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 […]
Remember — Human subject protection-related decisions are the purview of the UAMS IRB
Word has reached us, through the grapevine, of investigators being told things like, “You’ll have to rerecord that recruitment video” and “Unless you get a reconsent, you won’t be able to use that subject’s data because you didn’t follow your approved consent process” by people who are NOT the IRB. We’ve also heard that some […]
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, […]
Seeking study subjects? The ARresearch.org Registry may be able to help
If you’re trying to think of ways to find people who might be interested in your study, the UAMS Translational Research Institute (TRI) may be able to help. TRI’s ARresearch.org volunteer registry provides investigators with access to nearly 3,000 potential research participants located primarily in Arkansas. Like all recruitment mechanisms, ARresearch.org database access requires IRB […]
Remember, NICE reviews aren’t “audits”
The New Investigation Consult and Education (NICE) reviews provided by the ACH and UAMS research compliance staff are wonderful tools. They can help a newly approved study get off to a good start by identifying and fixing any problems before subject enrollment begins. Keep this important tip in mind when following up on NICE review findings. […]
Answering the CLARA New Submission Form’s accrual questions
Confusion reigns about how to complete the new submission forms asking what your study’s enrollment goal is, and how many people you’ll need to consent to reach that goal. Here is a guide for how to handle these queries for various study types: For studies with consented subjects: The first question the submission form asks what […]
Updating your study? You may need to revise some form responses as well
A reminder when submitting modified documents, or when responding to contingencies – if the changes you are proposing relate to something that was asked on the new submission form, please edit the corresponding modification form response to match your changes. Example: Say that when you first proposed the study, you were going to provide compensation […]
A couple of hints when reviewing new submissions
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 […]