Former Harvard University Chemistry and Chemical Biology Department chairman Charles Lieber has been convicted on charges related to what law enforcement said was his failure to disclose his participation in some programs based in China, according to a news release from the US Attorneys Office in Massachusetts. He had been accused of failing to disclose […]

A participant in the Moderna COVID vaccine trial has some thoughts about trial participation; more precisely, he has some thoughts about why he stopped trial participation. His views were recently posted online here in STAT. In summary, he objects to participating in experiments that result in what he claims are large profits for pharma companies. […]

The journal Human Genetics has retracted a paper for reasons related to informed consent of vulnerable populations in China,  the website of The Intercept reported recently. The paper reported on genetic variation among and within ethnic groups. The 38,000 subjects included Tibetans and Uyghurs in China, who, per the article, “almost certainly did not give proper consent.” […]

When you’re revising a document that has already been revised and approved at least once before, please accept any previous changes and only then start tracking the current set of revisions. Making sure the previously approved changes no longer show as “new” will help the IRB discern what, exactly, you’re changing in this round of revisions. […]

Those attending PRIM&R’s Advancing Ethical Research conference this week were able to hear from Dr. David Fajgenbaum, a physician and also the author of Chasing My Cure. Fajgenbaum was in medical school when he first fell seriously ill, with what was eventually diagnosed as idiopathic multicentric Castleman disease. His experience, which included nearly dying five times, pushed […]

A recent New York Times article describes ethical concerns related to research involving Roma people. Much of this research involves genetic work using blood samples and DNA collected over decades. The Roma are a group of people who lived primarily in Europe. The Romani are often marginalized in the societies in which they live. Of […]

The Administrative Guide policy about Honest Brokers in Research, policy no. 16.1.19, has been updated to make it easier for staff to document their qualifications and training to act as an honest broker. Honest Brokers provide de-identified data and samples to investigators for the purpose of research. Rather than the application, certification, and audit processes […]

Emergency use INDs and Single Patient INDs – they’re sorta the same, but not really. Each time we get one or the other in the IRB office, we scramble for the relevant FDA guidances for a refresher on their processing. We finally wised up and created a summary table describing the two types of IND […]

This particular story may relate more to IACUC ethics than to human research protections, but recent stories about testing a kidney grown in a genetically modified pig in a brain-dead human certainly caught our attention. Here’s one from the New York Times and another from the BBC. We’re not sure we can even articulate all […]

We’ve finally accomplished a goal of ours – adding a new checklist for multisite studies relying on the UAMS IRB for oversight to the IRB’s “Single/Central IRB Review” web page. See the “checklist for UAMS investigators leading a multisite study for which the UAMS IRB is the IRB of record” link under “Resources.” This new […]