Artal Raul, Rubenfeld Sheldon
Department of Obstetrics, Gynecology and Women's Health, Saint Louis University, St. Louis, USA.
Baylor College of Medicine, Center for Medicine After the Holocaust, Houston, USA.
Best Pract Res Clin Obstet Gynaecol. 2017 Aug;43:107-114. doi: 10.1016/j.bpobgyn.2016.12.006. Epub 2017 Jan 23.
Biomedical research is currently guided by ethical standards that have evolved over many centuries. Historical and political events, social and legal considerations, and continuous medical and technological advances have led to the prevailing research ethics and practice. Currently, patients and research subjects have complete autonomy while under medical care or when volunteering as research subjects. Enrolling volunteers in human subjects research includes a detailed and meaningful informed consent process that follows the cardinal principles of ethics: autonomy, beneficence, nonmaleficence, and justice. These principles were gradually adopted after World War II, primarily in response to the unethical behavior of German physicians and scientists during the Third Reich. This review emphasizes the importance of historical milestones and the essential role that ethics has in contemporary medical research. Research protocols should achieve maximum benefits for the society, have clinical and scientific value, be subject to independent review, respect human dignity, and follow the principles of informed consent, and most importantly, subjects should have complete autonomy. However, current principles and regulations cannot cover every conceivable situation, particularly in view of the new advances in science and technology. New and evolving medical technology, genetic research, therapeutic interventions, and innovations challenge society to maintain the highest moral and ethical principles.
生物医学研究目前受历经多个世纪演变而来的伦理标准指导。历史和政治事件、社会及法律考量，以及医学和技术的不断进步，造就了当前盛行的研究伦理与实践。当前，患者及研究对象在接受医疗护理或作为研究对象自愿参与时拥有完全自主权。将志愿者纳入人体研究对象范畴包括一个详细且有意义的知情同意过程，该过程遵循伦理的基本原则：自主、有益、无害和公正。这些原则在第二次世界大战后逐渐被采用，主要是为了回应纳粹德国时期德国医生和科学家的不道德行为。本综述强调了历史里程碑的重要性以及伦理在当代医学研究中所起的关键作用。研究方案应为社会带来最大利益，具有临床和科学价值，接受独立审查，尊重人类尊严，遵循知情同意原则，并且最重要的是，研究对象应拥有完全自主权。然而，当前的原则和规定无法涵盖每一种可想象到的情况，尤其是鉴于科学技术的新进展。新出现且不断发展的医学技术、基因研究、治疗干预措施及创新对社会提出挑战，要求其维持最高的道德和伦理原则。
