We’re working furiously to prepare for the implementation of the Revised Common Rule, now scheduled for Jan. 21, 2019. Below is a recap of some of the more notable changes in the rule, followed by an explanation of how we anticipate incorporating those changes at UAMS. Please note this is only the tip of the […]

Please remember discussions that happen inside the IRB’s meeting room need to stay inside the meeting room. IRB determinations and contingencies are considered group decisions. Those decisions are relayed to the research team via correspondence through CLARA. Reviewers – If someone on a research team asks you for specifics about their project’s IRB review, please […]

A study involving pregnant women and fetuses was terminated early in The Netherlands after the deaths of 11 neonates. We post this here as a reminder of some of the things the IRB has in the back of its mind when reviewing studies, and that investigators think about when they develop and join studies.

There has been significant discussion lately about making it possible for patients to access drugs that are not yet approved for use in certain cases. Desperate patients might view this access as their last, best hope – even though the risks and benefits of these items are not yet fully known. Right to try laws […]

A recent Washington Post article and podcast got us started looking around for more information about the notorious Tuskegee experiment, which, according to the Post author, “destroyed the trust many African Americans held for medical institutions – a legacy that persists today.” Clicking around the internet for more information led us to an American Scholar […]

Considerations and recommendations for returning individual results to human research participants are the focus of a newly released report by the National Academy of Sciences. The full report exceeds 300 pages, but the executive summary runs to a much more manageable 27 pages. The NIH’s Office of Science Policy has a blog item about the […]

Most of us working in research know the story of Henrietta Lacks, a woman whose cells were collected from her without her knowledge or consent in 1951. The so-called HeLa cells have been extensively used in research ever since, without her family’s knowledge or approval for much of that time. An attorney representing some members […]

Chicago Magazine recently published a piece about the AbbVie  Clinical Pharmacology Research Unit, a Illinois phase 1 clinical trial managed by a pharmaceutical company. Some of the issues mentioned make us wonder if they’re shared with our local study subject population. Some key take-aways: The article is a very engaging read – we encourage you […]

If you’re assigned to review a reportable new information report (RNI), here are a couple of reminders and resources that may be helpful:  

As a reminder to our reviewers, please remember to note any comments, contingencies, notes, or topics for discussion in CLARA before the meeting, keeping in mind the chair has asked for reviews to be completed by noon Monday. Having everything documented in CLARA provides a record for the IRB of topics discussed, makes everything visible to everyone […]