Federal regulations are silent on the matter of researchers who want to participate in their own studies. However, the regulations do not distinguish between self-experimentation and research on individuals who are recruited for a specific research project. As part of its commitment to the protection of the rights and welfare of all subjects participating in research, the University of Houston’s human research protection program requires investigators who wish to act as participants in their own studies to follow standard procedures for IRB review and approval.
Though investigator self-experimentation may not raise the conventional ethical concerns outlined in the Belmont Report, all human research projects must undergo ethical review to assure the safety of subjects involved (including investigators collecting samples from themselves) and the integrity of the research at the university. Submissions may be in the form of an individual research protocol if the investigator will be the only subject, or as part of a protocol that involves multiple subjects. A revision to a currently approved protocol to add self-experimentation will also be considered.
The IRB will review each protocol and determine the appropriateness of the research. The committee will consider as part of its review the level of self-experimentation and the potential risks and benefits to the investigator as a research subject. A main concern for the IRB when reviewing a protocol that involves self-experimentation is that the ideation of a novel concept may outweigh the investigator’s concern for his/her own welfare. An application for review allows the IRB to review such concerns as a neutral third party, and to institute additional safeguards for the research project if necessary.
A standard consent form must be developed that includes all of the elements required under current human subjects regulations. In addition, in cases where the PI or key personnel is/are the sole subject(s), the following statement should be incorporated into the consent form:
I am an investigator or key personnel on the above-referenced research study and intend to conduct the procedures as described in the approved protocol on myself. I am aware that the procedures are considered to constitute research on human subjects. I am performing these procedures on myself voluntarily.