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 […]
Institutional Review Board Members
Reminders for our Institutional Review Board reviewers about policies, using Clinical Research Administration (CLARA), and other news. Feel free to click on this blog even if you aren’t on the Institutional Review Board. You may get some pointers about what the Institutional Review Board is looking for when it reviews your studies.
Will the FDA look more closely at some devices?
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 […]
Reminder to check for the person obtaining consent signature line on consent forms
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 […]
Reminders about transitioning to the Revised Common Rule
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 […]
Questions about a study at the San Diego VA
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.
Kudos to two of our IRB reviewers
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 […]
A small but noteworthy change in the informed consent regulation
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 […]
Posting clinical trial consent forms, as required by the RCR
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 […]
The context in which we consider subject privacy and data confidentiality
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 […]
The TWO reasons to start with a fresh template every time
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. […]