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Informed Consent in Chinese Clinical Research
Zhai, Xiaomei
Zhai, Xiaomei
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EJAIB72006-2.pdf
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Abstract
"Informed consent is a richly textured legal and ethical concept. The process of informed consent is based on two fundamental ethical principles: protecting human subjects (non-maleficence) and allowing potential subjects freedom of choice (autonomy). The concept of “informed consent” is addressed in detail by the World Medical Association’s Declaration of Helsinki of 1964. The core of the 2000 version of the Declaration with respect to informed consent is its Article 22: “In any research on human beings, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail. The subject should be informed of the right to abstain from participation in the study or to withdraw consent to participate at any time without reprisal. After ensuring that the subject has understood the information, the physician should then obtain the subject’s freely given informed consent, preferably in writing."
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2006
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With permission of the license/copyright holder