IRB Advisor – September 1, 2007
September 1, 2007
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Bioethics training program for Africans helps professionals bring expertise home
Major corporate research sponsors and large institutional sponsors in the United States increasingly are conducting clinical trial research overseas. Sometimes this raises concerns among IRBs and human subjects protection leaders about human subjects protection measures taken by these organizations. -
Improve quality control following expert suggestions
One of the most important services an IRB can provide is rapid turnaround on protocol reviews. The next most important service is providing quality documents, says the president of a large independent IRB in Austin, TX. -
Heading off headaches with multisite IRB review
Reams have been written about the logistical problems of dealing with local IRBs on multisite trials - the delays, the countless changes demanded by individual boards, the overall hassle. -
Consent monitoring proposed to improve informed consent
Many IRBs spend countless hours of review focusing on the consent documents needed for research studies. Are they too technical? Written at too high a level of readability? Too vague? Not extensive enough in their description of potential risks? -
Preventive misconception: Study shows misunderstanding
IRBs already are attuned to the dangers of therapeutic misconception, in which research subjects confuse research interventions with personalized medical care. Meaningful informed consent explaining clearly the potential risks and benefits of participation in a study is believed to be the best method of combating the problem.