UT-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, 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.

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 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. 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.

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.

All CPHS 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.  The minutes for IRB meetings will designate members versus alternates in attendance.

Individuals who are responsible for business development including individuals from the Office of Sponsored Projects may not serve as members or ex-officio members of CPHS or be involved in the day to day operations of the IRB

PROCEDURE

Appointment of CPHS 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 CPHS Membership. The VP, HRPP will forward this list to the Executive Vice President for Academic and Research Affairs (EVPARA).

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

Appointment of the CPHS Executive Chairperson and Panel Chairs- The VP, HRPP and individual IRB panel chairs shall be designated from the CPHS membership by the Executive Vice President for Academic and Research Affairs.

Reappointment of a CPHS 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

2.       21 CFR 50

3.  UTHealth Handbook of Operating Procedures

REFERENCES TO OTHER POLICIES

1.       None.

ATTACHMENTS

1.       CPHS Membership Roster.

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

Document Number:

101-B02

Document Name:

CPHS Membership

Approved by:

Executive Director, Research Compliance 

Effective:

1 Aug 2008

Revision History:

1 Aug 2011, 1 Jun 2016, 1 Sept 2016


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

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Committee for the Protection of Human Subjects
6410 Fannin, Suite 1100
Houston, Texas 77030

Phone 713-500-7943
Fax     713-500-7951
Email cphs@uth.tmc.edu 

IRIS Support 713-500-7960

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