The University of Pittsburgh IRB requires investigators to complete the human subjects training program developed by CITI (Collaborative Institutional Training Institute). Because CITI is so widely used, Pitt/UPMC investigators who fulfill the requirements will likely meet most or all of the training requirements 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). Detailed information on training requirements is available on the Office of Research Protections (ORP) website.
All Pitt/UPMC investigators must access CITI using a designated Pitt CITI Portal available at www.citi.pitt.edu. Learners do have the opportunity to merge an existing CITI account from another institution during the initial creation of the Pitt CITI account. Credit for modules completed at other institutions may transfer but only if completed within the past two years and were not refresher courses. Learners are strongly encouraged to review the training requirements document on the ORP website before selecting their CITI curriculum.
It may take 24-48 hours after completion of the required modules before access to the IRB application is granted since reports are generated nightly. Plan to devote approximately 3 to 5 hours to complete the entire curriculum, which can be taken over a period of time.
For human subject research, please start with the CITI training portal.
At a minimum, the IRB requires successful completion of the Responsible Conduct of Research course and one of the Human Subject courses prior to accessing the IRB application (OSIRIS) and prior to any interactions/interventions with human subjects or identifiable private information. It is the Principal Investigator's responsibility to ensure that all members of the study team complete the required training based on the research being conducted and complete the refresher courses before they expire.
CITI offers two human subjects training courses. The learner has the opportunity to select the course most relevant to their discipline.
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.
All Learners will be required to complete Refresher Courses for the Responsible Conduct of Research and Human Subjects Research courses every 4 years. Learners required to complete the GCP course must complete the Refresher Courses every 3 years. CITI will send an email reminder before the courses are due to expire. It is important to remember that current training certifications must be maintained throughout the conduct of the research and cannot be expired at any time during the research process.
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.
Clinical Protocol Complexity: Negative Impact and Opportunities to Improve Study Success
Kenneth Getz, MBA
Director of Sponsored Research & Associate Professor
Tufts Center for the Study of Drug Development
Tufts University School of Medicine
April 16, 2015
During the past several decades, the scope and administration burden of industry-funded clinical trial protocols has increased dramatically. This talk reviews more than a decade of scholarly study conducted by a research team at Tufts University School of Medicine. Trends in the scientific and operating complexity of protocol designs will be discussed. The impact of protocol complexity on clinical trial durations and patient recruitment and retention effectiveness will also be presented. The talk will culminate with a discussion of new opportunities to optimize study design and improve study feasibility and success.
International Research: Logistical and Ethical Considerations
Theresa Colecchia, JD
Michelle LeMenager, BS, CIP
February 24, 2015
As the world becomes more accessible through technology and networking, international research activities are increasing in the academic arena. This program will provide specific information for faculty and students who are planning to conduct international research now or in the future. It is highly recommended that all faculty mentors who will be advising students going abroad attend this session. Ms. Colecchia will discuss administrative, legal and financial policies when conducting research in a foreign location. Ms. LeMenager will provide an overview of IRB considerations which include federal regulations, local ethics review, familiarity with the local culture and norms, in-country collaborators, and a meaningful consent process.