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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The Declaration of Helsinki should be a mandatory, rather than optative, undertaking to comply, included in all the Consent Letters for participation in research trials by any human being. Continuing navigation will be considered as acceptance of this use.

In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. The primary purpose of medical research involving human subjects is to understand dwclaracion causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions methods, procedures and treatments.

Legal, ethical and practical issuesworkshop, http: Measures to minimise the risks must be implemented. Physicians who combine medical research with medical care should involve their patients in research only to the extent that this is justified by its potential preventive, diagnostic or therapeutic value and if the physician has good reason to df that participation in the research study will not adversely affect the health of the patients who serve as research subjects. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication.

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. The aim of this journal is that of adopting not only an interdisciplinary but also an delcaracion methodology, offering a space for a rigorous critical analysis of controversial issues, in which the confrontation of rational arguments could lead to recognizing the differences but also to finding out certain points of convergence.

Even the best proven interventions must be evaluated continually through research for their safety, effectiveness, efficiency, accessibility and quality.

According to my interpretation, the Declaration of Helsinki identifies two different types of post-trial obligations, namely, 1 obligations of access to health care and 2 the obligations of access to information. El problema con Emanuel et al. The scope of this journal will correspond to the wide horizon of themes and problems that are now included in the domain of bioethics, and special stress will be laid on the interdisciplinary methodology required for a profitable work in this field.


No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this Declaration. There may be exceptional situations where consent would be impossible or impracticable to obtain for such research. If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed.

Negative and inconclusive as well as positive results must be published or otherwise made publicly available. The problem of transitioning research participants when the study is concluded to the appropriate health care is a global problem.

For a potential research subject who is incapable of giving informed consent, the physician must seek informed consent from the legally authorised representative. Scientific Drclaracion and Research Protocols This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy.

The risks declaraciion be continuously monitored, assessed and documented by the researcher. The protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed.

Declaracion de Helsinki by gerardo calderon on Prezi

Previous article Next article. Groups that are underrepresented in medical research should hdlsinki provided appropriate access to participation in research. Use of Placebo The World Medical Association WMA has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.

From Monday to Friday from 9 a. Philosopher’s Index See more Follow us: Research Registration and Publication and Dissemination of Results Facultat de Dret, Universitat de Barcelona, Avda. Are you a health professional able to prescribe or dispense drugs?

Consistent with the mandate of the WMA, the Declaration is addressed primarily to physicians. Sobre las obligaciones de disponibilidad razonable ver Glantz, L.

These individuals must not be included in a research study that has no likelihood of benefit for them unless it is intended to promote the health of the group represented by the potential subject, the research cannot instead be performed with persons capable of providing informed consent, and the research entails only minimal risk and minimal burden. 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.


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. Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject.

WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects

You can change the settings or obtain more information by clicking here. In such situations the research may be done only after consideration and approval of a research ethics committee. Ver Rawlsop. Researchers have a df to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports.

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:.

Medical progress is based on research that ultimately must include studies involving human subjects. Participation by individuals capable of giving informed consent as subjects in medical research must be voluntary. In advance of a clinical trial, sponsors, researchers and host country helsjnki should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial.

This paper presents a framework of ethical considerations regarding research on human beings, to outline a number of proposals and argumentations on the Declaration of Helsinki Articles 2, 15, 19, 23, 32, 33, In addition, this group should stand to benefit from the knowledge, practices or interventions that result from the research.

Appropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured.