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Every study participant has seen some variation of this assurance in informed consent documents: "You are free to participate in this research or to withdraw at any time without penalty or loss of benefits you are entitled to receive."
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Two or more IRBs reviewing the same study might reach strikingly different conclusions about the study's risks and suitability for human subjects.
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The growing field of biobanking has added new wrinkles to issues of withdrawal from research. Withdrawing from participation in a biobank or a large cohort study is a very different matter from withdrawing from a clinical trial. Because of the technology involved, it may not be possible to completely remove one's information from the research.
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The very first step to becoming accredited is to collect all of your institution's policies and procedures related to the human research protection program in a searchable electronic format, an expert advises.
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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?
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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.
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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.
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Researchers using magnetic resonance imaging (MRI) in a cognitive psychology study note a suspicious mass in the brain of a supposedly healthy volunteer.
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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.
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A recent legal case involving a clinical trial participant who committed suicide raises a variety of questions for IRBs.