Enrolling the uninsured in clinical trials: An ethical perspective

Enrolling the uninsured in clinical trials: An ethical perspective
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DOI:
10.1097/01.ccm.0000054907.33928.48
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发表时间:
2003-03-01
影响因子:
8.8
通讯作者:
Danis, M
Danis, M
中科院分区:
医学1区
文献类型:
--
作者:
Pace, C;Miller, FG;Danis, M

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缺乏健康保险的个人参与研究给临床研究人员带来了重大但很少讨论的伦理问题。特别令人关切的是,他们在登记时缺乏获得护理的选择,这可能使没有保险的人容易受到不适当的诱惑而加入试验,以及他们在试验后无法获得研究产品导致他们被剥削的可能性。然而,与这些担忧相矛盾的是,未投保者有权公平考虑参与研究。我们讨论这些相互竞争的问题,并提出建议,研究人员如何既可以保护未投保的研究参与者,并提供公平的研究,在他们的招聘和招生策略。
Research participation by individuals who lack health insurance raises significant but seldom-discussed ethical issues for clinical investigators. Of particular concern are the possibility that their lack of options for getting care at the time of enrollment makes the uninsured susceptible to undue inducement to join trials and the possibility that their inability to access research products after trials leads to their exploitation. In tension with these concerns, however, is the right of the uninsured to fair consideration for research participation. We discuss these competing issues and make recommendations for how investigators can both protect uninsured research participants and provide the uninsured with fair access to research in their recruitment and enrollment strategies.