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 […]

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 […]

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 […]

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 […]

The IRB has posted an updated version of its policy 3.1, titled Qualifications of Committees. This policy describes the steps the IRB takes to ensure its convened boards include members with the appropriate expertise to review the research they’re assigned. We also try to ensure our boards are able to understand potential subjects’ perspectives, and that […]

The IRB’s mission is clear – to ensure human research subjects’ rights, safety, and welfare are protected to the extent possible. It cannot allow itself to be influenced by outside pressures as it makes its determinations, and must remain independent. IRB Policy 1.5, IRB Independence from Undue Influence, has just been revised, and the updated […]

The COVID-19 pandemic has forced us to make many adaptations in both our personal and professional lives. Should those changes extend to loosening some of the usual ethical restrictions related to human subject protections for studies related to the pandemic? Authors of an April 27, 2020, op-ed piece in the Washington Post say yes, we […]

Once we got on a policy roll, there’s no stopping us. We’ve posted the following revised IRB policies on the IRB’s website: IRB Policy 1.1, Principles Governing the Committee, describes the principles underpinning human subject research and the IRB’s responsibility to ensure they are upheld. IRB Policy 1.2, Authority of the Committee, indicates all human […]

The U.S. Food and Drug Administration (FDA) says it is making available a free app to facilitate the obtaining of informed consent in situations where face-to-face consent processes are not practical. The app, now called COVID MyStudies, is designed to address situations where a potential participant with COVID-19 may be in an isolation room, or […]

An updated IRB Policy 3.3, Reviewer and Consultant Conflict of Interest, is now available on the IRB’s website. The revisions add another criterion to the definition of a financial conflict (the addition of a financial relationship for which a reviewer is on a management plan); highlights’ reviewers responsibilities to notify the IRB office or chair […]