ("While IRB members, unlike jurors, generally have scientific expertise, expert risk perceptions are also affected by cognitive biases ... [and] experts tend to be unduly confident in judgments that stem from cognitive distortions."). He also argues, more convincingly, that members of IRBs may have other sorts of biases that one would not typically encounter in jury trials. See id. at 19 (noting that IRBs "tend to be dominated by institutional insiders with similar backgrounds").
47. See id. at 22 ("While IRB members, unlike jurors, generally have scientific expertise, expert risk perceptions are also affected by cognitive biases ... [and] experts tend to be unduly confident in judgments that stem from cognitive distortions."). He also argues, more convincingly, that members of IRBs may have other sorts of biases that one would not typically encounter in jury trials. See id. at 19 (noting that IRBs "tend to be dominated by institutional insiders with similar backgrounds").
48. See Goldner, supra note 7, at 106-09 (explaining that IRBs in Australia and Denmark include a greater number of laypersons, and recommending that non-scientists play a more central role in reviewing informed consent documents).
49. Coleman, supra note 1, at 19.
50. This category would, for instance, surely include Coleman's hypothetical research protocol involving the amputation of healthy limbs. See id. at 10.
51. See id. at 15 (noting that "IRB decisions are not appealable to any higher authority"); id. at 43 ("[T]he system does nothing to prevent arbitrary or irrational decision-making. A system that treats all IRB decisions as essentially unreviewable also makes it unlikely that coherent decision-making principles or guidelines will develop over time."). Although IRB members certainly make good-faith mistakes operating under serious constraints of time and information, I marvel at the implication that they essentially sit around in smoke-filled rooms rolling dice to decide what to do with a protocol.
52. See id. at 15 (noting that "IRB decisions are not appealable to any higher authority"); id. at 43 ("[T]he system does nothing to prevent arbitrary or irrational decision-making. A system that treats all IRB decisions as essentially unreviewable also makes it unlikely that coherent decision-making principles or guidelines will develop over time."). Although IRB members certainly make good-faith mistakes operating under serious constraints of time and information, I marvel at the implication that they essentially sit around in smoke-filled rooms rolling dice to decide what to do with a protocol.
53. See 21 C.F.R. § 56.112 (2003); 45 C.F.R. § 46.112 (2003).
54. See 21 C.F.R. § 56.112 (2003); 45 C.F.R. § 46.112 (2003).
55. See Lars Noah, Scientific "Republicanism": Expert Peer Review and the Quest for Regulatory Deliberation, 49 EMORY L.J. 1033, 1068-73 (2000). The Office of Management and Budget recently proposed mandating such reviews. See Shankar Vedantam, Bush Would Add Review Layer for Rules, WASH. POST, Aug. 30, 2003, at A10.
56. See Lars Noah, Scientific "Republicanism": Expert Peer Review and the Quest for Regulatory Deliberation, 49 EMORY L.J. 1033, 1068-73 (2000). The Office of Management and Budget recently proposed mandating such reviews. See Shankar Vedantam, Bush Would Add Review Layer for Rules, WASH. POST, Aug. 30, 2003, at A10.
57. On this score, Coleman may have given the federal regulatory agencies far too much credit. See Coleman, supra note 1, at 43 ("[T]he IRB system's radical localism reflects an intentional policy decision by the system's designers, who believed that the protocol review process must be entrusted to individuals familiar with local conditions and the attitudes of the population from which subjects are drawn."). Although an entirely plausible explanation, the agencies also may well have jumped at the opportunity to avoid taking on this enormous workload themselves. Moreover, even if localism serves no genuine purpose related to a research site's peculiar circumstances, it may offer a bulwark against the consequences of politicization in a centralized system. Cf. Lars Noah, A Postmodernist Take on the Human Embryo Research Debate, 36 CONN. L. REV. 1133 (2004) (criticizing the Bush administration's use of an ideological litmus test in selecting experts for scientific and bioethics advisory panels); James Glanz, Scientists Say Administration Distorts Facts, N. Y. TIMES, Feb. 19, 2004, at A18; Rick Weiss, HHS Seeks Science Advice to Match Bush Views, WASH. POST, Sept. 17, 2002, at A1 (reporting that an advisory committee, which was rethinking federal protections for human research subjects, was disbanded prematurely and reconfigured because it "had drawn the ire of administration supporters on the religious right").
58. On this score, Coleman may have given the federal regulatory agencies far too much credit. See Coleman, supra note 1, at 43 ("[T]he IRB system's radical localism reflects an intentional policy decision by the system's designers, who believed that the protocol review process must be entrusted to individuals familiar with local conditions and the attitudes of the population from which subjects are drawn."). Although an entirely plausible explanation, the agencies also may well have jumped at the opportunity to avoid taking on this enormous workload themselves. Moreover, even if localism serves no genuine purpose related to a research site's peculiar circumstances, it may offer a bulwark against the consequences of politicization in a centralized system. Cf. Lars Noah, A Postmodernist Take on the Human Embryo Research Debate, 36 CONN. L. REV. 1133 (2004) (criticizing the Bush administration's use of an ideological litmus test in selecting experts for scientific and bioethics advisory panels); James Glanz, Scientists Say Administration Distorts Facts, N. Y. TIMES, Feb. 19, 2004, at A18; Rick Weiss, HHS Seeks Science Advice to Match Bush Views, WASH. POST, Sept. 17, 2002, at A1 (reporting that an advisory committee, which was rethinking federal protections for human research subjects, was disbanded prematurely and reconfigured because it "had drawn the ire of administration supporters on the religious right").
59. On this score, Coleman may have given the federal regulatory agencies far too much credit. See Coleman, supra note 1, at 43 ("[T]he IRB system's radical localism reflects an intentional policy decision by the system's designers, who believed that the protocol review process must be entrusted to individuals familiar with local conditions and the attitudes of the population from which subjects are drawn."). Although an entirely plausible explanation, the agencies also may well have jumped at the opportunity to avoid taking on this enormous workload themselves. Moreover, even if localism serves no genuine purpose related to a research site's peculiar circumstances, it may offer a bulwark against the consequences of politicization in a centralized system. Cf. Lars Noah, A Postmodernist Take on the Human Embryo Research Debate, 36 CONN. L. REV. 1133 (2004) (criticizing the Bush administration's use of an ideological litmus test in selecting experts for scientific and bioethics advisory panels); James Glanz, Scientists Say Administration Distorts Facts, N. Y. TIMES, Feb. 19, 2004, at A18; Rick Weiss, HHS Seeks Science Advice to Match Bush Views, WASH. POST, Sept. 17, 2002, at A1 (reporting that an advisory committee, which was rethinking federal protections for human research subjects, was disbanded prematurely and reconfigured because it "had drawn the ire of administration supporters on the religious right").
60. On this score, Coleman may have given the federal regulatory agencies far too much credit. See Coleman, supra note 1, at 43 ("[T]he IRB system's radical localism reflects an intentional policy decision by the system's designers, who believed that the protocol review process must be entrusted to individuals familiar with local conditions and the attitudes of the population from which subjects are drawn."). Although an entirely plausible explanation, the agencies also may well have jumped at the opportunity to avoid taking on this enormous workload themselves. Moreover, even if localism serves no genuine purpose related to a research site's peculiar circumstances, it may offer a bulwark against the consequences of politicization in a centralized system. Cf. Lars Noah, A Postmodernist Take on the Human Embryo Research Debate, 36 CONN. L. REV. 1133 (2004) (criticizing the Bush administration's use of an ideological litmus test in selecting experts for scientific and bioethics advisory panels); James Glanz, Scientists Say Administration Distorts Facts, N. Y. TIMES, Feb. 19, 2004, at A18; Rick Weiss, HHS Seeks Science Advice to Match Bush Views, WASH. POST, Sept. 17, 2002, at A1 (reporting that an advisory committee, which was rethinking federal protections for human research subjects, was disbanded prematurely and reconfigured because it "had drawn the ire of administration supporters on the religious right").
61. This perspective coincides with recent suggestions that, instead of asking how to make private actors more accountable and consistent, scholars should "substitute instead the notion of regulatory regimes in which agencies are in dynamic relationships with private actors." Jody Freeman, Private Parties, Public Functions and the New Administrative Law, 52 ADMIN. L. REV. 813, 857-58 (2000); see also Cary Coglianese & David Lazer, Management-Based Regulation: Prescribing Private Management to Achieve Public Goals, 37 LAW & SOC'Y REV. 691 (2003).
62. This perspective coincides with recent suggestions that, instead of asking how to make private actors more accountable and consistent, scholars should "substitute instead the notion of regulatory regimes in which agencies are in dynamic relationships with private actors." Jody Freeman, Private Parties, Public Functions and the New Administrative Law, 52 ADMIN. L. REV. 813, 857-58 (2000); see also Cary Coglianese & David Lazer, Management-Based Regulation: Prescribing Private Management to Achieve Public Goals, 37 LAW & SOC'Y REV. 691 (2003).
63. See Michael A. Morse et al., Monitoring and Ensuring Safety During Clinical Research, 285 J.A.M.A. 1201, 1201 (2001) ("In all trials, ensuring the safety of participants is not solely the responsibility of IRBs, but also of a multitude of others: investigator, sponsors, the [FDA] ... and data monitoring committees (DMCs), also called data and safety monitoring boards...."); Robertson, supra note 9, at 524 n.207 (noting that "the IRB is but one part of an institution's efforts to comply with [federal] policy for the protection of subjects"). See generally Michael Baram, Making Clinical Trials Safer for Human Subjects, 27 AM. J.L. & MED. 253 (2001).
64. See Michael A. Morse et al., Monitoring and Ensuring Safety During Clinical Research, 285 J.A.M.A. 1201, 1201 (2001) ("In all trials, ensuring the safety of participants is not solely the responsibility of IRBs, but also of a multitude of others: investigator, sponsors, the [FDA] ... and data monitoring committees (DMCs), also called data and safety monitoring boards...."); Robertson, supra note 9, at 524 n.207 (noting that "the IRB is but one part of an institution's efforts to comply with [federal] policy for the protection of subjects"). See generally Michael Baram, Making Clinical Trials Safer for Human Subjects, 27 AM. J.L. & MED. 253 (2001).
65. See Michael A. Morse et al., Monitoring and Ensuring Safety During Clinical Research, 285 J.A.M.A. 1201, 1201 (2001) ("In all trials, ensuring the safety of participants is not solely the responsibility of IRBs, but also of a multitude of others: investigator, sponsors, the [FDA] ... and data monitoring committees (DMCs), also called data and safety monitoring boards...."); Robertson, supra note 9, at 524 n.207 (noting that "the IRB is but one part of an institution's efforts to comply with [federal] policy for the protection of subjects"). See generally Michael Baram, Making Clinical Trials Safer for Human Subjects, 27 AM. J.L. & MED. 253 (2001).
66. See Jeffrey M. Drazen, Controlling Research Trials, 348 NEW ENG. J. MED. 1377 (2003). For additional discussion of the federal grant review process, see U.S. CONGRESS, GEN. ACCOUNTING OFFICE, No. RCED-99-99, FEDERAL RESEARCH: PEER REVIEW PRACTICES AT FEDERAL SCIENCE AGENCIES VARY (1999); Thomas O. McGarity, Peer Review in Awarding Federal Grants in the Arts and Sciences, 9 HIGH TECH. L.J. 1 (1994). Occasionally, a funding agency will demand prior IRB review of research protocols in grant proposals. See, e.g., 59 Fed. Reg. 12,964, 12,968 (1994) (Indian Health Service).
67. See Jeffrey M. Drazen, Controlling Research Trials, 348 NEW ENG. J. MED. 1377 (2003). For additional discussion of the federal grant review process, see U.S. CONGRESS, GEN. ACCOUNTING OFFICE, No. RCED-99-99, FEDERAL RESEARCH: PEER REVIEW PRACTICES AT FEDERAL SCIENCE AGENCIES VARY (1999); Thomas O. McGarity, Peer Review in Awarding Federal Grants in the Arts and Sciences, 9 HIGH TECH. L.J. 1 (1994). Occasionally, a funding agency will demand prior IRB review of research protocols in grant proposals. See, e.g., 59 Fed. Reg. 12,964, 12,968 (1994) (Indian Health Service).
68. See Jeffrey M. Drazen, Controlling Research Trials, 348 NEW ENG. J. MED. 1377 (2003). For additional discussion of the federal grant review process, see U.S. CONGRESS, GEN. ACCOUNTING OFFICE, No. RCED-99-99, FEDERAL RESEARCH: PEER REVIEW PRACTICES AT FEDERAL SCIENCE AGENCIES VARY (1999); Thomas O. McGarity, Peer Review in Awarding Federal Grants in the Arts and Sciences, 9 HIGH TECH. L.J. 1 (1994). Occasionally, a funding agency will demand prior IRB review of research protocols in grant proposals. See, e.g., 59 Fed. Reg. 12,964, 12,968 (1994) (Indian Health Service).
69. See Jeffrey M. Drazen, Controlling Research Trials, 348 NEW ENG. J. MED. 1377 (2003). For additional discussion of the federal grant review process, see U.S. CONGRESS, GEN. ACCOUNTING OFFICE, No. RCED-99-99, FEDERAL RESEARCH: PEER REVIEW PRACTICES AT FEDERAL SCIENCE AGENCIES VARY (1999); Thomas O. McGarity, Peer Review in Awarding Federal Grants in the Arts and Sciences, 9 HIGH TECH. L.J. 1 (1994). Occasionally, a funding agency will demand prior IRB review of research protocols in grant proposals. See, e.g., 59 Fed. Reg. 12,964, 12,968 (1994) (Indian Health Service).
70. Coleman, supra note 1, at 12.
71. See 21 U.S.C. §§ 355(i), 360j(g) (2000); 21 C.F.R. pts. 312, 812 (2003); see also David A. Kessler, The Regulation of Investigational Drugs, 320 NEW ENG. J. MED. 281, 281-83, 286 (1989); Richard A. Merrill, The Architecture of Government Regulation of Medical Products, 82 VA. L. REV. 1753, 1777-83 (1996) (discussing the FDA's oversight of clinical research); id. at 1845-48 (explaining the basis for the agency's resistance to proposals to transfer some of its IND responsibilities to IRBs); Stuart L. Nightingale, Challenges in Human Subject Protection, 50 FOOD & DRUG L.J. 493 (1995) (discussing the FDA's supervision of researchers and IRBs).
72. See 21 U.S.C. §§ 355(i), 360j(g) (2000); 21 C.F.R. pts. 312, 812 (2003); see also David A. Kessler, The Regulation of Investigational Drugs, 320 NEW ENG. J. MED. 281, 281-83, 286 (1989); Richard A. Merrill, The Architecture of Government Regulation of Medical Products, 82 VA. L. REV. 1753, 1777-83 (1996) (discussing the FDA's oversight of clinical research); id. at 1845-48 (explaining the basis for the agency's resistance to proposals to transfer some of its IND responsibilities to IRBs); Stuart L. Nightingale, Challenges in Human Subject Protection, 50 FOOD & DRUG L.J. 493 (1995) (discussing the FDA's supervision of researchers and IRBs).
73. See 21 U.S.C. §§ 355(i), 360j(g) (2000); 21 C.F.R. pts. 312, 812 (2003); see also David A. Kessler, The Regulation of Investigational Drugs, 320 NEW ENG. J. MED. 281, 281-83, 286 (1989); Richard A. Merrill, The Architecture of Government Regulation of Medical Products, 82 VA. L. REV. 1753, 1777-83 (1996) (discussing the FDA's oversight of clinical research); id. at 1845-48 (explaining the basis for the agency's resistance to proposals to transfer some of its IND responsibilities to IRBs); Stuart L. Nightingale, Challenges in Human Subject Protection, 50 FOOD & DRUG L.J. 493 (1995) (discussing the FDA's supervision of researchers and IRBs).
74. See 21 U.S.C. §§ 355(i), 360j(g) (2000); 21 C.F.R. pts. 312, 812 (2003); see also David A. Kessler, The Regulation of Investigational Drugs, 320 NEW ENG. J. MED. 281, 281-83, 286 (1989); Richard A. Merrill, The Architecture of Government Regulation of Medical Products, 82 VA. L. REV. 1753, 1777-83 (1996) (discussing the FDA's oversight of clinical research); id. at 1845-48 (explaining the basis for the agency's resistance to proposals to transfer some of its IND responsibilities to IRBs); Stuart L. Nightingale, Challenges in Human Subject Protection, 50 FOOD & DRUG L.J. 493 (1995) (discussing the FDA's supervision of researchers and IRBs).
75. See 21 U.S.C. §§ 355(i), 360j(g) (2000); 21 C.F.R. pts. 312, 812 (2003); see also David A. Kessler, The Regulation of Investigational Drugs, 320 NEW ENG. J. MED. 281, 281-83, 286 (1989); Richard A. Merrill, The Architecture of Government Regulation of Medical Products, 82 VA. L. REV. 1753, 1777-83 (1996) (discussing the FDA's oversight of clinical research); id. at 1845-48 (explaining the basis for the agency's resistance to proposals to transfer some of its IND responsibilities to IRBs); Stuart L. Nightingale, Challenges in Human Subject Protection, 50 FOOD & DRUG L.J. 493 (1995) (discussing the FDA's supervision of researchers and IRBs).
76. See 21 U.S.C. §§ 355(i), 360j(g) (2000); 21 C.F.R. pts. 312, 812 (2003); see also David A. Kessler, The Regulation of Investigational Drugs, 320 NEW ENG. J. MED. 281, 281-83, 286 (1989); Richard A. Merrill, The Architecture of Government Regulation of Medical Products, 82 VA. L. REV. 1753, 1777-83 (1996) (discussing the FDA's oversight of clinical research); id. at 1845-48 (explaining the basis for the agency's resistance to proposals to transfer some of its IND responsibilities to IRBs); Stuart L. Nightingale, Challenges in Human Subject Protection, 50 FOOD & DRUG L.J. 493 (1995) (discussing the FDA's supervision of researchers and IRBs).
77. 21 C.F.R. § 812.30(b)(4); see also id. § 312.22(a) ("FDA's primary objectives in reviewing an IND are ... to ensure the safety and rights of subjects...."). However, IDEs for devices that do not pose a significant risk need not be reviewed by the FDA; a sponsor need only secure IRB approval. See id. § 812.2(b)(1)(ii).
78. 21 C.F.R. § 812.30(b)(4); see also id. § 312.22(a) ("FDA's primary objectives in reviewing an IND are ... to ensure the safety and rights of subjects...."). However, IDEs for devices that do not pose a significant risk need not be reviewed by the FDA; a sponsor need only secure IRB approval. See id. § 812.2(b)(1)(ii).
79. 21 C.F.R. § 812.30(b)(4); see also id. § 312.22(a) ("FDA's primary objectives in reviewing an IND are ... to ensure the safety and rights of subjects...."). However, IDEs for devices that do not pose a significant risk need not be reviewed by the FDA; a sponsor need only secure IRB approval. See id. § 812.2(b)(1)(ii).
80. Most universities abide by federal requirements for all research-regardless of funding source-conducted under their roofs. See Richard S. Saver, Critical Care Research and Informed Consent, 75 N.C. L. REV. 205, 216 (1996). A few states separately require IRB review of human subject research regardless of funding source. See, e.g., MD. HEALTH-GEN. CODE §§ 13-2001 to -2004 (2002); N.Y. PUB. HEALTH LAW §§ 2444-2445 (2003); WIS. STAT. ANN. § 51.61(4) (2002). Some biomedical research does not receive either federal or industry funding, but much of this work would escape IRB scrutiny as well. See R. Alta Charo, Human Subjects Have It Worse Than Guinea Pigs, CHRON. HIGHER EDUC., June 25, 1999, at A64.
81. Most universities abide by federal requirements for all research-regardless of funding source-conducted under their roofs. See Richard S. Saver, Critical Care Research and Informed Consent, 75 N.C. L. REV. 205, 216 (1996). A few states separately require IRB review of human subject research regardless of funding source. See, e.g., MD. HEALTH-GEN. CODE §§ 13-2001 to -2004 (2002); N.Y. PUB. HEALTH LAW §§ 2444-2445 (2003); WIS. STAT. ANN. § 51.61(4) (2002). Some biomedical research does not receive either federal or industry funding, but much of this work would escape IRB scrutiny as well. See R. Alta Charo, Human Subjects Have It Worse Than Guinea Pigs, CHRON. HIGHER EDUC., June 25, 1999, at A64.
82. Most universities abide by federal requirements for all research-regardless of funding source-conducted under their roofs. See Richard S. Saver, Critical Care Research and Informed Consent, 75 N.C. L. REV. 205, 216 (1996). A few states separately require IRB review of human subject research regardless of funding source. See, e.g., MD. HEALTH-GEN. CODE §§ 13-2001 to -2004 (2002); N.Y. PUB. HEALTH LAW §§ 2444-2445 (2003); WIS. STAT. ANN. § 51.61(4) (2002). Some biomedical research does not receive either federal or industry funding, but much of this work would escape IRB scrutiny as well. See R. Alta Charo, Human Subjects Have It Worse Than Guinea Pigs, CHRON. HIGHER EDUC., June 25, 1999, at A64.
83. Most universities abide by federal requirements for all research-regardless of funding source-conducted under their roofs. See Richard S. Saver, Critical Care Research and Informed Consent, 75 N.C. L. REV. 205, 216 (1996). A few states separately require IRB review of human subject research regardless of funding source. See, e.g., MD. HEALTH-GEN. CODE §§ 13-2001 to -2004 (2002); N.Y. PUB. HEALTH LAW §§ 2444-2445 (2003); WIS. STAT. ANN. § 51.61(4) (2002). Some biomedical research does not receive either federal or industry funding, but much of this work would escape IRB scrutiny as well. See R. Alta Charo, Human Subjects Have It Worse Than Guinea Pigs, CHRON. HIGHER EDUC., June 25, 1999, at A64.
84. Most universities abide by federal requirements for all research-regardless of funding source-conducted under their roofs. See Richard S. Saver, Critical Care Research and Informed Consent, 75 N.C. L. REV. 205, 216 (1996). A few states separately require IRB review of human subject research regardless of funding source. See, e.g., MD. HEALTH-GEN. CODE §§ 13-2001 to -2004 (2002); N.Y. PUB. HEALTH LAW §§ 2444-2445 (2003); WIS. STAT. ANN. § 51.61(4) (2002). Some biomedical research does not receive either federal or industry funding, but much of this work would escape IRB scrutiny as well. See R. Alta Charo, Human Subjects Have It Worse Than Guinea Pigs, CHRON. HIGHER EDUC., June 25, 1999, at A64.
85. See JONATHAN D. MORENO, UNDUE RISK: SECRET STATE EXPERIMENTS ON HUMANS (1999); Barbara A. Noah, The Participation of Underrepresented Minorities in Clinical Research, 29 AM. J.L. & MED. 221 (2003).
86. See JONATHAN D. MORENO, UNDUE RISK: SECRET STATE EXPERIMENTS ON HUMANS (1999); Barbara A. Noah, The Participation of Underrepresented Minorities in Clinical Research, 29 AM. J.L. & MED. 221 (2003).
87. See 21 C.F.R. §§ 312.53(d), 312.56 (INDs); id. §§ 812.43(d), 812.46 (IDEs); Thomas R. Fleming, Data Monitoring Committees and Capturing Relevant Information of High Quality, 12 STAT. MED. 565, 569 (1993); see also DeVito v. HEM, Inc., 705 F. Supp. 1076, 1079 (M.D. Pa. 1988) (rejecting subject's lawsuit against drug manufacturer for discontinuing a clinical trial of an AIDS drug in which he had enrolled because, barring intervention by the FDA, the decision to terminate a clinical investigation "is left to the discretion of the sponsors"); BioMarin Halts Trials of Neutralase Heart Drug, L.A. TIMES, Sept. 23, 2003, at C6 (reporting that a sponsor's drug safety monitoring board intervened to stop a recent clinical trial).
88. See 21 C.F.R. §§ 312.53(d), 312.56 (INDs); id. §§ 812.43(d), 812.46 (IDEs); Thomas R. Fleming, Data Monitoring Committees and Capturing Relevant Information of High Quality, 12 STAT. MED. 565, 569 (1993); see also DeVito v. HEM, Inc., 705 F. Supp. 1076, 1079 (M.D. Pa. 1988) (rejecting subject's lawsuit against drug manufacturer for discontinuing a clinical trial of an AIDS drug in which he had enrolled because, barring intervention by the FDA, the decision to terminate a clinical investigation "is left to the discretion of the sponsors"); BioMarin Halts Trials of Neutralase Heart Drug, L.A. TIMES, Sept. 23, 2003, at C6 (reporting that a sponsor's drug safety monitoring board intervened to stop a recent clinical trial).
89. See 21 C.F.R. §§ 312.53(d), 312.56 (INDs); id. §§ 812.43(d), 812.46 (IDEs); Thomas R. Fleming, Data Monitoring Committees and Capturing Relevant Information of High Quality, 12 STAT. MED. 565, 569 (1993); see also DeVito v. HEM, Inc., 705 F. Supp. 1076, 1079 (M.D. Pa. 1988) (rejecting subject's lawsuit against drug manufacturer for discontinuing a clinical trial of an AIDS drug in which he had enrolled because, barring intervention by the FDA, the decision to terminate a clinical investigation "is left to the discretion of the sponsors"); BioMarin Halts Trials of Neutralase Heart Drug, L.A. TIMES, Sept. 23, 2003, at C6 (reporting that a sponsor's drug safety monitoring board intervened to stop a recent clinical trial).
90. See 21 C.F.R. §§ 312.53(d), 312.56 (INDs); id. §§ 812.43(d), 812.46 (IDEs); Thomas R. Fleming, Data Monitoring Committees and Capturing Relevant Information of High Quality, 12 STAT. MED. 565, 569 (1993); see also DeVito v. HEM, Inc., 705 F. Supp. 1076, 1079 (M.D. Pa. 1988) (rejecting subject's lawsuit against drug manufacturer for discontinuing a clinical trial of an AIDS drug in which he had enrolled because, barring intervention by the FDA, the decision to terminate a clinical investigation "is left to the discretion of the sponsors"); BioMarin Halts Trials of Neutralase Heart Drug, L.A. TIMES, Sept. 23, 2003, at C6 (reporting that a sponsor's drug safety monitoring board intervened to stop a recent clinical trial).
91. See 21 C.F.R. §§ 312.53(d), 312.56 (INDs); id. §§ 812.43(d), 812.46 (IDEs); Thomas R. Fleming, Data Monitoring Committees and Capturing Relevant Information of High Quality, 12 STAT. MED. 565, 569 (1993); see also DeVito v. HEM, Inc., 705 F. Supp. 1076, 1079 (M.D. Pa. 1988) (rejecting subject's lawsuit against drug manufacturer for discontinuing a clinical trial of an AIDS drug in which he had enrolled because, barring intervention by the FDA, the decision to terminate a clinical investigation "is left to the discretion of the sponsors"); BioMarin Halts Trials of Neutralase Heart Drug, L.A. TIMES, Sept. 23, 2003, at C6 (reporting that a sponsor's drug safety monitoring board intervened to stop a recent clinical trial).
92. See 21 C.F.R. § 312.42.
93. See id. §§ 56.102(c), 56.103(b). In one recent case, a drug manufacturer sought to rely on research originally conducted overseas and without any intention of supporting an application to the FDA, but the agency declined to consider it because of failures to comply with domestic human subject protection requirements. See Shankar Vedantam, Firm Pulls Application for AIDS Drug Use in U.S., WASH. POST, Mar. 23, 2002, at A8.
94. See id. §§ 56.102(c), 56.103(b). In one recent case, a drug manufacturer sought to rely on research originally conducted overseas and without any intention of supporting an application to the FDA, but the agency declined to consider it because of failures to comply with domestic human subject protection requirements. See Shankar Vedantam, Firm Pulls Application for AIDS Drug Use in U.S., WASH. POST, Mar. 23, 2002, at A8.
95. See id. §§ 56.102(c), 56.103(b). In one recent case, a drug manufacturer sought to rely on research originally conducted overseas and without any intention of supporting an application to the FDA, but the agency declined to consider it because of failures to comply with domestic human subject protection requirements. See Shankar Vedantam, Firm Pulls Application for AIDS Drug Use in U.S., WASH. POST, Mar. 23, 2002, at A8.
96. See Kay Dickersin et al., Factors Influencing Publication of Research Results: Follow-up of Applications Submitted to Two Institutional Review Boards, 267 J.A.M.A. 374, 377-78 (1992).
97. See Int'l Comm. of Med. Journal Editors, Uniform Requirements for Manuscripts Submitted to Biomedical Journals, 277 J.A.M.A. 927, 929 (1997) (requiring, among other things, that researchers state whether they have abided by the ethical strictures found in the Declaration of Helsinki); see also Frank Davidoff et al., Sponsorship, Authorship, and Accountability, 286 J.A.M.A. 1232, 1233 (2001) ("We will not review or publish articles based on studies that are conducted under conditions that allow the sponsor to have sole control of the data or to withhold publication."); John Maddox, Can Journals Influence Science?, 339 NATURE 657, 657 (1989) (suggesting that publication policies affect the design of experiments).
98. See Int'l Comm. of Med. Journal Editors, Uniform Requirements for Manuscripts Submitted to Biomedical Journals, 277 J.A.M.A. 927, 929 (1997) (requiring, among other things, that researchers state whether they have abided by the ethical strictures found in the Declaration of Helsinki); see also Frank Davidoff et al., Sponsorship, Authorship, and Accountability, 286 J.A.M.A. 1232, 1233 (2001) ("We will not review or publish articles based on studies that are conducted under conditions that allow the sponsor to have sole control of the data or to withhold publication."); John Maddox, Can Journals Influence Science?, 339 NATURE 657, 657 (1989) (suggesting that publication policies affect the design of experiments).
99. See Int'l Comm. of Med. Journal Editors, Uniform Requirements for Manuscripts Submitted to Biomedical Journals, 277 J.A.M.A. 927, 929 (1997) (requiring, among other things, that researchers state whether they have abided by the ethical strictures found in the Declaration of Helsinki); see also Frank Davidoff et al., Sponsorship, Authorship, and Accountability, 286 J.A.M.A. 1232, 1233 (2001) ("We will not review or publish articles based on studies that are conducted under conditions that allow the sponsor to have sole control of the data or to withhold publication."); John Maddox, Can Journals Influence Science?, 339 NATURE 657, 657 (1989) (suggesting that publication policies affect the design of experiments).
100. See, e.g., Kus v. Sherman Hosp., 644 N.E.2d 1214, 1220-21 (Ill. App. 1995); Grimes v. Kennedy Krieger Inst., 782 A.2d 807, 841-52 (Md. 2001); see also Michelle M. Mello et al., The Rise of Litigation in Human Subjects Research, 139 ANN. INTERN. MED. 40 (2003); Noah, supra note 8; Roger L. Jansson, Comment, Researcher Liability for Negligence in Human Subject Research: Informed Consent and Researcher Malpractice Actions, 78 WASH. L. REV. 229 (2003).
101. See, e.g., Kus v. Sherman Hosp., 644 N.E.2d 1214, 1220-21 (Ill. App. 1995); Grimes v. Kennedy Krieger Inst., 782 A.2d 807, 841-52 (Md. 2001); see also Michelle M. Mello et al., The Rise of Litigation in Human Subjects Research, 139 ANN. INTERN. MED. 40 (2003); Noah, supra note 8; Roger L. Jansson, Comment, Researcher Liability for Negligence in Human Subject Research: Informed Consent and Researcher Malpractice Actions, 78 WASH. L. REV. 229 (2003).
102. See, e.g., Kus v. Sherman Hosp., 644 N.E.2d 1214, 1220-21 (Ill. App. 1995); Grimes v. Kennedy Krieger Inst., 782 A.2d 807, 841-52 (Md. 2001); see also Michelle M. Mello et al., The Rise of Litigation in Human Subjects Research, 139 ANN. INTERN. MED. 40 (2003); Noah, supra note 8; Roger L. Jansson, Comment, Researcher Liability for Negligence in Human Subject Research: Informed Consent and Researcher Malpractice Actions, 78 WASH. L. REV. 229 (2003).
103. See, e.g., Kus v. Sherman Hosp., 644 N.E.2d 1214, 1220-21 (Ill. App. 1995); Grimes v. Kennedy Krieger Inst., 782 A.2d 807, 841-52 (Md. 2001); see also Michelle M. Mello et al., The Rise of Litigation in Human Subjects Research, 139 ANN. INTERN. MED. 40 (2003); Noah, supra note 8; Roger L. Jansson, Comment, Researcher Liability for Negligence in Human Subject Research: Informed Consent and Researcher Malpractice Actions, 78 WASH. L. REV. 229 (2003).
104. See, e.g., Kus v. Sherman Hosp., 644 N.E.2d 1214, 1220-21 (Ill. App. 1995); Grimes v. Kennedy Krieger Inst., 782 A.2d 807, 841-52 (Md. 2001); see also Michelle M. Mello et al., The Rise of Litigation in Human Subjects Research, 139 ANN. INTERN. MED. 40 (2003); Noah, supra note 8; Roger L. Jansson, Comment, Researcher Liability for Negligence in Human Subject Research: Informed Consent and Researcher Malpractice Actions, 78 WASH. L. REV. 229 (2003).
105. See Coleman, supra note 1, at 6. This would, of course, present no barrier in the case of injuries to healthy volunteers.
106. See Michelle M. Mello & Troyen A. Brennan, Deterrence of Medical Errors: Theory and Evidence for Malpractice Reform, 80 TEX. L. REV. 1595, 1603-21 (2002); Frank A. Sloan et al., Tort Liability and Obstetricians' Care Levels, 17 INT'L REV. L. & ECON. 245, 255-58 (1997); cf. Gary T. Schwartz, Reality in the Economic Analysis of Tort Law: Does Tort Law Really Deter?, 42 UCLA L. REV. 377, 397-405, 437-44 (1994) (explaining that tort law is moderately successful at reducing malpractice).
107. See Michelle M. Mello & Troyen A. Brennan, Deterrence of Medical Errors: Theory and Evidence for Malpractice Reform, 80 TEX. L. REV. 1595, 1603-21 (2002); Frank A. Sloan et al., Tort Liability and Obstetricians' Care Levels, 17 INT'L REV. L. & ECON. 245, 255-58 (1997); cf. Gary T. Schwartz, Reality in the Economic Analysis of Tort Law: Does Tort Law Really Deter?, 42 UCLA L. REV. 377, 397-405, 437-44 (1994) (explaining that tort law is moderately successful at reducing malpractice).
108. See Michelle M. Mello & Troyen A. Brennan, Deterrence of Medical Errors: Theory and Evidence for Malpractice Reform, 80 TEX. L. REV. 1595, 1603-21 (2002); Frank A. Sloan et al., Tort Liability and Obstetricians' Care Levels, 17 INT'L REV. L. & ECON. 245, 255-58 (1997); cf. Gary T. Schwartz, Reality in the Economic Analysis of Tort Law: Does Tort Law Really Deter?, 42 UCLA L. REV. 377, 397-405, 437-44 (1994) (explaining that tort law is moderately successful at reducing malpractice).
109. If, contrary to the argument in the next section, IRBs really do exercise delegated governmental power, then the discretionary functions exception of the Federal Tort Claims Act (FTCA) might create a much more serious hurdle to recovery for injured subjects seeking compensation for the allegedly negligent exercise of judgment by a board. Although the FTCA covers only federal employees, see 28 U.S.C. § 1346(b)(1) (2000), and excludes independent contractors, see id. § 2671, it may extend to persons deputized to exercise federal authority, see id. (defining government employee to include "persons acting on behalf of a federal agency in an official capacity, temporarily or permanently in the service of the United States, whether with or without compensation"); Provancial v. United States, 454 F.2d 72, 75 (8th Cir. 1972) (treating deputized special officers as federal employees); Van Schaick v. United States, 586 F. Supp. 1023, 1033 (D.S.C. 1983) (holding that local police became federal agents when an assistant U.S. Attorney directed them to make an arrest). Nonetheless, lower courts have rejected arguments that an entity exercising delegated authority might qualify as a federal "agency" covered by the Act. See Charlima, Inc. v. United States, 873 F.2d 1078 (8th Cir. 1989) (airworthiness inspector); Lavitt v. United States, 177 F.2d 627 (2d Cir. 1949) (local committee that appointed persons to inspect crops in connection with loan application to USDA); Hagy v. United States, 976 F. Supp. 1373, 1376-78 (W.D. Wash. 1997) (holding that the National Hormone and Pituitary Program, run by the University of Maryland with an NIH grant, functioned as an independent contractor rather than a federal agency): Brown v. United States, 573 F. Supp. 740, 741-42 (M.D. Ala. 1982) (state employees making disability determinations for the Social Security Administration); see also Merrill, supra note 31, at 1860 n.332 ("[I]t is by no means clear that such immunity [for discretionary FDA approval decisions] would extend to 'accredited' third-party reviewers."); cf. Snyder v. Am. Ass'n Blood Banks, 676 A.2d 1036, 1050-54 (N.J. 1996) (rejecting such a defense to tort liability for a private organization). But cf. Boyle v. United Technologies Corp., 487 U.S. 500, 511 (1988) (invoking the policies served by the FTCA's discretionary functions exception to extend a cloak of immunity to defense contractors). IRBs affiliated with public universities may get protection under state versions of the FTCA. See, e.g., Kan. Atty. Gen. Op. No. 81-139 (1981).
110. If, contrary to the argument in the next section, IRBs really do exercise delegated governmental power, then the discretionary functions exception of the Federal Tort Claims Act (FTCA) might create a much more serious hurdle to recovery for injured subjects seeking compensation for the allegedly negligent exercise of judgment by a board. Although the FTCA covers only federal employees, see 28 U.S.C. § 1346(b)(1) (2000), and excludes independent contractors, see id. § 2671, it may extend to persons deputized to exercise federal authority, see id. (defining government employee to include "persons acting on behalf of a federal agency in an official capacity, temporarily or permanently in the service of the United States, whether with or without compensation"); Provancial v. United States, 454 F.2d 72, 75 (8th Cir. 1972) (treating deputized special officers as federal employees); Van Schaick v. United States, 586 F. Supp. 1023, 1033 (D.S.C. 1983) (holding that local police became federal agents when an assistant U.S. Attorney directed them to make an arrest). Nonetheless, lower courts have rejected arguments that an entity exercising delegated authority might qualify as a federal "agency" covered by the Act. See Charlima, Inc. v. United States, 873 F.2d 1078 (8th Cir. 1989) (airworthiness inspector); Lavitt v. United States, 177 F.2d 627 (2d Cir. 1949) (local committee that appointed persons to inspect crops in connection with loan application to USDA); Hagy v. United States, 976 F. Supp. 1373, 1376-78 (W.D. Wash. 1997) (holding that the National Hormone and Pituitary Program, run by the University of Maryland with an NIH grant, functioned as an independent contractor rather than a federal agency): Brown v. United States, 573 F. Supp. 740, 741-42 (M.D. Ala. 1982) (state employees making disability determinations for the Social Security Administration); see also Merrill, supra note 31, at 1860 n.332 ("[I]t is by no means clear that such immunity [for discretionary FDA approval decisions] would extend to 'accredited' third-party reviewers."); cf. Snyder v. Am. Ass'n Blood Banks, 676 A.2d 1036, 1050-54 (N.J. 1996) (rejecting such a defense to tort liability for a private organization). But cf. Boyle v. United Technologies Corp., 487 U.S. 500, 511 (1988) (invoking the policies served by the FTCA's discretionary functions exception to extend a cloak of immunity to defense contractors). IRBs affiliated with public universities may get protection under state versions of the FTCA. See, e.g., Kan. Atty. Gen. Op. No. 81-139 (1981).
111. If, contrary to the argument in the next section, IRBs really do exercise delegated governmental power, then the discretionary functions exception of the Federal Tort Claims Act (FTCA) might create a much more serious hurdle to recovery for injured subjects seeking compensation for the allegedly negligent exercise of judgment by a board. Although the FTCA covers only federal employees, see 28 U.S.C. § 1346(b)(1) (2000), and excludes independent contractors, see id. § 2671, it may extend to persons deputized to exercise federal authority, see id. (defining government employee to include "persons acting on behalf of a federal agency in an official capacity, temporarily or permanently in the service of the United States, whether with or without compensation"); Provancial v. United States, 454 F.2d 72, 75 (8th Cir. 1972) (treating deputized special officers as federal employees); Van Schaick v. United States, 586 F. Supp. 1023, 1033 (D.S.C. 1983) (holding that local police became federal agents when an assistant U.S. Attorney directed them to make an arrest). Nonetheless, lower courts have rejected arguments that an entity exercising delegated authority might qualify as a federal "agency" covered by the Act. See Charlima, Inc. v. United States, 873 F.2d 1078 (8th Cir. 1989) (airworthiness inspector); Lavitt v. United States, 177 F.2d 627 (2d Cir. 1949) (local committee that appointed persons to inspect crops in connection with loan application to USDA); Hagy v. United States, 976 F. Supp. 1373, 1376-78 (W.D. Wash. 1997) (holding that the National Hormone and Pituitary Program, run by the University of Maryland with an NIH grant, functioned as an independent contractor rather than a federal agency): Brown v. United States, 573 F. Supp. 740, 741-42 (M.D. Ala. 1982) (state employees making disability determinations for the Social Security Administration); see also Merrill, supra note 31, at 1860 n.332 ("[I]t is by no means clear that such immunity [for discretionary FDA approval decisions] would extend to 'accredited' third-party reviewers."); cf. Snyder v. Am. Ass'n Blood Banks, 676 A.2d 1036, 1050-54 (N.J. 1996) (rejecting such a defense to tort liability for a private organization). But cf. Boyle v. United Technologies Corp., 487 U.S. 500, 511 (1988) (invoking the policies served by the FTCA's discretionary functions exception to extend a cloak of immunity to defense contractors). IRBs affiliated with public universities may get protection under state versions of the FTCA. See, e.g., Kan. Atty. Gen. Op. No. 81-139 (1981).
112. If, contrary to the argument in the next section, IRBs really do exercise delegated governmental power, then the discretionary functions exception of the Federal Tort Claims Act (FTCA) might create a much more serious hurdle to recovery for injured subjects seeking compensation for the allegedly negligent exercise of judgment by a board. Although the FTCA covers only federal employees, see 28 U.S.C. § 1346(b)(1) (2000), and excludes independent contractors, see id. § 2671, it may extend to persons deputized to exercise federal authority, see id. (defining government employee to include "persons acting on behalf of a federal agency in an official capacity, temporarily or permanently in the service of the United States, whether with or without compensation"); Provancial v. United States, 454 F.2d 72, 75 (8th Cir. 1972) (treating deputized special officers as federal employees); Van Schaick v. United States, 586 F. Supp. 1023, 1033 (D.S.C. 1983) (holding that local police became federal agents when an assistant U.S. Attorney directed them to make an arrest). Nonetheless, lower courts have rejected arguments that an entity exercising delegated authority might qualify as a federal "agency" covered by the Act. See Charlima, Inc. v. United States, 873 F.2d 1078 (8th Cir. 1989) (airworthiness inspector); Lavitt v. United States, 177 F.2d 627 (2d Cir. 1949) (local committee that appointed persons to inspect crops in connection with loan application to USDA); Hagy v. United States, 976 F. Supp. 1373, 1376-78 (W.D. Wash. 1997) (holding that the National Hormone and Pituitary Program, run by the University of Maryland with an NIH grant, functioned as an independent contractor rather than a federal agency): Brown v. United States, 573 F. Supp. 740, 741-42 (M.D. Ala. 1982) (state employees making disability determinations for the Social Security Administration); see also Merrill, supra note 31, at 1860 n.332 ("[I]t is by no means clear that such immunity [for discretionary FDA approval decisions] would extend to 'accredited' third-party reviewers."); cf. Snyder v. Am. Ass'n Blood Banks, 676 A.2d 1036, 1050-54 (N.J. 1996) (rejecting such a defense to tort liability for a private organization). But cf. Boyle v. United Technologies Corp., 487 U.S. 500, 511 (1988) (invoking the policies served by the FTCA's discretionary functions exception to extend a cloak of immunity to defense contractors). IRBs affiliated with public universities may get protection under state versions of the FTCA. See, e.g., Kan. Atty. Gen. Op. No. 81-139 (1981).
113. If, contrary to the argument in the next section, IRBs really do exercise delegated governmental power, then the discretionary functions exception of the Federal Tort Claims Act (FTCA) might create a much more serious hurdle to recovery for injured subjects seeking compensation for the allegedly negligent exercise of judgment by a board. Although the FTCA covers only federal employees, see 28 U.S.C. § 1346(b)(1) (2000), and excludes independent contractors, see id. § 2671, it may extend to persons deputized to exercise federal authority, see id. (defining government employee to include "persons acting on behalf of a federal agency in an official capacity, temporarily or permanently in the service of the United States, whether with or without compensation"); Provancial v. United States, 454 F.2d 72, 75 (8th Cir. 1972) (treating deputized special officers as federal employees); Van Schaick v. United States, 586 F. Supp. 1023, 1033 (D.S.C. 1983) (holding that local police became federal agents when an assistant U.S. Attorney directed them to make an arrest). Nonetheless, lower courts have rejected arguments that an entity exercising delegated authority might qualify as a federal "agency" covered by the Act. See Charlima, Inc. v. United States, 873 F.2d 1078 (8th Cir. 1989) (airworthiness inspector); Lavitt v. United States, 177 F.2d 627 (2d Cir. 1949) (local committee that appointed persons to inspect crops in connection with loan application to USDA); Hagy v. United States, 976 F. Supp. 1373, 1376-78 (W.D. Wash. 1997) (holding that the National Hormone and Pituitary Program, run by the University of Maryland with an NIH grant, functioned as an independent contractor rather than a federal agency): Brown v. United States, 573 F. Supp. 740, 741-42 (M.D. Ala. 1982) (state employees making disability determinations for the Social Security Administration); see also Merrill, supra note 31, at 1860 n.332 ("[I]t is by no means clear that such immunity [for discretionary FDA approval decisions] would extend to 'accredited' third-party reviewers."); cf. Snyder v. Am. Ass'n Blood Banks, 676 A.2d 1036, 1050-54 (N.J. 1996) (rejecting such a defense to tort liability for a private organization). But cf. Boyle v. United Technologies Corp., 487 U.S. 500, 511 (1988) (invoking the policies served by the FTCA's discretionary functions exception to extend a cloak of immunity to defense contractors). IRBs affiliated with public universities may get protection under state versions of the FTCA. See, e.g., Kan. Atty. Gen. Op. No. 81-139 (1981).
114. If, contrary to the argument in the next section, IRBs really do exercise delegated governmental power, then the discretionary functions exception of the Federal Tort Claims Act (FTCA) might create a much more serious hurdle to recovery for injured subjects seeking compensation for the allegedly negligent exercise of judgment by a board. Although the FTCA covers only federal employees, see 28 U.S.C. § 1346(b)(1) (2000), and excludes independent contractors, see id. § 2671, it may extend to persons deputized to exercise federal authority, see id. (defining government employee to include "persons acting on behalf of a federal agency in an official capacity, temporarily or permanently in the service of the United States, whether with or without compensation"); Provancial v. United States, 454 F.2d 72, 75 (8th Cir. 1972) (treating deputized special officers as federal employees); Van Schaick v. United States, 586 F. Supp. 1023, 1033 (D.S.C. 1983) (holding that local police became federal agents when an assistant U.S. Attorney directed them to make an arrest). Nonetheless, lower courts have rejected arguments that an entity exercising delegated authority might qualify as a federal "agency" covered by the Act. See Charlima, Inc. v. United States, 873 F.2d 1078 (8th Cir. 1989) (airworthiness inspector); Lavitt v. United States, 177 F.2d 627 (2d Cir. 1949) (local committee that appointed persons to inspect crops in connection with loan application to USDA); Hagy v. United States, 976 F. Supp. 1373, 1376-78 (W.D. Wash. 1997) (holding that the National Hormone and Pituitary Program, run by the University of Maryland with an NIH grant, functioned as an independent contractor rather than a federal agency): Brown v. United States, 573 F. Supp. 740, 741-42 (M.D. Ala. 1982) (state employees making disability determinations for the Social Security Administration); see also Merrill, supra note 31, at 1860 n.332 ("[I]t is by no means clear that such immunity [for discretionary FDA approval decisions] would extend to 'accredited' third-party reviewers."); cf. Snyder v. Am. Ass'n Blood Banks, 676 A.2d 1036, 1050-54 (N.J. 1996) (rejecting such a defense to tort liability for a private organization). But cf. Boyle v. United Technologies Corp., 487 U.S. 500, 511 (1988) (invoking the policies served by the FTCA's discretionary functions exception to extend a cloak of immunity to defense contractors). IRBs affiliated with public universities may get protection under state versions of the FTCA. See, e.g., Kan. Atty. Gen. Op. No. 81-139 (1981).
115. If, contrary to the argument in the next section, IRBs really do exercise delegated governmental power, then the discretionary functions exception of the Federal Tort Claims Act (FTCA) might create a much more serious hurdle to recovery for injured subjects seeking compensation for the allegedly negligent exercise of judgment by a board. Although the FTCA covers only federal employees, see 28 U.S.C. § 1346(b)(1) (2000), and excludes independent contractors, see id. § 2671, it may extend to persons deputized to exercise federal authority, see id. (defining government employee to include "persons acting on behalf of a federal agency in an official capacity, temporarily or permanently in the service of the United States, whether with or without compensation"); Provancial v. United States, 454 F.2d 72, 75 (8th Cir. 1972) (treating deputized special officers as federal employees); Van Schaick v. United States, 586 F. Supp. 1023, 1033 (D.S.C. 1983) (holding that local police became federal agents when an assistant U.S. Attorney directed them to make an arrest). Nonetheless, lower courts have rejected arguments that an entity exercising delegated authority might qualify as a federal "agency" covered by the Act. See Charlima, Inc. v. United States, 873 F.2d 1078 (8th Cir. 1989) (airworthiness inspector); Lavitt v. United States, 177 F.2d 627 (2d Cir. 1949) (local committee that appointed persons to inspect crops in connection with loan application to USDA); Hagy v. United States, 976 F. Supp. 1373, 1376-78 (W.D. Wash. 1997) (holding that the National Hormone and Pituitary Program, run by the University of Maryland with an NIH grant, functioned as an independent contractor rather than a federal agency): Brown v. United States, 573 F. Supp. 740, 741-42 (M.D. Ala. 1982) (state employees making disability determinations for the Social Security Administration); see also Merrill, supra note 31, at 1860 n.332 ("[I]t is by no means clear that such immunity [for discretionary FDA approval decisions] would extend to 'accredited' third-party reviewers."); cf. Snyder v. Am. Ass'n Blood Banks, 676 A.2d 1036, 1050-54 (N.J. 1996) (rejecting such a defense to tort liability for a private organization). But cf. Boyle v. United Technologies Corp., 487 U.S. 500, 511 (1988) (invoking the policies served by the FTCA's discretionary functions exception to extend a cloak of immunity to defense contractors). IRBs affiliated with public universities may get protection under state versions of the FTCA. See, e.g., Kan. Atty. Gen. Op. No. 81-139 (1981).
116. If, contrary to the argument in the next section, IRBs really do exercise delegated governmental power, then the discretionary functions exception of the Federal Tort Claims Act (FTCA) might create a much more serious hurdle to recovery for injured subjects seeking compensation for the allegedly negligent exercise of judgment by a board. Although the FTCA covers only federal employees, see 28 U.S.C. § 1346(b)(1) (2000), and excludes independent contractors, see id. § 2671, it may extend to persons deputized to exercise federal authority, see id. (defining government employee to include "persons acting on behalf of a federal agency in an official capacity, temporarily or permanently in the service of the United States, whether with or without compensation"); Provancial v. United States, 454 F.2d 72, 75 (8th Cir. 1972) (treating deputized special officers as federal employees); Van Schaick v. United States, 586 F. Supp. 1023, 1033 (D.S.C. 1983) (holding that local police became federal agents when an assistant U.S. Attorney directed them to make an arrest). Nonetheless, lower courts have rejected arguments that an entity exercising delegated authority might qualify as a federal "agency" covered by the Act. See Charlima, Inc. v. United States, 873 F.2d 1078 (8th Cir. 1989) (airworthiness inspector); Lavitt v. United States, 177 F.2d 627 (2d Cir. 1949) (local committee that appointed persons to inspect crops in connection with loan application to USDA); Hagy v. United States, 976 F. Supp. 1373, 1376-78 (W.D. Wash. 1997) (holding that the National Hormone and Pituitary Program, run by the University of Maryland with an NIH grant, functioned as an independent contractor rather than a federal agency): Brown v. United States, 573 F. Supp. 740, 741-42 (M.D. Ala. 1982) (state employees making disability determinations for the Social Security Administration); see also Merrill, supra note 31, at 1860 n.332 ("[I]t is by no means clear that such immunity [for discretionary FDA approval decisions] would extend to 'accredited' third-party reviewers."); cf. Snyder v. Am. Ass'n Blood Banks, 676 A.2d 1036, 1050-54 (N.J. 1996) (rejecting such a defense to tort liability for a private organization). But cf. Boyle v. United Technologies Corp., 487 U.S. 500, 511 (1988) (invoking the policies served by the FTCA's discretionary functions exception to extend a cloak of immunity to defense contractors). IRBs affiliated with public universities may get protection under state versions of the FTCA. See, e.g., Kan. Atty. Gen. Op. No. 81-139 (1981).
117. If, contrary to the argument in the next section, IRBs really do exercise delegated governmental power, then the discretionary functions exception of the Federal Tort Claims Act (FTCA) might create a much more serious hurdle to recovery for injured subjects seeking compensation for the allegedly negligent exercise of judgment by a board. Although the FTCA covers only federal employees, see 28 U.S.C. § 1346(b)(1) (2000), and excludes independent contractors, see id. § 2671, it may extend to persons deputized to exercise federal authority, see id. (defining government employee to include "persons acting on behalf of a federal agency in an official capacity, temporarily or permanently in the service of the United States, whether with or without compensation"); Provancial v. United States, 454 F.2d 72, 75 (8th Cir. 1972) (treating deputized special officers as federal employees); Van Schaick v. United States, 586 F. Supp. 1023, 1033 (D.S.C. 1983) (holding that local police became federal agents when an assistant U.S. Attorney directed them to make an arrest). Nonetheless, lower courts have rejected arguments that an entity exercising delegated authority might qualify as a federal "agency" covered by the Act. See Charlima, Inc. v. United States, 873 F.2d 1078 (8th Cir. 1989) (airworthiness inspector); Lavitt v. United States, 177 F.2d 627 (2d Cir. 1949) (local committee that appointed persons to inspect crops in connection with loan application to USDA); Hagy v. United States, 976 F. Supp. 1373, 1376-78 (W.D. Wash. 1997) (holding that the National Hormone and Pituitary Program, run by the University of Maryland with an NIH grant, functioned as an independent contractor rather than a federal agency): Brown v. United States, 573 F. Supp. 740, 741-42 (M.D. Ala. 1982) (state employees making disability determinations for the Social Security Administration); see also Merrill, supra note 31, at 1860 n.332 ("[I]t is by no means clear that such immunity [for discretionary FDA approval decisions] would extend to 'accredited' third-party reviewers."); cf. Snyder v. Am. Ass'n Blood Banks, 676 A.2d 1036, 1050-54 (N.J. 1996) (rejecting such a defense to tort liability for a private organization). But cf. Boyle v. United Technologies Corp., 487 U.S. 500, 511 (1988) (invoking the policies served by the FTCA's discretionary functions exception to extend a cloak of immunity to defense contractors). IRBs affiliated with public universities may get protection under state versions of the FTCA. See, e.g., Kan. Atty. Gen. Op. No. 81-139 (1981).
118. If, contrary to the argument in the next section, IRBs really do exercise delegated governmental power, then the discretionary functions exception of the Federal Tort Claims Act (FTCA) might create a much more serious hurdle to recovery for injured subjects seeking compensation for the allegedly negligent exercise of judgment by a board. Although the FTCA covers only federal employees, see 28 U.S.C. § 1346(b)(1) (2000), and excludes independent contractors, see id. § 2671, it may extend to persons deputized to exercise federal authority, see id. (defining government employee to include "persons acting on behalf of a federal agency in an official capacity, temporarily or permanently in the service of the United States, whether with or without compensation"); Provancial v. United States, 454 F.2d 72, 75 (8th Cir. 1972) (treating deputized special officers as federal employees); Van Schaick v. United States, 586 F. Supp. 1023, 1033 (D.S.C. 1983) (holding that local police became federal agents when an assistant U.S. Attorney directed them to make an arrest). Nonetheless, lower courts have rejected arguments that an entity exercising delegated authority might qualify as a federal "agency" covered by the Act. See Charlima, Inc. v. United States, 873 F.2d 1078 (8th Cir. 1989) (airworthiness inspector); Lavitt v. United States, 177 F.2d 627 (2d Cir. 1949) (local committee that appointed persons to inspect crops in connection with loan application to USDA); Hagy v. United States, 976 F. Supp. 1373, 1376-78 (W.D. Wash. 1997) (holding that the National Hormone and Pituitary Program, run by the University of Maryland with an NIH grant, functioned as an independent contractor rather than a federal agency): Brown v. United States, 573 F. Supp. 740, 741-42 (M.D. Ala. 1982) (state employees making disability determinations for the Social Security Administration); see also Merrill, supra note 31, at 1860 n.332 ("[I]t is by no means clear that such immunity [for discretionary FDA approval decisions] would extend to 'accredited' third-party reviewers."); cf. Snyder v. Am. Ass'n Blood Banks, 676 A.2d 1036, 1050-54 (N.J. 1996) (rejecting such a defense to tort liability for a private organization). But cf. Boyle v. United Technologies Corp., 487 U.S. 500, 511 (1988) (invoking the policies served by the FTCA's discretionary functions exception to extend a cloak of immunity to defense contractors). IRBs affiliated with public universities may get protection under state versions of the FTCA. See, e.g., Kan. Atty. Gen. Op. No. 81-139 (1981).
119. If, contrary to the argument in the next section, IRBs really do exercise delegated governmental power, then the discretionary functions exception of the Federal Tort Claims Act (FTCA) might create a much more serious hurdle to recovery for injured subjects seeking compensation for the allegedly negligent exercise of judgment by a board. Although the FTCA covers only federal employees, see 28 U.S.C. § 1346(b)(1) (2000), and excludes independent contractors, see id. § 2671, it may extend to persons deputized to exercise federal authority, see id. (defining government employee to include "persons acting on behalf of a federal agency in an official capacity, temporarily or permanently in the service of the United States, whether with or without compensation"); Provancial v. United States, 454 F.2d 72, 75 (8th Cir. 1972) (treating deputized special officers as federal employees); Van Schaick v. United States, 586 F. Supp. 1023, 1033 (D.S.C. 1983) (holding that local police became federal agents when an assistant U.S. Attorney directed them to make an arrest). Nonetheless, lower courts have rejected arguments that an entity exercising delegated authority might qualify as a federal "agency" covered by the Act. See Charlima, Inc. v. United States, 873 F.2d 1078 (8th Cir. 1989) (airworthiness inspector); Lavitt v. United States, 177 F.2d 627 (2d Cir. 1949) (local committee that appointed persons to inspect crops in connection with loan application to USDA); Hagy v. United States, 976 F. Supp. 1373, 1376-78 (W.D. Wash. 1997) (holding that the National Hormone and Pituitary Program, run by the University of Maryland with an NIH grant, functioned as an independent contractor rather than a federal agency): Brown v. United States, 573 F. Supp. 740, 741-42 (M.D. Ala. 1982) (state employees making disability determinations for the Social Security Administration); see also Merrill, supra note 31, at 1860 n.332 ("[I]t is by no means clear that such immunity [for discretionary FDA approval decisions] would extend to 'accredited' third-party reviewers."); cf. Snyder v. Am. Ass'n Blood Banks, 676 A.2d 1036, 1050-54 (N.J. 1996) (rejecting such a defense to tort liability for a private organization). But cf. Boyle v. United Technologies Corp., 487 U.S. 500, 511 (1988) (invoking the policies served by the FTCA's discretionary functions exception to extend a cloak of immunity to defense contractors). IRBs affiliated with public universities may get protection under state versions of the FTCA. See, e.g., Kan. Atty. Gen. Op. No. 81-139 (1981).
120. If, contrary to the argument in the next section, IRBs really do exercise delegated governmental power, then the discretionary functions exception of the Federal Tort Claims Act (FTCA) might create a much more serious hurdle to recovery for injured subjects seeking compensation for the allegedly negligent exercise of judgment by a board. Although the FTCA covers only federal employees, see 28 U.S.C. § 1346(b)(1) (2000), and excludes independent contractors, see id. § 2671, it may extend to persons deputized to exercise federal authority, see id. (defining government employee to include "persons acting on behalf of a federal agency in an official capacity, temporarily or permanently in the service of the United States, whether with or without compensation"); Provancial v. United States, 454 F.2d 72, 75 (8th Cir. 1972) (treating deputized special officers as federal employees); Van Schaick v. United States, 586 F. Supp. 1023, 1033 (D.S.C. 1983) (holding that local police became federal agents when an assistant U.S. Attorney directed them to make an arrest). Nonetheless, lower courts have rejected arguments that an entity exercising delegated authority might qualify as a federal "agency" covered by the Act. See Charlima, Inc. v. United States, 873 F.2d 1078 (8th Cir. 1989) (airworthiness inspector); Lavitt v. United States, 177 F.2d 627 (2d Cir. 1949) (local committee that appointed persons to inspect crops in connection with loan application to USDA); Hagy v. United States, 976 F. Supp. 1373, 1376-78 (W.D. Wash. 1997) (holding that the National Hormone and Pituitary Program, run by the University of Maryland with an NIH grant, functioned as an independent contractor rather than a federal agency): Brown v. United States, 573 F. Supp. 740, 741-42 (M.D. Ala. 1982) (state employees making disability determinations for the Social Security Administration); see also Merrill, supra note 31, at 1860 n.332 ("[I]t is by no means clear that such immunity [for discretionary FDA approval decisions] would extend to 'accredited' third-party reviewers."); cf. Snyder v. Am. Ass'n Blood Banks, 676 A.2d 1036, 1050-54 (N.J. 1996) (rejecting such a defense to tort liability for a private organization). But cf. Boyle v. United Technologies Corp., 487 U.S. 500, 511 (1988) (invoking the policies served by the FTCA's discretionary functions exception to extend a cloak of immunity to defense contractors). IRBs affiliated with public universities may get protection under state versions of the FTCA. See, e.g., Kan. Atty. Gen. Op. No. 81-139 (1981).
121. If, contrary to the argument in the next section, IRBs really do exercise delegated governmental power, then the discretionary functions exception of the Federal Tort Claims Act (FTCA) might create a much more serious hurdle to recovery for injured subjects seeking compensation for the allegedly negligent exercise of judgment by a board. Although the FTCA covers only federal employees, see 28 U.S.C. § 1346(b)(1) (2000), and excludes independent contractors, see id. § 2671, it may extend to persons deputized to exercise federal authority, see id. (defining government employee to include "persons acting on behalf of a federal agency in an official capacity, temporarily or permanently in the service of the United States, whether with or without compensation"); Provancial v. United States, 454 F.2d 72, 75 (8th Cir. 1972) (treating deputized special officers as federal employees); Van Schaick v. United States, 586 F. Supp. 1023, 1033 (D.S.C. 1983) (holding that local police became federal agents when an assistant U.S. Attorney directed them to make an arrest). Nonetheless, lower courts have rejected arguments that an entity exercising delegated authority might qualify as a federal "agency" covered by the Act. See Charlima, Inc. v. United States, 873 F.2d 1078 (8th Cir. 1989) (airworthiness inspector); Lavitt v. United States, 177 F.2d 627 (2d Cir. 1949) (local committee that appointed persons to inspect crops in connection with loan application to USDA); Hagy v. United States, 976 F. Supp. 1373, 1376-78 (W.D. Wash. 1997) (holding that the National Hormone and Pituitary Program, run by the University of Maryland with an NIH grant, functioned as an independent contractor rather than a federal agency): Brown v. United States, 573 F. Supp. 740, 741-42 (M.D. Ala. 1982) (state employees making disability determinations for the Social Security Administration); see also Merrill, supra note 31, at 1860 n.332 ("[I]t is by no means clear that such immunity [for discretionary FDA approval decisions] would extend to 'accredited' third-party reviewers."); cf. Snyder v. Am. Ass'n Blood Banks, 676 A.2d 1036, 1050-54 (N.J. 1996) (rejecting such a defense to tort liability for a private organization). But cf. Boyle v. United Technologies Corp., 487 U.S. 500, 511 (1988) (invoking the policies served by the FTCA's discretionary functions exception to extend a cloak of immunity to defense contractors). IRBs affiliated with public universities may get protection under state versions of the FTCA. See, e.g., Kan. Atty. Gen. Op. No. 81-139 (1981).
122. See Coleman, supra note 1, at 4; see also Sharona Hoffman, Continued Concern: Human Subject Protection, the Institutional Review Board, and Continuing Review, 68 TENN. L. REV. 725, 731 (2001) ("[T]He FDA and DHHS themselves do not review research proposals. Instead, the federal regulations delegate authority for the review, approval, and monitoring of biomedical research studies to IRBs...."). In contrast, in one of the first comprehensive scholarly articles on the subject. Professor John Robertson emphasized the self-regulatory character of this arrangement. See Robertson, supra note 9, at 544 ("The IRB system repeats a quintessential form of government regulation: public incentives to induce self-regulation on the part of powerful professions or industries."); see also id. at 544-49 (identifying various shortcomings with this arrangement).
123. See Coleman, supra note 1, at 4; see also Sharona Hoffman, Continued Concern: Human Subject Protection, the Institutional Review Board, and Continuing Review, 68 TENN. L. REV. 725, 731 (2001) ("[T]He FDA and DHHS themselves do not review research proposals. Instead, the federal regulations delegate authority for the review, approval, and monitoring of biomedical research studies to IRBs...."). In contrast, in one of the first comprehensive scholarly articles on the subject. Professor John Robertson emphasized the self-regulatory character of this arrangement. See Robertson, supra note 9, at 544 ("The IRB system repeats a quintessential form of government regulation: public incentives to induce self-regulation on the part of powerful professions or industries."); see also id. at 544-49 (identifying various shortcomings with this arrangement).
124. See Coleman, supra note 1, at 4; see also Sharona Hoffman, Continued Concern: Human Subject Protection, the Institutional Review Board, and Continuing Review, 68 TENN. L. REV. 725, 731 (2001) ("[T]He FDA and DHHS themselves do not review research proposals. Instead, the federal regulations delegate authority for the review, approval, and monitoring of biomedical research studies to IRBs...."). In contrast, in one of the first comprehensive scholarly articles on the subject. Professor John Robertson emphasized the self-regulatory character of this arrangement. See Robertson, supra note 9, at 544 ("The IRB system repeats a quintessential form of government regulation: public incentives to induce self-regulation on the part of powerful professions or industries."); see also id. at 544-49 (identifying various shortcomings with this arrangement).
125. See Coleman, supra note 1, at 4; see also Sharona Hoffman, Continued Concern: Human Subject Protection, the Institutional Review Board, and Continuing Review, 68 TENN. L. REV. 725, 731 (2001) ("[T]He FDA and DHHS themselves do not review research proposals. Instead, the federal regulations delegate authority for the review, approval, and monitoring of biomedical research studies to IRBs...."). In contrast, in one of the first comprehensive scholarly articles on the subject. Professor John Robertson emphasized the self-regulatory character of this arrangement. See Robertson, supra note 9, at 544 ("The IRB system repeats a quintessential form of government regulation: public incentives to induce self-regulation on the part of powerful professions or industries."); see also id. at 544-49 (identifying various shortcomings with this arrangement).
126. LARS NOAH & BARBARA A. NOAH, LAW, MEDICINE, AND MEDICAL TECHNOLOGY 155 (2002) (prefacing this question with the following: "Don't forget that most IRBs are not federal government entities. Apart from the NIH's in-house IRBs, most of these Boards are affiliated with state-run or private hospitals."). In some ways, the sentence that immediately follows this question provides even greater support for Coleman's broader argument: "The inevitable ambiguities in the regulations result in potentially inconsistent and inexpert interpretations by IRBs." Id.
127. LARS NOAH & BARBARA A. NOAH, LAW, MEDICINE, AND MEDICAL TECHNOLOGY 155 (2002) (prefacing this question with the following: "Don't forget that most IRBs are not federal government entities. Apart from the NIH's in-house IRBs, most of these Boards are affiliated with state-run or private hospitals."). In some ways, the sentence that immediately follows this question provides even greater support for Coleman's broader argument: "The inevitable ambiguities in the regulations result in potentially inconsistent and inexpert interpretations by IRBs." Id.
128. See 21 C.F.R. § 56.103(c) (2003); 45 C.F.R. §§ 46.103, 46.120 (2003) (providing that federal grant funding agencies are not bound to accept local IRB conclusions that proposed research satisfies human subject protection requirements). Contrast this arrangement with the suggestion made by some commentators that federal delegations of powers of implementation to state officials should include granting states the power to announce binding interpretations of federal law. See Philip J. Weiser, Chevron, Cooperative Federalism, and Telecommunications Reform, 52 VAND. L. REV. 1, 39-44 (1999) (challenging assumptions about the benefits of uniformity in the interpretation of federal statutes, and arguing that judicial deference to state agencies involved in cooperative federalism schemes will promote beneficial experimentation).
129. See 21 C.F.R. § 56.103(c) (2003); 45 C.F.R. §§ 46.103, 46.120 (2003) (providing that federal grant funding agencies are not bound to accept local IRB conclusions that proposed research satisfies human subject protection requirements). Contrast this arrangement with the suggestion made by some commentators that federal delegations of powers of implementation to state officials should include granting states the power to announce binding interpretations of federal law. See Philip J. Weiser, Chevron, Cooperative Federalism, and Telecommunications Reform, 52 VAND. L. REV. 1, 39-44 (1999) (challenging assumptions about the benefits of uniformity in the interpretation of federal statutes, and arguing that judicial deference to state agencies involved in cooperative federalism schemes will promote beneficial experimentation).
130. See 21 C.F.R. § 56.103(c) (2003); 45 C.F.R. §§ 46.103, 46.120 (2003) (providing that federal grant funding agencies are not bound to accept local IRB conclusions that proposed research satisfies human subject protection requirements). Contrast this arrangement with the suggestion made by some commentators that federal delegations of powers of implementation to state officials should include granting states the power to announce binding interpretations of federal law. See Philip J. Weiser, Chevron, Cooperative Federalism, and Telecommunications Reform, 52 VAND. L. REV. 1, 39-44 (1999) (challenging assumptions about the benefits of uniformity in the interpretation of federal statutes, and arguing that judicial deference to state agencies involved in cooperative federalism schemes will promote beneficial experimentation).
131. See United States v. Garfinkel, 29 F.3d 451 (8th Cir. 1994) (prosecution of PI for violating FDA recordkeeping requirements); United States v. Keplinger, 776 F.2d 678 (7th Cir. 1985) (prosecution for fraudulent animal testing of drugs); see also 21 C.F.R. § 312.70 (2003) (authorizing the FDA to disqualify clinical investigators who have violated IND requirements).
132. See United States v. Garfinkel, 29 F.3d 451 (8th Cir. 1994) (prosecution of PI for violating FDA recordkeeping requirements); United States v. Keplinger, 776 F.2d 678 (7th Cir. 1985) (prosecution for fraudulent animal testing of drugs); see also 21 C.F.R. § 312.70 (2003) (authorizing the FDA to disqualify clinical investigators who have violated IND requirements).
133. See United States v. Garfinkel, 29 F.3d 451 (8th Cir. 1994) (prosecution of PI for violating FDA recordkeeping requirements); United States v. Keplinger, 776 F.2d 678 (7th Cir. 1985) (prosecution for fraudulent animal testing of drugs); see also 21 C.F.R. § 312.70 (2003) (authorizing the FDA to disqualify clinical investigators who have violated IND requirements).
134. See Goldner, supra note 7, at 103 ("[M]ost institutions generally make compliance with its policies on human research a condition of employment, or part of the faculty manual or contract so that the institution would be able to pursue disciplinary actions against an employee who failed to follow their policies."); Robertson, supra note 9, at 513; John Schwartz, Cloning Experiments Violated GWU Policies, WASH. POST, Dec. 7, 1994, at A26 (reporting one situation where researchers who failed to secure prior IRB approval were disciplined even though their work was not funded by NIH or private industry).
135. See Goldner, supra note 7, at 103 ("[M]ost institutions generally make compliance with its policies on human research a condition of employment, or part of the faculty manual or contract so that the institution would be able to pursue disciplinary actions against an employee who failed to follow their policies."); Robertson, supra note 9, at 513; John Schwartz, Cloning Experiments Violated GWU Policies, WASH. POST, Dec. 7, 1994, at A26 (reporting one situation where researchers who failed to secure prior IRB approval were disciplined even though their work was not funded by NIH or private industry).
136. See Goldner, supra note 7, at 103 ("[M]ost institutions generally make compliance with its policies on human research a condition of employment, or part of the faculty manual or contract so that the institution would be able to pursue disciplinary actions against an employee who failed to follow their policies."); Robertson, supra note 9, at 513; John Schwartz, Cloning Experiments Violated GWU Policies, WASH. POST, Dec. 7, 1994, at A26 (reporting one situation where researchers who failed to secure prior IRB approval were disciplined even though their work was not funded by NIH or private industry).
137. See Robertson, supra note 9, at 520 n.189 ("Private adherence to federal grant conditions should not become state action any more than private action that conforms to state-mandated standards becomes state action."); see also Blum v. Yaretsky, 457, U.S. 991, 1005-12 (1982) (holding that decisions made by private nursing homes to discharge or transfer Medicaid patients did not qualify as state action); cf. Mass. Sch. of Law v. Am. Bar Ass'n, 107 F.3d 1026, 1035-36 & n.7 (3d Cir. 1997) (rejecting the argument that ABA accreditation of law schools involves the exercise of delegated power).
138. See Robertson, supra note 9, at 520 n.189 ("Private adherence to federal grant conditions should not become state action any more than private action that conforms to state-mandated standards becomes state action."); see also Blum v. Yaretsky, 457, U.S. 991, 1005-12 (1982) (holding that decisions made by private nursing homes to discharge or transfer Medicaid patients did not qualify as state action); cf. Mass. Sch. of Law v. Am. Bar Ass'n, 107 F.3d 1026, 1035-36 & n.7 (3d Cir. 1997) (rejecting the argument that ABA accreditation of law schools involves the exercise of delegated power).
139. See Robertson, supra note 9, at 520 n.189 ("Private adherence to federal grant conditions should not become state action any more than private action that conforms to state-mandated standards becomes state action."); see also Blum v. Yaretsky, 457, U.S. 991, 1005-12 (1982) (holding that decisions made by private nursing homes to discharge or transfer Medicaid patients did not qualify as state action); cf. Mass. Sch. of Law v. Am. Bar Ass'n, 107 F.3d 1026, 1035-36 & n.7 (3d Cir. 1997) (rejecting the argument that ABA accreditation of law schools involves the exercise of delegated power).
140. When an IRB operates within a public institution, that provides an entirely distinct basis for claiming that it has engaged in "state action." See Halikas v. Univ. of Minn., 856 F. Supp. 1331, 1332-33 (D. Minn. 1994) (reviewing procedural due process claims against a public institution based in part on its IRB's suspension of the plaintiff's research: "The parties do not contest that the University's and the IRB's actions occurred under color of state law."); cf. Missert v. Trustees of Boston Univ., 73 F. Supp. 2d 68, 70-73 (D. Mass. 1999) (dismissing constitutional claims asserted by a graduate student who was dismissed from a dentistry program where he premised state action solely on the federal requirements for IRB review of research for his thesis). Some IRBs have no connection with either public or private universities. See Trudo Lemmens & Benjamin Freedman, Ethics Review for Sale? Conflict of Interest and Commercial Research Review Boards, 78 MILBANK Q. 547, 547-53 (2000).
141. When an IRB operates within a public institution, that provides an entirely distinct basis for claiming that it has engaged in "state action." See Halikas v. Univ. of Minn., 856 F. Supp. 1331, 1332-33 (D. Minn. 1994) (reviewing procedural due process claims against a public institution based in part on its IRB's suspension of the plaintiff's research: "The parties do not contest that the University's and the IRB's actions occurred under color of state law."); cf. Missert v. Trustees of Boston Univ., 73 F. Supp. 2d 68, 70-73 (D. Mass. 1999) (dismissing constitutional claims asserted by a graduate student who was dismissed from a dentistry program where he premised state action solely on the federal requirements for IRB review of research for his thesis). Some IRBs have no connection with either public or private universities. See Trudo Lemmens & Benjamin Freedman, Ethics Review for Sale? Conflict of Interest and Commercial Research Review Boards, 78 MILBANK Q. 547, 547-53 (2000).
142. When an IRB operates within a public institution, that provides an entirely distinct basis for claiming that it has engaged in "state action." See Halikas v. Univ. of Minn., 856 F. Supp. 1331, 1332-33 (D. Minn. 1994) (reviewing procedural due process claims against a public institution based in part on its IRB's suspension of the plaintiff's research: "The parties do not contest that the University's and the IRB's actions occurred under color of state law."); cf. Missert v. Trustees of Boston Univ., 73 F. Supp. 2d 68, 70-73 (D. Mass. 1999) (dismissing constitutional claims asserted by a graduate student who was dismissed from a dentistry program where he premised state action solely on the federal requirements for IRB review of research for his thesis). Some IRBs have no connection with either public or private universities. See Trudo Lemmens & Benjamin Freedman, Ethics Review for Sale? Conflict of Interest and Commercial Research Review Boards, 78 MILBANK Q. 547, 547-53 (2000).
143. Coleman, supra note 1, at 49.
144. See Goldner, supra note 7, at 100 ("At first blush, this decentralization of authority may appear to be extraordinary, in that non-governmentally appointed bodies, appointed by organizations within the private sector, are given significant control. In fact, however, this is not at all unusual."). Although not created at the behest of federal regulators, hospital ethics committees serve a similar function and have been criticized on similar grounds. See John C. Fletcher & Diane E. Hoffmann, Ethics Committees: Time to Experiment with Standards, 120 ANN. INTERN. MED. 335 (1994); Bernard Lo, Behind Closed Doors: Promises and Pitfalls of Ethics Committees, 317 NEW ENG. J. MED. 46 (1987); Symposium, Hospital Ethics Committees and the Law, 50 MD. L. REV. 742 (1991); see also 45 C.F.R. § 84.55(a) & (f) (2003) (encouraging hospitals to create "infant care review committees"). The federal government has demanded the creation of institutional boards to supervise the welfare of animals used in laboratories. See 7 U.S.C. § 2143(b) (2000); 42 U.S.C. § 289d(b) (2000).
145. See Goldner, supra note 7, at 100 ("At first blush, this decentralization of authority may appear to be extraordinary, in that non-governmentally appointed bodies, appointed by organizations within the private sector, are given significant control. In fact, however, this is not at all unusual."). Although not created at the behest of federal regulators, hospital ethics committees serve a similar function and have been criticized on similar grounds. See John C. Fletcher & Diane E. Hoffmann, Ethics Committees: Time to Experiment with Standards, 120 ANN. INTERN. MED. 335 (1994); Bernard Lo, Behind Closed Doors: Promises and Pitfalls of Ethics Committees, 317 NEW ENG. J. MED. 46 (1987); Symposium, Hospital Ethics Committees and the Law, 50 MD. L. REV. 742 (1991); see also 45 C.F.R. § 84.55(a) & (f) (2003) (encouraging hospitals to create "infant care review committees"). The federal government has demanded the creation of institutional boards to supervise the welfare of animals used in laboratories. See 7 U.S.C. § 2143(b) (2000); 42 U.S.C. § 289d(b) (2000).
146. See Goldner, supra note 7, at 100 ("At first blush, this decentralization of authority may appear to be extraordinary, in that non-governmentally appointed bodies, appointed by organizations within the private sector, are given significant control. In fact, however, this is not at all unusual."). Although not created at the behest of federal regulators, hospital ethics committees serve a similar function and have been criticized on similar grounds. See John C. Fletcher & Diane E. Hoffmann, Ethics Committees: Time to Experiment with Standards, 120 ANN. INTERN. MED. 335 (1994); Bernard Lo, Behind Closed Doors: Promises and Pitfalls of Ethics Committees, 317 NEW ENG. J. MED. 46 (1987); Symposium, Hospital Ethics Committees and the Law, 50 MD. L. REV. 742 (1991); see also 45 C.F.R. § 84.55(a) & (f) (2003) (encouraging hospitals to create "infant care review committees"). The federal government has demanded the creation of institutional boards to supervise the welfare of animals used in laboratories. See 7 U.S.C. § 2143(b) (2000); 42 U.S.C. § 289d(b) (2000).
147. See Goldner, supra note 7, at 100 ("At first blush, this decentralization of authority may appear to be extraordinary, in that non-governmentally appointed bodies, appointed by organizations within the private sector, are given significant control. In fact, however, this is not at all unusual."). Although not created at the behest of federal regulators, hospital ethics committees serve a similar function and have been criticized on similar grounds. See John C. Fletcher & Diane E. Hoffmann, Ethics Committees: Time to Experiment with Standards, 120 ANN. INTERN. MED. 335 (1994); Bernard Lo, Behind Closed Doors: Promises and Pitfalls of Ethics Committees, 317 NEW ENG. J. MED. 46 (1987); Symposium, Hospital Ethics Committees and the Law, 50 MD. L. REV. 742 (1991); see also 45 C.F.R. § 84.55(a) & (f) (2003) (encouraging hospitals to create "infant care review committees"). The federal government has demanded the creation of institutional boards to supervise the welfare of animals used in laboratories. See 7 U.S.C. § 2143(b) (2000); 42 U.S.C. § 289d(b) (2000).
148. See Goldner, supra note 7, at 100 ("At first blush, this decentralization of authority may appear to be extraordinary, in that non-governmentally appointed bodies, appointed by organizations within the private sector, are given significant control. In fact, however, this is not at all unusual."). Although not created at the behest of federal regulators, hospital ethics committees serve a similar function and have been criticized on similar grounds. See John C. Fletcher & Diane E. Hoffmann, Ethics Committees: Time to Experiment with Standards, 120 ANN. INTERN. MED. 335 (1994); Bernard Lo, Behind Closed Doors: Promises and Pitfalls of Ethics Committees, 317 NEW ENG. J. MED. 46 (1987); Symposium, Hospital Ethics Committees and the Law, 50 MD. L. REV. 742 (1991); see also 45 C.F.R. § 84.55(a) & (f) (2003) (encouraging hospitals to create "infant care review committees"). The federal government has demanded the creation of institutional boards to supervise the welfare of animals used in laboratories. See 7 U.S.C. § 2143(b) (2000); 42 U.S.C. § 289d(b) (2000).
149. See Goldner, supra note 7, at 100 ("At first blush, this decentralization of authority may appear to be extraordinary, in that non-governmentally appointed bodies, appointed by organizations within the private sector, are given significant control. In fact, however, this is not at all unusual."). Although not created at the behest of federal regulators, hospital ethics committees serve a similar function and have been criticized on similar grounds. See John C. Fletcher & Diane E. Hoffmann, Ethics Committees: Time to Experiment with Standards, 120 ANN. INTERN. MED. 335 (1994); Bernard Lo, Behind Closed Doors: Promises and Pitfalls of Ethics Committees, 317 NEW ENG. J. MED. 46 (1987); Symposium, Hospital Ethics Committees and the Law, 50 MD. L. REV. 742 (1991); see also 45 C.F.R. § 84.55(a) & (f) (2003) (encouraging hospitals to create "infant care review committees"). The federal government has demanded the creation of institutional boards to supervise the welfare of animals used in laboratories. See 7 U.S.C. § 2143(b) (2000); 42 U.S.C. § 289d(b) (2000).
150. See Goldner, supra note 7, at 100 ("At first blush, this decentralization of authority may appear to be extraordinary, in that non-governmentally appointed bodies, appointed by organizations within the private sector, are given significant control. In fact, however, this is not at all unusual."). Although not created at the behest of federal regulators, hospital ethics committees serve a similar function and have been criticized on similar grounds. See John C. Fletcher & Diane E. Hoffmann, Ethics Committees: Time to Experiment with Standards, 120 ANN. INTERN. MED. 335 (1994); Bernard Lo, Behind Closed Doors: Promises and Pitfalls of Ethics Committees, 317 NEW ENG. J. MED. 46 (1987); Symposium, Hospital Ethics Committees and the Law, 50 MD. L. REV. 742 (1991); see also 45 C.F.R. § 84.55(a) & (f) (2003) (encouraging hospitals to create "infant care review committees"). The federal government has demanded the creation of institutional boards to supervise the welfare of animals used in laboratories. See 7 U.S.C. § 2143(b) (2000); 42 U.S.C. § 289d(b) (2000).
151. See Lars Noah, Sanctifying Scientific Peer Review: Publication as a Proxy for Regulatory Decisionmaking, 59 U. PITT. L. REV. 677, 680 (1998) ("In the past few years, legislators, federal regulators, and judges have become enamored with the idea of using the results of the editorial peer review process in biomedical literature as a short-cut for making judgments about important matters of public health."); see also id. at 717 ("Although regulatory cross-references to peer reviewed scientific literature remain modest, legislators committed to the increased privatization of government activities may be tempted to seize on it as one convenient deregulatory technique in the future."). The United States Constitution does not forbid limited delegations of quasi-regulatory authority to private entities. See id. at 711-16.
152. See Lars Noah, Sanctifying Scientific Peer Review: Publication as a Proxy for Regulatory Decisionmaking, 59 U. PITT. L. REV. 677, 680 (1998) ("In the past few years, legislators, federal regulators, and judges have become enamored with the idea of using the results of the editorial peer review process in biomedical literature as a short-cut for making judgments about important matters of public health."); see also id. at 717 ("Although regulatory cross-references to peer reviewed scientific literature remain modest, legislators committed to the increased privatization of government activities may be tempted to seize on it as one convenient deregulatory technique in the future."). The United States Constitution does not forbid limited delegations of quasi-regulatory authority to private entities. See id. at 711-16.
153. See Lars Noah, Sanctifying Scientific Peer Review: Publication as a Proxy for Regulatory Decisionmaking, 59 U. PITT. L. REV. 677, 680 (1998) ("In the past few years, legislators, federal regulators, and judges have become enamored with the idea of using the results of the editorial peer review process in biomedical literature as a short-cut for making judgments about important matters of public health."); see also id. at 717 ("Although regulatory cross-references to peer reviewed scientific literature remain modest, legislators committed to the increased privatization of government activities may be tempted to seize on it as one convenient deregulatory technique in the future."). The United States Constitution does not forbid limited delegations of quasi-regulatory authority to private entities. See id. at 711-16.
154. See id. at 717 ("[S]erious questions about the effectiveness of the editorial peer review process should caution against too ready a dependence on the output of scientific journals in protecting the public health and welfare."); see also id. at 692 ("[I]ncreasing and sometimes uncritical reliance on the fruits of scientific peer review pose important questions about the wisdom of indirectly delegating policy questions to journal editors and referees."); id. at 696 ("Peer review can be a time-consuming process that depends on the voluntary efforts of busy scientists to serve as journal referees.").
155. See id. at 717 ("[S]erious questions about the effectiveness of the editorial peer review process should caution against too ready a dependence on the output of scientific journals in protecting the public health and welfare."); see also id. at 692 ("[I]ncreasing and sometimes uncritical reliance on the fruits of scientific peer review pose important questions about the wisdom of indirectly delegating policy questions to journal editors and referees."); id. at 696 ("Peer review can be a time-consuming process that depends on the voluntary efforts of busy scientists to serve as journal referees.").
156. See id. at 717 ("[S]erious questions about the effectiveness of the editorial peer review process should caution against too ready a dependence on the output of scientific journals in protecting the public health and welfare."); see also id. at 692 ("[I]ncreasing and sometimes uncritical reliance on the fruits of scientific peer review pose important questions about the wisdom of indirectly delegating policy questions to journal editors and referees."); id. at 696 ("Peer review can be a time-consuming process that depends on the voluntary efforts of busy scientists to serve as journal referees.").
157. See id. at 709-11.
158. See IAN AYRES & JOHN BRAITHWAITE, RESPONSIVE REGULATION: TRANSCENDING THE DEREGULATION DEBATE 101-32 (1992) (proposing more of a shift to audited self-regulation); Marshall J. Breger, Regulatory Flexibility and the Administrative State, 32 TULSA L.J. 325, 329 (1996) ("A number of different types of flexible and cooperative regulatory schemes have been created in the last few years."); Jay P. Kesan, Encouraging Firms to Police Themselves:
159. See IAN AYRES & JOHN BRAITHWAITE, RESPONSIVE REGULATION: TRANSCENDING THE DEREGULATION DEBATE 101-32 (1992) (proposing more of a shift to audited self-regulation); Marshall J. Breger, Regulatory Flexibility and the Administrative State, 32 TULSA L.J. 325, 329 (1996) ("A number of different types of flexible and cooperative regulatory schemes have been created in the last few years."); Jay P. Kesan, Encouraging Firms to Police Themselves: Strategic Prescriptions to Promote Corporate Self-Auditing, 2000 U. ILL. L. REV. 155, 156-63; Douglas C. Michael, Cooperative Implementation of Federal Regulations, 13 YALE J. ON REG. 535, 541 (1996) ("The government would rely on the regulated entities to develop specific and individual implementation plans, and would thus restrict its role to assisting in and providing incentives for self-implementation programs, and to maintaining a credible residual program of detection, surveillance and enforcement.").
160. See IAN AYRES & JOHN BRAITHWAITE, RESPONSIVE REGULATION: TRANSCENDING THE DEREGULATION DEBATE 101-32 (1992) (proposing more of a shift to audited self-regulation); Marshall J. Breger, Regulatory Flexibility and the Administrative State, 32 TULSA L.J. 325, 329 (1996) ("A number of different types of flexible and cooperative regulatory schemes have been created in the last few years."); Jay P. Kesan, Encouraging Firms to Police Themselves: Strategic Prescriptions to Promote Corporate Self-Auditing, 2000 U. ILL. L. REV. 155, 156-63; Douglas C. Michael, Cooperative Implementation of Federal Regulations, 13 YALE J. ON REG. 535, 541 (1996) ("The government would rely on the regulated entities to develop specific and individual implementation plans, and would thus restrict its role to assisting in and providing incentives for self-implementation programs, and to maintaining a credible residual program of detection, surveillance and enforcement.").
161. See IAN AYRES & JOHN BRAITHWAITE, RESPONSIVE REGULATION: TRANSCENDING THE DEREGULATION DEBATE 101-32 (1992) (proposing more of a shift to audited self-regulation); Marshall J. Breger, Regulatory Flexibility and the Administrative State, 32 TULSA L.J. 325, 329 (1996) ("A number of different types of flexible and cooperative regulatory schemes have been created in the last few years."); Jay P. Kesan, Encouraging Firms to Police Themselves: Strategic Prescriptions to Promote Corporate Self-Auditing, 2000 U. ILL. L. REV. 155, 156-63; Douglas C. Michael, Cooperative Implementation of Federal Regulations, 13 YALE J. ON REG. 535, 541 (1996) ("The government would rely on the regulated entities to develop specific and individual implementation plans, and would thus restrict its role to assisting in and providing incentives for self-implementation programs, and to maintaining a credible residual program of detection, surveillance and enforcement.").
162. See generally Symposium, The Place of Private Accrediting Among the Instruments of Government, LAW & CONTEMP. PROBS., Autumn 1994, at 1. For hospitals, adherence to private standards issued by the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) ensures participation in Medicare. See 42 U.S.C. § 1395bb(a)(1) (2000); see also Timothy Stoltzfus Jost, The Joint Commission on Accreditation of Hospitals: Private Regulation of Health Care and the Public Interest, 24 B.C. L. REV. 835, 840-60 (1983) (discussing the origins of this arrangement).
163. See generally Symposium, The Place of Private Accrediting Among the Instruments of Government, LAW & CONTEMP. PROBS., Autumn 1994, at 1. For hospitals, adherence to private standards issued by the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) ensures participation in Medicare. See 42 U.S.C. § 1395bb(a)(1) (2000); see also Timothy Stoltzfus Jost, The Joint Commission on Accreditation of Hospitals: Private Regulation of Health Care and the Public Interest, 24 B.C. L. REV. 835, 840-60 (1983) (discussing the origins of this arrangement).
164. See generally Symposium, The Place of Private Accrediting Among the Instruments of Government, LAW & CONTEMP. PROBS., Autumn 1994, at 1. For hospitals, adherence to private standards issued by the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) ensures participation in Medicare. See 42 U.S.C. § 1395bb(a)(1) (2000); see also Timothy Stoltzfus Jost, The Joint Commission on Accreditation of Hospitals: Private Regulation of Health Care and the Public Interest, 24 B.C. L. REV. 835, 840-60 (1983) (discussing the origins of this arrangement).
165. Jody Freeman, The Private Role in Public Governance, 75 N.Y.U. L. REV. 543, 587 (2000); see also id. at 665-66 (explaining that private parties exercising delegated authority face "multiple and overlapping checks" that promote accountability); Freeman, supra note 27, at 819 ("Importantly, private actors are often already constrained by alternative accountability mechanisms that go largely unrecognized in administrative law."); id. at 856-57 ("[S]cholars should resist the impulse to constrain private actors as if they were agencies.... The impulse to constrain them with traditional means may be misguided to the extent that it continues to assume that private and public actors operate independently....").
166. Jody Freeman, The Private Role in Public Governance, 75 N.Y.U. L. REV. 543, 587 (2000); see also id. at 665-66 (explaining that private parties exercising delegated authority face "multiple and overlapping checks" that promote accountability); Freeman, supra note 27, at 819 ("Importantly, private actors are often already constrained by alternative accountability mechanisms that go largely unrecognized in administrative law."); id. at 856-57 ("[S]cholars should resist the impulse to constrain private actors as if they were agencies.... The impulse to constrain them with traditional means may be misguided to the extent that it continues to assume that private and public actors operate independently....").
167. Jody Freeman, The Private Role in Public Governance, 75 N.Y.U. L. REV. 543, 587 (2000); see also id. at 665-66 (explaining that private parties exercising delegated authority face "multiple and overlapping checks" that promote accountability); Freeman, supra note 27, at 819 ("Importantly, private actors are often already constrained by alternative accountability mechanisms that go largely unrecognized in administrative law."); id. at 856-57 ("[S]cholars should resist the impulse to constrain private actors as if they were agencies.... The impulse to constrain them with traditional means may be misguided to the extent that it continues to assume that private and public actors operate independently....").
168. Jody Freeman, The Private Role in Public Governance, 75 N.Y.U. L. REV. 543, 587 (2000); see also id. at 665-66 (explaining that private parties exercising delegated authority face "multiple and overlapping checks" that promote accountability); Freeman, supra note 27, at 819 ("Importantly, private actors are often already constrained by alternative accountability mechanisms that go largely unrecognized in administrative law."); id. at 856-57 ("[S]cholars should resist the impulse to constrain private actors as if they were agencies.... The impulse to constrain them with traditional means may be misguided to the extent that it continues to assume that private and public actors operate independently....").
169. See Coleman, supra note 1, at 31-32, 34-35; see also id. at 44 (arguing that the dialogue generated by appellate scrutiny might help to "synthesize disparate approaches").
170. See Coleman, supra note 1, at 31-32, 34-35; see also id. at 44 (arguing that the dialogue generated by appellate scrutiny might help to "synthesize disparate approaches").
171. 304 U.S. 64, 78 (1938).
172. See, e.g., Scott D. Halpern et al., The Continuing Unethical Conduct of Underpowered Clinical Trials, 288 J.A.M.A. 358 (2002); Sharona Hoffman, The Use of Placebos in Clinical Trials: Responsible Research or Unethical Practice?, 33 CONN. L. REV. 449 (2001); Nancy Kraus et al., Intuitive Toxicology: Expert and Lay Judgments of Chemical Risks, 12 RISK ANALYSIS 215, 229-31 (1992) (finding "great divergence of opinion among the toxicologists themselves about fundamental issues in risk assessment and, in particular, the high percentage of toxicologists who doubted the validity of the animal and bacterial studies that form the backbone of their science"); Michael S. Lauer & Eric J. Topol, Editorial, Clinical Trials-Multiple Treatments, Multiple End Points, and Multiple Lessons, 289 J.A.M.A. 2575 (2003); Noah, supra note 2, at 400-07; see also Noah, supra note 25, at 1073 ("[S]ome peer reviewers predictably will disagree about how best to interpret ambiguous research or resolve uncertainties.").
173. See, e.g., Scott D. Halpern et al., The Continuing Unethical Conduct of Underpowered Clinical Trials, 288 J.A.M.A. 358 (2002); Sharona Hoffman, The Use of Placebos in Clinical Trials: Responsible Research or Unethical Practice?, 33 CONN. L. REV. 449 (2001); Nancy Kraus et al., Intuitive Toxicology: Expert and Lay Judgments of Chemical Risks, 12 RISK ANALYSIS 215, 229-31 (1992) (finding "great divergence of opinion among the toxicologists themselves about fundamental issues in risk assessment and, in particular, the high percentage of toxicologists who doubted the validity of the animal and bacterial studies that form the backbone of their science"); Michael S. Lauer & Eric J. Topol, Editorial, Clinical Trials-Multiple Treatments, Multiple End Points, and Multiple Lessons, 289 J.A.M.A. 2575 (2003); Noah, supra note 2, at 400-07; see also Noah, supra note 25, at 1073 ("[S]ome peer reviewers predictably will disagree about how best to interpret ambiguous research or resolve uncertainties.").
174. See, e.g., Scott D. Halpern et al., The Continuing Unethical Conduct of Underpowered Clinical Trials, 288 J.A.M.A. 358 (2002); Sharona Hoffman, The Use of Placebos in Clinical Trials: Responsible Research or Unethical Practice?, 33 CONN. L. REV. 449 (2001); Nancy Kraus et al., Intuitive Toxicology: Expert and Lay Judgments of Chemical Risks, 12 RISK ANALYSIS 215, 229-31 (1992) (finding "great divergence of opinion among the toxicologists themselves about fundamental issues in risk assessment and, in particular, the high percentage of toxicologists who doubted the validity of the animal and bacterial studies that form the backbone of their science"); Michael S. Lauer & Eric J. Topol, Editorial, Clinical Trials-Multiple Treatments, Multiple End Points, and Multiple Lessons, 289 J.A.M.A. 2575 (2003); Noah, supra note 2, at 400-07; see also Noah, supra note 25, at 1073 ("[S]ome peer reviewers predictably will disagree about how best to interpret ambiguous research or resolve uncertainties.").
175. See, e.g., Scott D. Halpern et al., The Continuing Unethical Conduct of Underpowered Clinical Trials, 288 J.A.M.A. 358 (2002); Sharona Hoffman, The Use of Placebos in Clinical Trials: Responsible Research or Unethical Practice?, 33 CONN. L. REV. 449 (2001); Nancy Kraus et al., Intuitive Toxicology: Expert and Lay Judgments of Chemical Risks, 12 RISK ANALYSIS 215, 229-31 (1992) (finding "great divergence of opinion among the toxicologists themselves about fundamental issues in risk assessment and, in particular, the high percentage of toxicologists who doubted the validity of the animal and bacterial studies that form the backbone of their science"); Michael S. Lauer & Eric J. Topol, Editorial, Clinical Trials-Multiple Treatments, Multiple End Points, and Multiple Lessons, 289 J.A.M.A. 2575 (2003); Noah, supra note 2, at 400-07; see also Noah, supra note 25, at 1073 ("[S]ome peer reviewers predictably will disagree about how best to interpret ambiguous research or resolve uncertainties.").
176. See, e.g., Scott D. Halpern et al., The Continuing Unethical Conduct of Underpowered Clinical Trials, 288 J.A.M.A. 358 (2002); Sharona Hoffman, The Use of Placebos in Clinical Trials: Responsible Research or Unethical Practice?, 33 CONN. L. REV. 449 (2001); Nancy Kraus et al., Intuitive Toxicology: Expert and Lay Judgments of Chemical Risks, 12 RISK ANALYSIS 215, 229-31 (1992) (finding "great divergence of opinion among the toxicologists themselves about fundamental issues in risk assessment and, in particular, the high percentage of toxicologists who doubted the validity of the animal and bacterial studies that form the backbone of their science"); Michael S. Lauer & Eric J. Topol, Editorial, Clinical Trials-Multiple Treatments, Multiple End Points, and Multiple Lessons, 289 J.A.M.A. 2575 (2003); Noah, supra note 2, at 400-07; see also Noah, supra note 25, at 1073 ("[S]ome peer reviewers predictably will disagree about how best to interpret ambiguous research or resolve uncertainties.").
177. See Coleman, supra note 1, at 41, 46.
178. See, e.g., Daniel J. Gifford, Adjudication in Independent Tribunals: The Role of an Alternative Agency Structure, 66 NOTRE DAME L. REV. 965, 968, 992-99 (1991). As Professor Gifford explained: In a mass-justice agency, adjudication is unsuited for use as a vehicle for announcing or formulating policy. The cases come too fast and in too great a volume for decisionmakers to look to other cases as guides; sorting out, distinguishing or following large volumes of cases whose holdings are necessarily circumscribed by their unique factual configurations is impractical. Id. at 997 (footnotes omitted).
179. See, e.g., Daniel J. Gifford, Adjudication in Independent Tribunals: The Role of an Alternative Agency Structure, 66 NOTRE DAME L. REV. 965, 968, 992-99 (1991). As Professor Gifford explained: In a mass-justice agency, adjudication is unsuited for use as a vehicle for announcing or formulating policy. The cases come too fast and in too great a volume for decisionmakers to look to other cases as guides; sorting out, distinguishing or following large volumes of cases whose holdings are necessarily circumscribed by their unique factual configurations is impractical. Id. at 997 (footnotes omitted).
180. JERRY L. MASHAW ET AL., ADMINISTRATIVE LAW: THE AMERICAN PUBLIC LAW SYSTEM 412 (4th ed. 1998); see also id. at 410-19 (discussing controversies surrounding the use of other managerial techniques in an effort to promote consistent ALJ decisions); U.S. CONGRESS, GEN. ACCOUNTING OFFICE, No. HEHS-97-102, SOCIAL SECURITY DISABILITY: SSA MUST HOLD ITSELF ACCOUNTABLE FOR CONTINUED IMPROVEMENT IN DECISION-MAKING 51-53 (1997); Gifford, supra note 63, at 1005-19. For a criticism of suggestions that agencies appropriately act in the fashion of common law courts, see Lars Noah, Interpreting Agency Enabling Acts: Misplaced Metaphors in Administrative Law, 41 WM. & MARY L. REV. 1463, 1480-84, 1526-30 (2000).
181. JERRY L. MASHAW ET AL., ADMINISTRATIVE LAW: THE AMERICAN PUBLIC LAW SYSTEM 412 (4th ed. 1998); see also id. at 410-19 (discussing controversies surrounding the use of other managerial techniques in an effort to promote consistent ALJ decisions); U.S. CONGRESS, GEN. ACCOUNTING OFFICE, No. HEHS-97-102, SOCIAL SECURITY DISABILITY: SSA MUST HOLD ITSELF ACCOUNTABLE FOR CONTINUED IMPROVEMENT IN DECISION-MAKING 51-53 (1997); Gifford, supra note 63, at 1005-19. For a criticism of suggestions that agencies appropriately act in the fashion of common law courts, see Lars Noah, Interpreting Agency Enabling Acts: Misplaced Metaphors in Administrative Law, 41 WM. & MARY L. REV. 1463, 1480-84, 1526-30 (2000).
182. JERRY L. MASHAW ET AL., ADMINISTRATIVE LAW: THE AMERICAN PUBLIC LAW SYSTEM 412 (4th ed. 1998); see also id. at 410-19 (discussing controversies surrounding the use of other managerial techniques in an effort to promote consistent ALJ decisions); U.S. CONGRESS, GEN. ACCOUNTING OFFICE, No. HEHS-97-102, SOCIAL SECURITY DISABILITY: SSA MUST HOLD ITSELF ACCOUNTABLE FOR CONTINUED IMPROVEMENT IN DECISION-MAKING 51-53 (1997); Gifford, supra note 63, at 1005-19. For a criticism of suggestions that agencies appropriately act in the fashion of common law courts, see Lars Noah, Interpreting Agency Enabling Acts: Misplaced Metaphors in Administrative Law, 41 WM. & MARY L. REV. 1463, 1480-84, 1526-30 (2000).
183. JERRY L. MASHAW ET AL., ADMINISTRATIVE LAW: THE AMERICAN PUBLIC LAW SYSTEM 412 (4th ed. 1998); see also id. at 410-19 (discussing controversies surrounding the use of other managerial techniques in an effort to promote consistent ALJ decisions); U.S. CONGRESS, GEN. ACCOUNTING OFFICE, No. HEHS-97-102, SOCIAL SECURITY DISABILITY: SSA MUST HOLD ITSELF ACCOUNTABLE FOR CONTINUED IMPROVEMENT IN DECISION-MAKING 51-53 (1997); Gifford, supra note 63, at 1005-19. For a criticism of suggestions that agencies appropriately act in the fashion of common law courts, see Lars Noah, Interpreting Agency Enabling Acts: Misplaced Metaphors in Administrative Law, 41 WM. & MARY L. REV. 1463, 1480-84, 1526-30 (2000).
184. JERRY L. MASHAW ET AL., ADMINISTRATIVE LAW: THE AMERICAN PUBLIC LAW SYSTEM 412 (4th ed. 1998); see also id. at 410-19 (discussing controversies surrounding the use of other managerial techniques in an effort to promote consistent ALJ decisions); U.S. CONGRESS, GEN. ACCOUNTING OFFICE, No. HEHS-97-102, SOCIAL SECURITY DISABILITY: SSA MUST HOLD ITSELF ACCOUNTABLE FOR CONTINUED IMPROVEMENT IN DECISION-MAKING 51-53 (1997); Gifford, supra note 63, at 1005-19. For a criticism of suggestions that agencies appropriately act in the fashion of common law courts, see Lars Noah, Interpreting Agency Enabling Acts: Misplaced Metaphors in Administrative Law, 41 WM. & MARY L. REV. 1463, 1480-84, 1526-30 (2000).
185. See Coleman, supra note 1, at 3 n.9.
186. Cf. Rita McWilliams et al., Problematic Variation in Local Institutional Review of a Multicenter Genetic Epidemiology Study, 290 J.A.M.A. 360, 361, 364-65 (2003) (decrying inconsistent reviews of identical protocols at different study sites, but proposing increased centralization and clearer NIH guidelines as possible solutions).
187. See Pub. L. No. 92-603, § 249F(b), 86 Stat. 1329, 1429-45 (1972) (codified as amended at 42 U.S.C. §§ 1320c to 1320c-12 (2000)); see also Ass'n Am. Physicians & Surgeons v. Weinberger, 395 F. Supp. 125 (N.D. Ill.) (rejecting challenges to the PSRO requirement), aff'd, 423 U.S. 975 (1975); Clark C. Havighurst & James F. Blumstein, Coping with Quality/Cost Trade-Offs in Medical Care: The Role of PSROs, 70 NW. U. L. REV. 6, 8, 38-60, 66 (1975); id. at 39 ("The federal government, in effect, undertook not to regulate medical care directly but instead to mandate and regulate peer review practices as an indirect means of imposing controls over individual physicians.").
188. See Pub. L. No. 92-603, § 249F(b), 86 Stat. 1329, 1429-45 (1972) (codified as amended at 42 U.S.C. §§ 1320c to 1320c-12 (2000)); see also Ass'n Am. Physicians & Surgeons v. Weinberger, 395 F. Supp. 125 (N.D. Ill.) (rejecting challenges to the PSRO requirement), aff'd, 423 U.S. 975 (1975); Clark C. Havighurst & James F. Blumstein, Coping with Quality/Cost Trade-Offs in Medical Care: The Role of PSROs, 70 NW. U. L. REV. 6, 8, 38-60, 66 (1975); id. at 39 ("The federal government, in effect, undertook not to regulate medical care directly but instead to mandate and regulate peer review practices as an indirect means of imposing controls over individual physicians.").
189. See Pub. L. No. 92-603, § 249F(b), 86 Stat. 1329, 1429-45 (1972) (codified as amended at 42 U.S.C. §§ 1320c to 1320c-12 (2000)); see also Ass'n Am. Physicians & Surgeons v. Weinberger, 395 F. Supp. 125 (N.D. Ill.) (rejecting challenges to the PSRO requirement), aff'd, 423 U.S. 975 (1975); Clark C. Havighurst & James F. Blumstein, Coping with Quality/Cost Trade-Offs in Medical Care: The Role of PSROs, 70 NW. U. L. REV. 6, 8, 38-60, 66 (1975); id. at 39 ("The federal government, in effect, undertook not to regulate medical care directly but instead to mandate and regulate peer review practices as an indirect means of imposing controls over individual physicians.").
190. See Pub. L. No. 92-603, § 249F(b), 86 Stat. 1329, 1429-45 (1972) (codified as amended at 42 U.S.C. §§ 1320c to 1320c-12 (2000)); see also Ass'n Am. Physicians & Surgeons v. Weinberger, 395 F. Supp. 125 (N.D. Ill.) (rejecting challenges to the PSRO requirement), aff'd, 423 U.S. 975 (1975); Clark C. Havighurst & James F. Blumstein, Coping with Quality/Cost Trade-Offs in Medical Care: The Role of PSROs, 70 NW. U. L. REV. 6, 8, 38-60, 66 (1975); id. at 39 ("The federal government, in effect, undertook not to regulate medical care directly but instead to mandate and regulate peer review practices as an indirect means of imposing controls over individual physicians.").
191. See Pub. L. No. 92-603, § 249F(b), 86 Stat. 1329, 1429-45 (1972) (codified as amended at 42 U.S.C. §§ 1320c to 1320c-12 (2000)); see also Ass'n Am. Physicians & Surgeons v. Weinberger, 395 F. Supp. 125 (N.D. Ill.) (rejecting challenges to the PSRO requirement), aff'd, 423 U.S. 975 (1975); Clark C. Havighurst & James F. Blumstein, Coping with Quality/Cost Trade-Offs in Medical Care: The Role of PSROs, 70 NW. U. L. REV. 6, 8, 38-60, 66 (1975); id. at 39 ("The federal government, in effect, undertook not to regulate medical care directly but instead to mandate and regulate peer review practices as an indirect means of imposing controls over individual physicians.").
192. 5 U.S.C. § 552 (2000).
193. Public Citizen Health Research Group v. HEW, 668 F.2d 537, 542-43 (D.C. Cir. 1981) (quoting SEN. REP. No. 92-1320, at 258-60 (1972)); see also id. at 543 ("Congress [intended] that PSROs should be independent medical organizations operated by practicing physicians in the private sector, and not government agencies run by government employees.").
194. Public Citizen Health Research Group v. HEW, 668 F.2d 537, 542-43 (D.C. Cir. 1981) (quoting SEN. REP. No. 92-1320, at 258-60 (1972)); see also id. at 543 ("Congress [intended] that PSROs should be independent medical organizations operated by practicing physicians in the private sector, and not government agencies run by government employees.").
195. Id. at 544; see also Schweiker v. McClure, 456 U.S. 188, 195-200 (1982) (rejecting a procedural due process challenge to the rule that made Medicare reimbursement decisions by private carriers appealable only to hearing officers selected by the carriers and paid by the government).
196. Id. at 544; see also Schweiker v. McClure, 456 U.S. 188, 195-200 (1982) (rejecting a procedural due process challenge to the rule that made Medicare reimbursement decisions by private carriers appealable only to hearing officers selected by the carriers and paid by the government).
197. See 42 U.S.C. § 1320c-4(e) (1976).
198. See Ronald L. Goldman, The Reliability of Peer Assessments of Quality of Care, 267 J.A.M.A. 958 (1992); Rodney A. Hayward et al., Evaluating the Care of General Medicine Inpatients: How Good Is Implicit Review?, 118 ANN. INTERN. MED. 550, 553-54 (1993); Haya R. Rubin et al., Watching the Doctor-Watchers: How Well Do Peer Review Organization Methods Detect Hospital Care Quality Problems?, 267 J.A.M.A. 2349, 2353-54 (1992).
199. See Ronald L. Goldman, The Reliability of Peer Assessments of Quality of Care, 267 J.A.M.A. 958 (1992); Rodney A. Hayward et al., Evaluating the Care of General Medicine Inpatients: How Good Is Implicit Review?, 118 ANN. INTERN. MED. 550, 553-54 (1993); Haya R. Rubin et al., Watching the Doctor-Watchers: How Well Do Peer Review Organization Methods Detect Hospital Care Quality Problems?, 267 J.A.M.A. 2349, 2353-54 (1992).
200. See Ronald L. Goldman, The Reliability of Peer Assessments of Quality of Care, 267 J.A.M.A. 958 (1992); Rodney A. Hayward et al., Evaluating the Care of General Medicine Inpatients: How Good Is Implicit Review?, 118 ANN. INTERN. MED. 550, 553-54 (1993); Haya R. Rubin et al., Watching the Doctor-Watchers: How Well Do Peer Review Organization Methods Detect Hospital Care Quality Problems?, 267 J.A.M.A. 2349, 2353-54 (1992).
201. Cf. Paul L. Scibetta, Note, Restructuring Hospital-Physician Relations: Patient Care Quality Depends on the Health of Hospital Peer Review, 51 U. PITT. L. REV. 1025, 1035-38, 1050 (1990) (explaining that due process requirements already have done so).
202. See 42 U.S.C. §§ 1320c-11 (a), 1320c-12 (1976).
203. See Pub. L. No. 97-248, § 143, 96 Stat. 324, 382-93 (1982); Alexander Morgan Capron, Does Assessment of Medical Practices Have a Future?, 82 VA. L. REV. 1623, 1630-32 (1996); Timothy Stoltzfus Jost, Administrative Law Issues Involving the Medicare Utilization and Quality Control Peer Review Organization (PRO) Program: Analysis and Recommendations, 50 OHIO ST. L.J. 1, 5, 19-20 (1989); see also id. at 2-3 ("From an administrative law perspective, however, the most striking feature of PROs is that, despite their substantial, often unreviewable power, they are private entities that provide services for the federal government. . . .The private nature of PROs is intentional and based on the philosophy of medical peer review.").
204. See Pub. L. No. 97-248, § 143, 96 Stat. 324, 382-93 (1982); Alexander Morgan Capron, Does Assessment of Medical Practices Have a Future?, 82 VA. L. REV. 1623, 1630-32 (1996); Timothy Stoltzfus Jost, Administrative Law Issues Involving the Medicare Utilization and Quality Control Peer Review Organization (PRO) Program: Analysis and Recommendations, 50 OHIO ST. L.J. 1, 5, 19-20 (1989); see also id. at 2-3 ("From an administrative law perspective, however, the most striking feature of PROs is that, despite their substantial, often unreviewable power, they are private entities that provide services for the federal government. . . .The private nature of PROs is intentional and based on the philosophy of medical peer review.").
205. See Pub. L. No. 97-248, § 143, 96 Stat. 324, 382-93 (1982); Alexander Morgan Capron, Does Assessment of Medical Practices Have a Future?, 82 VA. L. REV. 1623, 1630-32 (1996); Timothy Stoltzfus Jost, Administrative Law Issues Involving the Medicare Utilization and Quality Control Peer Review Organization (PRO) Program: Analysis and Recommendations, 50 OHIO ST. L.J. 1, 5, 19-20 (1989); see also id. at 2-3 ("From an administrative law perspective, however, the most striking feature of PROs is that, despite their substantial, often unreviewable power, they are private entities that provide services for the federal government. . . .The private nature of PROs is intentional and based on the philosophy of medical peer review.").
206. See Pub. L. No. 97-248, § 143, 96 Stat. 324, 382-93 (1982); Alexander Morgan Capron, Does Assessment of Medical Practices Have a Future?, 82 VA. L. REV. 1623, 1630-32 (1996); Timothy Stoltzfus Jost, Administrative Law Issues Involving the Medicare Utilization and Quality Control Peer Review Organization (PRO) Program: Analysis and Recommendations, 50 OHIO ST. L.J. 1, 5, 19-20 (1989); see also id. at 2-3 ("From an administrative law perspective, however, the most striking feature of PROs is that, despite their substantial, often unreviewable power, they are private entities that provide services for the federal government. . . .The private nature of PROs is intentional and based on the philosophy of medical peer review.").
207. See U.S. CONGRESS, GEN. ACCOUNTING OFFICE, No. PEMD-89-7FS, MEDICARE PROs: EXTREME VARIOTON IN ORGANIZATIONAL STRUCTURE AND ACTIVITIES 31 (1988).
208. See Coleman, supra note 1, at 15-16. Authors of scientific manuscripts do the same thing. See Noah, supra note 53, at 699 ("[P]ersistent authors eventually manage to find an outlet for publication of any work no matter what its intrinsic merit, because of the proliferation of obscure scientific journals."). Although this may result in the publication of shoddy work that could threaten the public health if uncritically relied upon by physicians or policymakers, one seems to criticize the practice of serial submission to peer reviewed journals.
209. See Coleman, supra note 1, at 15-16. Authors of scientific manuscripts do the same thing. See Noah, supra note 53, at 699 ("[P]ersistent authors eventually manage to find an outlet for publication of any work no matter what its intrinsic merit, because of the proliferation of obscure scientific journals."). Although this may result in the publication of shoddy work that could threaten the public health if uncritically relied upon by physicians or policymakers, one seems to criticize the practice of serial submission to peer reviewed journals.
210. Cf. Coleman, supra note 1, at 40 ("While investigators may rely on IRB decisions in structuring additional protocols, their ability to predict how the IRB will react in the future has few long-term consequences.").
211. As Coleman notes, the FDA already has floated a tentative proposal that might discourage this type of behavior. See id. at 16 & n.95.
212. For a recent summary of this literature, see Lior Jacob Strahilevitz, Social Norms from Close-Knit Groups to Loose-Knit Groups, 70 U. CHI. L. REV. 359 (2003)
213. See Lars Noah, Medicine's Epistemology: Mapping the Haphazard Diffusion of Knowledge in the Biomedical Community, 44 ARIZ. L. REV. 373, 374-75, 379, 392-95, 417 (2002); see also Lars Noah, Pigeonholing Illness: Medical Diagnosis as a Legal Construct, 50 HASTINGS L.J. 241 (1999) (discussing the social construction of disease, and focusing on the various ways that legal institutions influence nosology and diagnosis).
214. See Lars Noah, Medicine's Epistemology: Mapping the Haphazard Diffusion of Knowledge in the Biomedical Community, 44 ARIZ. L. REV. 373, 374-75, 379, 392-95, 417 (2002); see also Lars Noah, Pigeonholing Illness: Medical Diagnosis as a Legal Construct, 50 HASTINGS L.J. 241 (1999) (discussing the social construction of disease, and focusing on the various ways that legal institutions influence nosology and diagnosis).
215. See Coleman, supra note 1, at 15.
216. See id. at 50 & n.275.
217. See id. at 41.
218. See John M. Mendeloff, Decision Analysis and FDA Drug Review: A Proposal for "Shadow" Advisory Committees. 6 RISK: HEALTH, SAFETY & ENVT. 203, 204-05 (1995). Although the agency may release summaries to the public when it approves an application, FDA employees generate detailed written evaluations for internal use only. Apart from protecting trade secrets and other confidential material, see Public Citizen Health Research Group v. FDA, 185 F.3d 898, 903-06 (D.C. Cir. 1999) (IND files), the Freedom of Information Act (FOIA) exempts pre-decisional deliberative process materials from disclosure, see 5 U.S.C. § 552(b)(5) (2000); Wolfe v. HHS, 839 F.2d 768, 774-76 (D.C. Cir. 1988) (en bane) (NDA files); Hunt v. U.S. Marine Corps, 935 F. Supp. 46, 51-52 (D.D.C. 1996); Chem. Mfrs. Ass'n v. CPSC, 600 F. Supp. 114, 117-18 (D.D.C. 1984) (explaining that "agency scientists may, for example, discuss hypotheses which have not matured, and can be effectively shared only with peers in regular and confidential communication"); see also Kirk D. Jensen. Note, The Reasonable Government Official Test: A Proposal for the Treatment of Factual Information Under the Federal Deliberative Process Privilege, 49 DUKE L.J. 561, 561-81 (1999) (summarizing this common-law privilege, and comparing it to FOIA's exemption from disclosure).
219. See John M. Mendeloff, Decision Analysis and FDA Drug Review: A Proposal for "Shadow" Advisory Committees. 6 RISK: HEALTH, SAFETY & ENVT. 203, 204-05 (1995). Although the agency may release summaries to the public when it approves an application, FDA employees generate detailed written evaluations for internal use only. Apart from protecting trade secrets and other confidential material, see Public Citizen Health Research Group v. FDA, 185 F.3d 898, 903-06 (D.C. Cir. 1999) (IND files), the Freedom of Information Act (FOIA) exempts pre-decisional deliberative process materials from disclosure, see 5 U.S.C. § 552(b)(5) (2000); Wolfe v. HHS, 839 F.2d 768, 774-76 (D.C. Cir. 1988) (en bane) (NDA files); Hunt v. U.S. Marine Corps, 935 F. Supp. 46, 51-52 (D.D.C. 1996); Chem. Mfrs. Ass'n v. CPSC, 600 F. Supp. 114, 117-18 (D.D.C. 1984) (explaining that "agency scientists may, for example, discuss hypotheses which have not matured, and can be effectively shared only with peers in regular and confidential communication"); see also Kirk D. Jensen. Note, The Reasonable Government Official Test: A Proposal for the Treatment of Factual Information Under the Federal Deliberative Process Privilege, 49 DUKE L.J. 561, 561-81 (1999) (summarizing this common-law privilege, and comparing it to FOIA's exemption from disclosure).
220. See John M. Mendeloff, Decision Analysis and FDA Drug Review: A Proposal for "Shadow" Advisory Committees. 6 RISK: HEALTH, SAFETY & ENVT. 203, 204-05 (1995). Although the agency may release summaries to the public when it approves an application, FDA employees generate detailed written evaluations for internal use only. Apart from protecting trade secrets and other confidential material, see Public Citizen Health Research Group v. FDA, 185 F.3d 898, 903-06 (D.C. Cir. 1999) (IND files), the Freedom of Information Act (FOIA) exempts pre-decisional deliberative process materials from disclosure, see 5 U.S.C. § 552(b)(5) (2000); Wolfe v. HHS, 839 F.2d 768, 774-76 (D.C. Cir. 1988) (en bane) (NDA files); Hunt v. U.S. Marine Corps, 935 F. Supp. 46, 51-52 (D.D.C. 1996); Chem. Mfrs. Ass'n v. CPSC, 600 F. Supp. 114, 117-18 (D.D.C. 1984) (explaining that "agency scientists may, for example, discuss hypotheses which have not matured, and can be effectively shared only with peers in regular and confidential communication"); see also Kirk D. Jensen. Note, The Reasonable Government Official Test: A Proposal for the Treatment of Factual Information Under the Federal Deliberative Process Privilege, 49 DUKE L.J. 561, 561-81 (1999) (summarizing this common-law privilege, and comparing it to FOIA's exemption from disclosure).
221. See John M. Mendeloff, Decision Analysis and FDA Drug Review: A Proposal for "Shadow" Advisory Committees. 6 RISK: HEALTH, SAFETY & ENVT. 203, 204-05 (1995). Although the agency may release summaries to the public when it approves an application, FDA employees generate detailed written evaluations for internal use only. Apart from protecting trade secrets and other confidential material, see Public Citizen Health Research Group v. FDA, 185 F.3d 898, 903-06 (D.C. Cir. 1999) (IND files), the Freedom of Information Act (FOIA) exempts pre-decisional deliberative process materials from disclosure, see 5 U.S.C. § 552(b)(5) (2000); Wolfe v. HHS, 839 F.2d 768, 774-76 (D.C. Cir. 1988) (en bane) (NDA files); Hunt v. U.S. Marine Corps, 935 F. Supp. 46, 51-52 (D.D.C. 1996); Chem. Mfrs. Ass'n v. CPSC, 600 F. Supp. 114, 117-18 (D.D.C. 1984) (explaining that "agency scientists may, for example, discuss hypotheses which have not matured, and can be effectively shared only with peers in regular and confidential communication"); see also Kirk D. Jensen. Note, The Reasonable Government Official Test: A Proposal for the Treatment of Factual Information Under the Federal Deliberative Process Privilege, 49 DUKE L.J. 561, 561-81 (1999) (summarizing this common-law privilege, and comparing it to FOIA's exemption from disclosure).
222. See John M. Mendeloff, Decision Analysis and FDA Drug Review: A Proposal for "Shadow" Advisory Committees. 6 RISK: HEALTH, SAFETY & ENVT. 203, 204-05 (1995). Although the agency may release summaries to the public when it approves an application, FDA employees generate detailed written evaluations for internal use only. Apart from protecting trade secrets and other confidential material, see Public Citizen Health Research Group v. FDA, 185 F.3d 898, 903-06 (D.C. Cir. 1999) (IND files), the Freedom of Information Act (FOIA) exempts pre-decisional deliberative process materials from disclosure, see 5 U.S.C. § 552(b)(5) (2000); Wolfe v. HHS, 839 F.2d 768, 774-76 (D.C. Cir. 1988) (en bane) (NDA files); Hunt v. U.S. Marine Corps, 935 F. Supp. 46, 51-52 (D.D.C. 1996); Chem. Mfrs. Ass'n v. CPSC, 600 F. Supp. 114, 117-18 (D.D.C. 1984) (explaining that "agency scientists may, for example, discuss hypotheses which have not matured, and can be effectively shared only with peers in regular and confidential communication"); see also Kirk D. Jensen. Note, The Reasonable Government Official Test: A Proposal for the Treatment of Factual Information Under the Federal Deliberative Process Privilege, 49 DUKE L.J. 561, 561-81 (1999) (summarizing this common-law privilege, and comparing it to FOIA's exemption from disclosure).
223. See John M. Mendeloff, Decision Analysis and FDA Drug Review: A Proposal for "Shadow" Advisory Committees. 6 RISK: HEALTH, SAFETY & ENVT. 203, 204-05 (1995). Although the agency may release summaries to the public when it approves an application, FDA employees generate detailed written evaluations for internal use only. Apart from protecting trade secrets and other confidential material, see Public Citizen Health Research Group v. FDA, 185 F.3d 898, 903-06 (D.C. Cir. 1999) (IND files), the Freedom of Information Act (FOIA) exempts pre-decisional deliberative process materials from disclosure, see 5 U.S.C. § 552(b)(5) (2000); Wolfe v. HHS, 839 F.2d 768, 774-76 (D.C. Cir. 1988) (en bane) (NDA files); Hunt v. U.S. Marine Corps, 935 F. Supp. 46, 51-52 (D.D.C. 1996); Chem. Mfrs. Ass'n v. CPSC, 600 F. Supp. 114, 117-18 (D.D.C. 1984) (explaining that "agency scientists may, for example, discuss hypotheses which have not matured, and can be effectively shared only with peers in regular and confidential communication"); see also Kirk D. Jensen. Note, The Reasonable Government Official Test: A Proposal for the Treatment of Factual Information Under the Federal Deliberative Process Privilege, 49 DUKE L.J. 561, 561-81 (1999) (summarizing this common-law privilege, and comparing it to FOIA's exemption from disclosure).
224. See John M. Mendeloff, Decision Analysis and FDA Drug Review: A Proposal for "Shadow" Advisory Committees. 6 RISK: HEALTH, SAFETY & ENVT. 203, 204-05 (1995). Although the agency may release summaries to the public when it approves an application, FDA employees generate detailed written evaluations for internal use only. Apart from protecting trade secrets and other confidential material, see Public Citizen Health Research Group v. FDA, 185 F.3d 898, 903-06 (D.C. Cir. 1999) (IND files), the Freedom of Information Act (FOIA) exempts pre-decisional deliberative process materials from disclosure, see 5 U.S.C. § 552(b)(5) (2000); Wolfe v. HHS, 839 F.2d 768, 774-76 (D.C. Cir. 1988) (en bane) (NDA files); Hunt v. U.S. Marine Corps, 935 F. Supp. 46, 51-52 (D.D.C. 1996); Chem. Mfrs. Ass'n v. CPSC, 600 F. Supp. 114, 117-18 (D.D.C. 1984) (explaining that "agency scientists may, for example, discuss hypotheses which have not matured, and can be effectively shared only with peers in regular and confidential communication"); see also Kirk D. Jensen. Note, The Reasonable Government Official Test: A Proposal for the Treatment of Factual Information Under the Federal Deliberative Process Privilege, 49 DUKE L.J. 561, 561-81 (1999) (summarizing this common-law privilege, and comparing it to FOIA's exemption from disclosure).
225. See Lars Noah, A Miscarriage in the Drug Approval Process?: Mifepristone Embroils the FDA in Abortion Politics, 36 WAKE FOREST L. REV. 571, 582-85, 592-93 & n.104 (2001).
226. See Richard A. Merrill & Bryan J. Rose, FDA Regulation of Human Cloning: Usurpation or Statesmanship?, 15 HARV. J.L. & TECH. 85, 139 (2001).
227. See Noah, supra note 25, at 1054.
228. See Noah, supra note 2, at 383-84 ("The demand for written consent forms may have more to do with providing an IRB something concrete and uniform to review in advance of a clinical trial than an assessment of the relative effectiveness of communicating in this fashion.").
229. See 21 C.F.R. § 56.109(e) (2003); 45 C.F.R. § 46.109(d) (2003).
230. See 21 C.F.R. § 56.109(e) (2003); 45 C.F.R. § 46.109(d) (2003).
231. See Lars Noah, The FDA's New Policy on Guidelines: Having Your Cake and Eating It Too, 47 CATH. U. L. REV. 113(1997).
232. See NBAC REPORT, supra note 10, at 13-14 ("The quality of IRB review is often compromised by the burden of excessive paperwork . . . . In all of their deliberations, IRBs must keep track of a range of detailed regulations and document the grounds on which they make their decisions in accordance with them."). As Coleman points out, IRB minutes do not provide much information. See Coleman, supra note 1, at 14, 40 & 49.
233. See NBAC REPORT, supra note 10, at 13-14 ("The quality of IRB review is often compromised by the burden of excessive paperwork . . . . In all of their deliberations, IRBs must keep track of a range of detailed regulations and document the grounds on which they make their decisions in accordance with them."). As Coleman points out, IRB minutes do not provide much information. See Coleman, supra note 1, at 14, 40 & 49.
234. See David C. Hadorn, Emerging Parallels in the American Health Care and Legal-Judicial Systems, 18 AM. J.L. & MED. 73, 88 n.36 (1992) (explaining that the NIH consensus development program uses a peer review panel as a decision maker in a process that resembles a judicial trial); Drummond Rennie Editorial, Consensus Statements, 304 NEW ENG. J. MED. 665, 666 (1981) (complaining that the recommendations produced by NIH consensus conferences are "bland generalities that represent the lowest common denominator of a debate-the only points on which the experts could wholeheartedly agree-and that these points must be so mild, so far from the cutting edge of progress, and so well established that surely everyone must already know them"); Paul M. Wortman et al., Do Consensus Conferences Work? A Process Evaluation of the NIH Consensus Development Program, 13 J. HEALTH POL. POL'Y & L. 469, 489-95 (1988) (identifying a variety of flaws in the process).
235. See David C. Hadorn, Emerging Parallels in the American Health Care and Legal-Judicial Systems, 18 AM. J.L. & MED. 73, 88 n.36 (1992) (explaining that the NIH consensus development program uses a peer review panel as a decision maker in a process that resembles a judicial trial); Drummond Rennie Editorial, Consensus Statements, 304 NEW ENG. J. MED. 665, 666 (1981) (complaining that the recommendations produced by NIH consensus conferences are "bland generalities that represent the lowest common denominator of a debate-the only points on which the experts could wholeheartedly agree-and that these points must be so mild, so far from the cutting edge of progress, and so well established that surely everyone must already know them"); Paul M. Wortman et al., Do Consensus Conferences Work? A Process Evaluation of the NIH Consensus Development Program, 13 J. HEALTH POL. POL'Y & L. 469, 489-95 (1988) (identifying a variety of flaws in the process).
236. See David C. Hadorn, Emerging Parallels in the American Health Care and Legal-Judicial Systems, 18 AM. J.L. & MED. 73, 88 n.36 (1992) (explaining that the NIH consensus development program uses a peer review panel as a decision maker in a process that resembles a judicial trial); Drummond Rennie Editorial, Consensus Statements, 304 NEW ENG. J. MED. 665, 666 (1981) (complaining that the recommendations produced by NIH consensus conferences are "bland generalities that represent the lowest common denominator of a debate-the only points on which the experts could wholeheartedly agree-and that these points must be so mild, so far from the cutting edge of progress, and so well established that surely everyone must already know them"); Paul M. Wortman et al., Do Consensus Conferences Work? A Process Evaluation of the NIH Consensus Development Program, 13 J. HEALTH POL. POL'Y & L. 469, 489-95 (1988) (identifying a variety of flaws in the process).
237. At least that is premise underlying state statues and decisional law protecting such documents from disclosure. See Susan O. Scheutzow, State Medical Peer Review: High Cost but No Benefit-Is It Time for a Change?, 25 AM. J. L. & MED. 7, 27-36, 49-60 (1999) (surveying state laws on the subject, but concluding that they do not by themselves adequately encourage hospitals to engage in peer review); Laurent B. Frantz, Annotation, Discovery of Hospital's Internal Records or Communications as to Qualifications or Evaluations of Individual Physician, 81 A.L.R.3D 944 (1977 & Supp. 2003); see also Doe v. Ill. Masonic Med. Ctr., 696 N.E.2d 707, 709-11 (Ill. App. 1998) (extending one state's peer review privilege to IRB documents). But see Konrady v. Oesterling, 149 F.R.D. 592 (D. Minn. 1993) (holding that the privilege did not cover IRBs).
238. At least that is premise underlying state statues and decisional law protecting such documents from disclosure. See Susan O. Scheutzow, State Medical Peer Review: High Cost but No Benefit-Is It Time for a Change?, 25 AM. J. L. & MED. 7, 27-36, 49-60 (1999) (surveying state laws on the subject, but concluding that they do not by themselves adequately encourage hospitals to engage in peer review); Laurent B. Frantz, Annotation, Discovery of Hospital's Internal Records or Communications as to Qualifications or Evaluations of Individual Physician, 81 A.L.R.3D 944 (1977 & Supp. 2003); see also Doe v. Ill. Masonic Med. Ctr., 696 N.E.2d 707, 709-11 (Ill. App. 1998) (extending one state's peer review privilege to IRB documents). But see Konrady v. Oesterling, 149 F.R.D. 592 (D. Minn. 1993) (holding that the privilege did not cover IRBs).
239. At least that is premise underlying state statues and decisional law protecting such documents from disclosure. See Susan O. Scheutzow, State Medical Peer Review: High Cost but No Benefit-Is It Time for a Change?, 25 AM. J. L. & MED. 7, 27-36, 49-60 (1999) (surveying state laws on the subject, but concluding that they do not by themselves adequately encourage hospitals to engage in peer review); Laurent B. Frantz, Annotation, Discovery of Hospital's Internal Records or Communications as to Qualifications or Evaluations of Individual Physician, 81 A.L.R.3D 944 (1977 & Supp. 2003); see also Doe v. Ill. Masonic Med. Ctr., 696 N.E.2d 707, 709-11 (Ill. App. 1998) (extending one state's peer review privilege to IRB documents). But see Konrady v. Oesterling, 149 F.R.D. 592 (D. Minn. 1993) (holding that the privilege did not cover IRBs).
240. At least that is premise underlying state statues and decisional law protecting such documents from disclosure. See Susan O. Scheutzow, State Medical Peer Review: High Cost but No Benefit-Is It Time for a Change?, 25 AM. J. L. & MED. 7, 27-36, 49-60 (1999) (surveying state laws on the subject, but concluding that they do not by themselves adequately encourage hospitals to engage in peer review); Laurent B. Frantz, Annotation, Discovery of Hospital's Internal Records or Communications as to Qualifications or Evaluations of Individual Physician, 81 A.L.R.3D 944 (1977 & Supp. 2003); see also Doe v. Ill. Masonic Med. Ctr., 696 N.E.2d 707, 709-11 (Ill. App. 1998) (extending one state's peer review privilege to IRB documents). But see Konrady v. Oesterling, 149 F.R.D. 592 (D. Minn. 1993) (holding that the privilege did not cover IRBs).
241. Cf. Philip M. Boffey, Scientists and Bureaucrats: A Clash of Cultures on FDA Advisory Panel, 191 SCIENCE 1244, 1244-45 (1976) (describing complaints by members of an expert advisory committee about open meetings). Some IRBs already do open up parts of their meetings. See Coleman, supra note 1, at 14 n.84; see also id. at 50 (suggesting that concerns about confidentiality in publishing decisions "might be addressed by redacting sensitive information"). FOIA does not require public disclosure of IRB records because these boards do not qualify as governmental agencies. See Goldner, supra note 7, at 110; Robertson, supra note 9, at 538, 542; see also Forsham v. Harris, 445 U.S. 169, 178 (1980) (concluding, in a case involving NIH-funded research relied on by the FDA, that "data generated by a privately controlled organization which has received grant funds from an agency . . . but which data has [sic] not at any time been obtained by the agency, are not 'agency records' accessible under FOIA").
242. Cf. Philip M. Boffey, Scientists and Bureaucrats: A Clash of Cultures on FDA Advisory Panel, 191 SCIENCE 1244, 1244-45 (1976) (describing complaints by members of an expert advisory committee about open meetings). Some IRBs already do open up parts of their meetings. See Coleman, supra note 1, at 14 n.84; see also id. at 50 (suggesting that concerns about confidentiality in publishing decisions "might be addressed by redacting sensitive information"). FOIA does not require public disclosure of IRB records because these boards do not qualify as governmental agencies. See Goldner, supra note 7, at 110; Robertson, supra note 9, at 538, 542; see also Forsham v. Harris, 445 U.S. 169, 178 (1980) (concluding, in a case involving NIH-funded research relied on by the FDA, that "data generated by a privately controlled organization which has received grant funds from an agency . . . but which data has [sic] not at any time been obtained by the agency, are not 'agency records' accessible under FOIA").
243. Cf. Philip M. Boffey, Scientists and Bureaucrats: A Clash of Cultures on FDA Advisory Panel, 191 SCIENCE 1244, 1244-45 (1976) (describing complaints by members of an expert advisory committee about open meetings). Some IRBs already do open up parts of their meetings. See Coleman, supra note 1, at 14 n.84; see also id. at 50 (suggesting that concerns about confidentiality in publishing decisions "might be addressed by redacting sensitive information"). FOIA does not require public disclosure of IRB records because these boards do not qualify as governmental agencies. See Goldner, supra note 7, at 110; Robertson, supra note 9, at 538, 542; see also Forsham v. Harris, 445 U.S. 169, 178 (1980) (concluding, in a case involving NIH-funded research relied on by the FDA, that "data generated by a privately controlled organization which has received grant funds from an agency . . . but which data has [sic] not at any time been obtained by the agency, are not 'agency records' accessible under FOIA").
244. Cf. Philip M. Boffey, Scientists and Bureaucrats: A Clash of Cultures on FDA Advisory Panel, 191 SCIENCE 1244, 1244-45 (1976) (describing complaints by members of an expert advisory committee about open meetings). Some IRBs already do open up parts of their meetings. See Coleman, supra note 1, at 14 n.84; see also id. at 50 (suggesting that concerns about confidentiality in publishing decisions "might be addressed by redacting sensitive information"). FOIA does not require public disclosure of IRB records because these boards do not qualify as governmental agencies. See Goldner, supra note 7, at 110; Robertson, supra note 9, at 538, 542; see also Forsham v. Harris, 445 U.S. 169, 178 (1980) (concluding, in a case involving NIH-funded research relied on by the FDA, that "data generated by a privately controlled organization which has received grant funds from an agency . . . but which data has [sic] not at any time been obtained by the agency, are not 'agency records' accessible under FOIA").
245. Cf. Philip M. Boffey, Scientists and Bureaucrats: A Clash of Cultures on FDA Advisory Panel, 191 SCIENCE 1244, 1244-45 (1976) (describing complaints by members of an expert advisory committee about open meetings). Some IRBs already do open up parts of their meetings. See Coleman, supra note 1, at 14 n.84; see also id. at 50 (suggesting that concerns about confidentiality in publishing decisions "might be addressed by redacting sensitive information"). FOIA does not require public disclosure of IRB records because these boards do not qualify as governmental agencies. See Goldner, supra note 7, at 110; Robertson, supra note 9, at 538, 542; see also Forsham v. Harris, 445 U.S. 169, 178 (1980) (concluding, in a case involving NIH-funded research relied on by the FDA, that "data generated by a privately controlled organization which has received grant funds from an agency . . . but which data has [sic] not at any time been obtained by the agency, are not 'agency records' accessible under FOIA").
246. Cf. Philip M. Boffey, Scientists and Bureaucrats: A Clash of Cultures on FDA Advisory Panel, 191 SCIENCE 1244, 1244-45 (1976) (describing complaints by members of an expert advisory committee about open meetings). Some IRBs already do open up parts of their meetings. See Coleman, supra note 1, at 14 n.84; see also id. at 50 (suggesting that concerns about confidentiality in publishing decisions "might be addressed by redacting sensitive information"). FOIA does not require public disclosure of IRB records because these boards do not qualify as governmental agencies. See Goldner, supra note 7, at 110; Robertson, supra note 9, at 538, 542; see also Forsham v. Harris, 445 U.S. 169, 178 (1980) (concluding, in a case involving NIH-funded research relied on by the FDA, that "data generated by a privately controlled organization which has received grant funds from an agency . . . but which data has [sic] not at any time been obtained by the agency, are not 'agency records' accessible under FOIA").
247. See Coleman, supra note 1, at 42-43; see also NRC REPORT, supra note 13, at 160 ("[A]n important benefit of peer review occurs before the review begins: risk assessors who expect an assessment to be subjected to serious scrutiny by eminent qualified reviewers are likely to be more careful and clear about the use and limits of scientific evidence."); DARYL E. CHUBIN " EDWARD J. HACKETT, PEERLESS SCIENCE: PEER REVIEW AND U.S. SCIENCE POLICY 88-89 (1990) (suggesting that "the anticipation of peer review may raise the general quality of scientific research because scientists may draw on their prior experience as reviewers and reviewees to imagine the criticisms that reviewers might make of their work and take measures to forestall or remedy them").
248. See Coleman, supra note 1, at 42-43; see also NRC REPORT, supra note 13, at 160 ("[A]n important benefit of peer review occurs before the review begins: risk assessors who expect an assessment to be subjected to serious scrutiny by eminent qualified reviewers are likely to be more careful and clear about the use and limits of scientific evidence."); DARYL E. CHUBIN " EDWARD J. HACKETT, PEERLESS SCIENCE: PEER REVIEW AND U.S. SCIENCE POLICY 88-89 (1990) (suggesting that "the anticipation of peer review may raise the general quality of scientific research because scientists may draw on their prior experience as reviewers and reviewees to imagine the criticisms that reviewers might make of their work and take measures to forestall or remedy them").
249. See Coleman, supra note 1, at 42-43; see also NRC REPORT, supra note 13, at 160 ("[A]n important benefit of peer review occurs before the review begins: risk assessors who expect an assessment to be subjected to serious scrutiny by eminent qualified reviewers are likely to be more careful and clear about the use and limits of scientific evidence."); DARYL E. CHUBIN " EDWARD J. HACKETT, PEERLESS SCIENCE: PEER REVIEW AND U.S. SCIENCE POLICY 88-89 (1990) (suggesting that "the anticipation of peer review may raise the general quality of scientific research because scientists may draw on their prior experience as reviewers and reviewees to imagine the criticisms that reviewers might make of their work and take measures to forestall or remedy them").
250. Similarly, some have described editorial peer review as analogous to an independent audit conducted by an accounting firm. See KENNETH R. FOSTER & PETER W. HUBER, JUDGING SCIENCE: SCIENTIFIC KNOWLEDGE AND THE FEDERAL COURTS 180 (1997); Drummond Rennie, Editorial, Editors and Auditors, 261 J. A.M.A. 2543 (1989).
251. Similarly, some have described editorial peer review as analogous to an independent audit conducted by an accounting firm. See KENNETH R. FOSTER & PETER W. HUBER, JUDGING SCIENCE: SCIENTIFIC KNOWLEDGE AND THE FEDERAL COURTS 180 (1997); Drummond Rennie, Editorial, Editors and Auditors, 261 J. A.M.A. 2543 (1989).
252. See 5 U.S.C. § 701(a)(2) (2000); Lincoln v. Vigil, 508 U.S. 182, 192-94 (1993) (allocation of funds from a lump-sum appropriation); Webster v.
253. See 5 U.S.C. § 701(a)(2) (2000); Lincoln v. Vigil, 508 U.S. 182, 192-94 (1993) (allocation of funds from a lump-sum appropriation); Webster v. Doe, 486 U.S. 592, 600-01 (1988) (termination of CIA employee thought to pose a security threat); ICC v. Brotherhood of Locomotive Eng'rs, 482 U.S. 270, 282 (1987) (refusal to grant a petition for reconsideration); Heckler v. Chaney, 470 U.S. 821, 831-38 (1985) (decision not to take enforcement action against drugs used for lethal injection); see also Ronald M. Levin, Understanding Unreviewability in Administrative Law, 74 MINN. L. REV. 689, 702-34 (1990) (elaborating on the Court's evolving gloss on this basis for precluding judicial review).
254. See 5 U.S.C. § 701(a)(2) (2000); Lincoln v. Vigil, 508 U.S. 182, 192-94 (1993) (allocation of funds from a lump-sum appropriation); Webster v. Doe, 486 U.S. 592, 600-01 (1988) (termination of CIA employee thought to pose a security threat); ICC v. Brotherhood of Locomotive Eng'rs, 482 U.S. 270, 282 (1987) (refusal to grant a petition for reconsideration); Heckler v. Chaney, 470 U.S. 821, 831-38 (1985) (decision not to take enforcement action against drugs used for lethal injection); see also Ronald M. Levin, Understanding Unreviewability in Administrative Law, 74 MINN. L. REV. 689, 702-34 (1990) (elaborating on the Court's evolving gloss on this basis for precluding judicial review).
255. See 5 U.S.C. § 701(a)(2) (2000); Lincoln v. Vigil, 508 U.S. 182, 192-94 (1993) (allocation of funds from a lump-sum appropriation); Webster v. Doe, 486 U.S. 592, 600-01 (1988) (termination of CIA employee thought to pose a security threat); ICC v. Brotherhood of Locomotive Eng'rs, 482 U.S. 270, 282 (1987) (refusal to grant a petition for reconsideration); Heckler v. Chaney, 470 U.S. 821, 831-38 (1985) (decision not to take enforcement action against drugs used for lethal injection); see also Ronald M. Levin, Understanding Unreviewability in Administrative Law, 74 MINN. L. REV. 689, 702-34 (1990) (elaborating on the Court's evolving gloss on this basis for precluding judicial review).
256. See 5 U.S.C. § 701(a)(2) (2000); Lincoln v. Vigil, 508 U.S. 182, 192-94 (1993) (allocation of funds from a lump-sum appropriation); Webster v. Doe, 486 U.S. 592, 600-01 (1988) (termination of CIA employee thought to pose a security threat); ICC v. Brotherhood of Locomotive Eng'rs, 482 U.S. 270, 282 (1987) (refusal to grant a petition for reconsideration); Heckler v. Chaney, 470 U.S. 821, 831-38 (1985) (decision not to take enforcement action against drugs used for lethal injection); see also Ronald M. Levin, Understanding Unreviewability in Administrative Law, 74 MINN. L. REV. 689, 702-34 (1990) (elaborating on the Court's evolving gloss on this basis for precluding judicial review).
257. See 5 U.S.C. § 701(a)(2) (2000); Lincoln v. Vigil, 508 U.S. 182, 192-94 (1993) (allocation of funds from a lump-sum appropriation); Webster v. Doe, 486 U.S. 592, 600-01 (1988) (termination of CIA employee thought to pose a security threat); ICC v. Brotherhood of Locomotive Eng'rs, 482 U.S. 270, 282 (1987) (refusal to grant a petition for reconsideration); Heckler v. Chaney, 470 U.S. 821, 831-38 (1985) (decision not to take enforcement action against drugs used for lethal injection); see also Ronald M. Levin, Understanding Unreviewability in Administrative Law, 74 MINN. L. REV. 689, 702-34 (1990) (elaborating on the Court's evolving gloss on this basis for precluding judicial review).
258. "See Halikas v. Univ. of Minn., 856 F. Supp. 1331, 1334 (D. Minn. 1994) ("The IRB is the mechanism by which a medical research institution maintains this integrity and humanity [of its research investigations]. . . . [A]n unwarranted intrusion [through a preliminary injunction] into the IRB's supervisory efforts would inflict grievous harm upon the University and this vital function."); see also Bd. of Curators of the Univ. of Mo. v. Horowitz, 435 U.S. 78, 89-90 (1978) (deferring to the presumed expertise underlying a medical school's decision to expel without a prior hearing a student on academic grounds).
259. "See Halikas v. Univ. of Minn., 856 F. Supp. 1331, 1334 (D. Minn. 1994) ("The IRB is the mechanism by which a medical research institution maintains this integrity and humanity [of its research investigations]. . . . [A]n unwarranted intrusion [through a preliminary injunction] into the IRB's supervisory efforts would inflict grievous harm upon the University and this vital function."); see also Bd. of Curators of the Univ. of Mo. v. Horowitz, 435 U.S. 78, 89-90 (1978) (deferring to the presumed expertise underlying a medical school's decision to expel without a prior hearing a student on academic grounds).
260. See Coleman, supra note 1, at 49 (recognizing that "the proposal will require a major infusion of resources to a system that already is severely underfunded").
261. John Robertson also has recommended the use of additional procedures, including written decisions and rights of appeal, but in an effort to protect the interests of researchers against overly rigid IRBs. See Robertson, supra note 9, at 511 n.149, 526-28 (cautioning, however, against taking these procedural rights too far). If, instead, we seek to protect the interests of subjects from overly lax IRBs, such additional procedures will only make the situation worse.
262. Coleman properly recognizes the problem caused-by this asymmetry. See Coleman, supra note 1, at 45 ("[T]he only individuals with a sufficient stake in the process to request an appeal will be the investigators, who would obviously appeal only when the IRB rejects their proposed research. However, the purpose of appellate oversight should be to ensure the quality and consistency of IRB deliberations, not simply to give disgruntled investigators a second bite at the apple."). The existing system, of course, ensures that PIs will not have an opportunity to seek a reversal of an IRB rejection. See supra note 24 and accompanying text. Coleman's interesting suggestions for facilitating appeals for protocol approvals, see Coleman, supra note 1, at 45, probably would not do much to reduce the imbalance.
263. Coleman properly recognizes the problem caused-by this asymmetry. See Coleman, supra note 1, at 45 ("[T]he only individuals with a sufficient stake in the process to request an appeal will be the investigators, who would obviously appeal only when the IRB rejects their proposed research. However, the purpose of appellate oversight should be to ensure the quality and consistency of IRB deliberations, not simply to give disgruntled investigators a second bite at the apple."). The existing system, of course, ensures that PIs will not have an opportunity to seek a reversal of an IRB rejection. See supra note 24 and accompanying text. Coleman's interesting suggestions for facilitating appeals for protocol approvals, see Coleman, supra note 1, at 45, probably would not do much to reduce the imbalance.
264. Coleman properly recognizes the problem caused-by this asymmetry. See Coleman, supra note 1, at 45 ("[T]he only individuals with a sufficient stake in the process to request an appeal will be the investigators, who would obviously appeal only when the IRB rejects their proposed research. However, the purpose of appellate oversight should be to ensure the quality and consistency of IRB deliberations, not simply to give disgruntled investigators a second bite at the apple."). The existing system, of course, ensures that PIs will not have an opportunity to seek a reversal of an IRB rejection. See supra note 24 and accompanying text. Coleman's interesting suggestions for facilitating appeals for protocol approvals, see Coleman, supra note 1, at 45, probably would not do much to reduce the imbalance.
265. See Henry J. Friendly, "Some Kind of Hearing," 123 U. PA. L. REV. 1267, 1316 (1975); Richard J. Pierce, Jr., The Due Process Counterrevolution of the 1990s?, 96 COLUM. L. REV. 1973, 1973, 1980-84 (1996); Edward L. Rubin, Due Process and the Administrative State, 72 CAL. L. REV. 1044, 1109-10, 1136-60 (1984); id. at 1045 ("The procedural due process doctrine's fall from grace may be ascribed to an excess of ambition.")
266. See Henry J. Friendly, "Some Kind of Hearing," 123 U. PA. L. REV. 1267, 1316 (1975); Richard J. Pierce, Jr., The Due Process Counterrevolution of the 1990s?, 96 COLUM. L. REV. 1973, 1973, 1980-84 (1996); Edward L. Rubin, Due Process and the Administrative State, 72 CAL. L. REV. 1044, 1109-10, 1136-60 (1984); id. at 1045 ("The procedural due process doctrine's fall from grace may be ascribed to an excess of ambition.")
267. See Henry J. Friendly, "Some Kind of Hearing," 123 U. PA. L. REV. 1267, 1316 (1975); Richard J. Pierce, Jr., The Due Process Counterrevolution of the 1990s?, 96 COLUM. L. REV. 1973, 1973, 1980-84 (1996); Edward L. Rubin, Due Process and the Administrative State, 72 CAL. L. REV. 1044, 1109-10, 1136-60 (1984); id. at 1045 ("The procedural due process doctrine's fall from grace may be ascribed to an excess of ambition.")
268. See Henry J. Friendly, "Some Kind of Hearing," 123 U. PA. L. REV. 1267, 1316 (1975); Richard J. Pierce, Jr., The Due Process Counterrevolution of the 1990s?, 96 COLUM. L. REV. 1973, 1973, 1980-84 (1996); Edward L. Rubin, Due Process and the Administrative State, 72 CAL. L. REV. 1044, 1109-10, 1136-60 (1984); id. at 1045 ("The procedural due process doctrine's fall from grace may be ascribed to an excess of ambition.")
269. See Goldberg v. Kelly, 397 U.S. 254, 269-71 (1970); see also id. at 266-67 ("[T]he pre-termination hearing need not take the form of a judicial or quasi-judicial trial . . . . Thus, a complete record and a comprehensive opinion, which would serve primarily to facilitate judicial review and to guide future decisions, need not be provided at the pre-termination stage.").
270. See Goldberg v. Kelly, 397 U.S. 254, 269-71 (1970); see also id. at 266-67 ("[T]he pre-termination hearing need not take the form of a judicial or quasi-judicial trial . . . . Thus, a complete record and a comprehensive opinion, which would serve primarily to facilitate judicial review and to guide future decisions, need not be provided at the pre-termination stage.").
271. See Bd. of Regents of State Colleges v. Roth, 408 U.S. 564, 588, 591 (1972) (Marshall, J., dissenting) ("[I]t is not burdensome to give reasons when reasons exist . . . . It can scarcely be argued that government would be crippled by a requirement that the reason be communicated to the person most directly affected by the government's action. Where there are numerous applicants for jobs, it is likely that few will choose to demand reasons for not being hired."); see also id. at 592 ("When the government knows it may have to justify its decisions with sound reasons, its conduct is likely to be more cautious, careful, and correct."). Of course, if the Court had ever adopted such an expansive trigger for procedural due process, then it would surely have expressed dissatisfaction with boilerplate rejection letters that simply explain that many other qualified persons had applied for the same position or other scarce resource.
272. See Bd. of Regents of State Colleges v. Roth, 408 U.S. 564, 588, 591 (1972) (Marshall, J., dissenting) ("[I]t is not burdensome to give reasons when reasons exist . . . . It can scarcely be argued that government would be crippled by a requirement that the reason be communicated to the person most directly affected by the government's action. Where there are numerous applicants for jobs, it is likely that few will choose to demand reasons for not being hired."); see also id. at 592 ("When the government knows it may have to justify its decisions with sound reasons, its conduct is likely to be more cautious, careful, and correct."). Of course, if the Court had ever adopted such an expansive trigger for procedural due process, then it would surely have expressed dissatisfaction with boilerplate rejection letters that simply explain that many other qualified persons had applied for the same position or other scarce resource.
273. See Mathews v. Eldridge, 424 U.S. 319, 348 (1976) ("The judicial model of an evidentiary hearing is neither a required, nor even the most effective, method of decisionmaking in all circumstances."); see also Pierce, supra note 103, at 1981 ("The Court qualified and clarified its prior opinions in myriad ways that negated many of the broad interpretations suggested by the bold dicta sprinkled throughout the revolutionary decisions."); id. at 1999 ("Courts systematically overestimate the benefits and underestimate the costs of formal decisionmaking. The net result is the diversion of scarce resources from the intended beneficiaries of a program to the army of lawyers and administrative judges required to implement the new decisionmaking procedures." (footnotes omitted)); William H. Simon, Legality, Bureaucracy, and Class in the Welfare System, 92 YALE L.J. 1198, 1240-45 (1983) (arguing against the dominant vision that urged resort to legal tools in order to constrain the "discretion" in a system premised on "informality, decentralization, and professionalization").
274. See Mathews v. Eldridge, 424 U.S. 319, 348 (1976) ("The judicial model of an evidentiary hearing is neither a required, nor even the most effective, method of decisionmaking in all circumstances."); see also Pierce, supra note 103, at 1981 ("The Court qualified and clarified its prior opinions in myriad ways that negated many of the broad interpretations suggested by the bold dicta sprinkled throughout the revolutionary decisions."); id. at 1999 ("Courts systematically overestimate the benefits and underestimate the costs of formal decisionmaking. The net result is the diversion of scarce resources from the intended beneficiaries of a program to the army of lawyers and administrative judges required to implement the new decisionmaking procedures." (footnotes omitted)); William H. Simon, Legality, Bureaucracy, and Class in the Welfare System, 92 YALE L.J. 1198, 1240-45 (1983) (arguing against the dominant vision that urged resort to legal tools in order to constrain the "discretion" in a system premised on "informality, decentralization, and professionalization").
275. See Mathews v. Eldridge, 424 U.S. 319, 348 (1976) ("The judicial model of an evidentiary hearing is neither a required, nor even the most effective, method of decisionmaking in all circumstances."); see also Pierce, supra note 103, at 1981 ("The Court qualified and clarified its prior opinions in myriad ways that negated many of the broad interpretations suggested by the bold dicta sprinkled throughout the revolutionary decisions."); id. at 1999 ("Courts systematically overestimate the benefits and underestimate the costs of formal decisionmaking. The net result is the diversion of scarce resources from the intended beneficiaries of a program to the army of lawyers and administrative judges required to implement the new decisionmaking procedures." (footnotes omitted)); William H. Simon, Legality, Bureaucracy, and Class in the Welfare System, 92 YALE L.J. 1198, 1240-45 (1983) (arguing against the dominant vision that urged resort to legal tools in order to constrain the "discretion" in a system premised on "informality, decentralization, and professionalization").
276. See Mathews v. Eldridge, 424 U.S. 319, 348 (1976) ("The judicial model of an evidentiary hearing is neither a required, nor even the most effective, method of decisionmaking in all circumstances."); see also Pierce, supra note 103, at 1981 ("The Court qualified and clarified its prior opinions in myriad ways that negated many of the broad interpretations suggested by the bold dicta sprinkled throughout the revolutionary decisions."); id. at 1999 ("Courts systematically overestimate the benefits and underestimate the costs of formal decisionmaking. The net result is the diversion of scarce resources from the intended beneficiaries of a program to the army of lawyers and administrative judges required to implement the new decisionmaking procedures." (footnotes omitted)); William H. Simon, Legality, Bureaucracy, and Class in the Welfare System, 92 YALE L.J. 1198, 1240-45 (1983) (arguing against the dominant vision that urged resort to legal tools in order to constrain the "discretion" in a system premised on "informality, decentralization, and professionalization").
277. See Noah, supra note 25, at 1040 n.23, 1074 nn. 185-86.
278. See Colin S. Diver, Policymaking Paradigms in Administrative Law, 95 HARV. L. REV. 393, 410-22, 428 (1981) ("At its best, comprehensive rationality makes ravenous demands on agencies' limited investigative resources and cognitive faculties. Judged by its demanding standards, policymakers are virtually defenseless against reproof for falling short."); see also Harold H. Bruff, Legislative Formality, Administrative Rationality, 63 TEX. L. REV. 207, 240-41 (1984); Martin Shapiro, APA: Past, Present, Future, 72 VA. L. REV. 447,466 & n.21, 478-80 (1986).
279. See Colin S. Diver, Policymaking Paradigms in Administrative Law, 95 HARV. L. REV. 393, 410-22, 428 (1981) ("At its best, comprehensive rationality makes ravenous demands on agencies' limited investigative resources and cognitive faculties. Judged by its demanding standards, policymakers are virtually defenseless against reproof for falling short."); see also Harold H. Bruff, Legislative Formality, Administrative Rationality, 63 TEX. L. REV. 207, 240-41 (1984); Martin Shapiro, APA: Past, Present, Future, 72 VA. L. REV. 447,466 & n.21, 478-80 (1986).
280. See Colin S. Diver, Policymaking Paradigms in Administrative Law, 95 HARV. L. REV. 393, 410-22, 428 (1981) ("At its best, comprehensive rationality makes ravenous demands on agencies' limited investigative resources and cognitive faculties. Judged by its demanding standards, policymakers are virtually defenseless against reproof for falling short."); see also Harold H. Bruff, Legislative Formality, Administrative Rationality, 63 TEX. L. REV. 207, 240-41 (1984); Martin Shapiro, APA: Past, Present, Future, 72 VA. L. REV. 447,466 & n.21, 478-80 (1986).
281. Compare Frank B. Cross, Pragmatic Pathologies of Judicial Review of Administrative Rulemaking, 78 N.C. L. REV. 1013 (2000), with Mark Seidenfeld, Demystifying Deossification: Rethinking Recent Proposals to Modify Judicial Review of Notice and Comment Rulemaking, 75 TEX. L. REV. 483, 523-24 (1997) (defending its value). See generally THOMAS O. MCGARITY, REINVENTING RATIONALITY: THE ROLE OF REGULATORY ANALYSIS IN THE FEDERAL BUREAUCRACY (1991) (discussing the virtues and limitations of regulatory impact analysis).
282. Compare Frank B. Cross, Pragmatic Pathologies of Judicial Review of Administrative Rulemaking, 78 N.C. L. REV. 1013 (2000), with Mark Seidenfeld, Demystifying Deossification: Rethinking Recent Proposals to Modify Judicial Review of Notice and Comment Rulemaking, 75 TEX. L. REV. 483, 523-24 (1997) (defending its value). See generally THOMAS O. MCGARITY, REINVENTING RATIONALITY: THE ROLE OF REGULATORY ANALYSIS IN THE FEDERAL BUREAUCRACY (1991) (discussing the virtues and limitations of regulatory impact analysis).
283. Compare Frank B. Cross, Pragmatic Pathologies of Judicial Review of Administrative Rulemaking, 78 N.C. L. REV. 1013 (2000), with Mark Seidenfeld, Demystifying Deossification: Rethinking Recent Proposals to Modify Judicial Review of Notice and Comment Rulemaking, 75 TEX. L. REV. 483, 523-24 (1997) (defending its value). See generally THOMAS O. MCGARITY, REINVENTING RATIONALITY: THE ROLE OF REGULATORY ANALYSIS IN THE FEDERAL BUREAUCRACY (1991) (discussing the virtues and limitations of regulatory impact analysis).
284. See Lars Noah, Doubts About Direct Final Rulemaking, 51 ADMIN. L. REV. 401, 403-05 (1999).
285. See e.g.. Asbestos Info. Ass'n/North Am. v. OSHA, 727 F.2d 415, 425-27 (5th Cir. 1984); Gulf South Insulation v. CPSC, 701 F.2d 1137, 1146-47 (5th Cir. 1983); Flue-Cured Tobacco Co-op, v. EPA, 4 F. Supp.2d 435, 456-63 (M.D.N.C. 1998); see also Sheila Jasanoff & Dorothy Nelkin, Science, Technology, and the Limits of Judicial Competence, 22 JURIMETRICS J. 266, 272-73 (1982).
286. See e.g.. Asbestos Info. Ass'n/North Am. v. OSHA, 727 F.2d 415, 425-27 (5th Cir. 1984); Gulf South Insulation v. CPSC, 701 F.2d 1137, 1146-47 (5th Cir. 1983); Flue-Cured Tobacco Co-op, v. EPA, 4 F. Supp.2d 435, 456-63 (M.D.N.C. 1998); see also Sheila Jasanoff & Dorothy Nelkin, Science, Technology, and the Limits of Judicial Competence, 22 JURIMETRICS J. 266, 272-73 (1982).
287. See e.g.. Asbestos Info. Ass'n/North Am. v. OSHA, 727 F.2d 415, 425-27 (5th Cir. 1984); Gulf South Insulation v. CPSC, 701 F.2d 1137, 1146-47 (5th Cir. 1983); Flue-Cured Tobacco Co-op, v. EPA, 4 F. Supp.2d 435, 456-63 (M.D.N.C. 1998); see also Sheila Jasanoff & Dorothy Nelkin, Science, Technology, and the Limits of Judicial Competence, 22 JURIMETRICS J. 266, 272-73 (1982).
288. See e.g.. Asbestos Info. Ass'n/North Am. v. OSHA, 727 F.2d 415, 425-27 (5th Cir. 1984); Gulf South Insulation v. CPSC, 701 F.2d 1137, 1146-47 (5th Cir. 1983); Flue-Cured Tobacco Co-op, v. EPA, 4 F. Supp.2d 435, 456-63 (M.D.N.C. 1998); see also Sheila Jasanoff & Dorothy Nelkin, Science, Technology, and the Limits of Judicial Competence, 22 JURIMETRICS J. 266, 272-73 (1982).
289. Industrial Union Dep't v. Am. Petroleum Inst., 448 U.S. 607,655 (1980) (plurality opinion). A few years later, the Court had the good sense to announce that it would discontinue such amateurish attempts at reviewing risk assessments. See Baltimore Gas & Elec. Co. v. NRDC, 462 U.S. 87, 103 (1983) (emphasizing that, when an agency is making predictions "at the frontiers of science . . . a reviewing court must generally be at its most deferential"); cf. Andrew D. Siegel, "The Aftermath of Baltimore Gas & Electric Co. v. NRDC: A Broader Notion of Judicial Deference to Agency Expertise, 11 HARV. ENVTL. L. REV: 331, 378-80 (1987) (criticizing this excessively deferential posture).
290. Industrial Union Dep't v. Am. Petroleum Inst., 448 U.S. 607,655 (1980) (plurality opinion). A few years later, the Court had the good sense to announce that it would discontinue such amateurish attempts at reviewing risk assessments. See Baltimore Gas & Elec. Co. v. NRDC, 462 U.S. 87, 103 (1983) (emphasizing that, when an agency is making predictions "at the frontiers of science . . . a reviewing court must generally be at its most deferential"); cf. Andrew D. Siegel, "The Aftermath of Baltimore Gas & Electric Co. v. NRDC: A Broader Notion of Judicial Deference to Agency Expertise, 11 HARV. ENVTL. L. REV: 331, 378-80 (1987) (criticizing this excessively deferential posture).
291. Industrial Union Dep't v. Am. Petroleum Inst., 448 U.S. 607,655 (1980) (plurality opinion). A few years later, the Court had the good sense to announce that it would discontinue such amateurish attempts at reviewing risk assessments. See Baltimore Gas & Elec. Co. v. NRDC, 462 U.S. 87, 103 (1983) (emphasizing that, when an agency is making predictions "at the frontiers of science . . . a reviewing court must generally be at its most deferential"); cf. Andrew D. Siegel, "The Aftermath of Baltimore Gas & Electric Co. v. NRDC: A Broader Notion of Judicial Deference to Agency Expertise, 11 HARV. ENVTL. L. REV: 331, 378-80 (1987) (criticizing this excessively deferential posture).
292. If one converts the chlorinated water example to "regular exposure" (assuming that an average person drinks 2 glasses of water a day over the course of 70 years), then a person would face a 1-in-20,000 increased risk of a cancer death, still far smaller than the hypothesized 1-in-50 risk for benzene but a good deal larger than other risks of concern to regulatory agencies. See Lars Noah, The Imperative to Warn: Disentangling the "Right to Know" from the "Need to Know" About Consumer Product Hazards, 11 YALE J. ON REG. 293, 364, 393-94, (1994); Lars Noah & Richard A, Merrill, Starting from Scratch?: Reinventing the Food Additive Approval Process, 78 B.U. L. REV. 329, 395-401 (1998). In addition, if one compares the population of Americans who drink water to those who regularly inhale benzene fumes on the job, the aggregate number of excess cancer deaths becomes nearly identical. Finally, reasonable consumers may view undisclosed risks from drinking water as more worrisome than voluntarily encountered risks by those who work in dangerous occupational settings (whether or not any wage premium compensates for the added risk).
293. If one converts the chlorinated water example to "regular exposure" (assuming that an average person drinks 2 glasses of water a day over the course of 70 years), then a person would face a 1-in-20,000 increased risk of a cancer death, still far smaller than the hypothesized 1-in-50 risk for benzene but a good deal larger than other risks of concern to regulatory agencies. See Lars Noah, The Imperative to Warn: Disentangling the "Right to Know" from the "Need to Know" About Consumer Product Hazards, 11 YALE J. ON REG. 293, 364, 393-94, (1994); Lars Noah & Richard A, Merrill, Starting from Scratch?: Reinventing the Food Additive Approval Process, 78 B.U. L. REV. 329, 395-401 (1998). In addition, if one compares the population of Americans who drink water to those who regularly inhale benzene fumes on the job, the aggregate number of excess cancer deaths becomes nearly identical. Finally, reasonable consumers may view undisclosed risks from drinking water as more worrisome than voluntarily encountered risks by those who work in dangerous occupational settings (whether or not any wage premium compensates for the added risk).
294. See Coleman, supra note 1, at 26-27.
295. See Noah, supra note 25, at 1034-37, 1047-59.
296. See id. at 1070-83; id. at 1037 ("[B]y harnessing nongovernmental expertise and retaining current mechanisms for review by nonexperts, regulatory peer review may help administrative agencies . . . ."); id. at 1044 ("A number of federal health and safety agencies have used outside experts to scrutinize their decisions, with varying degrees of success depending in part on whether peer review aspires to a collaborative rather than an adversarial model."); id. at 1071 (concluding that "peer review is best understood as a supplement to, rather than a substitute for, existing forms of external scrutiny" of agency actions); see also H.R. REP. No. 96-1020, at 4-5 (1980), reprinted in 1980 U.S.C.C.A.N. 6721, 6723-24 (noting concerns that the EPA's Scientific Advisory Panel "may be functioning under adversary procedures attempting to act as an administrative law judge or as an arbitrator between scientists of conflicting opinions"); STEPHEN BREYER, BREAKING THE Vicious CIRCLE: TOWARD EFFECTIVE RISK REGULATION 68 (1993) (mentioning the creation of the EPA's Science Advisory Board and other specialized advisory committees, and noting that "[t]hose who have studied the work of these committees find that they have led to significant improvements . . . [in part because] consultation is often private and nonadversarial").
297. See id. at 1070-83; id. at 1037 ("[B]y harnessing nongovernmental expertise and retaining current mechanisms for review by nonexperts, regulatory peer review may help administrative agencies . . . ."); id. at 1044 ("A number of federal health and safety agencies have used outside experts to scrutinize their decisions, with varying degrees of success depending in part on whether peer review aspires to a collaborative rather than an adversarial model."); id. at 1071 (concluding that "peer review is best understood as a supplement to, rather than a substitute for, existing forms of external scrutiny" of agency actions); see also H.R. REP. No. 96-1020, at 4-5 (1980), reprinted in 1980 U.S.C.C.A.N. 6721, 6723-24 (noting concerns that the EPA's Scientific Advisory Panel "may be functioning under adversary procedures attempting to act as an administrative law judge or as an arbitrator between scientists of conflicting opinions"); STEPHEN BREYER, BREAKING THE Vicious CIRCLE: TOWARD EFFECTIVE RISK REGULATION 68 (1993) (mentioning the creation of the EPA's Science Advisory Board and other specialized advisory committees, and noting that "[t]hose who have studied the work of these committees find that they have led to significant improvements . . . [in part because] consultation is often private and nonadversarial").
298. See id. at 1070-83; id. at 1037 ("[B]y harnessing nongovernmental expertise and retaining current mechanisms for review by nonexperts, regulatory peer review may help administrative agencies . . . ."); id. at 1044 ("A number of federal health and safety agencies have used outside experts to scrutinize their decisions, with varying degrees of success depending in part on whether peer review aspires to a collaborative rather than an adversarial model."); id. at 1071 (concluding that "peer review is best understood as a supplement to, rather than a substitute for, existing forms of external scrutiny" of agency actions); see also H.R. REP. No. 96-1020, at 4-5 (1980), reprinted in 1980 U.S.C.C.A.N. 6721, 6723-24 (noting concerns that the EPA's Scientific Advisory Panel "may be functioning under adversary procedures attempting to act as an administrative law judge or as an arbitrator between scientists of conflicting opinions"); STEPHEN BREYER, BREAKING THE Vicious CIRCLE: TOWARD EFFECTIVE RISK REGULATION 68 (1993) (mentioning the creation of the EPA's Science Advisory Board and other specialized advisory committees, and noting that "[t]hose who have studied the work of these committees find that they have led to significant improvements . . . [in part because] consultation is often private and nonadversarial").
299. See id. at 1070-83; id. at 1037 ("[B]y harnessing nongovernmental expertise and retaining current mechanisms for review by nonexperts, regulatory peer review may help administrative agencies . . . ."); id. at 1044 ("A number of federal health and safety agencies have used outside experts to scrutinize their decisions, with varying degrees of success depending in part on whether peer review aspires to a collaborative rather than an adversarial model."); id. at 1071 (concluding that "peer review is best understood as a supplement to, rather than a substitute for, existing forms of external scrutiny" of agency actions); see also H.R. REP. No. 96-1020, at 4-5 (1980), reprinted in 1980 U.S.C.C.A.N. 6721, 6723-24 (noting concerns that the EPA's Scientific Advisory Panel "may be functioning under adversary procedures attempting to act as an administrative law judge or as an arbitrator between scientists of conflicting opinions"); STEPHEN BREYER, BREAKING THE Vicious CIRCLE: TOWARD EFFECTIVE RISK REGULATION 68 (1993) (mentioning the creation of the EPA's Science Advisory Board and other specialized advisory committees, and noting that "[t]hose who have studied the work of these committees find that they have led to significant improvements . . . [in part because] consultation is often private and nonadversarial").
300. See id. at 1070-83; id. at 1037 ("[B]y harnessing nongovernmental expertise and retaining current mechanisms for review by nonexperts, regulatory peer review may help administrative agencies . . . ."); id. at 1044 ("A number of federal health and safety agencies have used outside experts to scrutinize their decisions, with varying degrees of success depending in part on whether peer review aspires to a collaborative rather than an adversarial model."); id. at 1071 (concluding that "peer review is best understood as a supplement to, rather than a substitute for, existing forms of external scrutiny" of agency actions); see also H.R. REP. No. 96-1020, at 4-5 (1980), reprinted in 1980 U.S.C.C.A.N. 6721, 6723-24 (noting concerns that the EPA's Scientific Advisory Panel "may be functioning under adversary procedures attempting to act as an administrative law judge or as an arbitrator between scientists of conflicting opinions"); STEPHEN BREYER, BREAKING THE Vicious CIRCLE: TOWARD EFFECTIVE RISK REGULATION 68 (1993) (mentioning the creation of the EPA's Science Advisory Board and other specialized advisory committees, and noting that "[t]hose who have studied the work of these committees find that they have led to significant improvements . . . [in part because] consultation is often private and nonadversarial").
301. See id. at 1070-83; id. at 1037 ("[B]y harnessing nongovernmental expertise and retaining current mechanisms for review by nonexperts, regulatory peer review may help administrative agencies . . . ."); id. at 1044 ("A number of federal health and safety agencies have used outside experts to scrutinize their decisions, with varying degrees of success depending in part on whether peer review aspires to a collaborative rather than an adversarial model."); id. at 1071 (concluding that "peer review is best understood as a supplement to, rather than a substitute for, existing forms of external scrutiny" of agency actions); see also H.R. REP. No. 96-1020, at 4-5 (1980), reprinted in 1980 U.S.C.C.A.N. 6721, 6723-24 (noting concerns that the EPA's Scientific Advisory Panel "may be functioning under adversary procedures attempting to act as an administrative law judge or as an arbitrator between scientists of conflicting opinions"); STEPHEN BREYER, BREAKING THE Vicious CIRCLE: TOWARD EFFECTIVE RISK REGULATION 68 (1993) (mentioning the creation of the EPA's Science Advisory Board and other specialized advisory committees, and noting that "[t]hose who have studied the work of these committees find that they have led to significant improvements . . . [in part because] consultation is often private and nonadversarial").
302. See James A. Martin, The Proposed "Science Court", 75 MICH. L. REV. 1058, 1069-86 (1977) (summarizing this suggestion, and emphasizing its adversarial character); id. at 1076 ("The virtue of the science court proposal is that it harnesses bias and self-interest through the use of advocates, while judges remain as impartial as possible in considering scientific questions."); Jeffrey N. Martin, Note, Procedures for Decisionmaking Under Conditions of Scientific Uncertainty: The Science Court Proposal, 16 HARV. J. ON LEGIS. 443, 454-68 (1979) (contrasting the science court proposals with the use of scientific advisory committees); see also Jeremy D. Fraiberg & Michael J. Trebilcock, Risk Regulation: Technocratic and Democratic Tools for Regulatory Reform, 43 McGILL L.J. 835, 874-75 (1998) (advocating that peer review of risk assessments emulate the science court model); Arthur Kantrowitz, The Science Court Experiment, 17 JURIMETRICS J. 332 (1977).
303. See James A. Martin, The Proposed "Science Court", 75 MICH. L. REV. 1058, 1069-86 (1977) (summarizing this suggestion, and emphasizing its adversarial character); id. at 1076 ("The virtue of the science court proposal is that it harnesses bias and self-interest through the use of advocates, while judges remain as impartial as possible in considering scientific questions."); Jeffrey N. Martin, Note, Procedures for Decisionmaking Under Conditions of Scientific Uncertainty: The Science Court Proposal, 16 HARV. J. ON LEGIS. 443, 454-68 (1979) (contrasting the science court proposals with the use of scientific advisory committees); see also Jeremy D. Fraiberg & Michael J. Trebilcock, Risk Regulation: Technocratic and Democratic Tools for Regulatory Reform, 43 McGILL L.J. 835, 874-75 (1998) (advocating that peer review of risk assessments emulate the science court model); Arthur Kantrowitz, The Science Court Experiment, 17 JURIMETRICS J. 332 (1977).
304. See James A. Martin, The Proposed "Science Court", 75 MICH. L. REV. 1058, 1069-86 (1977) (summarizing this suggestion, and emphasizing its adversarial character); id. at 1076 ("The virtue of the science court proposal is that it harnesses bias and self-interest through the use of advocates, while judges remain as impartial as possible in considering scientific questions."); Jeffrey N. Martin, Note, Procedures for Decisionmaking Under Conditions of Scientific Uncertainty: The Science Court Proposal, 16 HARV. J. ON LEGIS. 443, 454-68 (1979) (contrasting the science court proposals with the use of scientific advisory committees); see also Jeremy D. Fraiberg & Michael J. Trebilcock, Risk Regulation: Technocratic and Democratic Tools for Regulatory Reform, 43 McGILL L.J. 835, 874-75 (1998) (advocating that peer review of risk assessments emulate the science court model); Arthur Kantrowitz, The Science Court Experiment, 17 JURIMETRICS J. 332 (1977).
305. See James A. Martin, The Proposed "Science Court", 75 MICH. L. REV. 1058, 1069-86 (1977) (summarizing this suggestion, and emphasizing its adversarial character); id. at 1076 ("The virtue of the science court proposal is that it harnesses bias and self-interest through the use of advocates, while judges remain as impartial as possible in considering scientific questions."); Jeffrey N. Martin, Note, Procedures for Decisionmaking Under Conditions of Scientific Uncertainty: The Science Court Proposal, 16 HARV. J. ON LEGIS. 443, 454-68 (1979) (contrasting the science court proposals with the use of scientific advisory committees); see also Jeremy D. Fraiberg & Michael J. Trebilcock, Risk Regulation: Technocratic and Democratic Tools for Regulatory Reform, 43 McGILL L.J. 835, 874-75 (1998) (advocating that peer review of risk assessments emulate the science court model); Arthur Kantrowitz, The Science Court Experiment, 17 JURIMETRICS J. 332 (1977).
306. See James A. Martin, The Proposed "Science Court", 75 MICH. L. REV. 1058, 1069-86 (1977) (summarizing this suggestion, and emphasizing its adversarial character); id. at 1076 ("The virtue of the science court proposal is that it harnesses bias and self-interest through the use of advocates, while judges remain as impartial as possible in considering scientific questions."); Jeffrey N. Martin, Note, Procedures for Decisionmaking Under Conditions of Scientific Uncertainty: The Science Court Proposal, 16 HARV. J. ON LEGIS. 443, 454-68 (1979) (contrasting the science court proposals with the use of scientific advisory committees); see also Jeremy D. Fraiberg & Michael J. Trebilcock, Risk Regulation: Technocratic and Democratic Tools for Regulatory Reform, 43 McGILL L.J. 835, 874-75 (1998) (advocating that peer review of risk assessments emulate the science court model); Arthur Kantrowitz, The Science Court Experiment, 17 JURIMETRICS J. 332 (1977).
307. See David L. Bazelon, Coping with Technology Through the Legal Process, 62 CORNELL L. REV. 817, 827-28 (1977); Joel Yellin, Science, Technology, and Administrative Government: Institutional Designs for Environmental Decisionmaking, 92 YALE L.J. 1300, 1307-12, 1332 (1983) (disputing the underlying premise that one can separate technical and political questions, and questioning the value of an adversarial process); see also Noah, supra note 25, at 1064 (&[L]egislative over-specification of the procedures for peer review will make this hybridized process unduly cumbersome. If understood as a structured form of brainstorming by a group of scientists from different backgrounds, peer review cannot function as effectively if the process becomes excessively proceduralized.& (footnote omitted)); id. at 1077-78 ("A peer review panel should not become a science court, brought in at the end of the process and asked to resolve the conflicting positions of adversaries about issues that often transcend science.").
308. See David L. Bazelon, Coping with Technology Through the Legal Process, 62 CORNELL L. REV. 817, 827-28 (1977); Joel Yellin, Science, Technology, and Administrative Government: Institutional Designs for Environmental Decisionmaking, 92 YALE L.J. 1300, 1307-12, 1332 (1983) (disputing the underlying premise that one can separate technical and political questions, and questioning the value of an adversarial process); see also Noah, supra note 25, at 1064 (&[L]egislative over-specification of the procedures for peer review will make this hybridized process unduly cumbersome. If understood as a structured form of brainstorming by a group of scientists from different backgrounds, peer review cannot function as effectively if the process becomes excessively proceduralized.& (footnote omitted)); id. at 1077-78 ("A peer review panel should not become a science court, brought in at the end of the process and asked to resolve the conflicting positions of adversaries about issues that often transcend science.").
309. See David L. Bazelon, Coping with Technology Through the Legal Process, 62 CORNELL L. REV. 817, 827-28 (1977); Joel Yellin, Science, Technology, and Administrative Government: Institutional Designs for Environmental Decisionmaking, 92 YALE L.J. 1300, 1307-12, 1332 (1983) (disputing the underlying premise that one can separate technical and political questions, and questioning the value of an adversarial process); see also Noah, supra note 25, at 1064 (&[L]egislative over-specification of the procedures for peer review will make this hybridized process unduly cumbersome. If understood as a structured form of brainstorming by a group of scientists from different backgrounds, peer review cannot function as effectively if the process becomes excessively proceduralized.& (footnote omitted)); id. at 1077-78 ("A peer review panel should not become a science court, brought in at the end of the process and asked to resolve the conflicting positions of adversaries about issues that often transcend science.").
310. See David L. Bazelon, Coping with Technology Through the Legal Process, 62 CORNELL L. REV. 817, 827-28 (1977); Joel Yellin, Science, Technology, and Administrative Government: Institutional Designs for Environmental Decisionmaking, 92 YALE L.J. 1300, 1307-12, 1332 (1983) (disputing the underlying premise that one can separate technical and political questions, and questioning the value of an adversarial process); see also Noah, supra note 25, at 1064 (&[L]egislative over-specification of the procedures for peer review will make this hybridized process unduly cumbersome. If understood as a structured form of brainstorming by a group of scientists from different backgrounds, peer review cannot function as effectively if the process becomes excessively proceduralized.& (footnote omitted)); id. at 1077-78 ("A peer review panel should not become a science court, brought in at the end of the process and asked to resolve the conflicting positions of adversaries about issues that often transcend science.").
311. See Noah, supra note 25, at 1055-56; see also Sidney A. Shapiro, Scientific Issues and the Function of Hearing Procedures: Evaluating the FDA 's Public Board of Inquiry, 1986 DUKE L.J. 288, 345 ("In an analysis of whether a 'scientific' or 'adversarial' process better resolves issues of scientific judgment, the results are mixed.").
312. See Noah, supra note 25, at 1055-56; see also Sidney A. Shapiro, Scientific Issues and the Function of Hearing Procedures: Evaluating the FDA 's Public Board of Inquiry, 1986 DUKE L.J. 288, 345 ("In an analysis of whether a 'scientific' or 'adversarial' process better resolves issues of scientific judgment, the results are mixed.").
313. See Coleman, supra note 1, at 50. In contrast, researchers do a poor job of finding and evaluating "precedent" in the published biomedical literature. See Noah, supra note 53, at 704 ("Unlike judicial precedent, whose continued authoritativeness can be checked quite easily, retractions or corrections to scientific articles are less readily found.").
314. See Coleman, supra note 1, at 50. In contrast, researchers do a poor job of finding and evaluating "precedent" in the published biomedical literature. See Noah, supra note 53, at 704 ("Unlike judicial precedent, whose continued authoritativeness can be checked quite easily, retractions or corrections to scientific articles are less readily found.").
315. See Coleman, supra note 1, at 22 ("IRBs . . . rely largely on the information submitted by the investigator, which may present a one-sided view of the relevant risks."); id. at 26 ("[T]he individuals with the greatest stake in IRB decisions-the prospective research subjects-do not even participate in the process of IRB review").
316. See Coleman, supra note 1, at 22 ("IRBs . . . rely largely on the information submitted by the investigator, which may present a one-sided view of the relevant risks."); id. at 26 ("[T]he individuals with the greatest stake in IRB decisions-the prospective research subjects-do not even participate in the process of IRB review").
317. Contrast this scenario with Coleman's assertion that his system would empower dissenting members of IRBs to challenge the positions staked out by the primary reviewer. See id. at 34.
318. See William J. Burman et al., Breaking the Camel's Back. Multicenter Clinical Trials and Local Institutional Review Boards, 134 ANN. INTERN. MED. 152, 155 (2001) (referring to the continuing value of the local IRBs in the "training of investigators in performance of ethical clinical research"); Hoffman, supra note 44, at 768-69 (recommending that ERBs place a greater emphasis on this role); Robertson, supra note 9, at 526 n.211 ("If IRBs are viewed as having important educational functions, they might consider more forthrightly educating or socializing investigators about subject rights and the ethics of experimentation."); see also Hazel Glenn Beh, The Role of Institutional Review Boards in Protecting Human Subjects: Are We Really Ready to Fix a Broken System?, 26 LAW & PSYCHOL. REV. 1, 36 (2002) ("IRB education in ethics is particularly essential because there is no assurance that principal investigators and scientists have necessarily received training on ethical human subject research.").
319. See William J. Burman et al., Breaking the Camel's Back. Multicenter Clinical Trials and Local Institutional Review Boards, 134 ANN. INTERN. MED. 152, 155 (2001) (referring to the continuing value of the local IRBs in the "training of investigators in performance of ethical clinical research"); Hoffman, supra note 44, at 768-69 (recommending that ERBs place a greater emphasis on this role); Robertson, supra note 9, at 526 n.211 ("If IRBs are viewed as having important educational functions, they might consider more forthrightly educating or socializing investigators about subject rights and the ethics of experimentation."); see also Hazel Glenn Beh, The Role of Institutional Review Boards in Protecting Human Subjects: Are We Really Ready to Fix a Broken System?, 26 LAW & PSYCHOL. REV. 1, 36 (2002) ("IRB education in ethics is particularly essential because there is no assurance that principal investigators and scientists have necessarily received training on ethical human subject research.").
320. See William J. Burman et al., Breaking the Camel's Back. Multicenter Clinical Trials and Local Institutional Review Boards, 134 ANN. INTERN. MED. 152, 155 (2001) (referring to the continuing value of the local IRBs in the "training of investigators in performance of ethical clinical research"); Hoffman, supra note 44, at 768-69 (recommending that ERBs place a greater emphasis on this role); Robertson, supra note 9, at 526 n.211 ("If IRBs are viewed as having important educational functions, they might consider more forthrightly educating or socializing investigators about subject rights and the ethics of experimentation."); see also Hazel Glenn Beh, The Role of Institutional Review Boards in Protecting Human Subjects: Are We Really Ready to Fix a Broken System?, 26 LAW & PSYCHOL. REV. 1, 36 (2002) ("IRB education in ethics is particularly essential because there is no assurance that principal investigators and scientists have necessarily received training on ethical human subject research.").
321. See William J. Burman et al., Breaking the Camel's Back. Multicenter Clinical Trials and Local Institutional Review Boards, 134 ANN. INTERN. MED. 152, 155 (2001) (referring to the continuing value of the local IRBs in the "training of investigators in performance of ethical clinical research"); Hoffman, supra note 44, at 768-69 (recommending that ERBs place a greater emphasis on this role); Robertson, supra note 9, at 526 n.211 ("If IRBs are viewed as having important educational functions, they might consider more forthrightly educating or socializing investigators about subject rights and the ethics of experimentation."); see also Hazel Glenn Beh, The Role of Institutional Review Boards in Protecting Human Subjects: Are We Really Ready to Fix a Broken System?, 26 LAW & PSYCHOL. REV. 1, 36 (2002) ("IRB education in ethics is particularly essential because there is no assurance that principal investigators and scientists have necessarily received training on ethical human subject research.").
322. See ROBERT J. LEVINE, ETHICS AND REGULATION OF CLINICAL RESEARCH 348-50 (2d ed. 1986); Jeffrey P. Kahn & Anna C. Mastroianni, Moving from Compliance to Conscience: Why We Can and Should Improve on the Ethics of Clinical Research, 161 ARCH. INTERN. MED. 925, 925 (2001).
323. See ROBERT J. LEVINE, ETHICS AND REGULATION OF CLINICAL RESEARCH 348-50 (2d ed. 1986); Jeffrey P. Kahn & Anna C. Mastroianni, Moving from Compliance to Conscience: Why We Can and Should Improve on the Ethics of Clinical Research, 161 ARCH. INTERN. MED. 925, 925 (2001).
324. See Noah, supra note 53, at 693 ("[P]eer review contributes to the advancement of science not merely through the screening of scientific work (its quality control function), but also by helping proponents of new hypotheses to improve their research and interpretations and by engaging others in a dialogue about important new discoveries."); id. at 694 ("Referees enlisted to peer review manuscripts . . . provide constructive criticism so that a manuscript or the underlying research can be improved. This process is iterated so that a manuscript may go through several rounds of review and revision . . . ."); Noah, supra note 25, at 1059, 1075 ("[J]ust as referees may help authors improve a manuscript before publication, regulatory peer review may help the agency better anticipate adverse public comments.").
325. See Noah, supra note 53, at 693 ("[P]eer review contributes to the advancement of science not merely through the screening of scientific work (its quality control function), but also by helping proponents of new hypotheses to improve their research and interpretations and by engaging others in a dialogue about important new discoveries."); id. at 694 ("Referees enlisted to peer review manuscripts . . . provide constructive criticism so that a manuscript or the underlying research can be improved. This process is iterated so that a manuscript may go through several rounds of review and revision . . . ."); Noah, supra note 25, at 1059, 1075 ("[J]ust as referees may help authors improve a manuscript before publication, regulatory peer review may help the agency better anticipate adverse public comments.").
326. See Noah, supra note 53, at 693 ("[P]eer review contributes to the advancement of science not merely through the screening of scientific work (its quality control function), but also by helping proponents of new hypotheses to improve their research and interpretations and by engaging others in a dialogue about important new discoveries."); id. at 694 ("Referees enlisted to peer review manuscripts . . . provide constructive criticism so that a manuscript or the underlying research can be improved. This process is iterated so that a manuscript may go through several rounds of review and revision . . . ."); Noah, supra note 25, at 1059, 1075 ("[J]ust as referees may help authors improve a manuscript before publication, regulatory peer review may help the agency better anticipate adverse public comments.").
327. Some commentators have described the PDA's new drug approval process in similar terms. See Merrill, supra note 31, at 1781, 1799.
328. See 21 C.F.R. §§ 56.109(f), 56.113 (2003) ("Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the investigator, appropriate institutional officials, and the [FDA]."); 45 C.F.R. § 46.113 (2003) (same).
329. See 21 C.F.R. §§ 56.109(f), 56.113 (2003) ("Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the investigator, appropriate institutional officials, and the [FDA]."); 45 C.F.R. § 46.113 (2003) (same).
330. See Lars Noah, Administrative Arm-Twisting in the Shadow of Congressional Delegations of Authority, 1997 WIS. L. REV. 873, 874-908.
331. See id. at 929, 935-41.
332. See Coleman, supra note 1, at 45 n.248; see also id. at 47-48 (arguing that these agencies should issue regulations that address recurring issues or impanel national specialty ERBs). He also notes that some bills pending in Congress would permit IRBs to charge recipients of federal grants a user fee for reviews. See id. at 12. Such incremental reforms would do more good than completely refashioning IRBs.
333. See Coleman, supra note 1, at 45 n.248; see also id. at 47-48 (arguing that these agencies should issue regulations that address recurring issues or impanel national specialty ERBs). He also notes that some bills pending in Congress would permit IRBs to charge recipients of federal grants a user fee for reviews. See id. at 12. Such incremental reforms would do more good than completely refashioning IRBs.