The ethics of uninsured participants accessing healthcare in biomedical research: A literature review

Abstract

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.

Fair payment and just benefits to enhance diversity in clinical research

“…At a minimum, the informed consent document and process should clearly present these additional costs of participation. As a matter of justice [27,28] and of scientific integrity, however, this is an insufficient solution. In the short term, health insurance could be provided to participants for their role, paid by either sponsoring pharmaceutical entities, institutions, and non-profit funders, or cost waivers or debt-forgiveness could be engineered by sites.…”

Depressed and Socioeconomically Disadvantaged Mothers’ Progression Into a Randomized Controlled Mobile Mental Health and Parenting Intervention: A Descriptive Examination Prior to and During COVID-19

“…In general, recruitment of depressed participants into clinical trials is difficult, and lower resourced individuals are not wellrepresented within these efforts. In the United States, large numbers of individuals from non-dominant cultures are underor uninsured, contributing barriers to health-related service receipt (Lillie-Blanton and Hoffman, 2005) as well as inclusion in clinical trials (Cho et al, 2018). Given the ubiquity of digital technologies, mobile health interventions increase intervention access for those who are traditionally missed (Anderson-Lewis et al, 2018).…”

Practices and Attitudes toward Returning Genomic Research Results to Low-Resource Research Participants

“…However, the debate of ancillary care is not limited to low-income countries: "research participants in high income countries who are uninsured or otherwise lack access to healthcare encounter limitations similar to those faced by participants in LMIC" [37]. In a literature review study of the ethics of uninsured participants accessing health care through research studies, Cho et al [37] examine the ancillary care debate in high-income countries.…”

“…However, the debate of ancillary care is not limited to low-income countries: "research participants in high income countries who are uninsured or otherwise lack access to healthcare encounter limitations similar to those faced by participants in LMIC" [37]. In a literature review study of the ethics of uninsured participants accessing health care through research studies, Cho et al [37] examine the ancillary care debate in high-income countries. They found that some researchers assert that providing ancillary care could increase participants' misunderstanding of the purpose of research, expand occurrence of therapeutic misconception, and may serve as a potential disincentive for researchers to recruit from low-income communities [38].…”