Introduction

On July 26, 2011, the U.S. Department of Health and Human Services issued an advance notice of proposed rulemaking (ANPRM) with the purpose of soliciting comments on how current regulations for protecting research participants under Title 45, Part 46 in the Code of Federal Regulations (“the Common Rule”) could be modernized and revised. The rationale for revising the regulations was as follows:

This ANPRM seeks 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. The current regulations governing human subjects research 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, the proliferation of multisite clinical trials and observational studies, the expansion of health services research, research in the social and behavioral sciences, and research involving databases, the Internet, and biological specimen repositories, and the use of advanced technologies, such as genomics. (U.S. Department of Health and Human Services, 2011, p. 44512)

More than 1,000 commentaries were submitted in response to the ANPRM (see http://www.regulations.gov/#!docketDetail;D=HHS-OPHS-2011-0005 [June 2013]). While revisions to the regulations were still under consideration, a workshop was held in Washington, DC, in March 2013 to explore the implications of the proposed revisions and alternative



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Introduction O n July 26, 2011, the U.S. Department of Health and Human Ser- vices issued an advance notice of proposed rulemaking (ANPRM) with the purpose of soliciting comments on how current regula- tions for protecting research participants under Title 45, Part 46 in the Code of Federal Regulations (“the Common Rule”) could be modernized and revised. The rationale for revising the regulations was as follows: This ANPRM seeks 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. The current regulations governing human subjects research were developed years ago when research was predominantly conducted at universities, col- leges, 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, the proliferation of multisite clinical trials and observational studies, the expansion of health services research, research in the social and behavioral sciences, and research involving databases, the Internet, and biological specimen repositories, and the use of advanced technolo- gies, such as genomics. (U.S. Department of Health and Human Services, 2011, p. 44512) More than 1,000 commentaries were submitted in response to the ANPRM (see http://www.regulations.gov/#!docketDetail;D=HHS- OPHS-2011-0005 [June 2013]). While revisions to the regulations were still under consideration, a workshop was held in Washington, DC, in March 2013 to explore the implications of the proposed revisions and alternative 1

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2 PROPOSED REVISIONS TO THE COMMON RULE approaches for protecting human participants while at the same time advancing the behavioral, social, educational, and economic sciences. 1 The workshop was planned and organized by a committee gathered by the Board on Behavioral, Cognitive, and Sensory Sciences of the National Research Council’s (NRC’s) Division of Behavioral and Social Sciences and Education. Eighteen presenters, mainly from academia but also from industry, government agencies, and professional societies, provided their insights into various aspects of the topic. The workshop presenters focused on six broad topic areas (see agenda in Appendix A): 1. Evidence on the functioning of the Common Rule and of institutional review boards (IRBs), to provide context for the proposed revisions. 2. The types and levels of risks and harms encountered in social and behavioral sciences, and issues related to the severity and probability of harm, because the ANPRM asks for input on calibration of levels of review to levels of risk. 3. The consent process and special populations, because new rules have been proposed to improve informed consent (e.g., standard consent form, consent for future uses of biospecimens, and re-consenting for further use of existing research data). 4. Issues related to the protection of research participants in studies that involve use of existing data and data sharing, because the ANPRM proposed applying standards for protecting the privacy of healthcare data to research data. 5. Multidisciplinary and multisite studies, because the ANPRM proposed a revision to the regulations that would allow multisite studies to be covered by a single IRB. 6. The purview and roles of IRBs, because the ANPRM included possible revisions to categories of research that could entail changes in IRB oversight. These topic areas were selected at a workshop planning meeting held in January 2013. The committee developed an extensive list of experts from a range of social and behavioral science disciplines and methods, including anthropology, economics, education, healthcare services, psy- chology, and sociology, who could address the topic areas. The final selec- tion of speakers for each topic area was based on the experts’ availability. Each speaker was asked to address the three objectives for the workshop: 1For convenience, this report uses the phrase “social and behavioral sciences” to refer to these disciplines.

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INTRODUCTION 3 1. To examine how the proposed revisions to the Common Rule might affect different types of research studies and methods in the behavioral, social, and educational sciences. 2. To identify strategies that may currently be used to protect participants and advance science, and suggest refinements or alternatives to the proposed rulemaking that will make them more workable for behavioral, social, and educational sciences as well as for biomedical sciences. 3. To identify topics for research emerging from the proposed rulemaking that might assist in developing best practices for implementing the new human research protections and assessing the effectiveness of the rules and their implementation by institutional research boards and researchers. This report is a summary of the presentations and discussions that took place at the two-day workshop and does not offer additional com- ment, interpretation, or analysis. During discussion periods, speakers, committee members, and audience members commented on the pre- sentations, and some of their comments are included in this summary. Although the perspectives of a broad range of behavioral and social sci- entists were provided at the workshop, some topics may not have been covered in sufficient depth. Among these are privacy issues and disclo- sure risks presented by advances in technology, such as data mining and tracking of individuals. The workshop also did not cover the full body of evidence on the functioning of the Common Rule and IRBs, particularly questions related to the evidence for over-regulation or under-regulation of human participants in social and behavioral sciences research. How- ever, the workshop did provide the basis for additional study of these issues and topics by the committee. REFERENCE U.S. Department of Health and Human Services. (2011). Human subjects research protec- tions: Enhancing protections for research subjects and reducing burden, delay, and ambiguity for investigators. Advance notice of proposed rulemaking. Federal Regis- ter 76(143):44512–44531. Available: http://www.gpo.gov/fdsys/pkg/FR-2011-07-26/ pdf/2011-18792.pdf [June 2013].

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