Recruitment of Subjects with Status Relationship with the Research Team
Relatives of research staff, employees, and students
Recruitment and enrollment of family members of the research team as well as students and employees (including fellows and residents) who may be in a status relationship with the investigators raise special ethical concerns. The existence of a status relationship between the prospective subject and members of the research team may result in 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. The concerns about enrolling individuals with status relationships have a basis in actual events at the University of Wisconsin. IRBs on campus have received complaints from individuals who felt they could not decline participation in a research study because they believed that refusal would lead to adverse consequences for their employment or student careers.
Generally, UW-Madison IRBs discourage investigators from enrolling family members of a research team as well as employees or students who are in a status relationship with the researcher. Students are considered to be in a status relationship with a researcher if the researcher has authority to make decisions about the student’s grades, performance, and/or progress. See, also, the Guidance Regarding Self-Experimentation of Researchers as Study Subjects, which addresses the conduct of research procedures on the principal investigator and other members of the research team.
Enrollment of individuals with a potential status relationship, including family members of the research team, should be declared in an application to the IRB (Initial Review Application, Change of Protocol) and justification for the inclusion of these subjects provided. The IRB will then assess on a case-by-case basis whether the inclusion is warranted by the protocol, the recruitment and consent process are free from undue influence, and the confidentiality of these subjects will be protected adequately. The IRB chairs or their designees may decide individual cases.
The UW-Madison IRBs will consider the following factors in support of potential exceptions to the general prohibition on enrollment of subjects with potential status relationships with the research team:
- 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 IRBs acknowledge that patients have an inherent status relationship with their health care providers and manage these relationships differently.