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Informed Consent Requirements – N.Y. Pub. Health Law § 2442
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Current as of June 2015
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Informed Consent Requirements for Human Subjects in Medical Research Projects
Article 24 A (§2440-46) of the New York Public Health Law protects human subjects participating in medical research projects. This section specifically governs the issue of “informed consent” (as defined under § 2441-5). This section requires that the researchers obtain subjects’ voluntary, informed consent in writing. If the subject is a minor, the minor’s parent or legal guardian must consent in writing. If the subject is unable to consent, the person legally able to make medical decisions on behalf of the subject is required to consent in writing. The informed consent may not include consent to waive subject’s legal rights, including the right to sue for negligence.
Current as of June 2015
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