Standard Operating Procedures - Chapter 19

EDUCATION AND TRAINING

19.1	Investigators
19.2	IRB Members

19.1 Investigators

Investigators seeking IRB approval must complete the minimum institutional requirements for education in human participant protection prior to participating in the conduct of research. This requires completion of the web-based tutorial for investigators, which provides an introduction to issues important to conducting human participant research, the ethical principles for human participant research, a review of the informed consent requirements, confidentiality and privacy of data and patient records, assessment of risks and benefits, regulatory requirements and institutional policies for protecting human participants and the process for review by the IRB.

The training is required for all key personnel who are involved in the design and/or conduct of the research, have access to human participants, and/or confidential and identifying information, including principal investigators, co-investigators, associates/assistants, students and other support staff or persons assisting with the research. The principal investigator is responsible for ensuring that he or she and the research staff complete the investigator tutorial, including taking and passing related quiz, before beginning to conduct the research. The proposed research study will not be approved until this basic education requirement is met.

19.2 IRB Members

Upon appointment to the IRB, new members undergo an orientation process, either individually or as a group to review procedures of the IRB and the general regulatory framework from which procedures and policies are derived. Instruction includes reviewing IRB member responsibilities, and excerpts from the OHRP Institutional Review Board (IRB) Guidebook, the Belmont Report, and other guidance documents.

Continuing IRB member education consists of education material (periodicals, news or journal articles on human participant protection), informational materials presented at the full meetings. In addition, opportunities to attend relevant regional and national workshops and conferences are also offered.