Use of Human Subjects in Instructional Activities

1300.330 USE OF HUMAN SUBJECTS IN INSTRUCTIONAL ACTIVITIES PROCEDURE

A. PURPOSE

The purpose of this procedure is to establish guidelines to meet the requirements for implementing policy 300.330—use of human subjects in instructional activities.

These practices and procedures for the conduct of academic activities involving human subjects are established in an effort to balance the college’s responsibility to protect the rights of individuals, to assure a favorable climate for the acquisition of practical skills and the conduct of academically oriented inquiry, and to protect the interests of the college.

B. WRITTEN PROTOCOL AND INFORMED CONSENT FORM

1. Instructors whose curriculum indicates the use of human subjects in the classroom or lab in an activity that creates a risk, as defined below, must establish a written protocol and an informed consent form with their appropriate program coordinator/program director/division chair and instructional dean.
2. The 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.

C. REVIEW AND APPROVAL

1. No activity which requires a written protocol shall be initiated until it has been reviewed and approved by the appropriate program coordinator/program director, division chair, instructional dean and the vice president of instruction.
2. Before beginning an activity that requires written student consent, it is the responsibility of the instructor and appropriate instructional dean to submit to the vice president of instruction a description of the proposed activity and an informed consent form for subjects for review and approval.

D. SUPERVISION

All activities which use human subjects and require a written protocol shall be conducted under supervision of a faculty member and/or administrator who assumes the responsibility for the conduct of approved activity.

E. INFORMED CONSENT

Students or others who act as human subjects in approved activities shall not do so unless they have first given their informed consent. If subjects are under the age of 18, written informed consent must be obtained from the parent or legal guardian unless the subject is determined to be an emancipated minor. The consent shall be a free-will choice obtained from the subject, parent or legal guardian, without undue inducement or any element of constraint or coercion. The basic elements of information necessary prior to such consent include:

1. Notification of the procedures to be followed, including a description of the attendant risks and discomforts to the subject. The subject and/or parent or legal guardian shall have up to seven days to consider whether or not to participate.
2. A description of the benefits to be expected or the knowledge to be gained.
3. A disclosure of appropriate alternative procedures, if available.
4. An offer to answer any questions the subject or representative may have concerning the activity.
5. An instruction that the subject is free to withdraw his or her consent at any time unless the procedure is required of the student to master a critical competence.
6. An assurance that the subject’s identity will remain confidential or a statement describing any disclosure that may be made.

F.  STUDENT PROGRAMS AND COURSES

Students who are being considered as human subjects shall be informed of the procedures involving human subjects at a reasonable time at the beginning of the course or program.

1. Students may withdraw from the course within a reasonable time after being notified of required participation in an activity he/she finds objectionable.
2. Students must inform instructors within seven days of obtaining written consent of their refusal to participate.
3. Students who do not give their consent to be a human subject may be given alternative learning experiences at the discretion of the instructor.
4. Students who choose neither to participate as a human subject nor to accept an alternative activity approved by the instructor will be informed that they may not be able to complete some courses or programs successfully.

G. APPEALS

1. Students who feel there is a conflict regarding the administration of the policy or this procedure with the instructor may appeal to the appropriate instructional dean.
2. The instructional dean, in consultation with the instructor, will review the student’s concerns with the class and department’s requirements, and make appropriate adjustments if possible.
3. If a satisfactory resolution is not reached, the matter is referred to the vice president of instruction for a final decision.

H. DEFINITIONS

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.

The use of human subjects in research studies conducted at WVC or involving WVC students or employees is governed by policy 000.250, protection of human subjects.

Approved by the president’s cabinet: 2/26/13
Presented to the board of trustees: 3/20/13
Procedure contact: Instruction

Related policies, procedures and other regulations:
100.330 Use of Human Subjects in Instructional Activities Policy
CFR 46.116 General Requirements for Informed Consent