Medical Student Handbook

Ad Hoc Committee to Review Teaching Exercises with Student Subjects

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Purpose:

To provide a committee and a process to review and approve proposals from faculty for teaching exercises that involve students as subjects.

Committee composition includes the directors of the course; the Division of the Medical Humanities; the University Health Services and Research Subjects Review Board. In addition, a second year medical student serves on the committee.

Procedure:

1. Course director submits to committee a written description of the proposed teaching exercise, including:
   1. the purpose of the exercise
   2. the actual procedure
   3. the safety of the exercise including detailed OER protocol specifying equipment, care, storage, maintenance, sterilization, and schedule for review of these factors
   4. the risks of the exercise
   5. the efficacy of the exercise
   6. number of student subjects
   7. how student subjects will be selected
   8. the written information that will be given to student subjects describing the exercise, the risks, side effects, contraindications for participation, opportunity to withdraw
2. Committee review will include consideration of the above factors as well as the voluntariness of student participation and the issues of privacy and confidentiality. When necessary, the committee will identify appropriate faculty members for consultation outside the committee's expertise.
3. Requests for approval should be submitted to the Director of the Division of the Medical Humanities no less than six weeks before the date of the teaching exercise.
4. Approval will be in writing, and will be renewed annually for two additional years according to the following procedure. At the end of the academic year, the course director will submit an annual report detailing for each exercise the number of student participants, any deviations from the exercise as it was approved, any problems or student complaints that arose during the exercise, any anticipated changes in the exercise. Any substantial modification in the exercise will require reapplication.
5. If a proposal cannot be approved as submitted, the committee will provide the course director with a written explanation of the reasons for the decision and recommendations for changes that would allow for approval of the exercise.
6. Decisions of the committee can be appealed to the Senior Associate Dean for Medical Education (SADME).

Student participation in experiments/exercises as subjects is voluntary. Consequently, students retain the right to withdraw or to decline to participate as subjects.

Students with questions or concerns should contact Professor Jane Greenlaw, Director of the Division of the Medical Humanities at 275-5800.