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 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 […]
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 […]
Human subject research in the time of Coronavirus (COVID-19)
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 […]
Forward-looking informed consent
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 […]
There’s a short form to find out if your project needs IRB review
If you’re wondering whether your project meets the definition of human subject research requiring review, you don’t need to go through the complete new submission form process to find out. Instead, you can complete the much shorter and simpler human subject research determination form in CLARA to find out. Not only is the form much simpler […]
Our CLARA account creation form is now fully online
We’ve revised the CLARA account request form so that it’s now fully online. That means there’s no more Word document for you to complete and email to the IRB office. To access the form, go to the CLARA home page, and click on the “Don’t have an account?” link. An electronic form will pop up […]
Recap of federal reporting requirements related to foreign involvement
“When in doubt, disclose” relationships with foreign entities to the federal government, advise the authors of a recent recap of disclosure requirements that appeared in The Scientist. The federal government seems to be increasing its oversight of this kind of disclosure, leading to some criminal cases. In addition, different federal agencies have different policies regarding […]