Policy on Access to Students as Research Subjects

Background

Due to the increasing number of research projects utilizing medical students as subjects, a committee has been established to review and approve these requests for student participation. The purpose of this review is to ensure that the issues of power are addressed. Power issues may arise, for example, when the researcher/PI requesting student participation is in an evaluative role in relationship to the student(s) such as a clerkship or elective director.  The members of The Committee to Review Student Participation in Research (The Committee) are the Associate Dean for Student Affairs, the Associate Dean for Curriculum, the Associate Dean for Educational Scholarship who serves as chair, and a student representative.

Policy

Yale Medical School faculty, residents and students proposing research intended to utilize Yale medical students, as subjects must obtain written approval from The Committee and approval or exemption from review from the Institutional Review Board (IRB).

The use of class time for surveys or other types of research participation will not be approved except in exceptional circumstances. 

Program evaluation and curricular assessment conducted for curricular oversight and improvement are not reviewed by The Committee unless they are being carried out for the purpose of publication.

Procedure

  1. The researcher/PI must email the following materials to the chair of The Committee:
    • A written description of the research proposal (IRB application or exemption request), which includes all data collection instruments and the Informed Consent Document or Verbal/Online Script 
    • An explanation of how issues of power dynamics that may exert undue influence on students’ participation will be handled.
    • A copy of the invitation to the students to participate as well as advertisements, postings, etc.

The committee will review the proposal and send an email to the researcher/PI of approval, revision, or rejection.

  1. Once approval is obtained, the researcher/PI then submits the study documents and approval letter from The Committee to the IRB.
    • The IRB will review and either 1) request revisions to be addressed before approval or exemption are granted, 2) grant approval or 3) grant an exemption from review.
    • The IRB will communicate their decision to the researcher/PI.