The University of Pittsburgh IRB requires that investigators complete the human subjects training program developed by CITI (Collaborative Institutional Training Institute). 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).
All students, faculty and staff must complete specific training that may vary, depending on their discipline and research activities. University of Pittsburgh training draws on resources provided by the Collaborative Institutional Training Institute (CITI), as well as by University of Pittsburgh Internet-based Studies in Education & Research (ISER) where other modules including HIPAA are displayed. General training requirements are available at http://www.rcco.pitt.edu/ResearchTrainingRequirements.htm.
All Pitt/UPMC investigators must access CITI using a designated Pitt CITI Portal available at www.citi.pitt.edu. You will have the opportunity to merge an existing CITI account from another institution during the initial creation of your Pitt CITI account. If you completed CITI courses by affiliating with UPMC, you will need to merge your account when accessing the Pitt CITI portal. It is important to note that each institution selects specific modules for each course so it is possible that completion of courses from another institution may not meet all Pitt requirements and additional modules may be required. Credit is only provided for modules completed within the past two years and were not refresher courses. There are two documents available on the Pitt CITI Portal page, Pitt Training Requirements and an Instruction Sheet for Accessing and Navigating CITI. We strongly encourage you review the documents before initiating the courses.
It may take 24 hours after completion of all the required modules (including electives) before access to OSIRIS is granted. The IRB receives CITI completion reports every evening. Plan to devote approximately 3 to 5 hours to complete the entire curriculum, which can be taken over a period of time.
The IRB requires, at a minimum, that the Responsible Conduct of Research course (question 2) and the Human Subjects course which is displayed as the Basic/Refresher course (question 3) be completed before access to the IRB application (OSIRIS) is granted and before interactions/interventions with human subjects are permitted.
CITI offers three human subjects training courses. The user has the opportunity to select the course most relevant to their discipline.
- Biomedical Research (includes all health science students)
- Social & Behavioral Research
- Undergraduate Student Research (Note: not more than minimal risk research)
The National Institutes of Health (NIH) recently announced a new policy that requires Good Clinical Practice (GCP) training for all NIH funded “clinical trials” effective on January 1, 2017. The University is extending this requirement to all research studies that meet the definition of a clinical trial regardless of the funding source. All Investigators and research team members who are engaged in the conduct, oversight or management of clinical trials (as defined by the NIH) must complete the CITI GCP training course before they participate in any research activities effective January 1, 2017. Go to http://www.rcco.pitt.edu/gcp.html for more information.
Everyone will be required to complete Refresher Courses for the Responsible Conduct of Research and Human Subjects Research courses every 4 years. CITI will send an email reminder before the courses are due to expire. It is important to remember that current CITI certification must be maintained when conducting research with human subjects and it is the responsibility of the Principal Investigator to ensure that all members of the research team have completed required training. Key personnel is defined as any member of the research team who is interacting or intervening with research subjects or accessing their personally identifiable 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 firstname.lastname@example.org.
Continuing Education Credits
HRPO provides continuing education credits (CEUs) for all our programs through the UPMC Center for Continuing Education in the Health Sciences office. Credits are awarded only if attendees complete the CEU form available at the registration table for each event. Credit transcripts can be downloaded from the Center for Continuing Education website at https://ccehs.upmc.com/home.jsf.