ORAL HISTORIES AND HUMAN SUBJECTS RESEARCH PROTECTION REQUIREMENTS

February 27, 2010

Objectives of Presentation

Better understand when oral histories are subject to Federal human subjects protection requirements

Review of Tulane policies with regard to when oral histories are subject to exempt or expedited review

The Challenge

Is ORAL HISTORY considered “research involving human subjects”?

Who decides?

Why does it matter if oral history interviews are human subjects research?

If oral history interviewing activities meets the Federal definition of “research” If not, then the activity is not subject to

myriad of Federal human subject protection requirements

If so, then the activity is subject to: Convened review by Tulane’s IRB (i.e., full board

review), Exempt review, or Expedited review

2-Step process for review of oral histories

Step 1: Does the activity constitute human subjects research; and

Step 2: If so, does the research qualify for exempt review or expedited review

Step 1Regulatory 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) asA “systematic investigation, including

research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”

Lack of Guidance

Federal regulations do not provide a definition for either: “systematic investigation” “designed” “generalizable knowledge”

The regulations fail to say who is to make that determination

Such decisions are made on a case-by-case basis depending upon the facts

Practical Interpretations

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

Human Subject Research Determination 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.

Request to HRPO can be made via e-mail at irbmain@tulane.edu

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 (E-mail at irbmain@tulane.edu) for guidance before commencing their research.

What is oral history?

There is no Federal definition of “oral history” 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.

What is oral history? (cont)

Oral history interviews are not analyzed as qualitative data is generally analyzed.

No content analysis, discourse analysis, coding for themes or other qualitative analysis methods of data analysis are performed on the interviews.

They stand alone as unique perspectives.

It depends upon the facts & investigator’s intent 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

General principles for evaluating oral history type activities

Open Ended Interviews 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

Example 1:Video Interviews

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?

Answer: 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: Open 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?

Answer: 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

Example 3: Interviews for Publications

Question: Does interviewing prisoners for a magazine article on prison life constitute human subjects research?

Answer: 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. Compare: Doing very similar interviews for an

anthropological study would require review Thus, no institutional review is required

Example 4: Oral 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? 

Answer: 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

What is exempt research?

While exempt research is human subject research requiring institutional review, it does not require convened (i.e., full) IRB review. Such review is approved typically by the IRB chair (or designee)

One category of exempt research is applicable to oral histories Research involving the collection or study of existing data,

documents, or records; AND The sources are publicly available; or de-identified (i.e.,

the information is recorded by the investigator in such a manner that it cannot be identified, directly or through identifiers linked to subject [see Tulane SOPs 3.4.2(4)]

Exempt research can never include research involving children, prisoners or is international in nature [Tulane SOPs 3.4.1]

If planned oral research is not exempt, consider whether it qualifies for expedited review

What is expedited research? Requires one or more experienced IRB

reviewers, but does not require a convened IRB [see Tulane SOPs 3.5]

There must be no more than minimal risk to subjects.

The identification of participants will not place them at risk of criminal or civil liability or be otherwise damaging

Categories of expedited research The research must fit into one of several specific

categories to qualify as expedited research Category 5

Research involving materials (data, documents, records, or specimens that have been collected; OR

Research involving materials that will be selected solely for non-research purposes (medical treatment or diagnosis).

Category 6 Collection of data from voice, video, digital, or image

recordings made for research purposes Category 7

Research on individual or group characteristics or behavior (including research on perception, cognition, motivation, identify, language, cultural beliefs, social behavior, etc.)

If planned oral research does not qualify for expedited review, then it must go to full board review (and take more time to review)

Ethnographic Work

An “ethnographic interview” is the study of human behavior in its natural context, involving observation of behavior and physical setting

Like oral histories, ethnographic interviews may or may not meet the definition of human subjects research

Summary

If possible (without compromising the study), try to structure activity to: Avoid definition of human subjects research, which

eliminates the need for institutional 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 irbmain@tulane.edu