TAG ARCHIVES FOR protocol review

14
Nov2015

Exempting, expediting, and generally reviewing categories in social, behavioral, and educational research

Like three wise owls perched on the speakers platform, Kristina Borror, PhD, Jeffrey M. Cohen, PhD, and Dean R. Gallant, AB rolled out multiple vignettes in an interactive teaching format to review some bread and butter topics on IRB guidance at AER15. “What about this example makes it outside the exempt category?” asked Borror, director of Division of Compliance Oversight of the Office of Human Research Protections, of a skeptical audience member.

This triumvirate of veteran educators was simultaneously kind but persistent and demanding of precision in reinforcing one of the teaching points: [...] Read more

31
Mar2015

By Avery Avrakotos, education and policy manager

Last year, I was fortunate to have an opportunity to attend Ethical Issues in Global Health Research (EIGHR): Blending Cultures, Building Capacities, and Bolstering Collaboration. The four-day program, offered by the Harvard T.H. Chan School of Public Health, examined the unique issues that face institutional review boards (IRBs) and researchers reviewing and conducting international research.

As education and policy manager at PRIM&R, I regularly prepare written updates on federal laws, regulations, and news stories related to human subjects protections for distribution to PRIM&R's members, the majority of whom are [...] Read more

14
Nov2014

by James E. Lewis, PhD, an independent consultant and formerly a columnist for the Association of American Medical Colleges blog, Wing of Zock

A little known, but intentional, loophole in the federal regulations allows activities involving human subjects to be labeled “innovative care.” In spite of all that has been done since World War II to protect human subjects in clinical research, this ambiguity offers a mechanism through which unscrupulous individuals can avoid the ethical and regulatory obligations for the protection of human research subjects and the norms of professional and scholarly behavior. Recent cases demonstrating this dilemma can be found on the internet, but my purpose here is not [...] Read more

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