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 46 (9):601-609 (2020)
  Copy   BIBTEX

Abstract

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.

Other Versions

No versions found

Links

PhilArchive



    Upload a copy of this work     Papers currently archived: 98,098

External links

Setup an account with your affiliations in order to access resources via your University's proxy server

Through your library

Similar books and articles

HCs and ASDs.Justin Donhauser - 2020 - Medical Hypotheses 141.

Analytics

Added to PP
2020-05-08

Downloads
43 (#411,746)

6 months
12 (#235,758)

Historical graph of downloads
How can I increase my downloads?

Author's Profile

Michael Selgelid
Monash University

References found in this work

Bioethics, vulnerability, and protection.Ruth Macklin - 2003 - Bioethics 17 (5-6):472--486.
The Right to Withdraw from Research.G. Owen Schaefer & Alan Wertheimer - 2010 - Kennedy Institute of Ethics Journal 20 (4):329-352.
Undue Inducement: Nonsense on Stilts?Ezekiel J. Emanuel - 2005 - American Journal of Bioethics 5 (5):9-13.

View all 30 references / Add more references