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

One noticeable new aspect of the Revised Common Rule is the requirement to include a “concise and focused” presentation of key information that would help a subject decide whether or not to join a study in the consent process. Although guidance as to what form this summary should take is only trickling out, we have […]

The Revised Common Rule (RCR), slated to be implemented Jan. 19, 2019, will be here before you know it. IRB staff recently gave a talk on the (RCR) changes most likely to affect research teams. For those who couldn’t attend, the talk was recorded, and will be rebroadcast in a webinar format at the following […]

Continuing review forms include a query asking you to summarize study progress in a free-text response. Please use this space to provide a complete summary of the study’s status, including describing how many subjects have completed the study, what part of the study any that haven’t completed yet are in, whether any notable positive or negative issues […]

If you couldn’t make it to the IRB’s October 30th talk about the changes coming with the Revised Common Rule, here are a few ways to catch up on what you missed. Feeling sociable? Attend one of the upcoming webinar replays: There will be two showings on Friday Nov. 9, Cancer Institute 10th floor, Room […]

Please remember discussions that happen inside the IRB’s meeting room need to stay inside the meeting room. IRB determinations and contingencies are considered group decisions. Those decisions are relayed to the research team via correspondence through CLARA. Reviewers – If someone on a research team asks you for specifics about their project’s IRB review, please […]