Thursday, July 19, 2018

OHRP Video: Oral History of "Specific Leaders" Would Qualify as Research

On June 22, OHRP posted a video to YouTube, dated March 2018 and entitled “When Does the Common Rule Apply?,” featuring Misti Ault Anderson, Senior Advisor for Public Health Education at OHRP. The video includes a passage stating that while an oral history interview of “one individual” will no longer be considered research under the new Common Rule, a project about “specific leaders” would still be regulated.

I consider this statement to be at odds with the 18 January 2017 Federal Register announcement of the revised rule. However, Anderson tells me the video is an “education tool,” not official guidance, and that “we will be seeking public comment for consideration before developing the final guidance.”

The passage comes 3 minutes and 28 seconds into the video:

The first category of activities that is deemed not to be research is scholarly and journalistic activities, and these include the collection and use of information that focuses directly on specific individuals about whom the information is collected. The key to understanding this set of activities is what was right in the middle of that description. It’s about only the specific individuals that are providing the information. So examples include: oral history, journalism, biography, literary criticism, legal research, and historical scholarship. So the activities being done are the things that make the difference. So let me give you some examples. Looking at historical scholarship: a historical study about the life of a specific civil rights leader, and only about that individual, would meet the requirements of this set of activities. It’s only about one individual, and cannot be generalized to a larger group. So that would not be research under the regulatory definition. However, a historical study about the societal impacts of the Civil Rights Movement and how it was driven by specific leaders in that movement, would qualify as research, under the regulatory definition.

Compare the video’s example of “one individual” to the Federal Register announcement, describing the deregulation of oral history and related fields.

The final rule also explicitly cites those fields and traditions as examples, in order to clarify that the focus is on the specific activities that collect and use information about specific individuals themselves, and not generalizing to other individuals, and that such activities occur in various fields of inquiry and methodological traditions.

Thus, in January 2017, OHRP assured historians that we could study “specific individuals” (plural) without triggering IRB jurisdiction, but now it suggests that we can only study “one individual” at a time.

In response to my queries, Anderson writes,

My wording in the example isn't sufficiently clear, and I think that is causing the confusion.
The main point isn't that people would be interviewed. In the example, the point I was trying to make was this: (1) if information was collected about an individual or specific individuals in order to understand those individuals themselves, it would not be considered research, and (2) -and this is where I could be more clear-if information was gathered (people interviewed, etc.) to try to identify and understand characteristics, commonalities, or patterns of behaviors of people in general who participated in a movement or societal change (in this case), it might be considered to be research because it does not focus on the interviewed individuals themselves, but rather is designed to use information collected from those individuals to draw conclusions about other - in some ways similar - individuals.
In short, as long as the activity is "focus[ing] directly on the specific individuals," it will not fall under the Common Rule.

I leave readers to judge whether the video is consistent with that interpretation.

Anderson also writes,

OHRP is working on a draft guidance document focusing on the scholarly and journalistic activities category of activities that are deemed not to be research. Once that document is ready, we will make it available and invite public comment on the guidance. At that point you, and others, will have the opportunity to provide feedback and comments on the draft guidance.

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