The IRB has changed the formatting of the convened board rosters available on its website. We have removed individual reviewer names in an effort to enhance the privacy of our IRB reviewers. This practice is in line with what many other institutions do. If a sponsor or someone needs one of our older rosters, please […]

We can’t predict the future, and we need to be prepared to continue to protect human research subjects in the event of an emergency that disrupts human research protection program operations. UAMS has extensive plans in place to maintain operations if an emergency happens. To meet requirements put in place by the Association for the […]

The HIPAA regulation describes 18 pieces of information that can be used to identify an individual, either directly or indirectly. One of these is any geographic subdivision smaller than a state. Limited Data Sets are protected health information that lack certain specific identifiers. Limited Data Sets can include town, city, state, and full zip code, […]

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The FDA has released for comment a draft guidance about the inclusion of research-specific biopsies in research. The draft guidance addresses the issues of risk v. benefit and informed consent, and outlines the differences between adult and minor patients when it comes to research-specific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