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  1. Policies & Procedures

IRB Staff Training

Initial Education and Orientation

New hires to the University of Pittsburgh must complete a general orientation conducted by the University of Pittsburgh, Office of Human Resources.  The University orientation is an introduction to the University working environment and includes an overview of University policies and procedures, employment expectations, performance and relationships, and mandatory training requirements set forth by the University.

New HRP staff members will spend their provisional period of employment (six months) under the direct supervision of the Director and Associate Director and will be oriented to the following:

  • The Belmont Report;
  • Federal Regulations (DHHS 45 CFR 46 and FDA 21 CFR 50 and 56);
  • Full Board Committee Review Process;
  • Expedited Review Process;
  • Exempt Review Process;
  • University of Pittsburgh IRB Policies and Procedures;
  • Job Description and Core Duties;
  • Performance Evaluation Process.

Overview of reference websites which include the following:

  • University of Pittsburgh Human Research Protection;
  • University of Pittsburgh Office of Research Protections;
  • Office for Human Research Protections;
  • Food and Drug Administration;
  • Health Insurance Portability and Accountability Act (HIPAA);
  • Public Responsibility in Medicine and Research (PRIM&R).

New staff must also fulfill the following requirements:

  • Complete additional courses on IRB Member Education, Good Clinical Practice, and Conflict of Interest
  • Observe at least three IRB Committee meetings during the first three months of employment.  The new staff member will then review the minutes from the committee meeting with the assigned IRB Coordinator.
  • Attend the Orientation to Research Fundamentals offered by the Clinical and Translational Science Institute (CTSI).  This course consists of an overview of human subject research, a description of the ethical principles underlying the concept of human subject research, and an overview of the federal regulations governing IRB operations and human subject research.

After completion of the outlined training procedures, the Director and Associate Director make the determination if the IRB Coordinator has obtained sufficient experience to work independently.  This will be documented in the employee record.  All IRB Coordinators are listed as members of the IRB on the roster submitted to OHRP. 

Continuing Education

HRP Staff members are expected to take part in additional continuing education activities as follows:

  • As part of their professional development, HRP staff members are expected to continue their education.  Each is offered the opportunity to attend  local, regional, or national conferences in human subject protection during each year of employment. The office routinely subscribes to webinars for the staff and invites guest speakers to address the staff at several time points throughout the year.
  • It is expected that staff obtain the Certified IRB Professional (CIP) certificate after three years of employment;

5/10/2021