Regulating creativity: Research and survival in the IRB iron cage

Northwestern University Law Review

Volumn 101, Issue 2, 2007, Pages 593-641

  Bledsoe, Caroline H ^a   Sherin, Bruce ^a   Galinsky, Adam G ^b   Headley, Nathalia M ^e   Heimer, Carol A ^a,c   Kjeldgaard, Erik ^a   Lindgren, James ^a   Miller, Jon D ^d   Roloff, Michael E ^a   Uttal, David H ^a  

^a NORTHWESTERN UNIVERSITY   (United States)

^b NORTHWESTERN UNIVERSITY   (United States)

^c AMERICAN BAR FOUNDATION   (United States)

^d MICHIGAN STATE UNIVERSITY   (United States)

^e NONE

Author keywords

[No Author keywords available]

Indexed keywords

EID: 34547991166     PISSN: 00293571     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (126)

1. See generally United States Department of Health and Human Services, Human Research Protections Database, http://ohrp.cit.nih.gov/search/ asearch.asp (last visited Nov. 10, 2006) (providing a list of approved assurances and related information).
2. See, e.g., University of Kentucky Regulations, http://www.uky.edu/Regs/(last visited Nov. 10, 2006). (The University of Kentucky's page on university regulations shows how a search of any university's web site quickly reveals the great number of such regulations. It has a list of twenty-eight links, each to a separate area of university regulations, spanning such things as "Administrative Regulations" as well as "Bicycle Regulations.").
3. See, e.g., Christopher Shea, Don't Talk to the Humans: The Crackdown on Social Science Research, LINGUA FRANCA: THE REVIEW OF ACADEMIC LIFE, Sept. 2000, at 27, 29; Emory University, Human Subjects and the Humanities, http://www.emory.edu/ACAD_EXCHANGE/2002/aprmay/humsubj.html (last visited Nov. 10,2006);
4. University of North Carolina, Human Research Ethics, http://ohre.unc.edu/ (last visited Nov. 10, 2006);
5. University of Illinois at Chicago, Institute for the Humanities, http://www.uic.edu/depts/huminst/ovcr-aah/guidelines.html (last visited Nov. 10, 2006).
6. See, e.g., AMERICAN PSYCHOLOGICAL ASSOCIATION, ETHICAL PRINCIPLES OF PSYCHOLOGISTS AND CODE OF CONDUCT § 8.01 (2002), available at http://www.apa.org/ethics/code2002.pdf.
7. See Office for Human Research Protections, International Assurances ("FWA") by Location, http://ohrp.cit.nih.gov/search/ actrypck.asp (last visited Nov. 10, 2006). Based on personal correspondence with Jonathan Knight of the American Association of University Professors ("AAUP"), it seems reasonable to believe that, worldwide, there are now over 7000 FWA agreements between individual institutions and the U.S. government.
8. Students Dan Montgomery and Sam Lim first drew this to our attention, recounting their own IRB experience at the Illinois Mathematics and Science Academy.
9. Science Service, Background, http://www.sciserv.org/isefabout/background. asp (last visited Nov. 10, 2006). The International Science and Engineering Fair (ISEF) is under the auspices of "Science Service," which issues guidelines for local science fairs that seek affiliation with it, and for the students, teachers, and judges who participate in them. See SCIENCE SERVICE, INTERNATIONAL RULES FOR PRECOLLEGE RESEARCH: GUIDELINES FOR SCIENCE AND ENGINEERING FAIRS 12-14 (2006).
10. See, e.g., Discovery School, Before You Begin Section, http://school.discovery.com/sciencefaircentral/dysc/tips/tips.html (last visited Nov. 10, 2006) (providing links to Science Serve, Affiliated Fairs, http://www.sciserv.org/dcysc/fairs/fairlist.asp).
11. Guidelines for the Clarksville-Montgomery County Schools Science Fair 4 (2006), http://www.apsu.edu/robertsonr/sciencefair/ 2006%20COMPLETE%20SCIENCE%20FAIR%20MANUAL .doc (last visited Nov. 10, 2006). Aside from science fair participation, the rationale for extending IRB rules to pre-college schools is unclear. These schools may have been drawn in by a combination of convenience and academic aura - a ready-made, standardized package of rules used by universities. Alternatively, their adoption of IRB culture may have arisen from the entry into professional life of new cohorts of high school teachers who have been imprinted with IRB experience in their own training.
12. See, e.g., Protecting Human Beings: Institutional Review Boards and Social Science Research, ACADEME, May-June 2001, at 55;
13. For the Record: Should All Disciplines Be Subject to the Common Rule? Human Subjects of Social Science Research, ACADEME, May-June 2002, at 62;
14. Research on Human Subjects: Academic Freedom and the Institutional Review Board, ACADEME, Sept.-Oct. 2006, at 95;
15. Charles L. Bosk & Raymond G. De Vries, Bureaucracies of Mass Deception: Institutional Review Boards and the Ethics of Ethnographic Research, 595 ANNALS AM. ACAD. POL. & SOC. SCI. 249, 249 (2004);
16. James Boster, Towards IRB Reform, ANTHROPOLOGY NEWS, May 2006, at 21;
17. Richard A. Shweder, Protecting Human Subjects and Preserving Academic Freedom: Prospects at the University of Chicago, 33 AM. ETHNOLOGIST 507 (2006).
18. Philip Hamburger, The New Censorship: Institutional Review Boards, 2004 SUP. CT. REV. 271, 271.
19. See Thomas I. Emerson, Toward a General Theory of the First Amendment, 72 YALE L.J. 877, 880 (1963).
20. Id. at 881-82.
21. In personal correspondence with Don Workman, the Executive Director of the Office for the Protection of Research Subjects at Northwestern, he has pointed out that the institutional focus on the "high-risk" biomedical research does not only disenfranchise the social scientist. Whole colleges and the great bulk of the undergraduate population whose universities accept federal money may face IRB burdens of time and effort reporting requirements as well as research integrity efforts, without themselves receiving direct benefit.
22. The AAUP has produced two general statements on IRBs (in 2001 and 2006). Protecting Human Beings, supra note 10;
23. Research on Human Subjects, supra note 10.
24. For a discussion on the appropriateness of IRB oversight in the social sciences, see also Should All Disciplines Be Subject to the Common Rule?, supra note 10.
25. There are undoubtedly a number of reviews of university IRBs that include faculty members as members of standard university review cycle teams, but these are seldom made public. An ad hoc committee at the University of Arizona conducted by five anthropologists produced a report on the University of Arizona that was made available to us. Rhonda Gillett-Netting et al., Review and Approval of Human Subjects-Related Research at the University of Arizona: A Critical Assessment (2003) (unpublished report, on file with the University of Arizona); see also Shweder, supra note 10 (describing the current situation at the University of Chicago).
26. Subpart A of 45 C.F.R. § 46 (2005) is often referred to as the "Common Rule." It was so named because it was generalized to all relevant government agencies sponsoring human subjects research that have signed and endorsed it. The most recent agency to do so was - perhaps most incongruously, because of its association with militarism - the Department of Homeland Security. See, e.g., DEP'T OF HOMELAND SEC, BOARD AGENCY ANNOUNCEMENT 21 (June 18, 2004), available at http://www.dhs.gov/xlibrary/assets/S_T_BAA06July2004. pdf. For a general history of human subjects review in the United States, see Laura Jeanine Morris Stark, Morality in Science: How Research Is Evaluated in the Age of Human Subjects Regulation 23-127 (Nov. 2006) (unpublished Ph.D. dissertation, Princeton University) (on file with author).
27. See, e.g., JAMES H. JONES, THE TUSKEGEE SYPHILIS EXPERIMENT (1993);
28. see also National Center for Juvenile Justice, The Juvenile Justice Professional's Guide to Human Subjects Protection and the IRB Process: What We've Learned from History, http://ncjj.servehttp.com/irb/History.asp (last visited Nov. 10, 2006);
29. Office of the Vice President for Research, University of Minnesota, Teaching Ethics for Research, Scholarship, & Practice, http://www.research. umn.edu/ethics/curriculum/human_subjects.htrnl#History (last visited Nov. 10, 2006).
30. 2 U.S. GOV'T PRINTING OFFICE, TRIALS OF WAR CRIMINALS BEFORE THE NUREMBERG MILITARY TRIBUNALS UNDER CONTROL COUNCIL LAW NO. 10, at 181-82(1949).
31. WORLD MEDICAL ASSOCIATION, DECLARATION OF HELSINKI (1964), available at http://www.wma.net/e/ policy/b3.htm.
32. THE BELMONT REPORT: ETHICAL PRINCIPLES AND GUIDELINES FOR THE PROTECTION OF HUMAN SUBJECTS OF RESEARCH, 44 Fed. Reg. 23, 192 (Apr. 18, 1979).
33. See, e.g., Harvard School of Public Health, Human Subjects Committee, http://www.hsph.harvard.edu/hsc/links.html (last visited Nov. 10, 2006); Northwestern University, Institutional Review Board, http://www.research. northwestern.edu/research/oprs/irb/resources/ (last visited Nov. 10, 2006).
34. 45 C.F.R. § 46.103 (2005).
35. 45 C.F.R. § 46.102(d) (2005).
36. 45 C.F.R. §46.109(e) (2005).
37. 45 C.F.R. § 46.108(2005).
38. 45 C.F.R. § 46.101(b) (2005);
39. C.F.R. § 46.110(b) (2005).
40. 45 C.F.R. § 46.107(2005).
41. National Institutes of Health, Appropriations, http://www.nih.gov/about/ almanac/appropriations/part2.htm (last visited Nov. 10, 2006).
42. This last feature seems even more significant, given that there is no adjustment for inflation.
43. American Association for the Advancement of Science, Funding Update on NIH R&D Spending for 2006, http://www.aaas.org/spp/rd/nih06f.htm (last visited Nov. 10, 2006).
44. This connection was noted by a knowledgeable source who asked not to be cited directly.
45. See David Korn et al., The NIHBudget in the "Postdoubling" Era, 296 SCI. 1401 (2002).
46. Id. at 1401.
47. Recent NIH budgets have reflected even more strongly the sag in Bush administration health priorities. While the biodefense level for 2006 is at the same $1.75 billion level of the 2003 NIH package, much initial building infrastructure investment is now completed, meaning that funding for biodefense research itself has increased, one of the few areas of NIH funding that has done so. American Association for the Advancement of Science, supra note 30.
48. According to some observers, the effects of the 1998-2003 doubling phase will be lost altogether by 2007. See Office of Public Affairs, Chart on Budget Gains from NIH Doubling, http://opa.faseb.org/pdf/ DoublingEliminationChart.pdf (last visited Nov. 10, 2006).
49. Shea, supra note 3, at 28.
50. Id.
51. For more general information, see OHRP's instructions for reporting "unanticipated problems involving risks to subjects or others," "serious or continuing non-compliance with DHHS ... or IRB," and "suspension or termination of IRB approval." Office of Human Research Protections, Department of Health and Human Services, Guidance on Reporting Incidents to OHRP (May 27, 2005), available at http://www.hhs.gov/ohrp/ policy/procedures_for reporting_052505.pdf.
52. Jack Katz, Ethical Routes for Underground Ethnographers, 33 AM. ETHNOLOGIST 499, 500 (2006).
53. Other examples from the field of risk management include firefighting, now a cliché among managers; disaster planning; terrorism prevention; and insurance underwriting for hospitals. See generally CAROL A. HEIMER, REACTIVE RISK AND RATIONAL ACTION: MANAGING MORAL HAZARD IN INSURANCE CONTRACTS (1985) (providing a general social science treatment of the professionalization of risk); Marilyn Strathern, Introduction, New Accountabilities, in AUDIT CULTURES: ANTHROPOLOGICAL STUDIES IN ACCOUNTABILITY, ETHICS AND THE ACADEMY 1 (Marilyn Strathern ed., 2000) (providing analyses of attempts to monitor responsibility, ethics, and accountability).
54. KARL E. WEICK & KATHLEEN M. SUTCLIFFE, MANAGING THE UNEXPECTED: ASSURING HIGH PERFORMANCE IN AN AGE OF COMPLEXITY 3 (2001).
55. Id. at 27.
56. Id. at 25.
57. Id. at 25-26.
58. Id. at 10-11.
59. Id. at 3.
60. Id. at 4.
61. The evolution of voluntary compliance through "e-govemment" offers a striking parallel to the eIRB system that many universities are putting in place. Presenting itself as a trusted servant that seeks to improve efficiency and reduce administrative "nuisance," virtual government results in citizens willingly ceding their rights to privacy by allowing government to collect and retain data about every aspect of their lives. See, Giovanni Navarria, E-Government: Who Controls the Controllers?, OPEN DEMOCRACY, Feb. 9, 2006, http://www.opendemocracy.net/ content/articles/PDF/3254.pdf.
62. MAX WEBER, THE PROTESTANT ETHIC AND THE SPIRIT OF CAPITALISM 182 (Talcott Parsons trans., 1958) (1904).
63. ROBERT K. MERTON, SOCIAL THEORY AND SOCIAL STRUCTURE: TOWARD THE CODIFICATION OF THEORY AND RESEARCH 200 (1957).
64. Richard A. Hubert, Bureaucracy as Belief, Rationalization as Repair: Max Weber in a Post-Functionalist Age, 5 SOC. THEORY 70, 81 (1987).
65. EUGENE BARDACH & ROBERT A. KAGAN, GOING BY THE BOOK: THE PROBLEM OF REGULATORY UNREASONABLENESS 93-119 (1982).
66. There are inevitably shades of gray in interpretation, but any single act of deviation is supposed to result in redressive steps. If these steps are not taken, the institution has essentially failed in its obligations, rendering it noncompliant as a whole.
67. 45 C.F.R. § 46 (2005). Institutions that have not pledged in their FWA contracts to apply federal IRB rules to all their projects are not legally bound to do this, but since most continue to apply these rules to all projects, we will speak, for simplicity, of IRB rules as a uniform system, at least within institutions.
68. MAX WEBER, ECONOMY AND SOCIETY: AN OUTLINE OF INTERPRETIVE SOCIOLOGY 212 (Ephraim Fischoff et al. trans., Bedminster Press 1968) (1925).
69. 45 C.F.R. § 46.102(d) (2005).
70. Oral History Ass'n, Oral History Excluded from IRB Review, http://omega.dickinson.edu/organizations/oha/org_irb.html (last visited Nov. 9, 2006) ("While historians reach for meaning that goes beyond the specific subject of their inquiry, unlike researchers in the biomedical and behavioral sciences they do not reach for generalizable principles of historical or social development, nor do they seek underlying principles or laws of nature that have predictive value and can be applied to other circumstances for the purpose of controlling outcomes. Historians explain a particular past; they do not create general explanations about all that has happened in the past, nor do they predict the future.")
71. See, e.g., id.;
72. Linda Shopes & Donald Ritchie, Exclusion of Oral History from IRB Reviews: An Update, PERSPECTIVES NEWSLETTER OF THE AMERICAN HISTORICAL ASSOCIATION, Mar. 2004, at 9.
73. INSTITUTIONAL REVIEW BOARD, NORTHWESTERN UNIVERSITY, GUIDELINES ON PROTOCOL DEVIATIONS/VIOLATIONS 2 (2002), available at http://www.research.northwestern.edu/research/OPRS/irb/forms/docs/ ProtocolViolationGuidelines.doc.
74. See, e.g., Letter from Patrick J. McNeilly & Michael Carome, Department of Health & Human Services, to Edward D. Miller, Chi Van Dang & Gregory F. Schaffer, Johns Hopkins University (July 19, 2001), available at http://www.hhs.gov/ohrp/detrm_letrs/jul01a.pdf (letter from OHRP after death of research subject at John Hopkins);
75. see also, e.g., ALLIANCE FOR HUMAN RESEARCH PROTECTION, NATIONAL BIOETHICS ADVISORY COMMITTEE (NBAC) FINAL REPORT (2001), available at http://www.ahrp.org/ethical/compliance.php (providing list of citations to other compliance determination letters sent to various universities for possible violations).
76. See, e.g., Erich Jensen & Judy Nowack, Warning! Warning! Warning! Letters: Rules for the Clinical Research Game (Nov. 17, 2003), available at http://www.wlap.org/wl-browser/browser.php? ID=20031117-annarbor-01 -Jensen.
77. For a general history of human subjects review in the U.S., see Stark, supra note 16, at 169-254.
78. See Institutional Review Board, Northwestern University, Forms, http://www.research.northwestem.edu/research/oprs/irb/forms/ (last visited Dec. 3, 2006).
79. Erik Kjeldgaard, Anthropology and IRBs: A Response to James Boster, ANTHROPOLOGY NEWS, Sept. 2006, at 5 (2006).
80. See OFFICE FOR PROTECTION FROM RESEARCH RISKS, UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, PROTECTING HUMAN RESEARCH SUBJECTS: THE INSTITUTIONAL REVIEW BOARD GUIDEBOOK 6-18 to -25 (1993).
81. This trend was pointed out in personal discussions with Andrew Ellis, an IRB Manager in the Office for the Protection of Research Subjects at Northwestern University.
82. 45 C.F.R. § 46.101(h)(i), at n.1 (2005); see also Exemption Guidelines for 45 C.F.R. 46, http://www.research.northwestern.edu/research/OPRS/ irb/forms/docs/NPSFExemptionGuidelines.doc (last visited Nov. 11, 2006).
83. Information Sheet from the Food and Drug Administration Regarding the Use of "Off Label" Drugs, http://www.fda.gov/oc/ohrt/irbs/offlabel.html (last visited Feb. 1, 2007).
84. 45 C.F.R. § 46.111(b) (2005).
85. See, e.g., Office of Fellowships, Northwestern University, Research Opportunities for Undergraduates at Northwestern University, http://www.northwestern.edu/undergrad-research/require.html (last visited Nov. 11, 2006);
86. Office of the Provost, Northwestern University, Undergraduate Research Symposium at Northwestern University, http://www.northwestern.edu/provost/ students/research_symposium/ (last visited Nov. 11, 2006);
87. School of Education and Social Policy, Northwestern University, Research Opportunities, http://www.sesp.northwestern.edu/ugrad/community/announce/ opportunities/ (last visited Nov. 11, 2006).
88. Louis Althusser, Ideology and Ideological State Apparatuses: Notes Toward an Investigation, in MAPPING IDEOLOGY 127 (Slavoj Zizek ed., 1969).
89. TALCOTT PARSONS, THE SOCIAL SYSTEM 207-226 (1964).
90. Michel Foucault, The Subject and the Power, in BEYOND STRUCTURALISM AND HERMENEUTICS 208 (Hubert Dreyfus & Paul Rabinow eds., 1982).
91. See, e.g., W. RICHARD SCOTT, ORGANIZATIONS: RATIONAL, NATURAL AND OPEN SYSTEMS 31 (2003);
92. PHILIP SELZNICK, TVA AND THE GRASS ROOTS: A STUDY IN THE SOCIOLOGY OF FORMAL ORGANIZATION (1949); Mark Granovetter, Economic Action and Social Structure: The Problem of Embeddedness, 91 AM. J. OF SOC 481, 501-02 (1985).
93. P.P. McDermott & H. Tylbor, On the Necessity of Collusion in Conversation, in THE DIALOGIC EMERGENCE OF CULTURE 218, 219 (D. Tedlock and B. Mannheim eds., 1995).
94. 45 C.F.R. § 46.116 (2005).
95. See, e.g., Bradford H. Gray, Complexities of Informed Consent, All ANNALS OF THE AM. ACAD. OF POL. & SOC. SCI. 37 (1978) (arguing that there is too much focus on consent forms rather than the collective relationship between doctor and subject);
96. see also Rena Lederman, IRB Consent Form Dilemmas and the Importance of Local Knowledge, ANTHROPOLOGY NEWS, May 2006, at 21, 22 (describing the difficulty of human rights researchers who are concerned about consent forms falling into the wrong hands and identifying those individuals that assisted with their research).
97. Emanuel A. Schegloff, Gail Jefferson & Harvey Sacks, The Preference for Self-Correction in the Organization of Repair in Conversation, 53 LANGUAGE 361, 361 (1977).
98. For just two of many other universities' social science IRB committees, see, for example, Human Subjects Review Board at John Hopkins University, http://web.jhu.edu/Homewood-IRB (last visited Feb. 1, 2007) (separate website for review board handling social sciences); Office for the Vice President of Research, University of Minnesota, About the University of Minnesota Institutional Review Board, http://www.research.umn.edu/irb/about/ (last visited Nov. 11, 2006) (website listing different committees dealing with different topics, including social sciences).
99. See, e.g., Center for Advanced Study, Improving the System for Protecting Human Subjects: Counteracting IRB "Mission Creep" (U. 111. Law & Econ. Research Paper No. LE06-016, 2005), available at http://www.law.uiuc.edu/conferences/whitepaper/summary.html.
100. See, e.g., Forms for the Northwestern University Institutional Review Board, http://www.research.northwestern.edu/research/oprs/irb/forms/ (last visited Nov. 11, 2006) (all of Northwestern's current paper-based forms can be accessed at this site).
101. Don Workman, the Executive Director at Northwestern's Office for the Protection of Research Subjects, has pointed out in personal conversations that the wording of the institution's contract with the federal government itself-an "Assurance" (Federalwide)-implies that trust is at the center of the agreement.
102. The definition of research that 45 C.F.R. § 46 set out, and that later revisions embellished, is based not simply on a medical model, however, but a cultural model of mid-twentieth century of medical experimentation. See, e.g., Rena Lederman, Introduction: Anxious Borders Between Work and Life in a Time of Bureaucratic Ethics Regulation, 33 AM. ETHNOLOGIST 477 (2006);
103. Rena Lederman, The Perils of Working at Home: IRB "Mission Creep " as Context and Content for an Ethnography of Disciplinary Knowledges, 33 AM. ETHNOLOGIST 482 (2006).
104. This model looked out on the world of social science with what we might today see as an exceptionally naïve gaze. See, e.g., 45 C.F.R. § 46.117 (2005) (the handling of informed consent). The Code's attempt to legislate ways by which different forms of science under its jurisdiction should be handled or automatically exempted is revealing as a historical window into science four decades ago. Its treatment of exemption § 46.101, for example, treats methods as inherently risky (or not), a stance that contemporary debates about "essentialism" would question.
105. See, e.g., Shelley Fisher Fishkin, Essentialism and its Discontents, 48 AM. Q. 142 (1996) (reviewing ANN DUCILLE, THE COUPLING CONVENTION: SEX, TEST, AND TRADITION IN BLACK WOMEN'S FICTION (1994)).
106. See Northwestern University Institutional Review Board, New Project Submission Form for Social and Behavioral Science (NPSF-SBS), available at http://www.research.northwestern.edu/research/OPRS/irb/ forms/documents/NPSFBehavioralScience11-02-2006.doc (last viewed Nov. 11, 2006).
107. For a general description of Type 2 errors, see STEVE MCKILLUP, STATISTICS EXPLAINED: AN INTRODUCTORY GUIDE FOR LIFE SCIENTISTS 97 (2006).
108. Institutional Review Board, Northwestern University, Guidelines for Serious Adverse Event, http://www.research.northwestern.edu/research/OPRS/irb/ forms/docs/SeriousAdverseEventGuidelines.doc (last viewed Nov. 11, 2006).
109. Institutional Review Board, Northwestern University, Guidelines on Protocol Deviations/Violations (rev. Nov. 12, 2002), http://www.research. northwestern.edu/research/OPRS/irb/forms/docs/ProtocolViolationGuidelines.doc.
110. 45 C.F.R. § 46.203 (2005).
111. Office for the Protection of Research Subjects: Institutional Review Board, Northwestern University, IRB Regulatory Authority and Governing Principles § I.G, http://www.northwestern.edu/research/OPRS/irb/policies/ manual/,section_I.html#I_G (last visited Nov. 21, 2005) (website no longer available, on file with author and available at http://web.archive.org/ web/20041113172049/http:/www.northwestern.edu/research/OPRS/irb/policies/manual/ section_I.html#I_G).
112. See, e.g., IRB Member News, http://www.orau.gov/communityirb/news. htm (last visited Nov. 11, 2006); Office for Human Research Protection, Applicability of 45 CFR Part 46 to Clinical Investigations Conducted Under FDA's Interim Rule at 21 CFR 50.23(e) (June 7, 2006), http://www.hhs.gov/ohrp/ humansubjects/guidance/invitrodev.html.
113. See, e.g., Association for the Accreditation of Human Research Protection Programs, http://www.aahrpp.org/www.aspx (last visited Nov. 11, 2006);
114. National Association of IRB Managers, http://www.naim.org/ (last visited Nov. 11, 2006).
115. Carol A. Heimer, Risk and Rules: The Legalization of Medicine, in ORGANIZATIONAL ENCOUNTERS WITH RISK 92 (Bridget Hutter & Michael Power eds., 2005).
116. KARL R. POPPER, THE LOGIC OF SCIENTIFIC DISCOVERY (1980).
117. See Lederman, The Perils of Working at Home, supra note 81, at 484-85 (on the IRB-medical model's assumption of tightly controlled research space in an environment controlled exclusively by the researcher, as opposed to one often controlled more by the "subjects," as ethnographic work requires).
118. Email from Thomas Schnitzer, Member, Northwestern IRB Advisory Committee, to Caroline Bledsoe, Professor, Northwestern University (Sept. 23, 2006, 22:35:40 CST) (on file with author).
119. BELMONT REPORT, supra note 20, at 23, 195-96.
120. Office for the Protection of Research Subjects, Northwestern University, Informed Consent Templates, http://www.research.northwestem.edu/research/oprs/ irb/templates/ (last visited Nov. 12, 2006).
121. Sam Dillon and Stephen Labaton, Colleges Oppose Call to Upgrade Online Systems, N.Y. TIMES, Oct. 23, 2005, at Al (article regarding concerns on the growth of the Communications Assistance for Law Enforcement Act, which allows for government to monitor colleges' online communication systems).
122. Office for Human Research Protections (OHRP), Guidance on Certificates of Confidentiality (Feb. 25, 2003), http://www.hhs.gov/ohrp/humansubjects/ guidance/certconf.htm.
123. Mahadev Murthy, Clinical Trials in India: Current Trends and Future Opportunities, REG. AFFAIRS FOCUS MAG., Aug. 2006, at 10, 10.
124. See, e.g., Posting of Stuart Rennie to http://blog.bioethics.net/2005/08/ is-your-country-attractive-for.html (Aug. 19, 2005);
125. Paul P. Brown, What's Offline: Outsourcing RX, N.Y. TIMES, Mar. 11, 2006, at C5; PBS Capsule on Episode Regarding Medical Testing on Humans, http://www.pbs.org/wnet/air/episodes_102.html (last visited Nov. 12, 2006).
126. 45 C.F.R. § 46, at subpts. B-D (2005) (subparts pertaining to extra protections for prisoners and children).