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Guidance Regarding Self-Experimentation of Researchers as Study Subjects
Effective March 25, 2007
As part of its commitment to the protection of the rights and welfare of individuals participating in research and compliance with federal regulations governing human subjects research, research activities involving self-experimentation require review by a University of Wisconsin-Madison Institutional Review Board (IRB). The Common Rule and Food and Drug Administration (FDA) do not regard research on oneself as different from research involving other human subjects. Prior to commencing any research activities involving self-experimentation (e.g., blood draws, equipment testing), an Initial Review Application must be submitted to and approved by an appropriate UW-Madison IRB. The IRB will review the application to ensure the activities do not raise any ethical concerns and that adequate protections are in place.
The Common Rule and FDA regulations also require that informed consent be obtained from all research participants unless certain conditions are met. The IRB recommends researchers provide with their Initial Review Application a document based on the template below that will serve as the basis for documentation of informed consent for participation in human subjects research when the experimentation involves the researcher.