The IRB has updated policies 10.2, Events that must be reported to the IRB and IRB actions, and 10.3, Protocol content and IRB submissions. Again, the vast majority of the changes relate to formatting and adding references. While the content hasn’t changed much, consider this a friendly reminder to review IRB policies frequently. We find […]
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New Data Sharing policy now in effect
A new institutional Data Sharing for Research policy is now available. It describes requirements and best practices for, well, sharing research data, as its name implies. The policy was jointly developed by Cancer Clinical Trials & Regulatory Affairs, IRB, research compliance, and legal, among others. It contains limits on the eligibility of data sharing that […]
New policies about noncompliance and UPIRTSO determinations now posted
The IRB has posted updated policies regarding reviews and determinations about reports of potential noncompliance and potential UPIRTSOs. These processes are described in IRB Policy 12.5, Reports of Potential Noncompliance and Potential UPIRTSOs, and 12.6, IRB Determinations of Noncompliance and UPIRTSOs. We’ve also posted a revised IRB Policy 2.6, which describes the IRB’s procedures for […]
Revised IRB Policy 6.1 posted
Because we know you all lie awake at night wondering about the process the IRB uses to create its weekly agenda, we’ve updated IRB policy 6.1, Agenda, to include more details about the process. A few takeaways from this revised version: When submissions are ready for full board review, we will put them on the […]
Reconsenting minors when they turn 18 for continued specimen storage
Research subjects who are minors when they join a protocol typically must be reconsented after they turn 18 to be able to continue on the study. While the IRB can waive this reconsent requirement when such a waiver is justified, this issue falls into an ethical gray area when it comes to the long-term storage […]
Revised IRB Policy 3.4, IRB Chair and Vice Chair, now posted
Because having too many policies does not bring us joy, we’ve taken the bold step of combining our two separate policies on IRB Chairs and IRB Vice-Chairs into a single policy, descriptively titled IRB Chair and Vice-Chair. The policy, IRB Policy Number 3.4, describes chair appointments and responsibilities and indicates the chair is the person […]
Revised informed consent policies posted
The IRB has posted revised versions of two of our most popular (can policies be “popular”? Maybe we should call them “the most referred-to”?) policies – IRB Policies 15.1, Elements of Informed Consent, and 15.3 Waivers of Signed Informed Consent Documents and Waivers of Informed Consent Elements. The biggest changes relate to formatting, as we’re […]
Revised Policy 17.1, Children in Research, Now Posted
An updated version of IRB Policy 17.1, Children in Research, is now available on the IRB’s website. The changes are limited to formatting changes and the occasional language clarification, as the regulations and requirements related to human subject research involving children have not changed. However, we in the IRB office find ourselves having to refer […]
New CITI course, “COVID-19: Back to Campus (Fall 2020)” now available
A new course discussing the return to campuses in the fall, when we may be still be dealing with Covid-19, is now available via UAMS’ CITI training course. The course was developed by CITI and the Association of American Medical Colleges. The course “provides an overview of COVID-19, prevention strategies, recommended laboratory practices, and points […]
Challenge trials — when do potential benefits outweigh the potential risks?
It could be argued that we need a safe, effective coronavirus vaccine, like, yesterday. We also know that approving new FDA-regulated medical products such as vaccines takes time. The normal approval path involves extensive testing in the lab, in animals, and then in humans for safety and efficacy. Human subject research is closely overseen to […]