Wednesday, January 10, 2007

"Generalizable" revisited

One persistent question about the need for IRB oversight of oral history is whether oral history interviews come under the jurisdiction of 45 CFR 46, which defines research as a "systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." Any project not "designed to develop or contribute to generalizable knowledge" is therefore excluded from the requirement for review.

In October 2003, Dr. Michael Carome, associate director of the Office of Human Research Protection, U.S. Department of Health and Human Services (OHRP), sought to answer that question in a discussion with representatives of the UCLA Office for Protection of Research Subjects. UCLA prepared an outline of that discussion, and Carome subsequently confirmed it in correspondence to Northern Illinois University. Carome offered descriptions of three hypothetical projects, explaining that one of them would be excluded from review, while the other two would require IRB approval. Because these were hypothetical, it was impossible to tease out the distinctions among them, so the guidance was unclear.

In 2004, however, OHRP offered a concrete example of non-generalizable oral history. OHRP staff, including director Bernard A. Schwetz, conducted a series of videotaped interviews with former members and staff of the the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Recordings and transcripts of those interviews, entitled the Belmont Oral History Project, are online at

I recently asked OHRP if the project had been reviewed by an IRB, and received the following reply:

Date: Wed, 10 Jan 2007 09:39:42 -0500
Subject: RE: Belmont Report Oral History
Sender: "Nellis, Kevin (HHS/OPHS)"
To: "Zachary M. Schrag"
Cc: "ElHinnawy, Patricia C (HHS/OPHS)"

Dear Dr. Schrag,

OHRP determined that obtaining oral histories of members and staff of the National Commission did not represent research as defined at 45 CFR 46.102(d) because the activity was not a systematic investigation, nor was it intended to contribute to generalizable knowledge. This oral history activity was designed merely to preserve a set of individuals' recollections; therefore, this activity was not subject to IRB review. The interviewers had no specific training related to this activity; and those interviewed did not sign a consent document.

I am delighted that you found the interviews informative and helpful. If you have any more questions regarding the protection of human subjects in research or need clarifications on this response, please do not hesitate to contact OHRP.

Best Regards,

Kevin L. Nellis, M.S., M.T. (A.S.C.P.)
Public Health Analyst
Division of Education and Development
Office of Human Research Protections

Zach comments:

Based on this project, then, recorded interviews do not represent research as defined at 45 CFR 46.102(d) even when:

  • interviewers ask some standardized questions (several narrators are asked, for example, how much time they spent deliberating about social and behavioral, as opposed to biomedical, science).
  • interviewers ask prepared questions tailored to the narrators' individual experiences.
  • interviewers ask follow-up questions based on the narrators' replies to initial questions.
  • interviewers ask narrators to draw conclusions about the lasting significance of their work.
  • recordings and transcripts are posted on the Internet and labeled "Oral History Archive."
  • portions of the interviews are used in an interpretive work of history (in this case a video
    arguing that the 1970s "marked a turning point in how human research was controlled in the United States," and that the authors of the Belmont Report should be thanked "for their help in guiding our decisions far into the future").
  • the interviews appear as part of a website that draws on history to inform present policy ("Today, the Belmont Report continues as an essential reference for institutional review boards (IRBs) that review HHS-conducted or -supported human subjects research proposals involving human subjects, in order to ensure that the research meets the ethical foundations of the regulations").

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