HS IRB Policy on Investigators as Study Participants

Federal regulations do not distinguish between self-experimentation and research on subjects who are recruited for a specific project.  At Tufts Medical Center and Tufts University, faculty and staff who wish to act as participants in their own research should consider themselves human subjects. The institutions require submission of an application to an IRB following standard procedures prior to enrollment in a project or initiation of an experiment.  The plan for self-experimentation must be described in the IRB submission, and the informed consent form should include all necessary elements of consent. The Tufts Health Sciences IRB is authorized to review and approve requests for self-experimentation.

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.

When submitting a request to the IRB that proposes self-experimentation, include the following in your Protocol:

1. The rationale for self-experimentation
2. If applicable, confirm that you meet eligibility criteria to enroll in the research study
3. State whether the exact same procedures will be performed on you as on any other subject in the study, or whether there will be differences
4. If you will enroll in a blinded study, clarify whether you will be blinded to your own assignment
5. Specify who will perform the study procedures on you
6. State who will perform the informed consent process with you
7. Describe how the data obtained from your participation will be analyzed and processed and who will perform the analysis

If the research study has an Informed Consent Form (ICF), the following should be added as an addendum to the ICF to be used to enroll investigators:

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 and consent form on myself. I am aware that the procedures are considered to constitute research on human subjects. I am performing these procedures on myself voluntarily.

Self-experimentation may not meet the regulatory definition of Research: a systematic¹  investigation², including research development, testing, and evaluation, designed to develop or contribute to generalizable³ knowledge. If you believe your project is not Research, you may submit a Not Human Subjects Research (NHSR) Request Form in place of a full Protocol. Include your responses to the above items #1-6 in the form as applicable.

¹ Systematic: Having or involving a system, method, or plan

² Investigation: A searching inquiry for facts; detailed or careful examination

³ Generalizable: Universally or widely applicable (i.e. not only applicable to Tufts)