Developing regulations for research involving adults who lack decision-making capacity.
作者信息
Fleischman A R
机构信息
New York Academy of Medicine, NY 10029, USA.
出版信息
Trans Am Clin Climatol Assoc. 1999;110:131-43; discussion 143-5.
Abstract
摘要
相似文献
1
Developing regulations for research involving adults who lack decision-making capacity.
Trans Am Clin Climatol Assoc. 1999;110:131-43; discussion 143-5.
2
Regulating research involving adults who lack decision making capacity.
Pharos Alpha Omega Alpha Honor Med Soc. 2001 Spring;64(2):12-7.
3
Research involving persons with mental disorders that may affect decisionmaking capacity.
J Int Bioethique. 2002 Sep-Dec;13(3-4):173-9.
4
Research involving adults who lack capacity: how have research ethics committees interpreted the requirements?
J Med Ethics. 2009 Jun;35(6):377-81. doi: 10.1136/jme.2008.027094.
5
Research regulations on subjects' "capacity to give consent" were unconstitutional.
Hum Res Rep. 2000 Jun;15(6):7-8.
6
The case of Chester M. Southam: research ethics and the limits of professional responsibility.
Pharos Alpha Omega Alpha Honor Med Soc. 2002 Spring;65(2):4-9.
7
Research involving the newly dead: an institutional response.
Crit Care Med. 2003 May;31(5 Suppl):S385-90. doi: 10.1097/01.CCM.0000065142.41379.5C.
8
Enrolling decisionally impaired adults in clinical research.
Med Care. 2002 Sep;40(9 Suppl):V20-9. doi: 10.1097/01.MLR.0000023952.15394.88.
9
Protection of human subjects; informed consent; standards for institutional review boards for clinical investigations--FDA. Final rule.
Fed Regist. 1991 Jun 18;56(117):28025-9.
10
The expert surrogate system: a role for the Golden Rule in clinical practice.
Humane Med. 1988 Nov;4(2):89-95.
引用本文的文献
1
Informed consent in psychiatry clinical research: A conceptual review of issues, challenges, and recommendations.
Perspect Clin Res. 2012 Jan;3(1):8-15. doi: 10.4103/2229-3485.92301.
2
The doctor's duty to the elderly patient in clinical trials.
Drugs Aging. 2003;20(15):1087-97. doi: 10.2165/00002512-200320150-00002.
本文引用的文献
1
Research with children.
Am J Law Med. 1998;24(2-3):213-44.
2
Research with cognitively impaired subjects. Unfinished business in the regulation of human research.
Arch Gen Psychiatry. 1997 Feb;54(2):105-11. doi: 10.1001/archpsyc.1997.01830140013002.
3
What is the moral authority of family members to act as surrogates for incompetent patients?
Milbank Q. 1996;74(4):599-618.
4
Legal and ethical complexities of consent with cognitively impaired research subjects: proposed guidelines.
J Law Med Ethics. 1996 Spring;24(1):18-35. doi: 10.1111/j.1748-720x.1996.tb01830.x.
5
Mentally disabled research subjects. The enduring policy issues.
JAMA. 1996 Jul 3;276(1):67-72.
6
In loco parentis. Minimal risk as an ethical threshold for research upon children.
Hastings Cent Rep. 1993 Mar-Apr;23(2):13-9.
7
Ethics and clinical research.
N Engl J Med. 1966 Jun 16;274(24):1354-60. doi: 10.1056/NEJM196606162742405.
Zotero 插件