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How Talking Became Human Subjects Research: The Federal Regulation of the Social Sciences, 1965-1991
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.
... 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). ...
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). ...
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). ...
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. ...
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). ...
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. ...
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. ...
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). ...
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. ...
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. ...
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. ...
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. ...
Ethics in Elite Experiments: A Perspective of Officials and Voters - Elin Naurin, Patrik Öhberg
Ethnography and Virtual Worlds is the only book of its kind--a concise, comprehensive, and practical guide for students, teachers, designers, and scholars interested in using ethnographic methods to study online virtual worlds, including both game and nongame environments. Written by leading ethnographers of virtual worlds, and focusing on the key method of participant observation, the book provides invaluable advice, tips, guidelines, and principles to aid researchers through every stage of a project, from choosing an online fieldsite to writing and publishing the results. In this useful volume, the coauthors, each of whom is an accomplished virtual world ethnographer, pretty much put to rest threshold questions that might be raised about whether virtual worlds and online cultures can be proper objects of anthropological research. . . . [T]he authors provide as much insight and instructive commentary about traditional ethnography as they do about the ethnography of virtual worlds. © 2012 by Tom Boellstorff, Bonnie Nardi, Celia Pearce, and T.L. Taylor. All Rights Reserved.
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
This paper examines the conceptual basis for the governance of human subjects research in Canada, focusing on the REB (Research Ethics Boards, also known as, IRB, and REC in other countries). It explores the logic of the harmonization and standardization of the approaches to ethical oversight, which resulted in the rapid expansion of the system of research oversight (“REB mission creep”) from biomedical sciences to the areas of research involving humans, where physical harms are no longer obvious. It suggests that REB positivism, prevalent at the local level, provides a sufficient basis for understanding the phenomenon of ethics creep and the problems that accompany it. REB positivism, which applies a reductionist understanding of research and redefines research ethics in terms of universalism, methodological reductionism, solipsism, and approaches the unknown in terms of danger, rather than risk, helps to clarify why the localized interpretation of the general principles articulated in the Tri-Council Policy Statement (TCPS) have not lead to a reflexive mode of regulation.
Much of the literature on human subject regulation asserts that Institutional Review Boards (IRBs) have failed at the task of regulating human subjects research. These critiques of IRB law can be grouped into three loose categories: critiques of IRB law as law, critiques of IRBs as regulation, and critiques of IRBs as a system of norm creation. Moving beyond critique, we rethink the literature on IRBs drawing on the tools and scholarship of the social sciences. In particular, we examine human subjects regulation as an insufficient remedy to inequalities between weak and powerful actors, as a site of professional claims- and career-making, and as an occasion for institutionalization. Finally, distinguishing between the regulation of science and the regulation of ethics, we observe that the latter is far more difficult because ethics are contextual and subject to social construction. For these reasons, IRBs often substitute bureaucratic ethics for professional ethics.
IntroductionKey Questions for EthnobiologistsCase Study 4.1Conclusion
AcknowledgmentsReferences
Effective interpretation of, and compliance with, data protection and freedom of information law across the range of administrative and educational activities undertaken in a UK higher educational institution are tasks which, over a decade after the passage of the legislation, remain fertile ground for disagreement, misunderstanding and poorly conceived institutional policymaking. For social science researchers, the issue is further complicated by the need to simultaneously interpret and implement research ethics guidelines promulgated by diverse external bodies: the Research Councils, subject-specific research associations and other cross-disciplinary special interest groups. The cascade of new information communication technologies (ICTs) available to the social science researcher completes a triangle of policy variables and uncertainties for both researchers and institutional research scrutiny bodies. The aim of this article is threefold: first, to examine some of the issues raised by the application of data protection and freedom of information law to research in the social sciences, with a particular eye to the impact of ICTs; second, to discuss how the interplay between legal rules, ethical guidelines, and institutional regulation is developing; and finally, to suggest some potential ways forward.
In the 1950s, sensory deprivation research emerged as an influential new field for behavioral science researchers, supported by the intelligence community. Within a few years, deprivation research had become ubiquitous; images of sensory deprivation were invoked to explain a wide range of phenomena, from religious revelations to the very structure of psychoanalysis. Yet within a decade and a half, this field of research became implicated in cases of torture and abuse. This article examines the history of University of Manitoba psychologist John Zubek, who remained one of the final researchers still conducting sensory deprivation research in the 1970s. It raises questions on how might it be possible to successfully and cautiously perform controversial research.
Formal research-ethics committees in Canada now function as an industry, costing over thirty-five million dollars annually. The Seduction of Ethics argues that while ethics codes are alluring to the public, they fuel moral panic and increase demands for institutional accountability. Will C. van den Hoonaard explores the research-ethics review process itself by analysing the moral cosmology and practices of ethics committees regarding research and researchers. The Seduction of Ethics also investigates how researchers have tailored their approaches in response to technical demands — leading social science disciplines to resemble each other more closely and lose the richness of their research. Van den Hoonaard reveals an idiosyncratic and inconsistent world in which researchers employ particular strategies of avoidance or partial or full compliance as they seek approval from ethics committees.
Nursing is underpinned by a commitment to evidence-based practice. Practitioners are expected to have the competence to understand scientific research that is underpinning nursing practice. Increasingly, nurses at all levels of training are involved in conducting nursing research. Research ethics is dedicated to reflecting on ethical concerns that arise in the practice of research. In this chapter, research ethical concerns will be discussed through the lens of core concepts from feminist ethics: power, vulnerability, agency, care and trust. This chapter describes research ethical requirements as situated in specific social and institutional contexts that are characterised by power relationships. It is proposed to understand research as relational where the researcher’s ability to engage in research activities that respect the participant’s agency, their establishment of caring research relationships and their trustworthiness are proposed as underpinnings for traditional research ethical requirements.
“United in Diversity”: Research Ethics in European Political Science - Volume 49 Issue 4 - Daniela R. Piccio
Based on the author's more than fifty years of experience as a professional historian in academic and other capacities, Being a Historian addresses both aspiring and mature historians. It offers an overview of the state of the discipline of history today and the problems that confront it and its practitioners in many professions. James M. Banner, Jr., argues that historians remain inadequately prepared for their rapidly changing professional world and that the discipline as a whole has yet to confront many of its deficiencies. He also argues that, no longer needing to conform automatically to the academic ideal, historians can now more safely and productively than ever before adapt to their own visions, temperaments, and goals as they take up their responsibilities as scholars, teachers, and public practitioners. Critical while also optimistic, this work suggests many topics for further scholarly and professional exploration, research, and debate.
The Office of the Secretary of the Department of Health and Human Services (HHS) in coordination with the Office of Science and Technology Policy (OSTP) is issuing this advance notice of proposed rulemaking (ANPRM) to request comment on how current regulations for protecting human subjects who participate in research might be modernized and revised to be more effective. The current regulations... were developed years ago when research was predominantly conducted at universities, colleges, and medical institutions, and each study generally took place at only a single site. Although the regulations have been amended over the years, they have not kept pace with the evolving human research enterprise.
Field research - leaving one’s home institution in order to acquire data, information or insights that significantly inform one’s research - remains indispensable, even in a digitally networked era. This book, the first of its kind in political science, reconsiders the design and execution of field research and explores its role in producing knowledge. First, it offers an empirical overview of fieldwork in the discipline based on a large-scale survey and extensive interviews. Good fieldwork takes diverse forms yet follows a set of common practices and principles. Second, the book demonstrates the analytic benefits of fieldwork, showing how it contributes to our understanding of politics. Finally, it provides intellectual and practical guidance, with chapters on preparing for field research, operating in the field and making analytic progress while collecting data, and on data collection techniques including archival research, interviewing, ethnography and participant observation, surveys, and field experiments. © Diana Kapiszewski, Lauren M. MacLean and Benjamin L. Read 2015.
El propósito de este artículo es mostrar algunas de las particularidades, alcances y limitaciones de la privacidad, la confidencialidad y el anonimato en el ámbito de la ética de la investigación en ciencias sociales.
El presente artículo está organizado en tres apartados. En primer lugar, se definirán y distinguirán los conceptos de privacidad y confidencialidad y se mostrarán sus características singulares en investigación social. En segundo lugar, se analizarán algunos debates y críticas actuales en torno al anonimato. Finalmente, se examinarán los alcances y limitaciones al resguardo de la información y los desafíos que implican nuevos entornos de investigación social.
For most of political science's history, discussions about professional ethics had nothing to do with human subjects. Professional ethics involved integrity in the classroom, fair tenure and promotion rule, and the careful avoidance of plagiarism. As most research was observational, there was little need for attention to how scholarly activities might directly affect the subjects of our work. Times have changed. The dramatic growth in the use of experiments in social science, especially overseas, is generating unexpected ethical controversies. The purpose of this volume is to identify, debate, and propose practical solutions to the most critical of these new ethical issues. A leading team of internationally distinguished political science scholars presents the first examination of the practical and ethical challenges of research with human subjects in social science and policy studies. Part 1 examines contextual challenges provided by experiments conducted overseas - questions of culture, religion, security, and poverty. Part 2 examines questions of legal constraints on research, focusing on questions of foreign review of international experiments. Part 3 tackles the critical issues in field experiments, including deception and consent, impact on elections and careers, the boundaries of the public officials' exemption, and the use of partner organizations to avoid Institutional Review Body (IRB) review. Part 4 considers strategies for the future, including training and education, IRB reform, institutional changes, and norm development.
Senior academic researchers and research administrators whose careers have spanned decades have witnessed a monotonic trend in the growth of bureaucratic rules and structures pertaining to research policy. The increase in administrative requirements takes many forms, some directly related to research and others tangentially related. While the onslaught of rules has increased administrative burdens, not all of these requirements are red tape; many are useful and even vital. But when taken together, the amount of administrative procedure and documentation associated with research conduct and administration becomes crushing. Others have well documented the bureaucratization of university research policy and administration. Our primary purpose is to explain why rules and regulations and the bureaucratic structures supporting them continue to grow, extracting an ever-greater toll on time and resources available for actual research. Absent an explanation of the growth of administrative burden, it is not possible to provide valid assessment of the effectiveness of rules and regulations pertaining to research policy. We examine the problem from the lens of a well-developed theory of organizational red tape specifically, applying it specifically to the problem of research administration red tape. The theory suggests that the increase in research policy bureaucratization can be explained chiefly by three different factors: crisis response, pressures for bureaucratic over-control, and the use of research policy for side-payments, both social side-payments (to achieve social goals not directly related to research) and political side-payments (conferring factor with political supporters by proving rules or policy symbols favored by them). To help elaborate the theory as well as to provide context, we provide case illustrations of ranging from the vitally important (research misconduct) to mundane bureaucratic requirements (standardization of required biosketches).
Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. Enhancing Food Safety: The Role of the Food and Drug Administration, a new book from the Institute of Medicine and the National Research Council, responds to a congressional request for recommendations on how to close gaps in FDA's food safety systems. Enhancing Food Safety begins with a brief review of the Food Protection Plan (FPP), FDA's food safety philosophy developed in 2007. The lack of sufficient detail and specific strategies in the FPP renders it ineffectual. The book stresses the need for FPP to evolve and be supported by the type of strategic planning described in these pages. It also explores the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management. Conclusions and recommendations include adopting a risk-based decision-making approach to food safety; creating a data surveillance and research infrastructure; integrating federal, state, and local government food safety programs; enhancing efficiency of inspections; and more. Although food safety is the responsibility of everyone, from producers to consumers, the FDA and other regulatory agencies have an essential role. In many instances, the FDA must carry out this responsibility against a backdrop of multiple stakeholder interests, inadequate resources, and competing priorities. Of interest to the food production industry, consumer advocacy groups, health care professionals, and others, Enhancing Food Safety provides the FDA and Congress with a course of action that will enable the agency to become more efficient and effective in carrying out its food safety mission in a rapidly changing world. © 2010 by the National Academy of Sciences. All rights reserved.
This article summarizes various applications of oral history interviews at local sites to represent the writing of underrepresented groups. The coauthors (a rhetorician and an archivist) discuss the important disciplinary implications for tending to the local, especially at sites where formal archives are hard to come by, offering three principles for sustaining the local by combining research design with archival development. © 2012 by the National Council of Teachers of English. All rights reserved.
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.
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.
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).
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)
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
- Richard A Tropp
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
- D C Washington
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
- B Richard
- Robert P Stephenson
- Akers
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
- Technology Science
- Policy
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
- Ithiel De Sola Pool Papers
- Cornelius E Mc
- Gallagher
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.
- J David
- Sheila M Rothman
- Rothman
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
- K Henry
- 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.