Compliance & Training Update - 2020 Q3

During this past quarter of 2020, the OHSRP Education Series included a 2-part presentation by the IRB Office Reliance and Single IRB team (July and August 2020) that is now available in the archived presentations section on the OHSRP website. This link provides access to the slides and videocasts for all past sessions of the OHSRP Education Series. The Reliance and Single IRB team is also hard at work updating their presence on the IRBO website including revisions of existing resources and preparing new tools to assist investigators/study teams to conduct multisite research. These will be available later in 2020 and will include resources for those relying on an external IRB, such as NIH Institutional Review guidelines and consent templates. For NIH study teams leading multi-site research, resources will include a revised decision tree to help establish if and what type of agreement may be needed e.g., reliance agreement. Additionally, the slides and videocast link for the September session, NIH Policies Related to Enrollment of Pregnant Women, Participants Lacking Capacity to Provide Informed Consent, and Prisoners: Current Status and Recent Updates are also available on that link. The next session on October 6th from 3-4 PM will be available via live NIH videocast at which time Dr. Jonathan Green and Meredith Mullan from OHSRP will present “Transition to a new eIRB [electronic IRB] System: Where we are now, and where we are going.” The videocast and slides will also be available after the session on the OHSRP archived presentations.

As new investigators join NIH, OHSRP has been receiving more questions lately related to human subjects research training requirements, and individuals can refer to Policy 103, Education Program, which spells out the NIH HRPP training requirements based on what type of human subjects research will be conducted. Additional information is available in the guidance document that accompanies the policy. We also have been responding to queries regarding accessing the current site for the required CITI training via the NIH CITI portal. The only portal that NIH investigators should use to access CITI training is the one that links from the Compliance and Training page on the ORSRP website. This is critical because this is the only site that allows CITI training completion records to download automatically into iRIS, the system that the NIH Intramural Research Program uses for IRB document management purposes. These FAQs explain how to access the appropriate NIH CITI portal, how to create an account in CITI via that portal, how to transfer CITI completion records completed at another site into the NIH CITI portal and other questions that will help the user navigate the processes needed to complete and document the required training. The OHSRP Division of Compliance and Training has posted additional educational resources to the OHSRP website including a guide for completing reportable event forms (REF) in iRIS. This provides step by step instructions as well as screenshots and tips to assist investigators in REF submission. We have also added a Reportable Events Flow Diagram to assist investigators in understanding the process of REF submission and review as well as referral to the NIH IRB if the event is a possible unanticipated problem or to the NIH Research Compliance Review Committee if the event constitutes possible serious and/or continuing noncompliance. FAQs related to handling of IND and IDE Safety Reports have also been added, and these clarify when these reports should be submitted to the NIH IRB. Coming soon-we will be posting a topical index that lists the various resources available on the OHSRP Website as well as links to federal guidance documents for each topic.