Committee For the Protection of Human Subjects

CPHS Executive Committee

POLICY

The CPHS Executive Committee (hereafter referred to as Executive Committee) will oversee the operations of the IRB Panels of the CPHS (hereafter referred to as IRB), and set policies and guidelines for research ethics in UTHSC-H.

Membership requirements - The Executive Committee will consist of at least five (5) members who collectively have the qualifications and experience to carry out the Committee’s stated objectives and terms of reference. The Executive Committee shall be composed of the Executive Chairperson of CPHS, the Chairpersons and Vice Chairpersons all IRB Panels and the ORSC Director. Additional members may be recruited by the Executive Chairperson.

Charge of the Executive Committee

1.       To establish, administer and oversee the UTHSC-H Human Subjects Protection Program.

2.       Develop, implement and maintain a set of written policies and procedures relevant to human subjects protections.

3.       Provide oversight to IRB Panels.

4.       Ensure that the composition of the IRB Panels meets regulatory requirements. Propose nominees for appointment to each IRB Panel.

5.       Evaluate whether the number of boards is appropriate to the volume and types of human research reviewed so that reviews are accomplished in a thorough and timely manner. Evaluate the workload of each IRB Panel and re-distribute workload when there is an imbalance.

6.       Ensure that the IRB Panels have adequate resources to perform their duties.

7.       Ensure that members of the IRB Panels are given adequate training opportunities to perform their roles.

8.       Manage allegations of investigator and research staff noncompliance with approved protocol or UTHSC-H policies and procedures.

9.       Manage allegations of noncompliance by CPHS members.

10.   Manage allegations of undue influence to CPHS members and staff.

PROCEDURE

Executive Committee Meetings - The Executive Committee will meet at a convened meeting at least once a month. If necessary, the Executive Committee will meet at more frequent intervals.

Regular Updates - At each Executive Committee meeting, the Committee will be provided information on any serious or continuing non compliance issues since previous Executive Committee meetings

HRPP Policies and Procedures Updates - The ORSC Director will submit amended / new chapters to the Executive Committee members for comments and suggestions. When necessary, the Executive Committee will seek advice from legal counsel.

Undue Influence – CPHS Members and Staff must report any attempt to unduly influence the IRB Panel’s decision making process to the Executive Chairperson. The Executive Chairperson will review the information and may seek additional information as necessary. The Executive Committee Secretary will include this issue for discussion at the subsequent Executive Committee meeting. The Executive Committee will deliberate on the issue and the outcome of review. If deemed necessary, the Executive Committee will notify the Institutional Official, who has the authority to determine the appropriate action.

UT Houston officials may not approve human subjects research that has not been approved by CPHS, however institutional officials may disapprove research that has been approved by CPHS.

Outreach Activities – The ORSC Director will submit a report of the outreach activities. The Executive Committee will review ongoing outreach activities to evaluate if they are adequate. The Executive Committee will also recommend if the additional activities must be implemented for outreach to investigators, research staff and community.

APPLICABLE REGULATIONS

1.       None.

RELEVANT AAHRPP ELEMENTS

1.       I.3.B

REFERENCES TO OTHER POLICIES

1.       None.

ATTACHMENTS

1.       None.

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

 

Document Number:

101-B01

Document Name:

Executive Committee

Approved by:

ORSC Director

Effective:

1 Aug 2008

Revision History:

1 Aug 2011

 

 

 


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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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