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For the first time in several years, The Joint Commission standards and goals with the lowest compliance rates are not directly related to the delivery of health care.
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President Barack Obama's long-stated goal for universal health insurance could have a ripple effect on the human subjects research field, possibly removing an incentive for people to enter clinical trails.
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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.
