IRB Advisor – February 1, 2009
February 1, 2009
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What impact will Obama administration have on human subjects research?
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. That is one of several possible changes on the horizon as a new administration takes the helm, experts tell IRB Advisor. -
New OHRP director on new priorities, changes
The Office for Human Research Protections (OHRP) of Rockville, MD, announced in October, 2008, that Jerry A. Menikoff, MD, JD, is the new director. -
OHRP's new transparency includes correspondence
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. -
Listening to the community pays off for biobank project
When the Marshfield (WI) Clinic launched an ambitious biobanking project, organizers knew they'd need significant community buy-in. -
Protecting suicidal teens in research requires care
Research with adolescents who are at risk for suicide can create daunting ethical and practical challenges for investigators and IRBs. -
Research with pregnant women still lags due to fears for fetuses
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. -
Ask2-4U: Vulnerability issues not clearly outlined in regs
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.