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Books on the topic 'Helsinki Declaration'

Author: Grafiati

Published: 4 June 2021

Last updated: 10 March 2023

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1

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

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2

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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3

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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4

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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5

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

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6

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

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7

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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8

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

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9

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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10

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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11

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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12

Hellman, Samuel. Medical Ethics and Learning. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780190650551.003.0002.

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Randomized clinical trials have become the preferred method of medical learning, but the author believes that they are often in conflict with an appropriate doctor-patient relationship. The physician’s primary obligation is to the individual patient rather than patients in general. Medical knowledge, by being gained by inductive reasoning, is always conditional and subject to being disproved. Medicine must be practiced with awareness of this uncertainty; while learned for patients as a group, it must be modified for the particular patient. From Tuskegee and Willowbrook to the Helsinki Declaration, medical ethics continues to evolve to favor individual rights rather than utilitarian benefit, and this trend should and will continue.

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13

Veatch, Robert M., Amy Haddad, and E. J. Last. Experimentation on Human Subjects. Edited by Robert M. Veatch, Amy Haddad, and E. J. Last. Oxford University Press, 2017. http://dx.doi.org/10.1093/med/9780190277000.003.0016.

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This chapter examines ethical issues in research involving human subjects. The Nuremberg trials, which exposed to all humankind the outrageous things that could be done in the name of medical science, led to the Nuremberg Code, the first international document from public sources setting out an ethic for research on human subjects. Basic differences are outlined between the goals of therapy for the good of a patient and those of research that focus on attainment of knowledge and the good of society. To protect the interests of human subjects who take part in research, guidelines such as the Declaration of Helsinki have been established for assessing risks and benefits, voluntary consent, protection of privacy and confidentiality, and equity in subject selection. The chapter focuses on the difficulty in calculating harms and benefits to subjects and challenges of obtaining informed consent for participation in research.

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14

Ray, Sumantra (Shumone), Sue Fitzpatrick, Rajna Golubic, Susan Fisher, and Sarah Gibbings, eds. Setting the scene and ICH GCP in clinical and healthcare research. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199608478.003.0008.

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This chapter looks at the purpose and history of the development of good clinical practice (GCP). The international conference on harmonisation (ICH) GCP is the international quality standard for conducting clinical research to ensure the rights and well-being of patients are protected and the resulting data are valid. The cornerstone of ethics in research stems from the Declaration of Helsinki and the chapter looks at the changes in the Declaration and the impact on clinical trials. The development of the ICH process is described and the E, S, Q and M guidelines are discussed, The efficacy guidelines affect the practical aspects of trials and the efficacy guideline number 6 (E6) is on GCP. The content of the E6 guidelines is reviewed including the responsibilities of ethics committees, investigator and sponsor. Documentation requirements including the Protocol and Investigator Brochure as well as all the other documents are outlined. The guidelines are written to be interpreted and companies and institutions have to document their interpretation using standard operating procedures (SOPs). Although ICH GCP is regarded as the world-wide standard it sits alongside countries' legislation. In Europe CTIMPs have to follow the EU Directives and Regulation. Non pharmaceutical/non interventional healthcare research has no legal requirements to adhere to ICH GCP and is carried out under different research governance frameworks (RGF), however they all have their principles based on ICH GCP. The chapter also discusses the definition of an IMP and the decisions and processes that have to be followed when conducting non CTIMP studies.

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15

Glavin, Ronnie, Sven Staender, and Andrew Smith. Human factors and simulation in anaesthetic practice. Edited by Philip M. Hopkins. Oxford University Press, 2017. http://dx.doi.org/10.1093/med/9780199642045.003.0035.

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Human factors is the study of how interactions between organizations, tasks, and the individual worker impact human behaviour and affect systems performance. The importance of human factors in anaesthesia and critical care has been increasingly recognized, leading to its inclusion in the European-wide standards for patient safety in anaesthesiology within the Helsinki Declaration for Patient Safety in Anaesthesiology. ‘Person’ factors include permanent characteristics such as an individual’s personality and temporary influences such as physical condition, stress, morale, and workload. ‘Task’ factors include task complexity, preparation and checking, timing, equipment, and working environment. ‘Organization’ factors include communication, leadership, staffing levels, and organizational (safety) culture. While some of these features rely on the technical domain of anaesthetic/critical care practice, most are in the domain of ‘non-technical’ skills. This chapter reviews a number of these influences in detail and describes how non-technical aspects of practice can be encouraged and promoted. Simulation has been used as an educational tool in healthcare for some years, often with anaesthetists closely involved in establishing and running simulation centres and programmes. However, recent changes in medical education, coupled with public demands for increased patient safety, have brought simulation to the fore. This chapter reviews the classification of simulation systems and outlines the use of scenario-based and in situ simulation, before examining the evidence for its effectiveness. The authors emphasize that simulation provides a means for achieving an educational aim rather than being a technological end in its own right.

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