Oral Histories and Human Subjects Research Protection Requirements. April 18, 2012. Objectives of Presentation. Better understand when oral histories are subject to Federal human subjects protection requirements
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Step 1: Does the activity constitute human subjects research; and
Step 2: If yes, does the research qualify for exempt review or expedited review
Step 1 definition of human subject research?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 DHHS 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 DHHS regulations at 45 CFR 46.102(d) as
A “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”
A “systematic investigation” is an activity that involves a prospective research plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a research question
“Generalizable knowledge” involves studies that are designed to draw general conclusions (i.e., knowledge gained from a study may be applied to populations outside the specific study population), inform policy, or generalize findings
The university has charged the IRB with monitoring all human subject research occurring at the university. The PI is responsible for the initial determination of whether the planned activity comprises human subjects research (Tulane SOPs 3.3)
The sponsor and Tulane hold the PI accountable for wrong determinations.
For this reason, PIs are strongly encouraged to request confirmation from Tulane’s HRPO that the activity does not constitute human subjects research.
REMINDER: The conduct of a research project without the appropriate review is a violation of Tulane policy and Federal regulations and subject to disciplinary action. Faculty and students should err on the side of caution and contact the HRPO Office via e-mail at [email protected] for guidance before commencing their research.
Oral history activities in general are designed to create a record of specific historical events and, as such, are not intended to contribute to generalizable knowledge
Oral history narrators are not anonymous individuals selected as part of a random sample for the purposes of a survey.
Interviewees are selected because of their personal relationship to the topic under investigation. An oral history interview provides one person’s unique perspective.
A series of oral history interviews offers up a number of particular, individual perspectives on the topic, not information that may be generalized to all participants in the event or time under investigation.
It is primarily on the grounds that oral history interviews, in general, are not systematic investigations designed to contribute to generalizable knowledge and are not subject to the requirements of 45 CFR part 46 and, therefore, can be excluded from IRB review.
However, some oral history interviewing projects may meet the definition of research and will require convened IRB review, expedited review, or exempt review
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 DHHS regulations 45 CFR part 46
Question: Is an oral history video recording of interviews with holocaust survivors created to preserve or describe individual experiences to be viewed at the Holocaust Museum considered “research” as defined by DHHS?
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.
Thus, no institutional review is required
Example 2: activitiesOpen Ended Interviews to Document Experiences & Draw Conclusions
Question: Is an oral history that involves interviews of Iraq War Veterans that is intended to draw general conclusions and otherwise learn about the impact of using National Guard soldiers in a war considered “research” as defined by DHHS?
Yes, as it is designed to develop or contribute to generalizable knowledge (e.g., designed to draw conclusions, inform policy, or generalize findings) and WOULD constitute “research” as defined by DHHS regulations at 45 CFR part 46
Yes, needs review. The investigator would have to submit an initial application to the IRB for either convened, exempt or expedited review
Question: Does interviewing prisoners for a magazine article on prison life constitute human subjects research?
No. The goal is not the production of generalizable or universal knowledge. Rather, the information generated is specific to the people interviewed in their current situation.
Thus, no institutional review is required
Example 4: activitiesOral Histories for Archival Purposes
Question: Whether open ended interviews conducted with surviving Negro League Baseball players intended to create an archive for future research constitutes research?
Yes. The creation of such an archive would constitute research under 45 CFR part 46 since the intent is to collect data for future 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.
The investigator would have to submit an initial application to the IRB for either convened, exempt or expedited review
Minimal risk studies that fall within set categories listed in Tulane SOPs 3.4.2. with a shortened IRB application.
While exempt research is human subject research requiring institutional review, it does not require convened (i.e., full) IRB review. Such review is typically approved by the IRB chair (or designee)
One category of exempt research potentially applicable to oral histories is research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior, unless:
Information obtained is recorded in such a manner that Human Subjects can be identified directly or through identifiers linked to the subjects; and
Any disclosure of the Human Subjects responses outside the research could reasonably place the subjects at risk
Exempt research can never include research involving children, prisoners or that is international in nature [Tulane SOPs 3.4.1]
If planned oral research is not exempt, consider whether it qualifies for expedited review
If you wish to avoid triggering federal human subjects research protection regulations, try to structure activity to avoid definition of human subjects research, which would eliminate the need for IRB review
Alternatively, meet the definition of exempt review
Benefits: shortened initial application, may be granted up to 3 years exempt IRB approval, and review by IRB chair (or designee) rather than full board
Alternatively, fit research into an expedited review category
Benefits: review by IRB chair (or designee) rather than full board review
If you have questions, please contact Tulane’s Office of Human Research Protection (HRPO) at 504-988-2665 or by E-mail at [email protected]