Protocols involving oral history still need review

Here’s what OHRP says

IRB members who are confused about whether research containing an oral history is subject to IRB review are not alone. The Office for Human Research Protections (OHRP) has written two letters on the matter, leaving some room for contradictory interpretation until guidelines are issued, possibly this year.

When first asked to revise guidelines in favor of exempting oral history from IRB review, OHRP responded in such a way that the American Historical Association of Washington, DC, and the Oral History Association of Carlisle, PA, assured members and published statements on their web sites that claimed oral history was excluded from IRB review. They asserted that oral historians did not need to submit their projects to an IRB — even to seek exemption.

This conclusion was based on OHRP’s response to a letter sent by a historical organization, which had drafted its own proposed guidelines regarding oral history interviewing.

In a question-and-answer statement on the American Hospital Association web site, it states, "The OHRP has affirmed that federal regulations were designed with biomedical research in mind, as well as behavioral and social scientific research that uses standard questionnaires with often anonymous sources to produce quantitative information that aims at generalizable knowledge.’ Since that is not the way oral historians operate, the type of research they do is now excluded from IRB review."

Overstating the case

In a Sept. 22, 2003, letter to Linda Shopes of the Pennsylvania Historical and Museum Commission of Harrisburg, Michael A. Carome, MD, wrote, "OHRP concurs with the proposed policy stating that oral history interviewing activities, in general, are not designed to contribute to generalizable knowledge and, therefore, do not involve research as defined by the Department of Health and Human Services [HHS] regulations at 45 CFR 46.102(d) and do not need to be reviewed by an institutional review board."

Then, in December, after OHRP was asked to clarify its position on oral history interviewing by Lori Bross, assistant to the vice president for research in the Office of Research Compliance at Northern Illinois University in DeKalb, a less clear-cut answer emerged. She discussed this issue at the PRIM&R 2003 annual IRB conference, held Dec. 5-7 in Washington, DC.

"Basically, what OHRP has said: If you are using oral history interviewing techniques to simply convey information or to retell a story,’ but people aren’t using it to draw conclusions or things like that, then that doesn’t fit the regulatory definition of research," Bross explains. "But other situations where oral history methodology is used [could be] for a research purpose that is of the type described in the definition of research in the regulations [and these would be subject to IRB review]."

Carome wrote this explanation to Bross in an e-mail dated Dec. 1, 2003: "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 unless the research is exempt under HHS regulations at 45 CFR 46.101(b). Indeed, in its Sept. 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."

Further, he wrote, "Based upon comments that we have received since OHRP’s letter regarding oral history activities was issued, it appears that many institutions and IRBs took the position that oral histories always involve research. Based upon the nature of oral histories, OHRP does not agree with such a position."

Carome also provides three principles for evaluating oral history type activities:

  • "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 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."
  • "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 feelings) 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 feelings."
  • "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."

Bross says she requested a clarification from OHRP because she didn’t want researchers to be put into an awkward position of conducting their activities without seeking IRB review only to find out they should have done so.

"People are scratching their heads, trying to figure out what to write into their own policies, and it’s confusing people," Bross says.

Hopefully, the letter OHRP sent to Bross will help clarify the situation, at least until OHRP issues its guidelines, she adds.