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  1. Deliberate Microbial Infection Research Reveals Limitations to Current Safety Protections of Healthy Human Subjects.David L. Evers, Carol B. Fowler, Jeffrey T. Mason & Rebecca K. Mimnall - 2015 - Science and Engineering Ethics 21 (4):1049-1064.
    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 (...)
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  • A few remarks on limits of research risks and research payments.Joanna Różyńska - 2023 - Medicine, Health Care and Philosophy 26 (1):155-156.
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  • The ethics of pandemics: an introduction.Iwao Hirose - 2023 - New York, NY: Routledge.
    The recent Covid-19 pandemic has brought a broad range of ethical problems to the forefront, raising fundamental questions about the role of government in response to such outbreaks, the scarcity and allocation of health care resources, the unequal distribution of health risks and economic impacts, and the extent to which individual freedom can be restricted. In this clear introduction to the topic Iwao Hirose explores these ethical questions and analyzes the central issues in the ethics of pandemic response and preparedness (...)
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  • Public perceptions on Controlled Human Infection Model (CHIM) studies—a qualitative pilot study from South India.Mario Vaz, Mala Ramanathan, Rathna Kumari S., Avita Rose Johnson, Olinda Timms & Manjulika Vaz - 2020 - Monash Bioethics Review 39 (1):68-93.
    Research using Controlled Human Infection Models is yet to be attempted in India. This study was conducted to understand the perceptions of the lay public and key opinion makers prior to the possible introduction of such studies in the country. 110 respondents from urban and rural Bangalore district were interviewed using qualitative research methods of Focus Group Discussions and In-depth Interviews. The data was analyzed using grounded theory. Safety was a key concern of the lay public, expressed in terms of (...)
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  • The Ethics of Human Challenge Trials Using Emerging SARS-CoV-2 Virus Variants.Abie Rohrig & Nir Eyal - manuscript
    The world’s first COVID-19 human challenge trial using the D614G strain of SARS-CoV-2 is underway in the United Kingdom. The Wellcome Trust is funding challenge stock preparation of the Beta variant (B.1.351) for a follow-up human challenge trial, and researchers at Imperial College London are considering conducting that trial. However, little has been written thus far about the ethical justifiability of human challenge trials with SARS-CoV-2 variants of concern. While vaccine resistance as such does not increase risks for volunteers in (...)
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  • Why continuing uncertainties are no reason to postpone challenge trials for coronavirus vaccines.Robert Steel, Lara Buchak & Nir Eyal - 2020 - Journal of Medical Ethics 46 (12):808-812.
    To counter the pandemic caused by severe acute respiratory syndrome coronavirus 2, some have proposed accelerating SARS-CoV-2 vaccine development through controlled human infection trials. These trials would involve the deliberate exposure of relatively few young, healthy volunteers to SARS-CoV-2. We defend this proposal against the charge that there is still too much uncertainty surrounding the risks of COVID-19 to responsibly run such a trial.
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  • Reconceptualising risk–benefit analyses: the case of HIV cure research.Robert Steel - 2020 - Journal of Medical Ethics 46 (3):212-219.
    Modern antiretroviral therapies are capable of suppressing HIV in the bloodstream to undetectable levels. Nonetheless, people living with HIV must maintain lifelong adherence to ART to avoid the re-emergence of the infection. So despite the existence and efficacy of ART, there is still substantial interest in development of a cure. But HIV cure trials can be risky, their success is as of yet unlikely, and the medical gain of being cured is limited against a baseline of ART access. The medical (...)
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  • Setting risk thresholds in biomedical research: lessons from the debate about minimal risk.Annette Rid - 2014 - Monash Bioethics Review 32 (1-2):63-85.
    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. Second, risk thresholds serve to demarcate risk (...)
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  • Ethical Criteria for Human Challenge Studies in Infectious Diseases: Table 1.Ben Bambery, Michael Selgelid, Charles Weijer, Julian Savulescu & Andrew J. Pollard - 2016 - Public Health Ethics 9 (1):92-103.
    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 (...)
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  • Unequal treatment of human research subjects.David B. Resnik - 2015 - Medicine, Health Care and Philosophy 18 (1):23-32.
    Unequal treatment of human research subjects is a significant ethical concern, because justice in research involving human subjects requires equal protection of rights and equal protection from harm and exploitation. Disputes sometimes arise concerning the issue of unequal treatment of research subjects. Allegedly unequal treatment occurs when subjects are treated differently and there is a genuine dispute concerning the appropriateness of equal treatment. Patently unequal treatment occurs when subjects are treated differently and there is not a genuine dispute about the (...)
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  • Examining the Social Benefits Principle in Research with Human Participants.David B. Resnik - 2018 - Health Care Analysis 26 (1):66-80.
    The idea that research with human participants should benefit society has become firmly entrenched in various regulations, policies, and guidelines, but there has been little in-depth analysis of this ethical principle in the bioethics literature. In this paper, I distinguish between strong and weak versions and the social benefits principle and examine six arguments for it. I argue that while it is always ethically desirable for research with human subjects to offer important benefits to society, the reasonable expectation of substantial (...)
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  • Challenging research on human subjects: justice and uncompensated harms.Stephen Napier - 2013 - Theoretical Medicine and Bioethics 34 (1):29-51.
    Ethical challenges to certain aspects of research on human subjects are not uncommon; examples include challenges to first-in-human trials (Chapman in J Clin Res Bioethics 2(4):1–8, 2011), certain placebo controlled trials (Anderson in J Med Philos 31:65–81, 2006; Anderson and Kimmelman in Kennedy Inst Ethics J 20(1):75–98, 2010) and “sham” surgery (Macklin in N Engl J Med 341:992–996, 1999). To date, however, there are few challenges to research when the subjects are competent and the research is more than minimal risk (...)
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  • Paternalism and Utilitarianism in Research with Human Participants.David B. Resnik - 2012 - Health Care Analysis (1):1-13.
    In this article I defend a rule utilitarian approach to paternalistic policies in research with human participants. Some rules that restrict individual autonomy can be justified on the grounds that they help to maximize the overall balance of benefits over risks in research. The consequences that should be considered when formulating policy include not only likely impacts on research participants, but also impacts on investigators, institutions, sponsors, and the scientific community. The public reaction to adverse events in research (such as (...)
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