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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 UTHealth.

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(who is also the VP, HRPP), the Chairpersons and Vice Chairpersons all IRB Panels and the IRB Director. Additional members may be recruited by the Executive Chairperson.

Charge of the Executive Committee

  1. To establish, administer and oversee the UTHealth 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. 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 and make recommendations to the VP Research.
  5. Evaluate the workload of each IRB Panel and make adjustments as needed.
  6. Ensure that members of the IRB Panels are given adequate training opportunities to perform their roles.
  7. Manage allegations of investigator and research staff noncompliance with approved protocol or UTHealth policies and procedures.
  8. Manage allegations of noncompliance by IRB members.
  9. Manage allegations of undue influence to IRB members and staff.

PROCEDURE

Executive Committee Meetings - The Executive Committee will meet at a convened meeting at least once a month. When there are no new items for discussion, the Executive Committee chair person may cancel the meeting. 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 IRB Director will submit new policies and procedures and any substantive changes to existing policies and procedures to the Executive Committee members for comments and suggestions. When necessary, the Executive Committee will seek advice from legal counsel.

Undue Influence – IRB Members and staff must report any attempt to unduly influence the IRB Panel’s decision making process to the VP HRPP. The VP HRRP will review the information and may seek additional information as necessary and determine appropriate course of action. The VP HRPP will include this issue for discussion at the subsequent Executive Committee meeting.

UTHealth 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 IRB 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. (this is required under Element I.1.B)

APPLICABLE REGULATIONS

REFERENCES TO OTHER POLICIES

ATTACHMENTS

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

 

Document Number:

101-B01

Document Name:

Executive Committee

Reviewed by:

Executive Director, Research Compliance

Effective:

1 Aug 2008

Revision History:

1 Aug 2011, 1 Jun 2016, 21 Jan 2019, 1 Jun 2021

 

 

 




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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