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 […]
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Principal Investigator Responsibilities policy — revised, renumbered, posted
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 […]
IRB Researchers Assessment Tool Results
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 […]
FDA COVID-19 Clinical Trial Guidance
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 […]
New Legally Authorized Representative policy posted
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 […]
New human subject research submissions during the pandemic
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 […]
Consent process adaptations in the time of Covid-19
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, […]
Commentary on Clinical Trials During the Pandemic
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 and human subject research
Social media is pervasive (anyone else staying glued to social media during the coronavirus 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 Informatics. The […]
Thalidomide’s lasting legacy
The New York Times had a recent article about the so-called survivors of thalidomide, who are the people who experienced birth defects associated with use of the drug during pregnancy. The article is interesting on several levels. It tells the stories of thalidomide survivors, their use of social media to find each other, and their […]