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 the IRB. The IRB realizes that individuals may construe our position on this issue as ambiguous. The IRB, however, needs 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.
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.
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.”