Institutional review boards: Is this the least worst we can do?

Northwestern University Law Review

Volumn 101, Issue 2, 2007, Pages 749-773

  Hyman, David A ^a  

^a UNIVERSITY OF ILLINOIS AT URBANA CHAMPAIGN   (United States)

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EID: 34547989955     PISSN: 00293571     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (174)

1. David A. Hyman, Does Technology Spell Trouble With a Capital "T"?: Human Dignity and Public Policy, 27 HARV. J.L. & PUB. POL'Y 3, 17 (2003-2004) ("[0]nce both sides have claimed that human dignity is at stake, even a modest dispute on a minor issue is converted into a super-charged normative battle.").
2. 45 C.F.R. §46.101 (2005). Strictly speaking, the regulations cover research that is "conducted, supported or otherwise subject to regulation by any federal department or agency which takes appropriate administrative action to make the policy applicable to such research." Id. At present, fifteen federal departments/agencies/commissions have adopted the "Common Rule," subjecting all research they conduct, support, or otherwise regulate to the IRB framework. A list of those agencies, and the enabling regulations, is found at HHS OFFICE FOR HUMAN RESEARCH PROTECTION, FEDERAL POLICY FOR THE PROTECTION OF HUMAN SUBJECTS, http://www.hhs.gov/ ohrp/policy/common.html (last visited Nov. 8, 2006).
3. Although there were classified regulations governing human experimentation issued by the Atomic Energy Commission and Department of Energy in the 1940s and 1950s, and the National Institutes of Health issued regulations on research involving human subjects in 1966, most scholars date the beginning of comprehensive federal regulation of human subjects research to 1974, when the regulation that ultimately gave rise to the Common Rule was issued. See Oral History of the Belmont Report and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Interview with Dr. Norman Fost, May 13, 2004, available at http://www.hhs.gov/ohrp/ docs/ InterviewFost.doc.
4. See also NAT'L COMM'N FOR THE PROT. OF HUMAN SUBJECTS OF BIOMEDICAL AND BEHAVIORAL RESEARCH, THE BELMONT REPORT: ETHICAL PRINCIPLES AND GUIDELINES FOR THE PROTECTION OF HUMAN SUBJECTS OF RESEARCH (1979), available at http://www.hhs.gov/ohrp/ humansubjects/guidance/belmont.htm.
5. 45 C.F.R. §46.102(d) (2005).
6. 45 C.F.R. §46.102(f) (2005).
7. 45 C.F.R. §46.107 (2005).
8. Id.
9. Id.
10. 45 CF.R. § 46.109 (2005).
11. 45 C.F.R. § 46.111 (2005).
12. 45 C.F.R. § 46.114 (2005).
13. 45 C.F.R. § 46.109 (2005).
14. 45 C.F.R. § 46.116(a) (2005).
15. 45 C.F.R. § 46.109 (2005).
16. 45 C.F.R. § 46.102(i) (2005).
17. 45 C.F.R. § 46.101(b) (2005);
18. Mark A. Hall & Ronald F. Wright, Empirical Legal Studies Blog, FAQs re. Legal Scholarship and IRBs, http://www.elsblog.org/ the_empirical_legal_studi/irb.html (last visited Nov. 10, 2006) ("University IRB committees normally have an expansive view of the activities that fall within their jurisdiction. Your institution probably expects you to apply for and receive verification that an exemption applies, especially in debatable situations.");
19. posting of Mark A. Hall to Empirical Legal Studies Blog, Confessions of an Undocumented Human Subjects Researcher, http://www.elsblog.org/ the_empirical_legal_studi/2006/03/confessions_of__l.html (Mar. 27, 2006, 10:34) ("[T]here are several bases to claim that interaction with, or data about, living humans in the course of legal scholarship is not a covered activity (not identifiable, not systematic, not private, etc.). Naturally, those concepts have room for interpretation. The hitch is that institutions expect researchers to notify the IRB so it can have the final say on whether the exclusionary concepts apply. But, that quickly leads to innumerable absurdities.").
20. The six specific categories are "survey procedures, interview procedures, or observation of public behavior" (as long as certain restrictions are satisfied); research in "established or commonly accepted educational settings, involving normal educational practices;" research on people who are "elected or appointed public officials or candidates for public office;" research on materials that are publicly available; and research designed to assess "public benefit or service programs." The full text describing each of these exemptions may be found at 45 C.F.R. §46.101(b) (2005).
21. 45 C.F.R. § 46.101(b) (2005).
22. 45 C.F.R. § 46.101(b)(2) (2005).
23. Judith Jarvis Thomson et al., Research on Human Subjects: Academic Freedom and the Institutional Review Board, ACADEME, Sept.-Oct. 2006, at 95.
24. Id.
25. Richard A. Schweder, Protecting Human Subjects and Preserving Academic Freedom: Prospects at the University of Chicago, 33 AM. ETHNOLOGIST 507, 507 (2006).
26. Thomson et al., supra note 19, at 99 (noting that 164 academic institutions have not agreed to subject non-federally funded research to the Common Rule, but "our impression at the moment, however, is that many of those institutions continue in practice to impose the same requirements on nonfederally funded research as on federally funded research-perhaps out of lack as yet of an agreed alternative....").
27. A false positive (Cell 2) is also commonly known as a Type I error. A false negative (Cell 3) is also commonly known as a Type II error.
28. For these purposes, I treat a protocol that was approved in a modified form as a false negative if the original protocol was properly approvable. Treating such cases as true positives is appropriate only if the original protocol was not properly approvable-which is precisely what many researchers say is in issue in many cases.
29. Thomson et al., supra note 19, at 96.
30. See generally Michelle M. Mello, David M. Studdert & Troyenn Brennan, The Rise in Litigation in Human Subjects Research, 139 ANNALS INTERNAL MED. 40 (2003) (tracking trends in litigation over research-related injuries, including diversification of the types of legal claims, expansion in the number and types of parties named as defendants and use of class-action techniques);
31. Robert Steinbrook, Improving Protection for Research Subjects, 346 NEW ENGL. J. MED. 1425 (2002) (reviewing how past tragedies have given rise to increased political and regulatory attention to research and research oversight).
32. See infra Part III.B.
33. HENRY I. MILLER, TO AMERICA'S HEALTH: A PROPOSAL TO REFORM THE FOOD AND DRUG ADMINISTRATION 42-43 (2000) (noting that a false positive "mistake is highly visible and has immediate consequences-the media pounces, the public denounces, and Congress pronounces. Both the developers of the product and the regulators who allowed it to be marketed are excoriated and punished in modem-day pillories: congressional hearings, television news magazines, and newspaper editorials. Because a regulatory official's career might be damaged irreparably by his good faith but mistaken approval of a high-profile product, decisions are often made defensively-in other words, to avoid [false positive] errors at any cost.");
34. see also posting of Ron Wright, Empirical Legal Studies Blog, IRBs and Regulatory Theory, http://www.elsblog.org/ the_empirical_legal_studi/2006/03/irb_and_regulat.html (Mar. 27, 2006, 14:07).
35. MILLER, supra note 28, at 41.
36. Michael J. Saks, Do We Really Know Anything about the Behavior of the lort Litigation System-And Why Not?, 140 U. PA. L. REV. 1147, 1161 (1992) ("It makes a difference if for every ten anecdotes in which an undeserving plaintiff bankrupts an innocent defendant, one, ten, one hundred, or one thousand equal and opposite injustices are done to innocent plaintiffs. The proportion of cases that results in one or the other error, and the ratio of one kind of error to the other, ought to be of greater interest to serious policy-makers than a handful of anecdotes on either side of the issue. Reforms are intended to change that ratio and the tens of thousands of anecdotes the ratio summarizes.").
37. That's right. None. Nada. Zip. This is based on my exhaustive search for such evidence, using LexisNexis and Westlaw, as well as my own inquiries to leading scholars. But why take my word for it? Go look for yourself. I'll pay $25 to the first person who finds anything in print (as of December 14, 2006) providing empirical evidence that IRBs have any benefit whatsoever.
38. One could reasonably draw an adverse inference from the absence of evidence indicating IRBs have any benefit. See GEORGE J. STIGLER, THE THEORY OF PRICE 24 (3d ed. 1987) ("How can we convince a skeptic that this 'law of demand' is really true of all consumers, all times, all commodities? . . . Perhaps as persuasive a proof as is readily summarized is this: if an economist were to demonstrate its failure in a particular market at a particular time, he would be assured of immortality, professionally speaking, and rapid promotion. Since most economists would not dislike either reward, we may assume that the total absence of exceptions is not from lack of trying to find them.").
39. Jeremy Sugarman et al., The Cost of Institutional Review Boards in Academic Medical Centers, 352 NEW ENG. J. MED. 1825 (2005).
40. Id.
41. Id.
42. Id.
43. Todd Wagner et al., Economies of Scale in Institutional Review Boards, 42 MED. CARE 817 (2004).
44. See J.H.U. Brown, Lawrence S. Schoenfeld & Patricia W. Allan, The Costs of an Institutional Review Board, 54 J. MED. EDU. 294 (1979);
45. Todd Wagner et al., The Cost of Operating Institutional Review Boards (IRBs), 78 ACAD. MED. 638 (2003).
46. See Lee A. Green et al., Impact of Institutional Review Board Practice Variation on Observational Health Services Research, 41 HEALTH SERVICES RES. 214 (2006);
47. Keith Humphreys et al., The Cost of Institutional Review Board Procedures in Multicenter Observational Research, 139 ANNALS INTERNAL MED. 77 (2003).
48. Green et al., supra note 38, at 219-20.
49. Id.
50. Humphreys et al., supra note 38, at 77;
51. Michelle L. Brandt, IRB Burden Studied in Cost Analysis, STAN. REP., Aug. 6, 2003, http://news-service.stanford.edu/ news/2003/august6/humphreys.html.
52. See William Burman et al., The Effects of Local Review on Informed Consent Documents from a Multicenter Clinical Trials Consortium, 24 CONTROLLED CLINICAL TRIALS 245 (2003);
53. Green et al., supra note 38, at 219-20;
54. Jon Mark Hirshon et al., Variability in Institutional Review Board Assessment of Minimal-Risk Research, 9 ACAD. EMERG. MED. 1417 (2002);
55. Rita McWilliams et al., Problematic Variation in Local Institutional Review of a Multicenter Genetic Epidemiology Study, 290 J. AM. MED. ASS'N 360 (2003);
56. Thomas O. Stair et al., Variation in Institutional Review Board Responses to a Standard Protocol for a Multicenter Clinical Trial, 8 ACAD. EMERG. MED. 636 (2001).
57. Green et al., supra note 38, at 214.
58. Id. at 223.
59. Id. at 221-22.
60. The authors ascribed this dynamic to the "irresistibility of editing." Id. at 225.
61. Id. at 215.
62. Humphreys et al., supra note 38, at 77.
63. Id.
64. Brandt, supra note 41.
65. See Burman et al., supra note 42, at 248-49.
66. REPORT AND RECOMMENDATION OF THE NATIONAL BIOETHICS ADVISORY COMM'N, ETHICAL AND POLICY ISSUES IN RESEARCH INVOLVING HUMAN SUBJECTS (2001);
67. INSTITUTE OF MEDICINE, RESPONSIBLE RESEARCH: A SYSTEMS APPROACH TO PROTECTING RESEARCH PARTICIPANTS (2002).
68. Seema Shah et al, How Do Institutional Review Boards Apply the Federal Risk and Benefit Standards for Pediatric Research, 291 J. AM. MED. ASS'N 476, 478 (2004).
69. Jerry Goldman & Martin D. Katz, Inconsistency and Institutional Review Boards, 248 J. AM. MED. ASS'N 197 (1982).
70. The study was criticized in Robert J. Levine, Inconsistency and IRBs: Flaws in the Goldman-Katz Study, 6 IRB 4 (1984).
71. Goldman & Katz, supra note 53, at 197.
72. Id. at 202.
73. Jerry Goldman, Current Publications: Revisiting the Problem of Inconsistency and IRB Review, http://www.oyez.org/goldman/currentpubs (2004) (website no longer available and on file with author).
74. See, e.g., Scott Burris & Kathryn Moss, U.S. Health Researchers Review Their Ethics Review Boards: A Qualitative Study, 1 J. EMPIRICAL RES. HUMAN RES. ETHICS 39 (2006). These problems are not unique to the United States.
75. See William J. Burman et al., Breaking the Camel's Back: Multicenter Clinical Trials and Local Institutional Review Boards, 134 ANNALS INTERNAL MED. 152, 154 (2001) ("A questionnaire-based study of the effect of birth weight on child development required submission of 1095 copies of the protocol, 1116 forms, and additional supporting documents to 145 IRBs in the United Kingdom. Responses to this remarkably duplicative process varied greatly, including diametrically opposed mandates, and 22% of the IRBs had not responded within 3 months.").
76. See Jack Katz, Ethical Escape Routes for Underground Ethnographers, 33 AM. ETHNOLOGIST 499 (2006);
77. Cary Nelson, Can E. T Phone Home? The Brave New World of University Surveillance, ACADEME, Sept.-Oct. 2003, at 89, 90 (describing "insane review" by University of Illinois IRB of an essay in "creative nonfiction" and insistence of same IRB that undergraduates interviewing family members obtain signed consent forms);
78. posting of Mark Hall to Empirical Legal Studies Blog, http:// www.elsblog.org/the_empirical_legal_studi/2006/03/coping_with_the.html (Mar. 31, 2006, 15:05);
79. Christopher Shea, Don't Talk to the Humans, LINGUA FRANCA, Sept. 2000, at 27 (presenting litany of horror and woe);
80. J. Michael Bailey, Academic McCarthyism, NW. CHRON., Oct. 9, 2005, available at http://www.chron.org/tools/ viewart.php?artid=1248;
81. Sharon Begley, Review Boards Pose Threat To Social Scientists' Work, WALL ST. J., NOV. 1, 2002, at Bl;
82. Carol Tavris, The High Cost of Skepticism: Here's What Happened to Two Scientists who Believed that Tenure and the First Amendment Would Protect their Rights to Free Inquiry, SKEPTICAL INQUIRER, Jul.-Aug. 2002, available at http:// www.csicop.org/si/2002-07/high-cost.hrml.
83. See supra note 58 and accompanying text.
84. See Nelson, supra note 58 ("[T]he boards assembled to supervise biomedical research often haven't a clue about the culture of history or anthropology or literature departments.");
85. Jonathan T. Church et al., Should AU Disciplines Be Subject to the Common Rule: Human Subjects of Social Science Re- search, ACADEME, May-June 2002, at 62;
86. J. Michael Oakes, Risks and Wrongs in Social Science Research: An Evaluator's Guide to the IRB, 26 EVALUATION REV. 443, 447-50 (2002);
87. Posting of Jack Katz to Empirical Legal Studies Blog, http://www.elsblog.org/the_empirical_legal_studi/2006/03/ outside_of_biom.html (Mar. 28, 2006, 19:25);
88. Posting to Savage Minds, Notes and Queries in Anthropology, http://savageminds.org/2006/02/08/ethnography-and-the-irb (Feb. 8, 2006, 21:17).
89. See Posting of Jason Czarnezki to Empirical Legal Studies Blog, http://www.elsblog.org/ the_empirical_legal_studi/2006/02/working_with_ir.html (Feb. 21, 2005, 10:23);
90. posting of Dan Filler to Concurring Opinions, http://www. concurringopinions.com/archives/2006/05/volokhs_law_rev.html (May 10, 2006);
91. Hall & Wright, supra note 16; posting of Mike Madison to madisionian.net, http:// madisonian.net/archives/2006/03/23/irbs-ethnography- and-blogging (Mar. 23, 2006, 13:12).
92. Thomson et al., supra note 19, at 96. The first four of these examples are drawn from Joan E. Sieber, Stuart Plattner &
93. Philip Rubin, How (Not) to Regulate Social and Behavioral Research, 15 PROF. ETHICS REP. 1 (2002).
94. See, e.g., Katz, supra note 58;
95. Shea, supra note 58;
96. Nelson, supra note 58;
97. Begley, supra note 58;
98. Church et al., supra note 60.
99. Sharona Hoffman & Jessica Wilen Berg, The Suitability of IRB Liability, 67 U. PITT. L. REV. 365, 374-75 (2005).
100. See also INSTITUTE OF MEDICINE, RESPONSIBLE RESEARCH: A SYSTEMS APPROACH TO PROTECTING RESEARCH PARTICIPANTS (2002);
101. JUNE GIBBS BROWN, DEP'T. OF HEALTH AND HUMAN SERVICES, INSTITUTIONAL REVIEW BOARDS: A TIME FOR REFORM (1998) (DHHS publication no. OEI01-97-00193);
102. Donald F. Phillips, Institutional Review Boards Under Stress: Will They Explode or Change?, 276 J. AM. MED. ASS'N 1623, 1623 (1996) (noting that IRBs "find themselves under pressure from mounds of paperwork, regulatory fire from the federal bureaucracy, and economic constraints from the institutions they serve" and that "[n]ever before has such a pressure cooker atmosphere prevailed within the IRB system, leading government officials, university administrators, research sponsors, and IRB members to wonder whether the IRB system will crack or reform").
103. Hoffman & Berg, supra note 64, at 374.
104. Robert Steinbrook, Protecting Research Subject-The Crisis at Johns Hopkins, 346 NEW ENG. J. MED. 716, 719 (2002).
105. See CENTER FOR ADVANCED STUDY, IMPROVING THE SYSTEM FOR PROTECTING HUMAN SUBJECTS: COUNTERACTING IRB "MISSION CREEP" (2005) [hereinafter Illinois White Paper];
106. C.K. Gunsalus et al., Mission Creep in the IRB World, 312 SCIENCE 1441 (2006). One example of mission creep that has not attracted much attention is the penetration of IRBs into high schools, middle schools, elementary schools and kindergartens. Science fairs that are sanctioned by a national coordinating agency (Science Service) must set up a scientific review committee and an IRB to review all research protocols. Science Service, http://www.sciserv.org/dcysc/Fairs/FAIRLIST.ASP (last visited Nov. 29, 2006). This is not a law school hypothetical-one science fair for students in grades K-5 designated a university IRB that would handle their research oversight. Guidelines for the Clarksville-Montgomery County Schools Science Fair Grades K-5, http://www.apsu.edu/robertsonr/sciencefair/2006% 20COMPLETE%20SCIENCE%20FAIR%20MANUAL.doc (last visited Nov. 29, 2006).
107. See supra note 16 and accompanying text.
108. See Burris & Moss, supra note 57 and accompanying text. HIPAA is the Health Insurance Portability and Accountability Act.
109. In all fairness, such duplication is unnecessary to satisfy IRB regulations. See supra note 11 and accompanying text. It is a question for another day why institutions are willing to incur such duplicative expenditures, but the effect is the creation of institution-specific monopolies on research oversight.
110. See infra notes 116-17 and accompanying text.
111. See Burris & Moss, supra note 57, at 43-52; Gunsalus et al., supra note 67, at 1441.
112. See Illinois White Paper, supra note 67, at 7 ("[T]he most frequently cited lapses in IRB audits by the two main federal oversight agencies, OHRP and FDA, are 'poor or missing Standard Operating Procedures' (28%) and 'poor minute-keeping' (21%), together accounting for about half the citations. Quorum failures account for an additional 13%. Thus, most citations have to do with internal IRB processes and are relatively trivial, not directly related to actual research protocols.");
113. Gunsalus, supra note 67, at 1441;
114. Fost, supra note 3, at 15 ("OHRP, when it began shutting down places at Duke and subsequent medical centers some years ago, understandably, when they visited an institution, looked at everything. So they would find things like failure to document quorum requirements, and established a principle that goes beyond Robert's Rules. That is what all IRBs had been using, prior to that, was Robert's Rules, which was-you establish a quorum at the beginning of a meeting, and if it's not challenged, it's presumed to exist throughout the meeting. OHRP felt that was not sufficient; that a quorum needed to be proven for every one of a hundred action items. So IRBs now, as a result ofthat, have to record the actual vote and document the existence of a quorum. Well, that requires an enormous amount of paperwork. Our minutes are 150 single-spaced pages for a two-hour meeting, because of the need to document that and many things like that."). To be sure, the problem is not limited to the enforcement agencies; accrediting agencies have their own mishegoss: When the accreditation agencies came along, one of them . . . looked at our minutes about documenting the quorum, and noted that it didn't say whether the non-scientific member of the IRB was in the room at the time, because it didn't have the names of the members. And since there's a requirement that IRBs have a non-scientific member, if he or she's not in the room, then you don't have a duly constituted IRB. The result of that-at Johns Hopkins, to take one place that I'm familiar with-was they began passing a clipboard around the room for each protocol, and got the signatures of all 24 people in the room, for a hundred action items. So, for one meeting, they had 2,400 signatures to document that the non-scientific member and the other appropriate members were in the room. Now, has there ever in the history of the world been a research protocol that was approved, that shouldn't have been approved, because the non-scientific member was out of the room at the time? I don't think so. Does this improve protection of human subjects? No. Does it require an enormous infrastructure, and storage, and so on? And that's just one of many examples. But that's an example of an accreditation agency going beyond where OHRP had gone and, in my view, OHRP had gone already too far in terms of cost-benefit ratio of these sorts of compliance things. Id.
115. Steinbrook, supra note 66, at 719.
116. See Nelson Lund, The Conservative Case Against Racial Profiling in the War on Terror, 66 ALB. L. REV. 329, 337-38 (2002-03) (noting "natural tendencies of government bureaucracies to use easily administered rules, and to transform means into ends. . . . Government agencies are ordinarily very good at applying simple rules, but they are often very bad at using common sense, or taking appropriate risks, or adjusting their rules to take account of changing circumstances.").
117. C. NORTHCOTE PARKINSON, PARKINSON'S LAW, AND OTHER STUDIES IN ADMINISTRATION 1 (1957).
118. Health care compliance programs have been marked by a similar dynamic. See David A. Hyman, Health Care Fraud and Abuse: Market Change, Social Norms, and "The Trust Reposed in the Workmen, " 30 J. LEGAL STUD. 531, 559-60 (2001) ("The government encourages providers to invest in compliance programs directly (by effectively requiring providers to have such programs) and indirectly (by announcing high-profile antifraud initiatives). Once these programs are in place, compliance officers will predictably lobby for additional resources and remind supervisors of the threat of severe governmental sanctions to ensure that their wish list is taken seriously. External consultants offer increasingly elaborate educational programs, audits, and monitoring systems and emphasize the risks the institution is taking if it does not make these investments.").
119. Thomson et al., supra note 19, at 99.
120. See C.K. Gunsalus, The Nanny State Meets the Inner Lawyer: Overregulating While Underprotecting Human Participants in Research, 14 ETHICS & BEHAV. 369, 372 (2004) ("How many IRB meetings have gone from the imagined possibilities of what might go wrong to devising protections against those possibilities. . . In how many of those meetings have members imagined that 'the lawyers' might require such protections or that people 'might get sued' if the protections were not in place."). Ironically, the existence of IRBs has given those inclined to sue an additional set of defendants and new causes of action.
121. See Hoffman & Berg, supra note 64, at 381-95.
122. Stephen J. Ceci, Douglas Peters & Jonathan Plotkin, Human Subjects Review, Personal Values, and the Regulation of Social Science Research, 40 AM. PSYCH. 994, 999 (1985) (noting political skew to IRB approval process, with hypothetical studies involving "sensitive" topics rejected as often as proposals with serious ethical problems for studying non-sensitive topics). Indeed, "the primary reason for rejection of sensitive proposals was the potential political impact of the proposed findings." Id. at 994.
123. Those who have doubts as to whether involving lawyers in the process might have these effects should ponder how things played out with product warning labels. See JOEY GREEN, TONY DIERCKINS & TIM NYBERG, THE WARNING LABEL BOOK (1998).
124. IRBs that obtain the necessary approvals can collectively agree to "share the load" in evaluating multi-side studies, but there is no comparable provision allowing an IRB to evaluate and approve a study that would be conducted at another institution.
125. See Mello et al, supra note 26.
126. See Grimes v. Kennedy Krieger, 782 A.2d 807 (Md. 2001).
127. See Jack Schwartz, The Kennedy Krieger Case: Judicial Anger and the Research Enterprise, 6 J. HEALTH CARE L. & POL'Y 148, 149 (2002) ("Many of KKI's patients came from low-income neighborhoods in Baltimore, where 95% of the housing stock had lead paint.").
128. See Joanne Pollak, The Lead-Based Paint Abatement Repair & Maintenance Study in Baltimore: Historic Framework and Study Design, 6 J. HEALTH CARE L. & POL'Y 89, 95-96 (2002).
129. Id. at 96, 107.
130. Motion of Appellee at 10-11, Grimes v. Kennedy Krieger Institute; Higgins v. Kennedy Krieger Institute, Sept. Term 2000-128, Sept. Term 2000-129 (Md. Sept. 17, 2001) [hereinafter Appellee's Motion] (on file with author).
131. Pollak, supra note 84, at 107 n. 140.
132. See id. at 98.
133. Id. at 98-104.
134. See Appellee's Motion, supra note 86.
135. See Brief for Public Justice Center as Amicus Curiae Supporting Appellant, Grimes v. Kennedy Krieger, 782 A.2d 807 (Md. 2001).
136. Grimes, 782 A.2d at 816.
137. Id. at 852.
138. Id. at 858 (observing that a parent "cannot consent to the participation of a child or other person under legal disability in nontherapeutic research or studies in which there is any risk of injury or damage to the health of the subject"). The language was described in the opinion as a holding, but was actually dicta. Jack Schwartz, The Kennedy Krieger Case: Judicial Anger and the Research Enterprise, 6 J. HEALTH L. & POL'Y 148, 157 (2002).
139. See Appellee's Motion, supra note 86.
140. See Karen Smith Thiel, Parental Consent For Children's Participation in Biomedical Research: The Ethical, Regulatory, and Judicial Framework of Grimes v. Kennedy Krieger Institute, 6 J. HEALTH L. & POL'Y 169, 187-90 (2002);
141. Schwartz, supra note 94, at 158-59; Memorandum of Law of Public Justice Center In Partial Support of Appellee's Motion for Partial Reconsideration and Modification of Opinion, Grimes v. Kennedy Krieger, 782 A.2d 807 (Md. 2001) (on file with author).
142. See Johns Hopkins University, Lead-Based Paint Study, available at http:// www.hopkinsmedicine.org/press/2001/SEPTEMBER/leadfactsheet.htm.
143. Grimes, 782 A.2d at 862 (asserting that by "any risk of injury or damage to the health of the subject" it had actually meant "any articulable risk beyond the minimal kind of risk that is inherent in any endeavor").
144. Id. at 861 ("I cannot join the majority in holding that, in Maryland, a parent or guardian cannot consent to the participation of a minor child in a nontherapeutic research study in which there is any risk of injury or damage to the health of the child without prior judicial approval and oversight.").
145. David R. Buchanan & Franklin G. Miller, Justice and Fairness in the Kennedy Krieger Institute Lead Paint Study: The Ethics of Public Health Research on Less Expensive, Less Effective Interventions, 96 AM. J. PUB. HEALTH 781,782 (2006).
146. See generally Schwartz, supra note 83, at 148 ("[T]he Court's rhetoric was heated, its historical comparisons inflammatory and unjust, and aspects of its decision ill-considered."). The same article later describes the court's opinion as marked by "rhetorical excess and [a] condemnatory tone." Id. at 164. Further, it noted that the opinion "suffers badly from imprecision and superficiality." Id. at 166. When an assistant attorney general in the Maryland Attorney General's Office describes the work of thehighest state court in Maryland using such words, the words "intellectual embarrassment" may be too kind.
147. NEIL K. KOMESAR, IMPERFECT ALTERNATIVES: CHOOSING INSTITUTIONS IN LAW, ECONOMICS AND PUBLIC POLICY (1997).
148. See ROBERT CORAM, BOYD: THE FIGHTER PILOT WHO CHANGED THE ART OF WAR 211 (2002) ('"General, if you're not having accidents, your training program is not what it should be,' Boyd said. He told the general about Nellis and how realistic the training was-and how it resulted in a ten-to-one exchange ratio in Korea. 'Goddamnit, General, you need more accidents,' he said. 'You need to kill some pilots.'").
149. See also Steinbrook, supra note 66, at 716 ('"At a certain point, some patient is going to die in clinical trials,' Miller said. 'There is no question about it.' The challenge is to do everything possible to ensure the safety of research subjects and to make the risk as small as possible.") (quoting Dr. Edward D. Miller, dean of the Johns Hopkins University School of Medicine).
150. See Steinbrook, supra note 66, at 716 (quoting Dr. Edward D. Miller, Dean of the Johns Hopkins University School of Medicine).
151. See supra notes 6-8 and accompanying text.
152. See supra Part IV.
153. Howard B. Dickler & David Kom, The Costs of Institutional Review Boards, 353 NEW ENGL. J. MED. 315, 316 (2005).
154. Thomson et al., supra note 19, at 97-98.
155. Id.
156. See Time to Cut Regulations That Protect Only Regulators, 414 NATURE 379 (2001) ("The time spent by committees reviewing such routine protocols to the full extent required by law is time that could be better spent on the more controversial applications.").
157. Thomson et al., supra note 19, at 97.
158. 45 C.F.R. § 46.101(b)(2) (2005).
159. Thomson et al., supra note 19, at 97.
160. Id.
161. Indeed, the IRB regulations flatly prohibit such stratagems. See 45 C.F.R. § 46.111(a)(2) (2005) ("The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility."). This clear prohibition has not stopped IRBs from doing precisely the opposite.
162. See supra note 58 and accompanying text;
163. see also Ceci, Peters & Plotkin, supra note 79, at 1000 (noting an IRB rejected a study of reverse discrimination on the grounds that "the findings could set affirmative action back 20 years if it came out that women with weaker vitae were asked to interview more often for managerial positions than men with stronger vitae").
164. Stop laughing. This is serious.
165. 45 C.F.R. § 46.112 (2005).
166. Predictable, that is, to anyone with the slightest knowledge of regulatory theory or bureaucracy-subjects that are apparently not part of the bioethics canon. On the lawyerization of bioethics, see David A. Hyman, How Law Killed Ethics, 34 PERSP. BIOLOGY & MED. 134 (1990).
167. For example, the Kennedy Krieger study was criticized by several bioethicists on the grounds the researchers should not have accepted the proposition that resource constraints made full abatement unlikely. Buchanan & Miller, supra note 100, at 783-84 (cataloging and criticizing such complaints). From this exalted perspective, trying to find more cost-effective abatement strategies meant that the researchers were, in fact, capitulating or colluding with "status quo conditions of gross social injustice." Id. at 783.
168. How could anyone believe that "sticking it to the man" was a better strategy than actually doing something to help the children of Baltimore? As George Orwell has noted, "[O]ne has to belong to the intelligentsia to believe things like that: no ordinary man could be such a fool." GEORGE ORWELL, Notes on Nationalism, in ENGLAND YOUR ENGLAND 41, 65 (1945).
169. Similar complaints will predictably be raised anytime anyone acknowledges the reality of resource constraints instead of wishing them away. See David A. Hyman, Professional Responsibility, Legal Malpractice, and the Eternal Triangle: Will Lawyers or Insurers Call the Shots? 4 CONN. INS. L.J. 353, 391-94 (1997-1998) (analyzing similar episode involving placebo controlled trials of short-course AZT in Africa). As I noted in that article, "Some commentators are unable to understand that scarcity is not an artificial construct or a conspiracy against the less fortunate." Id. at 394 n. 178.
170. See, e.g., David A. Hyman, Commentary, in ETHICAL CHALLENGES IN MANAGED CARE: A CASEBOOK 176 (1999);
171. David A. Hyman, Case Discussion, MID-ATLANTIC ETHICS COMM. NEWSL., Fall 1995, at 8;
172. Hyman, supra note 118.
173. See supra note 78.
174. GRANT GILMORE, THE AGES OF AMERICAN LAW 111 (1977).