Is any of your human subject research NIH-supported? If so, please review the newly released NIH notice about implementation of the final rule on the federal policy for protection of human subjects for a recap of how the Revised Common Rule (RCR) will affect your projects. Two changes in particular are specific to NIH-funded or […]

When studies involve collecting data on pairs or groups of individuals, remember that each person about whom you plan to collect data counts as a separate study subject. For example, if you are collecting datafrom both chronically ill people and their caregivers, each dyad counts as two subjects, not one. The same is true if […]

When you’re reviewing something for an IRB agenda, whether it’s a new submission, a modification, a continuing review, or anything else, please document a very brief summary of your review as a note in CLARA. You can describe the intent of the study, planned (or actual enrollment), whether any reports of note are included, etc. […]

So, someone in your department (maybe even you!) has set up a repository of human data and/or specimens, and now you’re ready to use that repository for research. Since the repository had IRB approval, and the subjects signed a consent for future use of the data/specimens, you’re good to go, right? Actually, no, you’re not. […]

Please bear with us in the IRB Office as we work to implement the Revised Common Rule (RCR) and forgive any delays in IRB responses between Dec. 15 and Feb. 15. The RCR goes live Jan. 22. In the weeks before that day, we’re scrambling furiously to maximize our chances for a smooth transition. Being […]

You may recall our earlier blog post about well-known food researcher Brian Wansink resigning after questions were raised about his research. We recently came across a piece in the New Yorker about a previous Wansink-related kerfuffle. Messing with data is one thing. Messing with the “Joy of Cooking” cookbook, however, is just stirring up trouble. […]

The Food and Drug Administration has issued guidance related to FDA-regulated studies that are also subject to the Revised Common Rule.  As you may already know, the Revised Common Rule (RCR) is to take effect in January 2019 (the 22nd here, to be specific; the first workday after the rule’s implementation date). The RCR will […]

In addition to requiring a “concise and focused summary of key elements” in consent processes, the Revised Common Rule (RCR) makes a few other changes to consent elements. Under the RCR, the following statements must be included when applicable: —The subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether […]

The more we learn about the Revised Common Rule’s (RCR) requirement that “informed consent begin with a concise and focused presentation of the key information … most likely to assist” in the decision whether or not to join a study, the more we realize that there’s still a lot more to learn, much of which […]

As Arkansas Children’s (AC) and the Arkansas Children’s Research Institute (ACRI) continue the process of reworking their corporate structure, the IRB will notice some changes in some research-related documents. AC has made a new HIPAA authorization template available for AC researchers. You’ll notice at least two changes on the template. First, its format is closer […]