Burke Nancy J
Department of Anthropology, History, and Social Medicine, University of California, San Francisco, Box 0128, 1450 3rd Street HD552, PO Box 589001, San Francisco, CA 94158-9001, USA.
BMC Med Ethics. 2014 Sep 20;15:68. doi: 10.1186/1472-6939-15-68.
Approximately 20% of adult cancer patients are eligible to participate in a clinical trial, but only 2.5-9% do so. Accrual is even less for minority and medically underserved populations. As a result, critical life-saving treatments and quality of life services developed from research studies may not address their needs. This study questions the utility of the bioethical concern with therapeutic misconception (TM), a misconception that occurs when research subjects fail to distinguish between clinical research and ordinary treatment, and therefore attribute therapeutic intent to research procedures in the safety net setting. This paper provides ethnographic insight into the ways in which research is discussed and related to standard treatment.
In the course of two years of ethnographic fieldwork in a safety net hospital, I conducted clinic observations (n=150 clinic days) and in-depth in-person qualitative interviews with patients (n=37) and providers (n=15). I used standard qualitative methods to organize and code resulting fieldnote and interview data.
Findings suggest that TM is limited in relevance for the interdisciplinary context of cancer clinical trial recruitment in the safety net setting. Ethnographic data show the value of the discussions that happen prior to the informed consent, those that introduce the idea of participation in research. These preliminary discussions are elemental especially when recruiting underserved and vulnerable patients for clinical trial participation who are often unfamiliar with medical research and how it relates to medical care. Data also highlight the multiple actors involved in research discussions and the ethics of social justice and patient advocacy they mobilize, suggesting that class, inequality, and dependency influence the forms of ethical engagements in public hospital settings.
On the ground ethics of social justice and patient advocacy are more relevant than TM as guiding ethical principles in the context of ongoing cancer disparities and efforts to diversify clinical trial participation.
约20%的成年癌症患者有资格参与临床试验，但实际参与的比例仅为2.5%至9%。少数族裔和医疗服务不足人群的参与率更低。因此，研究得出的关键救命治疗方法和生活质量服务可能无法满足他们的需求。本研究对生物伦理学界关注的治疗性误解（TM）的实用性提出质疑，治疗性误解是指研究对象无法区分临床研究与普通治疗，从而将治疗意图归因于安全网环境下的研究程序。本文提供了人种志视角，以洞察研究讨论的方式以及研究与标准治疗的关系。
在一家安全网医院进行的为期两年的人种志实地研究过程中，我进行了临床观察（共150个临床日），并对患者（n = 37）和医护人员（n = 15）进行了深入的面对面定性访谈。我使用标准的定性方法来组织和编码实地记录及访谈数据。
研究结果表明，在安全网环境下的癌症临床试验招募的跨学科背景中，治疗性误解的相关性有限。人种志数据显示了在知情同意之前进行的讨论的价值，这些讨论引入了参与研究的概念。这些初步讨论至关重要，尤其是在招募医疗服务不足和易受伤害的患者参与临床试验时，这些患者往往不熟悉医学研究及其与医疗护理的关系。数据还突出了参与研究讨论的多个行为主体以及他们所倡导的社会正义和患者权益伦理，表明阶级、不平等和依赖性会影响公立医院环境中的伦理参与形式。
在当前癌症治疗差距以及努力使临床试验参与多样化的背景下，社会正义和患者权益的实地伦理作为指导伦理原则比治疗性误解更具相关性。
