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Clinical Research Coordinator
Full course · Informed Consent in Practice
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The full CRC track covers 8 courses from study start-up to close-out — the skills sponsors actually look for.
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Covers capacity assessment using the Appelbaum-Grisso framework, consent accommodations for cognitively impaired participants, combined consent approaches, and ongoing capacity monitoring obligations.
The previous lesson addressed a situation where the question of capacity was, in a sense, already answered. The participant could not consent independently. A legally authorized representative was identified, verified, and engaged. The triad conversation proceeded. But that lesson deliberately set aside the harder question -- the one that arises before anyone reaches for a surrogate consent form. How do you determine whether a participant with cognitive impairment can consent at all?
This is the question that distinguishes careful, ethical practice from the two errors that bracket it. The first error is assuming that a diagnosis of cognitive impairment automatically extinguishes the capacity to consent. It does not. A person with early-stage Alzheimer's disease, a stable traumatic brain injury, or well-managed schizophrenia may understand a research protocol, appreciate its implications for their own situation, reason about the risks and benefits, and express a clear choice. Denying that person the opportunity to make their own decision -- routing them automatically to a surrogate -- is paternalism, not protection.
The second error is the opposite: assuming that because a person can carry on a conversation, they can provide informed consent. Conversational ability and decisional capacity are not the same thing. I have seen participants with moderate cognitive impairment charm a room, answer social questions fluidly, and then prove entirely unable to explain what a clinical trial is, what they are being asked to do, or what would happen if they said no. The ability to speak coherently is necessary for consent but nowhere near sufficient.
Your obligation is to determine where each participant falls on the capacity spectrum -- and to do so with rigor, with humility, and without assumption. This lesson gives you the framework for that determination.
What you will learn4 objectives
By the end of this lesson, you will be able to:
Progress saves itself — finish reading and this lesson completes