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 […]

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 […]

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 […]

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 […]

A science reporter for National Public Radio weighs in on the quality of biomedical research in a new book out this month. The title of Richard Harris’ book, “Rigor Mortis: How Sloppy Science Creates Worthless Cures, Crushes Hopes, and Wastes Billions,” does little to instill confidence in those of us who make our careers in, […]

Hint No. 1 – We sometimes see mention of a missing NCT number when reviewing a new submission. Please note that sometimes PIs won’t have received an NCT number from clinicaltrials.gov before the study comes to the IRB for review and approval. Therefore, any IRB request to obtain and document the NCT number should be […]

A procedure that fell somewhere between “research” and “treatment,” depending on who you ask, involving the injection of stem cells into the eye led to severe vision problems in three women, one of whom went blind as a result, according to a recent report in the New York Times. The article raises some interesting points. […]

You may remember the San people from the 1980s movie titled “The Gods Must Be Crazy.” That effort wasn’t the first time this community was under scrutiny. As a recent article in the online publication Quartz notes, the group has been studied and photographed for a long time, and “The traditional knowledge and culture of the […]

Here at the IRB, we see a fair number of social/behavioral studies that are designed with the help of community advisory boards or other representatives of the intended study population. However, that kind of patient involvement seems to be more rare in clinical studies, at least the ones we see. The NCI-MATCH study, per one […]

Researchers and health-care providers have long worried about how to ensure patients and potential subjects understand treatment and research options. Two medical doctors weigh in in a recent New York Times piece, acknowledging the shortcomings of current methods. (Example: “Over your lifetime of seeing us, we have trained you that we will look impatient and concerned if you […]