Ethic review in clinical research:informed consent

Abstract

Abstract: Informed consent is one of the primary ethical requirements underpinning biomedical research involving human subjects.The general IRB considerations regarding informed consent are as follow:adequacy of the information, language expressed, consent procedure, documentation, exempt from consent, withholding information and deception, randomization double-masked and placebos clinical trials, and renewing consent.

Key words: medicinal ethic, clinical research, institutional review board, ethic review, informed consent

CLC Number:

R96
R969

WANG Xiu-Qin, XIONG Ning-Ning, LIU Shen-Lin, LI Qi-Yi, JIANG Meng, LIU Fang, ZOU Jian-Dong, BO Qing-Yan, GAO Wei-Min. Ethic review in clinical research:informed consent[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2004, 9(1): 117-120.

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Ethic review in clinical research:informed consent

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