The Journal of Medical Ethics blog has a recent entry addressing findings of a study that examined the extent to which IRB members were familiar with some basic study design concepts. (In summary: not very familiar.) The blog entry author writes that she would expect IRB members to know enough about research design to be […]

It seems as though everyone involved in human subject protections struggles with the informed consent process. The desire to provide complete information to subjects can collide with a need to keep informed consent forms and processes simple and understandable. Eliza Hurley, director of the research professional organization Public Responsibility in Medicine and Research (PRIM&R), recently […]

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 […]

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 […]

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 […]