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 […]

Our plan was to make the slides from each monthly training session available on the IRB members blog, along with a little background information for each. Our reality, however, fell a little short of that goal. (Hey, we may have just found our 2021 New Year’s Resolution!) Below are the slides for education presentations we’ve […]

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 […]

We’re still cranking out the revised policies here at IRB Policy central. Newly posted are: IRB Policy 1.1, which describes the IRB’s principles and authority. We’ve added language about International Conference on Harmonization (ICH) guidelines. ICH guidelines are a standards many clinical trials involving investigational products follow. At UAMS, studies for which the institution holds […]

Under the Revised Common Rule (RCR), expedited status studies initially approved after January 19, 2019, (and older expedited studies that switched to the RCR), are no longer required to undergo a complete continuing review. Those studies instead will get the two-question annual check-in form, which basically tells the IRB that the study is still a […]