Initial IRB Training Requirement: Who, What, When FAQs
What training is required for the IRB to approve human research protocols?
The University of Kentucky's Human Subject Protection (HSP) training requirement, initially implemented in 2000, requires all study personnel conducting research involving living human subjects, or data or biological specimens derived there from, to be trained in the protection of human subjects initially and complete refresher training every three years. IRB policy also requires mandatory sponsor-investigator training course for investigators who are also serving as sponsors for an FDA regulated clinical investigation. The Collaborative Institutional Training Initiative (CITI), a learning management platform, is the sole source for initial HSP training and the primary source for refresher HSP and sponsor-investigator training. Instructions for creating a user account on CITI are available on the CITI User Information FAQs webpage and instructions for enrolling in the initial HSP course are available on the Initial CITI HSP Training for Approval FAQs webpage.
Is the Human Subjects Protection (HSP) requirement the same as the Responsible Conduct of Research (RCR) requirement?
No, they are two separate requirements.
The University of Kentucky's HSP training requirement requires all study personnel conducting research involving living human subjects, or data or biological specimens derived there from, to be trained in the protection of human subjects initially and complete refresher training every three years. This training must be completed before an IRB protocol will be approved by the UK Institutional Review Board (IRB).
The RCR training requirement is mandated by the Vice President for Research (VPR). The mandatory RCR training applies to all full-time faculty, staff, graduate students or trainees (undergraduates, postdoctoral fellows, visiting scientists) who participate in research or creative work. This mandate also includes any individual supported in part or fully through research funding, grants and contracts. Basic or Refresher online Collaborative Institutional Training Initiative (CITI) RCR training requirements must be completed by eligible personnel annually. As of May 1, 2022, any UK personnel listed on an IRB or Institutional Animal Care and Use Committee (IACUC) protocol, must complete RCR training before the protocol will be reviewed.
Must all study personnel complete HSP training prior to the IRB submission?
No, all personnel must be trained as a condition of IRB approval, however, you may submit the protocol for review as personnel are concurrently completing training.
What if an individual listed as study personnel on my initial review has not completed HSP training?
IRB approval will be withheld until documentation is submitted supporting HSP training completion or the study personnel is removed from the protocol. Once trained, the personnel may be added back to the protocol with a Modification Request.
Who is considered study personnel on human subject protocols?
An individual who interacts and/or intervenes with human subjects or handles personally identifiable data from a human subject. For detailed information, download “What Constitutes Study Personnel on a Protocol Involving Human Subjects?” [PDF].
Is the faculty advisor signing the protocol assurance statement for a student's research project required to be HSP trained?
Yes, the student's faculty advisor is accepting a supervisory role in guiding the student in conducting regulatory compliant research. Therefore, the faculty advisor is considered study personnel subject to this training requirement.
I need a description of UK's human subject protection training that I can use in my grant application. Where do I get that?
The Collaborative IRB Training Initiative (CITI) web-based learning management platform provides initial human subject protection (HSP) training and three-year renewal HSP training courses. The initial HSP training provides a comprehensive overview of the regulatory framework and ethical principles involved in the conduct of human research. Learners gain an appreciation of historical events that influence the development of current regulatory requirements. Modules outlining the role of the Institutional Review Board (IRB) and the various IRB review mechanisms prepare new investigators to navigate the review and approval process. Additional modules cover the core fundamental tenets of research protections including informed consent, privacy and confidentiality, conflict of interest management, and data safety monitoring and reporting. Separate modules on specific classes of vulnerable subjects prepare the learner to consider and implement safeguards and protections where applicable (i.e., children, prisoners, pregnant women, fetuses, neonates, students, vulnerable international, cultural or community groups). Learners are able to recognize risks and benefits unique to social and behavioral research (SBR) as well as ethical considerations for common SBR research techniques such as records review or internet research. Modules specific to biomedical research cover the regulatory requirements for research regulated by the Food and Drug Administration (FDA) as well as ethical and regulatory issues involved with the conduct of genetic research. Examples and cases throughout the course help the learner apply the core ethical principles of beneficence, respect for persons and justice to their human research. The CITI HSP renewal courses provide a comprehensive review of core material provided in the initial HSP training. Topical information and regulatory updates are incorporated throughout the renewal training modules. The course serves to remind investigators of the fundamental ethical principles while informing them of regulatory changes and relevant trends in human research protections.