IRB Advisor articles from August 2008

IRB Advisor archives from August 2008

Clinical trial participant's suicide raises ethical questions for IRBs.
August 1, 2008... Clinical trial participant's suicide raises ethical questions for IRBs Conflict of interest and informed consent issues pondered A recent legal case involving a clinical trial participant who committed suicide raises a variety of...

Conflict of interest issues raised by subject's suicide.
August 1, 2008... Conflict of interest issues raised by subject's suicide Subject's mother sued based on COI When is the dual role of physician/investigator a conflict of interest? This is the question IRBs might consider in the aftermath of clinical...

In rare instances, IRBs may need to go beyond regulatory framework.
August 1, 2008... In rare instances, IRBs may need to go beyond regulatory framework What's ethical might require planning, creativity Sometimes IRB members will need to view a particular human subject research issue with more of an eye on what is the...

When clinical research turns up the unexpected.(Clinical report)
August 1, 2008... When clinical research turns up the unexpected Anticipate incidental findings in every study Researchers using magnetic resonance imaging (MRI) in a cognitive psychology study note a suspicious mass in the brain of a supposedly healthy...

Elements of an incidental findings management plan.
August 1, 2008... Elements of an incidental findings management plan Questions IRBs should ask 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...

Give research results to study participants.
August 1, 2008... Give research results to study participants Research shows participants want it 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...

CNE/CME Objectives/questions.
August 1, 2008... CNE/CME Objectives The CNE/CME objectives for IRB Advisor are to help physicians and nurses be able to: *establish clinical trial programs using accepted ethical principles for human subject protection; *apply the mandated...