Chapter 5 - Management of the HRP and IRB

Institutional Official

The Vice Chancellor for Research Protections has been delegated authority to serve as the Institutional Official by the Senior Vice Chancellor for Research who reports to the Chancellor of the University of Pittsburgh.

The HRP and IRB Committees are managed as determined by the Institutional Official.   Management on a day-to-day basis is carried out under the direction of the HRP Leadership Team   which consists of the IRB Chair, Director, and Associate Directors operating under broad delegated authority from the Institutional Official.
The Institutional Official ensures that adequate facilities, equipment, and resources are available to . support the IRB-related activities of the HRP Leadership Team, IRB Vice Chairs, and staff.  The Institutional Official is also responsible for approving organizational relationships with other institutions or sites where human subject research activities of University faculty, students or staff or UPMC staff may or will be conducted.

The HRP reports to the Institutional Official through the Office of Research Protections. The IRB Committees report to the Institutional Official through the IRB Chair.  

Legal Counsel

HRP staff consult regularly with the Office of University Counsel and UPMC Legal Counsel with respect to legal issues that arise during the review of human subject research. This includes a review of instances where HRP staff has identified a potential conflict between federal, state, and/or local laws, and determines whether federal has preempted state and/or local laws, or whether the conflict may be reconciled in a manner that avoids a direct conflict between federal and state laws.  

Appointment of IRB Chair and Vice Chairs

The IRB Chair and Vice Chairs will be appointed by the Institutional Official.

  1. In appointing the IRB Chair and Vice Chairs, primary consideration will be given to current or past members of the IRB.
  2. The IRB Chair should be a highly respected individual fully capable of managing the IRB committees and the matters brought before them with fairness and impartiality. This individual is charged with building and maintaining the institutional community's respect for the IRB.
  3. Vice Chairs are appointed based on previous experience as an IRB member and/or past experience in the conduct of human subject research.
  4. The terms of appointment of the IRB Chair and Vice Chairs are based on a contract and will be reassessed periodically by the Institutional Official.

Only the Institutional Official has the authority to terminate the appointment of the IRB Chair and Vice Chairs. Termination of appointment (by the Institutional Official) or resignation of appointment by the IRB Chair and Vice Chairs shall be subject to a minimum of 3 months advanced notice unless extenuating circumstances exist.

Responsibilities of the IRB Chair

The IRB Chair will hold leadership responsibility for IRB review and approval of human subject research in accordance with current guidelines, institutional policies, and federal and state regulations governing human subject protections.  In addition, the IRB Chair will:

  • Oversee the recruitment, orientation, continuing education and retention of IRB members;
  • Oversee implementation of appropriate policies, procedures and guidelines directed at human subject protections and the functions and activities of the IRB;
  • Peside over IRB Executive Committee (Committee F) meetings;
  • Oversee the communications of the IRB Executive Committee (Committee F) decisions, directives, and sanctions relating to known or suspected problems in the conduct of human subject research to involved investigators;
  • Have authority to request audits of human subject research activities;
  • Have the authority to suspend some or all research activities if exceptional human subject safety issues are identified. This authority is only exercised if an action is required prior to a convened meeting, and it is not feasible to assemble an emergency meeting.  When this authority is exercised, it will be reported at the next convened University IRB meeting;
  • Represent the IRB in interactions related to issues surrounding the ethical and regulatory compliant conduct of human subject research. Such interactions may involve:
    • University and UPMC investigators
    • University and UPMC administrators
    • University deans, department chairs, division or center directors
    • Other University and UPMC committees and offices involved in the oversight of human research studies
    • Applicable federal and state regulatory agencies.
  • Approve written correspondence to state and federal regulatory agencies having jurisdiction over human subject research prior to final approval and signature of the Institutional Official;
  • Represent the IRB at national and local meetings related to institutional review board activities and human subject protections.

All deans, department chairs, program directors, and/or other unit administrators of the institutional sites that fall under the authority of the HRP are responsible for ensuring that the human subject research activities of faculty, staff and students under their responsibility are carried out in compliance with HRP guidelines and directives.  These individuals take direction from the IRB Chair in fulfilling these responsibilities.

All research investigators involved in the conduct of human subject research that falls under the authority of the IRB take direction from the IRB Chair.

The IRB Chair receives support in the performance of their responsibilities from the IRB Vice Chairs, Legal Counsel to the IRB, and the HRP staff.

Responsibilities of the HRP Director

The HRP Director provides day-to-day oversight of the operations of the HRP staff.  In addition, the HRP Director is also responsible for the following:

  • The development and implementation of appropriate policies, procedures and guidelines directed at human subject protections and the functions and activities of the IRB;
  • Interactions related to issues surrounding the ethical and regulatory-compliant conduct of human subject research; Such interactions may involve:
    • University and UPMC investigators
    • University and UPMC administrators
    • University deans, department chairs, and division or center directors
    • Other University and UPMC committees and offices involved in the oversight of human research studies
    • Applicable federal and state regulatory agencies
  • The drafting of written correspondence to state and federal regulatory agencies having jurisdiction over human subject research activities.

The HRP Director serves as a member of the IRB Executive Committee (Committee F) and is also expected to represent the University of Pittsburgh at national and local meetings related to IRB activities and human subject protections.    

The HRP Director is also responsible for the employment and termination of HRP staff.

Responsibilities of the IRB Vice Chairs

A sufficient number of IRB Vice Chairs will be appointed to provide adequate support to the IRB Chair. The number of IRB Vice Chairs will be determined by the IRB Chair and Institutional Official based on the current number of IRB committees and volume of IRB submissions reviewed by the convened committees.

The primary responsibilities of the IRB Vice Chairs are to the assist the IRB Chair in the:

  • Leadership responsibility for IRB review and approval of human subject research studies in accordance with current guidelines, institutional polices, and federal and state regulations governing human subject protections;
  • Recruitment, orientation, continuing education and retention of IRB members;
  • Implementation of appropriate policies, procedures and guidelines directed at human subject protections and the functions and activities of the HRP.

In addition, Vice Chairs are to serve as voting members of the IRB and the IRB Executive Committee (Committee F). They are also expected to represent the University of Pittsburgh at national and local meetings related to IRB activities and human subject protections.

Evaluation of the Chair

The IRB Chair is evaluated on an annual basis by the Institutional Official. The basis for this evaluation includes, but is not limited to:

  • Knowledge and consistent application of the ethical principles of the Belmont Report and the federal regulations and HRP policies governing human subject protections;
  • Responsiveness to the concerns of IRB committee members;
  • Ability to interact constructively with and to manage the activities of the IRB Vice Chairs;
  • Ability to manage the efficient and effective conduct of IRB committee meetings;
  • Ability to interact with and achieve the respect of human subject investigators;
  • Ability to manage the functions of the HRP

Evaluation of Vice Chairs

The IRB Vice Chairs are evaluated on an annual basis by the IRB Chair. The basis for this evaluation includes, but is not limited to:

  • Knowledge and consistent application of the ethical principles of the Belmont Report and the federal regulations and IRB policies governing human subject protections
  • Responsiveness to the concerns of IRB committee members
  • Ability to manage the efficient and effective conduct of IRB committee meetings and post meeting activities
  • Ability to interact with and achieve the respect of human subject investigators.

Evaluation of HRP Staff

The HRP staff will be evaluated per polices of the University of Pittsburgh Department of Human Resources.

Compensation of the IRB Leadership and Staff

The IRB Chair and Vice Chairs will be compensated for their IRB duties and responsibilities. The rate of compensation is at the discretion of the Institutional Official and will consider the professional background of the individual and the expected time commitment of the appointed position to IRB activities.

The compensation of HRP staff is determined by the HRP Leadership in accordance with University policies.

Indemnification

University Policy AO 20 Faculty and Staff Indeminification sets forth the conditions under which indemnification and legal defense may be available to faculty and staff. Indemnification may be afforded to the IRB Chair, IRB Vice Chairs and HRP staff as set forth in that policy.

revised 4/26/21, 11/6/23