Adventures with the IRB

Of course, when I was designing the dissertation research (as well as some research I am doing on IBM and the emerging Service Research and Service Science, Management, and Engineering agendas), the topic of IRB approval came up. When I went to the UM eResearch website and started an application for the IBM project, it became quicly apparent that I had no idea how to answer most of the questions. This is definitely not because I have no experience in research design or filling out the forms - I do. Rather, it was because the questions ask in the IRB application didn't even seem to have relevance to the projects or methods I am using to conduct them.

I spoke with a colleague who is involved with the Behavioral Sciences IRB group at UM to ask for guidance and advice. She pointed out that what I am proposing sounded like the methods being used fall into the category of "oral history", and that a 2003 agreement among the Association for Oral History, the U.S. Department of Human Research Protection, and the U.S. Department of Health and Human Services had concluded that oral history does not fall under the understood definition of "research" that needs review. As a result, it was decided that oral history projects are excluded from IRB review (which is a different category than "exempt", which still requires an IRB application and review), as long as the appropriate provosts, deans, chairs, and directors are notified and approve the research.

Why isn't oral history considered research? For the types of research the IRB plays a major role, the point of the inquiry is to generate results, theories, or concepts that can be generalized and are designed to have predictive power. Oral histories (which are more akin to journalism, which is also excluded from IRB) aim to collect and analyze the particulars of people, places, dates, and events related to a specific historical vector (or set of vectors). The intention is not to predict the future, but to understand the past. Not to generalize, but to contextualize. Even thinking about it with a modicum of common sense (as well as research sense), it would be impossible to construct a historical account of any value if one could not refer to the roles of identified people, places, or statements with attribution.

I read over all of the links and resources this colleague sent, and constructed a letter with printouts of the relevant documents. These were then sent to the seven key people who would need to provide approval. All seven gave approval, and these notes were placed in my doctoral student file.

The next step was generating an informed consent document that makes clear the parameters of the study. Even though IRB is not involved in moderating the project, it is still important to provide and collect informed consent. I tried to be as explicit as possible about the nature of the project, the fact that it falls outside of IRB review and what this means, and how I envision participation playing out. A link to the approved Informed Consent Form that can be used as an example and template for non-IRB projects appears below.

The point of this entry? Just to keep an accurate record of what steps I needed to follow in approaching this kind of research. Possibly, it can help others that come after who run into the same set of issues. If you have further questions about my experience with living outside the IRB, and how the story unfolds, feel free to email.

Links

• Oral History Excluded from IRB Review - article


• Oral History Association Evaluation Guidelines


• UM Human Protections Research Manual - see bottom of page 42


• UM Behavioral Science Informed Consent Template


• Sample Informed Consent form for non-IRB project