伦理与医学毒理学研究
Ethics and Medical Toxicology Research.
作者信息
Sugarman Jeremy, Stolbach Andrew
机构信息
Berman Institute of Bioethics, Johns Hopkins University, 1809 Ashland Ave, Baltimore, MD, 21205, USA.
Department of Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.
出版信息
J Med Toxicol. 2017 Sep;13(3):255-258. doi: 10.1007/s13181-017-0618-4. Epub 2017 May 24.
Optimizing care in medical toxicology necessitates designing and conducting ethical research. Nevertheless, the context of medical toxicology can make clinical research ethically challenging for a variety of reasons: medical toxicology is typified by relative rare conditions; making precise and rapid diagnoses is often fraught with uncertainty; emergent and urgent clinical exigencies make consent difficult or impossible; and some exposures are stigmatized or related to illegal activities that can compromise collecting accurate data from patients. In this paper, we examine some of the ethical issues in medical toxicology research that are especially salient in effort to promote optimal research in the field. The particular issues to be addressed are as follows: (1) rare conditions and orphan agents, (2) randomization and control arms, (3) inclusion and exclusion criteria, (4) outcome measures, (5) consent, (6) confidentiality, (7) registries, (8) oversight, and (9) transparency and reporting. Thinking about these ethical issues prospectively will help researchers and clinicians appropriately navigate them.
优化医学毒理学护理需要设计和开展符合伦理的研究。然而，由于多种原因，医学毒理学背景下的临床研究在伦理方面具有挑战性：医学毒理学以相对罕见的病症为典型；做出精确快速的诊断往往充满不确定性；紧急和急迫的临床紧急情况使得同意变得困难或不可能；而且一些暴露情况会受到污名化或与非法活动相关，这可能会影响从患者那里收集准确数据。在本文中，我们探讨医学毒理学研究中的一些伦理问题，这些问题在努力促进该领域的最佳研究方面尤为突出。要解决的具体问题如下：（1）罕见病症和孤儿药，（2）随机化和对照组，（3）纳入和排除标准，（4）结局指标，（5）同意，（6）保密，（7）登记处，（8）监督，以及（9）透明度和报告。前瞻性地思考这些伦理问题将有助于研究人员和临床医生妥善应对它们。
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