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Training and Education



Required Tutorials

For individuals engaged in human subjects research we offer two self-paced web-based Research Tutorials, the Collaborative Institutional Training Initiative (CITI) Human Research Protections Training Course and the HIPAA Research Tutorial. These tutorials review core concepts for the responsible conduct of research involving human subjects and guide users through the major principles for conducting research in a way that is consistent with federal and University requirements and with accepted scientific standards.  Completion of the following tutorials is required for individuals (i.e., Lead Researcher, Co-Investigators, Research Personnel and Faculty Sponsors) who wish to engage in human subject research at UCI before submission of IRB documentation.

CITI Human Research Protections Training Course

UCI offers two versions of the Basic Human Research Training course: one for Biomedical Investigators and one for Social & Behavioral Investigators. Individuals choose the course that best matches their research activities. A CITI Refresher course is required every 5 years to ensure ongoing education about human research protections. There are also two versions of the refresher course.

How to Enroll in the UCI CITI Human Research Protections Course

UCI students, staff, faculty and research personnel will be able to log in to the Collaborative Institutional Training Initiative (CITI) website using their UCINetID and password.  This process, known as Single Sign-On or SSO, provides distinct advantages over the old system of individual account access:

  • Enhanced security
  • No additional Username/Password for users to remember
  • Automatic log-in if you have already authenticated yourself with your UCINetID on another page
  • Training records linked more accurately with internal Research Protections databases
  • Easy registration for new members – personal information automatically transfers from your UCI record to CITI
  • For those already registered with CITI:  new CITI login and course enrollment step-by-step instructions 
  • For those that need to register with CITI: new CITI login and course enrollment step-by-step instructions

Note: For new researchers without a UCINetID, please visit the FAQ page for registration instructions.

The Basic and Refresher Courses require approximately two hours to complete. The modules may be completed over multiple sessions. You must complete a module and the related quiz before you log out of a session. If you do not complete the module, you will be required to take it again.  The minimum "passing" aggregate score is 80%.  A passing score is based on the whole course, and not on the individual modules within a course.  When your Grade Book gives you an option to print a "Completion Report," it means you passed the course. A running tally is compiled in the Grade Book. If you want to improve a score on a quiz, you may repeat the module and the quiz.  You can print or download a Course Completion Report as evidence of completion. You can view or print your completion reports any time by logging into CITI.

Frequently Asked Questions (FAQs) and Registration Instructions



NIH Policy on GCP Training for NIH-Funded Clinical Trials

On September 16, 2016, the National Institutes of Health (NIH) issued a new policy (Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials; NOT-OD-16-148) that specifies NIH-funded investigators and staff should be trained in Good Clinical Practice (GCP). 

  • Who does this policy apply to?
    • The NIH (2016) policy states that all NIH-funded investigators and staff “who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2)."
  • When is this policy effective?
    • This policy takes effect January 1, 2017
    • A refresher GCP course should be completed every 3 years.
  • CITI GCP Training
    • CITI provides the following GCP courses:
      • Good Clinical Practice (US FDA focus), and Refresher Course
      • GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus), and a Refresher Course
      • GCP for Clinical Investigations of Device, and a Refresher Course
  • Additional Guidance on the NIH Policy and CITI Instructions



NIH Best Practices for Clinical Trials using Behavioral Interventions and Social Science Research (SBE GCP)

In September 2016, the NIH issued a Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials.  Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials.  The principles of GCP help assure the safety, integrity, and quality of clinical trials.  Investigators and clinical trial staff who are competent in GCP principles will be better able to assure that the rights, safety and well-being of human subjects are protected; that clinical trials are conducted in accordance with approved plans and with rigor and integrity, and that data derived from clinical trials are reliable.

The National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH), through the Clinical and Translational Science Awards (CTSA) Program initiated a project in 2014 to streamline and standardize GCP training for clinical study personnel, including researchers conducting clinical trials. Ample GCP training exists for investigators conducting drug-, device-, or biologic-related studies, but it does not address clinical trials using behavioral interventions and social science research.

The CTSA Program project team recognized a critical need for training in applying GCP principles to social and behavioral research and thus developed the Best Practices in Social and Behavioral Research e-Learning Course for GCP to fill the gap. In 2016, the Best Practices in Social and Behavioral Research Course e-Learning Course for GCP was released to provide researchers with training that applies GCP principles to social and behavioral research.

HIPAA Research Tutorial

The HIPAA Research Tutorial is required for individuals engaged in Human Subjects Research and whose research involves access, use, creation, or disclosure of Protected/Personal Health Information. This tutorial is UC specific and must be taken for credit. The UCI IRB will not accept completion of HIPAA Research tutorials from other institutions.  In order to receive credit for completing a tutorial, UCI faculty, staff and students must use their UCINetID (UCI Network ID). The tutorial can also be taken anonymously to practice or review core concepts.

Videos

OHRP has developed educational videos on a variety of topics regarding the regulations for the protection of human subjects of research (45 CFR Part 46). Each video is approximately 20-25 minutes in length.

News Briefs

Responsible Conduct of Research

In-Service Training Requests

  • To request an inservice by a member of Human Research Protections staff, visit this web page and submit a request.
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