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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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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 the dual-consent framework for pediatric research, age-appropriate communication across developmental stages, assent waiver conditions, parent management, and the majority transition.
Everything you have learned in this course so far has assumed that the person sitting across from you is an adult making their own decision. The general consent process covered in Modules 1 through 4 -- the ethical foundations, the conversational techniques, the comprehension assessment methods -- all of it presumes a single autonomous individual who can evaluate the information, weigh the risks, and decide for themselves.
Pediatric research changes the equation fundamentally. When the prospective participant is a child, you are not conducting one consent conversation. You are conducting two. The first is with the parent or legally authorized guardian, who must grant permission for the child to participate. The second is with the child, who must provide something called assent -- an affirmative agreement to participate that is appropriate to their developmental capacity. And these two conversations, while related, are not the same conversation. They have different purposes, different audiences, different vocabularies, and different ethical stakes.
I want to say something at the outset that I believe deeply: the smaller voice at the table may be the most important one. A parent's permission is legally necessary. But a child's willingness -- their genuine, uncoerced willingness -- is ethically essential. A child who participates in research against their wishes, even with parental permission, has been wronged. Not in a way that violates a regulation. In a way that violates a person.
This lesson addresses the regulatory framework, the communication skills, and the ethical sensitivities required to conduct pediatric consent well. It is not, I should note, a lesson about consent with smaller chairs. It is a lesson about a fundamentally different ethical conversation.
What you will learn4 objectives
By the end of this lesson, you will be able to:
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