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 […]

Challenge trials – in which human volunteers are deliberately infected with pathogens that can get them sick – have a long history, according to a recent New York Times opinion piece. The article describes a British research center where volunteers were deliberately infected with coronaviruses in a quest to find a cure for the common […]

Brazilian families who enrolled their children in research about Zika later had concerns about not having the research results returned to them, according to this article in the online magazine Undark. Although this article is specific to research done in Brazil, the challenge of returning study results to research participants will look familiar to researchers […]

Federal regulations include additional protection for certain so-called vulnerable populations, including pregnant women and fetuses. These restrictions run the risk of being unethical by discouraging, or disallowing, people who might benefit from research to participate in it, according to the author of a recent Washington Post opinion column. Sarah N. Cross writes that pregnant women […]

Is your study team participating in a multi-site study in which each site will undergo separate IRB review? If so, take advantage of the option to submit a “local protocol addendum” to add detail about the main protocol the main site sends you. The IRB knows that asking for a correction or an addition to […]