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LETTERS TO THE EDITOR

Comment on article: “Bioethics and traslational medicine”

José Luis Sandoval-Gutiérrez^a

^aDepartamento de Áreas Críticas, Instituto Nacional de Enfermedades Respiratorias, Distrito Federal, México

Communication with: José Luis Sandoval-Gutiérrez

Email: sandovalgutierrez@gmail.com

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Perez Rodriguez et al.¹ present an interesting writing on clinical trial ethics in human research; in it they describe the little interest in medical publications in emphasizing whether the study had the approval of the ethics committee or if informed consent was used with the subject of experimentation.
Despite global efforts by the code of Helsinki,² good clinical practices,³ and research codes of conduct in each institution that conducts research, studies are still published with large numbers of patients and it is assumed that consent was granted by subjects and with the authorization of the local ethics committee.

The good will of researchers and clinicians involved in the study has never been doubted, but patients (or their families) can hardly understand the needs and commitment that consent entails (total number of samples, hours of waiting, repeat study, biopsies, etc.).

Usually informed consent ends up neither consenting nor informed, for it is daunting to consider that a patient will understand the 30 pages that an informed consent can be, especially if this involves the pharmaceutical industry; the researcher involved will usually talk with the patient about the study characteristics, but in the end the researcher-patient relationship is the key for the latter authorize their participation.

Unfortunately, many non-clinical researchers currently participating in thousands of studies worldwide, do not have as their strength oral communication with patients, meaning that sometimes patients are not 100% sure what they will face.

Publications such as that which prompted this letter in response, in the future will urge researchers on the dire need for every formality of bioethics in their future work, for the benefit of patients and themselves.

References

1. Pérez Rodríguez M, Palacios Cruz L, Rivas Ruiz R, Talavera J. Del juicio clínico a la ética en la investigación en humanos. Rev Med Inst Mex Seguro Soc 2014;52(6):666-72.
2. Declaración de Helsinki. Asamblea Médica Mundial. Disponible en: http://www.saludinvestiga.org.ar/pdf/resoluciones/Guia-de-BPC.pdf(acceso: 04 enero de 2015).
3. Guía de buenas prácticas clínicas de investigación en salud humana. Ministerio de Salud, Argentina. Disponible en: http://www.wma.net/es/30publications/10policies/b3/17c_es.pdf (acceso: 03 enero de 2015).              

 

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