Chapter 5 - Management of the HRPO and IRB

Institutional Official

The Chancellor, University of Pittsburgh, has delegated authority and responsibility for the University’s human research protection program to the Vice Provost for Research Conduct and Compliance (i.e., the Institutional Official).

The HRPO 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 HRPO Leadership Team which consists of the IRB Chair, Director of Regulatory Affairs, Associate Director of Education, and Manager of Operations, 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 HRPO Leadership Team, IRB Vice Chairs, Medical Director, and IRB Office staff. The Institutional Official is also responsible for approving organizational relationships with other institutions or sites wherein the human subject research activities of University faculty, students or staff or UPMC staff may or will be conducted.

The HRPO reports to the Institutional Official through the Research Conduct and Compliance Office.  The IRB Committees report to the Institutional Official through the IRB Chair.

Appointment of IRB Chair, Vice Chairs and Medical Director

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

  1. In appointing the IRB Chair, IRB Vice Chairs, and Medical Director; primary consideration will be given to current or past members of the IRB.
  2. The IRB Chair should be highly respected individuals fully capable of managing the IRB and the matters brought before it with fairness and impartiality. The task of making the IRB a respected part of the institutional community will fall primarily on the shoulders of these individuals.
  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, IRB Vice Chairs, and Medical Director 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, IRB Vice Chairs, or Medical Director. Termination of appointment (i.e., by the Institutional Official) or resignation of appointment by the IRB Chair, IRB Vice Chairs, or Medical Director 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 the development and implementation of appropriate policies, procedures and guidelines directed at human subject protections and the functions and activities of the IRB. The IRB Chair or his designee is responsible for reviewing the IRB’s policies and procedures for currency, accuracy and consistency on an ongoing basis but not less than every three years. Ad hoc committees will be formed to review guidance issued by regulatory agencies to determine whether updates to the policies and procedures are required;
  • reside over IRB Executive Committee (Committee F) meetings;
  • communicate 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. (Note that 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 regulation-compliant conduct of human subject research; such interactions involving:
    • 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 HRPO are responsible for ensuring that the human subject research activities of faculty, staff and students under their span of responsibility are carried out in compliance with IRB 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 his/her responsibilities from the IRB Vice Chairs, the Medical Director, Legal Counsel to the IRB, the HRPO staff and the Co-Director of the RCCO.

The IRB Chair, in consultation with the Manager of Operations, is also responsible for the development and maintenance of the budget, as well as employment and termination of HRPO Office staff

Responsibilities of the Medical Director

The primary responsibilites of the Medical Director are:

  • assume some or all responsibilities noted above at the descretion of the IRB Chair
  • consult as needed with the research community as well as the HRPO 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 qualifying for administrative (i.e., expedited) IRB review versus full board consideration.

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;
  • development and implementation of appropriate policies, procedures and guidelines directed at human subject protections and the functions and activities of the IRB.

In addition, vice chairs are to serve as voting members of the IRB. 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 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 HRPO 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 HRPO

Evaluation of Vice Chairs and Medical Director

The IRB Vice Chairs and Medical Director 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 IRB Staff

The HRPO 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, IRB Vice Chairs, and Medical Director will be compensated for their IRB duties and responsibilities. The rate of compensation is at the discretion of the Institutional Official and will take into account the professional background of the individual and the expected time commitment of the appointed position to IRB activities.

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

Indemnification

University Policy 07-06-06 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, Medical Director, and HRPO staff as set forth in that policy.

version 8.14.2015