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No. 9: July 2-5, 2010

What to do when the researcher is the only study subject

Scenario: A faculty member in the psychology department of a university wonders if the institution’s IRB must review and approve his research if he is the only research subject.

Issue: Bioethics plays an important role in clinical research. Some IRBs take the position that if a researcher wants to experiment on his/herself that the researcher is knowledgeable about the research and freely consents to being the subject in the research. The IRB does not need to review and approve the research. On the other hand, if the researcher decides to involve others in this research it must be reviewed and approved by the IRB before it can commence.

Solution: The researcher should inquire of his institution’s IRB regarding their position on this issue. There may be other issues to consider such as the institution’s ethics rules. Perhaps there should be an observer present in case of an adverse event. There are exemptions to the Common Rule that are described in 45 CFR 46.101(b).

Lesson learned: What we do not know is the type of research to be conducted. Is it interventional or observational? Will the results be submitted for publication? Does the research involve an FDA regulated product? Is the research funded by Federal money? What does the American Psychological Association code of ethics say regarding such research?

The primary set of Federal regulations regarding research on human subjects is covered under the Common Rule [45 CFR 46]. Some government agencies have established their own implementation of these rules. One such agency is the FDA. All clinical research regulated by the FDA must comply with 21 CFR Parts 50 and 56.

Pertinent regulations and guidance documents:

Federal Policy for the Protection of Human Subjects. Common Rule. 45 CFR Part 46
Protection of Human Subjects. 21 CFR Part 50
Institutional Review Boards. 21 CFR Part 56
National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research. The Belmont Report identifies three basic ethical principles that underlie human experimentation. The Belmont Principles include: Respect for persons, Beneficence, and Justice.

Comments by Harvey M. Arbit, PharmD, MBA, the president of Arbit Consulting, LLC. He specializes in FDA regulatory affairs related to investigator-initiated IND and IDE research.

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