Overview

The University of Pittsburgh IRB has migrated to a new human subjects training program that has been developed by CITI (Collaborative Institutional Training Institute). As of March 5, 2012, this program will replace “Module 1 –Research Integrity” and “Module 2 – Human Subjects Research” that have been required by the Pitt IRB for more than 10 years. CITI training modules have become the de facto standard around the world. Because they are so widely used, Pitt/UPMC investigators who complete our new requirements will likely meet most or all of the training requirements that are mandated at other institutions (including the VA Healthcare System) or by certain funding agencies (including the Department of Defense).

We have tailored 3 somewhat different CITI course curricula, based on the background of our researchers, and the types of studies they plan to conduct. For each of these three ‘user groups’ there are a series of required modules that focus on human subjects protections, as well as a series that are more broadly directed at the responsible conduct of research. In addition, all users are required to complete two elective modules on topics that interest them, drawn from a large library of topics.

Access to OSIRIS will not be granted without successful completion of all modules (including electives) required for each user group (see Timetable, below). It may take up to 3 to 5 hours to complete the entire curriculum, which can be taken over a period of time. Re-certification will be required every 3 years and a briefer CITI ‘Refresher Couse’ will be available at that time.

Designated User Groups

• Biomedical Researcher (including all Health Science students)
• Social & Behavioral Researcher
• Undergraduate Student Researcher

All key personnel who are involved in the conduct of FDA-regulated studies MUST ALSO complete the Good Clinical Practice (GCP) curriculum before beginning an FDA-regulated study.

Timetable

New OSIRIS users (i.e., students, faculty or staff who have not completed modules 1 and 2 by March 4, 2012) must complete the CITI training prior to obtaining access to OSIRIS.

Current OSIRIS users (i.e., those who completed modules 1 and 2 at some time in the past) have one year to complete these new requirements (by March 31, 2013).

After March 31, 2013, no individual can be listed on an IRB protocol or can obtain access to OSIRIS unless the required CITI modules are completed.

More Information

For direct access to the new training portal for human subjects research, click here. Links are also available from the OSIRIS home page. More detailed information, including a series of FAQs, are also available. Researchers who are having difficulty accessing or navigating the site should e-mail irb@pitt.edu. Faculty members who have specific questions about these changes are welcome to contact the IRB Director, Christopher Ryan, at ryancm@upmc.edu.

Click here for Guidance regarding requirements and recommendations on who must complete training courses on other topics.