When the IRB approves your study, it is required by regulation to make certain determinations. Two criteria the IRB must be able to be able to document as being met are that risks to subjects are minimized by using procedures consistent with sound research design, and that selection of subjects is equitable (45 CFR 46.111). To be […]
Reminder — No IRB meeting Sept. 29
September is a five-Tuesday month, and the UAMS IRB meets only the first four Tuesdays of every month. If you have anything needing full-board review in a hurry, it should probably already be in the CLARA system if it is to make it onto the agenda for our last September meeting on the 22nd. And […]
Big changes possible to the Common Rule — learn more at upcoming class
A lot has changed in human subject research since 1991. You know, things like the widespread use of electronic systems in research, genetic research and its associated risks, different ways of obtaining informed consent, the rise of central IRB reviews of research, etc. etc. One thing that hasn’t changed much in the last almost-quarter-century is […]
A Court Decision, and More Debate, About Research Risks, Informed Consent, and Neonates
A federal judge has thrown out a lawsuit filed by parents who claimed their infants were injured as a result of research participation, the New York Times reported this week. The study, known by its acronym SUPPORT, was in the news a few years ago, after the federal Office of Human Research Protections (OHRP) accused the […]
Upcoming Class on Proposed Common Rule changes — Potentially a “Big Deal”
The Common Rule (45 CFR 46) is the regulation that UAMS must follow as it oversees research involving human subjects. It was first published in 1991, when the research environment was much different than it is today, on multiple levels. Now, four years after the Office for Human Research Protections (OHRP) indicated that it was […]
Potential Red Flags When Reviewing Research
The Journal of Clinical Research Best Practices (“Happy Trials to You” is its motto) recently published a list of items to be aware of when reviewing research. The authors, Dennis J. Mazur and Norman M. Goldfarb, call them “red flags” that should be addressed before an IRB begins its in-depth review of the project. The […]
Helpful FDA Guidance on Significant Risk and Nonsignificant Risk Device Studies
We’ve been seeing device studies off and on for years, but we still don’t fell like we’ve mastered all the regulatory ins and outs of studies that involve investigational devices. In trolling around the FDA’s website not long ago, we found a guidance that has a lot of good information about device studies and what […]
A change in how to access documents in CLARA
In the past, CLARA users could access study documents via live links at the bottom of a particular form (new submission form, modification form, etc.). We’ve made some changes in CLARA related to document access, so those links will no longer be live. To see documents in CLARA, you’ll now go to the “documents” tab. When […]
A hint from the technical side for drafting contingencies
When they’re reviewing a study, some reviewers (and some of the IRB office staff too!) like to open a separate document in Word or some other program to draft contingencies as they work through a study. Then, they copy and paste those contingencies into CLARA when they wrap up their review. There’s nothing inherently wrong […]
First blog quiz for CRS credit hour expires soon
The first IRB Blog quiz you can take to earn 0.5 hours toward earning or retaining your Certified Research Specialist (CRS) certificate will be available for only about another month! So hurry and log on at learnondemand.org to earn your credit. We’re planning to post a second quiz around September 18, and the first quiz […]