The FDA continue to set speed records in drafting and updating guidances as the Covid-19 pandemic continues. The agency has again updated its guidance titled FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.  The changes were made to the Q&A section at the end of the guidance. “The updated […]

All consent process that involve direct interaction with subjects should be documented with a separate note in the research record, according to IRB Policy 15.5. This extra documentation requirement takes on greater importance in situations like that presented by Covid-19. If your study is enrolling Covid-19 patients, you may not want to put study staff […]

The federal Office for Human Research Protections has released guidance about research subject to the Common Rule under Covid-19. We took a quick look at it and are relieved to note it accords with what we’ve been telling people about current goings-on. Read it straight from the source here.

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 […]

Hot off the presses – the UAMS IRB has updated and moved its “Principal Investigator Responsibilities and Qualifications” policy. The new policy,IRB Policy 10.4, is available in policy section 10, titled, creatively, “Principal Investigator Responsibilities.” This policy replaces the now-archived IRB Policy 7.2, which, for some reason, had been filed in the “Procedures for Study […]

Thank you to everyone who took the time to complete our recent IRB Researchers Assessment Tool (IRB RAT, which is pretty much our favorite acronym). We have recently finished collating the survey responses. A description of who responded to our survey is also available. We appreciate everyone who took the time to give us their […]

We’ve linked to the FDA’s Guidance on Clinical Trials of Medical Products During the COVID-19 Pandemic on at least two other blog items, but we like this updated version of the guidance so much that we think it merits its own blog entry. Strictly speaking, it applies to FDA-regulated clinical trials, of course. However, it […]

IRB Policy 17.13, Legally Authorized Representatives, has been updated and the new version is available on the IRB’s website. The most notable change in the revised policy is the expansion of who can serve as the legally authorized representative and therefore provide consent for participation in research that does not involve healthcare. We anticipate this change will […]

We the IRB liken ourselves to ducks on a pond – calm on the surface, but paddling furiously underwater to keep up. Some institutions have disallowed the submission of new studies at this time, due to new time constraints or human subject protections concerns created by dealing with the Covid 19 pandemic. The UAMS IRB […]

The IRB has always encouraged researchers to think creatively about consent processes. The “standard” consent process – a discussion in a “quiet, private room,” and a handwritten signature on a consent form works for some studies, but not for all of them, even when there’s no pandemic raging. And now that we’re dealing with Covid-19, […]