Compliance & Training Update - 2019 Q4

By: Peg Sanders

In the months since Policies 801 and 802 as well as use of the new Reportable Event Form (REF) have been implemented, we hope you have become more familiar with the process for reporting such events to the OHSRP Division of Compliance and Training via iRIS.  We continue to see a reduction in number of REF submissions compared to prior to the new reporting policy.  As a reminder, when you are reviewing events that occur during the conduct of non-exempt human subjects research, deviations that do not meet the criteria for a major deviation do not require expedited reporting in iRIS but can, instead, be included as part of a high-level summary of deviations provided at the time of Continuing Review (CR). Major deviations that require expedited reporting in iRIS are those that have EITHER the potential to negatively impact the rights, safety or welfare of subjects or others OR have the potential to negatively impact the scientific integrity or validity of the study. Also, regarding reporting of deaths in iRIS, if the death of a research subject is possibly, probably or definitely related to the research, it must be reported within 24 hours of the investigator becoming aware of the death.  Deaths that are unrelated to the research, however, do not require expedited reporting and are considered SAEs that are not unanticipated problems, and these deaths may be reported as part of a high-level summary of SAEs and AEs at the time of CR.

The Research Compliance Review Committee (RCRC) has been meeting monthly to review events that rise to the level of possible serious and/or continuing noncompliance.  The RCRC, a duly convened NIH IRB, is a group of 9 specific members who provide thoughtful review and insightful discussion regarding the events that have been brought to that Committee for its deliberation. The stable membership of this committee provides consistency in determinations across protocols and ensures that there is robust corrective action in place to address concerns related to the noncompliance.

The OHSRP Compliance and Training group is gearing up for the 2020 OHSRP Education Series, and our next session will occur on Tuesday, January 14, 2020 from 3-4 PM in Lipsett.  We plan to cover updates related to informed consent based on questions we have received from the IRP community.  After that, these monthly sessions will occur the first Tuesday of the month from 3-4 PM.  The location will vary based on conference room availability, and I urge you to check the OHSRP calendar to confirm the location for specific sessions.

How are you notified when FDA makes labeling changes or adds a Black Box Warning to approved drugs being administered as part of your protocol? Click here and you will find instructions describing how you can register to receive these updates from the FDA.  Email updates are provided roughly once per week and an example is included below.  If there is a drug of interest, simply click on the drug, and this will take you to a page where you can click on the link to the updates.”