Evans John Grimley, Beck Peter
Department of Clinical Geratology, Radcliffe Infirmary, University of Oxford.
Clin Med (Lond). 2002 May-Jun;2(3):267-72. doi: 10.7861/clinmedicine.2-3-267.
That people should only be enrolled in medical research if they have given free and informed consent is now an unquestioned principle of research ethics. It is however a recent innovation. Prior to the prominence given to consent to participation in research in the condemnation of German doctors arraigned at Nuremberg in 1945, informed consent had appeared in American litigation, but only as an issue in clinical malpractice suits. Informed consent as an ethical requirement in medical research had arisen in some earlier European contexts. Despite the Nuremberg judgement, informed consent by participants in research was not widely recognised as ethically mandatory until the early 1970s. This delay seems to have been due in part to scepticism about the practicability of truly informed consent, but medical paternalism and the circumstances surrounding military research during the Cold War period may have contributed.
人们只有在给予自由和知情同意的情况下才能参与医学研究，这如今已成为研究伦理中毋庸置疑的原则。然而，这是一项近期才出现的创新。在1945年纽伦堡受审的德国医生因参与研究而遭到谴责，在此之前，参与研究的同意权并未受到重视，知情同意曾出现在美国的诉讼中，但仅作为医疗事故诉讼中的一个问题。在一些早期的欧洲背景下，知情同意作为医学研究中的一项伦理要求已经出现。尽管有纽伦堡判决，但直到20世纪70年代初，研究参与者的知情同意才被广泛认可为伦理上的强制性要求。这种延迟部分原因似乎是对真正知情同意的可行性持怀疑态度，但医疗家长主义以及冷战时期军事研究的相关情况可能也起到了一定作用。
