Chapter 22 - Education and Training
It is policy of the University of Pittsburgh IRB that all involved in the review, conduct and oversight of human subject research (investigators, research staff, key personnel, mentors, IRB members, IRB chairs and IRB staff) must complete initial and continuing education in human research protections.
General Initial Training and Education Requirements
The University of Pittsburgh HRP utilizes CITI (Collaborative Institutional Training Institute) as its human subjects training program. Individuals engaged in human subjects research, as well as faculty mentors, are required to complete the Responsible Conduct of Research course as well as one of the following human subjects courses:
- Biomedical Research (including all Health Science students)
- Social & Behavioral Research
- Undergraduate Student Research (Note: research must not be more than minimal risk)
Investigators and research team members who are engaged in the conduct, oversight or management of clinical trials (as defined by the NIH) are required to complete the CITI GCP training course regardless of funding before participating in any research activities. There are two GCP training courses available: GCP for Clinical Trials involving FDA regulated research and GCP for Clinical Trials Involving Behavioral or non-FDA regulated research. HRP considers research to be FDA-regulated if it falls under one of the following sections of the Federal Food, Drug, and Cosmetic Act: section 505 (New Drug Application) or 520 (Devices intended for human use). Clinical investigations that support applications for research or marketing permits for products regulated by the FDA, including food and color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products are also considered to be FDA-regulated research.
Investigators and study team members who will access medical records are required to take Privacy and Information Security.
There are a number of optional courses that are available through CITI and study teams can choose those when registering for the required courses.
Continuing Education Requirements
In order to meet Continuing Education Requirements, individuals engaged in human subjects research, as well as faculty mentors, must complete the CITI Refresher Course at least every four years with the exception of Good Clinical Practice which expires after three years. In addition, it is recommended that three hours of continuing education credit related to human subjects protection or ethical considerations in the conduct of human subject research be completed over a four year period. Examples of available programs include:
- Designated IRB-sponsored programs
- Other Modules through CITI
- Research Coordinator Orientation program
- Participation in a Research Investigator Start-up Education (RISE) Interview
- FDA Training Continuing Education Courses
- Attendance at IRB-approved bioethics programs
- Attendance at programs sponsored by PRIM&R or its affiliates on human subjects protections
Community Partners Research Ethics Training (CPRET)
As an alternative to the CITI training requirements, CPRET training is available through CTSI for community partners who are actively involved with research involving human subjects. This training is intended to permit study teams to tailor research ethics training for a specific study and to encourage dialogue with community members who will participate on the research team. Upon completion of the program, a certificate is provided to the community partner.
Educational requirements that are unique to various groups are outlined below: