July 2005

Federal regulations do not distinguish between self-experimentation and research on subjects who are recruited for a specific project.  At JHM, faculty and staff members who wish to act as participants in their own research should consider themselves human subjects.  The Institutions require submission of an application to the JHM IRB prior to enrollment in a project or initiation of an experiment.  The JHM IRB is authorized to review and approve requests for self-experimentation.  There are two reasons for the required JHM IRB review and approval:

1. To protect faculty and staff from taking unwarranted risks in the excitement of generating new knowledge.  Under these circumstances, investigators are enthused about the prospect of new knowledge and concern for any associated risk may be minimized or escape attention.
   
2. To protect the process of human investigation/research in an era when the process has articulate critics.  While the requirement for review may be viewed as a limitation on personal freedom, it is the price one must pay to protect clinical investigation and research.