Questions Regarding the Policy Statement
The recently announced policy excluding most oral history interviewing projects
from Institutional Review Board review according to federal regulations governing
research involving human subjects (codified as 45 CFR 46 and generally referred
to as the Common Rule) has raised a number of questions about oral history
and ethics. Following are brief answers to some of the most common questions.
For further information, see the bibliography, "Historians
and Institutional Review Boards": Brief Bibliography.
1. The new policy excludes oral history from IRB review. What's the difference
between "exclusion" and "exemption"?
The operative word in the policy statement is "exclude" rather than
"exempt." Until now, researchers had to submit protocols for oral
history projects to Institutional Review Boards, which then decided
whether to "exempt" oral history from review according to categories of
exemption outlined in the Common Rule. The U.S. Department of Health
and Human Service's Office for Human Research Protection has now agreed
that oral history as the practice has been professionally defined does
not meet the regulatory definition of "research" and therefore is
excluded entirely from IRB review, without seeking formal exemption. If
oral historians deem that their oral history projects do not meet the
regulatory definition of research, they can proceed without
consultation with an IRB. If a project does meet the regulatory
definition of research, it could still be "exempted" by an IRB, but
that must be determined by the IRB. [For the regulatory definitions,
see: http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm ]
2. Within their institutions, whom should historians inform about this policy statement?
Rather than going to an IRB, oral historians should take the policy
statement to their chairs, deans, provosts or other administrators
responsible for institutional compliance with federal regulations.
3. Does the regulatory definition of research mean that oral history is not research?
The policy statement does not say that oral history is "not research."
It says that oral history does "not involve research as defined by the
HHS regulations." The OHRP has affirmed that federal regulations were
designed with biomedical research in mind, as well as behavioral and
social scientific research that uses standard questionnaires with often
anonymous sources to produce quantitative information that aims at
"generalizable knowledge." Since that is not the way oral historians
operate, the type of research they
do is now excluded from IRB review. The OHRP has no authority to define
what constitutes legitimate research in any field, only what research
is covered by federal regulations.
4. Why did oral historians seek exclusion from IRB review?
Years of complaints from historians at colleges and universities across
the country have amply documented rulings that directly contradicted
the professional standards of oral history. IRB members with
backgrounds largely in the medical and behavioral sciences applied
their research practices to the humanities. IRBs have required oral
historians to submit questions in advance, not to ask questions about
sensitive or difficult topics, not to use interviewees' real names
(despite their willingness-even eagerness-to be identified), and not to
save the tapes once the project is completed, requests that directly
contradict historians' professional standards. IRBs have eventually
exempted most oral history from review, but only after the filing of
considerable paperwork and protracted deliberations that have delayed
course work and research and also have had the unintended effect of
weakening IRBs' overall credibility. Rulings have been inconsistent
from university to university, and sometimes from board to board within
the same institution. Some historians chose not to conduct interviews
to avoid the frustrations of dealing with IRBs , suggesting the
chilling effect IRBs were having on legitimate research. It was because
of these mounting professional complaints that representatives of the
Oral History Association and American History Association met with
government regulators to develop the policy statement.
5. Does exclusion of most oral history from IRB review mean that historians need not be sensitive to ethical issues?
Not at all. It only means that oral historians are freer to act in
accordance with ethical and legal standards appropriate to oral
history, not biomedical or behavioral research. For decades, oral
historians have promulgated high ethical and professional standards,
including their ethical requirement to gain informed consent prior to
conducting an interview, and a signed legal release at the conclusion
of the interview. These issues are codified in the Oral History
Association's Principles and Standards and Evaluation Guidelines:
The OHRP took these standards into consideration when assessing whether
oral history met the criteria for federal regulation.
6. Why do interviewers still need to get informed consent and secure
legal releases? Doesn't that inhibit historians' right to free inquiry?
Simply talking with someone for background is not oral history. Oral
history involves interviews for the record, explicitly intended for
preservation as a historical document. Informed consent means that
those being interviewed fully understand the purposes and potential
uses of the interview, as well as their freedom not to answer some
questions, and their identification in research and writing drawn from
the interview. Legal releases are linked to issues of evidence and
copyright. If a researcher makes explicit use of an interview in
written work (both in direct quotation and paraphrase), the interview
should be cited in a footnote, so that others can identify and locate
that information within the framework of extant evidence. Recorded
interviews involve copyright, and interviewees must sign an agreement
that establishes access for those who use the interview in any way. If
the interviews are deposited in a library or archives, legal releases
will establish ownership of the copyright and the terms of access and
reproduction. If the interviews are published, legal releases will
satisfy publishers' concerns over copyright. [For further information
see: John A. Neuenschwander, Oral History and the Law: