We’ll just jump right into it here.
Q. Do I need to report a hold on enrollment due to Covid-19 on a reportable new information form?
A. No. Holding enrollment because you cannot safely enroll subjects while we are dealing with the Covid-19 pandemic does not meet the criteria for immediate reporting under UAMS IRB Policy 10.2.
Q. Do I need to report changes I make to an ongoing study in response to Covid-19 to the IRB?
A. Yes. However, if they are changes made to reduce or eliminate an apparent immediate hazard to subjects (i.e. doing study visits online instead of in person), you can go ahead and implement them, and then submit a protocol modification to the IRB describing the change. Please take into consideration any possible risks associated with the change — for example, if subjects need to come to UAMS to receive an investigational drug, and decline to do so right now, will they need to stop the drug? If so, can they do so safely? Will they need any additional monitoring as a result of stopping the drug?
Q. Is the IRB still reviewing non-Covid-19-related new submissions at this time?
A. Yes. The IRB is working full-steam right now. While Covid-19-related submissions, particularly studies that involve interventions, are getting high priority right now, we are still keeping up with the other submissions we receive.
Q. Should I address Covid-19-related measures in new submissions and continuing review submissions right now?
A. Yes, if your study involves in-person contacts. The IRB will want to know what changes you are making to minimize risks to subjects and study staff. The continuing review form is the appropriate form to use to tell us that you’ve held enrollment due to Covid-19. For an open study that involves direct subject contact and for which you have not submitted a modification, you’ll get a contingency if your CR doesn’t address what you’re doing to protect subjects and staff from Covid-19.