2/25/97
Policy
Use of Human Participants in
Instructional Activities
In the use of human participants in instructional
activities,
This policy for the Use of Human Participants in Instructional Activities addresses classroom, laboratory or clinical activities in which learning by students requires the use of human participants as part of the training procedures, demonstrations, and/or classroom experiments. This policy does not pertain to medical patients seen in clinical settings.
Procedural Guidelines
1. Instructors whose curriculum indicates the use of human participants in the classroom or lab in an activity that creates a risk must establish a written protocol with their department and Division Chair which protects the safety of all participants from the risk of harm or injury.
2. “Risk” means that as a consequence of participating in an activity, an individual may reasonably be expected to be exposed to the possibility of injury (physical and/or psychological), beyond the ordinary risks of daily life.
3. This policy is intended to restrict and regulate the use of students as human participants in such activities as training procedures, demonstrations, and classroom experiments where students are exposed to such risk.
4. The instructor’s protocol will include guidelines for student safety, consider universal precautions when appropriate, reflect WISHA and OSHA requirements, and delineate the criteria and procedures for reporting an incident. Guidelines should assume that risks involved will be minimal and reasonable, document informed consent, assure appropriate safety monitoring and adequately protect individual privacy. The department coordinator and department instructors will meet to develop these guidelines.
5. Should any instructional activity involve risk as defined in #2 above, then a written protocol must be filed with, and approved by, the Department, Division, and the Vice President for Academic Affairs. Notwithstanding the degree of risk, this must be done prior to carrying out instructional activities which involve:
a. The collection of bodily secretions.
b. Performing electrocardiography, and the use of radioactive materials.
c. Collection of blood samples by venipuncture in amounts which exceed 450 milliliters in an 8-week period or more than two times per week from subjects 18 years of age or older or who are not pregnant.
d. Collection of supra and sub gingival dental plaque and calculus if the procedure is more invasive than routine prophylactic scaling of the teeth or the process is not accomplished in accordance with accepted prophylactic techniques.
e. Research on individual or group behavior or characteristics of individuals which manipulates student behavior and involves significant stress.
6. Activities that use human participants and require a written protocol shall be conducted only under the direct supervision of the instructor(s) who has(have) been assigned to teach the course that has received the appropriate prior approval. Direct supervision means that the instructor is on the premises.
7. Before involvement as a human participant in an activity that requires a written protocol, a student must give written informed consent. If under the age of 18, written informed consent must be obtained form the parent or the legal guardian unless the participant is determined to be an emancipated minor. The consent is to be freely given, obtained from the subject, parent or legal guardian without undue inducement or any element of constraint or coercion. The following elements of information necessary for such consent shall be included in syllabi materials of courses involving the use of human participants.
a. A timely notification of the procedures to be followed, including a description of the attendant risks and/or discomforts.
b. A description of the benefits to be expected or the knowledge to be gained.
c. A disclosure of appropriate alternative procedures, if available.
d. An offer to answer any questions the participant has concerning an activity.
e. The student who wishes to may withdraw from the course within a reasonable time after being notified of required participation in an activity s/he finds objectionable.
f. The student who does not consent to be a human participant may be given alternative learning experiences at the discretion of the instructor.
g. The student who chooses neither to act as a human participant nor to accept alternative activities will be informed that he or she may not be able to complete some courses or programs successfully.
h. An assurance that the participant’s identity will remain confidential where possible.
8. Review and Approval Procedures
a. No activity which requires a written protocol shall be initiated until it has been reviewed and approved by the Department Coordinator, Division Chairperson, and the Vice President for Academic Affairs.
b. Before beginning an activity that requires written student consent, it shall be the responsibility of the instructor and the Division Chairperson to submit to the Vice President for Academic Affairs a description of the proposed activity and an informed consent form for participants for review and approval.
c. This policy implementation should become a part of the course adoption process, which will assure proper implementation of the policy. The course adoption form will be revised to include a check-off box if there are human participant activities and/or a requirement for a written protocol within the course. A new form needs to be designed to record the data required by this policy to be included with the initial course adoption form and with the three-year review if changes need to be documented.
9. Appeal Procedures
a. Students must inform instructors at the time of obtaining written consent of their refusal to participate and reasons for refusal.
b. If the instructor deems the student’s refusal and reasons to be valid, the instructor will excuse the student and provide an acceptable alternative activity if such an activity is necessary to the student’s success in the course.
c. If the instructor does not deem the student’s refusal and reason to be valid and does not waive the student’s participation, the student may appeal to the Division Chairperson.
d. The instructor shall advise the Division Chairperson of any individuals who are unwilling to participate in an approved activity.
e. The Division Chairperson, in consultation with the instructor, shall review the student’s objections by consulting the class and department requirements, and make appropriate adjustments if possible.
f. If a satisfactory resolution is not reached, the matter is referred tot eh Vice President for Academic Affairs for a final decision.
(Reviewed by the Assistant Attorney General 2/25/97)
Approved by Council on Councils 2/9/99
Approved by President Ed Command 3/31/2000