The Food and Drug Administration has published a draft guidance on charging for investigational drugs under an investigational new drug application (IND). The draft guidance is being made available for comment purposes only; comments on it are due Oct. 24, 2022. If/when finalized (the FDA works in mysterious ways, remember), this draft guidance would replace […]

The UAMS Institutional Review Board has posted several updated policies on its website. We try to review policies at least annually, and make changes as indicated. In this most recent round of update, most of the changes are pretty minor, and some are limited to formatting/typo correction. However, a few are more substantive. This table […]

Mount Sinai Health System in New York and pharmaceutical company Regeneron are collaborating to create a DNA and related health data database focusing on New Yorkers, according to a recent New York Times article. Regeneron will do the sequencing work, and will gain access to the genetic data and partial medical records of each participant. […]

It was 50 years ago this weekend that the Tuskegee story became public, in a report in the now-defunct Washington Star, an afternoon newspaper, and then, a day later, via an Associated Press news story. The wire service moved the story again today to mark the anniversary. This is a bit of history we’ve all […]

Sign up now to discuss “Chasing My Cure,” by Dr. David Fajgenbaum, at the next meeting of the Research Ethics Book and Journal Club. Featured speakers are the author, Dr. Fajgenbaum, and UAMS’ own Frits van Rhee. You can sign up at this link. The class will be via Zoom, and is scheduled for Sept. […]

To minimize the delays in approving new submissions, modifications, and continuing reviews, the UAMS Institutional Review Board will no longer send contingencies about a study staffer not having current Collaborative Institutional Training Initiative (CITI) training. Instead, the Institutional Review Board will send a note reminding the team that this staffer does not have Institutional Review […]

It was a half-century ago that the public first learned of the extent of the Tuskegee syphilis study, despite its having gone on for decades and journal articles about it being published as early as 1926. Author Martin J. Tobin recounts the story of this study and of another U.S. Public Health Service (PHS)-led study […]

We’ve made updates to the document we’ve created to help study teams complete local context forms (for xIRB studies) and site-specific forms for sponsors. The form now contains links to policies relevant to certain topics, and we’ve added language to the “Children in Research” section describing wards of the state. You can access the form […]

The UAMS Institutional Review Board has updated its policy 17.1, Children in Research. We have added language to increase flexibility on parental permission requirements for research not subject to federal regulations. Specifically, this policy revision codifies the Institutional Review Board’s flexibility to consider requiring only one parent’s permission for a child to participate in research […]

Big news! We are thrilled to announce the expected speaker lineup at the next meeting of our Research Ethics Book and Journal Club. The book we’ll talk about is “Chasing My Cure.” The best part? Our scheduled speakers are Dr. David Fajgenbaum, who wrote the book, and our very own Dr. Frits van Rhee, who figures […]