That sound you hear is a giant sigh of relief from a whole lot of institutions subject to OHRP oversight. Late this afternoon, we received word of the planned Federal Register Publication of an interim Final Rule, delaying the effective and compliance date of the Revised Common Rule until July 19, 2018, which is 6 […]
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.
Still in a holding pattern regarding the revised Common Rule
Will we, or won’t we, have to comply with the revised Common Rule in a few short weeks? That’s the big question to which there’s still no solid answer as of this writing. January 19, 2018, has a big, red circle around it on our calendar. That’s the date the revised Common Rule is slated […]
It sees you when you’re sleeping…aka musings about “data” and privacy
An IRB Blog Central staffer recently found herself purchasing one of those fancy-schmancy beds that can be adjusted all kinds of ways. While wandering around the showroom, she noticed a screen flashing statistics about Arkansans’ sleep patterns, and how they compared to those in the rest of the country. All of it based on *data* […]
Author: Research disputes head to court, create barrier
Research findings and publications can lead to more than just heated discussions and letters to the editor. It turns out they can also lead to lawsuits, according to a recent New York Times column. Its author goes on to discuss the chilling effects legal action can have on the research enterprise. Author Aaron E. Carroll […]
The final* Revised Final Rule
Remember that asterisk in our blog items that talked about the final* Revised Common Rule? Well, it’s still there. Most of the Revised Common Rule was, and still is as of this writing, slated to take effect in January 2018. However, even its authors agree that the revised rule introduces a lot of changes to […]
Thinking about research ethics, with help from PRIM&R and First Clinical Research
We encourage our reviewers to use the “Question of the Month” feature on the Public Responsibility in Medicine & Research (PRIM&R) web page as a prompt about ethical questions in research. Per the website, “each month we share a new question and accompanying anonymous survey, designed to encourage critical thinking about questions in clinical research and […]
Research participation basics for potential subjects, and others
We know the federal Office for Human Research Protections (OHRP) mainly through its interactions with researchers and research sites. Now, however, OHRP has made available a wealth of resources for potential research subjects and others interested in research. The About Research Participation web page has videos and other resources describing research concepts. One aspect we […]
Great education opportunity at UAMS next week
Some of the biggest sessions at next week’s Advancing Ethical Research conference in San Antonio will be available remotely on the UAMS campus, thanks to the UAMS Office of Research Compliance. The conference, organized each year by Public Responsibility in Medicine and Research (PRIM&R), is the big human subject research conference each year, where thousands of […]
Holidays, inclement weather, can complicate IRB meeting scheduling
It’s that time of year again – winter (which is kinda of feeling like potentially a real thing so far this year) and the holidays both loom. Keep that in mind in your end-of-year planning if you have approval deadlines you really, truly need to meet. Here’s a reminder that, for reasons that are a […]
Joint OHRP and FDA guidance on meeting minutes
The federal Office for Human Research Protections and the Food and Drug Administration have released a joint guidance addressing the requirements for IRB meeting minutes. We are excited about this for at least two reasons. First, we love it when OHRP and FDA work together on something. The two agencies have separate regulations, and while […]