The IRB has posted new informed consent and HIPAA authorization templates on its website. Both documents have been revised to advise participants that if an investigator leaves UAMS before completing a study, their study information may follow the investigator to his or her new institution. Note that information cannot leave the institution until the proper […]
Blog
Reporting adverse events at CR
Studies required to submit full continuing review forms must include a list of adverse events (AEs) with their CR submissions. The IRB asks that in addition to including dates of occurrence of AEs, these reports reflect the outcome of the AE, such as “ongoing,” or “resolved.” If the date of resolution is known, please include […]
The continuing review study summary
Continuing review, for studies that require it, is an opportunity for the IRB to reevaluate the study in its entirety to ensure the criteria for approval remain met. The IRB needs complete information about what has happened on the study in the past review period to be able to thoroughly assess the study. We have […]
Additional review for some studies
The UAMS Research Legal Office has advised that some types of human subject research may not be allowable under recent federal and state requirements related to diversity, equity, and inclusion measures. These restrictions apply to both new studies and to those that are ongoing, per information provided by research legal. The following information was provided […]
Protocol template update
The IRB has an updated protocol template available on its website. The new template has added some new information and moved some previous language around. You’ll note that the new template has far more guidance than earlier iterations, and less suggested text. This change’s intent is to provide prompts to study teams to draft their […]
CITI courses updates
The CITI program includes several courses required for people involved with human subject research, animal research, or export control. Because CITI has recently changed its fee schedule, with charges accruing based on the number of course completions, the Division of Research and Innovation has started limiting access to the UAMS CITI courses. People whose email […]
Meet your research administrators
Get to know all the main players who support research efforts at the upcoming Research Administration Roundtable. The Division of Research and Innovation has scheduled this event for Sept. 2, from 1:30 to 2:30 pm. Come to the Rayford Auditorium in Biomed II to hear from the various departments that help you get funding and […]
Single IRB Review Reminders
Single IRB review of multi-site studies is becoming increasingly common. The UAMS IRB has developed new procedures (and continues to review and refine them) to ensure adequate human subject protections AND regulatory compliance for sIRB studies. To facilitate to review of these studies, we ask that all study teams do the following:
New Expanded Access Webpage
The IRB office, with the help of the Office of Research Regulatory Affairs, has updated its old “Emergency Use” webpage with new and (vastly) improved “Expanded Access” webpage. The new webpage addressed both compassionate and emergency uses of investigational products, and includes checklists and a consent template for these uses. Yes, the checklists are long, […]
Updated IRB Policies
The IRB has posted revised IRB policies to its website. This year, as we prepare for AAHRPP reaccreditation, the IRB office, with help from others on campus, made changes to almost every policy we have. (If it has “6.24.25” in its title on the webpage, it has been updated.) Many of these changes are minor, […]