ReviewJournal of medical ethics2020
Human infection challenge studies in endemic settings and/or low-income and middle-income countries: key points of ethical consensus and controversy.
Review in Journal of medical ethics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed.
- Ethical Frameworks for Conducting Social Challenge Studies.Journal of empirical research on human research ethics : JERHRE · 2026Review
- Article
- How community members in Uganda perceive controlled human infection studies.Research ethics · 2025Article
- Perceptions of a Buruli ulcer controlled human infection model: How, who, and why?PLoS neglected tropical diseases · 2025Article
- Controlled human malaria infection: overview and potential application in the evaluation of transmission-blocking interventions in malaria-endemic areas.Malaria journal · 2025Review
- Review of Current Tuberculosis Human Infection Studies for Use in Accelerating Tuberculosis Vaccine Development: A Meeting Report.The Journal of infectious diseases · 2024Article
- A scoping review of ethics review processes during public health emergencies in Africa.BMC medical ethics · 2024Article
- The Case for Human Challenge Trials in COVID-19.Journal of bioethical inquiry · 2024Article
- Perceptions and acceptability of the controlled human malaria infection (CHMI) model in The Gambia: a qualitative study.Scientific reports · 2023Article
- The Development and Distribution of the COVID-19 Vaccine.American journal of respiratory and critical care medicine · 2022Article
- Ethical and practical considerations arising from community consultation on implementing controlled human infection studies usingGlobal bioethics = Problemi di bioetica · 2022Article
- Vaccines against leishmaniasis: using controlled human infection models to accelerate development.Expert review of vaccines · 2021Article
- Article
- Back to WHAT? The role of research ethics in pandemic times.Medicine, health care, and philosophy · 2021Article
- Testing SARS-CoV-2 vaccine efficacy through deliberate natural viral exposure.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2021Review
- SARS-CoV-2 (COVID-19) Vaccine Development and Production: An Ethical Way Forward.Cambridge quarterly of healthcare ethics : CQ : the international journal of healthcare ethics committees · 2021Article
- Immunological Considerations forFrontiers in immunology · 2021Review
- "At first, I was very afraid"-a qualitative description of participants' views and experiences in the first Human Infection Study in Malawi.Wellcome open research · 2021Article
- Informed consent for controlled human infection studies in low- and middle-income countries: Ethical challenges and proposed solutions.Bioethics · 2020Article
- Ethics & utility of controlled human infection studies (CHIS) in low- & middle-income countries.The Indian journal of medical researchReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
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.
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