Committee For the Protection of Human Subjects

IRB Member Duties and Responsibilities

POLICY

The primary duty of CPHS is the protection of the rights, safety and welfare of human research subjects in accordance with the principles outlined in the Belmont Report. In order to fulfill this duty, CPHS members are expected to be familiar with CPHS Policies and Procedures.

CPHS Terms of Reference

§  To provide an independent and timely review of proposals to conduct research involving UTHSC-H patients, staff, facilities and / or being conducted on UTHSC-H premises.

§  CPHS shall have the authority to approve research proposals, request modifications to secure approval, and disapprove all research activities overseen and conducted by UTHSC-H.

§  Research that has not been approved or has been disapproved by the CPHS may not be conducted in UTHSC-H or by UTHSC-H staff.

§  CPHS shall have the authority to suspend or terminate approval of research that is not conducted in accordance with the CPHS’s requirements or that has been associated with unexpected serious harm to research subjects.

§  CPHS shall have the authority to observe or have a third party observe the conduct of the research including the consent process.

 

Responsibilities of the Chairperson (in addition to responsibilities of members)

§  Chair IRB Panel Meetings;

§  Adhere to and administer Board decisions;

§  Maintain the independence of the Board;

§  Be knowledgeable and up to date about relevant regulations and policy;

§  Participate in the resolution of controversial substantive or procedural matters;

§  To suspend the conduct of a study if he/she determines that an Investigator is not following CPHS’s requirements;

§  The Chairperson may delegate any of his/her responsibilities as appropriate to other qualified individual(s).

§  Report any undue influence to the Executive Committee or Executive Chairperson. The Executive Chairperson may report undue influence to the EVPARA.

 

Members

§  Attend regularly scheduled CPHS meetings either in person or via teleconference;

§  Review all research proposals/materials received prior to the meetings;

§  Actively participate in discussions at Board meetings;

§  Nonaffiliated members are expected to provide input regarding their knowledge about the local community and be willing to discuss issues and research from that perspective;

§  Nonscientific members are expected to provide input on areas germane to their knowledge, expertise and experience, professional and otherwise;

§  Scientific members are expected to contribute to the evaluation of a study on its scientific and statistical merits and standards of practice;

§  Vote to approve, disapprove, abstain, or request for modifications based on the regulatory requirements (unless a conflict of interest exists);

§  Maintain confidentiality of Board discussions and all materials included in the meeting;

§  Keep abreast of regulations and policies pertaining to human research; and

§  Report any undue influence to the Chairperson.

 

Sub-Committee Reviewers

§  In addition to the responsibilities of members, each member will be expected to act as a sub-committee reviewer for assigned studies at convened meetings. 

§  The sub-committee must perform an in depth review of assigned material and present an assessment of the scientific merits and safety of the research proposal and recommend specific actions to CPHS. 

§  The Sub-Committee Chairperson will lead CPHS discussion of the study. 

§  The Sub-Committee may be required to review additional material requested by the CPHS for the purpose of study approval.

 

CPHS Office Staff

§  Ensure that submitted research protocols are reviewed efficiently and consistent with the regulations, guidelines and policies.

§  Screen and process all applications and correspondence received by the review board.

§  Serve as a resource for Investigators and researchers regarding implementation of IRB policies, procedures and forms.

§  Ensure that Review Board’s meetings are properly conducted, including meeting agendas, ensuring quorum, documenting minutes and follow up action including correspondence to Investigators / Sponsors.

§  Report any undue influence to the CPHS Director or to the Executive Chairperson

PROCEDURE

The IRB Chairperson should notify all the members of their responsibilities. When a new member joins the IRB, the IRB Chairperson should discuss with them the terms of reference of IRB and their individual responsibilities.

The IRB Chairperson should ensure that board members are carrying out their expected functions and that there is adequate staff support to ensure that members are able to function as documented.

If the IRB Chairperson feels that staff support is not adequate, he / she is responsible for bringing this issue up to the Executive Committee. 

Training – New members are invited to attend a briefing conducted by one of the IRB Panel Chairs and the IRB Staff. The new members are assigned to sub-committees with experienced IRB Members for mentoring. New members also attend a comprehensive in-service within a few months of joining the IRB.

Members and Staff are encouraged to attend local conferences and seminars and several members and staff receive sponsorship for attending annual national conferences.

IRB Chairs update members on changes to regulations and guidance documents. CPHS Staff circulate relevant articles of interest to all members with monthly agenda.

 

APPLICABLE REGULATIONS

1.       45 CFR §46.109(a)

2.       45 CFR §46.109(e),

3.       45 CFR §46.113

4.       21 CFR §56.109(a)

5.       21 CFR §56.109(e)

6.       21 CFR §56.113

 

REFERENCES TO OTHER POLICIES

1. None

ATTACHMENTS

1. None

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

 

Document Number:

101-B05

Document Name:

CPHS Members Duties and Responsibilities

Approved by:

ORSC Director

Effective:

1 Aug 2008

Revision History:

1 Aug 2011

 

 


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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