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.

Author: Moogusho Vozahn
Country: Brunei Darussalam
Language: English (Spanish)
Genre: Spiritual
Published (Last): 9 March 2005
Pages: 381
PDF File Size: 11.92 Mb
ePub File Size: 11.88 Mb
ISBN: 764-1-64727-132-8
Downloads: 67069
Price: Free* [*Free Regsitration Required]
Uploader: Tojazshura

The risks must be continuously monitored, assessed and documented by the researcher. Continuing navigation will be considered as acceptance of this use.

Considerations on post-trial obligations in the Declaration of Helsinki To justify this interpretation of the types, agents and beneficiaries of post-trial obligations, I first introduce a tentative classification of post-trial obligations. The welfare of animals used for research must be respected.

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

Se continuar a navegar, consideramos que aceita o seu uso. Every research study involving human subjects must be registered in a publicly accessible hhelsinki before recruitment of the first subject. Medical research should be conducted in a manner that minimises possible harm to the environment.

This website uses cookies to ensure you get the best experience on our website. When seeking informed consent for participation in a research study the physician must be particularly cautious if the potential subject is in a dependent relationship with the physician or may consent under duress. 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.

Participation by individuals capable of giving informed consent as subjects in medical research must be voluntary.

Research on patients or healthy volunteers requires the supervision of a competent xe appropriately qualified physician or other health care professional. All medical research involving human subjects must be preceded by careful helsijki of predictable risks and burdens to the individuals and groups involved in the research in comparison with foreseeable benefits to them and to other individuals or groups affected by the condition under investigation. In medical research involving human subjects capable of giving informed consent, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, post-study provisions and any other relevant aspects of the study.


Consistent with the mandate of the WMA, the Declaration is addressed primarily to physicians. Princeton University Press; Ce, A. Sources of funding, institutional affiliations and conflicts of interest must be declared in the publication. 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.

Vulnerable Groups and Individuals Measures to minimise the risks must be implemented. The research protocol must be submitted for consideration, veclaracion, guidance and approval to the concerned research ethics committee before the study begins.

Appropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured. 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. When a potential research subject who is deemed incapable of giving informed consent is able to give assent to decisions about participation in research, the physician must seek that assent in addition to the consent of the legally authorised representative.


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. Scientific Requirements and Research Protocols Physicians must consider the ethical, legal and regulatory norms and standards for research involving human subjects in their own countries helsinnki well as applicable international norms and standards.

In such circumstances the physician must seek informed consent from the legally authorised representative. For a potential research subject who is incapable of giving informed consent, the physician must seek informed consent from the helsinoi authorised representative.

Medical research involving human subjects must be conducted only by individuals with the appropriate ethics and scientific education, training and qualifications.

Declaración de Helsinki by Pamela Dorantes on Prezi

Reports of research not in accordance with the declaracionn of this Declaration should not be accepted for publication. 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 issues, in which the confrontation of rational arguments could lead to recognizing the differences but also to finding out certain points of convergence.

In addition, this group should stand to benefit from the knowledge, practices or interventions that result from the research. In clinical trials, the protocol must also describe appropriate arrangements for post-trial provisions. In such situations the research hlsinki be done only after consideration and approval of a research ethics committee.