IRB Advisor – April 1, 2005
April 1, 2005
View Issues
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Inconsistent interpretation of HIPAA creates research recruitment barrier
Researchers are finding the HIPAA to be a significant barrier to recruiting research participants, in part because of the inconsistent way in which IRBs deal with requests for HIPAA waivers. -
Psychiatric research guidelines developed
Patients with psychiatric illness pose a particular problem to researchers and to the IRBs that review studies involving them. They can have widely varying capacity to give informed consent and that capacity can wax and wane depending upon the progression of the illness and the patients current treatment. Issues such as the use of placebo and the role of surrogates can be thorny. -
Video helps patients with decision-making process
A video created to dispel patient misconceptions about clinical trials benefited from a diverse array of viewpoints everyone from physicians and nurses to subjects and even those who decide not to take part in clinical trials, says the woman who spearheaded the effort. -
States move to mandate drug trial registration
Reacting to allegations that clinical trials showing unfavorable results often go unpublished, two states are proposing legislation that would require clinical researchers to register their studies with the NIHs clinical trials database if they involve studies designed to evaluate a drugs safety or effectiveness. -
Settlement reached in Gelsinger death
The 1999 research-related death of Jesse Gelsinger achieved one more step toward resolution with the announcement of a settlement between the federal government and researchers and research institutions involved in the case. -
Center for Pediatric Bioethics set for Seattle
Should a terminally ill 10-year-old have a say in determining her end-of-life care? Can a teenager make an informed consent to treatment? Questions of this type will be the mainstay of the Center for Pediatric Bioethics, the nation first center for bioethics solely dedicated to pediatrics, which will be located at Childrens Hospital and Regional Medical Center in Seattle. -
News Briefs
Public opinion of FDA sliding in Vioxx wake; CAM therapies must meet standards.