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 […]
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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 […]
Research toolkits, free for the taking (or for the clicking, more precisely)
We like to share resources that might be helpful to researchers whenever we find them. A recent find comes courtesy of the Multi-Regional Clinical Trials center at Brigham and Women’s Hospital and Harvard (look under “resources). This group has done some work on, among many other things, the return of research results to participants. Transparency […]
The value of research from the subjects’ perspective — the survivors
While the pundits argue whether scientific research results are meaningful, other people are demonstrating the value of biomedical research in their own lives. Chronic myeloid leukemia used to have a fairly grim prognosis, but the early trials of the drug that became Gleevec showed that more favorable outcomes were possible. STAT recently published a roundup of […]
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 […]