Generally, enrolling subjects who are in a status relationship with the researcher(s) is discouraged. It raises special ethical concerns such as a recruitment and consent process that is not free from undue influence. Additionally, enrollment of individuals already known to the research team may heighten the potential for loss of confidentiality for those subjects.

However, if enrolling subjects with a status relationship with the researcher(s), such as family members, students, and employees, is unavoidable, the status relationship should be declared in the IRB application and justification for the inclusion of these subjects provided. The IRB will consider, on a case-by-case basis, the following factors in support of potential exceptions to the general prohibition on enrollment of subjects with potential status relationships with the researcher(s):

• The research presents minimal risk to subjects.
• If the potential subjects are students or employees, participation in the research represents a potential educational opportunity for those individuals.
• The recruitment of these subjects involves only indirect methods (i.e., potential subjects are not recruited on a personal basis). These subjects are recruited through the posting of IRB-approved flyers/ads or through IRB-approved communications sent out to a larger group (e.g., mass mailings through email or letters).
• The consent process will not be conducted by someone with whom the potential subject has a status relationship.
• If the research is conducted within the classroom setting, the instructor is blinded to the identity of participants. For example, a third party who is not in a status relationship with the students could receive data directly from the participants and strip the data of identifiers before providing the information to the researcher who is in a status relationship with the students.

If the IRB agrees that subjects in a status relationship with the research team may be enrolled in a research study, the IRB generally would require the consent form to clarify that participation in the research study or refusal to do so will not affect the individual’s employment or status as a student (e.g., grades or class standing) at the university.

Other individual exceptions for studies where there may be therapeutic benefit but greater than minimal risk may be considered by the IRB. The IRB acknowledges that patients have an inherent status relationship with their health care providers and manage these relationships differently.