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OCR for page 217
B
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 Office for Human Research Protections in DHHS. It was re-
placed in October 2002 by the Secretary's Advisory Committee on
Human Research Protections. Information about NHRPAC and
its activities can be found at http://ohrp.osophs.dhhs.gov/nhrpac/
nhrpac.htm t4/10/034.
NHRPAC's Social and Behavioral Science Working Group (SB-
SWG): One of SBSWG's 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 files, risk
and harm, and third parties. It is continuing its work indepen-
dently of the new Secretary's Advisor 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
t4/10/031.
· National Institutes of Health (NIH) Office 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 "Progress and Promise in Research
on Social and Cultural Dimensions of Health: A Research Agenda,
217
OCR for page 218
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 OBSSR's products
and activities, consult http://obssr.od.nih.gov [4/10/031.
· Office for Human Research Protections (OHRP): OHRP is
"ErJesponsible for overseeing human research subjects protections
functions and related functions where research involves the use
of human subjects." This office was created in June 2000 when
this responsibility was transferred from the NIH Office for Pro-
tection from Research Risks. Information is available at http:
//ohrp.osophs.dhhs.gov f4/10/033.
Executive Office of the President, Office 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 OSTP's Committee on Sci-
ence and to the departments and agencies that promulgate the "Com-
mon Rule." The chair of the Subcommittee is OHRP's 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 confidentiality 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 scientific 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 E; ORM was posted on the Federation's web-
site, http://federation.apa.org f4/10/031.
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 final
iDHHS, Office of the Secretary. Federal Register, 65(114), June 13, 2000, page 37136.
OCR for page 219
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 University's National
Reference Center for Bioethics Literature maintains the NBAC web-
site, http://bioethics.georgetown.edu/nbac [4/10/031.
hlational Science Foundation's (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 (PRIMER): 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; scientific integrity and conflicts of interest; and the gen-
eral range of questions surrounding academic/industrial relations. For
information. see http://www.primr.org f4/10/031.
· Association for the Accreditation of Human Research Protection
Programs (AAHRPP): This affiliate of PRIMER was established
in May 2001 as PRIM&R's 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 [4/10/031.
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220 PROTECTING PARTICIPANTS AND FACILITATING SOCIAL AND BEHAVIORAL SCIENCES RESEARCH
BOX A-5 (continued)
use the expedited review procedure to review minor changes in
previously approved research during the period for which approval
is authorized...
Jan. 26, 1981: Research Activities Which May Be Reviewed Through Expedited
Review Procedures. . . [SBES-related categories only]
(6) Voice recordings made for research purposes such as investigations of
speech defects.
(8) The study of existing data, documents, records, pathological specimens, or
diagnostic specimens.
(9) Research on individual or group behavior or characteristics of individuals,
such as studies of perception, cognition, game theory, or test development,
where the investigator does not manipulate subjects' behavior and the
research will not involve stress to subjects.
June 18, 1991: 45 CFR 46, Subpart A Federal Policy for the Protection of Human
Sub jects
46. 1 1 eta) "essentially the same as Jan. 26, 198 1 ]
46.1 1 0tb) [essentially the same as Jan. 26,1 981 ~
.:;
Nov. 10, 1997: Suggested Revisions to the IRB Expedited Review List [SBES-Related
Categories Only]
(4) Research involving existing identifiable data, documents, records, or
biological specimens (including pathological or diagnostic specimens)
where these materials, in their entirety, have been collected prior to the
research, for a purpose other than the proposed research.
(5) Research involving solely (a} prospectively collected identifiable residual
or discarded specimens, or (b) prospectively collected identifiable data,
documents, or records, where (a) or (b) has been generated for nonresearch
purposes.
(7) Collection of data from voice, video, or image recordings made for research
purposes where identification of the subjects and/or their responses would
not reasonably place them at risk of criminal or civil liability or be damaging
to the subjects' financial standing, employability, or reputation.
(8) Research on individual or group characteristics or behavior {including but
not limited to research involving perception, cognition, surveys, interviews,
and focus groups) as follows:
(a) Involving adults, where (i) the research does not involve stress to
subjects, and (ii) identification of the subjects and/or their responses
would not reasonably place them at risk of criminal or civil liability
or be damaging to the subjects' financial standing, employability, or
reputation.
6
Representative terms from entire chapter:
research involving
