Consent for procedures and transfusions - University of Kentucky - uky 2025

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ing to the current definition of human subject in the Common Rule, informed consent is not required for use of samples and data that do not identify the person/donor (such as those stored in biobanks and data repositories for future research use) or for use of samples and data from people who are deceased.
Documenting informed consent occurs after explaining the research and assessing participant comprehension. At minimum, it involves obtaining the signature of the participant (or the legally-authorized representative or parent(s), when approved) as well as the person obtaining consent.
What is the difference between consent and assent? Consent may only be given by individuals who have reached the legal age of consent (in the U.S. this is typically 18 years old). Assent is the agreement of someone not able to give legal consent to participate in the activity.
Informed assent is a process through which minors agree to participate in clinical trials. This is different from informed consent, because minors cannot provide consent in the full meaning of the word, as they dont meet the legal age requirements and are considered to be a vulnerable population.
When conducting clinical research, the obtaining of informed consent is required. Informed consent is a procedure through which a competent subject, after having received and understood all the research-related information, can voluntarily provide his or her willingness to participate in a clinical trial.
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assent, consent, accede, acquiesce, agree, subscribe mean to concur with what has been proposed. assent implies an act involving the understanding or judgment and applies to propositions or opinions. consent involves the will or feelings and indicates compliance with what is requested or desired.

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