Drugs

Challenges in Using a Single IRB in Multisite Trials

Professors from Columbia University and the University of Massachusetts medical school say that new federal rules on the protection of human research participants calling for use of a central or single institutional review board in multisite research funded by the National Institutes of Health raise questions that must be resolved. Writing in an online opinion piece in the Journal of the American Medical Association, the three authors say there are three critical aspects that academic institutions, researchers, and policy makers will have to resolve before implementing the new policy: (1) the relationship between the single IRB and local institutions, including local IRBs; (2) the collection and incorporation of local knowledge in the single IRB review; and (3) the relationship between the single IRB and local researchers.

“These issues involve fundamental legal, ethical, institutional, and policy tensions that will profoundly shape the costs and effectiveness of future multistate research involving human research participants,” the authors write.

They say that data on the process and outcomes of a single IRB system should be collected and analyzed to formulate best practices for defining the relationships and boundaries between local IRBs and single IRBs, developing standardized ways for single IRBs to account for local practices, and establishing working relationships between single IRBs and investigators. “Appropriate implementation of the NIH single-IRB policy will be key to developing an efficient research-friendly process for multisite IRB reviews that continues to ensure the protection of human research participants,” the authors conclude.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome