Results for 'clinical trials'

651 found
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  1.  47
    An Argument for Fewer Clinical Trials.Kirstin Borgerson - 2016 - Hastings Center Report 46 (6):25-35.
    The volume of clinical research is increasing exponentially—far beyond our ability to process and absorb the results. Given this situation, it may be beneficial to consider reducing the flow at its source. In what follows, I will motivate and critically evaluate the following proposal: researchers should conduct fewer clinical trials. More specifically, I c onsider whether researchers should be permitted to conduct only clinical research of very high quality and, in turn, whether research ethics committees should (...)
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  2. Failures in Clinical Trials in the European Union: Lessons From the Polish Experience.Marcin Waligora - 2013 - Science and Engineering Ethics 19 (3):1087-1098.
    When discussing the safety of research subjects, including their exploitation and vulnerability as well as failures in clinical research, recent commentators have focused mostly on countries with low or middle-income economies. High-income countries are seen as relatively safe and well-regulated. This article presents irregularities in clinical trials in an EU member state, Poland, which were revealed by the Supreme Audit Office of Poland (the NIK). Despite adopting many European Union regulations, including European Commission directives concerning Good (...) Practice, these irregularities occurred. Causes as well as potential solutions to make clinical trials more ethical and safer are discussed. (shrink)
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  3.  26
    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 (...)
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  4. A Taxonomy of Multinational Ethical and Methodological Standards for Clinical Trials of Therapeutic Interventions.C. M. Ashton, N. P. Wray, A. F. Jarman, J. M. Kolman, D. M. Wenner & B. A. Brody - 2011 - Journal of Medical Ethics 37 (6):368-373.
    Background If trials of therapeutic interventions are to serve society's interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical - trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. Methods The authors rank-ordered the world's nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other (...)
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  5.  60
    CTO: A Community-Based Clinical Trial Ontology and Its Applications in PubChemRDF and SCAIViewH.Asiyah Yu Lin, Stephan Gebel, Qingliang Leon Li, Sumit Madan, Johannes Darms, Evan Bolton, Barry Smith, Martin Hofmann-Apitius, Yongqun Oliver He & Alpha Tom Kodamullil - 2021 - Proceedings of the 11th International Conference on Biomedical Ontologies (ICBO) and 10th Workshop on Ontologies and Data in Life Sciences (ODLS).
    Driven by the use cases of PubChemRDF and SCAIView, we have developed a first community-based clinical trial ontology (CTO) by following the OBO Foundry principles. CTO uses the Basic Formal Ontology (BFO) as the top level ontology and reuses many terms from existing ontologies. CTO has also defined many clinical trial-specific terms. The general CTO design pattern is based on the PICO framework together with two applications. First, the PubChemRDF use case demonstrates how a drug Gleevec is linked (...)
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  6.  88
    A Unified Framework for Building Ontological Theories with Application and Testing in the Field of Clinical Trials.Heller Barbara, Herre Heinrich & Barry Smith - 2001 - In IFOMIS Reports. Leipzig: University of Leipzig.
    The objective of this research programme is to contribute to the establishment of the emerging science of Formal Ontology in Information Systems via a collaborative project involving researchers from a range of disciplines including philosophy, logic, computer science, linguistics, and the medical sciences. The re­searchers will work together on the construction of a unified formal ontology, which means: a general framework for the construction of ontological theories in specific domains. The framework will be constructed using the axiomatic-deductive method of modern (...)
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  7. Modeling the Invention of a New Inference Rule: The Case of ‘Randomized Clinical Trial’ as an Argument Scheme for Medical Science.Jodi Schneider & Sally Jackson - 2018 - Argument and Computation 9 (2):77-89.
    A background assumption of this paper is that the repertoire of inference schemes available to humanity is not fixed, but subject to change as new schemes are invented or refined and as old ones are obsolesced or abandoned. This is particularly visible in areas like health and environmental sciences, where enormous societal investment has been made in finding ways to reach more dependable conclusions. Computational modeling of argumentation, at least for the discourse in expert fields, will require the possibility of (...)
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  8. Conflicts Among Multinational Ethical and Scientific Standards for Clinical Trials of Therapeutic Interventions.Jacob M. Kolman, Nelda P. Wray, Carol M. Ashton, Danielle M. Wenner, Anna F. Jarman & Baruch A. Brody - 2012 - Journal of Law, Medicine and Ethics 40 (1):99-121.
    There has been a growing concern over establishing norms that ensure the ethically acceptable and scientifically sound conduct of clinical trials. Among the leading norms internationally are the World Medical Association's Declaration of Helsinki, guidelines by the Council for International Organizations of Medical Sciences, the International Conference on Harmonization's standards for industry, and the CONSORT group's reporting norms, in addition to the influential U.S. Federal Common Rule, Food and Drug Administration's body of regulations, and information sheets by the (...)
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  9.  70
    The Ethics of Anti-Aging Clinical Trials.Parker Crutchfield - 2018 - Science and Engineering Ethics 24 (2):441-453.
    Interventions aiming to slow, stop, or reverse the aging process are starting to enter clinical trials. Though this line of research is nascent, it has the potential to not only prevent prolonged human suffering, but also to extend human well-being. As this line of research develops, it is important to understand the ethical constraints of conducting such research. This paper discusses some of these constraints. In particular, it discusses the ethical difficulties of conducting this research in a way (...)
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  10. Fighting Aging as an Effective Altruism Cause: A Model of the Impact of the Clinical Trials of Simple Interventions.Alexey Turchin - manuscript
    The effective altruism movement aims to save lives in the most cost-effective ways. In the future, technology will allow radical life extension, and anyone who survives until that time will gain potentially indefinite life extension. Fighting aging now increases the number of people who will survive until radical life extension becomes possible. We suggest a simple model, where radical life extension is achieved in 2100, the human population is 10 billion, and life expectancy is increased by simple geroprotectors like metformin (...)
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  11.  23
    Combining Optimization and Randomization Approaches for the Design of Clinical Trials.Julio Michael Stern, Victor Fossaluza, Marcelo de Souza Lauretto & Carlos Alberto de Braganca Pereira - 2015 - Springer Proceedings in Mathematics and Statistics 118:173-184.
    t Intentional sampling methods are non-randomized procedures that select a group of individuals for a sample with the purpose of meeting specific prescribed criteria. In this paper we extend previous works related to intentional sampling, and address the problem of sequential allocation for clinical trials with few patients. Roughly speaking, patients are enrolled sequentially, according to the order in which they start the treatment at the clinic or hospital. The allocation problem consists in assigning each new patient to (...)
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  12. Translating Trial Results in Clinical Practice: The Risk GP Model.Jonathan Fuller & Luis J. Flores - 2016 - Journal of Cardiovascular Translational Research 9:167-168.
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  13. Post‐Trial Access to Antiretrovirals: Who Owes What to Whom?Joseph Millum - 2011 - Bioethics 25 (3):145-154.
    ABSTRACTMany recent articles argue that participants who seroconvert during HIV prevention trials deserve treatment when they develop AIDS, and there is a general consensus that the participants in HIV/AIDS treatment trials should have continuing post‐trial access. As a result, the primary concern of many ethicists and activists has shifted from justifying an obligation to treat trial participants, to working out mechanisms through which treatment could be provided. In this paper I argue that this shift frequently conceals an important (...)
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  14. MRCT Center Post-Trial Responsibilities Framework Continued Access to Investigational Medicines. Guidance Document. Version 1.0, December 2016.Carmen Aldinger, Barbara Bierer, Rebecca Li, Luann Van Campen, Mark Barnes, Eileen Bedell, Amanda Brown-Inz, Robin Gibbs, Deborah Henderson, Christopher Kabacinski, Laurie Letvak, Susan Manoff, Ignacio Mastroleo, Ellie Okada, Usharani Pingali, Wasana Prasitsuebsai, Hans Spiegel, Daniel Wang, Susan Briggs Watson & Marc Wilenzik - 2016 - The Multi-Regional Clinical Trials Center of the Brigham and Women’s Hospital and Harvard (MRCT Center).
    I. EXECUTIVE SUMMARY The MRCT Center Post-trial Responsibilities: Continued Access to an Investigational Medicine Framework outlines a case-based, principled, stakeholder approach to evaluate and guide ethical responsibilities to provide continued access to an investigational medicine at the conclusion of a patient’s participation in a clinical trial. The Post-trial Responsibilities (PTR) Framework includes this Guidance Document as well as the accompanying Toolkit. A 41-member international multi-stakeholder Workgroup convened by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital (...)
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  15. A Randomized Controlled Pilot Trial of Classroom-Based Mindfulness Meditation Compared to an Active Control Condition in Sixth-Grade Children.W. Britton, N. Lepp, H. F. Niles, Tomas Rocha, N. Fisher & J. Gold - 2014 - Journal of School Psychology 52 (3):263-278.
    The current study is a pilot trial to examine the effects of a nonelective, classroom-based, teacher-implemented, mindfulness meditation intervention on standard clinical measures of mental health and affect in middle school children. A total of 101 healthy sixth-grade students (55 boys, 46 girls) were randomized to either an Asian history course with daily mindfulness meditation practice (intervention group) or an African history course with a matched experiential activity (active control group). Self-reported measures included the Youth Self Report (YSR), a (...)
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  16. Clinical Research: Should Patients Pay to Play?Ezekiel J. Emanuel, Steven Joffe, Christine Grady, David Wendler & Govind Persad - 2015 - Science Translational Medicine 7 (298):298ps16.
    We argue that charging people to participate in research is likely to undermine the fundamental ethical bases of clinical research, especially the principles of social value, scientific validity, and fair subject selection.
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  17. Data and Safety Monitoring Board and the Ratio Decidendi of the Trial.Roger Stanev - 2015 - Journal of Philosophy, Science and Law 15:1-26.
    Decision-making by a Data and Safety Monitoring Board (DSMB) regarding clinical trial conduct and termination is intricate and largely limited by cases and rules. Decision-making by legal jury is also intricate and largely constrained by cases and rules. In this paper, I argue by analogy that legal decision-making, which strives for a balance between competing demands of conservatism and innovation, supplies a good basis to the logic behind DSMB decision-making. Using the doctrine of precedents in legal reasoning as my (...)
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  18. Rhetoric and Argumentation: How Clinical Practice Guidelines Think.Jonathan Fuller - 2013 - Journal of Evaluation in Clinical Practice 19 (3):433-441.
    Introduction: Clinical practice guidelines (CPGs) are an important source of justification for clinical decisions in modern evidence-based practice. Yet, we have given little attention to how they argue their evidence. In particular, how do CPGs argue for treatment with long-term medications that are increasingly prescribed to older patients? Approach and rationale: I selected six disease-specific guidelines recommending treatment with five of the medication classes most commonly prescribed for seniors in Ontario, Canada. I considered the stated aims of these (...)
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  19. The Ethics of Placebo-Controlled Trials: Methodological Justifications.Joseph Millum & Christine Grady - 2013 - Contemporary Clinical Trials 36 (2):510-14.
    The use of placebo controls in clinical trials remains controversial. Ethical analysis and international ethical guidance permit the use of placebo controls in randomized trials when scientifically indicated in four cases: (1) when there is no proven effective treatment for the condition under study; (2) when withholding treatment poses negligible risks to participants; (3) when there are compelling methodological reasons for using placebo, and withholding treatment does not pose a risk of serious harm to participants; and, more (...)
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  20.  51
    Justifying the Risks of COVID-19 Challenge Trials: The Analogy with Organ Donation.Athmeya Jayaram, Jacob Sparks & Daniel Callies - 2022 - Bioethics 36 (1):100-106.
    In the beginning of the COVID pandemic, researchers and bioethicists called for human challenge trials to hasten the development of a vaccine for COVID. However, the fact that we lacked a specific, highly effective treatment for COVID led many to argue that a COVID challenge trial would be unethical and we ought to pursue traditional phase III testing instead. These ethical objections to challenge trials may have slowed the progress of a COVID vaccine, so it is important to (...)
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  21. Patient-Funded Trials: Opportunity or Liability?Danielle M. Wenner, Alex John London & Jonathan Kimmelman - 2015 - Cell Stem Cell 17 (2):135-137.
    Patient-funded trials are gaining traction as a means of accelerating clinical translation. However, such trials sidestep mechanisms that promote rigor, relevance, efficiency, and fairness. We recommend that funding bodies or research institutions establish mechanisms for merit review of patient-funded trials, and we offer some basic criteria for evaluating PFT protocols.
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  22. ImmPort, Toward Repurposing of Open Access Immunological Assay Data for Translational and Clinical Research.Sanchita Bhattacharya, Patrick Dunn, Cristel Thomas, Barry Smith, Henry Schaefer, Jieming Chen, Zicheng Hu, Kelly Zalocusky, Ravi Shankar & Shai Shen-Orr - 2018 - Scientific Data 5:180015.
    Immunology researchers are beginning to explore the possibilities of reproducibility, reuse and secondary analyses of immunology data. Open-access datasets are being applied in the validation of the methods used in the original studies, leveraging studies for meta-analysis, or generating new hypotheses. To promote these goals, the ImmPort data repository was created for the broader research community to explore the wide spectrum of clinical and basic research data and associated findings. The ImmPort ecosystem consists of four components–Private Data, Shared Data, (...)
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  23.  51
    International Clinical Research and Justice in the Belmont Report.Joseph Millum - 2020 - Perspectives in Biology and Medicine 63 (2):374-388.
    The Belmont Report was written by a US Commission charged by the US Congress to advise on research supported by the US government. Its focus was understandably domestic. In the 40 years since its publication, clinical research has become increasingly international. Many clinical trials have sites in multiple countries, and many of the host countries are relatively impoverished. Such research raises some distinctive ethical issues. This paper outlines some of the key ethical challenges that have been raised (...)
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  24. Rationality and the Generalization of Randomized Controlled Trial Evidence.Jonathan Fuller - 2013 - Journal of Evaluation in Clinical Practice 19 (4):644-647.
    Over the past several decades, we devoted much energy to generating, reviewing and summarizing evidence. We have given far less attention to the issue of how to thoughtfully apply the evidence once we have it. That’s fine if all we care about is that our clinical decisions are evidence-based, but not so good if we also want them to be well-reasoned. Let us not forget that evidence based medicine (EBM) grew out of an interest in making medicine ‘rational’, with (...)
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  25. Off-Label Prescription of COVID-19 Vaccines in Children: Clinical, Ethical, and Legal Issues.Govind Persad, Holly Fernandez Lynch & Patricia J. Zettler - 2021 - Pediatrics 2021:e2021054578.
    We argue that the universal recommendations against “off-label” pediatric use of approved COVID-19 issued by the FDA, CDC, and AAP are overbroad. Especially for higher-risk children, vaccination can be ethically justified even before FDA authorization or approval – and similar reasoning is relevant for even younger patients. Legal risks can also be managed, although the FDA, CDC, and Department of Health and Human Services (HHS) should move quickly to provide clarity.
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  26. How Evidence‐Based Medicine is Failing Due to Biased Trials and Selective Publication.Susanna Every-Palmer & Jeremy Howick - 2014 - Journal of Evaluation in Clinical Practice 20 (6):908-914.
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  27.  71
    Assessment of the Ethical Review Process for Non-Pharmacological Multicentre Studies in Germany on the Basis of a Randomised Surgical Trial.C. M. Seiler, P. Kellmeyer, P. Kienle, M. W. Buchler & H.-P. Knaebel - 2007 - Journal of Medical Ethics 33 (2):113-118.
    Objective: To examine the current ethical review process of ethics committees in a non-pharmacological trial from the perspective of a clinical investigator.Design: Prospective collection of data at the Study Centre of the German Surgical Society on the duration, costs and administrative effort of the ERP of a randomised controlled multicentre surgical INSECT Trial between November 2003 and May 2005.Setting: Germany.Participants: 18 ethics committees, including the ethics committee handling the primary approval, responsible overall for 32 clinical sites throughout Germany. (...)
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  28.  38
    Theory of Signs and Statistical Approach to Big Data in Assessing the Relevance of Clinical Biomarkers of Inflammation and Oxidative Stress.Pietro Ghezzi, Kevin Davies, Aidan Delaney & Luciano Floridi - 2018 - Proceedings of the National Academy of Sciences of the United States of America 115 (10):2473-2477.
    Biomarkers are widely used not only as prognostic or diagnostic indicators, or as surrogate markers of disease in clinical trials, but also to formulate theories of pathogenesis. We identify two problems in the use of biomarkers in mechanistic studies. The first problem arises in the case of multifactorial diseases, where different combinations of multiple causes result in patient heterogeneity. The second problem arises when a pathogenic mediator is difficult to measure. This is the case of the oxidative stress (...)
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  29. COVID-19 Pandemic: Evidences From Clinical Studies.Ravi Shankar Singh, Abhishek Kumar Singh, Kamla Kant Shukla & Amit Kumar Tripathi - 2020 - Journal of Community and Public Health Nursing 6 (4):251.
    The public health crisis is started with emergence of new coronavirus on 11 February 2020 which triggered as coronavirus disease-2019 (COVID-19) pandemics. The causative agent in COVID-19 is made up of positively wrapped single-stranded RNA viruses ~ 30 kb in size. The epidemiology, clinical features, pathophysiology, and mode of transmission have been documented well in many studies, with additional clinical trials are running for several antiviral agents. The spreading potential of COVID-19 is faster than its two previous (...)
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  30. Applications of the ACGT Master Ontology on Cancer.Mathias Brochhausen, Gabriele Weiler, Luis Martín, Cristian Cocos, Holger Stenzhorn, Norbert Graf, Martin Dörr, Manolis Tsiknakis & Barry Smith - 2008 - In R. Meersman & P. Herrero (eds.), Proceedings of 4th International IFIP Workshop On Semantic Web and Web Semantics (OTM 2008: Workshops), LNCS 5333. pp. 1046–1055.
    In this paper we present applications of the ACGT Master Ontology (MO) which is a new terminology resource for a transnational network providing data exchange in oncology, emphasizing the integration of both clinical and molecular data. The development of a new ontology was necessary due to problems with existing biomedical ontologies in oncology. The ACGT MO is a test case for the application of best practices in ontology development. This paper provides an overview of the application of the ontology (...)
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  31. Pandemic Ethics: The Case for Risky Research.Richard Yetter Chappell & Peter Singer - 2020 - Research Ethics 16 (3-4):1-8.
    There is too much that we do not know about COVID-19. The longer we take to find it out, the more lives will be lost. In this paper, we will defend a principle of risk parity: if it is permissible to expose some members of society (e.g. health workers or the economically vulnerable) to a certain level of ex ante risk in order to minimize overall harm from the virus, then it is permissible to expose fully informed volunteers to a (...)
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  32. Against Permitted Exploitation in Developing World Research Agreements.Danielle M. Wenner - 2016 - Developing World Bioethics 16 (1):36-44.
    This paper examines the moral force of exploitation in developing world research agreements. Taking for granted that some clinical research which is conducted in the developing world but funded by developed world sponsors is exploitative, it asks whether a third party would be morally justified in enforcing limits on research agreements in order to ensure more fair and less exploitative outcomes. This question is particularly relevant when such exploitative transactions are entered into voluntarily by all relevant parties, and both (...)
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  33. Informed Consent: What Must Be Disclosed and What Must Be Understood?Joseph Millum & Danielle Bromwich - 2021 - American Journal of Bioethics 21 (5):46-58.
    Over the last few decades, multiple studies have examined the understanding of participants in clinical research. They show variable and often poor understanding of key elements of disclosure, such as expected risks and the experimental nature of treatments. Did the participants in these studies give valid consent? According to the standard view of informed consent they did not. The standard view holds that the recipient of consent has a duty to disclose certain information to the profferer of consent because (...)
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  34. Comparing the Understanding of Subjects Receiving a Candidate Malaria Vaccine in the United States and Mali.R. D. Ellis, I. Sagara, A. Durbin, A. Dicko, D. Shaffer, L. Miller, M. H. Assadou, M. Kone, B. Kamate, O. Guindo, M. P. Fay, D. A. Diallo, O. K. Doumbo, E. J. Emanuel & J. Millum - 2010 - American Journal of Tropical Medicine and Hygiene 83 (4):868-72.
    Initial responses to questionnaires used to assess participants' understanding of informed consent for malaria vaccine trials conducted in the United States and Mali were tallied. Total scores were analyzed by age, sex, literacy (if known), and location. Ninety-two percent (92%) of answers by United States participants and 85% of answers by Malian participants were correct. Questions more likely to be answered incorrectly in Mali related to risk, and to the type of vaccine. For adult participants, independent predictors of higher (...)
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  35.  78
    The Memory-Modifying Potential of Optogenetics and the Need for Neuroethics.Agnieszka K. Adamczyk & Przemysław Zawadzki - 2020 - NanoEthics 14 (3):207-225.
    Optogenetics is an invasive neuromodulation technology involving the use of light to control the activity of individual neurons. Even though optogenetics is a relatively new neuromodulation tool whose various implications have not yet been scrutinized, it has already been approved for its first clinical trials in humans. As optogenetics is being intensively investigated in animal models with the aim of developing novel brain stimulation treatments for various neurological and psychiatric disorders, it appears crucial to consider both the opportunities (...)
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  36. Unethical Informed Consent Caused by Overlooking Poorly Measured Nocebo Effects.Jeremy Howick - 2020 - Journal of Medical Ethics 16:00-03.
    Unlike its friendly cousin the placebo effect, the nocebo effect (the effect of expecting a negative outcome) has been almost ignored. Epistemic and ethical confusions related to its existence have gone all but unnoticed. Contrary to what is often asserted, adverse events following from taking placebo interventions are not necessarily nocebo effects; they could have arisen due to natural history. Meanwhile, ethical informed consent (in clinical trials and clinical practice) has centred almost exclusively on the need to (...)
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  37. Disclosure and Consent to Medical Research Participation.Danielle Bromwich & Joseph Millum - 2013 - Journal of Moral Philosophy 10 (4):195-219.
    Most regulations and guidelines require that potential research participants be told a great deal of information during the consent process. Many of these documents, and most of the scholars who consider the consent process, assume that all this information must be disclosed because it must all be understood. However, a wide range of studies surveying apparently competent participants in clinical trials around the world show that many do not understand key aspects of what they have been told. The (...)
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  38. Philosophy of Psychedelics.Chris Letheby - 2021 - Oxford, UK: Oxford University Press.
    Recent clinical trials show that psychedelics such as LSD and psilocybin can be given safely in controlled conditions, and can cause lasting psychological benefits with one or two administrations. Supervised psychedelic sessions can reduce symptoms of anxiety, depression, and addiction, and improve well-being in healthy volunteers, for months or even years. But these benefits seem to be mediated by "mystical" experiences of cosmic consciousness, which prompts a philosophical concern: do psychedelics cause psychological benefits by inducing false or implausible (...)
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  39. Understanding, Interests and Informed Consent: A Reply to Sreenivasan.Danielle Bromwich - 2015 - Journal of Medical Ethics 41 (4):327-331.
    It is widely agreed that the view of informed consent found in the regulations and guidelines struggles to keep pace with the ever-advancing enterprise of human subjects research. Over the last 10 years, there have been serious attempts to rethink informed consent so that it conforms to our considered judgments about cases where we are confident valid consent has been given. These arguments are influenced by an argument from Gopal Sreenivasan, which apparently shows that a potential participant's consent to research (...)
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  40.  98
    Sharing the Benefits of Research Fairly: Two Approaches.Joseph Millum - 2012 - Journal of Medical Ethics 38 (4):219-223.
    Research projects sponsored by rich countries or companies and carried out in developing countries are often described as exploitative. One important debate about the prevention of exploitation in research centres on whether and how clinical research in developing countries should be responsive to local health problems. This paper analyses the responsiveness debate and draws out more general lessons for how policy makers can prevent exploitation in various research contexts. There are two independent ways to do this in the face (...)
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  41. Should DBS for Psychiatric Disorders Be Considered a Form of Psychosurgery? Ethical and Legal Considerations.Devan Stahl, Laura Cabrera & Tyler Gibb - 2018 - Science and Engineering Ethics 24 (4):1119-1142.
    Deep brain stimulation, a surgical procedure involving the implantation of electrodes in the brain, has rekindled the medical community’s interest in psychosurgery. Whereas many researchers argue DBS is substantially different from psychosurgery, we argue psychiatric DBS—though a much more precise and refined treatment than its predecessors—is nevertheless a form of psychosurgery, which raises both old and new ethical and legal concerns that have not been given proper attention. Learning from the ethical and regulatory failures of older forms of psychosurgery can (...)
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  42. Standard of Care, Institutional Obligations, and Distributive Justice.Douglas MacKay - 2015 - Bioethics 29 (4):352-359.
    The problem of standard of care in clinical research concerns the level of treatment that investigators must provide to subjects in clinical trials. Commentators often formulate answers to this problem by appealing to two distinct types of obligations: professional obligations and natural duties. In this article, I investigate whether investigators also possess institutional obligations that are directly relevant to the problem of standard of care, that is, those obligations a person has because she occupies a particular institutional (...)
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  43. Hollow Hunt for Harms.Jacob Stegenga - 2016 - Perspectives on Science 24 (5):481-504.
    Harms of medical interventions are systematically underestimated in clinical research. Numerous factors—conceptual, methodological, and social—contribute to this underestimation. I articulate the depth of such underestimation by describing these factors at the various stages of clinical research. Before any evidence is gathered, the ways harms are operationalized in clinical research contributes to their underestimation. Medical interventions are first tested in phase 1 ‘first in human’ trials, but evidence from these trials is rarely published, despite the fact (...)
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  44.  38
    An Ethical Analysis of Vaccinating Children Against COVID-19: Benefits, Risks, and Issues of Global Health Equity [Version 2; Peer Review: 1 Approved, 1 Approved with Reservations].Rachel Gur-Arie, Steven R. Kraaijeveld & Euzebiusz Jamrozik - forthcoming - Wellcome Open Research.
    COVID-19 vaccination of children has begun in various high-income countries with regulatory approval and general public support, but largely without careful ethical consideration. This trend is expected to extend to other COVID-19 vaccines and lower ages as clinical trials progress. This paper provides an ethical analysis of COVID-19 vaccination of healthy children. Specifically, we argue that it is currently unclear whether routine COVID-19 vaccination of healthy children is ethically justified in most contexts, given the minimal direct benefit that (...)
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  45. Evidence and Simplicity: Why We Should Reject Homeopathy.Scott Sehon & Donald Stanley - 2010 - Journal of Evaluation in Clinical Practice 16 (2):276-281.
    Homeopathic medications are used by millions, and hundreds of millions of dollars are spent on these remedies in the USA alone. In the UK, the NHS covers homeopathic treatments. Nonetheless, homeopathy is held in considerable disrepute by much of the medical and scientific community.Many proponents of homeopathy are well aware of these criticisms but remain unimpressed. The differences of opinion run deep, and the debate seems deadlocked. We aim to shed some light on this situation. We briefly recap some of (...)
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  46. The 50th Anniversary of the Declaration of Helsinki: Progress but Many Remaining Challenges.J. Millum - 2013 - Journal of the American Medical Association 310 (20):2143-44.
    Since 1964, through 7 revisions, the World Medical Association’s Declaration of Helsinki has stood as an important statement regarding the ethical principles guiding medical research with human participants. It is consulted by ethics review committees, funders, researchers, and research participants. It has been incorporated into national legislation and is routinely invoked to ascertain the ethical appropriateness of clinical trials. There is much to praise about the revision process and the latest revision, which coincides with the declaration’s 50th anniversary. (...)
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  47. VO: Vaccine Ontology.Yongqun He, Lindsay Cowell, Alexander D. Diehl, H. L. Mobley, Bjoern Peters, Alan Ruttenberg, Richard H. Scheuermann, Ryan R. Brinkman, Melanie Courtot, Chris Mungall, Barry Smith & Others - 2009 - In ICBO 2009: Proceedings of the First International Conference on Biomedical Ontology. Buffalo:
    Vaccine research, as well as the development, testing, clinical trials, and commercial uses of vaccines involve complex processes with various biological data that include gene and protein expression, analysis of molecular and cellular interactions, study of tissue and whole body responses, and extensive epidemiological modeling. Although many data resources are available to meet different aspects of vaccine needs, it remains a challenge how we are to standardize vaccine annotation, integrate data about varied vaccine types and resources, and support (...)
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  48.  29
    Auditable Blockchain Randomization Tool.Julio Michael Stern & Olivia Saa - 2019 - Proceedings 33 (17):1-6.
    Randomization is an integral part of well-designed statistical trials, and is also a required procedure in legal systems. Implementation of honest, unbiased, understandable, secure, traceable, auditable and collusion resistant randomization procedures is a mater of great legal, social and political importance. Given the juridical and social importance of randomization, it is important to develop procedures in full compliance with the following desiderata: (a) Statistical soundness and computational efficiency; (b) Procedural, cryptographical and computational security; (c) Complete auditability and traceability; (d) (...)
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  49. Applying Evidence to Support Ethical Decisions: Is the Placebo Really Powerless?Prof Dr Franz Porzsolt, Nicole Scholtz-Gorton, Nikola Biller-Andorno, Anke Thim, Karin Meissner, Irmgard Roeckl-Wiedmann, Barbara Herzberger, Renatus Ziegler, Wilhelm Gaus & Ernst Pöppel - 2004 - Science and Engineering Ethics 10 (1):119-132.
    Using placebos in day-to-day practice is an ethical problem. This paper summarises the available epidemiological evidence to support this difficult decision. Based on these data we propose to differentiate between placebo and “knowledge framing”. While the use of placebo should be confined to experimental settings in clinical trials, knowledge framing — which is only conceptually different from placebo — is a desired, expected and necessary component of any doctor-patient encounter. Examples from daily practice demonstrate both, the need to (...)
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  50. OntONeo: The Obstetric and Neonatal Ontology.Fernanda Farinelli, Mauricio Almeida, Peter Elkin & Barry Smith - 2016 - In Dealing with elements of medical encounters: An approach based on ontological realism. Aachen: CEUR, vol. 1747.
    This paper presents the Obstetric and Neonatal Ontology (OntONeo). This ontology has been created to provide a consensus representation of salient electronic health record (EHR) data and to serve interoperability of the associated data and information systems. More generally, it will serve interoperability of clinical and translational data, for example deriving from genomics disciplines and from clinical trials. Interoperability of EHR data is important to ensuring continuity of care during the prenatal and postnatal periods for both mother (...)
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