When should re-consent of subjects participating in a clinical trial be requested?: A case-oriented algorithm to assist in the decision-making process

被引：13

作者：

Dal-Re, R. ^{[1
]}

Avendano, C. ^{[2
]}

Gil-Aguado, A. ^{[3
]}

Gracia, D. ^{[4
]}

Caplan, A. L. ^{[5
,6
]}

机构：

[1] GlaxoSmithKline SA, Dept Med, Madrid, Spain

[2] Autonomous Univ Madrid, Hierro Univ Hosp, Clin Puerta, Dept Clin Pharmacol, E-28049 Madrid, Spain

[3] Autonomous Univ Madrid, La Paz Univ Hosp, Dept Internal Med, Madrid, Spain

[4] Univ Complutense Madrid, Sch Med, Dept Publ Hlth & Hist Sci, Madrid, Spain

[5] Univ Penn, Dept Med Eth, Philadelphia, PA 19104 USA

[6] Univ Penn, Ctr Bioeth, Philadelphia, PA 19104 USA

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2008年 / 83卷 / 05期

关键词：

D O I：

10.1038/sj.clpt.6100357

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Investigators, sponsors, and institutional review boards have to decide when re-consent of clinical trials' participants must be obtained when new information becomes available. We present an algorithm to help in the decision-making process, which takes into consideration the kind of new information, the risk of exposure ( patients could be on the treatment or in the follow-up phases), and the possibility of managing the case. Re-consent should be obtained in three of the eight possible situations.

引用

页码：788 / 793

页数：6

共 6 条

[1]

The Belmont report: Ethical principles and guidelines for the protection of human subjects for research, Fed Register, 44, pp. 23192-23197, (1979)

[2]

Levine R.J., Informed consent, Ethics and Regulation of Clinical Research, pp. 95-155, (1986)

[3]

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Tripartite Guideline for Good Clinical Practice, (1996)

[4]

International Ethical Guidelines for Biomedical Research Involving Human Subjects, (2002)

[5]

Code of Federal Regulations, 45, PART 46

[6]

Wendler D., Rackoff J., Consent for continuing research participation, IRB, 24, pp. 1-6, (2002)

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