Training Requirements for All Faculty, Students, and Staff Conducting Research
with Human Subjects at the University of Pittsburgh or UPMC
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
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
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.
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 firstname.lastname@example.org. Faculty members
who have specific questions about these changes are welcome to contact the IRB Director,
Christopher Ryan, at email@example.com.
Click here for Guidance regarding requirements and recommendations on who
must complete training courses on other topics.