Iltis Ana S
Health Care Ethics, Saint Louis University, St. Louis, Missouri 63103-2006, USA.
J Med Philos. 2009 Feb;34(1):68-90. doi: 10.1093/jmp/jhn036. Epub 2009 Feb 3.
Clinical investigators must engage in just subject recruitment and selection and avoid unduly influencing research participation. There may be tension between the practice of keeping payments to participants low to avoid undue influence and the requirements of justice when recruiting normal healthy volunteers for phase 1 drug studies. By intentionally keeping payments low to avoid unduly influenced participation, investigators, on the recommendation or insistence of institutional review boards, may be targeting or systematically recruiting healthy adult members of lower socio-economic groups for participation in phase 1 studies. Investigators are at risk of routinely failing to fulfill the obligation of justice, which prohibits the systematic targeting and recruiting of subjects for reasons unrelated to the nature of the study. Insofar as we take seriously the obligation to engage in just subject recruitment and selection, I argue that we must acknowledge the implications low payments might have for subject recruitment and selection and examine the effect of low payments. If low payments de facto target the less well-off for phase 1 studies, we must defend the priority ranking of the obligation to avoid undue influence over the obligation of justice or adopt an alternative recruitment approach. This paper identifies a number of alternatives to the current system of low-value payments to research participants.
临床研究人员必须进行公正的受试者招募和选择，避免对研究参与产生不当影响。在为1期药物研究招募正常健康志愿者时，为避免不当影响而尽量降低对参与者的报酬与公正要求之间可能存在矛盾。通过故意压低报酬以避免受到不当影响的参与，研究人员在机构审查委员会的建议或坚持下，可能会针对或系统性地招募社会经济地位较低群体的健康成年成员参与1期研究。研究人员有经常未能履行公正义务的风险，公正义务禁止出于与研究性质无关的原因系统性地针对和招募受试者。鉴于我们认真对待公正进行受试者招募和选择的义务，我认为我们必须承认低报酬可能对受试者招募和选择产生的影响，并研究低报酬的效果。如果低报酬事实上使较贫困者成为1期研究的对象，我们必须捍卫避免不当影响的义务优先于公正义务的排序，或者采用另一种招募方法。本文确定了一些替代当前向研究参与者支付低价值报酬的制度的方法。
