Tuesday, November 28, 2006

OHRP and Oral History

At the PRIM&R conference in Washington last week I moderated a panel with Michael Carome and Julie Kaneshiro from OHRP on "When is it Human Subjects Research?" In his presentation, Dr. Carome finally clarified OHRP's position on oral history. As many of you know, in 2003 Dr. Carome wrote a letter stating that OHRP concurred with the position that oral history activities in general do not involve research as defined by the HHS regulations. Many oral historians took that to say that oral history was excluded from IRB review, including the Oral History Association. In his presentation at PRIM&R Dr. Carome clarified that this was meant in the same sense that drawing blood "in general" was not research. It is not the methodology that determines whether an activity is human subjects research, but whether it meets the regulatory definition of research - a systematic investigation designed to develop or contribute to generalizable knowledge. That is to say, the determination as to whether an oral history activity is human subjects research is based on how it is conducted and the purpose for which the activity was conducted. If an oral history activity meets the regulatory definition, it is human subjects research and, unless it is exempt, needs IRB review. This is what many of us have been saying all along.

The problem is that the regulations don't define "systematic investigation" or "generalizable knowledge" and they don't say who is to make that determination. As a result, it is up to institutions to come up with policies and procedures for making this determination. Both OHRP and AAHRPP expect institutions to have written policies and procedures for determining when an activity meets the definition of human subjects research. Here are my recommendations for how an institution should handle this:

1) It would be a mistake to allow investigators to make this determination on their own. It's not that they can't be trusted, but that they can't be totally objective about their own work. Since it is the institution that will be held accountable if they make the wrong decision, then the institution should provide for an independent, objective determination. On the other hand, this determination does not have to be made by the IRB. For exempt research, the OHRP guidance states that the determination should be made by a "knowledgeable" person or persons. The same should hold here. The determination could be made by someone from the IRB or IRB office, but could also be made by a trained departmental representative or committee. The training should be provided by the IRB staff and there should be a way to monitor the determinations if they are not made by outside reviewers.

2) The institution should develop clear definitions for "systematic investigation" and "generalizable knowledge". Here are the definitions from the generic policies and procedures that I have developed for my clients:

"For the purposes of this policy, a 'systematic investigation' is an activity that involves a prospective research plan which incorporates data collection, either quantitative or qualitative, and data analysis to answer a research question. Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions (i.e., knowledge gained from a study may be applied to populations outside of the specific study population), inform policy, or generalize findings."

3) The institution should provide guidance on how to determine if an oral history activity meets this definition. The guidance should include examples of oral history activities that meet the definition and those that don't. I would recommend that this guidance be developed in conjunction with the oral historians at the institution.

4) For oral history activities that do meet the definition, I would strongly recommend that the IRB be trained on how to review oral history. Oral history and other qualitative research activities are different from the usual quantitative research reviewed by the IRB. I would suggest that the IRB bring in oral historians to provide training in oral history methodology and ethical issues.

5) When reviewing oral history research, the IRB needs to utilize the flexibility it has under the regulations to make its review appropriate to the research and not unduly burdensome on the historians. The IRB needs to use the exemptions and expedited review to minimize the time it takes for IRB review, develop submission forms appropriate to oral history projects, and utilize its waiver authority to make sure that the consent process is appropriate to oral history.

By working with the oral historians, providing clear guidance and using the flexibility in the regulations, an institution can come up with policies and procedures that provide appropriate

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