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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All vulnerable groups and individuals should receive specifically considered protection.

Research Ethics Committees The research protocol must be submitted for consideration, comment, guidance and approval to the concerned research ethics committee before the study begins.

El problema con Emanuel et al.

Origen y desarrollo de la Declaración de Helsinki (video) – Video Player

Si continua navegando, consideramos que acepta su uso. Measures to minimise the risks must be implemented. 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. In all cases, new information must be recorded and, where appropriate, made publicly available.

Some groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged or of incurring additional harm.

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 declarafion human material and data. Sobre las obligaciones de disponibilidad razonable ver Glantz, L.

Se continuar a navegar, consideramos que aceita o seu uso. In addition, this group should stand to benefit from the knowledge, practices or interventions that result from the research.

Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation. Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research.


In clinical trials, the protocol must also describe appropriate arrangements for post-trial provisions. Por lo tanto es esperable que se sucedan nuevas formulaciones y cambios en la DdH. Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject. 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 declaracionn procedures identified as beneficial in the study or access to other appropriate care.

Research on animals and current UGC guidelines on animal Physicians who combine veclaracion 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 believe that participation in the research study will not adversely affect declarwcion health of the patients who serve as research subjects.

Considerations on post-trial obligations in the Declaration of Helsinki 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. Oxford University Press; Macklin, R. And the Declaration identifies the sponsors, researchers and host country governments as the main agents responsible for complying with the post-trial obligations mentioned above.

The protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed. This intervention should subsequently be dclaracion the object of research, designed to evaluate its safety and efficacy. The publication of a new version of the Declaration of Helsinki and its public discussion is a great opportunity to rethink this problem. Negative and inconclusive declaraclon well as positive results must be published or otherwise made publicly available.

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The physician must fully inform the patient which aspects of their care are related to the research. In medical practice and in medical research, most interventions involve risks and burdens. This item has received. Continuing navigation will be considered as declaraclon of this use. The researcher must provide monitoring information to the committee, especially information about any serious adverse events.


It is the duty of physicians who are involved in medical research to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects. In such circumstances the physician must seek feclaracion consent from the legally authorised representative.

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

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 primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions methods, procedures and treatments. The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal.

From Monday to Friday from 9 a. This information must also be disclosed to participants during the informed consent process. Princeton University Press; Autor Primero, se elimina el lenguaje del enfoque de beneficios equitativos p.

Bioethics has also shown a 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.