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对医学研究和非医学研究的监管存在显著差异,这合理吗?

Can significant differences in regulating medical and non-medical research be justified?

作者信息

Hunter David

机构信息

Southgate Institute for Health, Society and Equity, School of Medicine, Flinders University, GPO Box 2100, Adelaide, SA, 5001, Australia,

出版信息

Monash Bioeth Rev. 2014 Sep-Dec;32(3-4):254-67. doi: 10.1007/s40592-015-0022-2.

Abstract

It is now typical for human subjects research to be regulated by review by an independent research ethics committee in most jurisdictions. However it is common for countries to opt to only compulsorily regulate medical research while leaving some or all non-medical research either unregulated or only regulated on a voluntary basis. In this paper I will argue, using regulation in the UK as an example, that it is difficult to justify this sharp distinction in practices. While I won't come to any definitive conclusions in this paper as to whether research ought to be regulated compulsorily I will suggest that we would be better to regulate all research, albeit perhaps with a lighter touch than the present UK system if we want to prevent some highly risky research avoiding appropriate regulation. I will examine several arguments to defend making such a distinction; that medical professionals have special moral duties, that medical research has a higher magnitude/frequency of risks and that regulating non-medical research constitutes the inappropriate imposition of the medical model onto non-medical research. Having critiqued these objections I will then discuss the advantages of harmonizing the regulation of research and conclude that there is not a good reason to treat medical and non-medical research as fundamentally different in kind.

摘要

在大多数司法管辖区,由独立的研究伦理委员会进行审查来规范人体受试者研究如今已成为常态。然而,各国通常选择仅强制规范医学研究,而让部分或所有非医学研究不受规范或仅在自愿基础上进行规范。在本文中,我将以英国的规范为例进行论证,说明在实践中这种鲜明区分难以自圆其说。虽然在本文中我不会就研究是否应被强制规范得出任何明确结论,但我将表明,如果我们想防止一些高风险研究逃避适当规范,那么最好对所有研究进行规范,尽管或许可以比当前英国的体系力度稍轻。我将审视一些为进行这种区分辩护的论点:医学专业人员负有特殊道德责任、医学研究的风险程度/发生频率更高,以及规范非医学研究构成了将医学模式不适当地强加于非医学研究。在对这些反对意见进行批判之后,我将接着讨论统一研究规范的好处,并得出结论:没有充分理由将医学研究和非医学研究从根本上视为不同类型。

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