What are the consent requirements for collecting and using biological samples for research?

In New York, the legal requirements for collecting and using biological samples for research depend on the type of sample being used. It is important to obtain consent from the individual donating the sample, as well as their parent or guardian if the donor is a minor. This consent must be written and signed, and must contain the name of the individual donating the sample, a description of how the sample will be used, a description of the potential risks associated with the research, and information about the compensation or other benefits the donor may receive for their donation. For research involving tissue samples or cell lines, informed consent must be obtained from the donor, or in the case of a deceased donor, from the heir or estate of the donor. Informed consent must include information on how the sample will be used, the potential risks related to the research, and any financial benefits the donor or heir may receive. For research involving genetic material or blood samples, consent must be given by the donor or their legal guardian, and must include detailed information about the research, the risks associated with it, and any potential benefits that the donor may receive. In all cases, the consent must be voluntary, secure, and properly documented. A physician or medical professional should be present to answer any questions from the donor and provide details about the research. Finally, the consent should not be revoked or changed without the express permission of the donor.

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