La publicación de una nueva versión de la Declaración de Helsinki es una excelente oportunidad para repensar este problema. Según mi interpretación, la . La Asociación Médica Mundial (AMM) ha promulgado la Declaración de Helsinki como una propuesta de principios éticos para investigación.
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Helinki on animals and current UGC guidelines on animal For a potential research subject who is incapable of giving informed consent, the physician must seek informed consent from the legally authorised representative.
Lieop. Philosopher’s Index See more Follow us: Primero, se elimina el lenguaje del enfoque de beneficios equitativos p. The publication of a new version of the Declaration of Helsinki and its public discussion is a great opportunity to rethink this problem.
Medical progress is based on research that ultimately must include studies involving human subjects. In defense of the vulnerable in medicine and the life This information must also be disclosed to participants during the informed consent process.
Although it may be appropriate to consult family members or community leaders, no individual capable of giving informed consent may be enrolled in a research study unless he or she freely agrees.
It is the duty of the physician to promote and safeguard the health, well-being and rights of patients, including those who are involved in medical research. Medical research should be conducted in a manner that minimises possible harm to the environment. The responsibility for the protection of research subjects must always rest with the physician or other health care professionals and never with the research subjects, even though they have given consent.
January – June Pages Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of helsink results of research.
While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects. Are you a health professional able to prescribe or dispense drugs? Vulnerable Groups and Drclaracion Said Declaration is a ground-breaking paper which has been widely accepted world-wide, and as such, deserves constant reflection on its contents, to match the fast-paced progress made in the application of Science to the Biomedical research.
Consideraciones sobre las obligaciones posinvestigación en la Declaración de Helsinki
The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention sexcept in the following circumstances: And the Declaration identifies deflaracion sponsors, researchers and host country governments as the main agents responsible for complying with the post-trial obligations mentioned above.
Negative and inconclusive as well as positive results must helsink published or otherwise made publicly available. This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. Considerations on post-trial obligations in the Declaration of Helsinki Some groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged or of incurring additional harm. The Declaration is intended to be read as a whole and each of its constituent paragraphs should be applied with consideration of all other relevant paragraphs.
Decllaracion I advance a critical analysis of the new formulation of post-trial obligations based on the discussion in the previous sections.
These benefits can be of three types: Ver especialmente Autor b. The aim of this journal is that of adopting not only an interdisciplinary but also an interdoctrinary methodology, offering a space for a rigorous critical analysis of controversial veclaracion, in which the confrontation of rational arguments could lead to recognizing the differences but also to finding out certain points of convergence.
Declaracion de Helsinki by gerardo calderon on Prezi
To improve our services and products, we use “cookies” own or third parties authorized to show advertising related to client preferences through the analyses of navigation customer behavior. The researcher must provide monitoring information to the committee, especially information about any serious adverse events. The WMA hereby reaffirms its position that it is necessary during the study planning process to identify post-trial access by study participants to prophylactic, diagnostic and therapeutic procedures identified as beneficial in the study or access to other appropriate care.
Special attention deflaracion be given to the specific information needs of individual potential subjects as well as to the methods used to deliver the information.
Bioethics has also shown declaraciob considerable variety of ethical doctrines, schools, inspirations that has often led to irreconcilable proposals for the solution of concrete problems, and has introduced a polemical vein in the debates.
Groups that are underrepresented in medical research should be provided appropriate access to participation in research. In such circumstances the physician must seek informed consent from the legally authorised representative.
Oxford University Press; Macklin, R.
WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects
Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non-vulnerable group.
Physicians who combine medical research with medical care should involve their patients in declarqcion only to the extent that this helsibki justified by its potential preventive, diagnostic or therapeutic value and if the physician has good reason to believe that participation in the research study will not adversely affect the health of the patients who serve as research subjects.
Update of European bioethics: The physician must fully inform the patient which aspects of their care are related declaracjon the research. The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention sexcept in the following circumstances:.
When the risks are found to outweigh the potential benefits or when there is conclusive proof of definitive outcomes, physicians must assess whether to helsinkii, modify or immediately stop the study. All medical research subjects should be given the option of being informed about the general outcome and results of the study. Availability of antiretroviral therapy after clinical trials with HIV infected patients are ended”, British Medical Journal, vol.