ETH Zurich, Health Ethics & Policy Lab, Department of Health Sciences & Technology (D-HEST), HOA H 13-17, Hottingerstrasse, 10, 8092, Zurich, Switzerland.
J Bioeth Inq. 2020 Mar;17(1):37-47. doi: 10.1007/s11673-020-09963-0. Epub 2020 Feb 26.
The past few years have witnessed several media-covered cases involving citizens actively engaging in the pursuit of experimental treatments for their medical conditions-or those of their loved ones-in the absence of established standards of therapy. This phenomenon is particularly observable in patients with rare genetic diseases, as the development of effective therapies for these disorders is hindered by the limited profitability and market value of pharmaceutical research. Sociotechnical trends at the cross-section of medicine and society are facilitating the involvement of patients and creating the digital infrastructure necessary to its sustainment. Such participant-led research (PLR) has the potential to promote the autonomy of research participants as drivers of discovery and to open novel non-canonical avenues of scientific research. At the same time, however, the extra-institutional, self-appointed, and, often, oversight-free nature of PLR raises ethical concern. This paper explores the complex ethical entanglement of PLR by critically appraising case studies and discussing the conditions for its moral justification. Furthermore, we propose a path forward to ensure the safe and effective implementation of PLR within the current research ecosystem in a manner that maximizes the benefits for both individual participants and society at large, while minimizing the risks.
在过去的几年中，有几起媒体报道的案例涉及公民在缺乏既定治疗标准的情况下积极寻求针对其医疗状况或其亲人的实验性治疗。这种现象在患有罕见遗传疾病的患者中尤为明显，因为这些疾病的有效治疗方法的开发受到制药研究有限的盈利性和市场价值的阻碍。医学和社会交叉点的社会技术趋势正在促进患者的参与，并为其维持创造必要的数字基础设施。这种由参与者主导的研究（PLR）有可能促进研究参与者作为发现者的自主权，并开辟新的非规范科学研究途径。然而，与此同时，PLR 的非正规、自我任命且往往缺乏监督的性质引发了伦理问题。本文通过批判性地评估案例研究，探讨了 PLR 的复杂伦理困境，并讨论了其道德辩护的条件。此外，我们提出了一个前进的道路，以确保在当前的研究生态系统中安全有效地实施 PLR，从而使个体参与者和整个社会都能最大程度地受益，同时将风险最小化。
