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l From
the News column of
the December 2003 Perspectives
Oral History Excluded from IRB Review
The
U.S. Office for Human Research Protection (OHRP), part of the
Department of Health and Human Services (HHS), working with the advice
of the American Historical Association (AHA) and the Oral History
Association (OHA), has determined "that oral history interviewing
activities, in general, are not designed to contribute to generalizable
knowledge and, therefore, do not involve research as defined by
Department of Health and Human Services (HHS) regulations at 45 CFR
46.102(d) and do not need to be reviewed by an institutional review
board (IRB)."
As one of the 17 federal agencies that have signed on to the Common
Rule (45 CFR part 46), HHS deals most with the type of "clinical"
research involving human subjects that the federal regulations were
originally intended to cover. The policy, however, applies only to
research that is funded by HHS or that takes place within institutions
that have filed a multiple project compliance with OHRP. It does not
apply to research funded by any of the other 16 signers of the common
rule. However, according to Donald A. Ritchie of the Oral History
Association, "the HHS determination along with the agency's concurrence
with a policy statement drawn up by the OHA and AHA should pave the way
for a uniform interpretation by other federal agencies."
Oral historians have long argued that federal regulations were
developed mostly to protect human subjects in biomedical and behavioral
research. Consequently, for several years, representatives of major
professional historical associations have been working to persuade the
federal research-protections office to "clarify" its definition of
research as it applies to oral history scholarship and to make it
clearer to IRBs what kinds of scholarship need be monitored.
During the October 2003 meeting of the OHA in Bethesda, Maryland,
OHRP officials announced the agency's decision regarding the
application of the common rule. Officials stated that these federal
regulations define research as "a systematic investigation, including
research development, testing and evaluation, designed to develop or
contribute to generalizable knowledge." It was explained that the type
of research encompassed by the regulations involves standard
questionnaires with a large sample of individuals who often remain
anonymous, and not the open-ended interviews with identifiable
individuals who give their interviews with "informed consent" that more
typically characterize oral history research. Officials state that only
those oral history projects that conform to the fairly narrow
regulatory definition of "research" will now need to submit their
research protocols for IRB review. Historians applauded the decision.
According to Linda Shopes, a Pennsylvania Historical and Museum
Commission historian who represented the AHA in talks with government
officials, the federal office "heard our concern and has responded
appropriately."
—Bruce Craig
Editor's Note: See also correspondence on the subject in the Letters
to the Editor column.
Copyright © American Historical Association.
http://www.historians.org/Perspectives/Issues/2003/0312/0312new5.cfm on April 25, 2005
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