Proxy and surrogate consent in geriatric neuropsychiatric research: update and recommendations.
OBJECTIVE
The ethics of involving decisionally incapable adults in research will continue to grow in importance as more research is conducted to address the problems of decisionally impaired persons, especially elderly persons. The authors provide an updated discussion, critique, and recommendations regarding the need for clear legal and regulatory policy on this issue.


METHODS
The authors summarize and build on discussions of a workshop on proxy and surrogate consent in geriatric neuropsychiatric research sponsored by the Aging Research Consortium of the National Institute of Mental Health. They incorporate the views of various stakeholders present at the workshop as well as review recent federal and state initiatives, recent empirical research and media reports, and various commission reports and relevant regulations.


RESULTS
Despite a wave of initiatives in the late 1990s to clarify policy, surrogate consent for research continues to be a murky legal area and incapable subjects in the United States still lack clear regulatory protection. There is evidence that conservative risk management strategies by institutional review boards and their institutions may severely restrict research with decisionally impaired subjects. A passive approach to this problem may no longer be feasible. A recent federal advisory report on human research protections and legislative initiatives in some states could begin to provide a blueprint for future policy making. Interim recommendations for various stakeholders are given.


CONCLUSIONS
It is imperative that the scientific community, patients and their advocates, and policy makers at all levels establish a constructive dialogue to clarify ethical and legal standards in the area of proxy and surrogate consent for research.
Kim
Scott Y H
SY
Department of Psychiatry and the Program in Clinical Ethics, University of Rochester Medical Center, Rochester, NY, USA. scottkim@med.umich.edu
Appelbaum
Paul S
PS
Jeste
Dilip V
DV
Olin
Jason T
JT
D000328:Adult; D000368:Aged; D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence / Q000592:standards; D017041:Ethics Committees; D028744:Ethics Committees, Research / Q000941:ethics / Q000331:legislation & jurisprudence / Q000592:standards; D032984:Ethics, Research; D005544:Forecasting; D005852:Geriatric Psychiatry / Q000331:legislation & jurisprudence / Q000592:standards*; D033161:Government Regulation; D006291:Health Policy / Q000639:trends; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence / Q000592:standards*; D001523:Mental Disorders / Q000523:psychology; D026684:Personal Autonomy; D019727:Proxy / Q000331:legislation & jurisprudence* / Q000523:psychology; D012107:Research Design / Q000331:legislation & jurisprudence / Q000592:standards*; D035842:Research Subjects / Q000331:legislation & jurisprudence; D014481:United States