Compliance & Training Update - 2020 Q2

The OHSRP Education Series for 2020 continues, albeit virtually for now, and the archived presentations can be found here on the OHSRP webpage.  Once you click on the title of a specific session, a link to the videocast is also provided. The IRB Office Reliance and Single IRB team will be presenting a two-part education session in July and August. Part I will cover fundamental concepts and requirements relating to multi-site research and review by a single IRB. Part II will outline the responsibilities, and related processes, when an NIH study team plans to lead a multi-site research study and requests that the NIH IRB serve as the single IRB for all Participating Sites. It will also discuss requirements when NIH Investigators wish to rely on an external IRB.

The NIH Intramural Research Program is approaching the one-year anniversary mark for the initial implementation of Policy 801, Reporting Research Events and Policy 802, Non-Compliance in Human Subjects Research that occurred 7/1/2019.  As was the case in 2019 after policy implementation, we continue to see fewer reportable events being submitted in iRIS in an expedited manner predominantly because protocol deviations that are minor in nature may now be reported as part of a high-level summary at the time of continuing review.  Information regarding these polices as well as helpful guidance documents can be found on this IRBO webpage under the section labeled “800 Series.”

Likewise, we are at the one year anniversary of the implementation of Policy 201, Education Program, that defines training requirements for investigators on protocols overseen by the NIH Intramural IRB.  As investigators submit new actions in iRIS, the IRB will be checking to confirm that investigators listed on the protocol have completed the appropriate human subjects research (HSR) training as described in the current policy.  We urge all investigators to check and confirm that they are up to date on the required training and that this information is reflected in iRIS, so that review of the submission is not delayed pending documentation of training completion in iRIS as required for all protocol investigators.  To check to see if training records are correctly updated in iRIS, investigators can go to this page on the IRBO webpage,  and scroll down to the section labeled “Personal Training Records.”  If the investigator has not completed the required training as listed in Policy 201, investigators can go to this link, which provides information about how to register for a new NIH CITI account and take the required training. Alternatively, if they have completed the correct training but it is not reflected in iRIS, this same link also includes instructions as to how to check HSR training completion records via the NIH CITI Portal. Only CITI training records that exist via this portal are automatically downloaded into iRIS. If an NIH investigator completed the appropriate training via another portal at NIH or at a non-NIH site, and the training is current, those records can be transferred into the NIH CITI database once the investigator has registered via that portal.  Instructions for all steps include screenshots. Please note that NIH investigators were required to complete a CITI basic HSR training course after 1/21/2019 without the option of testing out because these modules contained important changes included in the Revised Common Rule.  Policy 201 also outlines requirements for GCP training for those investigators conducting non-exempt (requiring IRB review) HSR.  Note that if investigators completed or tested out of CITI GCP or completed NIAID GCP within the prior 3 years, they are still considered current.  When this GCP training expires or, if investigators have never completed this training, they must complete or test out of CITI GCP (US FDA Focus).