COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS

Academic Senate Policy 4H (approved January 1987)

Throughout the policy:  change

Director of Research and Professional Development

to

the Associate Vice President for Research and Sponsored Programs and the Graduate Dean,

3.0  COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS

 

The Committee for the Protection of Human Subjects (CPHS) is a standing administrative committee of the university. The CPHS is administratively responsible to the Director of Research and Professional Development who serves as the director of university researchAssociate Vice President for Research and Sponsored Programs and the Graduate Dean.

3.1  MEMBERSHIP AND APPOINTMENT

The committee membership shall at all times be in compliance with federal regulations related to Human Subjects research.   The committee's membership shall include at least seven (7) persons.  These persons shall have varying backgrounds including consideration of both race and culture, and shall include persons with knowledge of applicable law and of appropriate professional standards.  Both sexes should  shall be represented.  At least one member will shall have non-scientific areas as a primary concern.  One member of the committee must shall be a community representative and, as such, may shall not be an employee or related to an employee of the CSU. No member shall be involved in either the initial or continuing review of an activity in which the member has a conflicting interest, except to provide information to the committee. When considering certain types of activities, e.g., investigation of new drugs on prisoners, the Director of Research and Professional Development Associate Vice President for Research and Sponsored Programs and the Graduate Dean shall appoint additional members (as required by HHS regulations) for those reviews only.  All such changes in membership will shall be reported to HHS and to the Executive Committee of the Academic Senate.  Where the subject of research is a fetus, a pregnant woman, a prisoner, or involves human in vitro in vitro fertilization or any other activity covered by federal requirements, the additional requirements of 45 CFR 46, subparts B and Call relevant federal requirements will shall apply.

The Associate Vice President for Research and Sponsored Programs and the Graduate Dean, rRepresentatives of the Office of the President, the San Francisco State University Foundation, Inc., and the executive secretary appointed committee coordinator shall be ex-officio members serve ex officio but without vote.

The Director of Research and Professional Development shall appoint committee members with the concurrence of the Executive Committee of the Academic Senate for three year terms The Associate Vice President for Research and Sponsored Programs and the Graduate Dean shall nominate committee members for approval by the Executive Committee of the Academic Senate.  Committee members shall be appointed to three-year, staggered terms.  In the case of faculty appointments, the Director of Research and Professional Development will Associate Vice President for Research and Sponsored Programs and the Graduate Dean shall consult with the faculty member's department chair regarding his/her qualifications to serve on the Committee for the Protection of Human Subjects.

The duties assigned to Associate Vice President for Research and Sponsored Programs and Graduate Dean shall fall to the administrators assigned to those responsibilities, regardless of formal title.

3.2  Committee Rules

The committee will elect a chair annually. The Chair of the Committee shall be nominated annually by the Associate Vice President for Research and Sponsored Programs and the Graduate Dean from the committee membership, for approval by the Executive Committee of the Academic Senate.  The Chair shall be a tenured faculty member with experience in research using human subjects.

The CPHS meets shall meet at least once a month during the academic year, or more often if necessary. If an emergency meeting is necessary in order that the CPHS's actions conform to any aspect of HHS policy, such a meeting will  shall be called by the chair.

A quorum of the CPHS is defined as shall be a majority of the total voting membership. In order for official committee business to be conducted, a quorum must be present. In order to review proposed research, the quorum must include at least one member whose principal concerns are in non-scientific areas. Research must be approved by a majority of those members present at the meeting.

Members shall be excluded from reviews of projects or activities in which they have an active role or a conflict of interest, except to provide information to the committee.

The Associate Vice President for Research and Sponsored Programs and the Graduate Dean may appoint a committee coordinator to assist the committee with its work.

3.3.  Committee Charge

The Committee shall determine that each activity is planned so that: