So, you’ve got a great multisite study started, for which the UAMS Institutional Review Board will be the institutional review board of record. You’re ready to take the step of submitting site addition modification forms in Clinical Research Administration (CLARA) to add additional sites. We’ve recently updated our method for entering sites into CLARA. Rather […]

We were thrilled to stumble across this newly available, open-access, paper titled Promoting Ethical Payment in Human Infection Challenge Studies in The American Journal of Bioethics. The paper discusses the process to determine ethically defensible compensation levels for research subjects, with special emphasis on trials that involve intentionally exposing participants to infectious agents, such as the virus that […]

The Association for the Accreditation of Human Research Protection Programs, or AAHRPP, sets standards for human research protection programs (HRPPs). AAHRPP is our accrediting body, and its website has several resources that may help IRB reviewers in their review. Of particular note are AAHRPP’s tip sheets, which delve into detail about specific topics. We use […]

Since the IRB has started allowing the submission of only tracked-changes copies of revised documents, we’ve found that our reviews are a little easier, and CLARA document files are a little cleaner, for studies that only submit the tracked-changes copy. Therefore, the IRB now asks that you submit only a single copy of any revised documents, […]

Happy New Year to all! Here’s our best guess as to what our IRB reviewers can look forward to in 2021. We’ll cover this information in our in-person education in January. Some of you will be selected to meet with our AAHRPP accreditation site visitors. We’re not quite sure when the site visit will take […]

Digital data collection tools, such as small wearable devices (think FitBits or Apple Watches) and apps downloaded onto a subject’s phone, are becoming increasingly common in human subject research. Some projects are testing the products themselves, while others use them merely to collect research data. You know that giant document that you never actually read […]

Among the many blessings HIPAA has rained upon us (ahem) is a requirement pertaining to reviews preparatory to research.  “Review preparatory to research” refers to accessing protected health information solely to prepare a research protocol before getting a signed HIPAA authorization or a HIPAA authorization waiver. A review preparatory to research can be done only […]

Additional agency-specific requirements apply to human subject research studies conducted or supported by the federal Department of Defense (DoD). Because we’re seeing a slight uptick in DoD funding applications, a trend we’re expecting to gain momentum, we’ve drafted a policy specific to DoD-supported research. Please note these policy requirements are in addition to all the […]

A December 4, 2020, update to the FDA’s policy on conducting clinical trials during the current public health emergency is now available. While we haven’t read all 38 single-spaced pages of it, we notice it contains information useful to our research community, such as guidance about informed consent options, and adapting study procedures to minimize […]

In a randomized, blinded trial, when one group gets the test article and the other a placebo, what happens when the intervention turns out to be wildly effective? From an ethical standpoint, it would make sense to halt the study and offer the placebo group the intervention. But from a scientific perspective, that greatly complicates […]