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 […]

The Revised Common Rule (RCR) requires federally conducted or supported clinical trials to post a consent form on a publicly available federal website. Because this requirement is new, we’re still figuring out how it works in practice. Here’s some information that may help. First, the RCR’s definition of a clinical trial is: A research study […]

Everywhere we go, we leave a trail of data behind. Every scan of our grocery store loyalty card, every time our phone tracks our location or activity level, every time we enter something into our diet tracker, or an online search engine, or a social media account, every time someone files a medical claim to […]

We know the temptation to pick up an old study’s documents and try to revise them to fit a new study is great. We also fervently hope you resist it each and every time you face it. Here are ALL of the reasons to NOT try to adapt an old document to a new study. […]

The ever-timely (ahem) Office for Human Research Protections (OHRP) has released a draft guidance about transitioning studies approved prior to the Jan. 21, 2019, Revised Common Rule implementation and compliance date. While this is only a draft and subject to revision, it supports what we’ve been hearing about how to handle studies initiated before Jan. […]

The Revised Common Rule (RCR), slated to take effect Monday, January 21, gives studies open prior to that date the choice of either staying with the current Common Rule regulations or transitioning to the RCR. The UAMS IRB will allow investigators to request consideration to change to the RCR with their next continuing review. The […]