Rapid Review of Human Subjects Research Related to the SARS-CoV-2 Pandemic

Dear Intramural Investigators,

As we all adapt to our current new reality, I would like to update you on what steps the IRB is taking to ensure continued operations and update you on the steps we are taking to facilitate the rapid review of any human subjects research related to the SARS-CoV-2 pandemic.

The IRB is prioritizing any study related to this pandemic. To assure the IRB can easily recognize that the submission is related to the pandemic, please do the following:

1. For a new submission, include COVID 19 in the short title.
2. For an amendment, check the COVID 19 box on the first page of the new amendment form.

If for some reason, you are concerned that your submission has been lost in the shuffle, you can contact the IRBO via email. We are discouraging direct phone calls unless necessary as frequent interruptions can really slow the workflow.

We have received several inquiries as to whether the Public Health Emergency Review Board (PHERRB) is operational. The PHERRB is no different than the NIH IRB. The NIH IRB when it acts as the PHERRB is identical in all respects to the NIH IRB when it does not act as the PHERRB. Regardless of whether we are called the PHERRB or just the NIH IRB, we stand ready to rapidly review any new COVID 19 protocol. If you are an intramural researcher submitting COVID 19 protocols, do not check the field in iRIS asking if you are submitting to the PHERRB.

Multi-site protocols that utilize a single IRB can pose challenges to rapid start up if there is a need to execute multiple reliance agreements. We are working hard to get processes and procedures in place that will facilitate our ability to rapidly get agreements in place if they are required and to more efficiently coordinate our activity with the other sites. If for some reason, it is determined that the NIH IRB cannot serve as the IRB of record for a multi-site COVID-19 study, we have in place master reliance agreements with Advarra and WIRB, either of which can serve as the IRB of record.

In order to expeditiously review any COVID related submission, we are redeploying our internal resources. As a result, your non-COVID submissions may be delayed in their review. We know this can be frustrating, but trust you understand the necessity. We are keeping a close eye on any expiration dates and do not anticipate that studies will lapse.

Lastly, the revised Common Rule has excluded certain public health surveillance activities from the requirement for IRB review. OHRP has provided guidance on this topic. If you believe your study may fit in this category, please review this guidance and contact me directly by email.

Sincerely,

Jonathan M. Green
Director, Office of Human Subjects Research Protections