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  1. Clinical equipoise: Why still the gold standard for randomized clinical trials?Charlemagne Asonganyi Folefac & Hugh Desmond - 2024 - Clinical Ethics 19 (1):1-11.
    The principle of clinical equipoise has been variously characterized by ethicists and clinicians as fundamentally flawed, a myth, and even a moral balm. Yet, the principle continues to be treated as the de facto gold standard for conducting randomized control trials in an ethical manner. Why do we hold on to clinical equipoise, despite its shortcomings being widely known and well-advertised? This paper reviews the most important arguments criticizing clinical equipoise as well as what the most prominent proposed alternatives are. (...)
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  • Is There an Ethical Upper Limit on Risks to Study Participants?Nir Eyal - 2020 - Public Health Ethics 13 (2):143-156.
    Are some risks to study participants too much, no matter how valuable the study is for society? This article answers in the negative.
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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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  • Four Faces of Fair Subject Selection.Katherine Witte Saylor & Douglas MacKay - 2020 - American Journal of Bioethics 20 (2):5-19.
    Although the principle of fair subject selection is a widely recognized requirement of ethical clinical research, it often yields conflicting imperatives, thus raising major ethical dilemmas regarding participant selection. In this paper, we diagnose the source of this problem, arguing that the principle of fair subject selection is best understood as a bundle of four distinct sub-principles, each with normative force and each yielding distinct imperatives: (1) fair inclusion; (2) fair burden sharing; (3) fair opportunity; and (4) fair distribution of (...)
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  • Context is Needed When Assessing Fair Subject Selection.G. Owen Schaefer - 2020 - American Journal of Bioethics 20 (2):20-22.
    Volume 20, Issue 2, February 2020, Page 20-22.
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  • An Argument for Fewer Clinical Trials.Kirstin Borgerson - 2016 - Hastings Center Report 46 (6):25-35.
    The volume of clinical research is increasing exponentially—far beyond our ability to process and absorb the results. Given this situation, it may be beneficial to consider reducing the flow at its source. In what follows, I will motivate and critically evaluate the following proposal: researchers should conduct fewer clinical trials. More specifically, I c onsider whether researchers should be permitted to conduct only clinical research of very high quality and, in turn, whether research ethics committees should prohibit all other, lower-quality (...)
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  • What Are the Implications of Applying Equipoise in Planning Citizens Basic Income Pilots in Scotland?Gerry McCartney, Neil Craig, Fiona Myers, Wendy Hearty & Coryn Barclay - 2021 - Public Health Ethics 14 (1):109-116.
    We have been asked to consider the feasibility of piloting a Citizens’ Basic Income : a basic, unconditional, universal, individual, regular payment that would replace aspects of social security and be introduced alongside changes to taxes. Piloting and evaluating a CBI as a Cluster Randomized Control Trial raises the question of whether intervention and comparison groups would be in equipoise, and thus whether randomization would be ethical. We believe that most researchers would accept that additional income, or reduced conditions on (...)
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  • Clarifying how to deploy the public interest criterion in consent waivers for health data and tissue research.G. Owen Schaefer, Graeme Laurie, Sumytra Menon, Alastair V. Campbell & Teck Chuan Voo - 2020 - BMC Medical Ethics 21 (1):1-10.
    Background Several jurisdictions, including Singapore, Australia, New Zealand and most recently Ireland, have a public interest or public good criterion for granting waivers of consent in biomedical research using secondary health data or tissue. However, the concept of the public interest is not well defined in this context, which creates difficulties for institutions, institutional review boards and regulators trying to implement the criterion. Main text This paper clarifies how the public interest criterion can be defensibly deployed. We first explain the (...)
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  • Can informed consent to research be adapted to risk?Danielle Bromwich & Annette Rid - 2015 - Journal of Medical Ethics 41 (7):521-528.
    The current ethical and regulatory framework for research is often charged with burdening investigators and impeding socially valuable research. To address these concerns, a growing number of research ethicists argue that informed consent should be adapted to the risks of research participation. This would require less rigorous consent standards in low-risk research than in high-risk research. However, the current discussion is restricted to cases of research in which the risks of research participation are outweighed by the potential clinical benefits for (...)
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  • Between Minimal and Greater Than Minimal Risk: How Research Participants and Oncologists Assess Data-Sharing and the Risk of Re-identification in Genomic Research.Sebastian Schleidgen, Alma Husedzinovic, Dominik Ose, Christoph Schickhardt, Christof Kalle & Eva Winkler - 2019 - Philosophy and Technology 32 (1):39-55.
    Data-sharing among genomic researchers is promoted for its potential to accelerate our understanding of the molecular basis of cancer. However, with genomic data sharing the risks of re-identifying study participants, revealing personal genomic information and data misuse might increase. This study aims at exploring perceptions of patients and physicians in Oncology regarding their assessment of the informational risks resulting from participating in whole genomic research studies in order to improve the informed consent process. For this purpose, we conducted a qualitative (...)
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  • (1 other version)The risk-benefit task of research ethics committees: An evaluation of current approaches and the need to incorporate decision studies methods. [REVIEW]Johannes J. M. Van Delden Rosemarie D. L. C. Bernabe, Ghislaine J. M. W. Van Thiel, Jan A. M. Raaijmakers - 2012 - BMC Medical Ethics 13 (1):6.
    BackgroundResearch ethics committees (RECs) are tasked to assess the risks and the benefits of a trial. Currently, two procedure-level approaches are predominant, the Net Risk Test and the Component Analysis.DiscussionBy looking at decision studies, we see that both procedure-level approaches conflate the various risk-benefit tasks, i.e., risk-benefit assessment, risk-benefit evaluation, risk treatment, and decision making. This conflation makes the RECs’ risk-benefit task confusing, if not impossible. We further realize that RECs are not meant to do all the risk-benefit tasks; instead, (...)
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  • Limits on risks for healthy volunteers in biomedical research.David B. Resnik - 2012 - Theoretical Medicine and Bioethics 33 (2):137-149.
    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 (...)
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  • Which Benefits Can Justify Risks in Research?Tessa I. van Rijssel, Ghislaine J. M. W. van Thiel, Helga Gardarsdottir, Johannes J. M. van Delden & on Behalf of the Trials@Home Consortium - forthcoming - American Journal of Bioethics:1-11.
    Research ethics committees (RECs) evaluate whether the risk-benefit ratio of a study is acceptable. Decentralized clinical trials (DCTs) are a novel approach for conducting clinical trials that potentially bring important benefits for research, including several collateral benefits. The position of collateral benefits in risk-benefit assessments is currently unclear. DCTs raise therefore questions about how these benefits should be assessed. This paper aims to reconsider the different types of research benefits, and their position in risk-benefit assessments. We first propose a categorization (...)
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  • Spheres of Morality: The Ethical Codes of the Medical Profession.Samuel Doernberg & Robert Truog - 2023 - American Journal of Bioethics 23 (12):8-22.
    The medical profession contains five “spheres of morality”: clinical care, clinical research, scientific knowledge, population health, and the market. These distinct sets of normative commitments require physicians to act in different ways depending on the ends of the activity in question. For example, a physician-scientist emphasizes patients’ well-being in clinic, prioritizes the scientific method in lab, and seeks to maximize shareholder returns as a board member of a pharmaceutical firm. Physicians increasingly occupy multiple roles in healthcare and move between them (...)
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  • Risk Limits in Fair Subject Selection.Robert Steel - 2020 - American Journal of Bioethics 20 (2):30-32.
    Volume 20, Issue 2, February 2020, Page 30-32.
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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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  • (1 other version)The risk-benefit task of research ethics committees: An evaluation of current approaches and the need to incorporate decision studies methods.D. L. C. Bernabe Rosemarie, J. M. W. van Thiel Ghislaine, A. M. Raaijmakers Jan & J. M. van Delden Johannes - 2012 - BMC Medical Ethics 13 (1):6.
    Background Research ethics committees are tasked to assess the risks and the benefits of a trial. Currently, two procedure-level approaches are predominant, the Net Risk Test and the Component Analysis. Discussion By looking at decision studies, we see that both procedure-level approaches conflate the various risk-benefit tasks, i.e., risk-benefit assessment, risk-benefit evaluation, risk treatment, and decision making. This conflation makes the RECs’ risk-benefit task confusing, if not impossible. We further realize that RECs are not meant to do all the risk-benefit (...)
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  • The Moral Permissibility of Perspective-Taking Interventions.Hannah Read & Thomas Douglas - 2024 - Ethical Theory and Moral Practice 27 (3):337-352.
    Interventions designed to promote perspective taking are increasingly prevalent in educational settings, and are also being considered for applications in other domains. Thus far, these perspective-taking interventions (PTIs) have largely escaped philosophical attention, however they are sometimes _prima facie_ morally problematic in at least two respects: they are neither transparent nor easy to resist. Nontransparent or hard-to-resist PTIs call for a moral defense and our primary aim in this paper is to provide such a defense. We offer two arguments for (...)
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  • Mission Creep or Mission Lapse? Scientific Review in Research Oversight.Margaret Waltz, Jill A. Fisher & Rebecca L. Walker - 2023 - AJOB Empirical Bioethics 14 (1):38-49.
    Background The ethical use both of human and non-human animals in research is predicated on the assumption that it is of a high quality and its projected benefits are more significant than the risks and harms imposed on subjects. Yet questions remain about whether and how IRBs and IACUCs should consider the scientific value of proposed research studies.Methods We draw upon 45 interviews with IRB and IACUC members and researchers with oversight experience about their perceptions of their own roles in (...)
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  • Collaborative partnership and the social value of clinical research: a qualitative secondary analysis.Sanna-Maria Nurmi, Arja Halkoaho, Mari Kangasniemi & Anna-Maija Pietilä - 2017 - BMC Medical Ethics 18 (1):57.
    Protecting human subjects from being exploited is one of the main ethical challenges for clinical research. However, there is also a responsibility to protect and respect the communities who are hosting the research. Recently, attention has focused on the most efficient way of carrying out clinical research, so that it benefits society by providing valuable research while simultaneously protecting and respecting the human subjects and the communities where the research is conducted. Collaboration between partners plays an important role and that (...)
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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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  • News media coverage of euthanasia: a content analysis of Dutch national newspapers. [REVIEW]Rosemarie D. L. C. Bernabe, Ghislaine J. M. W. Van Thiel, Jan A. M. Raaijmakers & Johannes J. M. Van Delden - 2013 - BMC Medical Ethics 14 (1):6-.
    BackgroundThe Netherlands is one of the few countries where euthanasia is legal under strict conditions. This study investigates whether Dutch newspaper articles use the term ‘euthanasia’ according to the legal definition and determines what arguments for and against euthanasia they contain.MethodsWe did an electronic search of seven Dutch national newspapers between January 2009 and May 2010 and conducted a content analysis.ResultsOf the 284 articles containing the term ‘euthanasia’, 24% referred to practices outside the scope of the law, mostly relating to (...)
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  • Ethics of HIV cure research: an unfinished agenda. [REVIEW]Jeremy Sugarman, John A. Sauceda, Brandon Brown, Parya Saberi, Mallory O. Johnson, Laney Henley, Samuel Ndukwe, Hursch Patel, Morénike Giwa Onaiwu, Danielle M. Campbell, David Palm, Orbit Clanton, David Kelly, Jan Kosmyna, Michael Louella, Laurie Sylla, Christopher Roebuck, Nora Jones, Lynda Dee, Jeff Taylor, John Kanazawa & Karine Dubé - 2021 - BMC Medical Ethics 22 (1):1-14.
    BackgroundThe pursuit of a cure for HIV is a high priority for researchers, funding agencies, governments and people living with HIV (PLWH). To date, over 250 biomedical studies worldwide are or have been related to discovering a safe, effective, and scalable HIV cure, most of which are early translational research and experimental medicine. As HIV cure research increases, it is critical to identify and address the ethical challenges posed by this research.MethodsWe conducted a scoping review of the growing HIV cure (...)
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  • The social value of candidate HIV cures: actualism versus possibilism.Regina Brown & Nicholas Greig Evans - 2017 - Journal of Medical Ethics 43 (2):118-123.
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  • Can significant difference in regulating medical and non-medical research be justified?David Hunter - 2014 - Monash Bioethics Review 32 (3-4):254-267.
    It is now typical for human subjects research to be regulated by review by an independent research ethics committee in most jurisdictions. However it is common for countries to opt to only compulsorily regulate medical research while leaving some or all non-medical research either unregulated or only regulated on a voluntary basis. In this paper I will argue, using regulation in the UK as an example, that it is difficult to justify this sharp distinction in practices. While I won’t come (...)
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  • The effect of study type on research ethics committees’ queries in medical studies.Saara M. Happo, Arja Halkoaho, Soili M. Lehto & Tapani Keränen - 2016 - Research Ethics 13 (3-4):115-127.
    Background:Medical research involving human subjects must be evaluated by a research ethics committee before a study is initiated. However, knowledge of REC decision processes, particularly in relation to evaluating the risk–benefit balance in various study types, appears scant.Methods:The study protocols and records of a Finnish university hospital REC were surveyed for a time span of 5 years. All study procedures in each study plan were examined, and the studies were divided into clinical drug trials, clinical trials with medical devices, studies (...)
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  • Between Minimal and Greater Than Minimal Risk: How Research Participants and Oncologists Assess Data-Sharing and the Risk of Re-identification in Genomic Research.Sebastian Schleidgen, Alma Husedzinovic, Dominik Ose, Christoph Schickhardt, Christof von Kalle & Eva C. Winkler - 2019 - Philosophy and Technology 32 (1):39-55.
    Data-sharing among genomic researchers is promoted for its potential to accelerate our understanding of the molecular basis of cancer. However, with genomic data sharing the risks of re-identifying study participants, revealing personal genomic information and data misuse might increase. This study aims at exploring perceptions of patients and physicians in Oncology regarding their assessment of the informational risks resulting from participating in whole genomic research studies in order to improve the informed consent process. For this purpose, we conducted a qualitative (...)
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