We plan to hold a training session for new IRB reviewers and current reviewers seeking a refresher the afternoon of Tuesday, April 30. That’s a fifth Tuesday, so there’s no regular IRB meeting that day. We will cover the basics of IRB reviewing and walk through the use of CLARA from the reviewer’s perspective. This […]

Remember that new Revised Common Rule requirement to start informed consent with a “concise and focused” summary of “key information” to help subjects decide whether or not to participate in a study? We all know we haven’t gotten too much direct guidance about what that “key information” should address. For some studies, that “key information” […]

Corrective action plans are often called for when you, or an auditor or monitor, notice a problem with a research study. The IRB may also request such a plan in response to an audit report or reportable new information submission. Corrective actions may also be appropriate for protocol deviations reported at continuing review. When drafting […]

Getting NIH funding is cool. Losing that funding due to bad behavior, not so much. NIH reports it looked at more than two dozen allegations of sexual harassment last year involving scientists whose work it supports, with 14 investigators who had received NIH grants being replaced, according to an article in Nature. Another 21 PIs […]

The Food and Drug Administration (FDA) may be on a trend to look more closely at some medical devices, according to a recent NPR report. Problems related to what FDA calls 510(k) devices are prompting this change, per the article. 510(k) devices are those the manufacturer has shown are “substantially equivalent” to a legally marketed […]

Here’s a reminder the UAMS IRB has NOT dropped its requirement that the person obtaining consent sign the consent form when a written form is used. An early iteration of the RCR-compliance plain language consent form on our website accidentally omitted the person obtaining consent signature line. We apologize for that error, and have since […]

When you hear that one impetus behind OHRP’s decision to revise the Common Rule was to minimize regulatory burdens where appropriate, you may be tempted to switch your studies initially reviewed under the old rule to the Revised Common Rule (RCR). You have the chance to do so at your next continuing review. But, before […]

We’ll just put this out there without much comment, other than to say this is the kind of situation human research protection programs try to avoid even the appearance of.    

You’d think we keep our IRB reviewers so busy that they’d barely have time to manage the whole rest of their careers. But you’d be wrong, as shown by two of our reviewers. Congratulations to Leah Eisenberg, J.D., M.A., HEC-C, on becoming one of the first bioethics experts in the United States to be certified […]

How significant can a two-word change be? In the case of a small revision to the informed consent regulations in the Revised Common Rule (RCR), two little words may spur investigators and IRB reviewers to think about the informed consent process more expansively. The change, as noted in a recent AAHRPP webinar on understanding in […]