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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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... Other principled and partially pragmatic objections include the argument that ethics review of social science research is generally derived from biomedical review (Cribb, 2004;D'Agostino, 1995;Hoeyer, Dahlager, & Lynöe, 2005;Illinois White Paper, 2003;Israel, 2004;Schrag, 2009;Whittaker, 2005). This argument can, however, only be grounds for changes in pragmatic or institutional forms of ethical review. ...
... Another principled objection is that ethics review is not necessary in social science research, as social science research carries far lower risks to research participants than biomedical research (Cribb, 2004;Oakes, 2002;Schrag, 2009). A related concern is that when REC resources are limited, REC review of minimal-risk research may lead to less oversight for higher-risk research (Rubin & Sieber, 2006). ...
Chapter
Although the ethics of social science research has not enjoyed as much scholarly attention as the ethics of biomedical research, social scientists continue to debate the relevance of research ethics and ethics review to social science research. Like social scientists, biomedical scientists have also objected to ethical review of biomedical research, and much has been gained from the ensuing debates. This chapter reviews much of this recent debate, and proposes the application of a framework developed by Emanuel, Wendler, and Grady (2008). We argue, however, that social scientists are generally inadequately trained in research ethics and may still espouse a dangerous view, common among behavioral scientists in the 1950s, that ethical concerns reflect a kind of methodological or scientific naiveté. We provide grounds for arguing, further, that social science research, with a few clear exceptions, should be rigorously ethically reviewed, and that research ethics committees have an obligation to be competent in the appropriate review of social science research, including qualitative research. Although the chapter refers largely to social science research, we include psychological research as a major domain of social science research.
... 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). ...
Article
The swift evolution of digital spaces challenges the established norms of ethical research policy. Ineffective ethical review diminishes researchers' ability to conduct cutting-edge and socially sensitive research, institu-tions' ability to engage at the forefront of technology, and the relationship between researcher and committee. In criminology and other disciplines that navigate sensitive research, especially when working with ephemeral data in digital field sites, researchers require fast ethical approval turnarounds and ethics committees that can navigate ethical issues that challenge norms of analogue research. Few publications consider the ethical challenges that digital research on topics of criminological interest encounter. This study appraises experiences of ethical review in published studies and draws on a survey of digital criminological researchers who faced rejections and roadblocks from ethical review. We show that, when researchers report a disconnect between their needs and their ethics committees' responses, roadblocks to ethics approval emerge and preclude research, that may be authorized in other comparable research institutions, from proceeding. ARTICLE HISTORY
... Criticism of the IRB system has turned into something of a subgenre in the research ethics and integrity literature, at least until its recent revision. The American system has, among other things, hampered methodological innovation, blocked potentially controversial research to protect institutional reputations, and subjected social science to controls more suited for biomedical fields (Israel, 2015;Schrag, 2009Schrag, , 2010. Some have even accused it of needlessly hindering research at the cost of human lives, for example by introducing a ban on studying resuscitation, since patients in such cases are unable to provide informed consent (Hiller et al., 2005). ...
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Researchers sometimes engage in various forms of dishonesty and unethical behavior, which has led to regulatory efforts to ensure that they work according to acceptable standards. Such regulation is a difficult task, as research is a diverse and dynamic endeavor. Researchers can disagree about what counts as good and acceptable standards, and these standards are constantly developing. This paper presents and discusses recent changes in research integrity and ethics regulation in Norway, Denmark, and Sweden. Recognizing that research norms are developed through practice and are therefore unsuited for comprehensive national regulation, the Scandinavian countries focus on empowering the research community to regulate itself instead, except for the most severe cases of misconduct. This empowerment takes the form of giving research institutions tools and investigatory powers while also holding them responsible for ensuring that both the institution and individual researchers are up to date on relevant norms. In this way, the Scandinavian governments seek to avoid some of the challenges found in more legalistic approaches, which risk lagging behind the continuous development of research norms and can be insensitive to the fact that different disciplines have different norms. While the new approach in Scandinavian has several potential benefits, it also involves potential trade-offs and limitations. The new laws can create confusion about what researchers are allowed to do. Another issue is that it only addresses the fundamental drivers of misconduct to a limited extent.
... Nonetheless, ethical review boards like IRBs have-since the 1970s, and particularly since the 1990s-been increasingly aggressive when it comes to regulating non-medical, nonexperimental research (Schrag, 2009). But for many qualitative researchers the "standard and formalised practices [of informed consent] do not sufficiently accommodate the social context in which qualitative research is now carried out" (Miller & Boulton, 2007, p. 2204. ...
Article
Respect for persons is a cornerstone value for any conception of research ethics--though how to best realize respect in practice is an ongoing question. In the late 19th and early 20th centuries, "informed consent" emerged as a particular way to operationalize respect in medical and behavioral research contexts. Today, informed consent has been challenged by increasingly advanced networked information and communication technologies (ICTs) and the massive amounts of data they produce--challenges that have led many researchers and private companies to abandon informed consent as untenable or infeasible online. Against any easy dismissal, we aim to recover insights from the history of informed consent as it developed from the late 19th century to today. With a particular focus on the United States policy context, we show how informed consent is not a fixed or monolithic concept that should be abandoned in view of new data-intensive and technological practices, but rather it is a mechanism that has always been fluid--it has constantly evolved alongside the specific contexts and practices it is intended to regulate. Building on this insight, we articulate some specific challenges and lessons from the history of informed consent that stand to benefit current discussions of informed consent and research ethics in the context of data science and Internet industry research.
... The argument in favor of appropriateness cites the relevancy to all research involving human participation (Michelfelder, 2001;Reidenberg, 2000), and a skepticism toward the need for different guidelines for business management research. The rationale here is that social science codes intrinsically reflect the biomedical guidelines from which they were first developed (Burgess, 2007;Crib, 2004;Israel, 2004;Schrag, 2009;Wax & Cassell, 1981). In contrast is the perspective that emphasizes the differences between science and social science as so fundamental to warrant differing codes (Redwood & Todres, 2006). ...
Article
This article discusses implications of participant withdrawal for inductive research. I describe and analyze how a third of my participants withdrew from a grounded theory study. I position my example, ensuing issues, and potential solutions as reflective of inductive methodologies as a whole. The crux of the problem is the disruption inflicted by withdrawal on inductive processes of generating knowledge. I examine the subsequent methodological and ethical issues in trying to determine the best course of action following withdrawal. I suggest three potential options for researchers: Continuing the study with partial data, continuing the study with all data, and discontinuing the study. Motivated by my experience, and wider theoretical considerations, I present several suggestions and questions, with the aim of supporting researchers in determining the best course of action for their individual field circumstances.
... 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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National regulations governing human subjects research differ with regard to whether they require survey research to be overseen by institutional ethics boards or committees. In cases where ethical review has been waived, or was provided by an individual or group other than an institutional ethics board, journals may question the appropriateness of the waiver or alternative review when making determinations about whether to accept the manuscript for publication. The purpose of this article is to provide guidance for journals to consider when making determinations about the necessity of ethical review for survey research projects. We review the functions of ethics oversight and consider the importance of those functions within the context of survey research. In survey research, no intervention is delivered to research participants. As a result, there is no risk of physical harm to individuals who participate. However, there can be a risk of informational or psychological harms. In situations where there is greater than minimal risk of informational or psychological harms, the survey research should have received institutional ethics oversight. Additionally, survey research projects that enroll vulnerable individuals with diminished autonomy should receive institutional ethics oversight. We hope that this article leads to further guidance on this subject by authoritative group such as the International Committee of Medical Journal Editors.
... Use of non-institutional recruiters might be a sound ethical strategy to overcome these threats to the ethical and scientific quality of the proposed study. Qualitative studies, while utilising seemingly innocuous 'conversations' [21,22] can mobilise much stronger emotional distress in participants than impersonal questionnaires or even transient pain caused by minimal risk routine biomedical procedures, and these must be anticipated and planned for. [3] Similarly, focus groups hold threats of disclosure of sensitive information that can harm individuals (and cause organisational instability) which the investigator cannot control, despite appeals to all members to observe confidentiality. ...
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Accessing research participants within some social institutions for research purposes may involve a simple single administrative event. However, accessing some institutions to conduct research on their data, personnel, clients or service users can be quite complex. Research ethics committee chairpersons frequently field questions from researchers wanting to know when and why gatekeeper permission should be sought. This article examines the role and influence of gatekeepers in formal and organisational settings and explores pragmatic methods to improve understanding and facilitation of this process. Conscientious and well-informed negotiations with gatekeepers are required in order to honour the ethical obligations to conduct appropriate stakeholder engagement before and during research, along with respect for the autonomy of institutions and their employees/clients/service recipients. Provision must be made to identify explicit and implicit gatekeepers to initiate and build collaborative networks that could best support the research process. Careful mutually respectful access agreements which consider the needs and vulnerabilities of both the gatekeeper and the researcher can improve the quality of the scientific data collected. Strategic planning in the research process must take these sometimes complex processes of gatekeeper permission into careful account. S Afr J BL 2016;9(1):42-46. DOI:7196/SAJBL.465
... Psychologists applying for ethics review of their studies may underestimate or understate the potential risks of their research. Some commentators argue that the risks of psychological research are trivial compared to the risks of biomedical research (Schrag, 2009;Wassenaar & Mamotte, 2012a). Yet, historically, the development of institutionalized ethics review was in part a response to several studies where participants experienced harms to dignity, rather than physical harms, including controversial psychosocial studies such Milgram's obedience study, Humphreys' Tearoom Trade study, and the Wichita Jury study (Amdur & Bankert, 2011;Wassenaar & Mamotte, 2012a). ...
Article
Ethics review of psychological and sociobehavioural research is increasingly required by leading South African research institutions and universities, following international trends, and national statutory developments. Local and international scholarly journals are also more routinely requesting proof of ethics approval before accepting empirical work for publication. In some instances, psychological researchers may regard ethics review as a process that imposes delays and adds little value to proposed studies, and they may experience the process as frustrating and unrewarding. This article aims to briefly review the issue of ethics review for such research and to focus on pragmatic recommendations for psychological researchers navigating ethical review, including how they could engage their research ethics committee more effectively to strengthen this critical relationship.
... 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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This paper has two aims. The first is to shed light on a remarkable archival source, namely survey responses from thousands of American psychologists during the 1960s in which they described their contemporary research practices and discussed whether the practices were "ethical." The second aim is to examine the process through which the American Psychological Association (APA) used these survey responses to create principles on how psychologists should treat human subjects. The paper focuses on debates over whether "deception" research was acceptable. It documents how members of the committee that wrote the principles refereed what was, in fact, a disagreement between two contemporary research orientations. The paper argues that the ethics committee ultimately built the model of "the resilient self" into the APA's 1973 ethics code. At the broadest level, the paper explores how prevailing understandings of human nature are written into seemingly universal and timeless codes of ethics.
... Historically, ethical review of research in Western universities has been and remains heavily dominated by a medical ethical worldview (Boden et al., 2009;Haggerty, 2004;Israel and Hay, 2006;Schrag, 2009). The institutionalization of research ethics principles and practices has largely developed from within the medical sciences. ...
Article
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This article illustrates how medicalized epistemologies and methodologies significantly influence the institutional ethical review processes applied to sociolegal research in law schools. It argues this development has elevated particular renderings of mental distress and objectivity to universal definitions, potentially placing a straitjacket on methodolo-gical innovation. The authors use two case studies from their experiences as researchers in a UK Law School, alongside a small-scale survey of sociolegal researchers in other UK law schools, to illustrate the problems that can arise in securing ethical approval for sociolegal research, in particular with participatory research designs that mobilize ideas of mental distress and objectivity not premised on conventional medical understandings. The article develops key proposals that the authors feel merit further inquiry. First, there should be a comprehensive evaluation of how the jurisdiction of ethical review for sociolegal research is established. Second, sociolegal scholarship can contribute to debates concerning the discursive, material and procedural constitution of institutional ethics approval processes. Finally, we might rethink the nature of, and relationship between, university-based research ethics committees and National Health Service research ethics committees, by placing both within wider ecologies of capacities for ethical decision-making.
... 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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Research Ethics Boards (REBs) at universities are chaired and staffed by researchers who serve to enforce codes of ethics by scrutinizing research proposals. Yet there is widespread dissatisfaction with the REB approval process. This article examines the sources of that dissatisfaction, the place for codes of ethics in the conducting of research, the evidence for risk to research participants as the basis for those codes, and the effectiveness of REBs in protecting research participants. We offer suggestions for how REB chairs, members, and researchers can improve the REB approval process so that it is fair and responsive.
... To give a background to the study: It is a commonly held belief in studies using elite experiments that politicians are less sensitive to experimental designs than ordinary citizens because they are used to being scrutinized by the media, voters, opponents and others. The perspective that politicians can probably 'take more' is borne out in that IRB processes often are interpreted to put fewer ethical constraints on elite experiments than on other types of experiments (see Grose 2016;Malesky 2016;Schrag 2009). 1 One reason for this is that politicians willingly put themselves in situations where they are 'tested' and 'mislead'. Their job is to be held accountable, so the harm that is done to them through manipulations in political science experiments can be regarded as small in comparison to the scrutiny they are accustomed to in the ordinary game of politics. ...
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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).
Article
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. (PsycINFO Database Record (c) 2012 APA, all rights reserved)
Article
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
  • Robert J Levine
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
  • Joan P Porter
Joan P. Porter, interview by author, Washington, D.C., 2 August 2007. In 2007, 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, " 3 May 1985, RES 3-1-D Proposed Mondel [ sic ] Federal Policy Protection of Human Subjects, National Institutes of Health, OD Central Files, Offi ce of the Director, NIH. 123. Porter, interview. 124. McCarthy, interview by El-Hinnawy.
Human Subjects Policy & Regulations 1965–67, RG 443. 16. See NIH Study Committee Psychology seems to have dominated In Fiscal Year 1972, for example, the NIH awarded fi ft y-eight research training grants in psychology, thirteen in sociology, and six in anthropology
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February 1966, Res 3-1. Human Subjects Policy & Regulations 1965–67, RG 443. 16. See NIH Study Committee, Biomedical Science and Its Administration (Washington, D.C., 1965), 130–31. Psychology seems to have dominated. In Fiscal Year 1972, for example, the NIH awarded fi ft y-eight research training grants in psychology, thirteen in sociology, and six in anthropology. Senate Committee on Labor and Human Resources, National Research Service Award Act, S. Report. 93-381, 93d Cong., 1st sess., 1973, 10. 17. Dael Wolfl e to Patricia Harris, 11 December 1980, box 25, Human Subjects Corresp.
Morality in Science: How Research Is Evaluated in the Age of Human Subjects Regulation
  • Morris Stark
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.
Res 3-1-A Study Group Review of Policies 1973–75, RG 443. 44 Res 3-1. Human Subjects Policy & Regulations 1973–82, RG 443. 45. Frankel Public Policymaking for Biomedical Research Res 3-1. Human Subjects Policy & Regulations Protection of Human Subjects: Proposed Policy
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Richard B. Stephenson to Robert P. Akers, 4 October 1972, Res 3-1-A Study Group Review of Policies 1973–75, RG 443. 44. Charles R. McCarthy to Study Group for Review of Policies on Protection of Human Subjects in Biomedical Research, 3 May 1973, Res 3-1. Human Subjects Policy & Regulations 1973–82, RG 443. 45. Frankel, " Public Policymaking for Biomedical Research, " 187, 202, 298. 46. Th omas J. Kennedy Jr. to Acting Director, NIH, 23 March 1973, Res 3-1. Human Subjects Policy & Regulations 1973–82, RG 443. 47. Kennedy to Assistant Secretary for Health, 7 September 1973, Res 3-1. Human Subjects Policy & Regulations 1973–82, RG 443. 48. D. T. Chalkley, draft letter to the editor of the Christian Century, 5 April 1974, Res 3-4. National Commission for the Protection of Human Subjects, Folder #1, 1974–75, RG 443. 49. DHEW, " Protection of Human Subjects: Proposed Policy, " Federal Register 38
e-mail to the author
  • Joan P Porter
Joan P. Porter, e-mail to the author, 23 August 2007.
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
  • Robert S Broadhead
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
  • F William Pool
  • Dommel
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.
Federal Policy for the Protection of Human Subjects: Notices and Rules): 28007. 129 Applicability to Social and Educational Research 130. Louttit
  • Of Offi Ce
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Offi ce of Science and Technology Policy et al., " Federal Policy for the Protection of Human Subjects: Notices and Rules, " Federal Register 56 (18 June 1991): 28007. 129. " Applicability to Social and Educational Research. " 130. Louttit, " Government Regulations, " in Sieber, ed., NIH Readings, 179. zachary m. schrag | 37
18. Shannon, interview by Frankel. 19 Why House Hearings on Invasion of Privacy
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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
  • Charles R Mccarthy
Charles R. McCarthy, interview by Patricia C. El-Hinnawy, Oral History of the Belmont Report and the NCPHS, 22 July 2004, http://www.hhs.gov/ohrp/belmontArchive. html (30 December 2006).
8369, 8373, 8386. 110. Tropp
January 1981): 8369, 8373, 8386. 110. Tropp, " A Regulatory Perspective on Social Science Research, " 398.
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
  • E Robert
  • Charlotte Windom
  • Kitler
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
  • Joel M Spiegler
  • Richard A Mangel
  • Mary Hamilton
  • Berry
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
  • Joan Z Bernstein
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
  • P Stephen
  • Hatchett
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
  • L Edward
  • Ed Pattullo Knudson
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?
  • T Richard
  • E L Louttit
  • Pattullo
Richard T. Louttit, " Government Regulations: Do Th ey Facilitate or Hinder Social and Behavioral Research? " in Joan E. Sieber, ed., NIH Readings on the Protection of Human Subjects in Behavioral and Social Science Research: Conference Proceedings and Background Papers (Frederick, Md., 1984), 180. 112. Bettina Huber, " New Human Subjects Policies Announced; Exemptions Outlined, " American Sociological Association Footnotes, November 1981, 1. 113. Robert Reinhold, " New Rules for Human Research Appear to Answer Critics' Fear, " New York Times, 22 January 1981. 114. E. L. Pattullo, " How General an Assurance? " IRB: Ethics and Human Research 3 (May 1981): 8. 115. E. L. Pattullo, e-mail to the author, 14 August 2007; Patullo to McCarthy, 30
Director, NIH, to Assistant Secretary for Health and Surgeon General Res 3-1-B. Proposed Policy Protections Human Subjects 1978–79, RG 443. 83. Richmond to Deputy General Counsel, draft memorandum, attached to Donald F
  • F Donald
  • Frederickson
Donald F. Frederickson, Director, NIH, to Assistant Secretary for Health and Surgeon General, 18 April 1979, Res 3-1-B. Proposed Policy Protections Human Subjects 1978–79, RG 443. 83. Richmond to Deputy General Counsel, draft memorandum, attached to Donald F. Frederickson, Director, NIH, to Assistant Secretary for Health and Surgeon General, 18
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
  • Hamilton To
  • Secretary
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
  • Walter Sullivan
Walter Sullivan, " Project on Hepatitis Research Is Now Praised by State Critic, " New York Times, 24 March 1971.
American Association of University Professors Research on Human Subjects: Academic Freedom and the Institutional Review Board
  • Alan Sica
Alan Sica, " Sociology as a Worldview, " American Journal of Sociology 102 (July 1996): 254. 137. American Association of University Professors, " Research on Human Subjects: Academic Freedom and the Institutional Review Board " (2006), http://www.aaup.org/ AAUP/comm/rep/A/humansubs.htm (2 September 2008).
Applications Involving Research on Human Subjects
  • James A Haggarty
James A. Haggarty, " Applications Involving Research on Human Subjects, " 28
Federal Policy for the Protection of Human Subjects: Notices and Rules
Office of Science and Technology Policy et al., " Federal Policy for the Protection of Human Subjects: Notices and Rules, " Federal Register 56 (18 June 1991): 28002–28032.
As Ethics Panels Expand Grip, No Field Is Off Limits Carolyn Fluehr-Lobban Informed Consent in Anthropological Research: We Are Not Exempt
  • Christopher Shea
Christopher Shea, " Don't Talk to the Humans: Th e Crackdown on Social Science Research, " Lingua Franca, September 2000; Patricia Cohen, " As Ethics Panels Expand Grip, No Field Is Off Limits, " New York Times, 28 February 2007. 135. Carolyn Fluehr-Lobban, " Informed Consent in Anthropological Research: We Are Not Exempt, " Human Organization 53 (Spring 1994): 4, 5, 9 n. 7.
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David J. Rothman and Sheila M. Rothman, Th e Willowbrook Wars: Bringing the Mentally Disabled into the Community (1984; reprint, New Brunswick, N.J., 2005), 260–66;
): 1355. 11. James A. Shannon, interview by Mark Frankel Recording in author's possession. 12. House Committee on Government Operations, Th e Use of Social Research in Federal Domestic Programs: Part IV—Current Issues in the Administration of Federal Social Research
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  • Beecher
Henry K. Beecher, " Ethics and Clinical Research, " New England Journal of Medicine 274 (16 June 1966): 1355. 11. James A. Shannon, interview by Mark Frankel, New York City, 13 May 1971. Recording in author's possession. 12. House Committee on Government Operations, Th e Use of Social Research in Federal Domestic Programs: Part IV—Current Issues in the Administration of Federal Social Research, 90th Cong., 1st. sess., 1967, 217.
Res 3-1-B. Proposed Policy Protections Human Subjects 1979–80, RG 443. 94. For a range of critics, see Society
October 1979, Res 3-1-B. Proposed Policy Protections Human Subjects 1979–80, RG 443. 94. For a range of critics, see Society (November–December 1980). 95. " Issues Related to HHS Human Subject Research, " c. 20 May 1980, Res 3-1-B.
Status of action to revise policy statement on the use of human subjects in PHS-sponsored activities, and to improve the implementation of these policies
  • Eugene A Confrey
Eugene A. Confrey, " Status of action to revise policy statement on the use of human subjects in PHS-sponsored activities, and to improve the implementation of these policies, " 18 June 1968, Res 3-1. Human Subjects Policy & Regulations 1968–72, RG 443.
Res 3-1-B. Proposed Policy Protections Human Subjects 1978–79, RG 443. 77
March 1979, Res 3-1-B. Proposed Policy Protections Human Subjects 1978–79, RG 443. 77. Julius Richmond to Acting General Counsel, draft, 12 June 1979, Res 3-1-B.