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 […]
New xIRB notification process
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 […]
Clinical Investigator Warning Letter
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 Trial Documents 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 […]
Updated sIRB web page
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 […]
Alzheimer’s Drug Study Raises Questions
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 […]
CLARA question changes
Some CLARA form questions have been revised with the intent of making them clearer about the information requested. In the “Subjects” section of the new submission form, questions about enrollment have been revised to read as follows: How many subjects/charts/specimens do you need to include to be able to complete your study? See help text […]
Revised IRB Policies Now Posted
The IRB, with the assistance of the Human Research Protection Program Advisory Committee, recently completed its annual policy review, and revised IRB policies are now posted on the IRB’s website. A summary of the changes made is available here. Note that we did not edit the grammar on our summary of changes; please excuse any […]
New FDA guidance on electronic documents and signatures
The FDA has released a new guidance titled Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations. The guidance provides information in a Q and A format about the FDA’s expectations for the use of electronic systems and records in research. The guidance also includes a section specific to electronic signatures in research. Do […]
Compensating research participants
Many study teams use gift cards to compensate research participants for their time. UAMS now limits the gift cards allowed to be used in research to those from the following vendors: Amazon, Tango, and ClinCard. Also, UAMS does not allow study teams to use services such as Venmo or CashApp to pay research subjects. Please […]