Q. How can I search for a specific blog item that I know I’ve seen, but I don’t know when? A. Short answer: If you know of a way, do let us know, because we haven’t been able to figure one out. Long answer: Someone had a great idea that we thought we’d share. If […]
Institutional Review Board Members
Reminders for our Institutional Review Board reviewers about policies, using Clinical Research Administration (CLARA), and other news. Feel free to click on this blog even if you aren’t on the Institutional Review Board. You may get some pointers about what the Institutional Review Board is looking for when it reviews your studies.
What do IRB members need to know about study design?
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 […]
PRIM&R director comments about new Common Rule’s informed consent requirements
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
Is much biomedical research nothing more than bad science?
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, […]