Rethinking the therapeutic misconception: social justice, patient advocacy, and cancer clinical trial recruitment in the US safety net

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.