A draft FDA guidance on protocol deviations has been posted for comment. This guidance contains, among other tidbits, proposed definitions for “important protocol deviation” and “protocol deviation.” The guidance touches on considerations that might minimize protocol deviation occurrence, such as careful protocol design that allows appropriate flexibility, and offers information about reporting and reviewing deviations. […]

Will any part of your research project take place outside the United States? If so, the federal Office for Human Research Protections International Compilation of Human Research Standards may be of help. The most recent iteration collects in one place relevant research regulations and standards from around the world, sorted by geographic location. This information […]

The FDA has released for comment a draft guidance about the inclusion of research-specific biopsies in research. The draft guidance addresses the issues of risk v. benefit and informed consent, and outlines the differences between adult and minor patients when it comes to research-specific biopsies. It outlines some of the considerations investigators and IRBs must […]

“Can these data be used?” is a question the IRB finds itself considering every now and again. It usually comes up when there has been some kind of problem on a study – say, data were collected after continuing review expired, or before a complete consent process occurred. The answer to this question, however, is […]

A new protocol template, dated 12.18.2024, is now available on the IRB’s “Templates, Training and Tools” webpage. The most notable changes to this template are to beef up the various options related to HIPAA authorization waivers. There are different types of waivers, and the protocol should specify the type of waiver (or alteration) the team […]

Starting January 2, the UAMS IRB will require prior notification via an online form of UAMS investigators’ plans to either rely on an outside IRB for review or to have UAMS serve as the relying IRB. The form can be found here. It’s short, we promise. It should be completed as early in the submission […]

A recent FDA warning letter to a clinical investigator shows the type of activity the FDA finds to represent noncompliance with regulatory requirements. We found this letter to be unusually, um, comprehensive, and recommend clinical trial teams review it for guidance.

Clinical trials involve a LOT of recordkeeping. Our own Laura Adkins, MAP, director of the UAMS Office of Research Regulatory Affairs, has an article in the November 2024 issue of SOCRA Source describing the ins and outs of clinical trial documentation. The article provides in-depth discussion of required and recommended documents and tips for completing […]

The IRB has updated its single IRB review webpage to make it easier to navigate. (And it looks a lot better too!) Note that, starting Jan. 2, study teams participating in single IRB review studies will be asked to complete a reliance request to let the IRB know about the reliance arrangement. This requirement applies […]

A recent New York Times article has been the talk of the human research protection community of late. The article describes how some participants in an investigational Alzheimer’s disease drug study were not told they had a genetic test result that may have indicated increased risks of the test article for them. The story raises […]