If you have an IRB-related question, others probably do too! This column is an opportunity to answer your questions. Check in each month to see the answers to some of the most common questions asked by the research community. To find more questions from previous months, click here to search the archive.
Please send your questions to crtimes@bu.edu.
Q. We recently held our first meeting with our DSMB and they have just provided their report with recommendations. We would like to submit this report to the IRB, but it is unclear which steps we need to follow. Do we need to use the guide titled “How to Submit a Deviation Report”? The DSMB feedback is related to the design of our intervention, and not with the reporting of any adverse events.
Any feedback is appreciated.
A: Here are our policies on submitting this type of information:
6.6.3.3 Reporting of Safety Monitors’ Reports with Recommended Changes to the IRB
(Revised 2/24/17)
Principal Investigators must notify the IRB through the electronic system when they receive a report from a safety monitoring body that contains recommended changes in the protocol, consent form, or other aspect of the research (see Section 7.4.5). Reporting is required in addition to the submission of the amendment request (see Section 7.4.1.2). This report is due no later than 7 days after the investigator or research staff member receives the report from the safety monitoring body.
This is done by submitting a Reportable Event and New Information Form (RENI). One of the radio buttons in this form is for DSMB reports with recommended changes.
Here are instructions for submitting this form.
https://www.bumc.bu.edu/irb/files/2011/03/How-to-Create-and-Submit-a-RENI.pdf
The RENI should attach the DSMB report/letter and describe the recommendations. The subsequent amendment should incorporate the changes by revising the INSPIR application, consent, etc., as needed. The amendment description should explain each change and provide a justification.