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:

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, […]

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, […]

We know the research community regularly refers to the HIPAA Research administrative guide policy while preparing and carrying out human subject research studies. We want to tell you about the newly posted, updated administrative guide policy about HIPAA and Research. This latest version reflects the first updates to the policy since 2013. Extensive revisions were […]

The Journal of the American Medical Association recently published an opinion piece about how IRBs are affected by larger changes in the nation’s research enterprise. We wanted to share the piece with our blog readers. We also wanted to express our gratitude to the institution, our IRB reviewers, and the entire human subject research community […]

The HIPAA regulations have language specific to research involving only deceased individuals. Studies involving information from only deceased individuals must have a HIPAA certification on file regarding the use of the deceased individuals’ protected health information. A new CLARA form, called the “HIPAA Certification for Research Involving Only Deceased Individuals,” allows this certification to be […]

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. […]