Writing a case report about my own medical problems without treating physician

Question

I am a postdoc in epidemiology. Last year I had a very rare viral infectious disease that got me admitted to the hospital for more than a week, and it is worth a case report because it's a fairly unknown disease and physicians had troubles in finding out what it was. I had discussed writing a case report with my treating physicians, but eventually they stopped answering my emails or picking up the phone.

Therefore, I wonder if it's OK to write the case report myself, about myself, with the help of a senior physician that works with me and is willing to help, without involving the physicians who treated me. I have all the tests, diagnosis, course of the disease, and my own patient consent.

Answer 1

As correctly pointed out by @Anonymous Physicist, the “Common Rule” defines research as:

A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

Simply reading the “Common Rule” definition of research, it would seem that a case report would not qualify as “research” because it is non-systematic. If a case report is not research, then it would seem that it does not need to be reviewed by an Institutional Review Board (IRB).

But, like so much related to the requirement (or non-requirement) for review of particular activities by the IRB (or ethics board), policies about case reports in the United States are not uniform among institutions. And there are further regulatory wrinkles due to HIPAA and problems that may arise from journal policies.

HIPAA

Writing up and publishing a case report generally uses protected health information, that is information that permits an individual to be identified. Access to and use of this information is regulated by the Health Information and Portability Act (HIPAA) and, at the institutional level, decisions about access to and use of such information is overseen by a “privacy board” or a “privacy officer.” The IRB often, but not always, serves both as an ethics board and a privacy board.

An institution might not require IRB review of a case report but would require review by a privacy board or a privacy office (or the IRB acting as a privacy board).

Empiric Data from 2017

A 2007 JAMA publication reported on the policies with regard to review requirements for case reports at medical schools in the United States. [1]

Of 124 medical schools surveyed, 116 (94%) responded. The following results were reported:

• “Ninety-one (78%) of the responding schools did not require IRB approval for a case report.”

• “None of the 25 [that required IRB approval] required full IRB board review; 17 (68%) required IRB notification; and 8 (32%) did not have a fixed policy but considered whether the report should have full or expedited review on an individual basis. Six (24%) conducted reviews because they considered case reports to be research, 8 (32%) for privacy requirement, and 11 (44%) for both purposes.”

The Journal Problem

A further problem that can arise when attempting to publish about work that was not reviewed by an IRB is a requirement by a journal that the work being presented has been reviewed by an IRB (whether or not it was required to be reviewed) or a request by a journal for documentation from the IRB that the work was NOT required to be reviewed.

Bottom Line

The advice by others to “ask your IRB” seems apt. The advice might be expanded a bit to suggest (given the additional complexities that arise because an author of the case report is also the patient whose information is being reported) that the OP ask their IRB to review the work formally and issue a formal approval of a plan to publish the information by those who will be authors/co-authors. This is the safest thing to do (although bureaucratic)

Reference

[1] Panda M, Heath GW, Desbiens NA, Moffitt B. Research Status of Case Reports for Medical School Institutional Review Boards. JAMA. 2007;298(11):1277-1278. doi:10.1001/jama.298.11.1277 https://jamanetwork.com/journals/jama/fullarticle/208845 Johns Hopkins University

Answer 2

I don't know what an ethics board would say about this, and you need to check. If they approve then I see no issue, though you may need to anonymize the attending physicians.

But whether you can actually publish it would be up to a publisher.

Be honest, of course, about the fact that you are the subject of the study unless an ethics board rules otherwise.