ArticlePublic health ethics2016
Ethical Criteria for Human Challenge Studies in Infectious Diseases.
Article in Public health ethics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 56 papers, 1 of them a synthesis that pooled it.
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
56 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Key criteria for the ethical acceptability of COVID-19 human challenge studies: Report of a WHO Working Group.Vaccine · 2021Guideline
- Ethical Frameworks for Conducting Social Challenge Studies.Journal of empirical research on human research ethics : JERHRE · 2026Review
- Motivations and experiences in controlled human infection trials vs. phase I clinical trials: a survey study.BMC medical ethics · 2026Article
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- Balancing altruism, risk and ethics: Vietnamese students' views on human challenge studies.PloS one · 2026Article
- Article
- An Ethical Analysis of Public Attitudes towards Controlled Human Infection Studies in Singapore: Acceptability and Payment.Asian bioethics review · 2026Article
- Lipid nanoparticle-based mRNA platforms for mucosal HIV vaccines: formulation advances, immune mechanisms, and translational pathways.Archives of microbiology · 2025Review
- How community members in Uganda perceive controlled human infection studies.Research ethics · 2025Article
- Controlled human malaria infection: overview and potential application in the evaluation of transmission-blocking interventions in malaria-endemic areas.Malaria journal · 2025Review
- Ethical approval for controlled human infectious model clinical trial protocols - A workshop report.Biologicals : journal of the International Association of Biological Standardization · 2024Article
- From setbacks to success: lessons from the journey of RSV vaccine development.Therapeutic advances in vaccines and immunotherapy · 2024Review
- Ethical acceptability of human challenge trials: Consultation with the US public and with research personnel.PloS one · 2024Article
- Human Challenge Studies with Coronaviruses Old and New.Current topics in microbiology and immunology · 2024Review
- Article
- Ethics of Controlled Human Infection Studies With Hepatitis C Virus.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023Article
- A human model of Buruli ulcer: The case for controlled human infection and considerations for selecting a Mycobacterium ulcerans challenge strain.PLoS neglected tropical diseases · 2023Review
- Risk, benefit, and social value in Covid-19 human challenge studies: pandemic decision making in historical context.Monash bioethics review · 2022Article
- Ethical and practical considerations arising from community consultation on implementing controlled human infection studies usingGlobal bioethics = Problemi di bioetica · 2022Article
- Controlled human infectious models, a path forward in uncovering immunological correlates of protection: Lessons from enteric fevers studies.Frontiers in microbiology · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
Purposeful infection of healthy volunteers with a microbial pathogen seems at odds with acceptable ethical standards, but is an important contemporary research avenue used to study infectious diseases and their treatments. Generally termed 'controlled human infection studies', this research is particularly useful for fast tracking the development of candidate vaccines and may provide unique insight into disease pathogenesis otherwise unavailable. However, scarce bioethical literature is currently available to assist researchers and research ethics committees in negotiating the distinct issues raised by research involving purposefully infecting healthy volunteers. In this article, we present two separate challenge studies and highlight the ethical issues of human challenge studies as seen through a well-constructed framework. Beyond the same stringent ethical standards seen in other areas of medical research, we conclude that human challenge studies should also include: (i) independent expert reviews, including systematic reviews; (ii) a publicly available rationale for the research; (iii) implementation of measures to protect the public from spread of infection beyond the research setting; and (iv) a new system for compensation for harm. We hope these additions may encourage safer and more ethical research practice and help to safeguard public confidence in this vital research alternative in years to come.
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.