ArticleMonash bioethics review
Setting risk thresholds in biomedical research: lessons from the debate about minimal risk.
Article in Monash bioethics review. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
What it found
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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
13 citing papers in PubMed.
- Article
- Waiver of informed consent in clinical research: a summary of contemporary guidelines and a resource for researchers.BMJ open · 2025Review
- Ethics of Controlled Human Infection Studies With Hepatitis C Virus.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023Article
- Is there a civic duty to support medical AI development by sharing electronic health records?BMC medical ethics · 2022Article
- Pandemic vaccine testing: Combining conventional and challenge studies.Pharmacoepidemiology and drug safety · 2022Article
- Ethical Considerations in Clinical Trials for Disorders of Consciousness.Brain sciences · 2022Article
- Prioritizing second-generation SARS-CoV-2 vaccines through low-dosage challenge studies.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2021Article
- Should practice and policy be revised to allow for risk-proportional payment to human challenge study participants?Journal of medical ethics · 2020Article
- Article
- 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
- Is There an Ethical Upper Limit on Risks to Study Participants?Public health ethics · 2020Article
- Towards Identifying an Upper Limit of Risk: A Persistent Area of Controversy in Research Ethics.Perspectives in biology and medicine · 2020Article
- Facilitating the ethical use of health data for the benefit of society: electronic health records, consent and the duty of easy rescue.Philosophical transactions. Series A, Mathematical, physical, and engineering sciences · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
One of the fundamental ethical concerns about biomedical research is that it frequently exposes participants to risks for the benefit of others. To protect participants' rights and interests in this context, research regulations and guidelines set out a mix of substantive and procedural requirements for research involving humans. Risk thresholds play an important role in formulating both types of requirements. First, risk thresholds serve to set upper risk limits in certain types of research (e.g., pediatric research that offers the participating children no prospect of clinical benefit). Second, risk thresholds serve to demarcate risk categories that streamline risk-adapted systems of ethical oversight (e.g., expedited or no prospective ethical review of minimal risk research). But although risk thresholds play such an important role in research governance, there is a need both to better define the existing risk thresholds and to delineate new thresholds in order to develop more risk-adapted systems of research oversight. The present paper examines the existing minimal risk threshold and the surrounding debates with the goal of deriving a systematic approach to setting thresholds of research risk.
Indexed as
Identifiers
25434065What 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.