2023-09-28 14:46:10 +00:00
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abstract: 'Background/aims Sparse literature exists on the challenges and ethical
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considerations of including people with limited access to healthcare,
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such as the uninsured and low-income, in clinical research in
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high-income countries. However, many ethical issues should be considered
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with respect to working with uninsured and low-income participants in
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clinical research, including enrollment and retention, ancillary care,
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and post-trial responsibilities. Attention to the uninsured and
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low-income is particularly salient in the United States due to the high
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rates of uninsurance and underinsurance. Thus, we conducted a scoping
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review on the ethical considerations of biomedical clinical research
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with uninsured and low-income participants in high-income countries in
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order to describe what is known and to pinpoint areas of needed research
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on this issue.
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Methods MEDLINE/PubMed, Embase, and Scopus databases were searched using
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terms that described main concepts of interest (e.g., uninsured,
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underinsured, access to healthcare, poverty, ethics, compensation,
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clinical research). Articles were included if they met four inclusion
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criteria: (1) English, (2) high-income countries context, (3) about
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research participants who are uninsured or low-income, which limits
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their access to healthcare, and in biomedical clinical research that
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either had a prospect of direct medical benefit or was offered to them
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on the basis of their ill health, and (4) recognizes and/or addresses
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challenges or ethical considerations of uninsured or low-income
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participants in biomedical clinical research.
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Results The searches generated a total of 974 results. Ultimately, 23
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papers were included in the scoping review. Of 23 articles, the majority
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(n = 19) discussed enrollment and retention of uninsured or low-income
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participants. Several barriers to enrolling uninsured and low-income
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groups were identified, including limited access to primary or
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preventive care; lack of access to institutions conducting trials or
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physicians with enough time or knowledge about trials; overall lack of
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trust in the government, research, or medical system; and logistical
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issues. Considerably fewer articles discussed treatment of these
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participants during the course of research (n = 5) or post-trial
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responsibilities owed to them (n = 4). Thus, we propose a research
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agenda that builds upon the existing literature by addressing three
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broad questions: (1) What is the current status of uninsured research
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participants in biomedical clinical research in high-income countries?
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(2) How should uninsured research participants be treated during and
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after clinical research? (3) How, if at all, should additional
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protections for uninsured research participants affect their enrollment?
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Conclusions This review reveals significant gaps in both data and
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thoughtful analysis on how to ethically involve uninsured research
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participants. To address these gaps, we propose a research agenda to
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gather needed data and theoretical analysis that addresses three broad
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research questions.'
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affiliation: 'Cho, HL (Corresponding Author), NIH, Dept Bioeth, Ctr Clin, 10 Ctr Dr,MSC
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1156,Bldg 10,Room 1C118, Bethesda, MD 20892 USA.
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Cho, Hae Lin; Danis, Marion; Grady, Christine, NIH, Dept Bioeth, Ctr Clin, 10 Ctr
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Dr,MSC 1156,Bldg 10,Room 1C118, Bethesda, MD 20892 USA.'
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author: Cho, Hae Lin and Danis, Marion and Grady, Christine
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author-email: hae.cho@nih.gov
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author_list:
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- family: Cho
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given: Hae Lin
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- family: Danis
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given: Marion
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- family: Grady
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given: Christine
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da: '2023-09-28'
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doi: 10.1177/1740774518792277
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eissn: 1740-7753
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files: []
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issn: 1740-7745
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journal: CLINICAL TRIALS
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keywords: 'Ethic; clinical research; insurance; income; socioeconomic status;
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enrollment; post-trial; ancillary care'
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keywords-plus: 'CANCER CLINICAL-TRIALS; LOW-INCOME; MINORITY PARTICIPATION;
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RACIAL/ETHNIC MINORITY; SOCIOECONOMIC-STATUS; INFORMED-CONSENT;
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AFRICAN-AMERICAN; INSURANCE STATUS; BREAST-CANCER; UNITED-STATES'
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language: English
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month: OCT
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number: '5'
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number-of-cited-references: '61'
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pages: 509-521
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papis_id: da8f9c534e5b7801b2e549aa03328e0a
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ref: Cho2018ethicsuninsured
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tags:
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- review
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times-cited: '17'
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title: 'The ethics of uninsured participants accessing healthcare in biomedical research:
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A literature review'
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2023-10-01 08:15:07 +00:00
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type: article
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2023-09-28 14:46:10 +00:00
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unique-id: WOS:000444401500009
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usage-count-last-180-days: '0'
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usage-count-since-2013: '14'
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volume: '15'
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web-of-science-categories: Medicine, Research \& Experimental
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year: '2018'
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