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知情同意与涉及儿童和青少年的临床研究:美国心理学会修订后的道德准则及《健康保险流通与责任法案》的影响

Informed consent and clinical research involving children and adolescents: implications of the revised APA ethics code and HIPAA.

作者信息

Fisher Celia B

机构信息

Fordham University, Center for Ethics Education, Department of Psychology, Bronx NY 10450, USA.

出版信息

J Clin Child Adolesc Psychol. 2004 Dec;33(4):832-9. doi: 10.1207/s15374424jccp3304_18.

Abstract

In 2003, 2 new sets of rules and regulations affecting the conduct of clinical research involving children and adolescents went into effect: the revised American Psychological Association's (APA) Ethical Principles of Psychologists and Code of Conduct (APA, 2002; effective June 1, 2003) and the Privacy Rule (45 CFR Part 160 and A and E of Part 164; effective April; 14, 2003) of the Health Insurance Portability and Accountability Act (HIPAA: Public Law 104-191). This article highlights those APA ethical standards and HIPAA regulations relevant to clinical research involving children and adolescents and discusses how psychologists can apply these rules in ways that will ensure ethical and legal compliance.

摘要

2003年,两套影响儿童和青少年临床研究行为的新规章制度开始生效:修订后的美国心理协会(APA)《心理学家伦理原则与行为准则》(APA,2002;2003年6月1日生效)以及《健康保险流通与责任法案》(HIPAA:公法104 - 191)的隐私规则(45 CFR Part 160以及Part 164的A和E部分;2003年4月14日生效)。本文重点介绍了与儿童和青少年临床研究相关的APA伦理标准和HIPAA规定,并讨论了心理学家如何以确保符合伦理和法律要求的方式应用这些规则。

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