A New York Times piece that appeared in the printed paper Sept. 9 addressed what it termed a prominent researcher’s failure to disclose conflicts of interest in research publications. We know that appropriate disclosure is a typical requirement of conflict of interest management plans. Please click on the link above to read more. Update: The researcher […]
Institutional Review Board Members
Reminders for our Institutional Review Board reviewers about policies, using Clinical Research Administration (CLARA), and other news. Feel free to click on this blog even if you aren’t on the Institutional Review Board. You may get some pointers about what the Institutional Review Board is looking for when it reviews your studies.
A very quick tour of the Revised Common Rule
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 […]
Reminder about IRB confidentiality
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 […]
Trial halted after infant deaths
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.
Right to Try versus Expanded Access — What’s what here?
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 […]
Tuskegee, and a whistleblower
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 […]
Returning individual results to subjects, in 300+ pages
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 […]
Further developments in the case of Henrietta Lacks’ immortal cells
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 […]
A view of how clinical trials are done on the outside
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: —“AbbVie touts altruism as a motive for volunteering. If chosen, “you […]
Reviewing reportable new information reports: A recap
If you’re assigned to review a reportable new information report (RNI), here are a couple of reminders and resources that may be helpful: –Please look over the entire CLARA form and any additional documents submitted with it. If you’d like more information about the event before the meeting, you can either contact the study team […]