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.'
affiliation: 'Cho, HL (Corresponding Author), NIH, Dept Bioeth, Ctr Clin, 10 Ctr Dr,MSC
  1156,Bldg 10,Room 1C118, Bethesda, MD 20892 USA.

  Cho, Hae Lin; Danis, Marion; Grady, Christine, NIH, Dept Bioeth, Ctr Clin, 10 Ctr
  Dr,MSC 1156,Bldg 10,Room 1C118, Bethesda, MD 20892 USA.'
author: Cho, Hae Lin and Danis, Marion and Grady, Christine
author-email: hae.cho@nih.gov
author_list:
- family: Cho
  given: Hae Lin
- family: Danis
  given: Marion
- family: Grady
  given: Christine
da: '2023-09-28'
doi: 10.1177/1740774518792277
eissn: 1740-7753
files: []
issn: 1740-7745
journal: CLINICAL TRIALS
keywords: 'Ethic; clinical research; insurance; income; socioeconomic status;

  enrollment; post-trial; ancillary care'
keywords-plus: 'CANCER CLINICAL-TRIALS; LOW-INCOME; MINORITY PARTICIPATION;

  RACIAL/ETHNIC MINORITY; SOCIOECONOMIC-STATUS; INFORMED-CONSENT;

  AFRICAN-AMERICAN; INSURANCE STATUS; BREAST-CANCER; UNITED-STATES'
language: English
month: OCT
number: '5'
number-of-cited-references: '61'
pages: 509-521
papis_id: da8f9c534e5b7801b2e549aa03328e0a
ref: Cho2018ethicsuninsured
tags:
- review
times-cited: '17'
title: 'The ethics of uninsured participants accessing healthcare in biomedical research:
  A literature review'
type: article
unique-id: WOS:000444401500009
usage-count-last-180-days: '0'
usage-count-since-2013: '14'
volume: '15'
web-of-science-categories: Medicine, Research \& Experimental
year: '2018'