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  1. Co-design and implementation research: challenges and solutions for ethics committees.Felicity Goodyear-Smith, Claire Jackson & Trisha Greenhalgh - 2015 - BMC Medical Ethics 16 (1):1-5.
    BackgroundImplementation science research, especially when using participatory and co-design approaches, raises unique challenges for research ethics committees. Such challenges may be poorly addressed by approval and governance mechanisms that were developed for more traditional research approaches such as randomised controlled trials.DiscussionImplementation science commonly involves the partnership of researchers and stakeholders, attempting to understand and encourage uptake of completed or piloted research. A co-creation approach involves collaboration between researchers and end users from the onset, in question framing, research design and delivery, (...)
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  • Can UK NHS research ethics committees effectively monitor publication and outcome reporting bias?Rasheda Begum & Simon Kolstoe - 2015 - BMC Medical Ethics 16 (1):1-5.
    BackgroundPublication and outcome reporting bias is often caused by researchers selectively choosing which scientific results and outcomes to publish. This behaviour is ethically significant as it distorts the literature used for future scientific or clinical decision-making. This study investigates the practicalities of using ethics applications submitted to a UK National Health Service research ethics committee to monitor both types of reporting bias.MethodsAs part of an internal audit we accessed research ethics database records for studies submitting an end of study declaration (...)
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  • The Social Value of Health Research and the Worst Off.Nicola Barsdorf & Joseph Millum - 2017 - Bioethics 31 (2):105-115.
    In this article we argue that the social value of health research should be conceptualized as a function of both the expected benefits of the research and the priority that the beneficiaries deserve. People deserve greater priority the worse off they are. This conception of social value can be applied for at least two important purposes: in health research priority setting when research funders, policy-makers, or researchers decide between alternative research projects; and in evaluating the ethics of proposed research proposals (...)
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  • The Social Value of Knowledge and the Responsiveness Requirement for International Research.Danielle M. Wenner - 2017 - Bioethics 31 (2):97-104.
    Ethicists have long recognized that two necessary features of ethical research are scientific validity and social value. Yet despite a significant literature surrounding the validity component of this dictate, until recently there has been little attention paid to unpacking what the social value component might require. This article introduces a framework for assessing the social value of research, and in particular, for determining whether a given research program is likely to have significant social value of the kind necessary to fulfill (...)
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  • What enables ethically conducted clinical research in hospitals? Views of the administrative staff.Sanna-Maria Nurmi, Mari Kangasniemi, Arja Halkoaho & Anna-Maija Pietilä - 2016 - Clinical Ethics 11 (4):166-175.
    Background Administrative staff, including principal investigators, administrative managers, and elected officials, have a crucial role in ensuring the ethical conduct of the clinical research that occurs in their organisations. However, only few studies have focused on their perspectives. Aim This study describes the ethical aspects of clinical research from the perspectives of the administrative staff at university hospitals in Finland. Methods Qualitative data were collected with semi-structured face-to-face interviews, and subjected to content analysis. Results Four core perspectives emerged: human subject (...)
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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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  • In Defense of a Social Value Requirement for Clinical Research.David Wendler & Annette Rid - 2017 - Bioethics 31 (2):77-86.
    Many guidelines and commentators endorse the view that clinical research is ethically acceptable only when it has social value, in the sense of collecting data which might be used to improve health. A version of this social value requirement is included in the Declaration of Helsinki and the Nuremberg Code, and is codified in many national research regulations. At the same time, there have been no systematic analyses of why social value is an ethical requirement for clinical research. Recognizing this (...)
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  • A framework for risk-benefit evaluations in biomedical research.Annette Rid & David Wendler - 2011 - Kennedy Institute of Ethics Journal 21 (2):141-179.
    One of the key ethical requirements for biomedical research is that it have an acceptable risk-benefit profile (Emanuel, Wendler, and Grady 2000). The International Conference of Harmonization guidelines mandate that clinical trials should be initiated and continued only if “the anticipated benefits justify the risks” (1996). Guidelines from the Council for International Organizations of Medical Sciences state that biomedical research is acceptable only if the “potential benefits and risks are reasonably balanced” (2002). U.S. federal regulations require that the “risks to (...)
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  • Canadian research ethics board members’ attitudes toward benefits from clinical trials.Kori Cook, Jeremy Snyder & John Calvert - 2015 - BMC Medical Ethics 16 (1):1-7.
    BackgroundWhile ethicists have for many years called for human subject trial participants and, in some cases, local community members to benefit from participation in pharmaceutical and other intervention-based therapies, little is known about how these discussions are impacting the practice of research ethics boards that grant ethical approval to many of these studies.MethodsTelephone interviews were conducted with 23 REB members from across Canada, a major funder country for human subject research internationally. All interviews were digitally recorded and transcribed verbatim. After (...)
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  • The Social Value Requirement Reconsidered.Alan Wertheimer - 2014 - Bioethics 29 (5):301-308.
    It is widely assumed that it is ethical to conduct research with human subjects only if the research has social value. There are two standard arguments for this view. The allocation argument claims that public funds should not be devoted to research that lacks social value. The exploitation avoidance argument claims that subjects are exploited if research has no social value. The primary purpose of this article is to argue that these arguments do not succeed. The allocation argument has little (...)
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  • Philosophical justifications of informed consent in research.D. Brock, E. J. Emanuel, C. Grady, R. Lie, F. Miller & D. Wendler - 2008 - In Ezekiel J. Emanuel (ed.), The Oxford textbook of clinical research ethics. New York: Oxford University Press.
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  • The Social Value of Knowledge and International Clinical Research.Danielle M. Wenner - 2013 - Developing World Bioethics 15 (2):76-84.
    In light of the growth in the conduct of international clinical research in developing populations, this paper seeks to explore what is owed to developing world communities who host international clinical research. Although existing paradigms for assigning and assessing benefits to host communities offer valuable insight, I criticize their failure to distinguish between those benefits which can justify the conduct of research in a developing world setting and those which cannot. I argue that the justification for human subjects research is (...)
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  • Becoming partners, retaining autonomy: ethical considerations on the development of precision medicine.Alessandro Blasimme & Effy Vayena - 2016 - BMC Medical Ethics 17 (1):67.
    Precision medicine promises to develop diagnoses and treatments that take individual variability into account. According to most specialists, turning this promise into reality will require adapting the established framework of clinical research ethics, and paying more attention to participants’ attitudes towards sharing genotypic, phenotypic, lifestyle data and health records, and ultimately to their desire to be engaged as active partners in medical research.Notions such as participation, engagement and partnership have been introduced in bioethics debates concerning genetics and large-scale biobanking to (...)
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  • Involving Communities in Deciding What Benefits They Receive in Multinational Research.David Wendler & Seema Shah - 2015 - Journal of Medicine and Philosophy 40 (5):584-600.
    There is wide agreement that communities in lower-income countries should benefit when they participate in multinational research. Debate now focuses on how and to what extent these communities should benefit. This debate has identified compelling reasons to reject the claim that whatever benefits a community agrees to accept are necessarily fair. Yet, those who conduct clinical research may conclude from this rejection that there is no reason to involve communities in the process of deciding how they benefit. Against this possibility, (...)
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  • Conflicts of Interest.Dennis F. Thompson & E. Emmanuel - 2008 - In Ezekiel J. Emanuel (ed.), The Oxford textbook of clinical research ethics. New York: Oxford University Press.
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  • The social value of clinical research.Michelle Gjl Habets, Johannes Jm van Delden & AnneLien L. Bredenoord - 2014 - BMC Medical Ethics 15 (1):66.
    International documents on ethical conduct in clinical research have in common the principle that potential harms to research participants must be proportional to anticipated benefits. The anticipated benefits that can justify human research consist of direct benefits to the research participant, and societal benefits, also called social value. In first-in-human research, no direct benefits are expected and the benefit component of the risks-benefit assessment thus merely exists in social value. The concept social value is ambiguous by nature and is used (...)
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  • Defining and Negotiating the Social Value of Research in Public Health Facilities: Perceptions of Stakeholders in a Research‐Active Province of South Africa.Elizabeth Lutge, Catherine Slack & Douglas Wassenaar - 2017 - Bioethics 31 (2):128-135.
    This article reports on qualitative research conducted in KwaZulu-Natal, South Africa, among researchers and gate-keepers of health facilities in the province. Results suggest disparate but not irreconcilable perceptions of the social value of research in provincial health facilities. This study found that researchers tended to emphasize the contribution of research to the generation of knowledge and to the health of future patients while gate-keepers of health facilities tended to emphasize its contribution to the healthcare system and to current patients. Furthermore, (...)
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  • Research partnerships between high and low-income countries: are international partnerships always a good thing?John D. Chetwood, Nimzing G. Ladep & Simon D. Taylor-Robinson - 2015 - BMC Medical Ethics 16 (1):1-5.
    BackgroundInternational partnerships in research are receiving ever greater attention, given that technology has diminished the restriction of geographical barriers with the effects of globalisation becoming more evident, and populations increasingly more mobile.DiscussionIn this article, we examine the merits and risks of such collaboration even when strict universal ethical guidelines are maintained. There has been widespread examples of outcomes beneficial and detrimental for both high and low –income countries which are often initially unintended.SummaryThe authors feel that extreme care and forethought should (...)
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  • Substantiating the Social Value Requirement for Research: An Introduction.Annette Rid & Seema K. Shah - 2017 - Bioethics 31 (2):72-76.
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