Open Journal Systems

LETTERS TO THE EDITOR

Response to comment on article: “Bioethics and traslational medicine”

Rodolfo Rivas-Ruiz^a

^aCentro de Adiestramiento en Investigación Clínica (CAIC), Coordinación de Investigación en Salud, Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, Distrito Federal, México

Communication with: Rodolfo Rivas-Ruíz

Telephone: (55) 8596 4707

Email: rivasrodolfo@gmail.com

Fortunately, it is increasingly common for scientific journals to include an endorsement by an ethics committee and the informed consent of participants in their requirements for the publishing of manuscripts.^1-3 However, that fact that we see published in the article that it meets the above criteria does not mean that the quality of obtaining informed consent has been adequate. As Dr. Jose Luis Sandoval Gutiérrez says so well, we do not doubt the good will of researchers, however, we recognize that obtaining truly informed consent involves a number of challenges. The first challenge is to include all necessary information and to do so with a limited number of words and simple language, and the second challenge in our practice as clinical researchers is that consent not be requested by the attending physician, that is to say, it should be requested by someone unaffiliated with the management of the patient.

The Council for International Organizations of Medical Sciences4 in collaboration with the World Health Organization state that the document of informed consent must contain 26 essential points, however, some of these points are unnecessary in observational studies. On the other hand, there is the task of identifying the potential participant’s degree of autonomy and decision-making capacity to identify if they are a person with one or several layers of vulnerability5 that could be at risk of exploitation by researchers and, if so, provide the person with additional protection. For example, it is necessary to examine whether the level of education, family status, cognitive status or age, among other features, put the individual at a disadvantage when deciding whether or not to join an investigation. It is also important to ensure that the potential participant truly understands the information that is provided, which can be achieved, for example, by asking them some questions on key points of the study: if they understood that their participation is voluntary and that they can withdraw from the study whenever they decide to, or if they understand that the study is not part of their regular medical care. Last but not least is to ensure that the decision to participate in the research study is made free from pressure. The Declaration of Helsinki6 mentions that, "when asking for informed consent in research participation, the physician should be particularly cautious if the potential subject is in a dependent relationship to him or her or may consent under duress. In such a situation, informed consent should be sought by an appropriately qualified individual who is completely independent of this relationship. It is possible that researchers who have no training in bioethics may consider this as counterintuitive because a doctor always seeks the best for his or her patient. However, in the field of research, benefits cannot be assured to patients beforehand because the existence of the benefits is being investigated.

Hence the importance of training in bioethics: although it is generally said that moral norms are inherent in human beings,7 bioethical guidelines for research cannot necessarily be deduced from common sense, and reviewing national and international documents is necessary as already mentioned. 8 Above all, we must put ourselves in the shoes of potential participants and give them the information as we would like them to give us if we were in their shoes.

References

1. [Cited 2015 May 3]. Available from: http://www.nejm.org/page/author-center/manuscript-submission
2. Instrucciones para autores. Rev Med Inst Mex Seguro Soc. 2014; 52(2):237-40
3. [Cited 2015 May 3]. Available from:http://jme.bmj.com/site/about/guidelines.xhtml
4. Pautas Éticas Internacionales para la Investigación Biomédica en Seres humanos. Preparadas por el Consejo de Organizaciones Internacionales de las Ciencias Médicas (CIOMS) en colaboración con la Organización Mundial de la Salud. Ginebra, 2002.
5. Florencia Luna. Vulnerabilidad: La metáfora de las capas. Jurisprudencia Argentina, IV, fascículo No 1, 2008, pp.: 60-67.
6. Declaración de Helsinki de la AMM - Principios éticos para las investigaciones médicas en seres humanos. 64^th Asamblea General, Fortaleza, Brasil, October 2013. World Medical Association.
7. Enmanuel Kant. Fundamentación de la metafísica de las costumbres.
8. 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.

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