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, which you can find here. (Note that the x-axis on these graphs is the number of responses received, NOT a percentage, and […]

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, […]

The COVID-19 has prompted a lot of rethinking of the conduct of clinical trials. The in-person contact many of these studies require may increase risk to both study staff and research participants. Institutions have taken a variety of approaches, everything from temporarily halting all research, to allowing only those essential to the subjects’ health or […]

Social media is pervasive (anyone else staying glued to social media during the corona virus pandemic, while at the same time wishing they could stop looking at social media so much?), and its utility and application in human subject research should be considered, according to the authors of a recent editorial in JCO Cancer Clinical […]

Please continue to watch this space, as conditions related to the spread of coronavirus seem to change at least hourly. Last updated 6/3/20  4:45 pm with a link to updated TRI/institutional guidance about research during Covid-19.  Q. Will the IRB office remain open? A. Yes. However, we plan to work from home, so we ask […]

Study data and specimens aren’t always easy to come by, and once you’ve got them in hand, you may want to keep them for future use. If there’s any possibility at all that you will retain study data (including genetic data) or specimens for future use, please make sure your consent process/form (or requested consent-related waivers) address […]