IRB Advisor – August 1, 2008
August 1, 2008
View Issues
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Clinical trial participant's suicide raises ethical questions for IRBs
A recent legal case involving a clinical trial participant who committed suicide raises a variety of questions for IRBs. -
Conflict of interest issues raised by subject's suicide
When is the dual role of physician/investigator a conflict of interest? This is the question IRBs might consider in the aftermath of clinical trial participant Dan Markingson's suicide. -
In rare instances, IRBs may need to go beyond regulatory framework
Sometimes IRB members will need to view a particular human subject research issue with more of an eye on what is the most ethical decision to make, as opposed to what is the best way to comply with rules and regulations. -
When clinical research turns up the unexpected
Researchers using magnetic resonance imaging (MRI) in a cognitive psychology study note a suspicious mass in the brain of a supposedly healthy volunteer. -
Elements of an incidental findings management plan
When the answer to the question of "Could there be incidental findings from this study?" is "Yes," experts agree that the protocol should include an incidental findings management plan. -
Give research results to study participants
For years, the debate has continued about returning the results of research to the study participants who made it possible. Would such a process be expensive and unwieldy? Could it cause more harm than good, when participants receive bad news?