ArticleScience and engineering ethics2015
Deliberate Microbial Infection Research Reveals Limitations to Current Safety Protections of Healthy Human Subjects.
Article in Science and engineering ethics, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 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
9 citing papers in PubMed.
- Experiences, perceptions and ethical considerations of the malaria infection study in Thailand.BMC medical ethics · 2025Article
- Exploring the participant experience in controlled human infection model (CHIM) trials: A modified grounded theory study.PloS one · 2025Article
- Ethical acceptability of human challenge trials: Consultation with the US public and with research personnel.PloS one · 2024Article
- Characterizing altruistic motivation in potential volunteers for SARS-CoV-2 challenge trials.PloS one · 2022Article
- 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 · 2020Review
- COVID-19 human challenge studies: ethical issues.The Lancet. Infectious diseases · 2020Review
- Article
- Expert voices and equal partnerships: establishing Controlled Human Infection Models (CHIMs) in Vietnam.Wellcome open research · 2019Article
- Ethical considerations in Controlled Human Malaria Infection studies in low resource settings: Experiences and perceptions of study participants in a malaria Challenge study in Kenya.Wellcome open research · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Here we identify approximately 40,000 healthy human volunteers who were intentionally exposed to infectious pathogens in clinical research studies dating from late World War II to the early 2000s. Microbial challenge experiments continue today under contemporary human subject research requirements. In fact, we estimated 4,000 additional volunteers who were experimentally infected between 2010 and the present day. We examine the risks and benefits of these experiments and present areas for improvement in protections of participants with respect to safety. These are the absence of maximum limits to risk and the potential for institutional review boards to include questionable benefits to subjects and society when weighing the risks and benefits of research protocols. The lack of a duty of medical care by physician-investigators to research subjects is likewise of concern. The transparency of microbial challenge experiments and the safety concerns raised in this work may stimulate further dialogue on the risks to participants of human experimentation.
Indexed as
Identifiers
25150847What 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.