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  1. Article: Will the real Charles Fried please stand up?

    Miller, Paul B / Weijer, Charles

    Kennedy Institute of Ethics journal

    2004  Volume 13, Issue 4, Page(s) 353–357

    Abstract: In response to the preceding commentary by Jerry Menikoff in this issue of the Journal, the authors argue that Fried's central concern is not that randomized clinical trials (RCTs) are conducted without consent, but rather that various aspects of the ... ...

    Abstract In response to the preceding commentary by Jerry Menikoff in this issue of the Journal, the authors argue that Fried's central concern is not that randomized clinical trials (RCTs) are conducted without consent, but rather that various aspects of the design and conduct of RCTs are in tension with physicians' duties of personal care to their patients. Although Fried does argue that the existence of equipoise cannot justify failure to obtain consent from research subjects, informed consent by itself does not supplant ill subjects' rights to personalized judgment and care embodied in Fried's equipoise.
    MeSH term(s) Disclosure/ethics ; Ethics, Medical ; Ethics, Research ; Humans ; Informed Consent ; Nontherapeutic Human Experimentation/ethics ; Patient Selection/ethics ; Physician-Patient Relations ; Physicians/ethics ; Randomized Controlled Trials as Topic/ethics ; Research Design ; Therapeutic Human Experimentation/ethics ; Uncertainty
    Language English
    Publishing date 2004-03-04
    Publishing country United States
    Document type Comment ; Journal Article
    ZDB-ID 1083645-7
    ISSN 1054-6863
    ISSN 1054-6863
    DOI 10.1353/ken.2004.0008
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Response to Merz.

    Al, Pepijn / Brehaut, Jamie / Weijer, Charles

    Trials

    2023  Volume 24, Issue 1, Page(s) 649

    Abstract: Jon Merz raises two objections to our article on the ethics of behavioral influences in trial recruitment. In this response, we defend our article against these objections. We argue that Merz's critique rests on a misunderstanding of our article, defend ... ...

    Abstract Jon Merz raises two objections to our article on the ethics of behavioral influences in trial recruitment. In this response, we defend our article against these objections. We argue that Merz's critique rests on a misunderstanding of our article, defend the daily life standard as a guardrail for leveraging cognitive biases, and argue that rejecting all behavioral influences is not a helpful nor a sustainable answer to their increasing use in trial recruitment.
    Language English
    Publishing date 2023-10-06
    Publishing country England
    Document type Letter
    ZDB-ID 2040523-6
    ISSN 1745-6215 ; 1468-6694 ; 1745-6215
    ISSN (online) 1745-6215
    ISSN 1468-6694 ; 1745-6215
    DOI 10.1186/s13063-023-07693-3
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Research bystanders, justice, and the state: Reframing the debate on third-party protections in health research.

    Murphy, Nicholas / Weijer, Charles

    Bioethics

    2022  Volume 36, Issue 8, Page(s) 865–873

    Abstract: Research participants are afforded protections to ensure their rights and welfare are not unduly jeopardized by research activities. Yet people who do not meet the criteria for research participant status may likewise be impacted by research activities, ... ...

    Abstract Research participants are afforded protections to ensure their rights and welfare are not unduly jeopardized by research activities. Yet people who do not meet the criteria for research participant status may likewise be impacted by research activities, and ethicists argue that protections should be afforded these "research bystanders." The standard rationale for extending protections to research bystanders contends that they are sufficiently like research participants that the ethical principles governing health research ought to extend to them. In this article we argue that this analogical reasoning is mistaken. Salient moral differences mean that research ethics frameworks are not fit for purpose. We defend the research bystander category by articulating a novel foundation for this new class of stakeholder. Focusing on bystanders directly impacted by publicly funded health research, we argue that bystanders are sometimes owed protections-but neither because of their similarity to research participants nor because research ethics principles should extend to them. Instead, we reframe the issue as a question of justice. Building on the work of Douglas MacKay, we argue that bystanders to publicly funded health research are owed protections as citizens of liberal states to whom the state owes duties of justice. The state has duties to protect the interests of citizens and to conduct health research. When the means by which the state fulfils the latter duty comes into conflict with the means by which it fulfils the former, the state must ensure that those impacted, including research bystanders, are afforded protections.
    MeSH term(s) Ethicists ; Ethics, Research ; Humans ; Moral Obligations ; Social Justice
    Language English
    Publishing date 2022-07-15
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 632984-6
    ISSN 1467-8519 ; 0269-9702
    ISSN (online) 1467-8519
    ISSN 0269-9702
    DOI 10.1111/bioe.13070
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Grey Matter - The Problems of Incidental Findings in Neuroimaging Research.

    Murphy, Nicholas / Weijer, Charles

    The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics

    2021  Volume 49, Issue 2, Page(s) 282–284

    MeSH term(s) Disclosure ; Gray Matter ; Humans ; Incidental Findings ; Neuroimaging
    Language English
    Publishing date 2021-12-20
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Comment
    ZDB-ID 1168812-9
    ISSN 1748-720X ; 1073-1105 ; 0277-8459
    ISSN (online) 1748-720X
    ISSN 1073-1105 ; 0277-8459
    DOI 10.1017/jme.2021.39
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Rules of the Road for Patient-Driven Consent Processes.

    Nix, Hayden P / Weijer, Charles

    The American journal of bioethics : AJOB

    2020  Volume 20, Issue 5, Page(s) 36–37

    MeSH term(s) Humans ; Informed Consent
    Language English
    Publishing date 2020-06-07
    Publishing country United States
    Document type Journal Article ; Comment
    ZDB-ID 2060433-6
    ISSN 1536-0075 ; 1526-5161
    ISSN (online) 1536-0075
    ISSN 1526-5161
    DOI 10.1080/15265161.2020.1745938
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Uses of equipoise in discussions of the ethics of randomized controlled trials of COVID-19 therapies.

    Nix, Hayden P / Weijer, Charles

    BMC medical ethics

    2021  Volume 22, Issue 1, Page(s) 143

    Abstract: Background: Early in the COVID-19 pandemic, the urgent need to discover effective therapies for COVID-19 prompted questions about the ethical problem of randomization along with its widely accepted solution: equipoise. In this scoping review, uses of ... ...

    Abstract Background: Early in the COVID-19 pandemic, the urgent need to discover effective therapies for COVID-19 prompted questions about the ethical problem of randomization along with its widely accepted solution: equipoise. In this scoping review, uses of equipoise in discussions of randomized controlled trials (RCT) of COVID-19 therapies are evaluated to answer three questions. First, how has equipoise been applied to COVID-19 research? Second, has equipoise been employed accurately? And third, do concerns about equipoise pose a barrier to the ethical conduct of COVID-19 RCTs?
    Methods: Google Scholar and Pubmed were searched for articles containing substantial discussion about equipoise and COVID-19 RCTs. 347 article titles were screened, 91 full text articles were assessed, and 48 articles were included. Uses of equipoise were analyzed and abstracted into seven categories.
    Results and discussion: Approximately two-thirds of articles (33/48 articles) used equipoise in a way that is consistent with the concept. They invoked equipoise to support (1) RCTs of specific therapies, (2) RCTs in general, and (3) the early termination of RCTs after achieving the primary outcome. Approximately one-third of articles (15/48 articles) used equipoise in a manner that is inconsistent with the concept. These articles argued that physician preference, widespread use of unproven therapies, patient preference, or expectation of therapeutic benefit may undermine equipoise and render RCTs unethical. In each case, the purported ethical problem can be resolved by correcting the use of equipoise.
    Conclusions: Our findings highlight the continued relevance of equipoise as it supports the conduct of well-conceived RCTs and provides moral guidance to physicians and researchers as they search for effective therapies for COVID-19.
    MeSH term(s) COVID-19 ; Humans ; Randomized Controlled Trials as Topic ; SARS-CoV-2 ; Therapeutic Equipoise
    Language English
    Publishing date 2021-10-21
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2041552-7
    ISSN 1472-6939 ; 1472-6939
    ISSN (online) 1472-6939
    ISSN 1472-6939
    DOI 10.1186/s12910-021-00712-5
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Why and when should we cluster randomize?

    Giraudeau, Bruno / Weijer, Charles / Eldridge, Sandra M / Hemming, Karla / Taljaard, Monica

    Journal of epidemiology and population health

    2024  Volume 72, Issue 1, Page(s) 202197

    Abstract: A cluster randomized trial is defined as a randomized trial in which intact social units of individuals are randomized rather than individuals themselves. Outcomes are observed on individual participants within clusters (such as patients). Such a design ... ...

    Abstract A cluster randomized trial is defined as a randomized trial in which intact social units of individuals are randomized rather than individuals themselves. Outcomes are observed on individual participants within clusters (such as patients). Such a design allows assessing interventions targeting cluster-level participants (such as physicians), individual participants or both. Indeed, many interventions assessed in cluster randomized trials are actually complex ones, with distinct components targeting different levels. For a cluster-level intervention, cluster randomization is an obvious choice: the intervention is not divisible at the individual-level. For individual-level interventions, cluster randomization may nevertheless be suitable to prevent group contamination, for logistical reasons, to enhance participants' adherence, or when objectives pertain to the cluster level. An unacceptable reason for cluster randomization would be to avoid obtaining individual consent. Indeed, participants in cluster randomized trials have to be protected as in any type of trial design. Participants may be people from whom data are collected, but they may also be people who are intervened upon, and this includes both patients and physicians (for example, physicians receiving training interventions). Consent should be sought as soon as possible, although there may exist situations where participants may consent only for data collection, not for being exposed to the intervention (because, for instance, they cannot opt-out). There may even be situations where participants are not able to consent at all. In this latter situation a waiver of consent must be granted by a research ethics committee.
    MeSH term(s) Humans ; Data Collection ; Ethics Committees, Research ; Informed Consent ; Research Design ; Randomized Controlled Trials as Topic
    Language English
    Publishing date 2024-02-09
    Publishing country France
    Document type Journal Article
    ISSN 2950-4333
    ISSN (online) 2950-4333
    DOI 10.1016/j.jeph.2024.202197
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article ; Online: It Does Not Matter Whether Research Interventions Are Usual Care.

    Goldstein, Cory E / Weijer, Charles

    The American journal of bioethics : AJOB

    2020  Volume 20, Issue 1, Page(s) 47–48

    MeSH term(s) Humans ; Morals ; Scientific Experimental Error
    Language English
    Publishing date 2020-01-10
    Publishing country United States
    Document type Journal Article ; Comment
    ZDB-ID 2060433-6
    ISSN 1536-0075 ; 1526-5161
    ISSN (online) 1536-0075
    ISSN 1526-5161
    DOI 10.1080/15265161.2019.1687779
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: Ethics of Controlled Human Infection Studies With Hepatitis C Virus.

    Rid, Annette / Feld, Jordan J / Liang, T Jake / Weijer, Charles

    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

    2023  Volume 77, Issue Suppl 3, Page(s) S216–S223

    Abstract: Global elimination of hepatitis C virus (HCV) will be difficult to attain without an effective HCV vaccine. Controlled human infection (CHI) studies with HCV were not considered until recently, when highly effective treatment became available. However, ... ...

    Abstract Global elimination of hepatitis C virus (HCV) will be difficult to attain without an effective HCV vaccine. Controlled human infection (CHI) studies with HCV were not considered until recently, when highly effective treatment became available. However, now that successful treatment of a deliberate HCV infection is feasible, it is imperative to evaluate the ethics of establishing a program of HCV CHI research. Here, we evaluate the ethics of studies to develop an HCV CHI model in light of 10 ethical considerations: sufficient social value, reasonable risk-benefit profile, suitable site selection, fair participant selection, robust informed consent, proportionate compensation or payment, context-specific stakeholder engagement, fair and open collaboration, independent review and oversight, and integrated ethics research. We conclude that it can be ethically acceptable to develop an HCV CHI model. Indeed, when done appropriately, developing a model should be a priority on the path toward global elimination of HCV.
    MeSH term(s) Humans ; Hepacivirus ; Hepatitis C/epidemiology ; Hepatitis C/prevention & control ; Hepatitis C/drug therapy ; Informed Consent ; Antiviral Agents/therapeutic use
    Chemical Substances Antiviral Agents
    Language English
    Publishing date 2023-01-17
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1099781-7
    ISSN 1537-6591 ; 1058-4838
    ISSN (online) 1537-6591
    ISSN 1058-4838
    DOI 10.1093/cid/ciad382
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: Nontherapeutic research with imminently dying and recently deceased study populations: addressing practical and ethical challenges.

    Murphy, Nicholas B / Weijer, Charles / Lalgudi Ganesan, Saptharishi / Dhanani, Sonny / Gofton, Teneille / Slessarev, Marat

    Canadian journal of anaesthesia = Journal canadien d'anesthesie

    2023  Volume 70, Issue 4, Page(s) 596–602

    MeSH term(s) Humans ; Nontherapeutic Human Experimentation ; Research Design ; Risk Assessment ; Informed Consent
    Language English
    Publishing date 2023-05-09
    Publishing country United States
    Document type Journal Article
    ZDB-ID 91002-8
    ISSN 1496-8975 ; 0832-610X
    ISSN (online) 1496-8975
    ISSN 0832-610X
    DOI 10.1007/s12630-023-02414-5
    Database MEDical Literature Analysis and Retrieval System OnLINE

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