II.02

 

 

CPHS Membership

 

 

Previous Page

 

PURPOSE

1. This Policy and Procedure outlines the composition of The University of Texas Health Science Center at Houston (UTHealth) Committee for the Protection of Human Subjects (CPHS ).

SCOPE

2. This policy and procedure is applicable to membership of each IRB panel of CPHS.

POLICY

3. The membership of each IRB panel shall be compliant with federal regulations relating to the protection of human subjects research.

3.1. Each IRB panel 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.

3.2. Each IRB panel 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.

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

3.4. Each IRB individually shall meet the following membership requirements:

  1. A minimum of five members.
  2. At least one member whose primary concerns are in scientific areas.
  3. At least one member whose primary concerns are in nonscientific areas.
  4. The IRB Panel may not consist entirely of members of one profession.
  5. Every effort will be made to ensure that the IRB Panel does not consist entirely of men or entirely of women.
  6. 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.

3.5. 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.

3.6. All CPHS members are assigned to at least one IRB Panel. Members from any IRB Panel may serve as alternates on either of the other two IRB Panels. The minutes for IRB meetings will designate members versus alternates in attendance.

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

PROCEDURE

4. Appointment of CPHS members

4.1. Nominations for membership are submitted to the ORSC Director or Executive Chairperson with a copy of the current curriculum vitae and any relevant materials.

4.2. The Executive Committee shall discuss and shortlist candidates suitable for CPHS Membership. The Executive Chairperson will forward this list to the Executive Vice President for Research. The Executive Vice President for Research will review the list and recommend the selected individuals to the UTHealth Nominating Committee.

4.3. The Nominating Committee shall review and recommend to the President of UTHealth (ŇPresidentÓ) candidates for membership on the CPHS.

4.4. The President shall send a letter of invitation to the potential members. If the potential member accepts, he/she signs the acceptance letter and sends it to the President. The PresidentŐs office forwards a copy of the signed acceptance letter to the ORSC.

5. Appointment of the CPHS Executive Chairperson and Panel Chairpersons - The Executive Chairperson and individual Panel Chairpersons shall be designated from the CPHS membership by the President on recommendation from the Executive Vice President for Research.

6. Reappointment of a CPHS member to extend term Đ The ORSC Director or designated ORSC staff person will provide information on the memberŐs attendance at IRB Panel meetings to the Executive Committee. The IRB Chairperson will evaluate performance, commitment and responsibility of the members annually and shares this information with the Executive Committee. The Executive Chairperson will evaluate performance, commitment and responsibility of the Chairpersons of the IRB Panels annually. The Executive Chairperson provides written feedback to the members about their performance and participation in CPHS activities. The Executive Chairperson may send a copy of this letter to the memberŐs supervisor.

6.1. The procedure for reappointment shall continue as per 5 above.

7. Independent Consultant - 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 at the IRB Panel Meetings.

RESPONSIBILITY

8. The Executive Vice President for Research and Executive Chairperson are responsible for reviewing nominations for membership to the CPHS and making recommendation to the Nominating Committee.

9. The ORSC Director is responsible for ensuring that each IRB panel meets the requirements set forth in this policy.

10. The ORSC Director or designated ORSC staff is responsible for maintaining a current roster for each IRB panel. The ORSC Director is responsible for reporting any changes in the membership to OHRP.

 

Applicable Regulations and Guidelines

1. 45 CFR 46.102
2. 21 CFR 50.3
3. 38 CFR 16
4. ICH E6
5. UTHealth HOOP

Return to Policies and Procedures Home Page

Updated 2/2009, Report broken links