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The draft guidance on financial conflicts of interest and research published March 31, 2003, in the Federal Register offers more questions to be considered than specifics to be followed.
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The Stanford (CA) University protocol application form includes a section that examines potential conflict of interest through seven questions.
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Preparing for an accreditation site visit is difficult enough, but the hard work doesnt end after an IRB receives a letter announcing that it has been fully accredited, according to the first IRBs to receive full accreditation from the Association for the Accreditation of Human Research Protection Programs Inc. (AAHRPP) of Washington, DC.
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A handbook for IRB members sets forth the policies of the IRB, and serves as a reference and working guide for members as they review protocols and carry on their work.
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With nearly two-thirds of biomedical research funded by industry, it is perhaps not surprising that there are financial conflicts of interest between companies, investigators, and universities.
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Question: Is informed consent needed for retrospective data research? Under what circumstances can informed consent be waived?
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Most IRBs long have provided education and training to IRB members; but in recent years, IRB members education has become a top priority for some boards.
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With the first non-Veterans Affairs (VA)-affiliated IRBs now achieving accreditation, IRB coordinators may have their clearest look so far at how the process has worked and what might be gained from jumping into the accreditation waters.
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In the summer of 1971, Philip Zimbardo, PhD, was lead investigator on The Stanford Prison Experiment, a study designed to measure the psychological effects that imprisonment and authority would have on participants.
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In an ideal world, researchers working with mentally ill subjects would be able to present information about their studies in such clear, comprehensive, and organized ways that IRBs could be assured that participants know exactly what to expect.
