Results for 'Biomedical Research'

992 found
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  1.  54
    Causal Inference in Biomedical Research.Tudor M. Baetu - 2020 - Biology and Philosophy 35 (4):1-19.
    Current debates surrounding the virtues and shortcomings of randomization are symptomatic of a lack of appreciation of the fact that causation can be inferred by two distinct inference methods, each requiring its own, specific experimental design. There is a non-statistical type of inference associated with controlled experiments in basic biomedical research; and a statistical variety associated with randomized controlled trials in clinical research. I argue that the main difference between the two hinges on the satisfaction of the (...)
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  2. The Obligation to Participate in Biomedical Research.G. Owen Schaefer, Ezekiel J. Emanuel & Alan Wertheimer - 2009 - Journal of the American Medical Association 302 (1):67-72.
    The current prevailing view is that participation in biomedical research is above and beyond the call of duty. While some commentators have offered reasons against this, we propose a novel public goods argument for an obligation to participate in biomedical research. Biomedical knowledge is a public good, available to any individual even if that individual does not contribute to it. Participation in research is a critical way to support an important public good. Consequently, all (...)
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  3.  74
    A Comparative Analysis of Biomedical Research Ethics Regulation Systems in Europe and Latin America with Regard to the Protection of Human Subjects.E. Lamas, M. Ferrer, A. Molina, R. Salinas, A. Hevia, A. Bota, D. Feinholz, M. Fuchs, R. Schramm, J. -C. Tealdi & S. Zorrilla - 2010 - Journal of Medical Ethics 36 (12):750-753.
    The European project European and Latin American Systems of Ethics Regulation of Biomedical Research Project (EULABOR) has carried out the first comparative analysis of ethics regulation systems for biomedical research in seven countries in Europe and Latin America, evaluating their roles in the protection of human subjects. We developed a conceptual and methodological framework defining ‘ethics regulation system for biomedical research’ as a set of actors, institutions, codes and laws involved in overseeing the ethics (...)
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  4. The Practical Implications of the New Metaphysics of Race for a Postracial Medicine: Biomedical Research Methodology, Institutional Requirements, Patient–Physician Relations.Joanna K. Malinowska & Tomasz Żuradzki - 2017 - American Journal of Bioethics 17 (9):61-63.
    Perez-Rodriguez and de la Fuente (2017) assume that although human races do not exist in a biological sense (“geneticists and evolutionary biologists generally agree that the division of humans into races/subspecies has no defensible scientific basis,” they exist only as “sociocultural constructions” and because of that maintain an illusory reality, for example, through “racialized” practices in medicine. Agreeing with the main postulates formulated in the article, we believe that the authors treat this problem in a superficial manner and have failed (...)
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  5. Run the Experiment, Publish the Study, Close the Sale: Commercialized Biomedical Research.Aleta Quinn - 2016 - De Ethica 2 (3):5-21.
    Business models for biomedical research prescribe decentralization due to market selection pressures. I argue that decentralized biomedical research does not match four normative philosophical models of the role of values in science. Non-epistemic values affect the internal stages of for-profit biomedical science. Publication planning, effected by Contract Research Organizations, inhibits mechanisms for transformative criticism. The structure of contracted research precludes attribution of responsibility for foreseeable harm resulting from methodological choices. The effectiveness of business (...)
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  6. Analytic Philosophy for Biomedical Research: The Imperative of Applying Yesterday's Timeless Messages to Today's Impasses.Sepehr Ehsani - 2020 - In P. Glauner & P. Plugmann (eds.), Innovative Technologies for Market Leadership - Investing in the Future. Springer. pp. 167-200.
    The mantra that "the best way to predict the future is to invent it" (attributed to the computer scientist Alan Kay) exemplifies some of the expectations from the technical and innovative sides of biomedical research at present. However, for technical advancements to make real impacts both on patient health and genuine scientific understanding, quite a number of lingering challenges facing the entire spectrum from protein biology all the way to randomized controlled trials should start to be overcome. The (...)
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  7. Pharmacogenomic Inequalities: Strategies for Justice in Biomedical Research and Healthcare.Giovanni De Grandis - 2017 - Diametros 51:153-172.
    The paper discusses the possibility that the benefits of pharmacogenomics will not be distributed equally and will create orphan populations. I argue that since these inequalities are not substantially different from those produced by ‘traditional’ drugs and are not generated with the intention to discriminate, their production needs not be unethical. Still, the final result is going against deep-seated moral feelings and intuitions, as well as broadly accepted principles of just distribution of health outcomes and healthcare. I thus propose two (...)
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  8.  86
    Ontology as the Core Discipline of Biomedical Informatics: Legacies of the Past and Recommendations for the Future Direction of Research.Barry Smith & Werner Ceusters - 2007 - In Gordana Dodig Crnkovic & Susan Stuart (eds.), Computation, Information, Cognition: The Nexus and the Liminal. Cambridge Scholars Publishing. pp. 104-122.
    The automatic integration of rapidly expanding information resources in the life sciences is one of the most challenging goals facing biomedical research today. Controlled vocabularies, terminologies, and coding systems play an important role in realizing this goal, by making it possible to draw together information from heterogeneous sources – for example pertaining to genes and proteins, drugs and diseases – secure in the knowledge that the same terms will also represent the same entities on all occasions of use. (...)
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  9. Towards a Reference Terminology for Ontology Research and Development in the Biomedical Domain.Barry Smith, Waclaw Kusnierczyk, Daniel Schober, & Werner Ceusters - 2006 - In Proceedings of KR-MED, CEUR, vol. 222. pp. 57-65.
    Ontology is a burgeoning field, involving researchers from the computer science, philosophy, data and software engineering, logic, linguistics, and terminology domains. Many ontology-related terms with precise meanings in one of these domains have different meanings in others. Our purpose here is to initiate a path towards disambiguation of such terms. We draw primarily on the literature of biomedical informatics, not least because the problems caused by unclear or ambiguous use of terms have been there most thoroughly addressed. We advance (...)
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  10. The Ontology for Biomedical Investigations.Anita Bandrowski, Ryan Brinkman, Mathias Brochhausen, Matthew H. Brush, Bill Bug, Marcus C. Chibucos, Kevin Clancy, Mélanie Courtot, Dirk Derom, Michel Dumontier, Liju Fan, Jennifer Fostel, Gilberto Fragoso, Frank Gibson, Alejandra Gonzalez-Beltran, Melissa A. Haendel, Yongqun He, Mervi Heiskanen, Tina Hernandez-Boussard, Mark Jensen, Yu Lin, Allyson L. Lister, Phillip Lord, James Malone, Elisabetta Manduchi, Monnie McGee, Norman Morrison, James A. Overton, Helen Parkinson, Bjoern Peters, Philippe Rocca-Serra, Alan Ruttenberg, Susanna-Assunta Sansone, Richard H. Scheuermann, Daniel Schober, Barry Smith, Larisa N. Soldatova, Christian J. Stoeckert, Chris F. Taylor, Carlo Torniai, Jessica A. Turner, Randi Vita, Patricia L. Whetzel & Jie Zheng - 2016 - PLoS ONE 11 (4):e0154556.
    The Ontology for Biomedical Investigations (OBI) is an ontology that provides terms with precisely defined meanings to describe all aspects of how investigations in the biological and medical domains are conducted. OBI re-uses ontologies that provide a representation of biomedical knowledge from the Open Biological and Biomedical Ontologies (OBO) project and adds the ability to describe how this knowledge was derived. We here describe the state of OBI and several applications that are using it, such as adding (...)
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  11. The Ethics of Biomedical Military Research: Therapy, Prevention, Enhancement, and Risk.Alexandre Erler & Vincent C. Müller - 2021 - In Daniel Messelken & David Winkler (eds.), Health care in contexts of risk, uncertainty, and hybridity. Berlin: Springer. pp. 235-252.
    What proper role should considerations of risk, particularly to research subjects, play when it comes to conducting research on human enhancement in the military context? We introduce the currently visible military enhancement techniques (1) and the standard discussion of risk for these (2), in particular what we refer to as the ‘Assumption’, which states that the demands for risk-avoidance are higher for enhancement than for therapy. We challenge the Assumption through the introduction of three categories of enhancements (3): (...)
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  12. Protein-Centric Connection of Biomedical Knowledge: Protein Ontology Research and Annotation Tools.Cecilia N. Arighi, Darren A. Natale, Judith A. Blake, Carol J. Bult, Michael Caudy, Alexander D. Diehl, Harold J. Drabkin, Peter D'Eustachio, Alexei Evsikov, Hongzhan Huang, Barry Smith & Others - 2011 - In Proceedings of the 2nd International Conference on Biomedical Ontology. Buffalo, NY: NCOR. pp. 285-287.
    The Protein Ontology (PRO) web resource provides an integrative framework for protein-centric exploration and enables specific and precise annotation of proteins and protein complexes based on PRO. Functionalities include: browsing, searching and retrieving, terms, displaying selected terms in OBO or OWL format, and supporting URIs. In addition, the PRO website offers multiple ways for the user to request, submit, or modify terms and/or annotation. We will demonstrate the use of these tools for protein research and annotation.
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  13. Creating a Controlled Vocabulary for the Ethics of Human Research: Towards a Biomedical Ethics Ontology.David Koepsell, Robert Arp, Jennifer Fostel & Barry Smith - 2009 - Journal of Empirical Research on Human Research Ethics 4 (1):43-58.
    Ontologies describe reality in specific domains in ways that can bridge various disciplines and languages. They allow easier access and integration of information that is collected by different groups. Ontologies are currently used in the biomedical sciences, geography, and law. A Biomedical Ethics Ontology would benefit members of ethics committees who deal with protocols and consent forms spanning numerous fields of inquiry. There already exists the Ontology for Biomedical Investigations (OBI); the proposed BMEO would interoperate with OBI, (...)
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  14. National Center for Biomedical Ontology: Advancing Biomedicine Through Structured Organization of Scientific Knowledge.Daniel L. Rubin, Suzanna E. Lewis, Chris J. Mungall, Misra Sima, Westerfield Monte, Ashburner Michael, Christopher G. Chute, Ida Sim, Harold Solbrig, M. A. Storey, Barry Smith, John D. Richter, Natasha Noy & Mark A. Musen - 2006 - Omics: A Journal of Integrative Biology 10 (2):185-198.
    The National Center for Biomedical Ontology is a consortium that comprises leading informaticians, biologists, clinicians, and ontologists, funded by the National Institutes of Health (NIH) Roadmap, to develop innovative technology and methods that allow scientists to record, manage, and disseminate biomedical information and knowledge in machine-processable form. The goals of the Center are (1) to help unify the divergent and isolated efforts in ontology development by promoting high quality open-source, standards-based tools to create, manage, and use ontologies, (2) (...)
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  15. The National Center for Biomedical Ontology.Mark A. Musen, Natalya F. Noy, Nigam H. Shah, Patricia L. Whetzel, Christopher G. Chute, Margaret-Anne Story & Barry Smith - 2012 - Journal of the American Medical Informatics Association 19 (2):190-195.
    The National Center for Biomedical Ontology is now in its seventh year. The goals of this National Center for Biomedical Computing are to: create and maintain a repository of biomedical ontologies and terminologies; build tools and web services to enable the use of ontologies and terminologies in clinical and translational research; educate their trainees and the scientific community broadly about biomedical ontology and ontology-based technology and best practices; and collaborate with a variety of groups who (...)
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  16.  57
    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 (...)
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  17.  38
    Normative Framework of Informed Consent in Clinical Research in Germany, Poland, and Russia.Marcin Orzechowski, Katarzyna Woniak, Cristian Timmermann & Florian Steger - 2021 - BMC Medical Ethics 22 (1):1-10.
    Background: Biomedical research nowadays is increasingly carried out in multinational and multicenter settings. Due to disparate national regulations on various ethical aspects, such as informed consent, there is the risk of ethical compromises when involving human subjects in research. Although the Declaration of Helsinki is the point of reference for ethical conduct of research on humans, national normative requirements may diverge from its provisions. The aim of this research is to examine requirements on informed consent (...)
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  18.  92
    A Unified Framework for Biomedical Terminologies and Ontologies.Werner Ceusters & Barry Smith - 2010 - Studies in Health Technology and Informatics 160:1050-1054.
    The goal of the OBO (Open Biomedical Ontologies) Foundry initiative is to create and maintain an evolving collection of non-overlapping interoperable ontologies that will offer unambiguous representations of the types of entities in biological and biomedical reality. These ontologies are designed to serve non-redundant annotation of data and scientific text. To achieve these ends, the Foundry imposes strict requirements upon the ontologies eligible for inclusion. While these requirements are not met by most existing biomedical terminologies, the latter (...)
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  19. Publication Ethics in Biomedical Journals From Countries in Central and Eastern Europe.Mindaugas Broga, Goran Mijaljica, Marcin Waligora, Aime Keis & Ana Marusic - 2013 - Science and Engineering Ethics (1):1-11.
    Publication ethics is an important aspect of both the research and publication enterprises. It is particularly important in the field of biomedical science because published data may directly affect human health. In this article, we examine publication ethics policies in biomedical journals published in Central and Eastern Europe. We were interested in possible differences between East European countries that are members of the European Union (Eastern EU) and South-East European countries (South-East Europe) that are not members of (...)
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  20.  75
    Philosophy and Biomedical Information Systems.Barry Smith & Bert Klagges - 2008 - In Katherine Munn & Barry Smith (eds.), Applied Ontology: An Introduction. Ontos. pp. 17-30.
    The pathbreaking scientific advances of recent years call for a new philosophical consideration of the fundamental categories of biology and its neighboring disciplines. Above all, the new information technologies used in biomedical research, and the necessity to master the continuously growing flood of data that is associated therewith, demand a profound and systematic reflection on the systematization and classification of biological data. This, however, demands robust theories of basic concepts such as kind, species, part, whole, function, process, fragment, (...)
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  21. The Environment Ontology: Contextualising Biological and Biomedical Entities.Pier Luigi Buttigieg, Norman Morrison, Barry Smith, Christopher J. Mungall & Suzanna E. Lewis - 2013 - Journal of Biomedical Semantics 4 (43):1-9.
    As biological and biomedical research increasingly reference the environmental context of the biological entities under study, the need for formalisation and standardisation of environment descriptors is growing. The Environment Ontology (ENVO) is a community-led, open project which seeks to provide an ontology for specifying a wide range of environments relevant to multiple life science disciplines and, through an open participation model, to accommodate the terminological requirements of all those needing to annotate data using ontology classes. This paper summarises (...)
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  22. Advance Research Directives in Germany: A Proposal for a Disclosure Standard.Matthé Scholten - 2018 - GeroPsych: The Journal of Gerontopsychology and Geriatric Psychiatry 31 (2):77-86.
    The fourth amendment to the German Medicinal Products Act (Arzneimittelgesetz) states that nontherapeutic research in incompetent populations is permissible under the condition that potential research participants expressly declare their wish to participate in scientific research in an advance research directive. This article explores the implementation of advance research directives in Germany against the background of the international legal and ethical framework for biomedical research. In particular, it addresses a practical problem that arises from (...)
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  23. Classificatory Theory in Data-Intensive Science: The Case of Open Biomedical Ontologies.Sabina Leonelli - 2012 - International Studies in the Philosophy of Science 26 (1):47 - 65.
    Knowledge-making practices in biology are being strongly affected by the availability of data on an unprecedented scale, the insistence on systemic approaches and growing reliance on bioinformatics and digital infrastructures. What role does theory play within data-intensive science, and what does that tell us about scientific theories in general? To answer these questions, I focus on Open Biomedical Ontologies, digital classification tools that have become crucial to sharing results across research contexts in the biological and biomedical sciences, (...)
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  24.  84
    Theorizing Participatory Research.Andrew Evans & Angela Potochnik - forthcoming - In Emily Anderson (ed.), Ethical Issues in Stakeholder-Engaged Health Research. Springer.
    A wide variety of scientific research projects include public participation in roles going beyond the classic use of subjects in human subjects research. “Participatory research” is an umbrella term for such projects. In this chapter, we begin by surveying the variety of participatory research approaches across fields. We examine what goals participatory research projects seek to achieve, both of social and scientific value. Next, we apply this theoretical framework to challenges that participatory research faces. (...)
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  25.  62
    The Nobel Prize as a Reward Mechanism in the Genomics Era: Anonymous Researchers, Visible Managers and the Ethics of Excellence. [REVIEW]Hub Zwart - 2010 - Journal of Bioethical Inquiry 7 (3):299-312.
    The Human Genome Project is regarded by many as one of the major scientific achievements in recent science history, a large-scale endeavour that is changing the way in which biomedical research is done and expected, moreover, to yield considerable benefit for society. Thus, since the completion of the human genome sequencing effort, a debate has emerged over the question whether this effort merits to be awarded a Nobel Prize and if so, who should be the one to receive (...)
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  26.  66
    Ethical Issues in Genomics Research on Neurodevelopmental Disorders: A Critical Interpretive Review.Signe Mezinska, L. Gallagher, M. Verbrugge & E. M. Bunnik - 2021 - Human Genomics 16 (15).
    Background Genomic research on neurodevelopmental disorders (NDDs), particularly involving minors, combines and amplifies existing research ethics issues for biomedical research. We performed a review of the literature on the ethical issues associated with genomic research involving children affected by NDDs as an aid to researchers to better anticipate and address ethical concerns. Results Qualitative thematic analysis of the included articles revealed themes in three main areas: research design and ethics review, inclusion of research (...)
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  27. The National Center for Biomedical Ontology: Advancing Biomedicine Through Structured Organization of Scientific Knowledge. Rubin - 2012 - Journal of the American Medical Informatics Association 19 (2):190-195.
    The National Center for Biomedical Ontology is now in its seventh year. The goals of this National Center for Biomedical Computing are to: create and maintain a repository of biomedical ontologies and terminologies; build tools and web services to enable the use of ontologies and terminologies in clinical and translational research; educate their trainees and the scientific community broadly about biomedical ontology and ontology-based technology and best practices; and collaborate with a variety of groups who (...)
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  28.  63
    Non-Epistemological Values in Collaborative Research in Neuroscience: The Case of Alleged Differences Between Human Populations.Joanna K. Malinowska & Tomasz Żuradzki - 2020 - American Journal of Bioethics Neuroscience 11 (3):203-206.
    The goals and tasks of neuroethics formulated by Farahany and Ramos (2020) link epistemological and methodological issues with ethical and social values. The authors refer simultaneously to the social significance and scientific reliability of the BRAIN Initiative. They openly argue that neuroethics should not only examine neuroscientific research in terms of “a rigorous, reproducible, and representative neuroscience research process” as well as “explore the unique nature of the study of the human brain through accurate and representative models of (...)
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  29. Respect the Author: A Research Ethical Principle for Readers.Jesper Ahlin Marceta - 2019 - Journal of Academic Ethics 19 (2):175-185.
    Much of contemporary research ethics was developed in the latter half of the twentieth century as a response to the unethical treatment of human beings in biomedical research. Research ethical considerations have subsequently been extended to cover topics in the sciences and technology such as data handling, precautionary measures, engineering codes of conduct, and more. However, moral issues in the humanities have gained less attention from research ethicists. This article proposes an ethical principle for reading (...)
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  30. The evaluation of scientific research in democratic societies: Kitcher, Rawls and the approach of scientific significant truths.Ignacio Mastroleo - 2011 - Revista Redbioética/UNESCO 2 (4):43-60.
    This paper critically assesses the model of evaluation of scientific research for democratic societies defended by Philip Kitcher. The “significant truth” approach proposes a viable alternative to two classic images of science: that of the “critics”, who believe that science always serves the interests of the powerful and that of the “faithful”, who argue that the pursuit of scientific knowledge is always valuable and necessary. However, the democratic justification of Kitcher’s proposal is not compatible with the ethical problems generated (...)
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  31. Negative Findings in Electronic Health Records and Biomedical Ontologies: A Realist Approach.Werner Ceusters, Peter Elkin & Barry Smith - 2007 - International Journal of Medical Informatics 76 (3):S326-S333.
    PURPOSE—A substantial fraction of the observations made by clinicians and entered into patient records are expressed by means of negation or by using terms which contain negative qualifiers (as in “absence of pulse” or “surgical procedure not performed”). This seems at first sight to present problems for ontologies, terminologies and data repositories that adhere to a realist view and thus reject any reference to putative non-existing entities. Basic Formal Ontology (BFO) and Referent Tracking (RT) are examples of such paradigms. The (...)
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  32. Deception in Social Science Research: Is Informed Consent Possible?Alan Soble - 1978 - Hastings Center Report 8 (5):40-46.
    Deception of subjects is used frequently in the social sciences. Examples are provided. The ethics of experimental deception are discussed, in particular various maneuvers to solve the problem. The results have implications for the use of deception in the biomedical sciences.
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  33. Exempting All Minimal-Risk Research From IRB Review: Pruning or Poisoning the Regulatory Tree?Mahesh Ananth & Mike Scheessele - 2012 - IRB: Ethics & Human Research 34 (2):9-14.
    In a recent commentary, Kim and colleagues argued that minimal-risk research should be deregulated so that such studies do not require review by an institutional review board. They claim that regulation of minimal-risk studies provides no adequate counterbalancing good and instead leads to a costly human subjects oversight system. We argue that the counterbalancing good of regulating minimal-risk studies is that oversight exists to ensure that respect for persons and justice requirements are satisfied when they otherwise might not be.
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  34. Should Research Ethics Encourage the Production of Cost-Effective Interventions?Govind Persad - 2016 - In Daniel Strech & Marcel Mertz (eds.), Ethics and Governance of Biomedical Research: Theory and Practice. Springer. pp. 13-28.
    This project considers whether and how research ethics can contribute to the provision of cost-effective medical interventions. Clinical research ethics represents an underexplored context for the promotion of cost-effectiveness. In particular, although scholars have recently argued that research on less-expensive, less-effective interventions can be ethical, there has been little or no discussion of whether ethical considerations justify curtailing research on more expensive, more effective interventions. Yet considering cost-effectiveness at the research stage can help ensure that (...)
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  35.  27
    Toward an Anti-Maleficent Research Agenda.Hope Ferdowsian, Agustin Fuentes, L. Syd M. Johnson, Barbara J. King & Jessica Pierce - 2022 - Cambridge Quarterly of Healthcare Ethics 31 (1):54-58.
    Important advances in biomedical and behavioral research ethics have occurred over the past few decades, many of them centered on identifying and eliminating significant harms to human subjects of research. Comprehensive attention has not been paid to the totality of harms experienced by animal subjects, although scientific and moral progress require explicit appraisal of these harms. Science is a public good and the prioritizing within, conduct of, generation of, and application of research must soundly address questions (...)
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  36. The Historical Foundations of the Research-Practice Distinction in Bioethics.Tom L. Beauchamp & Yashar Saghai - 2012 - Heoretical Medicine and Bioethics 33 (1):45-56.
    The distinction between clinical research and clinical practice directs how we partition medicine and biomedical science. Reasons for a sharp distinction date historically to the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, especially to its analysis of the “boundaries” between research and practice in the Belmont Report (1978). Belmont presents a segregation model of the research-practice distinction, according to which research and practice form conceptually (...)
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  37. Coordinating Coronavirus Research: The COVID-19 Infectious Disease Ontology.John Beverley, Shane Babcock, Gustavo Carvalho, Lindsay Cowell, Sebastian Duesing, Regina Hurley & Barry Smith - 2020 - Open Science Foundation Preprints.
    Rapidly, accurately and easily interpreting generated data is of fundamental concern. Ontologies – structured controlled vocabularies – support interoperability and prevent the development of data silos which undermine interoperability. The Open Biological and Biomedical Ontologies (OBO) Foundry serves to ensure ontologies remain interoperable through adherence by its members to core ontology design principles. For example, the Infectious Disease Ontology (IDO) Core includes terminological content common to investigations of all infectious diseases. Ontologies covering more specific infectious diseases in turn extend (...)
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  38.  37
    Adapt to Translate – Adaptive Clinical Trials and Biomedical Innovation.Daria Jadreškić - 2021 - European Journal of Analytic Philosophy 17 (2):(SI3)5-24.
    The article presents the advantages and limitations of adaptive clinical trials for assessing the effectiveness of medical interventions and specifies the conditions that contributed to their development and implementation in clinical practice. I advance two arguments by discussing different cases of adaptive trials. The normative argument is that responsible adaptation should be taken seriously as a new way of doing clinical research insofar as a valid justification, sufficient understanding, and adequate operational conditions are provided. The second argument is historical. (...)
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  39. Establishing and Harmonizing Ontologies in an Interdisciplinary Health Care and Clinical Research Environment.Barry Smith & Mathias Brochhausen - 2008 - Studies in Health, Technology and Informatics 134:219-234.
    Ontologies are being ever more commonly used in biomedical informatics and we provide a survey of some of these uses, and of the relations between ontologies and other terminology resources. In order for ontologies to become truly useful, two objectives must be met. First, ways must be found for the transparent evaluation of ontologies. Second, existing ontologies need to be harmonised. We argue that one key foundation for both ontology evaluation and harmonisation is the adoption of a realist paradigm (...)
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  40. Addressing the 'Global Basic Structure' in the Ethics of International Health Research Involving Human Subjects.Janet Borgerson - 2005 - Journal of Philosophical Research 30 (9999):235-249.
    The context of international health research involving human subjects, and this should appear obvious, is the human community. As such, basic questions of how human beings should be treated by other human beings, particularly in situations of unequal power – e.g., in the form of control, choice, or opportunity – lay at the foundations of related ethical discourse when ethics are discussed at all. I trace a narrative that follows upon a recent revision process of international guidelines for (...) research involving human subjects. I focus in particular upon the issue of a standard of care. In the second section, I draw upon philosophers John Rawls, Claudia Card, and Allen Buchanan to discuss concerns regarding the 'least advantaged members of society' in the context of global inequality. The paper includes reflections upon pedagogy in courses focused upon international health research involving human subjects. (shrink)
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  41. Neuroethics 1995–2012. A Bibliometric Analysis of the Guiding Themes of an Emerging Research Field.Jon Leefmann, Clement Levallois & Elisabeth Hildt - 2016 - Frontiers in Human Neuroscience 10.
    In bioethics, the first decade of the twenty-first century was characterized by the emergence of interest in the ethical, legal, and social aspects of neuroscience research. At the same time an ongoing extension of the topics and phenomena addressed by neuroscientists was observed alongside its rise as one of the leading disciplines in the biomedical science. One of these phenomena addressed by neuroscientists and moral psychologists was the neural processes involved in moral decision-making. Today both strands of (...) are often addressed under the label of neuroethics. To understand this development we recalled literature from 1995 to 2012 stored in the Mainz Neuroethics Database (i) to investigate the quantitative development of scientific publications in neuroethics; (ii) to explore changes in the topics of neuroethics research within the defined time interval; (iii) to illustrate the interdependence of different research topics within the neuroethics literature; (iv) to show the development of the distribution of neuroethics research on peer-reviewed journals; and (v) to display the academic background and affiliations of neuroethics Researchers ... (shrink)
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  42. Hormone Research as an Exemplar of Underdetermination.P. D. Magnus - 2005 - Studies in History and Philosophy of Science Part C: Studies in History and Philosophy of Biological and Biomedical Sciences 36 (3):559-567.
    Debates about the underdetermination of theory by data often turn on specific examples. Cases invoked often enough become familiar, even well worn. Since Helen Longino’s discussion of the case, the connection between prenatal hormone levels and gender-linked childhood behaviour has become one of these stock examples. However, as I argue here, the case is not genuinely underdetermined. We can easily imagine a possible experiment to decide the question. The fact that we would not perform this experiment is a moral, rather (...)
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  43. Between “Research” and “Innovative Therapy”: An Unsettled Moral Dilemma in the Muizelaar Case.Norman Swazo - manuscript
    Introduction In 2013, Dr. J. Muizelaar and Dr. R. Schrot, two neurosurgeons at the University of California Davis Medical Center (UCDMC), were found guilty of research misconduct due to failure to comply with institutional policies as well as Food and Drug Administration (FDA) regulations governing human subjects research. At issue here, however, is the difference between research and innovative therapy in the clinical setting of patient care where clinical judgment is reasonably to be privileged. Methods The UCDMC (...)
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  44. From Metagenomics to the Metagenome: Conceptual Change and the Rhetoric of Translational Genomic Research.Eric Thomas Juengst & John Edward Huss - 2009 - Genomics, Society, and Policy 5 (3):1-19.
    As the international genomic research community moves from the tool-making efforts of the Human Genome Project into biomedical applications of those tools, new metaphors are being suggested as useful to understanding how our genes work – and for understanding who we are as biological organisms. In this essay we focus on the Human Microbiome Project as one such translational initiative. The HMP is a new ‘metagenomic’ research effort to sequence the genomes of human microbiological flora, in order (...)
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  45. Special Section: Moving Forward in Animal Research Ethics Guest Editorial Reassessing Animal Research Ethics.David DeGrazia - 2015 - Cambridge Quarterly of Healthcare Ethics 24 (4):385-389.
    Animal research has long been a source of biomedical aspirations and moral concern. Examples of both hope and concern are abundant today. In recent months, as is common practice, monkeys have served as test subjects in promising preclinical trials for an Ebola vaccine or treatment 1 , 2 , 3 and in controversial maternal deprivation studies. 4 The unresolved tension between the noble aspirations of animal research and the ethical controversies it often generates motivates the present issue (...)
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  46. Disciplinary Capture and Epistemological Obstacles to Interdisciplinary Research: Lessons From Central African Conservation Disputes.Evelyn Brister - 2016 - Studies in History and Philosophy of Science Part C: Studies in History and Philosophy of Biological and Biomedical Sciences 56:82-91.
    Complex environmental problems require well-researched policies that integrate knowledge from both the natural and social sciences. Epistemic differences can impede interdisciplinary collaboration, as shown by debates between conservation biologists and anthropologists who are working to preserve biological diversity and support economic development in central Africa. Disciplinary differences with regard to 1) facts, 2) rigor, 3) causal explanation, and 4) research goals reinforce each other, such that early decisions about how to define concepts or which methods to adopt may tilt (...)
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  47. Is It Possible to Give Scientific Solutions to Grand Challenges? On the Idea of Grand Challenges for Life Science Research.Sophia Efstathiou - 2016 - Studies in History and Philosophy of Science Part C: Studies in History and Philosophy of Biological and Biomedical Sciences 56:46-61.
    This paper argues that challenges that are grand in scope such as "lifelong health and wellbeing", "climate action", or "food security" cannot be addressed through scientific research only. Indeed scientific research could inhibit addressing such challenges if scientific analysis constrains the multiple possible understandings of these challenges into already available scientific categories and concepts without translating between these and everyday concerns. This argument builds on work in philosophy of science and race to postulate a process through which non-scientific (...)
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  48. Are There Model Behaviours for Model Organism Research? Commentary on Nicole Nelson's Model Behavior.Jacqueline A. Sullivan - 2020 - Studies in History and Philosophy of Science Part C: Studies in History and Philosophy of Biological and Biomedical Sciences 82:101266.
    One might be inclined to assume, given the mouse donning its cover, that the behavior of interest in Nicole Nelson's book Model Behavior (2018) is that of organisms like mice that are widely used as “stand-ins” for investigating the causes of human behavior. Instead, Nelson's ethnographic study focuses on the strategies adopted by a community of rodent behavioral researchers to identify and respond to epistemic challenges they face in using mice as models to understand the causes of disordered human behaviors (...)
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  49. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications.Eric Schiffman, Richard Ohrbach, E. Truelove, Edmond Truelove, John Look, Gary Anderson, Werner Ceusters, Barry Smith & Others - 2014 - Journal of Oral and Facial Pain and Headache 28 (1):6-27.
    Aims: The Research Diagnostic Criteria for Temporomandi¬bular Disorders (RDC/TMD) Axis I diagnostic algorithms were demonstrated to be reliable but below target sensitivity and specificity. Empirical data supported Axis I algorithm revisions that were valid. Axis II instruments were shown to be both reliable and valid. An international consensus workshop was convened to obtain recommendations and finalization of new Axis I diagnostic algorithms and new Axis II instruments. Methods: A comprehensive search of published TMD diagnostic literature was followed by review (...)
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  50.  78
    What’s Right About the Medical Model in Human Subjects Research Regulation.Heidi Li Feldman - unknown
    Critics of Institutional Review Board (IRB) practices often base their charges on the claim that IRB review began with and is premised upon a "medical model" of research, and hence a "medical model" of risk. Based on this claim, they charge that IRB review, especially in the institutional Reviw boardsocial and behavioral sciences, has experienced "mission creep". This paper argues that this line of critique is fundamentally misguided. While it remains unclear what critics mean by "medical model", the point (...)
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