1

Introduction and Background

INTRODUCTION

The ethics of human-subjects research has captured scientific and regulatory attention for half a century. Honoring the Belmont Report’s principles (U.S. Department of Health and Human Services, 1979)—respect for persons, beneficence, and justice—ought to mean keeping abreast of the universe of changes that factor into the ethical conduct of research today. The U.S. Department of Health and Human Services (HHS) took a giant step in this direction with the publication of an Advance Notice of Proposed Rulemaking (ANPRM) in July 2011,1 a plan for the first general overhaul of the human subjects protection regulations (45 C.F.R. § 46) since they were first promulgated in 1981, followed by the revisions referred to as the “Common Rule” in 1991. Box 1-1 below provides a brief description of the Common Rule; a more lengthy explanation is provided in Appendix A.2

This committee applauds and supports the issuance of the ANPRM, and the committee’s review—concerning how updated human subjects protections regulations can effectively respond to current research contexts and methods—counts the ANPRM as a major stimulus. The committee takes this opportunity seriously and has engaged a wide variety of researchers and human-subjects regulatory experts in its process.

_________________

1See U.S. Department of Health and Human Services (2011) for the ANPRM; for the commentary portal, see http://www.hhs.gov/ohrp/humansubjects/anprm2011page.html [December 2013].

2For background and links to the regulations, see http://www.hhs.gov/ohrp/humansubjects/commonrule/index.html [December 2013].



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1 Introduction and Background INTRODUCTION The ethics of human-subjects research has captured scientific and regu- latory attention for half a century. Honoring the Belmont Report’s prin- ciples (U.S. Department of Health and Human Services, 1979)—respect for persons, beneficence, and justice—ought to mean keeping abreast of the universe of changes that factor into the ethical conduct of research today. The U.S. Department of Health and Human Services (HHS) took a giant step in this direction with the publication of an Advance Notice of Proposed Rulemaking (ANPRM) in July 2011,1 a plan for the first general overhaul of the human subjects protection regulations (45 C.F.R. § 46) since they were first promulgated in 1981, followed by the revisions referred to as the “Common Rule” in 1991. Box 1-1 below provides a brief description of the Common Rule; a more lengthy explanation is provided in Appendix A.2 This committee applauds and supports the issuance of the ANPRM, and the committee’s review—concerning how updated human subjects pro- tections regulations can effectively respond to current research contexts and methods—counts the ANPRM as a major stimulus. The committee takes this opportunity seriously and has engaged a wide variety of researchers and human-subjects regulatory experts in its process. 1  See U.S. Department of Health and Human Services (2011) for the ANPRM; for the com- mentary portal, see http://www.hhs.gov/ohrp/humansubjects/anprm2011page.html [December 2013]. 2  For background and links to the regulations, see http://www.hhs.gov/ohrp/humansubjects/ commonrule/index.html [December 2013]. 13

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14 PROPOSED REVISIONS TO THE COMMON RULE BOX 1-1 The “Common Rule” The Federal Policy for the Protection of Human Subjects or the “Common Rule” was published in 1991 and codified in separate regulations by 15 Federal departments and agencies. . . . The HHS regulations, 45 CFR part 46, include four subparts: subpart A, also known as the Federal Policy or the “Common Rule”; subpart B, additional protections for pregnant women, human fetuses, and neo- nates; subpart C, additional protections for prisoners; and subpart D, additional protections for children. Each agency includes in its chapter of the Code of Federal Regulations [CFR] section numbers and language that are identical to those of the HHS codification at 45 CFR part 46, subpart A. For all participating departments and agencies, the Common Rule outlines the basic provisions for institutional review boards (IRBs), informed consent, and Assurances of Compliance. SOURCE: U.S. Department of Health and Human Services Office for Human Research Protections. Available: http://www.hhs.gov/ohrp/humansubjects/commonrule/index.html [November 2013]. The aims of this National Research Council (NRC) consensus report align with the central aims of the ANPRM. With a specific focus on social and behavioral sciences, this report addresses the dramatic alterations in the research landscapes that institutional review boards (IRBs) have come to inhabit over the past 40 years. Like the ANPRM, it strives to balance respect for the individual persons whose consent to participate makes re- search possible and respect for the social benefits that productive research communities make possible. Recognizing that widespread technological and societal transformations have occurred in the contexts for and conduct of human research since the passage of the National Research Act of 1974,3 the ANPRM revisits the regulations mandated by that statute in a cor- respondingly comprehensive manner. Its proposals seek to modernize the Common Rule and to improve the efficiency of the work conducted under its auspices. Against that background, the ANPRM solicited “comment on how to better protect human subjects who are involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators” (76 Fed. Reg. 44,512). That is, the ANPRM’s intent is to reconcile two social goods: defense of the rights of individual research 3  See http://history.nih.gov/research/downloads/PL93-348.pdf [December 2013].

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INTRODUCTION AND BACKGROUND 15 participants4 and the advancement of knowledge about the human condi- tion, itself often aligned with justice and beneficence. While the Common Rule has always been applied to behavioral and social sciences, primary attention in the design of the regulations was given to biomedical procedures and dilemmas, as is evident in their heavy use of biomedical language and examples.5 However, these examples and language are treated as generic and as exemplars applicable beyond biomedicine to behavioral and social science. The inadequacy of this framework for ethical behavioral and social science research was articulated forcefully by social scientists in the late 1970s (Beauchamp et al., 1982; National Research Council, 2013, Session 1; Schrag, 2010), and the arguments have persisted (National Research Council, 2003). Fortunately, the ANPRM opens the door to acknowledge and address these differences in research fields. It states Questions have been raised about the appropriateness of the review pro- cess for social and behavioral research. The nature of the possible risks to subjects is often significantly different in many social and behavioral research studies as compared to biomedical research, and critics contend that the difference is not adequately reflected in the current rules. While physical risks generally are the greatest concern in biomedical research, social and behavioral studies rarely pose physical risk but may pose psy- chological or informational risks. Some have argued that, particularly given the paucity of information suggesting significant risks to subjects in certain types of survey and interview based research, the current system over-regulates such research. Further, many critics see little evidence that most IRB review of social and behavioral research effectively does much to protect research subjects from psychological or informational risks. Over- regulating social and behavioral research in general may serve to distract attention from attempts to identify those social and behavioral research studies that do pose threats to the welfare of subjects and thus do merit significant oversight. (76 Fed. Reg. 44,513) 4  This report uses a variety of terms for the people who provide data. The U.S. federal regula- tions and all international codes of research ethics use the word “subjects.” Use of “subjects” reflects the historical importance of biomedical experts in drafting the U.S. regulations and international codes. Although experimentalists in several fields use “subjects” or derivative terms (e.g., “Ss”), the committee considers “participants” to be a more discipline-neutral compromise term. Consider, for instance, that survey researchers often use “respondents,” oral historians refer to “narrators,” and ethnographers use “informants,” while anthropologists have been shifting to “interlocutors” and other terms. 5  For example, five of the seven “research categories” listed as expeditable on the Office for Human Research Protections website (http://www.hhs.gov/ohrp/policy/expedited98.html [February 2014]) provide explanations and examples relevant to biomedicine, whereas the remaining two categories list a grab bag of social and behavioral research methods without equivalent insight and detail. The wording of the expeditable “continuing review” categories also treats biomedicine as the generic model for research activity.

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16 PROPOSED REVISIONS TO THE COMMON RULE This report seeks to advise HHS concerning the revision of the Com- mon Rule as sought by the ANPRM, with a specific focus on the social and behavioral sciences. Purpose of the Report and Scope of Task While the Common Rule regulations started from and emphasize bio- medical models of research, the ANPRM did point to the needs of social and behavioral science research models in asking how proposed procedures would work for these sciences. To respond to the need for additional clarifi- cation regarding human subjects protection and the promotion of research in the social and behavioral sciences, the Division of Behavioral and Social Sciences and Education of the NRC sought support for a two-phase project. In the first phase, now completed, a workshop was held to “gather infor- mation about proposed revisions to the federal regulations and alternative ways of implementing the new regulations.” The summary of that work- shop is now published (National Research Council, 2013). In the second, current phase, the committee that designed and led the workshop used the workshop proceedings, previous NRC reports, and the empirical literature to prepare a consensus report with recommendations to inform the issuance, interpretation, and implementation of the new regula- tions. The complete Statement of Task to the committee for both phases is shown in Box 1-2. Although other study committees of the NRC have produced consensus reports on human subjects research ethics in the past (see National Re- search Council, 2013, Session 1), the ANPRM provides an opportunity for revisiting these issues in the context of 21st century social and behavioral sciences. Changing technology and increasingly blurred boundaries among social, behavioral, economic, and education sciences, as well as between these sciences and the biomedical sciences, necessitate new approaches to protecting human subjects and promoting research. The committee’s view is that, in order to respond effectively to current research approaches, the revised Common Rule needs to be less static and more contextual, dynamic, and self-renewing. The ANPRM indeed begins to work out how these goals might be achieved. With regard to the scope of the committee’s task and the recommenda- tions forthcoming in this report, it is the committee’s assumption that the regulatory changes that will result—from the ANPRM issued by the HHS Office for Human Research Protections (OHRP), the many organizations that responded to the ANPRM, and the efforts of the present committee— will take the form of one set of revised Common Rule regulations governing both biomedical and social and behavioral sciences. Because the federal regulations for protecting human subjects have tended historically to use

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INTRODUCTION AND BACKGROUND 17 BOX 1-2 Committee’s Statement of Task This project will be conducted in two phases. In Phase I, an ad hoc commit- tee will plan and conduct a public workshop, following which a designated rap- porteur will prepare an individually authored summary of the event. In Phase II the committee will gather additional data, conduct analyses, and prepare a report with findings, conclusions, and recommendations. The workshop summary and report will address prospective revisions to the Common Rule for the protection of human subjects in research of particular relevance to the behavioral and social sciences. The work of the committee is intended to inform the current efforts of the federal government to update the Common Rule (45 C.F.R. 46), last revised in 1991. The Phase II portion of the project and report will address the following objectives: • Identify issues raised in the proposed rulemaking which the panel iden- tifies as critical and feasible for the federal government to address for the protection of participants and for the advancement of the social and behavioral sciences. • For each issue, provide guidance for IRBs as needed to include tech- niques for addressing issues, specific examples, and best practice models to illustrate how the techniques would be applied to different behavioral and social sciences research procedures. • Identify topics for research emerging from the proposed rulemaking that will assist in developing best practices for implementing the new human research protections and assessing the effectiveness of the rules and their implementation by IRBs and researchers. biomedical sciences as the reference discipline for examples, with the social and behavioral sciences in the background, this consensus study provides an opportunity for the social and behavioral sciences to take the foreground in offering strategies and examples of how the revisions to the Common Rule could best fit social and behavioral science research methods. It is the committee’s hope that its input, through this consensus report, will influ- ence the final regulations for the benefit of social and behavioral sciences and for the biomedical sciences as well.6 Besides largely affirming the efforts of OHRP to update the Common Rule, the report strives to assist other key stakeholders. It aims to support IRBs in best practices, under not only the existing regulations and the po- tential changes proposed by the ANPRM but also in light of other changes 6  The ANPRM was issued in July 2011, but there has not yet been a Notice of Proposed Rulemaking (a required prerequisite to promulgation of regulations) as of the writing of the committee’s report in December 2013.

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18 PROPOSED REVISIONS TO THE COMMON RULE recommended here. The report suggests methods for prioritizing, stream- lining, and focusing IRB activities on those most central to their mission. It offers institutions that employ human-subjects researchers strategies to increase the efficiency and effectiveness of human subjects protection, while reducing burden overall. Finally, it seeks to provide investigators who con- duct such research with clarification concerning regulations and procedures. Overall, the report’s twin goals for all these audiences are to protect human subjects and to facilitate research that benefits society. Key Challenges that Drive the Report This report’s focus on 21st century social and behavioral sciences aims to balance human subjects protection—which encompasses respect, justice, and beneficence—with advancing the societal utility of research. It docu- ments the dramatic transformations in the social and behavioral science research landscape, as well as increases in the diversity and volume of social and behavioral science research activity. This introductory chapter provides background (a) describing the scope of social and behavioral sciences as they are referred to in the report, (b) discussing the definition of research and generalizable knowledge in the social and behavioral sciences, (c) ex- plaining how social and behavioral sciences’ specific benefits, burdens, and costs matter to revising the Common Rule, and (d) situating the report in the changing nature of social and behavioral science research. Chapter 2 considers the definition of human subjects research and the risk-based regulatory framework proposed in the ANPRM; it then turns to research that the ANPRM defines as excused from IRB oversight, a new regulatory category. How determinations are made regarding levels of IRB oversight required is a complex issue deeply affected by 21st century trans- formations in social and behavioral science research and the accompanying challenges to the ethical, efficient, and effective conduct of research. Some of these changes reflect concomitant changes in the risks of everyday life that humans face. Chapter 2 also describes the widening array of kinds of research that IRBs are presently reviewing, with special attention to new technological conditions of research, as well as to emergent sociocultural norms concerning large-scale data management and sharing. Chapter 3 considers core issues and challenges bearing on IRB decision making: defining “minimal risk” for the full range of current social and behavioral research, ensuring that IRBs and investigators have adequate guidance for avoiding under- and overestimations of minimal risk, and distinguishing between vulnerabilities in participants’ lives and their vul- nerability to research risks. The chapter also offers elements of guidance statements that would help investigators and IRBs distinguish between

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INTRODUCTION AND BACKGROUND 19 research that would be excused from IRB review, research requiring expe- dited review, and research requiring full review. Chapter 4 addresses informed consent practices, including questions of flexibility and efficiency in the process of gaining consent, waivers of con- sent, informing participants about risks of participation, informed consent in the context of special populations such as adolescents and subjects with impaired decisional capability, and informed consent with pre-existing data. To HHS and IRBs, this report recommends several best practices that would streamline human subjects protection, including best practices relating to full IRB review, the prototypic IRB activity. Chapter 5 examines crosscutting issues related to protecting human- subjects research data in the information age and addresses questions posed by the ANPRM related to methods that would work best for social and behavioral sciences. Special attention is paid to heightened privacy concerns in the context of informational risk and public information used for research. The chapter covers data protection plans for data collected in individual studies and for shared data, including the ANPRM proposal to make the Health Insurance Portability and Accountability Act of 1996 the mandated standard for data security and protection, which the committee does not endorse. It also considers approaches that would facilitate sug- gestions in the ANPRM to provide IRBs and researchers with information technology expertise. Chapter 6 addresses best practices to improve IRB processes, one of the committee’s charges under its Statement of Task. Throughout this report, the committee has been mindful of the Belmont Report’s principles of respect for persons, beneficence, and justice in its assessment of the empirical evidence for the degrees of risk for different populations associated with potential harms that may be posed by social and behavioral science research. With these principles in mind, recom- mendations are made in each chapter to improve the risk-based regulatory framework and how it is implemented to ultimately improve IRB protection of human subjects and the promotion of research. In making recommenda- tions, the committee has been keenly aware and sought not to recommend changes that would increase burdens on IRBs or to transfer burdens onto their larger parent institutions. Some of the recommendations are intended to transfer existing IRB responsibilities onto investigators and their obliga- tions to adhere to professional ethics. However, recognizing that institu- tions might react by adding their own requirements if they do not feel that the recommendations are robust enough, the committee has also made accompanying recommendations for OHRP to provide guidance for IRBs and researchers in implementing the changes. For example, the committee provides examples of social and behavioral sciences research that would be outside of the purview of the IRB because they are not considered to

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20 PROPOSED REVISIONS TO THE COMMON RULE be “human-subjects research,” types of research that would fall into the new category of “excused” research, and illustrations of how to distinguish between research that can be excused from IRB review (but have IRB over- sight) versus those that should undergo expedited IRB or full review. The committee then urges OHRP to provide supplemental guidance with these types of examples for IRBs and researchers. BACKGROUND Scope of Social and Behavioral Sciences It is important at the outset to define the terms and scope of the social and behavioral sciences as they are referenced throughout the report. The National Institutes of Health Office of Behavioral and Social Science Re- search defines social and behavioral sciences this way:7 The term “behavioral” refers to overt actions; to underlying psychological processes such as cognition, emotion, temperament, and motivation; and to bio-behavioral interactions. The term “social” encompasses sociocul- tural, socioeconomic, and socio-demographic status; biosocial interactions; and the various levels of social context from small groups to complex cultural systems and societal influences. The committee adopts this definition of behavioral and social sciences for the purposes of this report. In line with other NRC reports, the committee also includes as dis- ciplines and fields in social and behavioral sciences the following: an- thropology, cognitive science, communication and information sciences, demography, economics, education research, geography, health services research, history, political science, psychology, social work, sociology, and statistics (National Research Council, 1982, 2003). Note that the research methods in these disciplines are commonly used in many other disciplines (including the biomedical fields). Throughout the report, the committee uses the term “social and behavioral science” to refer to this broad and diverse spectrum of research disciplines and related fields. Social and behavioral science research has long respected the rights and welfare of human research participants. Early on, a broad shift occurred in the climate of ethical awareness within the varied social and behavioral research communities. Even before IRBs were formed—in the wake of the Nuremberg trials and especially in the context of 1960s social movements— social and behavioral science professional associations began paying closer 7  See http://obssr.od.nih.gov/about_obssr/BSSR_CC/BSSR_definition/definition.aspx [Octo- ber 2013].

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INTRODUCTION AND BACKGROUND 21 critical attention to the ethical conduct of research and developing explicit ethics codes and expectations.8 Two examples are the ethics codes of the American Anthropological Association (AAA) and the American Psychological Association. Since at least 1949, the AAA has sought to ensure that “the interests of the persons and communities or other social groups studied are protected” (Beals and The Executive Board, 1967). Intensive discussion in the mid-1960s led the AAA to form an ethics committee and to publish its Principles of Profes- sional Responsibility in 1971, amended and revised several times since then, most recently in 2012.9 The American Psychological Association’s ethics code dates to 1953 and has been revised regularly since then. For example, intensive discussion in the mid-1960s led the American Psychological As- sociation to form a commission that surveyed the membership; its 1972 statement of Ethical Principles was based in part on membership experi- ence (Rosnow, 1997). Similarly, the American Political Science Association formed a committee in 1967 that published a report the next year, which resulted in the association’s first written code.10 The Oral History Associa- tion has likewise had an active commitment to professional ethics since its founding: like the American Political Science Association, it adopted a first statement of “goals and guidelines” in 1968.11 The American Sociological Association published its first ethics code in 1970.12 Since the 1970s, they have also developed and expanded ethics educa- tion resources,13 just as universities—where most researchers are trained and many are employed—have likewise strengthened their internal mecha- nisms for reviewing academic ethics cases and for cultivating ethical aware- ness in their students. Defining Research and Generalizable Knowledge in the Social and Behavioral Sciences This report concurs with the ANPRM concerning the basic goal of reducing administrative burden on both IRBs and investigators, while 8  See Levine and Skedsvold (2008) for a brief history of the development of ethics programs in professional societies. 9  See, for example, http://www.aaanet.org/profdev/ethics/ [December 2013]. 10 See http://www.apsanet.org/content_9350.cfm [December 2013]. 11 See http://www.oralhistory.org/wp-content/uploads/2009/10/History-of-the-Evaluation- Guidelines.pdf [December 2013]. 12 See http://www2.asanet.org/taskforce/ethics/detail.cfm?id=36 [December 2013]. 13 For the Oral History Association, see http://www.oralhistory.org/about/principles-and- practices/ [February 2014]. For the AAA, see http://www.aaanet.org/cmtes/ethics/Ethics- Resources.cfm [February 2014]. For the American Sociological Association, see http://www. asanet.org/ethics/detail.cfm?id=all [February 2014]. For the American Psychological Associa- tion, see http://www.apa.org/pubs/books/4311504.aspx [December 2013].

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22 PROPOSED REVISIONS TO THE COMMON RULE promoting the ethical treatment of research participants. The big question, however, is how to achieve this goal. A number of observers have singled out the definition of “research” itself as an important source of burden. Indeed, a lack of clarity concerning the term’s range of reference and the meaning of its components may be one of the reasons why the quantity and variety of protocols reviewed by IRBs have expanded over the past decades.14 As noted in Chapter 2’s section, “Redefining Human-Subjects Re- search,” clarifying the ambiguity of some key regulatory definitions may help IRBs focus their oversight responsibilities. For example, the IRB should review only activities that conform to the regulatory definition of research, but even within research activities, not all should be reviewed by an IRB. The ANPRM has listed many of these activities in a proposed new “ex- cused” category (76 Fed. Reg. 44,517). Under the proposed rule, research in this category would be subject to regulation but would not be required to undergo IRB review. In Chapter 2, the committee clarifies the types of social and behavioral sciences that would fit under the proposed “excused” category. The definition of “research” contained in the Belmont Report and in 45 C.F.R. § 46 includes the word “generalizable,” which has been one source of confusion.15 Some of the terms in the definition of research require clarification to make the definition more clearly relevant to social and behavioral science research and helpful to IRB administrators. “Gen- eralizable” should be understood to mean that the results of the research are intended to apply to persons who are not participants in the research, through contributing to the development of new knowledge or applications, thereby extending the understanding of human behavior, context, or biol- ogy. “Systematic” should be understood to mean that the work is carried out according to a plan that is intended to contribute to the development 14  The ANPRM identifies “a marked increase in the volume of research” (76 Fed. Reg. 44,513) as an important reason for the expansion in IRB workloads. While the committee agrees that this is partially true, another contributing factor, particularly over the past decade, has been the tendency for IRBs to interpret their charge increasingly broadly; “human subjects research” has been interpreted to encompass oral history interviewing, linguistic elicitation, and even occasionally the activities of creative writing instructors and students (e.g., Wright, 2004). Also see the ANPRM commentaries, available: http://www.regulations.gov/#!search Results;rpp=50;po=0;s=HHS-OPHS-2011-0005;dct=PS [December 2013], by the American Historical Association, the Oral History Association, and the Linguistics Society of America. 15  Several professional groups attempted to address this confusion by proposing new defini- tions of research. Such groups include quality assurance/quality improvement, public health, and other professions. Several of these proposals excluded activities of the group that proposed the definition while including activities that other groups had excluded from their definitions. While there may be merit to some of these ideas, conceptual clarity will remain elusive so long as such efforts at innovation are uncoordinated.

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INTRODUCTION AND BACKGROUND 23 of generalizable new knowledge. The methodology of the design should be judged by the standards established by the investigators’ field of study. Participants in some types of research may indeed benefit from their par- ticipation, but this is not a defining attribute of research. Specific Benefits, Burdens, and Costs of the Social and Behavioral Sciences Matter to Revising the Common Rule Generalizable knowledge resulting from social and behavioral science research benefits society. Most scientists conduct research—and sponsors fund them—for the purpose of advancing knowledge. Regulations that govern the conduct of such research need to be examined, as the ANPRM notes (76 Fed. Reg. 44,513), and modified as needed to make them more effective and less burdensome. This report endorses the necessity and value of IRBs as part of the regulatory process and seeks to support efforts of IRBs and regulators in increasing their effectiveness and reducing their costs to institutions, sponsors, and researchers alike. The human subjects protection principle of beneficence as stated in the Belmont Report asserts that the ethical treatment of persons is achieved “not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being.”16 Research contributes to human flourishing not just because of its specialized knowledge outcomes but also because of short- and long-term contributions to physical and mental health, education, and public policy (see Box 1-3 for examples). The work of IRBs supports and facilitates the conduct of research in which people participate. How have the bureaucratic burdens of IRBs evolved, and what is the added value of the increased burden versus its cost? Over the 40 years since institutional review became a requirement,17 the field of research involving human subjects has become larger and more complex and its review by IRBs has become much more detailed and meticulously documented. The numbers of IRBs within institutions have proliferated, and the size of their staffs has enlarged greatly (Catania et al., 2008). Cross-pressures result from the expansion and professionalization of IRB staff, and a narrow focus on harm prevention that sometimes con- flicts with social and behavioral science researchers’ focus on the efficient conduct of their research for human well-being (Fiske, 2009). From these cross-pressures emerge both costs and benefits. The regulatory costs of IRBs 16  See part B.1. of the 1979 U.S. Department of Health and Human Services’ Belmont Report at http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html [November 2013]. 17  See National Research Act of 1974, Public Law 93-948 (July 1974), at http://history.nih. gov/research/downloads/PL93-348.pdf [October 2013].

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24 PROPOSED REVISIONS TO THE COMMON RULE BOX 1-3 Benefits of Social and Behavioral Science Research: Lives, Health, Environment, Improved Ways of Life Social and behavioral science research contributes to the solution of per- vasive social problems through a deeper understanding of patterns of learning, cognition, brain function, and social behavior. It affects Americans’ way of life through its impact on policies regarding health and longevity, pollution, economic competition, and trade. • The contributions from the social and behavioral sciences save lives. Tens of thousands of elderly people die every year—and tens of thou- sands of diabetics die or lose limbsa—because they do not follow their medical regimens (Beck et al., 2002; Hojat et al., 2011; Stewart, 1995; Street et al., 2009; Tarn et al., 2006). A substantial proportion of the tragedies can be traced to difficulties communicating with physicians and failures to understand instructions about treatment regime including the use of medicines (Haynes et al., 2008; Kripalani et al., 2007). Behavioral scientists have found many ways to increase understanding and compli- ance (Easthall et al., 2013; Heron and Smyth, 2010). • Social and behavioral science research develops and evaluates the effectiveness of interventions. Researchers have found ways to reduce alcoholism and alcohol abuse, especially among young people who often engage in dangerous binge drinking (Prentice and Miller, 1993). Researchers in these disciplines have identified procedures that can make organ and blood donation far more common than is currently the case (Thaler and Sunstein, 2008). They have found ways of reduc- ing the likelihood of unprotected sex and teen pregnancy (Allen et al., 1997; Dal Cin et al., 2006; O’Donnell et al., 2002; Stone et al., 1994). Effective ways to reduce crime for all age groups have been discovered (Wilson, 2011). Conversely, as research progresses, it has helped to identify unintended consequences of social policies. For example, some programs developed to help trauma victims have been shown to be iat- rogenic, worsening the degree and duration of suffering (Wilson, 2011). In contrast, techniques developed by behavioral scientists genuinely do reduce suffering from trauma (Pennebaker, 1993). Interventions de- signed to reduce delinquency in teenagers, sometimes actually increase juvenile crime rates (Dodge et al., 2006; Lilienfeld, 2005; Petrosino et al., 2002). Crimes have been committed that could have been avoided, had those programs never been implemented (Sherman et al., 1998; Wilson, 2011).

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INTRODUCTION AND BACKGROUND 25 • Social and behavioral science research reduces costs for society. Basic research detailing when and how social norms guide human conduct led to the establishment of a firm (Opower) that partners with utility compa- nies to send households information about their energy consumption relative to that of their closest neighbors. In less than 5 years of opera- tion, that partnership has reduced U.S. energy consumption by nearly 3 billion kilowatt-hours, cut carbon dioxide emissions by more than 4 billion pounds, and saved residents nearly $330 million in energy costs.b • Research in the social and behavioral sciences increases the efficiency of technology use. It provides the perceptual, motor, and cognitive under- pinnings assuring safety for many systems such as nuclear power plants and jet airplane cockpits (McCormick and Sanders, 1982; Roscoe and Williams, 1980; Wickens and Hollands, 2000). The value of technologies supporting kidney transfers was increased dramatically through the de- velopment of a kidney exchange that facilitates multilateral exchanges. This exchange optimizes the process in the organ transplant “market.” • Social and behavioral science research reduces air pollution and pro- tects the environment. Designs for emissions permits markets have proved successful in reducing nitrogen oxide (NOx) pollution in major problem areas such as California and Virginia. Ten northeastern states from Maryland to Maine launched the Regional Greenhouse Gas Initia- tive, which produced revenues of approximately $1.5 billion. The impact of research in the social and behavioral sciences was a key part of the testing, design, and implementation of the Kyoto protocols for interna- tional emissions trading and reductions of worldwide carbon dioxide emissions (Baron, 2001). • Research results from the social and behavioral sciences can improve Americans’ way of life. Such research contributed to changes in the communications industry through the creation of an efficient process for allocating the electromagnetic spectrum for cell phone use (McMillan, 1994). Early Federal Communication Commission auction architectures, based on considerable experimental work, produced $60 billion in rev- enues in the United States. Replications around the world produced over $200 billion in revenues.c Auction innovations continue, with a new form of auction, which the Federal Communication Commission used in the most recent spectrum auction, resulting in increased efficiency and approximately $19 billion in revenues (Goeree and Holt, 2010). aSee http://www.cdc.gov/diabetes/pubs/estimates11.htm [December 2013]. bSee http://opower.com/impact [December 2013]. cSee http://www.nsf.gov/about/congress/reports/sbe_research.pdf [December 2013].

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26 PROPOSED REVISIONS TO THE COMMON RULE must be weighed against the enhanced protection they provide for the rights and welfare of human research subjects. What have been the demonstrable benefits of IRB review? Assessing the benefits of IRB review might take the form of a before-and-after com- parison; however, the committee recognizes that such a comparison would be difficult to design because the sociocultural contexts of social and be- havioral research before and after the introduction of IRB reviews include many factors beyond the presence or absence of IRBs. The pervasiveness of IRBs makes an exploration of the counterfactual condition—a comparison of the current situation with one in which IRBs are absent—a theoretical exercise that, although difficult, is not impossible to design. Measuring the benefits of IRB review in terms of unethical studies that were prevented has obvious drawbacks: proving the influence of one factor in preventing an event requires ruling out a myriad of other factors potentially at play. A systematic review of the empirical literature evaluating IRBs concluded that much research needs to be undertaken to “understand how IRBs ac- complish their objectives, what issues they find important, what quality IRB review is, and how effective IRBs are at protecting human research participants” (Abbot and Grady, 2011, p. 3). The expansion of the IRB system, embedded within each institution’s Human Research Protection Program, has become increasingly expensive, costing as much as $400-$600 per protocol in medical schools, by one estimate (Wagner et al., 2010).18 The costs also include the burden on researchers.19 A study by the Fed- eral Demonstration Partnership on administrative burden reported that, of the time faculty spent on federal research, 42 percent was devoted to pre- and post-award administrative activities (16% of their average workweek) (Decker et al., 2007). The top burdens reported by faculty included grant progress reports, personnel hiring, project revenue management, equipment and supply purchases, IRB protocols and training, training personnel and students, and personnel evaluations. When including in the analysis only those who indicated that the task took at least “a little” time away from their active research or more, two of the five perceived greatest burdens on researchers concerned dealings with their IRB (Decker et al., 2007): 1. IRB protocols. 18  Even this may be a substantial underestimate. Estimates available in the early 1980s were considerably higher (Levine, 1988, pp. 360-361), and those estimates did not include the cost of the investigator’s time or that of the IRB members. 19  One epidemiologist (cited in Levine, 1988, p. 346) estimated that the investigator hours required to secure all necessary IRB approvals to initiate a large-scale epidemiological study is the equivalent of 3 percent of an epidemiologist’s active career.

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INTRODUCTION AND BACKGROUND 27 2. Institutional Animal Care and Use Committee protocols and training. 3. Training personnel and students. 4. Grant report submissions. 5. IRB compliance issues. Critics have described the contemporary Human Research Protection Plan system as “a crisis in confidence” (Levine, 2001), the “dysregulation of human subjects research” (Fost and Levine, 2007), “breaking the camel’s back” (Burman et al., 2001), and “mission creep” (White, 2007). Some commentators have described the current system as an immense bureau- cracy engaged excessively in correcting minor flaws in research protocols and documentation of having done so (Hamburger, 2007; Jacob and Riles, 2007). From the perspective of these critics, IRBs are so overburdened by meticulous attention to details that they have little time or energy left to attend to their primary mission: addressing and resolving ethical issues that arise in the design and execution of research involving human subjects. Part of this committee’s charge is to propose relevant research topics, so research that documents support for IRBs lies specifically within the committee’s scope. Research Needed: Research is needed on the regulatory costs and ben- efits of human-subjects research in the social and behavioral sciences, including the costs and benefits for institutions, IRBs, investigators, and sponsors. Some of this research can be done as part of the monitoring registries proposed in Chapter 2. Much of this report concerns reducing the burdens on both IRB staff and members. The following chapters consider means to that end. In part, the report focuses on the argument for narrowing the domain of the IRB system to only those types of research in which IRB review yields important benefits, especially when the necessary protections of subjects’ rights and welfare cannot be provided as well or better by other entities. Situating the Report in the Changing Nature of Social and Behavioral Science Research Large changes have occurred in social and behavioral science research since the Common Rule was applied to these disciplines. These changes occurred because knowledge in these fields has evolved (thereby blurring the lines between biomedical and social science research) and through the emerging ubiquity of digital record systems in all sectors of society, the rise of the Internet and digital connectivity in general, and more specifically the

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28 PROPOSED REVISIONS TO THE COMMON RULE related expansion in production of real-time data on most aspects of human behavior. In addition, the establishment of datasets shared among students and researchers in data archives has revolutionized the empirical social sciences. The informational risks of shared research data are themselves a research focus in social sciences, computer science, and statistics. To be current, a revision of the Common Rule needs to take into account these changes in society and research tools. The Internet has altered everyday lives of all potential human partici- pants in social and behavioral science research. Most of the records kept by institutions have been digitized, making them easy to analyze for research purposes with modern software. Massive datasets assembled by commercial firms store information on each person in American households. These data- sets have combined economic transaction data, such as retail purchase data, loan and payment data, and property ownership data. Facebook, Google, and Twitter data are publicly available, sometimes personally identifiable. The risks of personal harm in everyday life have radically changed, and “it is increasingly appropriate to include the risk of computer-related harms, such as hacking, phishing, breach, lack of appropriate security measures as among those risks encountered in daily life.”20 Harms could possibly result from disclosure of health, financial, educational, or reputational informa- tion. Chapter 5 argues that these changes in the probability and magnitude of harm from use of personal information demand new guidance to IRBs. The social and behavioral sciences have developed procedures for sharing research data among researchers. The research data are routinely stripped of all direct personal identifiers in an attempt to eliminate the prob- ability of harm from knowledge of attributes of individual subjects. As the availability of data with personal identifiers has increased, social scientists, statisticians, and computer scientists have determined that merely deleting direct personal identifiers from a data record does not eliminate the ability to indirectly identify a person through combining datasets. This realization has spurred a rapidly evolving research area to measure disclosure risk and reduce it, develop more robust methods to de-identify data that protect against inadvertent disclosure, and expand institutional mechanisms for use of data under restricted conditions. Chapter 5 argues that guidance to IRBs must acknowledge the complex and rapidly changing techniques to reduce the probability of revealing research data about participants and the evolving protections to minimize the reputational or psychological harm from such knowledge. 20  Secretary’s Advisory Committee on Human Research Protections (2013, p. 15).

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INTRODUCTION AND BACKGROUND 29 CONCLUSION In striving to balance the benefits of social and behavioral science re- search, the necessary burdens and costs of the infrastructure for protecting human participants, and the rapidly changing research context, this report affirms the need, recognized in the ANPRM, to reconsider what facilitates the ethical conduct of research and what creates barriers. The report spe- cifically considers the responsible conduct of researchers and recommends ways to move toward efficient and effective human subjects protection. REFERENCES Abbot, L., and Grady, C. (2011). A systematic review of the empirical literature evaluating IRBs: What we know and what we still need to learn. Journal of Empirical Research on Human Research Ethics, 6(1):3-19. Allen, J.P., Philliber, S., Herrling, S., and Kuperminc, G.P. (1997). Preventing teen pregnancy and academic failure: Experimental evaluation of a developmentally based approach. Child Development, 68(4):729-742. Baron, R. (2001). International Emission Trading: From Concept to Reality. Paris, France: International Energy Agency, OECD. Beals, R.L., and The Executive Board. (1967). Background information on problems of an- thropological research and ethics. American Anthropological Association Fellow News- letter, 8(l):1-13. Beauchamp, T.L., Faden, R.R., Wallace, R.J., and Walter, L. (Eds). (1982). Ethical Issues in Social Science Research. Baltimore, MD: Johns Hopkins University Press. Beck, R.S., Daughtridge, R., and Sloane, P.D. (2002). Physician-patient communication in the primary care office: A systematic review. The Journal of the American Board of Family Practice, 15(1): 25-38. Burman, W., Reves, R., Cohn, D.L., and Schooley, R.T. (2001). Breaking the camel’s back: Multicenter clinical trials and local institutional review boards. Annals of Internal Medi- cine, 134(2):152-157. Catania, J.A., Lo, B., Wolf., L.E., Dolcini, M.M., Pollack, L.M., Barker, J.C., Wertlieb, S., and Henne, J. (2008). Survey of U.S. human research protection organizations: Workload and membership. Journal of Empirical Research on Human Research Ethics, 3(4):57-69. Dal Cin, S., MacDonald, T.K., Fong, G.T., Zanna, M.P., and Elton-Marshall, T.E. (2006). Remembering the message: The use of a reminder cue to increase condom use following a safer sex intervention. Health Psychology, 25(3):438-443. Decker, R.S., Wimsatt, L., Trice, A.G., and Konstan, J.A. (2007). A Profile of Federal-Grant Administrative Burden among Federal Demonstration Partnership Faculty. Washington, DC: Federal Demonstration Partnership. Dodge, K.A., Lansford, J.E., and Dishion, T.J. (Eds.). (2006). Deviant Peer Influences in Pro- grams for Youth. New York: Guilford Press. Easthall, C., Song, F., and Bhattacharya, D. (2013). A meta-analysis of cognitive-based behaviour change techniques as interventions to improve medication adherence. BMJ Open, 3(8). Fiske, S.T. (2009). Institutional review boards: From bane to benefit. Perspectives on Psycho- logical Science, 4(1):30-31. Fost, N., and Levine, R.J. (2007). The dysregulation of human subjects research. Journal of American Medical Association, 298(18):2196-2198.

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30 PROPOSED REVISIONS TO THE COMMON RULE Goeree, J.K., and Holt, C.A. (2010). Hierarchical package bidding: A paper and pencil com- binatorial auction. Games and Economic Behavior, 70(1):146-169. Hamburger, P. (2007). Getting permission. Northwestern University Law Review, 101(2): 405-492. Haynes, R.B., Ackloo, E., Sahota, N., McDonald, H.P., and Yao, X. (2008). Interventions for enhancing medication adherence. Cochrane Database of Systematic Reviews, 2(2). Heron, K.E., and Smyth, J.M. (2010). Ecological momentary interventions: Incorporating mobile technology into psychosocial and health behaviour treatments. British Journal of Health Psychology, 15(1):1-39. Hojat, M., Louis, D.Z., Markham, F.W., Wender, R., Rabinowitz, C., and Gonnella, J.S. (2011). Physicians’ empathy and clinical outcomes for diabetic patients. Academic Medi- cine, 86(3):359-364. Jacob, M.A., and Riles, A. (2007). The new bureaucracies of virtue: Introduction. PoLAR: Political and Legal Anthropology Review, 30(2):181-191. Kripalani, S., Yao, X., and Haynes, R.B. (2007). Interventions to enhance medication adher- ence in chronic medical conditions: A systematic review. Archives of Internal Medicine, 167(6):540-550. Levine, F.J., and Skedsvold, P.R. (2008). Behavioral and social science research. Pp. 336-355 in E.J. Emanuel, C. Grady, R.A. Crouch, R.K. Lie, F.G. Miller, and D. Wendler (Eds.), The Oxford Textbook of Clinical Research Ethics. New York: Oxford University Press. Levine, R.J. (1988). Ethics and Regulation of Clinical Research. 2nd ed. New Haven, CT: Yale University Press. Levine, R.J. (2001). Institutional review boards: A crisis in confidence. Annals of Internal Medicine, 134(2):161-163. Lilienfeld, S.O. (2005). Scientifically unsupported and supported interventions for childhood psychopathology: A summary. Pediatrics, 115(3):761-764. McCormick, E.J., and Sanders, M.S. (1982). Human Factors in Engineering and Design. New York: McGraw-Hill. McMillan, J. (1994). Selling spectrum rights. The Journal of Economic Perspectives, 8(3):145-162. National Research Council. (1982). Behavioral and Social Science Research: A National Resource, Part I. Committee on Basic Research in the Behavioral and Social Sciences. R. McC. Adams, N.J. Smelser, and D.J. Treiman (Eds). Commission on Behavioral and Social Sciences and Education. Washington, DC: National Academy Press. National Research Council. (2003). Protecting Participants and Facilitating Social and Be- havioral Sciences Research. Panel on Institutional Review Boards, Surveys, and Social Science Research. C.F. Citro, D.R. Ilgen, and C.B. Marrett (Eds.). Committee on National Statistics and Board on Behavioral, Cognitive, and Sensory Sciences. Division of Behav- ioral and Social Sciences and Education. Washington, DC: The National Academies Press. National Research Council. (2013). Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Committee on Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences. R. Pool (Rapporteur). Board on Behavioral, Cognitive, and Sensory Sci- ences. Division of Behavioral and Social Sciences and Education. Washington, DC: The National Academies Press. O’Donnell, L., Stueve, A., O’Donnell, C., Duran, R., San Doval, A., Wilson, R.F., and Pleck, J.H. (2002). Long-term reductions in sexual initiation and sexual activity among urban middle schoolers in the reach for health service learning program. Journal of Adolescent Health, 31(1):93-100. Pennebaker, J.W. (1993). Putting stress into words: Health, linguistic, and therapeutic implica- tions. Behavioral Research and Therapy, 31(6):539-548.

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INTRODUCTION AND BACKGROUND 31 Petrosino, A., Turpin-Petrosino, C., and Buehler, J. (2002). “Scared Straight” and other juvenile awareness programs for preventing juvenile delinquency. Campbell Systematic Reviews, (2), CD002796. Available: http://summaries.cochrane.org/CD002796/scared- straight-and-other-juvenile-awareness-programs-for-preventing-juvenile-delinquency [February 2014]. Prentice, D.A., and Miller, D.T. (1993). Pluralistic ignorance and alcohol use on campus: Some consequences of misperceiving the social norm. Journal of Personality and Social Psychology, 64(2):243-256. Roscoe, S.N., and Williams, A.C. (1980). Aviation Psychology. Ames: Iowa State University Press. Rosnow, R.L. (1997). Hedgehogs and foxes and the evolving social contract in psychological science. Psychological Methods, 2(4):345-356. Schrag, Z.M. (2010). Ethical Imperialism. Baltimore, MD: Johns Hopkins University Press. Secretary’s Advisory Committee on Human Research Protections. (2013). Considerations and Recommendations Concerning Internet Research and Human Subjects Research Regulations, with Revisions. (White paper approved, SACHRP meeting March 12-13.) Available: http://www.hhs.gov/ohrp/sachrp/mtgings/2013%20March%20Mtg/internet_ research.pdf [February 2014]. Sherman, L.W., Gottfredson, D.C., MacKenzie, D.L., Eck, J., Reuter, P., and Bushway, S.D. (1998). Preventing Crime: What Works, What Doesn’t, What’s Promising Report to the U.S. Congress. Washington, DC: U.S. Department of Justice. Available: https://www. ncjrs.gov/pdffiles/171676.PDF [October 2013]. Stewart, M.A. (1995). Effective physician-patient communication and health outcomes: A review. CMAJ: Canadian Medical Association Journal, 152(9):1423-1433. Stone, J., Aronson, E., Crain, A.L., Winslow, M.P., and Fried, C.B. (1994). Inducing hypocrisy as a means of encouraging young adults to use condoms. Personality and Social Psychol- ogy Bulletin, 20(1):116-128. Street, R.L., Jr., Makoul, G., Arora, N.K., and Epstein, R.M. (2009). How does communica- tion heal? Pathways linking clinician-patient communication to health outcomes. Patient Education and Counseling, 74(3):295-301. Tarn, D.M., Heritage, J., Paterniti, D.A., Hays, R.D., Kravitz, R.L., and Wenger, N.S. (2006). Physician communication when prescribing new medications. Archives of Internal Medi- cine, 166(17):1855-1862. Thaler, R.H., and Sunstein, C.R. (2008). Nudge: Improving Decisions about Health, Wealth, and Happiness. New York: Penguin Books. U.S. Department of Health and Human Services. (1979). The Belmont Report: Ethical Prin- ciples and Guidelines for the Protection of Human Subjects of Research. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Re- search. Washington, DC: U.S. Department of Health and Human Services. Available: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html [October 2013]. U.S. Department of Health and Human Services. (2011). Human subjects research protections: Enhancing protections for research subjects and reducing burden, delay, and ambiguity for investigators. Federal Register, 76(143):44,512-44,531. Throughout this report, spe- cific text references to the ANPRM are cited using the standard legal format for Federal Register citations, namely: 76 Fed. Reg. Wagner, T.H., Murray, C., Goldberg, J., Adler, J.M., and Abrams, J. (2010). Costs and benefits of the National Cancer Institute Central Institutional Review Board. Journal of Clinical Oncology, 28(4):662-666. White, R.F. (2007). Institutional review board mission creep: The Common Rule, social sci- ence, and the nanny state. The Independent Review, 6(4):547-564.

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32 PROPOSED REVISIONS TO THE COMMON RULE Wickens, C.D., and Hollands, J.G. (2000). Engineering Psychology and Human Performance. Upper Saddle River, NJ: Prentice Hall. Wilson, T.D. (2011). Redirect: The Surprising New Science of Psychological Change. New York: Little, Brown. Wright, D. (2004). Creative nonfiction and the academy: A cautionary tale. Qualitative In- quiry, 10(2):202-206.