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HHS regulations at 45 CFR 46.116 and 45 CFR 46.117 describe the informed consent requirements. Informed consent must be legally effective and prospectively obtained. The informed consent process involves three key features: (1) disclosing to potential research subjects information needed to make an informed decision (2) facilitating the understanding of what has been disclosed and (3) promoting the voluntariness of the decision about whether or not to participate in the research. The Belmont Report states that an autonomous agent is “an individual capable of deliberation about personal goals and of acting under the direction of such deliberation.” Respect for persons requires that prospective research subjects “be given the opportunity to choose what shall or shall not happen to them” and thus necessitates adequate standards for informed consent. The principle of respect for persons requires that individuals be treated as autonomous agents and that the rights and welfare of persons with diminished autonomy be appropriately protected. This requirement is founded on the principle of respect for persons, one of the three ethical principles governing human subjects research described in the Belmont Report. The requirement to obtain the legally effective informed consent of individuals before involving them in research is one of the central protections provided for under the HHS regulations at 45 CFR part 46. When informed consent is required, it must be sought prospectively, and documented to the extent required under HHS regulations at 45 CFR 46.117. The HHS regulations at 45 CFR part 46 for the protection of human subjects in research require that an investigator obtain the legally effective informed consent of the subject or the subject’s legally authorized representative, unless (1) the research is exempt under 45 CFR 46.101(b) (2) the IRB finds and documents that informed consent can be waived ( 45 CFR 46.116(c) or (d)) or (3) the IRB finds and documents that the research meets the requirements of the HHS Secretarial waiver under 45 CFR 46.101(i) that permits a waiver of the general requirements for obtaining informed consent in a limited class of research in emergency settings.