Information about Oral History Activities
Recently, representatives from the Office of Human Research Protection (OHRP) and the Oral History Association engaged in a dialog about whether oral history interviewing activities meet the OHRP’s definition of research. According to OHRP, oral history interviewing activities, in general, are not designed to contribute to generalizable knowledge and do not meet the definition of research offered by the Department of Health and Human Services. The University of Maine’s IRB recognizes this and concurs that the majority of oral history interviewing projects probably do not constitute research.
However, some oral history interviewing projects may meet the definition of research. Thus, it would be difficult and misleading to adopt a policy for any type of activities by any department, group, or individuals under a particular heading (e.g., oral history interviewing projects) that unequivocally states that the activity does not meet the definition of research and does not require review by a Unit Committee or the IRB. The IRB realizes that individuals may construe our position on this issue as ambiguous. The IRB and Unit Review Committees, however, need to make decisions about projects on a case by case basis. Thus, we cannot adopt a policy that directly states that all oral history interviewing activities are not considered research. We offer the following information that might be helpful in determining when a project is considered to be or not to be research.
To assist individuals in determining when/if oral history activities require human subjects review, we have provided the following information from Michael Carome (OHRP). (This information represents a response to Northern Illinois University’s request for clarification regarding oral history projects.)
The University of Maine’s IRB
found this information to be helpful. As University of Maine employees,
students, and agents read this and see statements such as, “Unless such
research is exempt under HHS regulations at 45 CFR 46.101(b)…” remember that it
is UMaine policy (as it is at most institutions) that someone OTHER than the
investigator must determine if a project fits one of the six categories judged
exempt from further review. “Exempt”
does not mean a review is NOT required.
More formal guidance is expected from OHRP, so we will post additional information when/if it is available.
The full text of Dr. Carome’s response may be found here. Listed below are the examples provided to assist in determining when a review might be required.
”As you are
aware, representatives of oral history organizations earlier this year asked
OHRP to review a policy statement that they had drafted regarding the
relationship between research (as defined by the Department of Health and Human
Services (HHS) regulations at 45 CFR 46.102(d)) and oral history
activities. They also asked whether OHRP agreed with the content of their
draft policy.
OHRP responded to the oral historians with a letter stating OHRP's concurrence
with the draft policy statement that oral history activities in general do not involve research as
defined by the HHS regulations and providing some suggested edits. I have attached
a pdf file containing a copy of OHRP's letter below. Please note that the
inclusion of the words "in general" in OHRP's response means that
certain human subjects research activities may include oral history activities,
and such research activities should be reviewed by an institutional review
board (IRB) unless the research is exempt under HHS regulations at 45 CFR
46.101(b). I
Indeed, in its
September 22 letter, OHRP noted that on occasion, investigators conducting
human subjects research as defined by the HHS regulations may use oral history
interviewing procedures. Unless such research is exempt under HHS
regulations at 45 CFR 46.101(b), IRB review would be required if the research
is conducted or supported by HHS or conducted under an applicable OHRP-approved
assurance.
History:
Issues regarding oral history and human subjects research date back to the
National Commission and most recently emerged with NBAC, NHRPAC, and a letter
from oral historians to OHRP.
The regulatory definition of research:
A decision whether oral history or other activities solely consisting of open
ended qualitative type interviews are subject to the policies and regulations
outlined in an institution's FWA and HHS regulations for the protection of
human research subjects (45 CFR 46) is based on the prospective intent of the
investigator and the definition of "research" under HHS regulations
at 45 CFR 46.102(d): "a systematic investigation, including
research development, testing and evaluation, designed to develop or contribute
to generalizable knowledge."
Specifically, for the purposes of our discussion, the evaluation of such
activities hinges upon whether the person is engaged in the creation of
"generalizable knowledge" that is, whether the activity represents a
systematic investigation in which the person engaged in such activities intends
to develop or contribute to generalizable knowledge. However, 45 CFR 46
does not provide a definition of "generalizable knowledge".
Oral history activities, as described to OHRP by the oral history
representatives, in general are designed to create a record of specific
historical events and, as such, are not intended to contribute to generalizable
knowledge.
General principles for evaluating Oral History type activities:
1. Oral history activities, such as open ended interviews, that ONLY
document a specific historical event or the experiences of individuals without
an intent to draw conclusions or generalize findings would NOT constitute
"research" as defined by HHS regulations 45 CFR part 46.
Example: An
oral history video recording of interviews with holocaust survivors is created
for viewing in the Holocaust Museum. The creation of the video tape does NOT
intend to draw conclusions, inform policy, or generalize findings. The
sole purpose is to create a historical record of specific personal events and
experiences related to the Holocaust and provide a venue for Holocaust
survivors to tell their stories.
2. Systematic investigations involving open-ended
interviews that are designed to develop or contribute to generalizable
knowledge (e.g., designed to draw conclusions, inform policy, or generalize
findings) WOULD constitute "research" as defined by HHS regulations
at 45 CFR part 46.
Example: An
open ended interview of surviving Gulf War veterans to document their
experiences and to draw conclusions about their experiences, inform policy, or
generalize findings.
3. Oral historians and qualitative investigators may want to create
archives for the purpose of providing a resource for others to do
research. Since the intent of the
archive is to create a repository of information for other investigators to
conduct research as defined by 45 CFR part 46, the creation of such an archive
WOULD constitute research under 45 CFR part 46.
Example:
Open ended interviews are conducted with surviving Negro League Baseball
players in order to create an archive for future research. The creation
of such an archive would constitute research under 45 CFR part 46 since the
intent is to collect data for future research.
An institution should perform an initial two step evaluation prior to deciding
whether an activity constitutes human subject research:
a. determine whether the activity constitutes
"research" as defined by 45 CFR 46.102(d), and
b. determine whether the "research"
includes human subjects as defined by 45 CFR 46.102(f).
In summary, the August 26, 2003 Policy Statement attached to OHRP's September
22, 2003 letter was not drafted by OHRP, does not constitute OHRP guidance, and
the characterizations of oral history activities in the third paragraph of the
Policy Statement alone do not provide sufficient basis for OHRP's determination
that oral history activities in general do not involve research as defined by
HHS regulations at 45 CFR part 46. Other activities involving open-ended
interview that have similar characteristics can involve research as defined by
the HHS regulations when the activities are part of a systematic investigation
designed to develop or contribute to generalizable
knowledge.”
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We hope that the above information may be helpful to individuals who engage in oral history interviewing activities. If an individual has any question as to whether his or her project could be considered research, please contact Gayle Anderson (581-1498) or on First Class.