Office of Human Research Ethics SOP 4502: Self and Family Member Experimentation

Summary

This SOP discusses rules governing investigator self-experimentation and experimentation on family members of investigators.

Body

1. Self-Experimentation

Generally, investigators at UNC-Chapel Hill may not enroll themselves as subjects in a study that they are supervising.  Such a practice presents obvious conflicts of interest issues and a variety of other ethical and practical issues (e.g., data integrity, welfare of researcher, informed consent, and oversight responsibilities).

2. Family Member Experimentation

While there is no absolute prohibition on an investigator enrolling family members in a study, due to the possibility of undue influence, conflict of interest, and equitable selection this typically should be avoided. 

If an investigator is recruiting or planning to enroll a family member, this should be identified in the IRB application and additional safeguards to mitigate coercion and ensure the family member’s participation is voluntary.  The IRB will then review the inclusion of the investigator’s family member’s being recruited as potential subjects and ensure that there are additional safeguards for these subjects. The voluntary nature of their participation must be primary and without undue influence on their decision.  Consent procedures and other study activities, when possible, should be administered or overseen by an individual who is not the family member, however still qualified to do so, such as a co-investigator.

Details

Details

Article ID: 136957
Created
Tue 11/23/21 3:09 PM
Modified
Wed 6/12/24 9:37 AM
Responsible Unit
School, Department, or other organizational unit issuing this document.
Research-IRB and Human Research Ethics
Issuing Officer
Name of the document Issuing Officer. This is the individual whose organizational authority covers the policy scope and who is primarily responsible for the policy.
Issuing Officer Title
Title of the person who is primarily responsible for issuing this policy.
Vice Chancellor
Next Review
Date on which the next document review is due.
11/23/2023 12:00 AM
Last Review
Date on which the most recent document review was completed.
11/24/2021 12:00 AM
Effective Date
If the date on which this document became/becomes enforceable differs from the Origination or Last Revision, this attribute reflects the date on which it is/was enforcable.
11/23/2021 12:00 AM
Origination
Date on which the original version of this document was first made official.
11/24/2021 12:00 AM