The Commission for Protection against Sanitary Risks issued new guidelines in June 2012 regarding good practices in health research activities. These guidelines were not published in the Federal Official Gazette, but they are expected to be mandatory for those individuals or legal entities engaged in activities related to health research as defined in the General Health Law Regulations in Health Research Matters (“Regulations”).
These new guidelines establish various definitions, among which we note the Sponsor and Contract Research Organization provisions that are not currently included in the Regulations:
- Contract Research Organization is defined as those individuals or legal entities contracted by a Sponsor (as defined in the guidelines) and to which all or part of the research activities promoted by the Sponsor are contractually transferred.
- Sponsors are defined as individuals or legal entities that are willing to finance totally or partially a health research protocol, and who will be considered liable for any and all activities related to such projects or protocols.
These guidelines also further develop various provisions included in the Regulations. Among these are obligations and requirements for the operation of the Ethical Committees of the Institutions where the research will take place. Likewise, various obligations and guidelines for the principal investigator are established.
Although these guidelines may be very useful for the practice of these activities, these guidelines do not in our view create legal obligations contemplated by the General Health Law and its Regulations for individuals or legal entities that are not legally responsible for health-related research activities, although they may participate indirectly in health-related research. Failure to comply with these guidelines may not be punishable in accordance with the current provisions. In our view, these guidelines should be included in the corresponding law.
José Alberto Campos-Vargas
Mexico City, Mexico
Mexico City, Mexico