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 IRB staff members will spend their provisional period of employment (six months) under the direct supervision of the Manager of Operations 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 Institutional Review Board;
- University of Pittsburgh Research Conduct and Compliance Office;
- 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 Research Review Coordinator.
- Attend the Research Coordinators’ Orientation Program. 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 Manager of Operations and Associate Director make the determination if the research review coordinator has obtained sufficient experience to work independently. This will be documented in the employee record. All research review coordinators (full board and exempt and expedited) are members of the IRB.
IRB Staff members are expected to take part in additional continuing education activities as follows:
- As part of their professional development, IRB staff members are expected to continue their education. Each is offered the opportunity to attend (at a minimum) one local, regional, or national conference 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.