Background/aims 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 United States 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. Methods 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 was offered to them on the basis of their ill health, and (4) recognizes and/or addresses challenges or ethical considerations of uninsured or low-income participants in biomedical clinical research. Results 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 preventive 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? Conclusions 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.
With their intersectional conceptual framework, Wilson and colleagues create a constructive platform through which physicians and other healthcare providers can discuss the multidisciplinary nature of patient care (Wilson et al. 2018). Their framework emphasizes how physicians should recognize the ways in which their patients' identities may impact their medical care, focusing on the patients' attitudes towards their providers and the efficacy of their treatment plans. Although this is an important aspect of using an intersectional framework in clinical medicine, I believe intersectionality also calls for physicians to recognize the ways in which they themselves are affected by their patients' identities. More specifically, I argue that physicians must pay special attention to the ways in which they or their field may be unconsciously biased towards or lack information about certain identity groups. This slight shift in directionality is especially important in tackling systematic errors and delays in diagnosis. Wilson and colleagues do briefly mention that intersectionality may aid diagnosis during their case presentation of Mr. Fuentes, but they do not provide concrete details on how this may be done (Wilson et al. 2018, 20). I propose that an intersectional framework that considers how patients' multiple identities affect both their own attitudes towards their physicians and their physicians' attitudes towards them may help improve diagnostic accuracy Missed diagnoses and misdiagnoses Despite improvements in diagnostic technologies, errors and delays in diagnosis continue to pose serious physical and psychological harm to patients, as well as financial harm to the healthcare system (Khullar et al. 2015). Systematic biases that disproportionately affect historically marginalized groups underlie some of these misdiagnoses (
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