Article

How Talking Became Human Subjects Research: The Federal Regulation of the Social Sciences, 1965-1991

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Abstract

In universities across the United States, institutional review boards, or IRBs, claim that they have the moral and legal authority to control the work of researchers in the humanities and social sciences. While IRBs may claim powers independent of federal regulations, they invariably point to these regulations as a key source of their authority. This article draws on previously untapped manuscript materials in the National Archives to trace the history of the federal regulation of social science research. Officials raised sincere concerns about dangers to participants in social science research, especially the unwarranted invasion of privacy as a result of poorly planned survey and observational research. On the other hand, the application of the regulations to the social sciences was far less careful than was the development of guidelines for biomedical research. Regulators failed to define the problem they were trying to solve, then insisted on a protective measure borrowed from biomedical research without investigating alternatives.

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... The direct application of these traditional medical ethics models to non-medical fields, particularly digital research, is hotly contested. Some authors describe this 'mission creep' as an inappropriate application of bioethical standards, unfit for contexts with differences in required standards, methodologies, and enquiry (Anabo et al., 2019;Buchanan, 2011;Gunsalus et al., 2007;Markham, 2018;Metcalf & Crawford, 2016;Schrag, 2009). Others recommend the removal or reduction of ethical review to digital research (Dingwall, 2008;A. ...
... Others recommend the removal or reduction of ethical review to digital research (Dingwall, 2008;A. Jones, 2007), arguing that ethical review penalizes innovation, enforces standardization, and fails to provide the flexibility that social scientific inquiry requires (Markham, 2012;Schrag, 2009;Warfield et al., 2019). Certainly, despite these critiques, ethics committees vary considerably not only between institutions but also, over time, within institutions ( Van den Hoonaard, 2011). ...
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Chapter
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... Generally speaking, the answer is less for social science research when compared to the potential for harm inherent in medical research (see Emmerich, 2016;Haggerty, 2004). Schrag (2009) highlighted two early reviews of social science research from the 1970s commissioned by the United States government, one a review of 2039 studies that found only three confidentiality breaches, and another a review of 729 projects that found only four produced any harmful effects. In terms of survey research, Singer (2004) investigated the question in a series of studies and concluded the greatest danger is a confidentiality breach but the actual risk of that is "small" (p. ...
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Article
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Article
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... For instance, risks of psy- chological harm may exist in situations where participants are asked to reflect on negative situations or poor health states, which could result in feelings of sadness or depression. Additionally, the risk of informational harm is greater when survey research collects identifiable infor- mation from participants, especially if that information could lead to downstream harms such as legal actions against an individual or group or social discrimination [9]. For example, as part of a survey research study, investi- gators might collect identifiable information about illegal drug use. ...
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... In 1966, U.S. Surgeon General William Stewart announced new federal rules that required researchers to get prior approval from a human subjects review committee if they planned to study people. Psychologists at universities and clinics across the United States received Stewart's memos, which specified that social and behavioral scientists were bound by the policy along with medical researchers (Stark, 2007;Schrag, 2009). APA leaders agreed that this new oversight might prompt questions about a technical practice in psychology research known as deception. ...
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Chapter
IntroductionKey Questions for EthnobiologistsCase Study 4.1Conclusion AcknowledgmentsReferences
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The 2010 edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) adopts a new language of human participants, leaving the previous central concept of “human subjects” behind. This paper seeks to identify the reasons for this important change and stimulate a debate over the main subject of the policy. In particular, it considers whether the transition to human participants was necessitated by harmonization and unification in approaches to ethical oversight on the basis of the biomedical standard, or whether it was an outcome of a given regulatory approach, which is prima facie congruent with “new governance” approaches. It also examines negative performativity of “human subjects” in relation to researchers and research subjects. Finally, it calls for a critical assessment of the current universalist framework to prevent the concept of “human participants” from becoming a euphemism.
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Prevailing sociological understandings of institutional ethical review tend to homogenize faculty responses to them, and are predominantly speculative. In this research, we conduct interviews with sociologists from 21 Ph.D.-granting departments across Canada, finding three predominant “ethics orientations” among them, with associated cognitive maps and strategic actions. In our analyses, we use these orientations to complicate homogeneous appraisals of social researchers’ responses to new bureaucratic requirements, enriching our understanding of how such requirements affect the ways sociologists think about their occupation, approach their research, and mentor successive generations. These ethics orientations suggest the field of sociology is comprised of distinct political cohorts with diverging understandings of ethical review, and by extension, power and intellectual work. For some, ethical review signals a more consultative and therefore better approach to knowledge production, while for others it marks the end of an era of unfettered (and superior) intellectual pursuit in sociology. KeywordsEthical review-Sociology-Qualitative research-Bureaucracy-Strategy
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Our system of research self-regulation, designed to provide internal checks and balances for those who participate in research involving human subjects, is under considerable stress. Much of this crisis has been caused by what we call mission creep, in which the workload of IRBs has expanded beyond their ability to handle effectively. Mission creep is caused by rewarding wrong behaviors, such as focusing more on procedures and documentation than difficult ethical questions; unclear definitions, which lead to unclear responsibilities; efforts to comply with unwieldy federal requirements even when research is not federally funded; exaggerated precautions to protect against program shutdowns; and efforts to protect against lawsuits. We recommend collecting data. We also call for refinements to our regulatory system that will provide a set of regulations designed for non-biomedical research. This will enable IRBs to direct attention to the areas of greatest risk while intentionally scaling back oversight in areas of lesser risk. We recommend removing some kinds of activity from IRB review altogether. Our system, if not broken, is seriously straining at the seams. It is imperative that we have a respected and effective system in place to protect human research subjects, so that much-needed research into the causes and prevention of disease and other research expanding the boundaries of knowledge can proceed. We hope that this White Paper will further the discussion about what reasonable procedures can be instituted to help get IRBs back on track and do what they were originally meant to do-protect the rights and welfare of human subjects while allowing the research enterprise to progress and its benefits to society to accrue.
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Rep. Cornelius E. Gallagher (D-N. J.), Chairman of the Special Inquiry committee into psychoogical testing and personnel selection, addresses issues related the invasion of privacy involved with such tests. Rep. Gallagher contends that the Federal Government has been engaged in a more insidious type of search than going through someone's home, mail, or personal papers. It has been searching the minds of Federal employees and job applicants through personality testing. Federal employees and job applicants have been compelled to take these tests under Government direction, or lose positions, promotions, assignments, not only then but also in the future. There is little or no effective appeal procedure for our citizens who wish to challenge personality testing as an invasion of privacy, or contest interpretations of the findings in the event they do take the tests.
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This article reports a study of the activities and performance of institutional review boards to protect human research subjects. Researchers and institutional review board members were generally supportive of the review system, although substantial criticisms were also heard. Institutional review boards had some direct impact on half of the proposals reviewed by requiring either modification of or additional information about proposed research. The data, however, raise questions about the effectiveness of some review board actions, for example, with regard to informed consent. Some policy implications of the study are presented.
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The article deals with the state research-laboratory institutions performing examinations for all branches of hygiene, giving expert opinions and providing other services for the State Administration of Public Health, as in our country were: the National Institute of Public Health in Prague (1925) and the State Social-Health Institute in Bratislava (1939).
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IN GENERAL, THE PROBLEMS OF ETHICS FALL INTO 2 MAIN CATEGORIES: (1) THE USE OF DECEPTION OR COERCION, EITHER TO SECURE THE PARTICIPATION OF SS OR AS AN INTEGRAL PART OF THE RESEARCH DESIGN; AND (2) POSSIBLE HARMFUL EFFECTS ON HUMAN SS, RANGING FROM AN UNWARRANTED INTERVENTION IN THE LIVES OF OTHERS TO THE CREATION OF PSYCHOLOGICAL HARMS. MISLEADING SS ABOUT THE NATURE OR PURPOSE OF THE RESEARCH PROJECT, INTRODUCING FALSE INFORMATION ABOUT PERFORMANCE ON TESTS, INDUCING CHEATING BEHAVIOR, THE USE OF CAPTIVE POPULATIONS SUCH AS PATIENTS IN A MENTAL HOSPITAL, THE INVASION OF PRIVACY, THE MANIPULATION OF DEEPLY HELD VALUES, THE VIOLATION OF ANONYMITY-ALL COME UNDER SCRUTINY. (PsycINFO Database Record (c) 2012 APA, all rights reserved)
Proposed Model Federal Policy for Protection of Human Subjects): 20206. 126. Porter, interview. 127. Ibid.; " Federal Policy for the Protection of Human Subjects: Notice and Proposed Rules
Offi ce of Science and Technology Policy, " Proposed Model Federal Policy for Protection of Human Subjects, " Federal Register 51 (3 June 1986): 20206. 126. Porter, interview. 127. Ibid.; " Federal Policy for the Protection of Human Subjects: Notice and Proposed Rules, " Federal Register 53 (10 November 1988): 45663, 45672.
A Regulatory Perspective on Social Science Research Mechanisms for Applying Ethical Principles to the Conduct of Research Involving Human Subjects: Th e Institutional Review Board, " preliminary draft
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Richard A. Tropp, " A Regulatory Perspective on Social Science Research, " in Tom L. Beauchamp et al., eds., Ethical Issues in Social Science Research (Baltimore, 1982), 39. 56. National Research Act, PL 93-348, 88 Stat 342. 57. " Mechanisms for Applying Ethical Principles to the Conduct of Research Involving Human Subjects: Th e Institutional Review Board, " preliminary draft, 5 November 1976, p. 7, box 11, meeting #24, tabs 5–6, NCPHS-GU. 58. National Research Act, sec. 202.
Th e Political, Legal, and Moral Limits to Institutional Review Board (IRB) Oversight of Behavioral and Social Science Research
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Robert J. Levine et al., panelists, " Th e Political, Legal, and Moral Limits to Institutional Review Board (IRB) Oversight of Behavioral and Social Science Research, " in Paula Knudson, ed., PRIM&R Th rough the Years: Th ree Decades of Protecting Human Subjects, 1974–2005 (Boston, 2006), 38–40.
my Freedom of Information Act request for records of the Common Rule was met with the reply that " no responsive records " exist. 122 Concurrences of Departments and Agencies Including Proposed Departures from Model Policy RES 3-1-D Proposed Mondel [ sic ] Federal Policy Protection of Human Subjects
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Morality in Science: How Research Is Evaluated in the Age of Human Subjects Regulation
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Laura Jeanine Morris Stark, " Morality in Science: How Research Is Evaluated in the Age of Human Subjects Regulation " (Ph.D. diss., Princeton University, 2006), uses National Archives record group 443, but she reads diff erent documents to answer diff erent questions from those posed here.
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Human Rights and Human Subjects: Ethics and Strategies in Social Science Research): 107. Broadhead cites two articles about controversial research, neither of which shows that such controversy led to IRBs' powers
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Robert S. Broadhead, " Human Rights and Human Subjects: Ethics and Strategies in Social Science Research, " Sociological Inquiry 54 (April 1984): 107. Broadhead cites two articles about controversial research, neither of which shows that such controversy led to IRBs' powers.
Human Subjects Mailings 2/4, Pool papers; Pool Censoring Research Protecting Human Subjects of Research: An Analysis on Proposed Amendments to HEW Policy
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Pool to F. William Dommel, 8 November 1979, box 24, Human Subjects Mailings 2/4, Pool papers; Pool, " Censoring Research, " Society, November–December 1980, 40; Pool, " Prior Restraint, " New York Times, 16 December 1979; Pool, " Protecting Human Subjects of Research: An Analysis on Proposed Amendments to HEW Policy, " PS 12 (Autumn 1979): 452. 89. E. L. Pattullo, e-mail to the author, 14 August 2007.
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Ithiel de Sola Pool Papers, MC 440, Institute Archives and Special Collections, MIT Libraries, Cambridge, Massachusetts. 18. Shannon, interview by Frankel. 19. House Committee on Government Operations, Special Inquiry on Invasion of Privacy, 89th Cong., 1st sess., 1965, 5. 20. Cornelius E. Gallagher, " Why House Hearings on Invasion of Privacy, " American Psychologist, November 1965, reprinted in House Committee on Government Operations, Special Inquiry on Invasion of Privacy, 397–99. 21. House Committee on Government Operations, Special Inquiry on Invasion of Privacy, 295. 22. Gallagher to Luther L. Terry, Surgeon General, 13 September 1965, Res 3-1. Human Subjects Policy & Regulations 1965–67, RG 443. 23. Philip R. Lee to Gallagher, 22 November 1965, Res 3-1. Human Subjects Policy & Regulations 1965–67, RG 443.
Oral History of the Belmont Report and the NCPHS
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Robert E. Windom to Charlotte Kitler, 13 September 1988, RES-6-01. Human Subjects, OD Central Files, Offi ce of the Director, NIH. 132. Offi ce for Protection from Research Risks, " Exempt Research and Research Th at May Undergo Expedited Review, " OPRR Reports 95-02 (5 May 1995), http://www.hhs.gov/ ohrp/humansubjects/guidance/hsdc95-02.htm (22 August 2007).
Res 3-1. Human Subjects Policy & Regulations 1973–82, RG 443 Res 3-1-B. Proposed Policy Protections Human Subjects 1978–79, RG 443. 75 Applicability to Social and Educational Research
  • Donna Mccarthy
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McCarthy and Donna Spiegler to Joel M. Mangel and Richard A. Tropp, 2 August 1978, Res 3-1. Human Subjects Policy & Regulations 1973–82, RG 443. 74. Hamilton to Mary Berry et al., 27 March 1979, Res 3-1-B. Proposed Policy Protections Human Subjects 1978–79, RG 443. 75. " Applicability to Social and Educational Research. " 76. Gerald L. Klerman to Assistant Secretary for Health and Surgeon General, 30
Th e Human Research Subjects H Ithiel de Sola Pool
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Joan Z. Bernstein, " Th e Human Research Subjects H.E.W. Wants to Protect, " New York Times, 24 January 1980; Ithiel de Sola Pool, " Censoring Research, " Society (November– December 1980): 39. 104. McCarthy to Director, NIH, 20 November 1980, Res 3-1-B. Proposed Policy Protections Human Subjects 1979–80, RG 443.
Status Report of Experience with PPO #129 Res 3-1. Human Subjects Policy & Regulations 1968–72, RG 443. 33 Origins of the DHEW Policy on Protection of Human Subjects
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Stephen P. Hatchett, " Status Report of Experience with PPO #129, " 31 May 1968, Res 3-1. Human Subjects Policy & Regulations 1968–72, RG 443. 33. " Origins of the DHEW Policy on Protection of Human Subjects, " in Senate Committee on Labor and Human Resources, National Advisory Commission on Health Science and Society, 92d Cong., 1st. sess., 1971, 1–3.
PRIM&R Th rough the Years, 40. 92. American Association of University Professors): 363. Th e full text is printed as J. W. Peltason
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Edward L. Pattullo, " Th e Political, Legal, and Moral Limits to Institutional Review Board (IRB) Oversight of Behavioral and Social Science Research, " in Knudson, ed., PRIM&R Th rough the Years, 40. 92. American Association of University Professors, " Regulations Governing Research on Human Subjects, " Academe (December 1981): 363. Th e full text is printed as J. W. Peltason, " Comment on the Proposed Regulations from Higher Education and Professional Social Science Associations, " IRB: Ethics and Human Research 2 (February 1980): 10. 93. Director, OPRR, to Assistant Secretary for Health and Surgeon General, 15
Government Regulations: Do Th ey Facilitate or Hinder Social and Behavioral Research Bettina Huber New Human Subjects Policies Announced; Exemptions Outlined New Rules for Human Research Appear to Answer Critics' Fear How General an Assurance?
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Res 3-1-B. Proposed Policy Protections Human Subjects 1978–79, RG 443 Proposed Regulations Amending Basic HEW Policy for Protection of Human Research Subjects
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Hamilton to the Secretary, draft memo, 4 June 1979, Res 3-1-B. Proposed Policy Protections Human Subjects 1978–79, RG 443. 86. " Proposed Regulations Amending Basic HEW Policy for Protection of Human Research Subjects, " Federal Register 44 (14 August 1979): 47693. 87. " Proposed Regulations Amending Basic HEW Policy, " 47688. zachary m. schrag | 35
Project on Hepatitis Research Is Now Praised by State Critic
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Walter Sullivan, " Project on Hepatitis Research Is Now Praised by State Critic, " New York Times, 24 March 1971.
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Applications Involving Research on Human Subjects
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James A. Haggarty, " Applications Involving Research on Human Subjects, " 28
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As Ethics Panels Expand Grip, No Field Is Off Limits Carolyn Fluehr-Lobban Informed Consent in Anthropological Research: We Are Not Exempt
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Res 3-1-B. Proposed Policy Protections Human Subjects 1979–80, RG 443. 94. For a range of critics, see Society
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