We’ve heard from some research staff, and confirmed with UAMS Information Security, that UAMS Box is now being offered as a storage option for research data. Box makes it easier to share data with collaborators, all while maintaining appropriate levels of access and security. “Box is a secure site and we have a Business Associate […]
Research News
Investigators, study staff, research administrators — keep up with research happenings in our Research News and Tips blog. Reminders for working with the Institutional Review Board, Clinical Research Administration (CLARA) tips, educational opportunities — we’ll post all that, and more, on this blog.
Staff-only modifications — don’t forget to change the staff list!
Staff-only modification forms will ask you what you are changing in your study, and that’s where people write in the staff changes they’re making with the form. A couple of hints to help your staff-only modification get quick approval: –Remember that to complete a staff change, the staff list in CLARA also needs to be updated […]
Communicating with people who aren’t scientists, e.g. your study subjects
Researchers have to communicate with a lot of different people – their peers, their funding agency, their research staff, their subjects, and the public. It’s these latter two groups – subjects and the public – that may be the most challenging for scientists to manage. But they may also be among the most important. Adequately […]
CLARA Modification form workflow change
The pilot process of routing all modifications through the Research Finance Team prior to IRB submission has ended. As of May 15, the original process of routing modification through the Research Finance Team based upon the information submitted in the modification form has been restored. This return to the original process is expected to speed […]
Confused by clinicaltrials.gov? Tracy Gatlin in ORRA can help you navigate it
Clinicaltrial.gov requirements can be a little intimidating, even to experienced investigators. There’s no need to try to navigate alone, however; Tracy Gatlin in the Office of Research Regulatory Affairs is available to assist research teams with everything clinicaltrials.gov related. Free services include individual training on clinicaltrials.gov, review of any new protocol to see if registration […]
More great — and free — tools for clinical trial investigators
If you’re an investigator who writes your own IND or IDE protocols – or you work with an investigator who does – here’s a new resource you’ll want to note. The NIH and FDA have jointly released a protocol template for phase 2 and 3 IND/IDE clinical trials. The link above takes you to a news […]
A not-so-short course in informed consent for research
When we think “informed consent process,” we very often think of an interaction that involves a written consent form. However, there are other ways of exchanging and documenting information, and some of those alternatives may be appropriate for certain low-risk studies. The New England Journal of Medicine recently published “an overview of innovative approaches to […]
Please describe subject compensation in great and gory detail
One issue the IRB pays close attention to is the proposed compensation for study subjects. When submitting studies, please make sure your materials clearly and thoroughly describe the compensation. The total amount it’s possible to earn for completing the study must be mentioned, as does how compensation will be prorated if subjects don’t complete all […]
Remember — Human subject protection-related decisions are the purview of the UAMS IRB
Word has reached us, through the grapevine, of investigators being told things like, “You’ll have to rerecord that recruitment video” and “Unless you get a reconsent, you won’t be able to use that subject’s data because you didn’t follow your approved consent process” by people who are NOT the IRB. We’ve also heard that some […]
Seeking study subjects? The ARresearch.org Registry may be able to help
If you’re trying to think of ways to find people who might be interested in your study, the UAMS Translational Research Institute (TRI) may be able to help. TRI’s ARresearch.org volunteer registry provides investigators with access to nearly 3,000 potential research participants located primarily in Arkansas. Like all recruitment mechanisms, ARresearch.org database access requires IRB […]