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Academic literature on the topic 'Helsinki Declaration'

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Published: 4 June 2021

Last updated: 10 March 2023

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Journal articles on the topic "Helsinki Declaration"

Grummitt, R. M. "Declaration of Helsinki." Anaesthesia 45, no. 6 (June 1990): 496. http://dx.doi.org/10.1111/j.1365-2044.1990.tb14357.x.

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Drummond, G. B. "Declaration of Helsinki." Anaesthesia 45, no. 1 (January 1990): 59. http://dx.doi.org/10.1111/j.1365-2044.1990.tb14513.x.

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Hardy, P. A. J. "Declaration of Helsinki." Anaesthesia 45, no. 12 (December 1990): 1088. http://dx.doi.org/10.1111/j.1365-2044.1990.tb14908.x.

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Lasagna, Louis. "The Helsinki Declaration." Journal of Clinical Psychopharmacology 15, no. 2 (April 1995): 96–98. http://dx.doi.org/10.1097/00004714-199504000-00002.

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Human, Delon. "Declaration of Helsinki." Lancet 353, no. 9167 (May 1999): 1888. http://dx.doi.org/10.1016/s0140-6736(05)75101-1.

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Human, Delon. "Declaration of Helsinki." Lancet 357, no. 9251 (January 2001): 236. http://dx.doi.org/10.1016/s0140-6736(05)71342-8.

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Goodyear, Michael D. E., Karmela Krleza-Jeric, and Trudo Lemmens. "The Declaration of Helsinki." BMJ 335, no. 7621 (September 27, 2007): 624–25. http://dx.doi.org/10.1136/bmj.39339.610000.be.

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Reynolds, T. "Declaration of Helsinki Revised." Journal of the National Cancer Institute 92, no. 22 (November 15, 2000): 1801–3. http://dx.doi.org/10.1093/jnci/92.22.1801.

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Ijichi, Shinji, and Naomi Ijichi. "Ignorance of Helsinki Declaration." Lancet 360, no. 9330 (August 2002): 415. http://dx.doi.org/10.1016/s0140-6736(02)09587-9.

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Suwanjandee, Junsuda, and David Wilson. "Helsinki Declaration and Thailand." Lancet 354, no. 9175 (July 1999): 343. http://dx.doi.org/10.1016/s0140-6736(05)75255-7.

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Dissertations / Theses on the topic "Helsinki Declaration"

Carlson, Robert V. "The fifth revision of the Declaration of Helsinki and the ethical landscape of medical research." Thesis, University of Edinburgh, 2011. http://hdl.handle.net/1842/24154.

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The Declaration of Helsinki (DoH) is a set of normative ethical guidelines developed by the World Medical Association (WMA) for doctors participating in medical research. Arguably the best known and most authoritative of such ethical guidelines, the DoH has roots in the Nuremberg Code (1947). First adopted in 1964, the DoH, by 2000, had been revised 5 times. The 5th (Edinburgh, 2000) revision gave rise to great controversy evidenced by the unprecedented step of the WMA issuing Notes of Clarification to the 2 most controversial paragraphs. This thesis considers in detail the text of the 5th (Edinburgh, 2000) revision. Beginning with a review of the historical evolution of the text, there follows description of the controversial issues, discussion of why controversy ensued and what may be the future of the text. Then a detailed paragraph-by-paragraph analysis details exactly what changed in the text and identifies the most significant changes. Seven major areas of change to the text were identified: use of placebos in research, postresearch duty of care to individual participants, duties to ensure reasonable likelihood of benefit to communities involved in research, ethical issues related to publication, the addition of observational research to the scope of the document, the DoH's enhanced statement of its own authority, an enhanced duty to conduct research as well as an 8th major change, a logical re-structuring of the document removing the category of "Non-Therapeutic Research". Based on observation of WMA meetings and archival research a "behind the scenes" analysis is undertaken - asking how the most controversial paragraphs came to take their form in the 5th revision and considering what lessons may be learned from the drafting process itself. Further, the DoH exists in three official languages (English, French and Spanish) and important differences were discovered. There follows a comparison of the three official language versions - investigating concerns as to how differences may lead to uneven application of the DoH but also asking how the differences may help in understanding the controversial paragraphs. This detailed analysis of the text of the 5th revision leads to the central thesis question: "Is the DoH providing adequate guidance as a set of normative ethical standards across the broad spectrum of those involved in the global medical research endeavour as evidenced by reasonable coherence of their interpretations of the DoH?" Or, on the other hand, are the interpretations so diverse that the DoH cannot be considered a source of clear guidance. Or, put another way and incorporating the symbolism inherent in the title of this thesis: "Does the DoH function adequately to map the 'landscape of medical research'"? Semi-structured interviews were constructed based on the 8 major changes identified above and 57 experts drawn from 3 major categories: the "Authors" (15 people involved in the drafting process); the "Medical Researchers" (21 interviewees directly involved in conduct or application of medical research) and the "Expert Commentators" (21 with expertise in other aspects of drafting documents such as the DoH but not directly involved in either of the above) were interviewed. The interpretation process as illustrated in the transcript of the interviews is analysed with a view to determining whether the 5th revision has been effective in achieving a workable agreement among interpretations. Analysis of the results showed the DoH to be variously successful in depicting the landscape of medical research between and amongthe above three groups of interviewees. During the course of this study a further revision of the DoH took place in 2008 and the WMA invited a submission from this author as part of the consultation process. This response is presented and some discussion of the possible influence of this ensues. Finally the summary and conclusions ask what has changed in the 2008 text in the critical parts of the DoH identified above before summing up and considering possible future trajectories for this globally important document addressing the ethical conduct of medical research.

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Yu, Kun Young. "Análise da bioética na Coréia." Pontifícia Universidade Católica de São Paulo, 2010. https://tede2.pucsp.br/handle/handle/5391.

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Made available in DSpace on 2016-04-26T20:19:32Z (GMT). No. of bitstreams: 1 Kun Young Yu.pdf: 738962 bytes, checksum: 7f8ae8dc1a8ea3f259e76465208eef4c (MD5) Previous issue date: 2010-11-05
The present research aims at analyzing the Korean bioethics through the analysis of the historical, social, cultural and philosophical elements of the country to understand how such elements influenced in the constitution of bioethics in that country. The work is started through the study of scandal perpetrated by the major scientist of the country in the area, Professor Hwang Woo Suk, and by analyzing the social and political impact of such event we learnt about the values that guided the local bioethics, which are pragmatism and its strong social appeal. We will see how this science was skillfully handled for propagandistic purposes by the local government, upon attribution of a patriotic character to its development and the complicity with which an entire nation embraced this "national project" under which they placed expectations much beyond the medical benefits initially targeted. In the analysis of the factors that participated in the formation of this unique bioethics, we will analyze the association of the bioethical researches to the economic plans of the government, the influence of the several social and philosophical elements such as cultural hedonism, the local culture of pragmatic and empiric nature, the Silhak, the economic influence of the research for the community capitalism practiced in the country, and the patriotic appeal attributed thereto by the historical factors and principles such as Social Darwinism. The analysis of the aforementioned elements helps us to understand how a country so advanced in the researches on the biotechnology area, has a bioethics that is so weak in ethical content, that in last analysis it was responsible for the outbreak of the fraud in the stem cells cloning research
A presente pesquisa tem por objetivo analisar a bioética coreana através da análise dos elementos históricos, sociais, culturais e filosóficos do país para entender como tais elementos influíram na constituição da bioética naquele país. Inicia-se o trabalho através do estudo do escândalo protagonizado pelo maior cientista do país na área, o Professor Hwang Woo Suk, e analisando a implicação social e política de tal evento, aprendemos sobre os valores que nortearam a bioética local, que são o pragmatismo e o seu forte apelo social. Veremos como esta ciência foi habilmente manuseada para fins propagandísticos pelo governo local, ao atribuir caráter patriótico ao seu desenvolvimento e a cumplicidade com que toda uma nação abraçou este projeto nacional sob o qual depositaram anseios muito além dos benefícios médicos que se propunha alcançar inicialmente. Na análise dos fatores que participaram na formação desta bioética singular analisaremos a vinculação das pesquisas bioéticas aos planos econômicos do governo, a influência de vários elementos sociais e filosóficos como o hedonismo cultural, a filosofia local de cunho pragmática e empírica, o Silhak, a influência econômica das pesquisas pelo capitalismo comunitário praticado no país, e o apelo patriótico atribuído ao mesmo pelos fatores históricos e princípios como o Darwinismo Social. A análise dos elementos mencionados acima ajuda a entender como um país tão avançado nas pesquisas na área de biotecnologia, possui uma bioética tão fraca em conteúdo ético, que em última análise foi a responsável pela eclosão da fraude nas pesquisas de clonagem de células-tronco

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Camporesi, S. "THE ETHICAL FOUNDATIONS OF CLINICAL RESEARCH: SHIFTING THE PARADIGM OF PARTICIPATION.THE CASE OF PHASE 0 CANCER TRIALS." Doctoral thesis, Università degli Studi di Milano, 2011. http://hdl.handle.net/2434/155519.

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In this dissertation I consider the ethical foundations of clinical research and propose a shift towards a new framework. Since the beginning, the ethical foundations of clinical research have been focused on the protection of human subjects, with a strong emphasis of the importance of the informed consent process and on issues of vulnerability, coercion, and exploitation. This is understandable, as the ethical guidelines regulating clinical research worldwide (Nuremberg Code, Helsinki Declaration, Belmont Report) were born in the aftermath of the WWII. But the historical context has changed, and the emphasis on the protection of subjects may be anachronistic today and have deleterious repercussions on the clinical research enterprise, by placing the regulatory bar too high. My case-study is the first Phase 0 clinical trial performed at NCI-NIH, the ABT-888 study. Phase 0 trials are clinical studies, which have no intention to treat and are performed before the traditional Phase 1 studies, with the aim of proving in humans a molecular mechanism of action which has been demonstrated in the animal models. In this work I first analyze the traditional topics in the ethics of clinical research, such as informed consent, the possibility of therapeutic misconception or misestimation, the vulnerability of terminally ill subjects. I then consider the arguments in favor and against the so-called “duty to participate in clinical research”, providing an extensive overview of the ethical debate. Considered the pros and cons, I conclude that there are sufficiently solid ethical arguments to support a shift in our attitude towards participation in research from the traditionally conceived super-erogatory view to a, even if imperfect, moral duty. I then switch to the policy level, and propose some practical implementations of the ethical arguments in favor of the duty in research based on the libertarian paternalistic view developed by Sunstein and Thaler. To conclude, the ethical foundations of clinical research need to be reshaped: we all have an interest in the advancement of medical research, and participation in research should be seen both as a duty and a right. Trust should become one the fundamental value of these new foundations, which also have practical implications, for the rewriting of Helsinki Declaration.

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Wu, Yi-Ching, and 吳倚晴. "A Study on Human Dignity being the Boundary of Human Subject Research- in the Analysis of the Declaration of Helsinki." Thesis, 2014. http://ndltd.ncl.edu.tw/handle/h8b6jc.

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Gomes, Francisca Gonçalves. "Relatório de Estágio e Monografia intitulada "Bioética no Desenvolvimento de Ensaios Clínicos"." Master's thesis, 2021. http://hdl.handle.net/10316/99079.

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Relatório de Estágio do Mestrado Integrado em Ciências Farmacêuticas apresentado à Faculdade de Farmácia
Nos dias que correm áreas como os ensaios clínicos, segurança e eficácia de medicamentos são cada vez mais comuns no nosso quotidiano. Ao longo desta dissertação pretende-se ilustrar não só qual o seu significado na literatura, mas também entender de que forma a história e a comunidade científica procuraram salvaguardar os participantes dos ensaios clínicos ao longo dos anos. Pretende-se refletir sobre as principais declarações que salvaguardam os direitos e os deveres dos participantes em ensaios clínicos e de que forma estas evoluíram permitindo garantir o bem-estar dos participantes e simultaneamente comprovar a eficácia e segurança de novas moléculas. Em suma, analisaremos os princípios universais que estão associados à ética dos ensaios clínicos com foco no voluntário. Estes contêm os pontos que iremos abordar ao longo desta reflexão tais como: o binômio bem individual-bem público, os interesses a médio longo prazo da comunidade quer científica quer social e também dos indivíduos que constituem o ensaio fomentando o respeito e o cumprimento dos direitos dos voluntários. Abordaremos ainda, de forma sucinta, se estes requisitos foram respeitados, durante o desenvolvimento de tratamentos para a COVID-19.
Nowadays, areas like clinical trials, drug safety and efficacy are more and more common in our daily lives. Throughout this dissertion it is intended to illustrate not only what it means in the literature, but also to understand how history and the scientific community have sought to safeguard participants in clinical trials over the years. It is intended to reflect on the main statements that safeguard the rights and duties of participants in clinical trials and how these evolved, allowing to ensure the well-being of participants and simultaneously prove the efficacy and safety of new molecules. In short, we will analyze the universal principles that are associated with the ethics of clinical trials with a focus on the volunteer. Those contains the points that we will address throughout this reflection, such as: the binomial individual-public good, the medium-long term interests of both the scientific and social community and also of the individuals who make up the essay, fostering respect and fulfillment of rights of volunteers. We will also briefly discuss whether these requirements were met during the development of treatments for COVID-19.

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White, Lucie Alexandra. "Constructing a Coherent Philosophical Basis for Research Ethics." Phd thesis, 2015. http://hdl.handle.net/1885/113298.

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The purpose of this dissertation is to identify some of the most pressing problems in the dominant contemporary approach to research ethics, and to devise an alternative approach that avoids these problems. I contend that the fundamental ethical values invoked in human research are often appealed to in contradictory or ambiguous ways, or in ways that do not adequately capture or do not show an adequate understanding of the specific ethical concerns of human research. One significant problem in this domain is that values for ethical research are often unreflectively imported from medical therapy, producing ill-suited guidelines that cannot capture the different ethical situations that arise in the context of research. Furthermore, ethical guidelines in this area are often not developed with a sufficient understanding of the deep philosophical issues that they invoke. I suggest that we can address these problems through examining the fundamental ethical concerns of research on a philosophical level. This method will reveal severe problems with the approach to two of the ethical values underlying research; beneficence and respect for autonomy (or respect for persons). Once the nature of these problems has been revealed, and with reference to ethical problems that typically arise in the domain of research, I construct a coherent philosophical foundation for research ethics, which both avoids these deep-seated problems and better captures the ethical issues that arise in the domain of human research. I argue that we need to radically depart from the values of beneficence and autonomy/respect for persons as they are currently understood in the guidelines. We need an idea of beneficence that is clearly distinct from that which is used in the therapeutic medical context from which this notion is currently drawn. I also contend that we need to move away from autonomy as a central value in research ethics. I posit an alternative choice-based approach to informed consent which is concerned both with respecting agents’ freedom of choice, and also with their wellbeing, as providing a good means of protecting and promoting the interests of the individual research subject. Although these two imperatives are often thought to clash on a fundamental level, I will show that, in research ethics, they can be reconciled with minimal conflict. Though this represents a departure from the ethics of medical therapy, this approach is far more suited to the context of research. This theoretical basis for informed consent can help to clarify the ethical problems that are specific to this domain and provide us with relevant ethical guidance in research ethics.

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Books on the topic "Helsinki Declaration"

Handbook of declarations. Ferney-Voltaire: World Medical Association, 1995.

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1929-, Deutsch Erwin, and Taupitz Jochen, eds. Forschungsfreiheit und Forschungskontrolle in der Medizin: Zur geplanten Revision der Deklaration von Helsinki = Freedom and control of biomedical research : the planned revision of the Declaration of Helsinki. Berlin: Springer, 2000.

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Der ethische Gehalt der Helsinki Deklaration: Eine historisch-systematische Untersuchung der Richtlinien des Weltärztebunds über biomedizinische Forschung am Menschen. Frankfurt am Main: P. Lang, 1993.

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Yhdistyneiden kansakuntien yhteydessä toimiva Helsingin kriminaalipoliittinen instituutti., ed. Changing victim policy: The United Nations Victim Declaration and recent developments in Europe : report on the Meeting of an ad hoc Expert Group Meeting, Helsinki, 17-20 November, 1988. Helsinki: Helsinki Institute for Crime Prevention and Control, 1989.

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Hutchinson, David. Declaration of Helsinki. Canary Publications, 2002.

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Staff, World Medical Association. WMA Declaration of Helsinki 2013: Ethical Principles for Medical Research Involving Human Subjects. Canary Publications, 2017.

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1967-, Schmidt Ulf, and Frewer Andreas, eds. History and theory of human experimentation: The declaration of Helsinki and modern medical ethics. Stuttgart: Franz Steiner Verlag, 2007.

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Ethical Research: The Declaration of Helsinki, and the Past, Present, and Future of Human Experimentation. Oxford University Press, Incorporated, 2020.

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Frewer, Andreas, Ulf Schmidt, and Dominique Sprumont. Ethical Research: The Declaration of Helsinki, and the Past, Present and Future of Human Experimentation. Oxford University Press, 2020.

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Division, Abbe Research. Helsinki Declaration: Bioethical Issues, Clinical Rights of Humans, Principles of Research on Humans and Nature of Human Experimentation. Abbe Pub Assn of Washington Dc, 2002.

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Book chapters on the topic "Helsinki Declaration"

Nahler, Gerhard. "Helsinki declaration." In Dictionary of Pharmaceutical Medicine, 86. Vienna: Springer Vienna, 2009. http://dx.doi.org/10.1007/978-3-211-89836-9_644.

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Nahler, Gerhard. "Declaration of Helsinki." In Dictionary of Pharmaceutical Medicine, 48. Vienna: Springer Vienna, 2009. http://dx.doi.org/10.1007/978-3-211-89836-9_367.

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Bădărău, Domniţa Oana. "Declaration of Helsinki." In Mental Health Practitioner's Guide to HIV/AIDS, 181–83. New York, NY: Springer New York, 2012. http://dx.doi.org/10.1007/978-1-4614-5283-6_30.

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Riis, Povl. "The Declaration of Helsinki: Concept, Development and Contents." In Veröffentlichungen des Instituts für Deutsches, Europäisches und Internationales Medizinrecht, Gesundheitsrecht und Bioethik der Universitäten Heidelberg und Mannheim, 257–60. Berlin, Heidelberg: Springer Berlin Heidelberg, 2000. http://dx.doi.org/10.1007/978-3-642-57326-2_17.

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Riis, Povl. "Revising the Helsinki Declaration: content of rules and their importance for science." In Veröffentlichungen des Instituts für Deutsches, Europäisches und Internationales Medizinrecht, Gesundheitsrecht und Bioethik der Universitäten Heidelberg und Mannheim, 63–67. Berlin, Heidelberg: Springer Berlin Heidelberg, 2002. http://dx.doi.org/10.1007/978-3-642-59424-3_5.

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Chinole, Cristina Cazacu. "Helsinki Declarations." In Encyclopedia of Immigrant Health, 815–17. New York, NY: Springer New York, 2012. http://dx.doi.org/10.1007/978-1-4419-5659-0_357.

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Zilgalvis, Peteris. "The European Convention on Human Rights and Biomedicine: Competition for the Declaration of Helsinki ?" In Veröffentlichungen des Instituts für Deutsches, Europäisches und Internationales Medizinrecht, Gesundheitsrecht und Bioethik der Universitäten Heidelberg und Mannheim, 261–71. Berlin, Heidelberg: Springer Berlin Heidelberg, 2000. http://dx.doi.org/10.1007/978-3-642-57326-2_18.

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Gallin, Stacy, and Ira Bedzow. "The Holocaust as an Inflection Point in the Development of Research Ethics." In The International Library of Bioethics, 229–46. Cham: Springer International Publishing, 2022. http://dx.doi.org/10.1007/978-3-031-01987-6_13.

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AbstractModern research ethics arose as a response to the scientific and medical communities’ participation in the Holocaust. The Holocaust remains the only example of medically sanctioned genocide and thus can provide critical lessons regarding the importance of valuing basic ethical principles ahead of the potential for scientific progress in the contemporary context of research ethics. This chapter will explore the trajectory of research ethics using the Holocaust as an inflection point. It will briefly describe the difference between medical and research ethics before and after the Holocaust, and then show how the lessons of the Holocaust not only influenced the creation of the Nuremberg Code but also the subsequent development of the Declaration of Helsinki, the Belmont Report, the Federal Policy for the Protection of Human Subjects (The Common Rule) and the International Ethical Guidelines for Biomedical Research Involving Human Subjects.

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Lang, Nicole. "Challenges in Establishing the Clinical Trials Centre at the University of Ulm." In Improving Oncology Worldwide, 83–90. Cham: Springer International Publishing, 2022. http://dx.doi.org/10.1007/978-3-030-96053-7_11.

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AbstractA Clinical Trials Centre (CTC) is an institution that unites experts and expertise for successful designing, conducting and publishing of clinical trials. It provides competence and the infrastructure required for conducting clinical trials in compliance with international and national regulations, guidelines and standards, ICH GCP (good clinical practice) and the Declaration of Helsinki. Mostly, the CTCs are institutions of the Medical Faculty of the University or the University Hospitals, sometimes both. In Germany, after passing an audit providing reassurance of compliance with required standards, a Clinical Trials Centre is invited to join the Network of Coordinating Centers for Clinical Trials (KKS-Network). Challenges in establishing these standards are diverse and start at the underlying IT (information technology) structure that might not be suitable for providing validated data systems and continue in generating awareness for the need of centralised structures for being compliant with regulations and guidance in conducting high-quality clinical trials.

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Silverstein, J. H. "Experimenting on Your Fellow Humans in 2001. Update of the Declaration of Helsinki and Progress from the International Conference on Harmonization." In Anaesthesia, Pain, Intensive Care and Emergency Medicine — A.P.I.C.E., 137–41. Milano: Springer Milan, 2002. http://dx.doi.org/10.1007/978-88-470-2099-3_11.

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Conference papers on the topic "Helsinki Declaration"

Cunha, Joao G., Carlos Faria, Ana Colim, Joao Oliveira, Luis A. Rocha, Marcio Silva, Sergio Monteiro, and Estela Bicho. "From Handcrafting to a Certified and Ergonomic Collaborative Workstation: the Digital Transformation Process**This work was supported by NORTE-06-3559-FSE-000018, integrated into the invitation NORTE-59-2018-41, aiming to hire highly-qualified human resources, co-financed by the Regional Operational Programme of the North 2020, thematic area of Competitiveness and Employment, through the European Social Fund (ESF). † This work was conducted according to the guidelines of the Declaration of Helsinki, and approved by the Committee of Ethics for Research in Social and Humans Sciences of the University of Minho (approval number CEICSH 095/2019). Informed consent was obtained from all subjects involved." In 2021 IEEE International Conference on Intelligence and Safety for Robotics (ISR). IEEE, 2021. http://dx.doi.org/10.1109/isr50024.2021.9419376.

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Reports on the topic "Helsinki Declaration"

International Ethical Guidelines for Health-related Research involving Humans. Council for International Organizations of Medical Sciences (CIOMS), 2016. http://dx.doi.org/10.56759/rgxl7405.

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Progress towards a world where all can enjoy optimal health and health care is crucially dependent on all kinds of research including research involving humans. Involving humans in medical research is necessary to improve the knowledge base on which medicine should be based. At the same time, individuals participating in health-related research have individual human rights and have a right to be protected against the risks that research may bring to them. The tension between these two considerations has led the medical community to endorse ethical guidelines for health-related research. Research Ethics Committees can use these guidelines to evaluate whether a given research protocol is ethically acceptable or not. -- In the late 1970s, CIOMS set out, in cooperation with WHO, to prepare guidelines to indicate how the ethical principles set forth in the Declaration of Helsinki of the World Medical Association, could be effectively applied, particularly in low-resource settings, given their socio-economic circumstances, laws and regulations, and executive and administrative arrangements. Since then, revised editions of the CIOMS ethical guidelines were published in 1993 and 2002. New developments in research prompted CIOMS to again revise their ethical guidelines. The result is available in this publication. -- In the 2016 version of the ethical Guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research. In providing this revised version, CIOMS hopes to ensure that the ethical Guidelines remain a living document that provides reasoned conditions for research in order to meet the challenges of modern research.

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