IRB Membership

POLICY

The membership of each IRB panel shall be compliant with federal regulations relating to the protection of human subjects research.  Each IRB panel shall be sufficiently qualified through the experience and expertise of its members (professional competence), 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.

Members will have varying backgrounds of scientific or scholarly expertise to promote complete and adequate review of research activities commonly conducted by the institution. Each IRB panel shall be knowledgeable and able to ascertain the acceptability of proposed research in terms of institutional commitments (including policies and procedures) and regulations, applicable law, and standards of professional conduct and practice.

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. Each IRB shall have at least one member not affiliated with the institution and not part of the immediate member of a family affiliated with the institution.

Each IRB that regularly reviews research that involves a category of subjects that is vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these categories of subjects.

IRB members are assigned to at least one IRB Panel. Members from any IRB Panel may serve as alternates on any of the other IRB Panels. Individuals who are responsible for business development including individuals from the Office of Sponsored Projects may not be voting members of CPHS.

PROCEDURE

Appointment of IRB members – Nominations for membership are received from many sources including self-nominations from individuals, recommendations from current members, recommendations from department chairs etc. Nominations for membership are submitted to the IRB Director or the VP HRPP with a copy of the current curriculum vitae and any relevant materials.

The CPHS Executive Committee shall discuss and shortlist candidates suitable for IRB Membership based on the types of research under CPHS oversight.

The  VP HRPP will send letter of invitation to the candidates. If the candidate accepts, he/she signs the acceptance letter and submits it to the IRB office.

Appointment of VP HRPP- VP HRPP is appointed by the Executive Vice President and Chief Academic Officer.

Appointment of the IRB Panel Chairs- The IRB panel chairs shall be designated from the IRB membership by the VP HRPP.

Reappointment of a IRB member to extend term – The research compliance staff provide detailed information on the current members of the IRB including review workload and meeting attendance to the Executive Committee.  The executive committee will also evaluate performance, commitment and responsibility of the members. The VP HRPP will evaluate performance, commitment and responsibility of the chairs of the IRB panels. The procedure for reappointment shall continue as above.

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.

APPLICABLE REGULATIONS

1. 45 CFR 46 Protection of Human Subjects
2. 21 CFR 56 Institutional Review Board
3. ICH E6 Good Clinical Practice Guidelines
4. SACHRP Recommendations IRB Membership

REFERENCES TO OTHER POLICIES

ATTACHMENTS

1. IRB Membership Roster

If` you find errors in this document, contact clinicaltrials@uth.tmc.edu

CPHS HELPLINE   713-500-7943
iRIS HELPLINE    713-500-7960
UTHealth’s Compliance Hotline (1-888-472-9868)

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