ArticleTheoretical medicine and bioethics2012
Limits on risks for healthy volunteers in biomedical research.
Article in Theoretical medicine and bioethics, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
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Who cites it
20 citing papers in PubMed.
- Article
- Mixed-methods study assessing the acceptability and feasibility of Human Challenge Studies for Disease X in Healthy UK Adults in a SARS-CoV-2 pandemic setting.BMJ public health · 2025Article
- Using AI to write scholarly publications.Accountability in research · 2024Article
- A few remarks on limits of research risks and research payments.Medicine, health care, and philosophy · 2023Article
- Pandemic vaccine testing: Combining conventional and challenge studies.Pharmacoepidemiology and drug safety · 2022Article
- Standards of evidence for institutional review board decision-making.Accountability in research · 2021Article
- The motivations, barriers, and sociodemographic characteristics of healthy Chinese volunteers in phase I research.European journal of clinical pharmacology · 2021Article
- 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
- Why continuing uncertainties are no reason to postpone challenge trials for coronavirus vaccines.Journal of medical ethics · 2020Article
- COVID-19 vaccines: ethical framework concerning human challenge studies.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2020Article
- Willingness to risk death endpoint in HIV cure-related research with otherwise healthy volunteers is misleading.Journal of virus eradication · 2020Article
- Towards Identifying an Upper Limit of Risk: A Persistent Area of Controversy in Research Ethics.Perspectives in biology and medicine · 2020Article
- The Role of Intuition in Risk/Benefit Decision-Making in Human Subjects Research.Accountability in research · 2017Article
- Ethical Criteria for Human Challenge Studies in Infectious Diseases.Public health ethics · 2016Article
- Deliberate Microbial Infection Research Reveals Limitations to Current Safety Protections of Healthy Human Subjects.Science and engineering ethics · 2015Article
- Paternalism and utilitarianism in research with human participants.Health care analysis : HCA : journal of health philosophy and policy · 2015Article
- Unequal treatment of human research subjects.Medicine, health care, and philosophy · 2015Article
- Strategy for recruitment and factors associated with motivation and satisfaction in a randomized trial with 210 healthy volunteers without financial compensation.BMC medical research methodology · 2015Article
- Challenging research on human subjects: justice and uncompensated harms.Theoretical medicine and bioethics · 2013Article
- Setting risk thresholds in biomedical research: lessons from the debate about minimal risk.Monash bioethics reviewArticle
Corrections and comments
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1 author.
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Abstract
Healthy volunteers in biomedical research often face significant risks in studies that offer them no medical benefits. The U.S. federal research regulations and laws adopted by other countries place no limits on the risks that these participants face. In this essay, I argue that there should be some limits on the risks for biomedical research involving healthy volunteers. Limits on risk are necessary to protect human participants, institutions, and the scientific community from harm. With the exception of self-experimentation, limits on research risks faced by healthy volunteers constitute a type of soft, impure paternalism because participants usually do not fully understand the risks they are taking. I consider some approaches to limiting research risks and propose that healthy volunteers in biomedical research should not be exposed to greater than a 1% chance of serious harm, such as death, permanent disability, or severe illness or injury. While this guideline would restrict research risks, the limits would not be so low that they would prevent investigators from conducting valuable research. They would, however, set a clear upper boundary for investigators and signal to the scientific community and the public that there are limits on the risks that healthy participants may face in research. This standard provides guidance for decisions made by oversight bodies, but it is not an absolute rule. Investigators can enroll healthy volunteers in studies involving a greater than 1% chance of serious harm if they show that the research addresses a compelling public health or social problem and that the risk of serious harm is only slightly more than 1%. The committee reviewing the research should use outside experts to assess these risks.
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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.