II.01

 

 

Committee for the Protection of Human Subjects Membership

 

 

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PURPOSE

1. The purpose of this policy and procedure is to outline the composition and functions of the UTHealth CPHS Executive Committee.

SCOPE

2. This policy and procedure is applicable to CPHS Executive Committee members.

POLICY

3. 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.

4. Membership requirements

4.1. The Executive Committee will consist of at least five (5) members who collectively have the qualifications and experience to carry out the CommitteeÕs stated objectives and terms of reference.

4.2. The Executive Committee shall be composed of the Executive Chairperson of CPHS, the Chairpersons all IRB Panels and the ORSC Director. Additional members may be recruited by the Executive Chairperson.

5. 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. 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 Panels 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 UTHealth policies and procedures.
  9. Manage allegations of noncompliance by CPHS members.
  10. Manage allegations of undue influence to CPHS members and staff.

6. Executive Committee Meetings

6.1. 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.

6.2. The Executive Committee Secretary will prepare the meeting agenda and distribute to all members at least 2 days prior to each meeting. The Executive Committee Secretary will prepare the Executive Committee minutes for approval by the Executive Committee Chair and circulation to all members at the subsequent Executive Committee meeting. The minutes will include meeting attendance, approval of minutes from previous meeting, and actions taken by the Executive Committee on each agenda item. The Executive Committee Secretary will maintain a copy of the agenda, materials and the meeting minutes in the Executive Committee files.

6.3. Regular Updates - At each Executive Committee meeting, the Committee will be provided adequate information including:
a. Results of audit findings since previous Executive Committee meetings
b. Serious or Continuing Non Compliance issues since previous Executive Committee meetings

6.4. 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.

6.5. Undue Influence Ð CPHS Members and Staff must report any attempt to unduly influence the IRB PanelÕs 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.

7. Outreach Activities Ð 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.

8. Reporting Guidelines

8.1. The Executive Committee Secretary will ensure that the outcome of review of subject calls, non compliance, undue influence etc. are communicated if appropriate to the Institutional Official.

RESPONSIBILITY

9. The Executive Chairperson is responsible for conducting the Executive Committee Meeting and for ensuring that all items on the agenda are addressed and proceedings recorded.

 

 

Applicable Regulations and Guidelines

None

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