The ethics of uninsured participants accessing healthcare in biomedical research: A literature review.
The ethics of uninsured participants accessing healthcare in biomedical research: A literature review.
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DOI：
10.1177/1740774518792277
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发表时间：
2018-10
期刊：
影响因子：
--
通讯作者：
Grady C
中科院分区：
文献类型：
--
作者：
Cho HL;Danis M;Grady C
关于在高收入国家的临床研究中纳入医疗保健机会有限的人（如无保险和低收入者）的挑战和伦理考虑的文献很少。然而，在临床研究中与无保险和低收入参与者一起工作时，应考虑许多伦理问题，包括入组和保留、辅助护理和试验后责任。由于没有保险和保险不足的比例很高，对没有保险和低收入人群的关注在美国尤为突出。因此，我们对高收入国家无保险和低收入参与者的生物医学临床研究的伦理考虑进行了范围审查，以描述已知的情况，并确定在这个问题上需要研究的领域。搜索MEDLINE/PubMed、Embase和Scopus数据库时，使用描述感兴趣的主要概念的术语（如未投保、保险不足、获得医疗保健、贫困、伦理、补偿、临床研究）。符合以下四个入选标准的文章被纳入：(1)英文；(2)高收入国家背景；(3)没有保险或低收入的研究参与者，这限制了他们获得医疗保健的机会，以及在生物医学临床研究中，要么有直接医疗福利的前景，要么是根据他们的健康状况提供给他们的；(4)承认和/或解决生物医学临床研究中未投保或低收入参与者的挑战或伦理考虑。这些搜索总共产生了974个结果。最终，23篇论文被纳入范围审查。在23篇文章中，大多数（n=19）讨论了未参保或低收入参与者的登记和保留。确定了未参保和低收入群体入学的若干障碍，包括获得初级或预防性保健的机会有限；缺乏接触进行试验的机构或有足够时间或知识了解试验的医生的机会；对政府、研究或医疗系统整体缺乏信任；还有后勤问题。相当少的文章讨论了这些参与者在研究过程中的治疗（n=5）或他们应承担的试验后责任（n=4）。因此，我们提出了一个基于现有文献的研究议程，通过解决三个广泛的问题：(1)高收入国家生物医学临床研究中未投保的研究参与者的现状如何？(2)未参保的研究参与者在临床研究期间和之后应如何对待？(3)如果有的话，对未参保的研究参与者的额外保护应该如何影响他们的入组？这篇综述揭示了数据和关于如何在道德上涉及未投保的研究参与者的深思熟虑的分析的重大差距。为了解决这些差距，我们提出了一个研究议程，以收集所需的数据和理论分析，解决三个广泛的研究问题。
Sparse literature exists on the challenges and ethical considerations of including people with limited access to healthcare such as the uninsured and low-income in clinical research in high-income countries. However, many ethical issues should be considered with respect to working with uninsured and low-income participants in clinical research, including enrollment and retention, ancillary care, and post-trial responsibilities. Attention to the uninsured and low-income is particularly salient in the U.S. due to the high rates of uninsurance and underinsurance. Thus, we conducted a scoping review on the ethical considerations of biomedical clinical research with uninsured and low-income participants in high-income countries in order to describe what is known and to pinpoint areas of needed research on this issue. MEDLINE/PubMed, Embase, and Scopus databases were searched using terms that described main concepts of interest (e.g. uninsured, underinsured, access to healthcare, poverty, ethics, compensation, clinical research). Articles were included if they met four inclusion criteria: (1) English; (2) high-income countries context; (3) about research participants who are uninsured or low-income, which limits their access to healthcare, and in biomedical clinical research that either had a prospect of direct medical benefit or were offered to them on the basis of their ill health; (4) recognizes and/or addresses challenges or ethical considerations of uninsured or low-income participants in biomedical clinical research. The searches generated a total of 974 results. Ultimately, 23 papers were included in the scoping review. Of 23 articles, the majority (n=19) discussed enrollment and retention of uninsured or low-income participants. Several barriers to enrolling uninsured and low-income groups were identified, including limited access to primary or preventative care; lack of access to institutions conducting trials or physicians with enough time or knowledge about trials; overall lack of trust in the government, research, or medical system; and logistical issues. Considerably fewer articles discussed treatment of these participants during the course of research (n=5) or post-trial responsibilities owed to them (n=4). Thus, we propose a research agenda that builds upon the existing literature by addressing three broad questions: (1) What is the current status of uninsured research participants in biomedical clinical research in high-income countries? (2) How should uninsured research participants be treated during and after clinical research? (3) How, if at all, should additional protections for uninsured research participants affect their enrollment? This review reveals significant gaps in both data and thoughtful analysis on how to ethically involve uninsured research participants. To address these gaps, we propose a research agenda to gather needed data and theoretical analysis that addresses three broad research questions.
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