Researchers as Their Own Subjects
Researchers as Subjects in Their Own Studies
Can researchers be subjects in their own studies? Does self-experimentation require IRB review?
Yes, researchers can be subjects in their own studies. However, MSU policy regards this type of research (investigator self-experimentation) as research with human participants, and generally requires the same review and approval as research that recruits other people as subjects.
Though investigator self-experimentation may not raise the conventional ethical concerns outlined in the Belmont Report<http://www.hhs.gov/ohrp/policy/belmont.html>, all human research projects should undergo ethical review to assure the safety of people involved and the integrity of the research at the university. While researchers may be aware of the risks of self-experimentation, they may also be more willing to accept risks that are ill-advised. Application for review with the IRB office allows a neutral third party to raise concerns and/or propose measures to promote the welfare of researchers.
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 a consent document based on the template provided on the MSU IRB website, with their Initial Review Application which will serve as the basis for documentation of informed consent for participation in human subjects research when the experimentation involves the researcher.