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 […]
Soldiers, animals, and research
This Memorial Day weekend, we honoring those who served. And since this is a research blog, we’ll guide you to a Foundation for Biomedical Research article about the animals who have served our veterans on the battlefield and in the research lab. There’s no shortage of stories about the ties between military working dogs and […]
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 […]
The verbal brawling over low-risk research under the new Common Rule begins
One goal for the revised Common Rule, according to its developers, was to streamline oversight requirements based on the risk level of proposed research. IRB oversight has caused its share of grousing among researchers here and elsewhere about overreach (a.k.a. mission creep) and focus on irrelevant details. Social and behavioral researchers are now weighing in in […]
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 […]
A peek into serving as a central IRB
As the research world keeps evolving, the IRB will adapt along with it. One looming change is the increasing use of single-IRB review of multisite studies. In fact, the UAMS IRB will serve as the central IRB for a 17-site pediatric clinical trial network (ISPCTN). While the official start date for the new study is not […]
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 […]
Certificates of Confidentiality are slated to become much easier to obtain
Certificates of Confidentiality can provide important legal protections to researchers who work in potentially sensitive areas. These certificates allow research teams to decline to provide sensitive information in response to certain legal requests, such as subpoenas. The process for obtaining a certificate of confidentiality involves submitting an application to the federal government. However, NIH recently […]
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 […]