Responsibility in Investigations on Human Subjects: M.R.C. Statement
Responsibility in Investigations on Human Subjects: M.R.C. Statement
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人类受试者调查的责任：M.R.C.
DOI：
10.1136/bmj.2.5402.178
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发表时间：
1964
影响因子：
--
通讯作者：
H. Brody
中科院分区：
文献类型：
--
作者：
H. Brody
在过去的50年里，医学知识的发展比历史上任何其他时期都要快。新的认识、新的治疗方法、新的诊断程序和新的预防方法已经并正在以越来越快的速度被引入;如果要获得现在正在成为可能的好处，这些发展必须继续下去。毫无疑问，我们现在所进入的医学新时代在很大程度上是由于科学方法与传统医学方法的结合。直到世纪之交，临床知识的进步一般仅限于通过观察获得的知识，而且很少有对健康和疾病现象进行深入分析的手段。然而，现在，可以安全地、认真地应用于病人和健康人的程序正在大量设计中，其结果是医学的确定性和理解正在迅速增加。然而，这些创新也给临床研究者带来了自己的问题。在过去，新的治疗方法或研究的引入并不频繁，而且它们很少超越既定实践的边际变化。今天，范围广泛的新程序是司空见惯的，它们的潜力如此之大，以至于它们的使用是不可忽视的考虑。因此，调查人员经常面临道德问题，有时甚至是非常困难的法律的问题。医学研究理事会发表这份声明，是希望在这个棘手的问题上给予一些指导。作为病人护理的一部分而采取的旨在通过治疗、预防或评估使个别病人受益的程序，与仅为了增进医学知识而对病人或健康受试者采取的程序，其本身并不是为了使所实施的特定个人受益，两者之间可以合理地加以区分。前者属于病人护理的范围，受医学专业行为的一般规则管辖;后者属于对志愿者的调查范围。重要的考虑来自这一区别。
During the last 50 years medical knowledge has advanced more rapidly than at any other period in its history. New understandings, new treatments, new diagnostic procedures, and new methods of prevention have been, and are being, introduced at an ever-increasing rate; and if the benefits that are now becoming possible are to be gained these developments must continue. Undoubtedly the new era in medicine upon which we have now entered is largely due to the marriage of the methods of science with the traditional methods of medicine. Until the turn of the century the advancement of clinical knowledge was in general confined to that which could be gained by observation, and means for the analysis in depth of the phenomena of health and disease were seldom available. Now, however, procedures that can safely, and conscientiously, be applied to both sick and healthy human beings are being devised in profusion, with the result that certainty and understanding in medicine are increasing apace. Yet these innovations have brought their own problems to the clinical investigator. In the past, the introduction of new treatments or investigations was infrequent, and only rarely did they go beyond a marginal variation on established practice. To-day far-ranging new procedures are commonplace, and such are their potentialities that their employment is no negligible consideration. As a result, investigators are frequently faced with ethical and sometimes even legal problems of great difficulty. It is in the hope of giving some guidance in this difficult matter that the Medical Research Council issue this statement. A distinction may legitimately be drawn between procedures undertaken as part of patient-care which are intended to contribute to the benefit of the individual patient, by treatment, prevention, or assessment, and those procedures which are undertaken either on patients or on healthy subjects solely for the purpose of contributing to medical knowledge and are not themselves designed to benefit the particular individual on whom they are performed. The former fall within the ambit of patient-care and are governed by the ordinary rules of professional conduct in medicine ; the latter fall within the ambit of investigations on volunteers. Important considerations flow from this distinction.