IRB Advisor
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Reanimation Study a Step Toward Brain-death Breakthrough?
A new reanimation study of brain death has many compelling and hopeful aspects to its principal investigator in India and biotech sponsor in the U.S.
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IRB Continuing Education Series Turns Students into Teachers
Newark, DE-based Christiana Care Health System’s long-time educational program was set up to keep research nurses up to date, but over time it lost its luster.
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Smart Training Can Prevent Problems with New Technology
Adopting new electronic submission technology across a research enterprise organization can prove to be challenging for IRBs, which have a long list of stakeholders to train and educate.
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Some Spit, Polish, and Creativity Can Solve IRBs’ Education Efforts
IRB leaders at Christiana Care Health System in Newark, DE, revamped their research education sessions in response to dwindling attendance numbers.
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Transparency About Participation Incentives Could Benefit IRBs, Researchers, and Patients
While the issue of incentives raises a host of ethical issues for discussion, the problem is the dearth of data on what study participants have been compensated for all manner of studies and clinical trials.
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What You Don’t Know About NIH RAC Review Changes Could Hurt
IRBs might not have asked for it, but the National Institutes of Health and the FDA have handed them a new responsibility when it comes to oversight of clinical trials involving human gene transfer.
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Who was Dan Markingson?
On May 8, 2004, Dan Markingson killed himself while participating in a University of Minnesota Department of Psychiatry drug study.
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U. of Minnesota Fights Bill Giving State Oversight of Psych Research
Reeling from a decade-long series of investigations and allegations after the suicide of a psychiatric research patient, the University of Minnesota is now facing a proposed state law that would assign oversight for its psychiatric drug research program to an independent ombudsman’s office.
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AMA calls for clinical trial transparency
The American Medical Association has joined the AllTrials initiative, giving the campaign for clinical trial data transparency a formidable ally with the largest physician membership in the U.S.
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Here’s how to improve reviews of socio-behavioral protocols
IRBs that predominantly review biomedical protocols might find it less clear in determining risks when reviewing socio-behavioral research.