Institutional review boards as academic bureaucracies: An economic and experiential analysis

Northwestern University Law Review

Volumn 101, Issue 2, 2007, Pages 861-895

  Zywicki, Todd J ^a,b  

^a GEORGE MASON UNIVERSITY   (United States)

^b James Buchanan Center for the Study of Political Economy

Author keywords

[No Author keywords available]

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EID: 34547956995     PISSN: 00293571     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (163)

1. From 2003 to 2004 I served as the Director of the Office of Policy Planning at the United States Federal Trade Commission.
2. See RICHARD A. HARRIS & SIDNEY M. MILKIS, THE POLITICS OF REGULATORY CHANGE: A TALE OF TWO AGENCIES (2d ed. 1996);
3. WILLIAM A. NISKANEN, JR., BUREAUCRACY AND REPRESENTATIVE GOVERNMENT (1971);
4. GORDON TULLOCK, THE POLITICS OF BUREAUCRACY (1965).
5. RYAN C. AMACHER & ROGER E. MEINERS, FAULTY TOWERS: TENURE AND THE STRUCTURE OF HIGHER EDUCATION 58 (2004). Some commentators have discussed certain aspects of university governance, but there seems to be no systematic model of the incentives of university administrators. Amacher and Meiners discuss academic bureaucracies briefly, but focus predominantly on tenure. Id. Gordon Tullock provides a model of the organization of academic research. GORDON TULLOCK, THE ORGANIZATION OF INQUIRY
6. reprinted in 3 THE SELECTED WORKS OF GORDON TULLOCK (Charles K. Rowley ed., Liberty Fund 2005). Stinchcombe explores some of the issues of the internal organization of universities, focusing specifically on administrative decisions such as teaching assignments, curriculum decisions, and space allocations.
7. ARTHUR L. STINCHCOMBE, INFORMATION AND ORGANIZATIONS (1990). Manne discussed the ownership and control structure of universities. Henry G. Manne, The Political Economy of Modern Universities, in EDUCATION IN A FREE SOCIETY 165 (Anne Husted Burleigh ed., 1973). None of these works addresses the questions of academic bureaucracies raised by IRBs.
8. AMACHER & MEINERS, supra note 3, at 57.
9. Id.
10. See discussions in other papers in this Symposium.
11. THE CENTER FOR ADVANCED STUDY, IMPROVING THE SYSTEM FOR PROTECTING HUMAN SUBJECTS: COUNTERACTING IRB "MISSION CREEP" 4-5 (2005).
12. See also id. at 7 (arguing that IRBs' standards are often difficult to measure and reward and that they often quantify intangibles-such as paperwork-losing their original values in the process).
13. Id. at 4-5.
14. Protecting Human Beings: Institutional Review Boards and Social Science Research, ACADEME, May-June 2001, at 55, 56 (citing JAMES BELL, JOHN WHITON, & SHARON CONNELLY, NATIONAL INSTITUTE OF HEALTH, EVALUATION OF NIH IMPLEMENTATION OF SECTION 491 OF THE PUBLIC HEALTH SERVICE ACT, MANDATING A PROGRAM FOR PROTECTION OF RESEARCH SUBJECTS (1998)) [hereinafter Protecting Human Beings].
15. Cary Nelson, Can E.T. Phone Home? The Brave New World of University Surveillance, ACADEME, Sept.-Oct. 2003, at 30, 33.
16. Editorial, Time To Cut Regulations that Protect Only Regulators, 414 NATURE 379, 379 (2001) [hereinafter Time to Cut].
17. Id.
18. Jeremy Sugarman, et al., The Cost of Institutional Review Boards in Academic Medical Centers, 352 NEW ENGLAND J. MED. 1825, 1827 (2005).
19. Id. at 1825-26.
20. Scott Burris & Kathryn Moss, U.S. Health Researchers Review Their Ethics Review Boards: A Qualitative Study, 1 J. EMPIRICAL RES. ON HUMAN RES. ETHICS 39, 49 (2006).
21. William Burman et al., The Effects of Local Review on Informed Consent Documents from a Multicenter Clinical Trials Consortium, 24 CONTROLLED CLINICAL TRIALS 245, 248 (2003).
22. Id. at 249.
23. Id. at 249-51.
24. The changes also led to more words per sentence and "a higher proportion of sentences in the passive voice." Id. at 248-419.
25. Burris and Moss note that IRB consent forms tend to be long and mired in legalese without any indication that subjects actually understand them. Burris & Moss, supra note 15, at 43.
26. Burris & Moss, supra note 15, at 50.
27. See discussion supra at note 16-18 and accompanying text.
28. Burns & Moss, supra note 15, at 50.
29. See id. at 47.
30. Id. at 50.
31. See Time to Cut, supra note 11, at 379 ("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.").
32. Burris & Moss, supra note 15, at 47 (quoting survey respondent).
33. Id.
34. Keith N. Humphreys et al., The Cost of Institutional Review Board Procedures in Multi-Center Observational Research, 139 ANNALS INTERNAL MED. 77, 77 (2003).
35. Id.
36. Caroline H. Bledsoe et al., Regulating Creativity: Research and Survival in the IRB Iron Cage, 101 NW. U. L. REV. 593, 641 (2007).
37. For the Record: Should All Disciplines Be Subject to the Common Rule? Human Subjects of Social Science Research, ACADEME, May-June 2002, at 62, 68 (remarks of Margaret A. Blanchard) [hereinafter For the Record].
38. For the Record, supra note 32, at 68.
39. Burris & Moss, supra note 15, at 47.
40. Id.
41. See Bledsoe et al., supra note 31, at 615-17.
42. Richard S. Saver, Medical Research Oversight from the Corporate Governance Perspective: Comparing Institutional Review Boards and Corporate Boards, 46 WM. & MARY L. REV. 619, 727 (2004).
43. According to one study, 43% of academic medical centers provided no monetary payment to IRB members. Sugarman et al., supra note 13, at 1825.
44. Jeffery Cohen, The Cost of IRB Review, in HUMAN SUBJECTS RESEARCH: A HANDBOOK FOR INSTITUTIONAL REVIEW BOARDS 39 (R.A. Greenwald, M.K. Ryan, & J.E. Mulvihill eds., 1982).
45. Burman et al., supra note 16, at 251.
46. Burris & Moss, supra note 15, at 52.
47. Christopher Shea, Don't Talk to the Humans: The Crackdown on Social Science Research, LINGUA FRANCA, Sept. 2000, at 27, 34 (Sept. 2000) (describing comments of Norman Bradburn, an assistant director at the National Science Foundation).
48. Supporters of IRBs often contend that their interventions improve the scholarly quality of a research program as well as preventing harm to subjects. This claim is highly doubtful. I am not aware of any scholar who shares this opinion of the value of IRBs in reviewing the quality of a research program, nor is it particularly plausible. Indeed, this meddling has been uniformly denounced by those scholars that have addressed it. See Burris & Moss, supra note 15, at 42. This argument appears to be a rationalization rather than a justification for this practice.
49. See MAXWELL STEARNS & TODD J. ZYWICKI, PUBLIC CHOICE CONCEPTS AND APPLICATIONS IN LAW ch. 1 (forthcoming 2008).
50. See NISKANEN, supra note 2.
51. Niskanen argues that these goals of maximizing power, prestige, and security actually may be manifested in a tendency to maximize the agency's budget (or size). Id. at 38. For purposes of this article I will keep these factors conceptually distinct.
52. See also James Q. Wilson, The Politics of Regulation, in THE POLITICS OF REGULATION 361 (James Q. Wilson ed., 1980).
53. As Dennis Mueller puts it, "Bureaucratic man pursues power. Economic man pursues profit.... [T]here is a close link between the economic theory of profit and the political theory of power." DENNIS C. MUELLER, PUBLIC CHOICE III 362 (2003). Much ink has been spilled by scholars on the issue to what extent empire-building by bureaucrats explains bureaucratic activity over time.
54. Based on my personal experience, those who consciously seek to maximize their agency's power do so primarily to take advantage of the "revolving door" phenomenon - by increasing the power and budget of the agency while in office, the regulator can increase his influence and value to clients outside government in later lobbying activities.
55. See STEARNS & ZYWICKI, supra note 44, ch. 1. For example, an exceedingly selfless and charitably inclined soul might contribute all his money to a worthy charity-but he would still benefit from securing increased wealth and power if those permitted him to contribute more to his preferred charity. From a purely descriptive or predictive perspective, therefore, we might observe the same wealthmaximizing behavior from this person as from a more consciously self-seeking individual.
56. See Jonathan R. Macey, Administrative Agency Obsolescence and Interest Group Formation: A Case Study of the SEC at Sixty, 15 CARDOZO L. REV. 909 (1994).
57. See Sam Peltzman, An Evaluation of Consumer Protection Legislation: The 1962 Drug Amendments, 81 J. POL. ECON. 1049 (1973);
58. see also MUELLER, supra note 47, at 370-71 (summarizing literature).
59. See MUELLER, supra note 47, at 370-71.
60. F.A. Hayek, The Use of Knowledge in Society, 35 AM. ECON. REV. 519, 526-28 (1945).
61. See Harry Case Brearly, The Origins of Underwriters ' Laboratories, in REPUTATION: STUDIES IN THE VOLUNTARY ELICITATION OF GOOD CONDUCT 75 (Daniel B. Klein ed., 1997).
62. See Benjamin Klein & Keith B. Leffler, The Role of Market Forces in Assuring Contractual Performance, 89 J. POL. ECON. 615 (1981).
63. See Mark L. Mitchell & Michael T. Maloney, Crisis in the Cockpit? The Role of Market Forces in Promoting Air Travel Safety, 32 J.L. & ECON. 329 (1989);
64. Mark L. Mitchell, The Impact of External Parties on Brand-Name Capital: The 1982 Tylenol Poisonings and Subsequent Cases, 27 ECON. INQUIRY 601 (1989).
65. DANIEL H. HENNING & WILLIAM R. MANGUN, MANAGING THE ENVIRONMENTAL CRISIS: INCORPORATING COMPETING VALUES IN NATURAL RESOURCE ADMINISTRATION 59-60 (1989);
66. Robert W. Hahn & Robert N. Stavins, Incentive-Based Environmental Regulation: A New Era from an Old Idea?, 18 ECOLOGY L.Q. 1, 35 n.186 (1991);
67. Walter A. Rosenbaum, The Bureaucracy and Environmental Policy, in ENVIRONMENTAL POLITICS AND POLICY: THEORIES AND EVIDENCE 212, 222 (James P. Lester ed., 1989);
68. Richard L. Stroup & Jane S. Shaw, Environmental Harms from Federal Government Policy, in TAKING THE ENVIRONMENT SERIOUSLY 51, 61-62 (Roger E. Meiners & Bruce Yandle eds., 1993);
69. Todd J. Zywicki, Environmental Externalities and Political Externalities: The Political Economy of Environmental Regulation and Reform, 73 TUL. L. REV. 845, 893 (1999).
70. Frank H. Knight, Lippman's The Good Society, 46 J. POL. ECON. 864, 869 (1938).
71. See Zywicki, supra note 57, at 850-51.
72. See FEDERAL TRADE COMMISSION, NO. 02N-0209, IN THE MATTER OF REQUEST FOR COMMENT ON FIRST AMENDMENT ISSUES (Sept. 13, 2002).
73. See, e.g., Thompson v. W. States Med. Ctr., 535 U.S. 537 (2002); Pearson v. Shalala, 164 F.3d 650, 655 (D.C. Cir. 1999).
74. Ken Young, How Scammers Run Rings Around eBay, THE REGISTER, Nov. 16, 2004, http://www.theregister.co.uk/2004/11/16/ petty_fraudsters_ebay/. This figure refers to confirmed fraud cases. There is no reliable way to know how many cases of actual fraud occur that are not confirmed.
75. See FEDERAL TRADE COMMISSION, INTERNET AUCTIONS A GUIDE FOR BUYERS AND SELLERS (2006), available at http://www.ftc.gov/bcp/conline/ pubs/online/auctions.htm.
76. See AMACHER & MEINERS, supra note 3, at 57 ("[T]he lack of a profit measure makes it difficult for any nonprofit organization to know how well it is doing.").
77. Cf. B. Peter Pashigian, A Theory of Prevention and Legal Defense with an Application to the Legal Costs of Companies, 25 J.L. & ECON. 247, 261-62 (1982) (noting that, in the private sector, large corporations spend less on legal compliance as a percentage of sales than smaller companies);
78. Zywicki, supra note 57, at 864-65 (noting that small businesses have more difficulty affording the costs of complying with environmental regulations).
79. Sugarman et al., supra note 13, at 1826 (estimating that 7% of IRB staff time is dedicated just to compliance with the Health Insurance Portability and Accountability Act).
80. Time to Cut, supra note 11, at 379.
81. Id.
82. AMACHER & MEINERS, supra note 3, at 59.
83. William Orzechowski, Economic Models of Bureaucracy: Survey, Extensions, and Evidence, in BUDGETS AND BUREAUCRATS: THE SOURCES OF GOVERNMENT GROWTH 229, 257 (Thomas Borcherding ed., 1977).
84. See Dennis Coates & Brad R. Humphreys, The Supply of University Enrollments: University Administrators as Utility Maximizing Bureaucrats, 110 PUB. CHOICE 365 (2002).
85. Richard A. Shweder, Protecting Human Subjects and Preserving Academic Freedom: Prospects at the University of Chicago, 33 AM. ETHNOLOGIST 507, 507 (2006). The figure is likely comparable elsewhere.
86. Burris & Moss, supra note 15, at 42.
87. For the argument that there are many alternative institutions that belie the claim that IRBs are necessary to constrain researchers, see discussion infra, notes 102-105 and accompanying text.
88. Kevin D. Haggerty, Accommodating Ethical Review: Response to Bosk and DeVries, SOC'Y ACAD. FREEDOM & SCHOLARSHIP NEWSLETTER, Apr. 2005, at 18.
89. Id. 77 Bledsoe et al., supra note 31, at 613.
90. Sugarman et al., supra note 13, at 1826 (noting that the median IRB dedicates a median of $463, 107 for staff salaries, about 62% of the total cost of IRB operations and that staff sizes range from 6 at low-volume institutions to 14 at high-volume institutions).
91. Such as the death of study participants a few years ago at Johns Hopkins University. See generally Donald Kennedy, Death at Johns Hopkins, 293 SCIENCE 1013 (Aug. 10, 2001) (noting critical coverage in New York Times);
92. Robert Steinbrook, Protecting Research Subjects - The Crisis at Johns Hopkins, 346 N. ENG. J. MED. 716 (Feb. 28, 2002) (describing the episode);
93. see also Larry Thompson, Human Gene Therapy: Harsh Lessons, High Hopes, FDA CONSUMER, Sept. Oct. 2000, at 19 (describing a 1999 episode involving the death of a participant in a clinical trial at the University of Pennsylvania's Institute for Gene Therapy that similarly spawned negative publicity).
94. In fact, some evidence suggests that IRBs may be even more risk-averse than the actual subjects who participate in the studies. See A. Smith & S.P. Berard, Why Are Human Subjects Less Concerned About Ethically Problematic Research than Human Subjects Committees?, 12 J. APPLIED SOC. PSYCHOL. 209 (1982).
95. Haggerty, supra note 75, at 18.
96. For the Record, supra note 32, at 68 (comments of Margaret A. Blanchard).
97. See Shea, supra note 42, at 28; For the Record, supra note 32, at 63 (comments of Jonathan T. Church, noting that "IRB membership is usually dominated by scholars whose expertise is in clinical and biomedical research").
98. See J. Michael Bailey, Academic McCarthyism, NW. CHRON., Oct. 9, 2005, at 1.
99. See Sharon Begley, Review Boards Pose Threat To Social Scientists ' Work, WALL ST. J., Nov. 1, 2002, at B1.
100. Nelson, supra note 10, at 34.
101. See Mary Jo Feldstein, Student Fights Research Board, DIGITAL MISSOURIAN, May 13, 2001, http://ludwig.missouri.edu/ 405/IRBstory.html;
102. see also Shea, supra note 42, at 32 ("One senior scholar echoes the sentiment, 'They are certainly not about to fuss with senior people.'").
103. See Protecting Human Beings, supra note 9, at 26-27.
104. Id. at 26 (citing Testimony of Murray L. Wax before the National Bioethics Advisory Commission).
105. Id. at 27.
106. See For the Record, supra note 32, at 62-63 (comments of Jonathan T. Church, describing a graduate student who chose not to pursue research on a controversial social topic because of the difficulty and delay of acquiring IRB approval);
107. id. at 68 (comments of Margaret A. Blanchard, noting that journalism grad students alter projects to avoid IRB contact or give up projects because of the "red tape" associated with securing IRB approval).
108. See For the Record, supra note 32, at 65 (comments of Linda Shopes).
109. Shea, supra note 42, at 34 (quoting Linda Shopes, former president of the Oral History Association).
110. Bledsoe et al., supra note 31, at 618.
111. For the Record, supra note 32, at 63 (comments of Jonathan T. Church).
112. Burris & Moss, supra note 15, at 45 (quoting survey respondent).
113. Id. (quoting survey respondent).
114. Id.
115. Id.
116. See id. at 42.
117. See id. at 50;
118. see also Jonathan D. Moreno, Goodbye to All That: The End of Moderate Protectionism in Human Subjects Research, HASTINGS CENTER REPORT, May-June 2001, at 9, 17 (2001).
119. MICHAEL MCDONALD, THE GOVERNANCE OF HEALTH RESEARCH INVOLVING HUMAN SUBJECTS 24-25 (Law Commission of Canada 2000).
120. Id. at 25;
121. see also Moreno, supra note 101, at 17.
122. Haggerty, supra note 75, at 18.
123. Id.
124. Burris & Moss, supra note 15, at 52. Compare id. with supra notes 55-56 and accompanying text.
125. See For the Record, supra note 32, at 68 (comments of Margaret Blanchard, describing efforts to accommodate First Amendment freedom of the press protections into institution's IRB review process).
126. Shea, supra note 42, at 34.
127. Burris & Moss, supra note 15, at 52.
128. Shea, supra note 42, at 32. As noted above, approximately 80% of social science research does not receive federal government funding.
129. See supra note 72 and accompanying text.
130. Shea, supra note 42, at 32.
131. Id. at 31-32.
132. Id.
133. One anthropologist who consciously chose to forego IRB approval before having students talk to passengers in a bus terminal, declares (presumably tongue-in-cheek) that if his projects are challenged "he'll claim the projects are not research but conceptual art. Universities, he says, don't hassle artists." Id.
134. Stephen J. Ceci, Douglas Peters, & Jonathan Plotkin, Human Subjects Review, Personal Values, and the Regulation of Social Science Research, 40 AM. PSYCHOL. 994 (1985).
135. Id. at 999.
136. Id. at 1000.
137. Id. at 999.
138. Id. at 1000.
139. Id. at 994. For example, the explanation for rejecting one of the reverse discrimination proposals was, "The findings could set Affirmative Action back 20 years if it came out that women with weaker [curricula] vitae were asked to interview more often for managerial positions than men with stronger vitae."
140. Id. at 1000.
141. Id. at 999.
142. 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.").
143. 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, July-Aug. 2002, at 41, 42 (noting prevalence of speech codes on college campuses today);
144. see also FOUNDATION FOR INDIVIDUAL RIGHTS IN EDUCATION, SPOTLIGHT ON SPEECH CODES 2006: THE STATE OF FREE SPEECH ON OUR NATION'S CAMPUSES (2006) (survey of 330 colleges and universities found that 68% maintain policies that clearly and substantially restrict free speech);
145. ALAN CHARLES KORS & HARVEY A. SILVERGLATE, THE SHADOW UNIVERSITY: THE BETRAYAL OF LIBERTY ON AMERICA'S CAMPUSES (1998) (discussing university speech codes and restraints on free speech on university campuses). The Foundation for Individual Rights in Education maintains a list of American universities with speech codes at www.thefire.org/index.php/allschools.
146. In this sense, IRB decision-making is similar to government regulators in economies that are subject to overly-intrusive regulations. Heavy economic regulation inevitably spawns violations of the rule of law and the predictability that it embodies, as the sheer weight of regulations and their contradictory mandates makes it practicably impossible for those regulated to comply with all the rules. As a result, regulators are forced to make ad hoc and arbitrary exceptions to the rules to make it possible for ordinary economic activity to occur. See Todd J. Zywicki, The Rule of Law, Freedom, and Prosperity, 10 SUP. CT. ECON. REV. 1 (2003).
147. See Brian C. Martinson et al., Scientists' Perception of Organizational Justice and Self-Reported Misbehaviors, 1 J. EMPIRICAL RES. HUM. RES. ETHICS 51, 54 (2006);
148. see also Burris & Moss, supra note 15, at 50.
149. Philip Hamburger, The New Censorship: Institutional Review Boards, 2004 SUP. CT. REV. 271 (2005).
150. Similarly, those who enforce campus speech codes appear not to be overly concerned about principles of fairness and due process in punishing violations of their mandates. See KORS & SILVERGLATE, supra note 123.
151. Because this individual is not publishing his remarks, I am quoting them without identification.
152. Unpublished paper presented at Symposium (emphasis added).
153. For instance, it appears that IRBs are more willing to permit questions that expose discrimination against minorities than concerns about reverse discrimination, suggesting different attitudes toward which political communities "count." See supra notes 115-21 and accompanying text.
154. C.F.R. § 46.107(a) (2006). In addition, IRBs must make every "nondiscriminatory effort" to ensure that no IRB "consists entirely of men or entirely of women." Id.
155. See, e.g., Freedman v. Maryland, 380 U.S. 51 (1965) (describing rules governing censorship of obscene movies by local licensing boards). There is substantial evidence that different IRBs reach divergent results on the propriety of research protocols.
156. See, e.g., Mary Terrell White & Jennifer Gamm, Informed Consent for Research on Stored Blood and Tissue Samples: A Survey of Institutional Review Board Practices, 9 ACCOUNTABILITY RES. 1 (2002);
157. Jon Mark Hirshon et al., Variability in Institutional Review Board Assessment of Minimal-Risk Research, 9 ACADEMIC EMERGENCY MED. 1417 (2002);
158. Thomas O. Stair et al., Variation in Institutional Review Board Responses to a Standard Protocol for a Multicenter Clinical Trial, 8 ACADEMIC EMERGENCY MED. 636 (2001). That consideration of subjective assessments of local communities might result in divergent outcomes was recognized in establishing the federal IRB scheme.
159. One of the advisors to the National Commission was Robert J. Levine, who observes that permitting these differential outcomes was deliberate. See ROBERT J. LEVINE, ETHICS AND REGULATION OF CLINICAL RESEARCH 342 (1986). OHRP stresses that the determination is subjective and subject to local variation: "The risk/benefit assessment is not a technical one valid under all circumstances; rather, it is a judgment that often depends upon prevailing community standards and subjective determinations of risk and benefit. Consequently, different IRBs may arrive at different assessments of a particular risk/benefit ratio." OFFICE FOR THE PROTECTION FROM RESEARCH RISKS, NATIONAL INSTITUTE OF HEALTH, PROTECTING HUMAN RESEARCH SUBJECTS: INSTITUTIONAL REVIEW BOARD GUIDEBOOK 3-8 (1993). I would like to thank Philip Hamburger for his insight on the issues discussed in this paragraph.
160. Burris & Moss, supra note 15, at 42-43. The IRB Director quoted above who participated in the Symposium was trained as a biomedical researcher.
161. See supra note 128 and accompanying text.
162. Id. at 43 (quoting anonymous survey respondent).
163. See supra notes 115-21 and accompanying text.