Is best interests a relevant decision making standard for enrolling non-capacitated subjects into clinical research?
The 'best interests' decision making standard is used in clinical care to make necessary health decisions for non-capacitated individuals for whom neither explicit nor inferred wishes are known. It has been also widely acknowledged as a basis for enrolling some non-capacitated adults into clinical research such as emergency, critical care, and dementia research. However, the best interests standard requires that choices provide the highest net benefit of available options, and clinical research rarely meets this criterion. In the context of modern norms of bioethics, the best interests standard rarely supports surrogate consent for research and should not be accepted as a routine provision.
Stony Brook University School of Medicine, Winthrop University Hospital, 222 Station Plaza North, Suite 518, Mineola NY 11501, USA. jberger@winthrop.org
Jeffrey T
JT
Berger
D000328:Adult; D035843:Biomedical Research / Q000941:ethics* / Q000331:legislation & jurisprudence; D003657:Decision Making / Q000941:ethics*; D006801:Humans; D007258:Informed Consent / Q000941:ethics* / Q000331:legislation & jurisprudence / Q000523:psychology; D016743:Mental Competency / Q000331:legislation & jurisprudence / Q000523:psychology*; D028701:Patient Rights / Q000941:ethics / Q000331:legislation & jurisprudence; D018579:Patient Selection / Q000941:ethics; D020458:Third-Party Consent / Q000941:ethics / Q000331:legislation & jurisprudence