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There have been a handful of bills introduced in the past few years that could have an impact human subjects research.
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The Office for Human Research Protections (OHRP) of Rockville, MD, announced in October, 2008, that Jerry A. Menikoff, MD, JD, is the new director. Menikoff also has served as the director of the Office of Human Subjects Research and has worked as a bioethicist at the National Institutes of Health (NIH).
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When the Marshfield (WI) Clinic launched an ambitious biobanking project, organizers knew they'd need significant community buy-in.
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Despite general agreement that medicine and medical research need to do more to meet the needs of pregnant women, there still are serious roadblocks that prevent wider enrollment of women during pregnancy.
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There's little data about exactly what is impeding research with pregnant women, says Ruth Faden, PhD, MPH, director of the Johns Hopkins Berman Institute of Bioethics in Baltimore, MD.
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Helen McGough, MA, CIP, is retired from the office of research at the University of Washington in Seattle, WA, and has worked as a faculty member of PRIM&R. McGough also has worked with the Collaborative IRB Training Initiative (CITI), and she served on an IRB for many years.
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The Office for Human Research Protections (OHRP) of Rockville, MD, recently added "OHRP Correspondence" to its Regulations and Policy Guidance portion of its Web site as part of an effort to improve transparency and provide some specific examples of how to interpret various guidelines.
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Research with adolescents who are at risk for suicide can create daunting ethical and practical challenges for investigators and IRBs.
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How effectively does the Medicaid Statistical Infor- mation System (MSIS), the only nationwide Medicaid eligibility and claims information source, detect fraud, waste, and abuse? Not very, according to a new report which found the MSIS failed to capture data elements that can assist in fraud, waste, and abuse detection.