43 results on '"Binik, Ariella"'
Search Results
2. On female body experience: "Throwing like a girl" and other essays (review)
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Binik, Ariella
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- 2009
3. Ethical and practical considerations related to data sharing when collecting patient-reported outcomes in care-based child health research
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Vanderhout, Shelley, Potter, Beth K., Smith, Maureen, Butcher, Nancy J., Vaters, Jordan, Chakraborty, Pranesh, Adams, John, Inbar-Feigenberg, Michal, Offringa, Martin, Speechley, Kathy, Trakadis, Yannis, and Binik, Ariella
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- 2023
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4. Research ethics
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Kerasidou, Angeliki, primary and Binik, Ariella, additional
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- 2022
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5. Should Children Be Included in Human Challenge Studies?
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Binik, Ariella, primary
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- 2024
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6. Minority report : can minor parents refuse treatment for their child
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Turnham, Helen Lynne, Binik, Ariella, and Wilkinson, Dominic
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- 2020
7. Delaying and withholding interventions : ethics and the stepped wedge trial
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Binik, Ariella
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- 2019
8. A Framework for Assessing Scientific Merit in Ethical Review of Clinical Research
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Binik, Ariella and Hey, Spencer Phillips
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- 2019
9. Ethical challenges in research on sexual dysfunction
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Binik, Ariella, primary and Binik, Yitzchak M., additional
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- 2023
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10. Position statement on ethics, equipoise and research on charged particle radiation therapy
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Sheehan, Mark, Timlin, Claire, Peach, Ken, Binik, Ariella, Puthenparampil, Wilson, Lodge, Mark, Kehoe, Sean, Brada, Michael, Burnet, Neil, Clarke, Steve, Crellin, Adrian, Dunn, Michael, Fossati, Piero, Harris, Steve, Hocken, Michael, Hope, Tony, Ives, Jonathan, Kamada, Tadashi, London, Alex John, Miller, Robert, Parker, Michael, Pijls-Johannesma, Madelon, Savulescu, Julian, Short, Susan, Skene, Loane, Tsujii, Hirohiko, Tuan, Jeffrey, and Weijer, Charles
- Published
- 2014
11. SARS-CoV-2 challenge studies: ethics and risk minimisation
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Bull, Susan, primary, Jamrozik, Euzebiusz, additional, Binik, Ariella, additional, and Parker, Michael J, additional
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- 2020
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12. What risks should be permissible in controlled human infection model studies?
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Binik, Ariella, primary
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- 2020
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13. Rethinking risk in pediatric research.
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Glass, Kathleen Cranley and Binik, Ariella
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Best interests of the child doctrine -- Laws, regulations and rules ,Informed consent (Medical law) -- Laws, regulations and rules ,Pediatric research -- Laws, regulations and rules ,Health risk assessment -- Laws, regulations and rules ,Government regulation - Abstract
Many activities concerning the unknown involve the potential for risk, and clinical research is no exception. Some research participants experience correlative benefit; others do not. When the participants are adults, [...]
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- 2008
14. When is informed consent required in cluster randomized trials in health research?
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Boruch Robert, Grimshaw Jeremy M, Binik Ariella, Weijer Charles, McRae Andrew D, Brehaut Jamie C, Donner Allan, Eccles Martin P, Saginur Raphael, White Angela, and Taljaard Monica
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Medicine (General) ,R5-920 - Abstract
Abstract This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the second of the questions posed, namely, from whom, when, and how must informed consent be obtained in CRTs in health research? The ethical principle of respect for persons implies that researchers are generally obligated to obtain the informed consent of research subjects. Aspects of CRT design, including cluster randomization, cluster level interventions, and cluster size, present challenges to obtaining informed consent. Here we address five questions related to consent and CRTs: How can a study proceed if informed consent is not possible? Is consent to randomization always required? What information must be disclosed to potential subjects if their cluster has already been randomized? Is passive consent a valid substitute for informed consent? Do health professionals have a moral obligation to participate as subjects in CRTs designed to improve professional practice? We set out a framework based on the moral foundations of informed consent and international regulatory provisions to address each of these questions. First, when informed consent is not possible, a study may proceed if a research ethics committee is satisfied that conditions for a waiver of consent are satisfied. Second, informed consent to randomization may not be required if it is not possible to approach subjects at the time of randomization. Third, when potential subjects are approached after cluster randomization, they must be provided with a detailed description of the interventions in the trial arm to which their cluster has been randomized; detailed information on interventions in other trial arms need not be provided. Fourth, while passive consent may serve a variety of practical ends, it is not a substitute for valid informed consent. Fifth, while health professionals may have a moral obligation to participate as subjects in research, this does not diminish the necessity of informed consent to study participation.
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- 2011
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15. Who is the research subject in cluster randomized trials in health research?
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Brehaut Jamie C, Boruch Robert, Grimshaw Jeremy M, White Angela, Binik Ariella, Weijer Charles, McRae Andrew D, Donner Allan, Eccles Martin P, Saginur Raphael, Zwarenstein Merrick, and Taljaard Monica
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Medicine (General) ,R5-920 - Abstract
Abstract This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the CRT is to be set on a firm ethical foundation. This paper addresses the first of the questions posed, namely, who is the research subject in a CRT in health research? The identification of human research subjects is logically prior to the application of protections as set out in research ethics and regulation. Aspects of CRT design, including the fact that in a single study the units of randomization, experimentation, and observation may differ, complicate the identification of human research subjects. But the proper identification of human research subjects is important if they are to be protected from harm and exploitation, and if research ethics committees are to review CRTs efficiently. We examine the research ethics literature and international regulations to identify the core features of human research subjects, and then unify these features under a single, comprehensive definition of human research subject. We define a human research subject as any person whose interests may be compromised as a result of interventions in a research study. Individuals are only human research subjects in CRTs if: (1) they are directly intervened upon by investigators; (2) they interact with investigators; (3) they are deliberately intervened upon via a manipulation of their environment that may compromise their interests; or (4) their identifiable private information is used to generate data. Individuals who are indirectly affected by CRT study interventions, including patients of healthcare providers participating in knowledge translation CRTs, are not human research subjects unless at least one of these conditions is met.
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- 2011
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16. Does clinical equipoise apply to cluster randomized trials in health research?
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Brehaut Jamie C, Boruch Robert, Grimshaw Jeremy M, McRae Andrew D, Weijer Charles, Binik Ariella, Donner Allan, Eccles Martin P, Saginur Raphael, Taljaard Monica, and Zwarenstein Merrick
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Medicine (General) ,R5-920 - Abstract
Abstract This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, Weijer and colleagues set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the third of the questions posed, namely, does clinical equipoise apply to CRTs in health research? The ethical principle of beneficence is the moral obligation not to harm needlessly and, when possible, to promote the welfare of research subjects. Two related ethical problems have been discussed in the CRT literature. First, are control groups that receive only usual care unduly disadvantaged? Second, when accumulating data suggests the superiority of one intervention in a trial, is there an ethical obligation to act? In individually randomized trials involving patients, similar questions are addressed by the concept of clinical equipoise, that is, the ethical requirement that, at the start of a trial, there be a state of honest, professional disagreement in the community of expert practitioners as to the preferred treatment. Since CRTs may not involve physician-researchers and patient-subjects, the applicability of clinical equipoise to CRTs is uncertain. Here we argue that clinical equipoise may be usefully grounded in a trust relationship between the state and research subjects, and, as a result, clinical equipoise is applicable to CRTs. Clinical equipoise is used to argue that control groups receiving only usual care are not disadvantaged so long as the evidence supporting the experimental and control interventions is such that experts would disagree as to which is preferred. Further, while data accumulating during the course of a CRT may favor one intervention over another, clinical equipoise supports continuing the trial until the results are likely to be broadly convincing, often coinciding with the planned completion of the trial. Finally, clinical equipoise provides research ethics committees with formal and procedural guidelines that form an important part of the assessment of the benefits and harms of CRTs in health research.
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- 2011
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17. Ethical issues posed by cluster randomized trials in health research
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Donner Allan, Brehaut Jamie C, Boruch Robert, Binik Ariella, Taljaard Monica, Grimshaw Jeremy M, Weijer Charles, Eccles Martin P, Gallo Antonio, McRae Andrew D, Saginur Raphael, and Zwarenstein Merrick
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Medicine (General) ,R5-920 - Abstract
Abstract The cluster randomized trial (CRT) is used increasingly in knowledge translation research, quality improvement research, community based intervention studies, public health research, and research in developing countries. However, cluster trials raise difficult ethical issues that challenge researchers, research ethics committees, regulators, and sponsors as they seek to fulfill responsibly their respective roles. Our project will provide a systematic analysis of the ethics of cluster trials. Here we have outlined a series of six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation: 1. Who is a research subject? 2. From whom, how, and when must informed consent be obtained? 3. Does clinical equipoise apply to CRTs? 4. How do we determine if the benefits outweigh the risks of CRTs? 5. How ought vulnerable groups be protected in CRTs? 6. Who are gatekeepers and what are their responsibilities? Subsequent papers in this series will address each of these areas, clarifying the ethical issues at stake and, where possible, arguing for a preferred solution. Our hope is that these papers will serve as the basis for the creation of international ethical guidelines for the design and conduct of cluster randomized trials.
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- 2011
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18. Ethical and policy issues in cluster randomized trials: rationale and design of a mixed methods research study
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Chaudhry Shazia H, Brehaut Jamie C, Boruch Robert, Binik Ariella, Belle Brown Judith, Grimshaw Jeremy M, Weijer Charles, Taljaard Monica, Eccles Martin P, McRae Andrew, Saginur Raphael, Zwarenstein Merrick, and Donner Allan
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Medicine (General) ,R5-920 - Abstract
Abstract Background Cluster randomized trials are an increasingly important methodological tool in health research. In cluster randomized trials, intact social units or groups of individuals, such as medical practices, schools, or entire communities – rather than individual themselves – are randomly allocated to intervention or control conditions, while outcomes are then observed on individual cluster members. The substantial methodological differences between cluster randomized trials and conventional randomized trials pose serious challenges to the current conceptual framework for research ethics. The ethical implications of randomizing groups rather than individuals are not addressed in current research ethics guidelines, nor have they even been thoroughly explored. The main objectives of this research are to: (1) identify ethical issues arising in cluster trials and learn how they are currently being addressed; (2) understand how ethics reviews of cluster trials are carried out in different countries (Canada, the USA and the UK); (3) elicit the views and experiences of trial participants and cluster representatives; (4) develop well-grounded guidelines for the ethical conduct and review of cluster trials by conducting an extensive ethical analysis and organizing a consensus process; (5) disseminate the guidelines to researchers, research ethics boards (REBs), journal editors, and research funders. Methods We will use a mixed-methods (qualitative and quantitative) approach incorporating both empirical and conceptual work. Empirical work will include a systematic review of a random sample of published trials, a survey and in-depth interviews with trialists, a survey of REBs, and in-depth interviews and focus group discussions with trial participants and gatekeepers. The empirical work will inform the concurrent ethical analysis which will lead to a guidance document laying out principles, policy options, and rationale for proposed guidelines. An Expert Panel of researchers, ethicists, health lawyers, consumer advocates, REB members, and representatives from low-middle income countries will be appointed. A consensus conference will be convened and draft guidelines will be generated by the Panel; an e-consultation phase will then be launched to invite comments from the broader community of researchers, policy-makers, and the public before a final set of guidelines is generated by the Panel and widely disseminated by the research team.
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- 2009
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19. Does benefit justify research with children?
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Binik, Ariella, primary
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- 2017
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20. Logistic, ethical, and political dimensions of stepped wedge trials: critical review and case studies
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Prost, Audrey, Binik, Ariella, Abubakar, Ibrahim, Roy, Anjana, De Allegri, Manuela, Mouchoux, Christelle, Dreischulte, Tobias, Ayles, Helen, Lewis, James J., and Osrin, David
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610 Medical sciences Medicine ,Medicine (miscellaneous) ,Pharmacology (medical) - Abstract
Background\ud\udThree arguments are usually invoked in favour of stepped wedge cluster randomised controlled trials: the logistic convenience of implementing an intervention in phases, the ethical benefit of providing the intervention to all clusters, and the potential to enhance the social acceptability of cluster randomised controlled trials. Are these alleged benefits real? We explored the logistic, ethical, and political dimensions of stepped wedge trials using case studies of six recent evaluations.\ud\udMethods\ud\udWe identified completed or ongoing stepped wedge evaluations using two systematic reviews. We then purposively selected six with a focus on public health in high, middle, and low-income settings. We interviewed their authors about the logistic, ethical, and social issues faced by their teams. Two authors reviewed interview transcripts, identified emerging issues through qualitative thematic analysis, reflected upon them in the context of the literature, and invited all participants to co-author the manuscript.\ud\udResults\ud\udOur analysis raises three main points. First, the phased implementation of interventions can alleviate problems linked to simultaneous roll-out, but also brings new challenges. Issues to consider include the feasibility of organising intervention activities according to a randomised sequence, estimating time lags in implementation and effects, and accommodating policy changes during the trial period. Second, stepped wedge trials, like parallel cluster trials, require equipoise: without it, randomising participants to a control condition, even for a short time, remains problematic. In stepped wedge trials, equipoise is likely to lie in the degree of effect, effectiveness in a specific operational milieu, and the balance of benefit and harm, including the social value of better evaluation. Third, the strongest arguments for a stepped wedge design are logistic and political rather than ethical. The design is advantageous when simultaneous roll-out is impractical and when it increases the acceptability of using counterfactuals.\ud\udConclusions\ud\udThe logistic convenience of phased implementation is context-dependent, and may be vitiated by the additional requirements of phasing. The potential for stepped wedge trials to enhance the social acceptability of cluster randomised trials is real, but their ethical legitimacy still rests on demonstrating equipoise and its configuration for each research question and setting.
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- 2015
21. On Female Body Experience: "Throwing like a Girl" and Other Essays Iris Marion Young
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Binik, Ariella
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- 2008
22. An Ethical Justification for Research with Children
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Binik, Ariella
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research with children ,clinical trials ,Philosophy ,minimal risk ,research ethics ,ethics ,humanities - Abstract
This thesis is a contribution to the ethical justification for clinical research with children. A research subject’s participation in a trial is usually justified, in part, by informed consent. Informed consent helps to uphold the moral principle of respect for persons. But children’s limited ability to make informed choices gives rise to a problem. It is unclear what, if anything, justifies their participation in research. Some research ethicists propose to resolve this problem by appealing to social utility, proxy consent, arguments explaining why it is permissible to expose children to some harm, and an argument concerning the appropriate balance between research harms and benefits. I argue that each of these is a necessary part of the justification for research with children, but that the argument concerning harms and benefits is under-developed. It relies on the concept of minimal risk, but minimal risk is inadequately justified. I propose an interpretation of minimal risk. I defend the idea that minimal risk should be interpreted according to the risks of daily life. I reject the most prominent defense of daily life, which claims that daily risks are morally relevant because they replace, rather than add to, the risks a child would ordinarily face. Instead, I propose that these risks are part of a reasonable trade-off between personal safety and our ability to pursue meaningful lives. I then examine whose daily life should be captured in the concept of minimal risk. I reject arguments that minimal risk should refer to healthy children or the subjects of the research (including healthy and sick children) and propose instead that the referent should be children who are not unduly burdened by their lives. I argue that children are not unduly burdened when they fare well and defend the idea that children fare well when they possess sufficiently high degrees of the substantive goods of childhood. I conclude by analyzing a controversial case study using my interpretation of minimal risk. I draw on this case to argue that my interpretation offers clear guidance for research ethics review and contributes to a determination that is more plausible than its rivals.
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- 2013
23. Does benefit justify research with children?
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Binik, Ariella
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CLINICAL medicine research , *ETHICS , *INFORMED consent (Medical law) , *RESEARCH ethics , *RISK assessment , *HUMAN research subjects , *CHILDREN - Abstract
The inclusion of children in research gives rise to a difficult ethical question: What justifies children's research participation and exposure to research risks when they cannot provide informed consent? This question arises out of the tension between the moral requirement to obtain a subject's informed consent for research participation, on the one hand, and the limited capacity of most children to provide informed consent, on the other. Most agree that children's participation in clinical research can be justified. But the ethical justification for exposing children to research risks in the absence of consent remains unclear. One prevalent group of arguments aims to justify children's risk exposure by appealing to the concept of benefit. I call these 'benefit arguments'. Prominent versions of this argument defend the idea that broadening our understanding of the notion of benefit to include non-medical benefits (such as the benefit of a moral education) helps to justify children's research participation. I argue that existing benefit arguments are not persuasive and raise problems with the strategy of appealing to broader notions of benefit to justify children's exposure to research risk. [ABSTRACT FROM AUTHOR]
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- 2018
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24. On the Minimal Risk Threshold in Research With Children
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Binik, Ariella, primary
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- 2014
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25. Randomization Should Be Disclosed to Potential Research Subjects
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Binik, Ariella, primary and Sheehan, Mark, additional
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- 2013
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26. Position statement on ethics, equipoise and research on charged particle radiation therapy
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Sheehan, Mark, primary, Timlin, Claire, additional, Peach, Ken, additional, Binik, Ariella, additional, Puthenparampil, Wilson, additional, Lodge, Mark, additional, Kehoe, Sean, additional, Brada, Michael, additional, Burnet, Neil, additional, Clarke, Steve, additional, Crellin, Adrian, additional, Dunn, Michael, additional, Fossati, Piero, additional, Harris, Steve, additional, Hocken, Michael, additional, Hope, Tony, additional, Ives, Jonathan, additional, Kamada, Tadashi, additional, London, Alex John, additional, Miller, Robert, additional, Parker, Michael, additional, Pijls-Johannesma, Madelon, additional, Savulescu, Julian, additional, Short, Susan, additional, Skene, Loane, additional, Tsujii, Hirohiko, additional, Tuan, Jeffrey, additional, and Weijer, Charles, additional
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- 2013
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27. When is informed consent required in cluster randomized trials in health research?
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McRae, Andrew D, primary, Weijer, Charles, additional, Binik, Ariella, additional, Grimshaw, Jeremy M, additional, Boruch, Robert, additional, Brehaut, Jamie C, additional, Donner, Allan, additional, Eccles, Martin P, additional, Saginur, Raphael, additional, White, Angela, additional, and Taljaard, Monica, additional
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- 2011
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28. Who is the research subject in cluster randomized trials in health research?
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McRae, Andrew D, primary, Weijer, Charles, additional, Binik, Ariella, additional, White, Angela, additional, Grimshaw, Jeremy M, additional, Boruch, Robert, additional, Brehaut, Jamie C, additional, Donner, Allan, additional, Eccles, Martin P, additional, Saginur, Raphael, additional, Zwarenstein, Merrick, additional, and Taljaard, Monica, additional
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- 2011
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29. Minimal Risk Remains an Open Question
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Binik, Ariella, primary, Weijer, Charles, additional, and Sheehan, Mark, additional
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- 2011
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30. Does clinical equipoise apply to cluster randomized trials in health research?
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Binik, Ariella, primary, Weijer, Charles, additional, McRae, Andrew D, additional, Grimshaw, Jeremy M, additional, Boruch, Robert, additional, Brehaut, Jamie C, additional, Donner, Allan, additional, Eccles, Martin P, additional, Saginur, Raphael, additional, Taljaard, Monica, additional, and Zwarenstein, Merrick, additional
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- 2011
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31. Ethical issues posed by cluster randomized trials in health research
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Weijer, Charles, primary, Grimshaw, Jeremy M, additional, Taljaard, Monica, additional, Binik, Ariella, additional, Boruch, Robert, additional, Brehaut, Jamie C, additional, Donner, Allan, additional, Eccles, Martin P, additional, Gallo, Antonio, additional, McRae, Andrew D, additional, Saginur, Raphael, additional, and Zwarenstein, Merrick, additional
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- 2011
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32. Ethical and policy issues in cluster randomized trials: rationale and design of a mixed methods research study
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Taljaard, Monica, primary, Weijer, Charles, additional, Grimshaw, Jeremy M, additional, Belle Brown, Judith, additional, Binik, Ariella, additional, Boruch, Robert, additional, Brehaut, Jamie C, additional, Chaudhry, Shazia H, additional, Eccles, Martin P, additional, McRae, Andrew, additional, Saginur, Raphael, additional, Zwarenstein, Merrick, additional, and Donner, Allan, additional
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- 2009
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33. Iris Marion Young,On female body experience: “Throwing like a girl” and other essays(Oxford University Press, 2005)
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Binik, Ariella, primary
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- 2008
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34. On female body experience: “Throwing like a girl” and other essays, by Iris Marion Young
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Binik, Ariella, primary
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- 2008
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35. Why the Debate over Minimal Risk Needs to be Reconsidered.
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Binik, Ariella and Weijer, Charles
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CHILD research , *RISK , *RESEARCH ethics , *RISK assessment , *MEDICAL research ethics , *ETHICS - Abstract
Minimal risk is a central concept in the ethical analysis of research with children. It is defined as the risks “. . . ordinarily encountered in daily life . . . .” But the question arises: who is the referent for minimal risk? Commentators in the research ethics literature often answer this question by endorsing one of two possible interpretations: the uniform interpretation (which is also known as the absolute interpretation) or the relative interpretation of minimal risk. We argue that describing the debate over minimal risk as a disagreement between the uniform and the relative interpretation impedes progress on the identification of a justifiable referent for minimal risk. There are two main problems with this approach: (1) constructing the debate over minimal risk as a disagreement between a uniform and a relative interpretation misconstrues the main difference between competing interpretations and (2) neither the uniform nor the relative interpretation identifies one unique and consistent group of children as the referent for minimal risk. We conclude that progress on the debate over minimal risk requires that we abandon the uniform and relative interpretations and address the main moral problem at stake: whether healthy children or the subjects of the research should be the referent for minimal risk. [ABSTRACT FROM PUBLISHER]
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- 2014
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36. ON THE MINIMAL RISK THRESHOLD IN RESEARCH WITH CHILDREN.
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BINIK, ARIELLA
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EVERYDAY life , *CHILDREN'S health , *SOCIOECONOMIC factors , *CANCER chemotherapy , *HAPPINESS - Abstract
To protect children in research, procedures that are not administered in the medical interests of a child must be restricted. The risk threshold for these procedures is generally measured according to the concept of minimal risk. Minimal risk is often defined according to the risks of "daily life." But it is not clear whose daily life should serve as the baseline; that is, it is not clear to whom minimal risk should refer. Commentators in research ethics often argue that "minimal risk" should refer to healthy children or the subjects of the research. I argue that neither of these interpretations is successful. I propose a new interpretation in which minimal risk refers to children who are not unduly burdened by their daily lives. I argue that children are not unduly burdened when they fare well, and I defend a substantive goods account of children's welfare. [ABSTRACT FROM AUTHOR]
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- 2015
37. SARS-CoV-2 challenge studies: ethics and risk minimisation
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Bull, Susan, Jamrozik, Euzebiusz, Binik, Ariella, and Parker, Michael J
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COVID-19 poses an exceptional threat to global public health and well-being. Recognition of the need to develop effective vaccines at unprecedented speed has led to calls to accelerate research pathways ethically, including by conducting challenge studies (also known as controlled human infection studies (CHIs)) with SARS-CoV-2 (the virus which causes COVID-19). Such research is controversial, with concerns being raised about the social, legal, ethical and clinical implications of infecting healthy volunteers with SARS-CoV-2 for research purposes. Systematic risk evaluations are critical to inform assessments of the ethics of any proposed SARS-CoV-2 CHIs. Such evaluations will necessarily take place within a rapidly changing and at times contested epidemiological landscape, in which differing criteria for the ethical acceptability of research risks have been proposed. This paper critically reviews two such criteria and evaluates whether the use of effective treatment should be a necessary condition for the ethical acceptability of SARS-CoV-2 CHIs, and whether the choice of study sites should be influenced by COVID-19 incidence levels. The paper concludes that ethical evaluations of proposed SARS-CoV-2 CHIs should be informed by rigorous, consultative and holistic approaches to systematic risk assessment.
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- 2021
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38. Applying Bostrom's Reversal Test to check the Principle of Procreative Beneficence's major critiques for the Status Quo Bias
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Singh, Karanveer, Binik, Ariella, and Philosophy
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Bioethics - Abstract
Julian Savulescu believes parents have a moral duty to use reproductive technologies like IVF and Prenatal screening to choose the best possible child. According to his principle of Procreative Beneficence, one should select the best child of the possible children one could have. However, this principle has attracted numerous critiques from numerous authors. This paper aims to demonstrate that most critiques suffer from a status quo bias. It means that these critiques overly emphasize the possible negative outcomes concerning the principle of Procreative Beneficence because these critiques have an implicit affinity toward the status quo. The affinity for the status quo renders these critiques unable to appreciate the potential positive outcomes of applying the principle of Procreative Beneficence. Some authors argue that these critiques overemphasize the potential negative outcomes. I employ Nick Bostrom's Reversal Test to check these critiques for implicit Status Quo Bias. In Bostrom's Reversal Test, we consider the desired trait, often a positive deviation from the status quo. Suppose we find selecting the embryo with the desired trait ethically contentious. In that case, we imagine selecting an embryo that lacks that desired trait and is a negative deviation from the Status Quo. If we find the latter also problematic, we conclude that choosing the embryo with the desired trait seems ethically contentious because of our affinity to the Status Quo, also called the Status Quo Bias. The thesis accomplishes two tasks. First, it analyzes the various critiques for the Principle of Procreative Beneficence. Second and last, it employs Bostrom's Reversal Test to check these critiques for any potential Status Quo Bias and concludes that PPB’s primary critiques do indeed suffer from the Status Quo Bias. Thesis Candidate in Philosophy
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- 2023
39. EXAMINING THE RELATIONSHIP BETWEEN PUBLIC OPINION AND TRIAL DESIGN SELECTION
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Marshall, Benjamin D., Binik, Ariella, Sciaraffa, Stefan, and Philosophy
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Public Trust ,Human Challenge Vaccine Trials - Abstract
In a challenge trial, “healthy volunteers are intentionally exposed to pathogens in a controlled environment, in order to promote understanding of the pathogenesis, transmission, prevention and treatment of infectious diseases in humans.” (WHO 2021, Preface). Intentional infection is an uncomfortable concept, and as a result there is a widely held belief amongst research ethics scholars and commentators that a significant ethical concern with challenge trials is their potential to negatively impact the public’s trust in the institution of medical research (Eyal 2022, 4). However, the relationship between public trust and the ethics of conducting and assessing challenge trials is complex and existing literature on the subject does not sufficiently clarify it. This paper will begin by examining the ethical permissibility of challenge trials. Once these trials are shown to be ethically permissible under particular circumstances, I will explore how concerns about the way these trials allegedly exacerbate public mistrust largely result from ambiguities in the terms ‘public’ and ‘trust’. After both terms are defined, I will formulate my own account of how public trust should apply to a risk/benefit analysis for the purpose of trial design selection called the community engagement account, which argues that trial design selection policy should focus on demonstrating trustworthiness rather than garnering trust. Because demonstrating trustworthiness requires meeting a set of known expectations, this account identifies local, specific publics as those whose expectations should be of concern when discussing public trust and trial design selection. To examine the expectations of these publics, this account defends community engagement as the measure which should be used to acquire evidence of harmful public mistrust towards the institution of science that could potentially result from conducting a challenge trial. Thesis Candidate in Philosophy In a challenge trial, “healthy volunteers are intentionally exposed to [diseases] in a controlled environment,” to give researchers a better understanding of a disease in order to develop cures or preventative measures for it (WHO 2021, Preface). Many research ethics scholars believe that conducting challenge trials could negatively impact the public’s faith in the institution of medical research, but the relationship between public trust and conducting challenge trials is complex and existing literature on the subject does not sufficiently clarify it. This paper begins by exploring whether or not challenge trials can be ethically conducted. Once I show that they can be under particular circumstances, I examine how public trust concerns largely result from the fact that ‘public’ and ‘trust’ are not well defined. After defining them, I formulate my own account of how public trust should apply to a risk/benefit analysis for the purpose of trial design selection.
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- 2022
40. The Ethics of Heritable Non-Therapeutic Human Genome Editing
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Guerra, Enzo, Binik, Ariella, and Humanities
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genome editing ,sense organs ,ethics - Abstract
This thesis considers the moral permissibility of heritable non-therapeutic human genome editing. That is, genetic changes that seek to alter the genes of future generations for enhancement and aesthetic reasons. Some examples include genetic changes to muscle mass, cognitive abilities, eye colour, hair texture, skin colour, and so on. Given relevant moral considerations, I argue that the case against heritable non-therapeutic human genome editing is stronger than the case in favour. Thesis Master of Philosophy (MA)
- Published
- 2021
41. A Combined Approach to Vulnerability for Research Ethics
- Author
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Vaters, Jordan, Binik, Ariella, and Philosophy
- Subjects
Vulnerability ,Research Ethics ,Bioethics - Abstract
There is a problem associated with the concept of vulnerability for research ethics. This problem is that we must identify populations in need of additional protections while also delineating these protections. Some have argued that the concept is too nebulous to warrant use since an increasing number of individuals may be deemed vulnerable such that virtually everyone is vulnerable in some way. In opposition to this, many have argued that that the concept of vulnerability needs to be more specific. In this thesis, I evaluate the concept of vulnerability in a number of ways. I touch on rejections of the concept, the history of the concept though both research guidelines and research ethics and seek to explore a way forward to a more useable account of vulnerability. I argue that no current account of vulnerability is adequality able to address the challenging questions posed by research trials involving human participants. A persuasive account of vulnerability should (1) have a plausible/persuasive definition of vulnerability; (2) figure out what the application of a theory of vulnerability looks like; and (3) what obligations or duties are owed to the vulnerable (and who is responsible for fulfilling these duties). In order to address this, I propose the Combined approach to vulnerability. This approach defines vulnerability as an increased likelihood to incur additional or greater wrongs. The Combined approach functions like a taxonomy and categorizes vulnerability into three groups with the use of layers and restricts the application of these layers with its formal the definition of vulnerability. This thesis marks a new novel contribution to the field of research ethics, in the way of a new theory to vulnerability that emerges from the current literature and makes progress towards a more useful concept of duties and obligations owed to the vulnerable grounded communal engagement. Thesis Master of Arts (MA) Vulnerability as a concept is thoroughly debated in the field of research ethics. Some argue that the concept is useless, while others argue that the concept of vulnerability needs to be more specific about who it applies to and why. This thesis situates itself within the latter side of the debate. The Combined approach to vulnerability is my answer to this question. The Combined approach defines vulnerability as an increased likelihood to incur additional or greater wrongs. The Combined approach functions like a taxonomy and categorizes vulnerability into three groups (inherent layers, contextual layers, cascade layers) with the use of the metaphor of layers and restricts the application of these layers with its formal the definition of vulnerability. The main contributions of this approach are its novel combination as well as its new approach to the duties owed to the vulnerable.
- Published
- 2021
42. Position statement on ethics, equipoise and research on charged particle radiation therapy
- Author
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Piero Fossati, Steve Clarke, Jeffrey Tuan, Ken Peach, Michael Dunn, Michael Brada, Charles Weijer, Madelon Pijls-Johannesma, Steve Harris, Jonathan Ives, Julian Savulescu, Hirohiko Tsujii, Ariella Binik, Michael Parker, Adrian Crellin, Tony Hope, Alex John London, Michael Hocken, Mark Sheehan, Wilson Puthenparampil, Loane Skene, Neil G. Burnet, Sean Kehoe, Susan C Short, C. Timlin, Mark Lodge, Tadashi Kamada, Robert C. Miller, Sheehan, Mark, Timlin, Claire, Peach, Ken, Binik, Ariella, Wilson, Puthenparampil, and Weijer, Charles
- Subjects
Research design ,medicine.medical_specialty ,Health (social science) ,Consensus ,Consensus Development Conferences as Topic ,Alternative medicine ,Social issues ,Radiotherapy, High-Energy ,Arts and Humanities (miscellaneous) ,Neoplasms ,Medicine ,Humans ,Ethical Review ,Therapeutic Equipoise ,Research ethics ,research ,Evidence-Based Medicine ,business.industry ,Health Policy ,charged particle radiation therapy ,Radiotherapy Dosage ,Evidence-based medicine ,ethics ,equipoise ,Clinical trial ,Issues, ethics and legal aspects ,Treatment Outcome ,Research Design ,Practice Guidelines as Topic ,Engineering ethics ,business ,Medical ethics ,Ethics Committees, Research - Abstract
The use of charged-particle radiation therapy (CPRT) is an increasingly important development in the treatment of cancer. One of the most pressing controversies about the use of this technology is whether randomised controlled trials are required before this form of treatment can be considered to be the treatment of choice for a wide range of indications. Equipoise is the key ethical concept in determining which research studies are justified. However, there is a good deal of disagreement about how this concept is best understood and applied in the specific case of CPRT. This report is a position statement on these controversies that arises out of a workshop held at Wolfson College, Oxford in August 2011. The workshop brought together international leaders in the relevant fields (radiation oncology, medical physics, radiobiology, research ethics and methodology), including proponents on both sides of the debate, in order to make significant progress on the ethical issues associated with CPRT research. This position statement provides an ethical platform for future research and should enable further work to be done in developing international coordinated programmes of research. Refereed/Peer-reviewed
- Published
- 2014
43. Logistic, ethical, and political dimensions of stepped wedge trials: critical review and case studies.
- Author
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Prost A, Binik A, Abubakar I, Roy A, De Allegri M, Mouchoux C, Dreischulte T, Ayles H, Lewis JJ, and Osrin D
- Subjects
- Humans, Policy Making, Randomized Controlled Trials as Topic ethics, Randomized Controlled Trials as Topic legislation & jurisprudence, Therapeutic Equipoise, Workflow, Health Policy legislation & jurisprudence, Organizational Objectives, Patient Selection ethics, Randomized Controlled Trials as Topic methods, Research Design legislation & jurisprudence, Socioeconomic Factors
- Abstract
Background: Three arguments are usually invoked in favour of stepped wedge cluster randomised controlled trials: the logistic convenience of implementing an intervention in phases, the ethical benefit of providing the intervention to all clusters, and the potential to enhance the social acceptability of cluster randomised controlled trials. Are these alleged benefits real? We explored the logistic, ethical, and political dimensions of stepped wedge trials using case studies of six recent evaluations., Methods: We identified completed or ongoing stepped wedge evaluations using two systematic reviews. We then purposively selected six with a focus on public health in high, middle, and low-income settings. We interviewed their authors about the logistic, ethical, and social issues faced by their teams. Two authors reviewed interview transcripts, identified emerging issues through qualitative thematic analysis, reflected upon them in the context of the literature, and invited all participants to co-author the manuscript., Results: Our analysis raises three main points. First, the phased implementation of interventions can alleviate problems linked to simultaneous roll-out, but also brings new challenges. Issues to consider include the feasibility of organising intervention activities according to a randomised sequence, estimating time lags in implementation and effects, and accommodating policy changes during the trial period. Second, stepped wedge trials, like parallel cluster trials, require equipoise: without it, randomising participants to a control condition, even for a short time, remains problematic. In stepped wedge trials, equipoise is likely to lie in the degree of effect, effectiveness in a specific operational milieu, and the balance of benefit and harm, including the social value of better evaluation. Third, the strongest arguments for a stepped wedge design are logistic and political rather than ethical. The design is advantageous when simultaneous roll-out is impractical and when it increases the acceptability of using counterfactuals., Conclusions: The logistic convenience of phased implementation is context-dependent, and may be vitiated by the additional requirements of phasing. The potential for stepped wedge trials to enhance the social acceptability of cluster randomised trials is real, but their ethical legitimacy still rests on demonstrating equipoise and its configuration for each research question and setting.
- Published
- 2015
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