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Suggested Citation:"Appendix B: Biographical Sketches of Speakers." National Research Council. 2013. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18383.
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Appendix B

Biographical Sketches of Speakers

George Alter is director of the Inter-university Consortium for Political and Social Research (ICPSR), research professor at the Population Studies Center, and professor of history at the University of Michigan, Ann Arbor. ICPSR is the world’s largest social science data archive with units that specialize in data on aging, childcare, criminal justice, demography, health, and substance abuse. Alter‘s research grows out of interests in the history of the family, demography, and economic history, and recent projects have examined the effects of early life conditions on health in old age and new ways of describing fertility transitions. Recent publications include “The Demographic Transition and Human Capital,” a chapter in The Cambridge Economic History of Modern Europe (Cambridge University Press, 2010); and “Widowhood, Family Size, and Post-Reproductive Mortality: A Comparative Analysis of Three Populations in Nineteenth Century Europe,” a 2007 article in Demography. He is past president of the Social Science History Association. He holds a Ph.D. in history from the University of Pennsylvania.

Susan Bouregy is chief Health Insurance Portability and Accountability Act (HIPAA) privacy officer and an institutional review board (IRB) vice-chair at Yale University. As privacy officer, Dr. Bouregy is responsible for the HIPAA privacy program throughout the university, which covers the health plan; the healthcare providers in the faculty practice; and University Health Services, a full-service care provider for students, employees, and their families. Dr. Bouregy has been responsible for oversight of

Suggested Citation:"Appendix B: Biographical Sketches of Speakers." National Research Council. 2013. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18383.
×

the social and behavioral science IRB at Yale. This IRB is responsible for review of the broad range of social, behavioral, and educational research conducted at the university. Dr. Bouregy also served as codirector of the university’s human research protection program accreditation project. Dr. Bouregy holds a Ph.D. in biology from Brandeis University.

Lois Brako is assistant vice president for research–regulatory and compliance oversight, at the University of Michigan, Ann Arbor. Her responsibilities include coordinating activities related to the development and modification of campuswide research policies and procedures and strategic planning for regulatory compliance oversight. Dr. Brako is the director of the University of Michigan’s Human Research Protections Program, which spans four IRB offices and nine IRBs, with oversight of more than 5,600 projects. Dr. Brako chairs the University of Michigan IRB Council, cochairs the Human Pluripotent Stem Cell Research Oversight Committee, serves as a member of the Institutional Biosafety Committee, and is a consultant to the University Committee on the Use and Care of Animals. She is also a member of the University of Michigan’s leadership team for electronic information system development and is currently helping to design a new system for conflict of interest review and management. Dr. Brako is cochair of the Federal Demonstration Partnership’s Human Subjects Protections Subcommittee, a group dedicated to reducing regulatory burden for investigators, and a participating member in the Council on Governmental Relations. Dr. Brako holds a Ph.D. in biology from the City University of New York.

Steven J. Breckler is executive director of the American Psychological Association’s (APA’s) Science Directorate, overseeing programs that promote psychological science in academic and scientific arenas and that advocate on behalf of scientific psychology. Before joining APA, Dr. Breckler directed the National Science Foundation’s (NSF’s) Social Psychology Program. He also helped to develop and lead the NSF Science of Learning Centers Program, which supports interdisciplinary teams of scientists to advance understanding of human and animal learning. Dr. Breckler was an associate professor of psychology at Johns Hopkins University. He is author or coauthor of more than 60 papers on topics ranging from attitude development to jury functioning. Dr. Breckler’s research has been supported by grants from the NSF, the National Institutes of Health, and the Department of Defense. He is also the coauthor of a widely used textbook, Social Psychology Alive! Dr. Breckler served on the editorial boards for Personality and Social Psychology Bulletin, Psychological Bulletin, and Psychological Science in the Public Interest. He is a fellow of the APA, the Association for Psychological Science, and the American Association

Suggested Citation:"Appendix B: Biographical Sketches of Speakers." National Research Council. 2013. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18383.
×

for the Advancement of Science. Dr. Breckler holds a Ph.D. in social psychology from the Ohio State University.

Richard T. Campbell is an emeritus professor of biostatistics and sociology at the University of Illinois, Chicago. Dr. Campbell’s current research involves the study of race and ethnic disparities in diagnosis and treatment of breast, colon, and prostate cancer using geocoded patient data derived from electronic medical records and other sources, along with data on the distribution of healthcare providers. His prior research, almost all of which has been based on large national datasets, has focused on aspects of health and aging and on social stratification. He has served on IRBs at both Duke University, where he also chaired the Faculty Senate Committee on Human Subjects, and at the University of Illinois, Chicago. Dr. Campbell has also served on several national panels and committees including the Working Group on Social Science Issues in Human Subjects Research and the National Science Foundation Subcommittee on Human Subjects Issues. Dr. Campbell holds a Ph.D. in sociology from the University of Wisconsin–Madison.

Constance F. Citro is director of the Committee on National Statistics (CNSTAT), a position she has held since 2004. She previously served as acting chief of staff (December 2003–April 2004) and as senior study director (1986–2003). She began her career with CNSTAT in 1984 as study director for the panel that produced The Bicentennial Census: New Directions for Methodology in 1990. Prior to joining CNSTAT, she held positions as vice president of Mathematica Policy Research, Inc., and Data Use and Access Laboratories, Inc. She was an American Statistical Association/National Science Foundation/Census research fellow in 1985–1986, and is a fellow of the American Statistical Association and an elected member of the International Statistical Institute. For CNSTAT, she directed evaluations of the 2000 census, the Survey of Income and Program Participation, microsimulation models for social welfare programs, and the NSF science and engineering personnel data system, in addition to studies on institutional review boards and social science research, estimates of poverty for small geographic areas, data and methods for retirement income modeling, and a new approach for measuring poverty. She coedited the second–fifth editions of Principles and Practices for a Federal Statistical Agency and contributed to studies on measuring racial discrimination, expanding access to research data, the usability of estimates from the American Community Survey, the National Children’s Study research plan, and the Census Bureau’s 2010 census program of experiments and evaluations. Dr. Citro holds M.A. and Ph.D. degrees in political science from Yale University.

Suggested Citation:"Appendix B: Biographical Sketches of Speakers." National Research Council. 2013. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18383.
×

Thomas J. Coates is director of the University of California, Los Angeles (UCLA), Program in Global Health, and is the Michael and Sue Steinberg endowed professor of Global AIDS Research within the Division of Infectious Diseases at UCLA. In 1986, he cofounded the Center for AIDS Prevention Studies at the University of California, San Francisco (UCSF), and directed it from 1991 to 2003. He was the founding executive director of the UCSF AIDS Research Institute, leading it from 1996 to 2003. His areas of emphasis and expertise are HIV prevention and the relationship of prevention and treatment for HIV and HIV policies. His domestic work has focused on a variety of populations, and he is currently finishing a nationwide clinical trial of an experimental HIV preventive intervention focused on high-risk men. He is also finishing domestic trials of post-exposure prophylaxis. With funding from USAID and the World Health Organization, he led a randomized controlled trial to determine the efficacy and cost-effectiveness of HIV voluntary counseling and testing for individuals and couples in Kenya, Tanzania, and Trinidad. He is now directing a 48-community randomized clinical trial in South Africa, Tanzania, Thailand, and Zimbabwe, to determine the impact of strategies for destigmatizing HIV. He is also leading a prevention clinical trial in South America as part of a five-country effort and has a trial in China to determine the impact of prevention in the context of care. He is coprincipal investigator of the National Institute of Allergy and Infectious Diseases–funded HIV Prevention Trials Network and is conducting policy research domestically and internationally. He was cited in Science in 2002 as the fourth-highest-funded scientist in the clinical, social, and behavioral sciences and was elected to the Institute of Medicine in 2000. He has a Ph.D. in psychology from Stanford University.

Roxane Cohen Silver is a professor in the Department of Psychology and Social Behavior, the Department of Medicine, and the Program in Public Health at the University of California, Irvine. She has spent the past three decades studying acute and long-term psychological and physical reactions to stressful life experiences, including personal traumas, such as physical disability, loss, and childhood sexual victimization; as well as larger collective events, such as war, firestorms, the Columbine High School shootings, the September 11, 2001, terrorist attacks, and other community disasters across the world (including the 2010 earthquake in Chile and the 2006 earthquake in Yogyakarta, Indonesia). Her research has been funded by the National Institute of Mental Health, the National Science Foundation, the U.S. Department of Homeland Security, and the U.S. Public Health Service. Since December 2003, Dr. Silver has served on numerous senior advisory committees and task forces for the U.S. Department of Homeland Security, providing ongoing advice to the department

Suggested Citation:"Appendix B: Biographical Sketches of Speakers." National Research Council. 2013. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18383.
×

and its component agencies on the psychological impact of disasters and terrorism. She is also one of the founding directors of Psychology Beyond Borders, an international nonprofit organization that facilitates research, intervention, and policy development in the prevention of, preparedness for, and response to terror attacks, conflict, or natural disasters across the world. Dr. Silver is a fellow of the American Psychological Association (in four divisions) and the Association for Psychological Science. In 2007, Dr. Silver received the American Psychological Association’s Award for Distinguished Service to Psychological Science and in 2010 she received the Public Advocacy Award from the International Society for Traumatic Stress Studies (for “outstanding and fundamental contributions to advancing social understanding of trauma”). In 2011, she received the American Psychological Association’s Award for Distinguished Contributions to Psychology in the Public Interest (Senior Career) and the Award for Outstanding Service to the Field of Trauma Psychology from the American Psychological Association’s Division 56 (Trauma Psychology). Dr. Silver holds a Ph.D. in social psychology from Northwestern University.

Celia B. Fisher is Marie Ward Doty University chair and professor of psychology and founding director of the Fordham University Center for Ethics Education. She is best known for research emerging from her federally funded research programs on ethical issues and well-being of vulnerable populations, including ethnic minority youth and families, active drug users, college students at risk for drinking problems, and adults with impaired consent capacity. She currently directs the National Institute on Drug Abuse–funded Fordham University Training Institute on HIV Prevention Research Ethics. She is past chair of the Environmental Protection Agency’s Human Studies Review Board, a past member of the Department of Health and Human Services Secretary’s Advisory Committee on Human Research Protections (SACHRP; and cochair of the SACHRP Subcommittee on Children’s Research) and a founding editor of the journal Applied Developmental Science. She chaired the American Psychological Association’s Ethics Code Task Force, the Society for Research in Child Development Common Rule Task Force, and the New York State Licensing Board for Psychology, and served on the National Institute of Mental Health Data Safety and Monitoring Board, and the Institute of Medicine’s Committee on Clinical Research Involving Children. Dr. Fisher is author of Decoding the Ethics Code: A Practical Guide for Psychologists (3rd Edition, 2013); coeditor of eight books, including The Handbook of Ethical Research with Ethnocultural Populations and Communities and Research with High-Risk Populations: Balancing Science, Ethics, and Law; and author of more than 100 theoretical and empirical publications

Suggested Citation:"Appendix B: Biographical Sketches of Speakers." National Research Council. 2013. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18383.
×

in the areas of ethics in medical and social science research and practice and lifespan development. She is the recipient of the 2010 Health Improvement Institute’s Lifetime Achievement Award for Excellence in Human Research Protection and fellow of the American Association for the Advancement of Science. She has a Ph.D. in experimental psychology from the New School for Social Research.

Rena Lederman is professor of anthropology at Princeton University. Dr. Lederman’s research background includes early work conducted in rural Papua New Guinea regarding the politics and everyday practice of “gift” (nonmarket) exchange, gender relations, and historical consciousness, which resulted in a Cambridge University Press book, several book chapters, and articles in Annual Review of Anthropology and other scholarly journals. Dr. Lederman’s current work concerns the anthropology of academic practice and involves comparative research on disciplinary knowledge and expertise in the humanities and social sciences. Dr. Lederman’s recent publications in American Ethnologist, PoLAR: Political and Legal Anthropology Review, and elsewhere have focused on the impacts on ethnography and related research styles of IRB regulations. She was an invited plenary speaker at Public Responsibility in Medicine and Research; served as both chair and member on the American Anthropological Association’s Committee on Ethics and as a member of Princeton University’s IRB; and was coauthor of the American Anthropological Association’s 2011 commentary on the proposed overhaul of IRB regulations (45 CFR 46). Dr. Lederman has been the recipient of research grants from the American Philosophical Society, Columbia University, the National Institutes of Health, the National Science Foundation, and Princeton University; and conference grants and sponsorship from the Wenner Gren Foundation and the National Endowment for the Humanities. Dr. Lederman holds a Ph.D. in anthropology from Columbia University.

Taylor Martin is an associate professor of instructional technology and learning sciences at Utah State University. Dr. Martin has worked in research and development on curriculum and design of instructional systems on such projects as the Adventures of Jasper Woodbury and the Algebra Project. She has also worked as an elementary mathematics teacher. She was an associate professor in the Department of Curriculum and Instruction and was an affiliate faculty member in the Department of Developmental Psychology and the Learning Technology Center at the University of Texas, Austin. Taylor collaborates extensively with partners in the College of Engineering, the Physics Department, and the Texas Advanced Computing Center at the University of Texas, Austin, in Computer Science and Learning Science at the University of Washington, and

Suggested Citation:"Appendix B: Biographical Sketches of Speakers." National Research Council. 2013. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18383.
×

with the Regional Educational Laboratory Mid-Atlantic. She is currently an associate professor in the Department of Instructional Technology and Learning Sciences at Utah State University. Dr. Martin holds a Ph.D. in educational psychology from Stanford University.

Brian Mustanski is an associate professor of medical social sciences and psychology at Northwestern University and director of the IMPACT LGBT Health and Development Research Program. The IMPACT Program conducts translational research that improves the health of the lesbian, gay, bisexual, and transgender (LGBT) community. Dr. Mustanski also has appointments at the Institute for Policy Research and the Center for Community Health. Dr. Mustanski’s research has focused on the relationships between mental, behavioral, and physical health, particularly as they relate to HIV/AIDS in vulnerable populations. Dr. Mustanski has been the principal investigator for multiple federal (Centers for Disease Control and Prevention, National Institutes of Health, National Science Foundation) and foundation research and training awards totaling more than $13 million in funding. Dr. Mustanski has also studied the health and development of LGBT youth and the application of new media and technology to sexual health promotion and HIV prevention. He is currently leading or coleading three studies of online/text messaging based HIV prevention for adolescent men who have sex with men. He has published on ethical and regulatory issues in sexual health with adolescents and served on an institutional review board. Dr. Mustanski has received a number of awards for his work in this area, including being named a William T. Grant Scholar and the 2011 recipient of the Award for Distinguished Scientific Contribution to LGBT Psychology from the American Psychological Association Division 44. He holds a Ph.D. in clinical science from Indiana University.

P. Pearl O’Rourke is director of Human Research Affairs at Partners HealthCare Systems in Boston and an associate professor of pediatrics at Harvard Medical School. Dr. O’Rourke is responsible for the systems that support the regulatory and ethical oversight of human research and human embryonic stem cell research. She has served as a pediatric critical care physician at Children’s Hospital, Boston, and at Children’s Hospital, University of Washington, Seattle, as director of the Pediatric Intensive Care Unit. Dr. O’Rourke did clinical research in extracorporeal membrane oxygenation, liquid ventilation, high frequency ventilation, and pediatric resuscitation. She has served as the deputy director of the Office of Science Policy in the Office of the Director at the National Institutes of Health, where she worked on such issues as privacy, gene therapy (transfer) embryonic stem cells, and genetic discrimination. Dr. O’Rourke has been

Suggested Citation:"Appendix B: Biographical Sketches of Speakers." National Research Council. 2013. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18383.
×

involved with Public Responsibility in Medicine and Research as a board member and past president of the board. Dr. O’Rourke holds an M.D. from the University of Minnesota.

Charles R. Plott is Edward S. Harkness professor of economics and political science and founder and director of the Laboratory for Experimental Economics and Political Science at the California Institute of Technology. Dr. Plott is widely acknowledged for his role as cofounder of experimental economics, which he founded with Vernon Smith. He has also been particularly influential in applying the methodology of experimental economics to address public policy issues and challenges. These include the design and implementation of computerized market mechanisms for allocating complex items such as the markets for pollution permits in Southern California, the Federal Communications Commission’s auction of licenses for Personal Communication Systems, the auctions for electric power in California, and the allocation of landing rights at major U.S. airports. Dr. Plott is a member of the National Academy of Sciences, fellow of the American Academy of Arts and Sciences, fellow of the Econometric Society, fellow of the Society for the Advancement of Economic Theory, and distinguished fellow from the American Economic Association. He has a Ph.D. in economics from the University of Virginia and honorary doctorates from L’université Pierre Mendès France and from Purdue University.

Sally I. Powers is a professor of psychology and associate dean for faculty and research of the College of Natural Sciences at the University of Massachusetts, Amherst. Dr. Powers is director of the Center for Research on Families and a faculty member in the Neuroscience and Behavior Interdisciplinary Graduate Program. The primary focus of her research is the study of biological and psychosocial risk factors (particularly endocrine dysregulation, and early life and current social and behavioral stressors in family and close relationship contexts) that influence the longitudinal course of depression and anxiety in children, adolescents, and young adults. Prior to joining the faculty at the University of Massachusetts, Amherst, Dr. Powers served as senior research associate at the Murray Research Center (now the Radcliffe Institute of Advanced Studies, Harvard University) and as director of family research at the Laboratory of Developmental Psychology and Developmental Psychopathology, of McLean Hospital and Harvard Medical School. Dr. Powers’ research has been funded by National Institute of Child Health and Human Development, the National Institute of Mental Health, the National Science Foundation, and the William T. Grant Foundation, and is currently funded by the National Cancer Institute and National Institute of General Medical

Suggested Citation:"Appendix B: Biographical Sketches of Speakers." National Research Council. 2013. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18383.
×

Sciences. She has previously served as a member of the Institute of Medicine’s (IOM’s) and National Research Council’s (NRC’s) Committee on the Science of Family Research and facilitator of the IOM and NRC’s Planning Meeting on The Science of Family Research: The Improvement of Family Measurement in Large Scale Studies. Dr. Powers holds an Ed.D. in human development and psychology from Harvard University.

Jeffery Rodamar is protection of human subjects coordinator with the U.S. Department of Education. Prior to assuming his current post, Mr. Rodamar worked in program evaluation with the Department’s Planning and Evaluation Service. Mr. Rodamar is an ex-officio member of the Secretary’s Advisory Committee on Human Research Protections, participates in the interagency Confidentiality and Data Access Committee, was selected as a member of the American Statistical Association’s Committee on Privacy and Confidentiality, and is chair of the Social and Behavioral Research Working Group of the interagency Human Subjects Research Interest Group. He is also a board member of the Journal of Empirical Research on Human Research Ethics.

Laura Stark is assistant professor at Vanderbilt University’s Center for Medicine, Health, and Society, and affiliate of the Department of History and Center for Biomedical Ethics and Society. Dr. Stark is also associate editor of the journal History & Theory. Stark is the author of Behind Closed Doors: IRBs and the Making of Ethical Research, an ethnography and new history of institutional review boards. She is the author of several book chapters on human-subjects regulation, as well as historical and contemporary studies of ethics decision making published in journals, such as Cambridge Quarterly of Healthcare Ethics, Law and Society Review, and Journal of the History of the Behavioral Science. Dr. Stark’s current research explores research settings through the lives of normal control research subjects enrolled in the first clinical trials at the National Institutes of Health after World War II. Dr. Stark holds a Ph.D. in sociology from Princeton University.

Suggested Citation:"Appendix B: Biographical Sketches of Speakers." National Research Council. 2013. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18383.
×

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Suggested Citation:"Appendix B: Biographical Sketches of Speakers." National Research Council. 2013. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18383.
×
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Suggested Citation:"Appendix B: Biographical Sketches of Speakers." National Research Council. 2013. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18383.
×
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Suggested Citation:"Appendix B: Biographical Sketches of Speakers." National Research Council. 2013. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18383.
×
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Suggested Citation:"Appendix B: Biographical Sketches of Speakers." National Research Council. 2013. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18383.
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Suggested Citation:"Appendix B: Biographical Sketches of Speakers." National Research Council. 2013. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18383.
×
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Suggested Citation:"Appendix B: Biographical Sketches of Speakers." National Research Council. 2013. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18383.
×
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Suggested Citation:"Appendix B: Biographical Sketches of Speakers." National Research Council. 2013. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18383.
×
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Suggested Citation:"Appendix B: Biographical Sketches of Speakers." National Research Council. 2013. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18383.
×
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Suggested Citation:"Appendix B: Biographical Sketches of Speakers." National Research Council. 2013. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18383.
×
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Suggested Citation:"Appendix B: Biographical Sketches of Speakers." National Research Council. 2013. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18383.
×
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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 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.

Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary focuses on six broad topic areas:

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.

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