Important information regarding COVID-19 related research

Good morning Investigators and Research Teams, 

We have begun to see an increased volume of protocols being submitted to the IRB related to COVID-19, either in the form of amendments or new protocols.  All COVID-19 related submissions are being prioritized in our office and we are doing our best to rapidly review this research based on the quality of the submission.

Most of the projects that have been submitted are new research ideas and should be submitted to the IRB as new protocols not as an amendment to an existing protocol. Typically they are enrolling a distinct population of people (people who have been exposed to COVID-19), and have distinct research objectives, inclusion criteria, and study designs. Therefore, they are not appropriate to be submitted as an amendment to an existing protocol.

Many protocols, if not therapeutic studies, can be very simple in their format and do not need to be lengthy or complex in order to address the regulatory criteria for IRB approval.   Many of these studies will qualify for the exempt or expedited Scientific or IRB review process, depending on the nature of the research. Although it may seem counterintuitive, in many cases the review for a new protocol will be faster than as an amendment. A substantive change to an existing greater than minimal risk protocol will need to undergo full board review even if the new procedures are all minimal risk.  In contrast, the same activities submitted as a new minimal risk study can undergo expedited review.

To avoid unneeded delay, if you are unsure if your project should be submitted as a new protocol vs. an amendment, please reach out directly to Nicole Grant and/or Tiffany Gommel and we would be happy to discuss this with you.

Thank you, 

Nicole