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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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From a bioethical perspective, payments to research participants are complicated, an expert says.
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Ethicists and others continue to find it troubling that payments to research participants are part of the recruitment process.
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The FDA's amended rule for acceptance of foreign clinical studies not conducted under an investigational new drug (IND) application has drawn fire from health advocates who say it weakens ethical protections.
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A recent legal case involving a clinical trial participant who committed suicide raises a variety of questions for IRBs.
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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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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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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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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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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?
