UAMS’ reach extends across the state and beyond – and that reach includes our research endeavors as well. The Association for the Accreditation of Human Research Protection Programs (AAHRPP), as it reviews our application for reaccreditation, will look at (among many other items) how UAMS engages with our research participants (current or prospective) and our […]

It’s tempting to review written consent forms closely and note all the little typos and grammar errors that could use correction. However, keep in mind that, when reviewing informed consent in research, the IRB’s role is to assure that informed consent will be appropriately sought and, if written consent is required, documented using an approved consent […]

The first big hurdle on the road to reaccreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) is behind us – our application has been submitted. There will be several other steps in the months ahead, one of which will be an AAHRPP visit to our site. During that visit, we […]

It’s free,  it’s full of good information, and some of our IRB members have been asking about it – it’s the IRB Forum. The IRB Forum is an online resource allowing exchange of ideas regarding human subject research, regulations, and protection. As described on its website, the Forum “promotes the discussion of ethical, regulatory and […]

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 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 […]

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 […]

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 […]

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 […]

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 […]