Mackay Douglas
Bioethics. 2014 Sep;28(7):352-9. doi: 10.1111/j.1467-8519.2012.02003.x. Epub 2012 Sep 17.
The problem of standard-of-care in clinical research concerns the level of care that investigators ought to provide to research subjects in the control arm of their clinical trials. Commentators differ sharply on whether subjects in trials conducted in lower income countries should be provided with the same level of care as subjects in trials conducted in higher income countries. I consider an argument that commentators have employed on both sides of this debate: professional role arguments. These arguments claim to justify a conclusion to the standard-of-care problem solely by appeal to the professional obligations that investigators possess. I argue that prominent versions of professional role arguments cannot justify a solution to the problem of standard-of-care that is both determinate and reasonable simply by appeal to the professional obligations of investigators. Instead, to do so, one must also (1) determine the level of care or types of treatment that individuals are entitled to as a matter of distributive justice, and (2) identify which agents possess the duties that correspond to these entitlements. The level of care that investigators owe to subjects in the control arm of their clinical trials is thus in part dependent on the level of care that these subjects are entitled to as a matter of distributive justice, and whether it is the investigators who possess the corresponding distributive obligation to provide them with the care that they are entitled to.
临床研究中的医疗标准问题涉及研究者在其临床试验的对照组中应向研究对象提供的医疗水平。对于在低收入国家进行的试验中的研究对象是否应获得与在高收入国家进行的试验中的研究对象相同水平的医疗,评论者们存在着尖锐的分歧。我考虑一种评论者在这场辩论双方都使用过的论点:职业角色论点。这些论点声称仅通过诉诸研究者所拥有的职业义务就能为医疗标准问题的结论提供正当理由。我认为,职业角色论点的突出版本无法仅通过诉诸研究者的职业义务就为医疗标准问题提供一个既明确又合理的解决方案。相反,要做到这一点,还必须(1)确定作为分配正义问题个人有权获得的医疗水平或治疗类型,以及(2)确定哪些行为主体承担与这些权利相对应的义务。因此,研究者在其临床试验对照组中对研究对象所负有的医疗水平部分取决于这些对象作为分配正义问题有权获得的医疗水平,以及是否是研究者承担向他们提供其有权获得的医疗的相应分配义务。