Mexican Regulation of Biobanks

Author:

Motta-Murguia Lourdes,Saruwatari-Zavala Garbiñe

Abstract

Biobank-based research in Mexico is mostly governed by research and data protection laws. There is no direct mention of biobanks in either statutory or regulatory law besides a requirement that the Federal Ministry of Health and a Mexican institution devoted to scientific research approve the transfer of biological materials outside of Mexico for population genetics research purposes. Such requirements are the basis of Genomic Sovereignty in Mexico, but such requirements have not prevented international collaboration. In addition, Mexican law singles out genetic research in informed consent provisions, but it does not specify whether all biobank-based research is genetic research. In order to facilitate international collaboration on biobank-based research, Mexico should directly address biobanking in its laws, building on the research framework and data protection framework already in place.

Publisher

Cambridge University Press (CUP)

Subject

Health Policy,General Medicine,Issues, ethics and legal aspects

Reference43 articles.

1. 6. Constitutional Reform Act published in the Diario Oficial de la Federación [Federal Official Journal] on February 3, 1983.

2. 8. IMSS: Instituto Mexicano del Seguro Social (Mexican Institute of Social Security); ISSSTE: Instituto de Seguridad Social y Servicios Sociales de los Trabajadores del Estado (Institute of Social Security and Social Services for the Public Servants); PEMEX: Petróleos Mexicanos (Mexico’s State owned Oil Company); and SEDENA: Secretaría de la Defensa Nacional (Ministry of National Defense).

3. 19. Article 100.-Research in humans will be developed pursuant to the following basis: “I. It shall be adjusted to the scientific and ethical principles that justify the medical research, particularly concerning its possible contribution to the solution of health problems and the development of new fields of medical science; II. It may only be conducted when the knowledge it aims to generate cannot be obtained through another suitable method; III. May only be carried out when there is reasonable assurance that the subject under experimentation shall not be exposed to unnecessary risks or damages; IV. It must have the informed written consent of the subject in whom the research will be carried out, or, in the event of legal inability of the subject, the written consent of their legal representative, once aware of the objectives of the experiment and the possible positive or negative health consequences; V. It may only be conducted by health professionals in medical institutions acting under the supervision of the competent health authorities. Conducting population genomic studies must be part of a research project; VI. The responsible professional shall suspend the investigation at any time if the risk of serious injury, disability, or death of the subject in whom the research is conducted, occurs; VII. It is the responsibility of the health care institution to provide medical care for the subject who has suffered any damage, if it were directly related to the research, without prejudice to the compensation legally due, and VIII. Any others established by the corresponding regulations.”

4. 37. Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects, adopted by the 18th WMA General Assembly in Helsinki, Finland, in June, 1964, last reviewed at the 64th WMA General Assembly in October, 2013, available at (last visited February 10, 2016).

5. 17. Please note that ‘Bis’ is a prefix or suffix designating the second instance of a thing. It is commonly used within the context of legislative drafting when an amendment is aimed to include a new article, paragraph or fraction after another one that already exists, in order to avoid renumbering an entire law.

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