Perhaps in an attempt to reverse previously identified declines in research funding awarded to younger scientists (see here and here), the National Institutes of Health recently announced a plan to focus more on early and midcareer researchers in making funding decisions. More information about the change can be found in recent postings in Science and […]

We’ve learned, here at IRB Blog headquarters, that Arkansas Children’s Hospital is revising its logo. A researcher asked if she needed to submit modifications for study documents she needs to change to replace only the logo. In a word, no. If the only change you need to make is to update the logo, there is […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]