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âBâ Selected Organizations and Resources for Human Research Participant Protection Department of Health and Human Services (DHHS): ⢠National Human Research Protections Advisory Committee (NHRPAC): This Committee was established in June 2000 and disbanded in September 2002. Its role was to provide advice to the Ofï¬ce for Human Research Protections in DHHS. It was re- placed in October 2002 by the Secretaryâs Advisory Committee on Human Research Protections. Information about NHRPAC and its activities can be found at http://ohrp.osophs.dhhs.gov/nhrpac/ nhrpac.htm [4/10/03]. ⢠NHRPACâs Social and Behavioral Science Working Group (SB- SWG): One of SBSWGâs major goals is to develop guidelines for the review of social and behavioral science research by institu- tional review boards (IRBs). This NHRPAC working group has addressed such issues as the review of public-use data ï¬les, risk and harm, and third parties. It is continuing its work indepen- dently of the new Secretaryâs Advisory Committee. It is planning an activity in July 2003 on best practices for IRBs for review of SBES research. The activity will include a workshop followed by preparation of a document to help train IRB members. Informa- tion is available at http://www.asanet.org/public/humanresearch [4/10/03]. ⢠National Institutes of Health (NIH) Ofï¬ce of Behavioral and So- cial Science Research (OBSSR): The mission of OBSSR is to stimulate and integrate social and behavioral science research throughout NIH. OBSSR has produced a research agenda, which contains several topics germane to the protection of human re- search participants, entitled âProgress and Promise in Research on Social and Cultural Dimensions of Health: A Research Agenda,â 217
218 PROTECTING PARTICIPANTS AND FACILITATING SOCIAL AND BEHAVIORAL SCIENCES RESEARCH and maintains a website on IRB review of NIH-sponsored social and behavioral research. To learn more about OBSSRâs products and activities, consult http://obssr.od.nih.gov [4/10/03]. ⢠Ofï¬ce for Human Research Protections (OHRP): OHRP is â[r]esponsible for overseeing human research subjects protections functions and related functions where research involves the use of human subjects.â1 This ofï¬ce was created in June 2000 when this responsibility was transferred from the NIH Ofï¬ce for Pro- tection from Research Risks. Information is available at http: //ohrp.osophs.dhhs.gov [4/10/03]. Executive Ofï¬ce of the President, Ofï¬ce of Science and Technology Pol- icy (OSTP), Committee on Science, Human Subjects Research Sub- committee (HSRS): HSRS provides advice about interdepartmental is- sues in protection of human participants to OSTPâs Committee on Sci- ence and to the departments and agencies that promulgate the âCom- mon Rule.â The chair of the Subcommittee is OHRPâs director. ⢠Non-Biomedical Working Group (NBMWG): The NBMWG was started in 2001 and is charged (1) with recommending or en- dorsing guidance or regulatory change to assist researchers, in- stitutions, funding agencies, and research participants involved in nonbiomedical research; and (2) to work cooperatively with relevant advisory groups and other entities. This HSRS work- ing group is addressing a variety of topics, including IRB review of public-use microdata and protection of the conï¬dentiality of data. The NBMWG is co-chaired by Philip Rubin, National Sci- ence Foundation, prubin@nsf.gov, and Caroline Miner, Bureau of Prisons, cminer@bop.gov. Federation of Behavioral, Psychological and Cognitive Sciences: The Federation is an association of scientiï¬c societies with interests in ba- sic research on problems of behavior, psychology, language, education, knowledge systems and their psychological, behavioral, and physiolog- ical bases. On April 18 and 19, 2001, it convened a Forum on Re- search Management (FORM) issues in human research protection via the IRB. A summary of this FORM was posted on the Federationâs web- site, http://federation.apa.org [4/10/03]. National Bioethics Advisory Committee (NBAC): NBAC was estab- lished in 1995 by President Clinton by Executive Order 12975. Its charter expired October 3, 2001. NBAC issued six reports. Its ï¬nal 1 DHHS, Ofï¬ce of the Secretary. Federal Register, 65(114), June 13, 2000, page 37136.
SELECTED ORGANIZATIONS AND RESOURCES FOR HUMAN RESEARCH PARTICIPANT PROTECTION 219 report, Ethical and Policy Issues in Research Involving Human Partic- ipants, issued in August 2001, is the most germane to the social, be- havioral, and economic sciences. Georgetown Universityâs National Reference Center for Bioethics Literature maintains the NBAC web- site, http://bioethics.georgetown.edu/nbac [4/10/03]. National Science Foundationâs (NSF) Advisory Committee on Social, Behavioral, and Economic (SBE) Subcommittee for Human Subjects: This SBE Subcommittee held its initial meeting in June 2001. Its charge was to develop case studies and examples of the Common Rule that pertain to social, behavioral, and economic sciences research. These have been gathered in a workbook, and NSF posted this mate- rial on its website for use by researchers, IRB members, and relevant federal agencies (see National Science Foundation, 2002). For infor- mation on the NSF ad hoc subcommittee, contact Stuart Plattner, NSF, splattne@nsf.gov. Public Responsibility in Medicine and Research (PRIM&R): Founded in 1974, this organization promotes the advancement of strong re- search programs and the consistent application of ethical precepts in both medicine and research. Through four national conferences per year and published reports from them, it has addressed a broad range of issues in biomedical and behavioral research, clinical practice, ethics, and the law, including the ethical and procedural issues surrounding IRBs; educating for the responsible conduct of research; the range of problems affecting AIDS research and treatment; reproductive and other technologies and their effects on patient care; health care ethics committees; scientiï¬c integrity and conï¬icts of interest; and the gen- eral range of questions surrounding academic/industrial relations. For information, see http://www.primr.org [4/10/03]. ⢠Association for the Accreditation of Human Research Protection Programs (AAHRPP): This afï¬liate of PRIM&R was established in May 2001 as PRIM&Râs national accrediting arm for protec- tion programs. It is establishing a voluntary, peer-driven human research accreditation program, using a site visit model. For in- formation, see http://www.aahrpp.org/principles.htm [4/10/03].