When may a legally authorized representative provide consent on behalf of an adult with diminished decision-making capacity?
In answering this question, the HHS regulations at 45 CFR part 46 should be consulted in addition to the laws of the jurisdiction in which the research is conducted. As a general matter, if an adult lacks capacity to consent, for example, as a result of trauma, mental retardation, some forms of mental illness, or dementiawhether temporary, progressive, or permanentonly a legally authorized representative for that adult can give consent for participation in the research, unless the requirement to obtain informed consent is waived by the IRB in accordance with the requirements at 45 CFR 46.116(c)(d), or in accordance with the provisions for emergency waiver, which are permitted under the authority of the HHS Secretary at 45 CFR 46.101(i). (See the Federal Register notice of this waiver at: http://www.hhs.gov/ohrp/documents/100296.pdf.) Should the subject regain or develop the capacity to consent, then his or her consent must be obtained for any further research, as the consent of the leg
Related Questions
- When may a legally authorized representative provide consent on behalf of an adult with diminished decision-making capacity?
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- May informed consent be obtained by telephone from a legally authorized representative?
