HSRC Guidance

Topic: Oral History, Qualitative Interviews and Human Subjects Research

Date: April 10, 2004

Scope: This document discusses the use of oral history and interviews in research and sets out criteria and best practices for determining when HSRC review is required.

Target Audience: This document is intended to assist CWU researchers who use oral history or interview methodology in their research.

BACKGROUND

There has been a recent movement to remove oral history from the purview of institutional review boards (IRBs) by taking the stand that it is not “research” under the federal definition which guides IRBs. While it is clear that much oral history does not constitute research, there are in fact cases where it clearly is research. An effort has been made to clarify the issue with the Office of Human Research Protections (OHRP) and those results and examples are included here. It has been confirmed that recent communication between OHRP and the Oral History community does not change the Department of Health and Human Services (DHHS) interpretation of the federal regulations for the protection of human subjects.

This is a particular issue on the CWU campus. Graduate students must declare whether their research included human subjects and, if so, provide proof of HSRC approval to the Office of Graduate Studies and Research. Similarly, undergraduates wishing to present at SOURCE (and professional conferences) must provide proof of approval when their research involves human subjects. Documentation can be very problematic after the fact.

Researchers familiar with the ethical guidelines of the Oral History Association will note that those guidelines very closely mirror the federal regulations for responsible, ethical treatment of research subjects.

REGULATORY REQUIREMENTS

A decision whether oral history or other activities solely consisting of open-ended qualitative interviews are subject to the policies and regulations outlined in an institution’s Federalwide Assurance and DHHS regulations for the protection of human research subjects (45 CFR 46) is based on (1) the prospective intent of the investigator and (2) the definition of “research” in 45 CFR 46.102(d): “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”

Essentially, the evaluation hinges upon whether the investigator is creating “generalizable knowledge,” i.e. whether the activity represents a systematic investigation in which the person intends to develop or contribute to generalizable knowledge. However, 45 CFR 46 does not define generalizable knowledge. In general, oral history activities, as described to OHRP by the oral history representatives, are designed to create a record of specific historical events and, as such, are not intended to contribute to generalizable knowledge.

CWU policy gives the responsibility to the HSRC, not the researcher, to decide whether a proposed study is exempt from federal regulations.

GUIDANCE FOR EVALUATING THE NEED FOR FORMAL HSRC REVIEW

  • Examples of oral history type activities that would NOT constitute “research” as defined in 45 CFR 46 and would not require HSRC application for review:
  • An oral history video recording of interviews with holocaust survivors is created for viewing in the Holocaust Museum. The creation of the videotape 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.
  • Historians conduct numerous open-ended interviews to document the history of a prominent community family who have donated family memorabilia to the local museum. The purpose of the interviews is to develop material to be used for placards and displays in the museum.
  • After doing a literature review about Rosie the Riveter and women in wartime, a student historian interviews her grandmother and an elderly friend. This type of project is mainly a review of publications (from which conclusions may be drawn). One or two open-ended interviews conducted to lend a human perspective to the topic or period under review would not be considered a “systematic investigation” nor would they be deemed to contribute to any conclusions drawn.
  • Examples of oral history type activities that WOULD constitute “research” as defined in 45 CFR 46 and would require HSRC application for review:
  • Open-ended interviews of surviving Gulf War veterans are recorded to document their experiences and to draw conclusions about their experiences, inform policy or generalize findings. This is a systematic investigation involving open-ended interviews that is designed with the intent to develop or contribute to generalizable knowledge.
  • 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 since the intent is to collect data for future research.

BEST PRACTICES

The institution, through the HSRC office, should perform an initial two step evaluation prior to deciding whether an activity constitutes human subject research:

1.Determine whether the activity constitutes “research” as defined by 45 CFR 46, and

2.Determine whether the “research” includes human subjects as defined by 45 CFR 46.102(f).

Clearly such evaluation requires attention to subtle details and working knowledge of the federal regulations. Therefore, it is recommended that investigators intending to use oral history activities such as open-ended interviews contact the HSRC office in the developmental stages of their research. A decision can be made regarding whether the project should be reviewed through HSRC. For projects that will not require review, the office would be able to provide student investigators with documentation that they have fulfilled their responsibility to the HSRC if they wish to present at SOURCE or an outside conference, or if their project is a graduate thesis. Having to document this “after the fact” may cause delays in approval for presentation or graduation. HSRC is prohibited from approving research that was conducted without appropriate HSRC review.

Investigators should be aware of their discipline’s standards regardless of HSRC review of their research activities. The Oral History Association’s guidelines for ethical conduct of interviews can be found at Principals and Standards of the Oral History Association.

Helpful sample documents for oral history Informed Consent , Deed of Gift--Organization and Deed ofGift—Individual are available on our forms page of HSRC website.