Ethical issues surrounding controlled human infection challenge studies in endemic low‐and middle‐income countries

Abstract The introduction of mobile communication technologies in health care in low- and middle-income countries offers an opportunity for increased efficiencies in provision of care, improved utilization of scarce resources, reductions in workload, and increased reach of services to a larger target population. Short message service (SMS) technologies offer promise, with several large-scale SMS-based implementations already under way. Still largely lacking in the research literature are evaluations of specific ethical issues that arise when SMS programs are implemented and studied in resource-limited settings. In this paper, we examine the ethical issues raised by the deployment of SMS messaging to support patient retention in HIV care and treatment and in the research conducted to evaluate that deployment. We use case studies that are based in Mozambique and ground our discussion in the ethical framework for international research proposed by Emanuel et al., highlighting ethical considerations needed to guide the design and implementation of future SMS-based interventions. Such guidance is increasingly needed in countries such as Mozambique, where the local capacity for ethical study design and oversight is still limited and the scale-up and study of mHealth initiatives are still driven predominantly by international collaborators. These issues can be complex and will need ongoing attention on a case-by-case basis to ensure that appropriate protections are in place, while simultaneously maximizing the potential benefit of new mHealth technologies.

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Informed consent for controlled human infection studies in low‐ and middle‐income countries: Ethical challenges and proposed solutions

Bioethics ◽

10.1111/bioe.12795 ◽

2020 ◽

Vol 34 (8) ◽

pp. 809-818

Author(s):

Vina Vaswani ◽

Abha Saxena ◽

Seema K. Shah ◽

Ricardo Palacios ◽

Annette Rid

Keyword(s):

Informed Consent ◽

Human Infection ◽

Ethical Challenges ◽

Middle Income ◽

Middle Income Countries ◽

Low And Middle Income

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Ethical issues in cluster randomized trials conducted in low- and middle-income countries: an analysis of two case studies

Trials ◽

10.1186/s13063-020-04269-3 ◽

2020 ◽

Vol 21 (S1) ◽

Author(s):

Augustine T. Choko ◽

Gholamreza Roshandel ◽

Donaldson F. Conserve ◽

Elizabeth L. Corbett ◽

Katherine Fielding ◽

...

Keyword(s):

Case Studies ◽

Randomized Trials ◽

Ethical Issues ◽

Cluster Randomized Trials ◽

Middle Income ◽

Middle Income Countries ◽

Cluster Randomized ◽

Low And Middle Income

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ETHICAL ISSUES IN MANAGING LYSOSOMAL STORAGE DISORDERS IN CHILDREN IN LOW AND MIDDLE INCOME COUNTRIES

Pakistan Journal of Medical Sciences ◽

10.12669/pjms.334.12975 ◽

2017 ◽

Vol 33 (4) ◽

Cited By ~ 3

Author(s):

Bushra - Afroze

Keyword(s):

Ethical Issues ◽

Lysosomal Storage Disorders ◽

Lysosomal Storage ◽

Middle Income ◽

Middle Income Countries ◽

Storage Disorders ◽

Low And Middle Income

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Ethical Issues in Health Systems Research in Low and Middle-Income Countries

Developing World Bioethics ◽

10.1111/dewb.12126 ◽

2016 ◽

Vol 16 (3) ◽

pp. 122-123 ◽

Cited By ~ 1

Author(s):

Paul Ndebele ◽

Adnan A. Hyder

Keyword(s):

Health Systems ◽

Ethical Issues ◽

Health Systems Research ◽

Middle Income ◽

Middle Income Countries ◽

Systems Research ◽

Low And Middle Income

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Human infection challenge studies in endemic settings and/or low-income and middle-income countries: key points of ethical consensus and controversy

Journal of Medical Ethics ◽

10.1136/medethics-2019-106001 ◽

2020 ◽

Vol 46 (9) ◽

pp. 601-609 ◽

Cited By ~ 1

Author(s):

Euzebiusz Jamrozik ◽

Michael J Selgelid

Keyword(s):

Low Income ◽

Ethical Issues ◽

Relevant Literature ◽

Human Infection ◽

Third Party ◽

Future Research ◽

Middle Income ◽

Middle Income Countries ◽

Trade Offs ◽

Widespread Agreement

Human infection challenge studies (HCS) involve intentionally infecting research participants with pathogens (or other micro-organisms). There have been recent calls for more HCS to be conducted in low-income and middle-income countries (LMICs), where many relevant diseases are endemic. HCS in general, and HCS in LMICs in particular, raise numerous ethical issues. This paper summarises the findings of a project that explored ethical and regulatory issues related to LMIC HCS via (i) a review of relevant literature and (ii) 45 qualitative interviews with scientists and ethicists. Among other areas of consensus, we found that there was widespread agreement that LMIC HCS can be ethically acceptable, provided that they have a sound scientific rationale, are accepted by local communities and meet usual research ethics requirements. Unresolved issues include those related to (i) acceptable approaches to trade-offs between the scientific aim to produce generalisable results and the protection of participants, (iii) the sharing of benefits with LMIC populations, (iii) the acceptable limits to risks and burdens for participants, (iv) the potential for third-party risk and whether the degree of acceptable third-party risk is different in endemic settings, (v) the conditions under which (if any) it would be appropriate to recruit children for disease-causing HCS, (v) appropriate levels of payment to participants and (vi) appropriate governance of (LMIC) HCS. This paper provides preliminary analyses of these ethical considerations in order to (i) inform scientists and policymakers involved in the planning, conduct and/or governance of LMIC HCS and (ii) highlight areas warranting future research. Insofar as this article focuses on HCS in (endemic) settings where diseases are present and/or widespread, much of the analysis provided is relevant to HCS (in HICs or LMICs) involving pandemic diseases including COVID19.

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