II.01

Committee for the Protection of Human Subjects Membership

Objective

This Policy and Procedure outlines the composition of The University of Texas Health Science Center at Houston (UTHSC-H) Committee for the Protection of Human Subjects (CPHS ) and is designed to ensure the membership is compliant with federal legislation and regulations relating to the protection of human subjects involved in research. The Objective is to assemble a Committee with the knowledge, skills, and expertise to function as an IRB.

Policy/Procedure

I. The CPHS as a whole and each IRB individually shall meet the following membership requirements.

A. Members shall be knowledgeable and able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice.

B. Each IRB shall have a minimum of five members.

C. Members will have varying backgrounds of scientific or scholarly expertise to promote complete and adequate review of research activities commonly conducted by the institution.

D. Each IRB shall have at least one member whose primary concerns are in scientific areas.

E. Each IRB shall have at least one member whose primary concerns are in nonscientific areas.

F. Each IRB shall have at least one member not affiliated with the institution and not an immediate member of a family affiliated with the institution (such individuals should be drawn from and represent the Houston metropolitan community). Affiliated members include but are not limited to individuals who are: part-time employees, current students; members of any governing panel or board of the institution; paid or unpaid consultants; healthcare providers holding credentials to practice at the institution; and volunteers working at the institution on business unrelated to the IRB. Individuals with no affiliation to the institution other than by serving on the IRB are considered unaffiliated.

G. Each IRB shall include one or more individuals who are knowledgeable about and experienced in working with any vulnerable human subject population (such as children, prisoners, pregnant women, or physically or mentally disabled persons) in which research is regularly reviewed.

H. The CPHS shall be sufficiently qualified through the experience, expertise and diversity of its members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.

I. The CPHS may not consist entirely of members of one profession.

J. Every effort will be made to ensure that the CPHS does not consist entirely of men or entirely of women. Qualified persons of both sexes will be considered, however, no selection will be made on the basis of gender.

K. Individuals from the Office of Sponsored Projects may not be voting members of CPHS.

L. While all CPHS members are assigned to at least one IRB, members from any of the three IRBs may serve as alternates on either of the other two IRBs. The minutes for IRB meetings will designate members versus alternates in attendance.

II. Appointment of CPHS members

A. Potential nominees’ information to be submitted to the executive chairperson shall contain at least

1. Current curriculum vitae;

2. Listing of board certifications, licenses, etc., sufficient to describe the nominee’s chief anticipated contributions to CPHS deliberations; and

3. Relationship between the member (or his/her family members) and the institution.

B. The CPHS Executive Committee, composed of the Executive Chairperson, the Chairperson and Vice Chair of each Panel and other members as deemed necessary, shall discuss the candidates and determine which will be presented for nomination for membership as members.

C. In May of each year, the Executive Chairperson will give the names of the recommended nominee(s) to the Executive Vice President for Research.

D. The Executive Vice President for Research shall recommend to the UTHSC-H Nominating Committee the list of names of member nominees.

E. The Nominating Committee shall consult appropriately and recommend to the President of UTHSC-H (“President”) candidates for membership on the CPHS.

F. The President shall send a letter of invitation to the potential members and when the signed letter of acceptance of appointment is received by the President and a copy is forwarded to the CPHS the appointment shall be in effect.

III. Appointment of the CPHS Executive Chairperson and Panel Chairpersons

A. The Executive Chairman and individual Panel Chairmen shall be designated from the CPHS membership by the President on recommendation from the Executive Vice President for Research.

IV. Reappointment of a CPHS member to extend term

A. The member will provide updated information as in II. A (1-3) above.

B. ORSC will provide the committee member’s meeting attendance report to the Executive Committee. The Executive Committee will also evaluate performance, commitment, and responsibility of the members.

C. Procedure shall continue as per II B-E above.

V. The CPHS may, at its discretion, invite individuals with competence in special areas to assist in the role of consultants in the review of complex issues which require expertise beyond or in addition to that available on the CPHS. These individuals may not vote with the CPHS.

Applicable Regulations and Guidelines

21CFR 50, 45CFR 46, ICH E6, 38CFR 16, UTHSC-H HOOP

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Updated 10/2007, Report broken links