1. Purpose
The purpose of this policy is to minimize the risk of coercion, undue influence, and conflicts of interest (COI) in human subjects research involving recruitment of individuals who have a pre-existing dependent, hierarchical, or familial relationship with the investigator or research staff.
The institution recognizes that recruitment involving existing professional, academic, supervisory, evaluative, or family relationships may compromise voluntariness and participants’ ability to freely decline participation or withdraw from a study without fear of adverse consequences or interpersonal repercussions.
2. Scope
This policy applies to all human subjects research conducted under the oversight of the Institutional Review Board (IRB), including research involving:
- Faculty, staff, students, trainees, employees, volunteers, or family members;
- Principal Investigators (PIs), co-investigators, and research personnel;
- Any recruitment setting in which an actual or perceived power differential, dependency, or close personal relationship exists.
3. Policy Statement
As a general rule, investigators should not recruit or enroll individuals with whom they have a current supervisory, instructional, evaluative, dependent, or familial relationship.
Examples include, but are not limited to:
- Principal Investigator–lab member relationships;
- Teacher–student relationships;
- Employer–employee relationships;
- Supervisor–trainee relationships;
- Clinical provider–patient relationships where the provider is also conducting the research;
- Investigator recruitment of spouses, domestic partners, parents, children, siblings, or other family members.
Recruitment of individuals with whom the investigator has an existing relationship may only be approved when the investigator provides compelling justification and demonstrates adequate safeguards to protect participant autonomy and voluntariness.
Convenience of sampling, ease of access, lower recruitment burden, personal familiarity, or faster enrollment are not sufficient justifications for recruiting one’s own students, employees, trainees, laboratory members, or family members.
4. Requirements for IRB Approval
Investigators seeking approval to recruit participants with whom they have a current relationship must provide the IRB with:
A. Scientific or Operational Justification
The investigator must provide a strong rationale explaining why recruitment is not feasible or would compromise the scientific validity or operational integrity of the research.
Acceptable justifications may include:
- The target population is uniquely situated within the investigator’s environment;
- Specialized expertise, training, or exposure is required for participation;
- The study addresses a narrowly defined population unavailable elsewhere.
The IRB may require investigators to document attempts to recruit from less vulnerable, non-dependent, or non-familial populations before permitting recruitment within dependent or family relationships.
B. Safeguards Against Coercion and Undue Influence
Investigators must implement additional protections designed to minimize actual or perceived pressure to participate. Such safeguards should generally include:
- Use of an independent third party to conduct recruitment, eligibility screening, and/or informed consent;
- Procedures ensuring that the investigator does not know who declined participation;
- Clear statements that participation or nonparticipation will have no effect on grades, employment status, performance evaluations, compensation, academic standing, laboratory opportunities, mentorship, personal relationships, or future opportunities;
- Mechanisms allowing participants to withdraw easily and confidentially throughout the study without penalty;
- Separation of research activities from academic evaluation, employment decisions, or family/personal obligations whenever possible;
- Delayed access by the investigator to identifiable participation data until evaluative or dependent relationships have ended, where feasible.
5. IRB Review Considerations
In reviewing such protocols, the IRB will consider:
- The nature and extent of the power differential or personal relationship;
- The vulnerability of the participant population;
- Whether alternative recruitment methods are available;
- The adequacy of proposed safeguards;
- Whether the investigator’s access to potential participants creates undue influence;
- Whether compensation could further contribute to coercion;
- Whether family relationships create additional concerns regarding voluntariness, privacy, or conflicts of interest.
The IRB may require modifications, additional safeguards, independent monitoring, or disallow the recruitment entirely if risks to voluntariness cannot be adequately mitigated.