Custom search User Password User ••••• Login Login Forgot your password? Forgot your username? Home | Directory | Contact | Site Map | Help . Copy of today Procedures Services Laws and Regulations Search Search ... Frequent questions DOF: 04/01/2013 Mexican Official NOM-012-SSA3-2012, which establishes the criteria for the execution of projects of research for health in humans. On the margin a seal with the National Shield, which says: United Mexican States.- Ministry of Health. GERMAN ENRIQUE FAJARDO DOLCI, Under Secretary of Integration and Development of the Health Sector and Chairman of the Committee National Consultative Standardization of Innovation, Development, Technologies and Information in Health, based on the provided by articles 39 of the Organic Law of the Federal Public Administration; 4th. of the Federal Procedure Law Administrative, 3rd. fraction XI, 38 fraction II, 40 fractions III and XI, 41, 43, 47 fractions III and IV of the Federal Law on Metrology and Normalization; 2nd. fraction VII, 3rd. fractions I, II and IX, 13 section A fractions I, II and IX, 45, 48, 78, 79, 81, 96, 98, 99, 100, 101, 102 and 103 of the General Health Law; 28 and 34 of the Regulation of the Federal Law on Metrology and Standardization; 3rd, 4th, 5th, 22, 62, 78, 108, 115, 116 and 119 of the Regulations of the General Health Law on Health Research; 2nd. section A fraction I, 8th. fraction V and 9o. section IV Bis of the Internal Regulations of the Ministry of Health, may I order the publication in the Official Gazette of the Federation of Mexican Official Standard NOM-012-SSA3-2012, which establishes the criteria for the execution of research projects for human health. CONSIDERING That on November 5, 2009, the draft of this standard was published in the Official Gazette of the Federation, in compliance with its approval by the National Consultative Committee for the Standardization of Innovation, Development, Technologies and Information in Health; in accordance with the provisions of article 47 section I of the Federal Law on Metrology and Standardization, so that in the following 60 calendar days after said publication, the interested parties will submit your comments to the National Consultative Committee for the Standardization of Innovation, Development, Technologies and Information in Health. That during the 60-day Public Consultation period, which ended on January 5, 2010, were received at the headquarters of the mentioned Committee, comments regarding the Draft Mexican Official Standard, why they were previously dated published in the Official Gazette of the Federation the answers to the comments received by the aforementioned Committee, in the terms of article 47 section III of the Federal Law on Metrology and Standardization. That in view of the above considerations, with the approval of the National Advisory Committee of Standardization of Innovation, Development, Technologies and Health Information, the following is issued: OFFICIAL MEXICAN STANDARD NOM-012-SSA3-2012, ESTABLISHING CRITERIA FOR THE EXECUTION OF RESEARCH PROJECTS FOR HEALTH IN HUMAN BEINGS PREFACE In the elaboration of this norm they participated: GENERAL HEALTH COUNCIL HEALTH SECRETARY Undersecretariat of Integration and Development of the Health Sector General Directorate of Quality and Health Education Coordinating Commission of National Institutes of Health and High Specialty Hospitals Ignacio Chavez National Institute of Cardiology National Institute of Medical Sciences and Nutrition Salvador Zubirán National Institute of Respiratory Diseases Ismael Cosío Villegas National Institute of Neurology and Neurosurgery Manuel Velasco Suárez National institute of pediatrics National Institute of Perinatology Isidro Espinosa de los Reyes National Institute of Psychiatry Ramón de la Fuente Muñiz National Institute of Rehabilitation National Institute of Genomic Medicine National Institute of Public Health General Hospital of Mexico Dr. Manuel Gea González General Hospital Children's Hospital of Mexico Federico Gómez Juarez Hospital of Mexico Federal Commission for Protection against Health Risks National Medical Arbitration Commission National Health Council INSTITUTE OF SECURITY AND SOCIAL SERVICES OF STATE WORKERS Medical address SECRETARY OF NATIONAL DEFENSE General Directorate of Military Health NATIONAL INSTITUTE OF STATISTICS, GEOGRAPHY AND INFORMATICS SECRETARY OF PUBLIC EDUCATION CHECK FOR DATE Undersecretary of Higher Education General Directorate of Higher University Education Jan 2013 NATIONAL SCIENCE AND TECHNOLOGY COUNCIL Do Lu Ma Mi Ju Vi Sá AUTONOMO NATIONAL UNIVERSITY OF MEXICO 1 2 3 4 5 Faculty of Medicine 6 7 8 9 10 11 12 NATIONAL POLITECHNICAL INSTITUTE 13 14 15 16 17 18 19 Higher School of Medicine 20 21 22 23 24 25 26 National School of Medicine and Homeopathy 27 28 29 30 31 ANAHUAC UNIVERSITY Medical School Create User LA SALLE UNIVERSITY Advanced search School of Medicine ASOCIACION NACIONAL DE HOSPITALES PRIVADOS, A.C. News NATIONAL CHAMBER OF INDUSTRY FARMACEUTICA, A.C. Top Notes MEXICAN FOUNDATION FOR HEALTH, A.C. Complaints and suggestions HOSPITAL ANGELES DE LAS LOMAS, S.A. OF C.V. AMERICAN BRITISH COWDRAY HOSPITAL, I.A.P. Get Copy of DOF HOSPITAL MEDICA SUR, S.A. OF C.V. Publications Relevant SOCIEDAD DE LA BENEFICENCIA ESPAÑOLA, I.A.P. Verify DOF Copy INDEX Relevant Links 0. Introduction 1. Objective Contact Us 2. Application field RSS filters 3. References History of the Official Gazette 4. Definitions Statistics 5. General Government Vacancies 6. The presentation and authorization of research projects or protocols 7. The follow-up of the investigation and the technical-descriptive reports Former workers Migratory 8. Of the institutions or establishments where an investigation is carried out 9. On the constitution, registration and operation of the Research, Ethics in Research and Biosafety Committees 10. From the Principal Investigator INDICATORS 11. The physical and legal security of the subject of investigation 12. Of the information involved in investigations Exchange Rate and Rates at 13. Concordance with international and Mexican standards 01/24/2020 14. Bibliography DOLAR UDIS 15. Surveillance 18.8018 6.432402 16. Validity 0. Introduction TIIE 28 DAYS TIIE 91 DAYS Scientific, clinical, biomedical, technological and biopsychosocial research in the field of health, are determining factors 7.5225% 7.4200% to improve actions aimed at protecting, promoting and restoring the health of the individual and society in general, so that it is essential to guide their development in specific matters and regulate their execution in human beings, in such a way so that the guarantee of the care of the ethical aspects, of the well-being and physical integrity of the person participating in a TIIE DE research project or protocol and respect for their dignity, become the rule of conduct for any FONDEO researcher from the health area. 7.20% This standard defines the minimum elements that must be compulsorily fulfilled by researchers who carry out this activity in human beings, in accordance with the provisions that in this matter are established on an indispensable basis to see the Ministry of Health as a health authority, as established by the General Law of Health itself and its Regulations in more of research for health. In this sense, once the mandatory provisions established by the legal framework have been fulfilled Mexican health, who conduct research for human health; they must adapt to the scientific principles and ethics that justify the medical research found in universally accepted international instruments and to the criteria that the National Bioethics Commission issues in the matter. SURVEYS 1. Objective This standard establishes the normative criteria of an administrative, ethical and methodological nature, which corresponds to the Did you like the new image General Health Law and the Regulation on health research, are mandatory to request the authorization of projects or protocols for research purposes, for the use in humans of medicines or of the Journal's website materials, for which there is still insufficient scientific evidence of its therapeutic or rehabilitative efficacy or is it an Official of the Federation? intend the modification of therapeutic indications of already known products, as well as for the execution and monitoring of said projects. No Yes 2. Field of application This rule is mandatory, for any health professional, institution or establishment for care medical of the public, social and private sectors that intend to carry out or conduct research activities for health in human beings, with the characteristics indicated in the objective of the present norm. 3. References Vote For the correct interpretation and application of this standard, it is necessary to consult the following Official Mexican Official Rules or those that replace them: 3.1 Official Mexican Standard NOM-004-SSA3-2012, Of the clinical file. 3.2 Official Mexican Standard NOM-220-SSA1-2002, Installation and operation of pharmacovigilance. 4. Definitions For the purposes of this standard, the following definitions shall apply: 4.1 Medical care, to the set of services provided to the individual in order to promote, protect and restore their Health. 4.2 Authorization of an investigation for the health in human beings, to the administrative act by means of which, the Ministry of Health allows the health professional to carry out health research activities, in which the human being is the research subject, for the use of medicines or materials according to the objective of this rule. 4.3 Informed consent letter on research, to the written document, signed by the researcher principal, the patient or his relative, guardian or legal representative and two witnesses, through which the subject of investigation accepts Participate voluntarily in an investigation and have an experimental maneuver applied once you have received the Sufficient, timely, clear and truthful information about the expected risks and benefits. The names of the witnesses, address and the relationship they have with the subject of investigation. 4.4 Committees on health research, to all professionals belonging to an institution or establishment where health research or other sectors are carried out, responsible for reviewing, approving and monitoring that research projects or protocols are carried out in accordance with the scientific principles of research, ethics in research and biosafety dictated by the medical lex artis and in accordance with the Mexican legal-health framework. 4.5 Adverse effect, to the set of signs and symptoms not calculated and unexpected that occur in a subject of research, as a result of the application of experimental maneuvers provided for in a protocol or project of research for health in humans and potentially representing a risk to their health. 4.6 Amendment, any change to a document that is part of the research project or protocol, derived from variations in the methodological structure, replacement of the principal investigator or in the identification of risks in the subjects of investigation. The documents subject to amendment are: project or protocol, informed consent letter, manual of the investigator, documents for the patient, measurement scales and schedule. 4.7 Sufficient scientific evidence, knowledge of which the validity of its content can be confirmed as true, with Certainty and without a doubt. 4.8 Annual report, to the document to be submitted by the Research Committees, Research Ethics and Biosafety to the Ministry of Health during the first 10 business days of the month of June of each year, on integration and activities of said Committees. 4.9 Final technical report, to the document presented by the principal investigator to the Ministry of Health, to communicate the final results of a research protocol or project in accordance with the objective and field of application of This rule, as well as, the main findings obtained at the beginning, during and at the end of the execution. 4.10 Partial technical report, to the document to be submitted by the principal investigator to the Ministry of Health in any time or at least once a year, to communicate the progress and partial results of an investigation, according to the objective and Field of application of this standard. 4.11 Institution or establishment where health research is carried out, to all those where they are provided health care services, belonging to the public, social or private sectors, whatever their denomination, which can carry out preventive, diagnostic, therapeutic and rehabilitation activities, by itself or subrogated, aimed at maintain or reintegrate people's health status and carry out training and staff development activities for the Health as well as research. 4.12 Research for health in human beings, in which the human being is the subject of research and who develops with the sole purpose of making scientific and technological contributions, to obtain new knowledge in health matter. 4.13 Principal investigator, the health professional, to whom the Ministry of Health authorizes a project or protocol for the execution of a research for health in human beings, in accordance with the objective and scope of this standard and is responsible for conducting, coordinating and monitoring the development of said research. 4.14 Lex artis medical, set of rules and knowledge generated for the practice of medicine, contained in different means of storage, conservation and consultation, about techniques and procedures that have been universally accepted, which are based on the scientific and ethical principles that guide medical practice. 4.15 Experimental maneuver, to the use of medicines or materials, for which there is no evidence yet Sufficient science of its therapeutic or rehabilitative efficiency or the modification of the therapeutic indications of products already known, in a research subject, with the purpose of obtaining scientific information regarding the effectiveness of its use for preventive, diagnostic, therapeutic or rehabilitative purposes. 4.16 Medicines or materials, to the principles of phamacolological, chemical, biological, materials and medical devices, used or applied in human beings for scientific research purposes, for which there is no evidence scientific enough to prove its preventive, therapeutic or rehabilitative efficacy. 4.17 Modification, any change of administrative type that does not alter the research project or protocol, such as: change of address, business name, change in the integration of the researcher's team or work group, among others. 4.18 Sponsor, natural or legal person who accepts responsibilities that are expressed in writing, to participate and fully or partially finance a research project or protocol. 4.19 Invasive procedure, is one that uses one or several medical techniques that invade the body, with an end Diagnostic or therapeutic. 4.20 Research project or protocol for human health, to the document describing the proposal for an investigation for human health, in accordance with the objective and scope of this standard, integrated at least by the chapters of: planning, programming, organization and budgeting; methodologically structured and systematized in its different phases of work, which will be carried out under the responsibility, conduct and supervision of a principal investigator. 4.21 Subject of investigation, to the individual who gives his informed consent, by himself or by conduct of his legal representative, so that in his person certain procedures are carried out for research purposes Health in humans. 5. General 5.1 For the purposes of this standard, when mention is made of "Regulation", "Secretariat", "investigation" and "institution", will understand that it is the Regulation of the General Health Law regarding health research, the Secretariat of Health, research for human health and the institution or establishment where research is conducted for health, respectively. 5.2 Any research project or protocol for the use of medicines or materials, for which they have not yet there is sufficient scientific evidence of their therapeutic or rehabilitative efficacy or the modification of the therapeutic indications of already known products, you must have authorization from the Secretariat before starting your development 5.3 The Secretariat, for the granting of the authorization of an investigation for health in human beings according to the objective and field of application of this standard, you must confirm that in the research oprotocol project, the criteria of respect for the dignity of the research subject, the protection of their rights, mainly that of the protection of health, as well as the well-being and conservation of their physical integrity. 5.4 It is the power of the Secretariat, within the scope of its competence, and in accordance with the applicable legal provisions, monitoring and control of research projects or protocols authorized according to the objective and scope of application of This standard, which must conform to the scientific and ethical principles that guide medical practice. 5.5 All research must ensure that it does not expose the research subject to unnecessary risks and that the benefits Expected are greater than the predictable risks inherent in the experimental maneuver. In the case of investigations in minors or disabled persons, the provisions of articles 38 and 39 of the Regulation. In pregnant women, what is specified in article 44 of the same system must be taken into account. 5.6 For the authorization of an investigation, according to the objective and field of application of this standard, the project or Research protocol should fully describe the elements and conditions that allow the Secretariat to evaluate the Safety assurance of the research subjects, where appropriate, may observe Good Clinical Research Practices. 5.7 All research must ensure in a clear, objective and explicit way, the free of the experimental maneuver for the research subject, which should be considered in the research budget, in accordance with the numeral 10.6, of this standard. 5.8 In any research project or protocol, its duration should be estimated, so it is necessary that the tentative start and end dates, as well as the period calculated for its development. 5.9 The conditions described in the research project or protocol, including the estimated start and end dates, as well as the necessary number of research subjects, will be considered indispensable requirements for the authorization of a research for health in humans. 5.10 The justification of the research projects or protocols presented with the request for authorization of a Human health research should include: sufficient information and technical elements to suppose that the knowledge that is intended to be acquired, it is not possible to obtain them by other means. 5.11 The principal investigator, as well as other health professionals and technicians involved in an investigation, they must comply ethically and professionally with the obligations imposed by the General Health Law and the Regulations, as well Like this norm 5.12 In any investigation, the files of the research subjects will be considered clinical records, so that must comply with the provisions of the Official Mexican Standard, referred to in paragraph 3.1 of this standard. 5.13 Whoever conducts an investigation without complying with the provisions of this standard, will become creditor to the sanctions that establishes the General Health Law and its Regulations. 5.14 The availability of a financial fund should be included in the research budget, as well as the mechanisms to guarantee the continuity of medical treatment and compensation to which the subject of law will legally be entitled investigation, in case of suffering damages directly related to it; where appropriate, this financial fund can be covered with study insurance. 5.15 In establishments in the public, social and private sectors, where projects or protocols for development are developed research for human health, the health officer, legal representative or person empowered to do so, may request conformity assessment with respect to this standard, before the accredited and approved bodies for said standard purpose. 6. The presentation and authorization of research projects or protocols 6.1 In order to request the authorization of a research for health in human beings, in accordance with the objective and Field of application of this standard, interested parties must complete the procedure before the Secretariat, using the format correspondent. 6.2 Annex to the authorization request format, the research project or protocol must contain at least following elements: 6.2.1 Project title or research protocol; 6.2.2 Theoretical framework; 6.2.3 Definition of the problem; 6.2.4 Background; 6.2.5 Justification; 6.2.6 Hypothesis (if applicable); 6.2.7 General objective (where appropriate, specific objectives); 6.2.8 Material and methods; 6.2.9 Design: inclusion and exclusion criteria, capture, processing, analysis and interpretation of information; 6.2.10 Bibliographic references; 6.2.11 Names and signatures of the principal investigator and associated investigators (indicate a maximum of 5, in order of research participation); Y 6.2.12 Other documents related to the research project or protocol. 6.3 To the application form for the authorization of a research project or protocol, a free writing must be attached, containing the following information: 6.3.1 Identification data, which integrates the title of the research project or protocol, name of the researcher and institution or establishment where the research will be carried out, as well as, where appropriate, the unit, department or services to the That will be attached. 6.3.2 List of documents, among which at least the following will be delivered: 6.3.2.1 Description of the risk level of the study, in accordance with Article 17 of the Regulation. 6.3.2.2 Expected duration: indicating month and year, of the estimated start and end dates, as well as the calculated period for the development of research. 6.3.2.3 Type of investigation in question; 6.3.2.4 External support: name of the institution or establishment and type of support (human, material, financial resources, advice, information and others); 6.3.2.5 Simple copy of the registration form of the Research Committees, Research Ethics and, where appropriate, of Biosafety, with acknowledgment of receipt from the Secretariat. 6.3.2.6 Letter of authorization from the head of the institution or establishment to carry out the investigation or part of she in her facilities; 6.3.2.7 If applicable, letter of express acceptance of the position of the research sponsor, in which it is required to be The obligations and rights that the research project or protocol imposes on the sponsor are indicated and accepted. In the In the case of legal persons, the position must be accepted by the person empowered to do so or by their legal representative, of according to its organic structure or constitutive regime; 6.3.2.8 Favorable opinion of the Research and Ethics Committees in Research of the institution or establishment in The investigation will be carried out. In case the use of ionizing radiation or engineering techniques is included genetic, the favorable opinion of the Biosafety Committee will also be necessary; 6.3.2.9 Generic description of the resources available for the management of medical emergencies, according to the type of research study that develops. Medical care must be provided with own resources or through third parties, this fact must be recorded in the content of the generic description referred to in this numeral; Y 6.3.2.10 Model informed consent letter on research. 6.3.2.11 Where appropriate, interested parties may submit with their application for authorization of the project or protocol of investigation, opinion issued by a third party authorized for this purpose by the Ministry of Health, under the terms of article 102 of the General Health Law. 6.4 The authorization of a research for human health does not authorize the commercialization of medications, procedures or resulting devices, even when the conclusion of the investigation has been made official, by delivery and acknowledgment of receipt of the final report. 7. The follow-up of the investigation and the technical-descriptive reports 7.1 Follow-up tasks are considered: the preparation and delivery to the Secretariat of a technical-descriptive report of partial, with respect to the progress of the investigation in question and at the end of the investigation, one of a final nature, which describes The results obtained. 7.1.1 When results are obtained with technological applications, the area in which the contributions will be provided must be indicated knowledge gained, among which the following stand out: the methodological, technical, clinical procedures area, epidemiological, new medications or improvement of existing ones, biological products for use in humans, medical equipment, prostheses, orthotics and functional aids, healing material, surgical and hygienic products, diagnostic agents or others. 7.2 The head of the institution or establishment, the Research Committees, Research Ethics or Biosafety, the Principal investigator and, where appropriate, the sponsor, will be responsible in accordance with their field of competence in matters of: a) Research follow-up; b) Health damage arising from the development of research; as well as those damages derived from the interruption or early suspension of treatment for causes not attributable to the subject of investigation; c) Timely compliance with the terms in which the authorization of an investigation for health of human goods has been issued; d) Timing of the information that must be presented to the Secretariat. 7.3 The Secretariat will monitor the investigations for the greeting of human beings, through the exercise of their administrative and legal-sanitary powers, among which is health surveillance. 7.4 Technical-descriptive reports 7.4.1 The partial or final technical-descriptive reports must contain at least the following elements: 7.4.1.1 Identification data, which will include the partial or final character of the report, the start date of the study and the phase, period or stage of the study in relation to the reported results or advances in question; 7.4.1.2 Material and methods, mentioning the devices and instruments and referring to the control mechanisms of quality and safety with which they were used; 7.4.1.3 Results, which must be presented descriptively, supported by tables, graphs, drawings or photographs, as the case may be, to which the corresponding analysis and interpretation must be attached; 7.4.1.4 Conclusions, which should describe whether or not they were related to the hypothesis (s), as well as to the objectives raised in the research project or protocol; 7.4.1.5 Bibliographic references, only those that served as the basis for planning and execution of the research, as well as for the analysis of the results; Y 7.4.1.6 The annexes that the investigator considers necessary for the sustenance of the technical-descriptive report or those required the institution or establishment where the investigation is carried out. 7.4.2 The principal investigator shall submit to the Secretariat a partial or final technical-descriptive report as appropriate, of the progress of the investigation and will have the responsibility of delivering a copy of each report to the head of the Committees of Research, Ethics in Research and, where appropriate, Biosafety, of the institution or establishment where the investigation. 7.4.3 The Secretariat has the power to request additional information or rethink the investigation, when consider that the information provided is insufficient, not clear or does not meet the requirements established by the Law General de Salud, the Regulation, this and other Mexican Official Norms, as well as the other legal systems applicable. 7.4.4 When the information contained in the technical-descriptive reports or the confirmation of the fact, it is possible to verify that the investigation has not been carried out in accordance with the initial research project or protocol, which served as the basis for the issuance of the original authorization, the health authority must establish an administrative procedure against the principal investigator and, where appropriate, may revoke said authorization and suspend the investigation, without prejudice to the sanctions that correspond to the facts possibly constituting a crime. 7.4.5 In the event that the research is sponsored by any public or private body, it must be ensured that it does not will generate conflicts of interest that may cause the interruption of the treatment for the research subject, for which a detailed explanation of the resources available and the form must be attached to the research project or protocol in which they will be provided and distributed. 8. Of the institutions or establishments where an investigation is carried out 8.1 All research in human beings must be carried out in an institution or establishment, which must have the infrastructure and sufficient resolution capacity to provide adequate medical care or, where appropriate, through third parties, in the presence of any adverse effect of the experimental maneuver expressed in the project or protocol of Authorized investigation 8.2 The head of the institution or establishment and the corresponding Health Research Committees, they must act impartially and objectively, with strict adherence to ethical and scientific principles, in all matters that are detach from the investigation that is being carried out in their facilities, especially when it comes to attending the Complaints made by research subjects, by themselves or through their legal representatives. 8.3 Authorizations or consent regarding research projects or protocols issued by the owner of the institution or establishment or their respective Committees, must be prepared and signed separately. 8.4 Every institution or establishment in whose facilities an investigation is conducted, you must supervise and ensure that its development is in charge of health professionals, with adherence to the scientific and ethical principles that guide the practice medical and that research subjects are not exposed to damage or unnecessary risks or greater than the benefits expected 8.5 Health care cannot be conditioned on a person in exchange for giving consent to participate or continue participating in an investigation. 8.6 Every institution or establishment, in which an investigation is carried out or intended to be carried out, must have a service for medical emergency care. In your case, you must have an agreement signed with an establishment for medical care with greater resolution capacity, which, as a third party, provides such emergency care. 8.7 The head of the institution or establishment must notify the Secretariat of any adverse effects arising from the experimental maneuver, within a maximum period of 15 working days from its presentation, which includes the measures of care taken, the sequelae identified, as well as a detailed report on the physical condition of the patient, in which Mention if you are free from all risks until the time of notification. 8.8 The head of the institution or establishment, the Research Committees, Research Ethics, Biosecurity or the principal investigator, must order the immediate suspension or cancellation of the investigation, in the presence of any severe adverse effect, which constitutes an ethical or technical impediment to continue the study, about which, you must Notify the Secretariat, in detail, with the opportunity indicated in paragraph 8.7. In that case, the resumption of the Research will require a new authorization. 8.9 The principal investigator must inform the Committee of Ethics in the Investigation of any probable adverse effects or directly related to the investigation. Likewise, it must inform said Committee as frequently as it establish, on the absence of adverse effects on research projects or protocols that are under its responsibility. 8.10 Serious or lethal adverse reactions or effects should be reported immediately to the Secretariat. In the cases If there is a suspicion of adverse effects due to medications, the Mexican Official Standard, referred to in the Section 3.2 of this standard. 9. On the constitution, registration and operation of the Research Committees, Research Ethics and Biosafety 9.1 On the constitution and registration of the Research Committees, Research Ethics and Biosafety. 9.1.1 The establishment of the Research and Biosafety Committees, which are required in the institution or establishment, must be multidisciplinary, with health professionals of different specialties relevant to the issues on which Research in the institution, may or may not have experience in scientific methodology applied to research. They must include professionals from other disciplines, users and people from civil society, representing moral, cultural and The social characteristics of the research subjects may come from the institution itself or from other medical institutions. In the case of the Research Ethics Committees, the provisions of current legislation and the provisions of criteria referred to in article 41 Bis of the General Health Law. 9.1.2 The Research and Biosafety Committees shall be integrated with a minimum of three scientists, plus representatives of civil society deemed necessary, with a total of at least 6 members and a maximum of 20. 9.1.3 When it is not possible to set up a Research or Biosafety Committee, with its own staff the holder may request the support of other Committees constituted at the immediate superior level of their own institution or in institutions or external health facilities. 9.1.4 The head of the institution or establishment must register the Research Committees, Research Ethics and Biosafety, as appropriate, before the Secretariat, to inform about the modification, designation or replacement of any of its members and deliver an annual report of their activities, referring to the evaluation of projects according to the objective and Field of application of this standard. 9.2 On the functioning of the Research Committees, Research Ethics and Biosafety 9.2.1 The constitution and operation of the Committees shall be subject to the provisions of current legislation and, where appropriate, to the criteria referred to in article 41 Bis of the General Health Law. 9.2.2 The members of the Committees shall remain in office for the time established in the installation minutes, being able to be ratified at the end of each period, if necessary replaced in a staggered manner, which should be documentary evidence. The operation and activities of the Committees must be described in the Rules of Operation of the Committee, which are issued in accordance with the provisions of current legislation and, where appropriate, in accordance with criteria referred to in article 41 Bis of the General Health Law. 9.2.3 The members of the Research Committees, Research Ethics and Biosafety shall refrain from participating in the evaluation and opinion of their own investigations. 9.2.4 Each Committee shall designate the person who will occupy the position of president, who will be responsible to the head of the institution or establishment of the activities developed by said Committee. 9.2.5 The secretary of each Committee shall take the necessary steps to develop the activities of the Committee of in question, so it must be provided with the administrative management powers for the exercise of its functions. 9.2.6 The Research and Biosafety Committees shall have at least four members representing each of the The areas related to the subject matter of the research project or protocol in the opinion phase may include medical personnel from nursing, administrative of the institution or establishment itself, as well as of other sectors that integrate said Committee. 9.2.7 In the sessions of each Committee, members of external Committees may participate or have the support of advisers external, which will have a voice but no vote. In these cases, the researchers themselves may participate institution or establishment, as long as they work in areas related to the subject of the research project or protocol in opinion phase 9.2.8 The Research Ethics Committee should evaluate at the beginning and periodically that the projects or protocols of investigation, adhere to the ethical principles and applicable regulations in accordance with the internal regulations that each Committee has prepared. Also, within its scope of responsibility, it will have the power to approve or not, such research projects or protocols, which will be submitted for authorization by the Secretariat. 9.2.9 The Research Ethics Committee will be responsible for reviewing and, where appropriate, approving the consent letter informed in the field of research, formulated by the principal investigator. 9.2.10 The Research Ethics Committee must propose to the head of the institution or establishment where it is carried out health investigation, that the investigation be suspended or canceled in the presence of any adverse effects that may be impediment from an ethical or technical point of view, to continue with the study. 9.2.11 The Biosafety Committee will monitor that for each study, as the case may be, with toxic, infectious or contagious risks radiology must meet the requirements for its realization, including that there is a person in charge of radiation safety, which must be registered with the National Commission for Nuclear Safety and Safeguards. 9.2.12 It is the responsibility of the Committees, to issue the technical opinion regarding research, ethics and biosafety in their field of competence, according to the nature of the proposed investigations. 10. From the Principal Investigator 10.1 The conduct of any investigation in accordance with this standard will be the responsibility of the principal investigator, who You must be a health professional with academic training and proven experience in the field, which will allow you to direct the research you intend to perform. 10.2 The principal investigator may plan and prepare the research project or protocol and must direct it in adherence to the methodological, ethical and safety aspects of the research subject. 10.3 When the principal investigator wishes to make amendments in the methodological design of the project or protocol of initial investigation, which served as the basis for the issuance of the original authorization of a Human health research, in accordance with this standard, should request a new Secretariat from the Secretariat authorization, prior favorable opinion of the Committee that validated the initial project or protocol, in the terms of section 4.6, of of definitions. In cases where the life of the research subjects is in danger, the amendments may be applied immediately, with the prior approval of the Research Ethics Committee and subsequently with the authorization of the Secretariat, of all of which, must be documented. 10.4 It is the responsibility of the principal investigator to select and specify the number of participants: technical support staff and administrative that will participate in the investigation, so it will be jointly responsible for the proceeding and their expertise in relation with the investigation, so you must have broad powers to, where appropriate, request the head of the institution or establishment, which suspends the participation of any of them. 10.4.1 For each principal or associate researcher, specify if they are attached to the institution or establishment, position or function, hours / week that you will dedicate to the research project or protocol, maximum academic degree, place and institution in that was obtained (national or foreign) as well as discipline; if applicable, category in the National System of Researchers (national researcher or candidate). 10.5 The investigator is responsible for suspending the investigation, in accordance with the provisions of section VI of the Article 100 of the General Health Law. 10.6 In formulating the informed consent letter regarding research, the investigator must ensure that it complies with the requirements and assumptions indicated in the Regulation, taking care that the gratuity is made explicit for the subject of investigation, the compensation to which he will be entitled in case of suffering damage to his health directly attributable to the research and the availability of free medical treatment for it, even if you decide to withdraw from it investigation, before it concludes. 10.7 The investigator must refrain from personally obtaining the informed consent of those subjects of research that are linked to it by some kind of dependence, ancestry or subordination. 10.8 It is the responsibility of the principal investigator to inform the research subject, family member, guardian or legal representative, during the development of the research, about the implications of each experimental maneuver and the characteristics of your condition Likewise, you must inform the appropriateness of taking a therapeutic option appropriate to your case. Its particular characteristics. 10.9 The researcher must inform the Committee of Ethics in the Investigation of any adverse effects likely or directly Research related. 10.10 The principal investigator must prepare and submit to the Secretariat the technical, descriptive, partial or final reports corresponding, referred to in paragraph 7.4.1, of this standard. 11. The physical and legal security of the subject of investigation 11.1 The safety of the research subject regarding the development of the experimental maneuver, responsibility of the institution or establishment, of the principal investigator and of the sponsor, in the terms of numeral 7.2, of this norm. 11.2 The research subject, his family, guardian or legal representative, have the right to withdraw, at any time, their consent to stop participating in the investigation in question, at the time requested. When this happen, the principal investigator must ensure that the research subject continues to receive care and treatment without any cost, until it is certain that there was no damage directly related to the investigation. 11.2.1 Where appropriate, the principal investigator may also withdraw the research subject so that he may participate in it, if you consider that during the development of said investigation, the risk is greater than the benefit and for that reason obliges your retirement. 11.2.2 To ensure the safety of the research subject, at the end of the investigation, the principal investigator You must provide what is necessary to continue the treatment and care, in order to avoid any effects secondary derived from the suspension of the experimental maneuver that has been practiced. 11.3 The informed consent letter is an essential requirement to request the authorization of a project or protocol of investigation, so you must comply with the speci fi cations established in articles 20, 21 and 22 of the Regulation. In cases of investigations without risk or with minimal risk, the informed consent letter will be a requirement to request authorization of the research project or protocol. 11.4 When the investigation involves the combined application of a procedure in experimental phase with another method already proven, the responsibility for the safety of the individual, because of his character of patient-subject of investigation, will be joint between the researcher and the doctor responsible for the method tested. 11.5 In the investigation, it is prohibited to charge recovery fees to the research subjects, their relatives or legal representative, for participating in it. 11.6 If during the development of a research project or protocol, the subject participating in it, presents signs and symptoms of an unintended pathology (comorbidity), which is not a consequence of the experimental maneuver and that could get to generate damage to your health or complicate as a result of such experimental maneuver, the principal investigator must evaluate the desirability of the subject continuing or being excluded from the investigation, in accordance with 11.2.1, of this norm. The decision and its justification must be recorded in the clinical file of the research subject. 11.7 All research subjects have the right to the protection of their personal data from access, rectification and cancellation of the same, as well as to express their opposition, in the terms established by the law, which will establish the cases of exception to the principles that fix the data processing, for reasons of national security, public order provisions, security and public health to protect the rights of third parties. 12. Of the information involved in investigations 12.1 The information related to any investigation that the principal investigator submits to the Secretariat will be classified as con fi dential. The Committees on health research of institutions or establishments in the For research to be conducted, they must be fully confidential regarding the reports and reports they receive from the researcher principal, in particular, in the case of investigations whose results are subject to patent or development and commercial exploitation. 12.2 The members of the Committees on health research of the institutions or establishments in the For research to be conducted, they must be fully confidential regarding the reports and reports they receive from the researcher principal, especially in the case of investigations whose results are subject to patent or development and commercial exploitation. 12.3 The principal investigator and the Health Research Committees of the institution or establishment must protect the identity and personal data of the research subjects, whether during the development of an investigation, as in the stages of publication or dissemination of the results thereof, adhering to the applicable legislation speci fi ed in The matter. 13. Concordance with international and Mexican standards This standard partially agrees with the following international standards: Helsinki Declaration of the World Medical Association on ethical principles for medical research on beings humans, and Istanbul Protocol: Manual for the effective investigation and documentation of torture and other cruel cruel punishment, Inhuman or degrading. It does not match any Mexican norm. 14. Bibliography 14.1 Decree establishing the decentralized body called the National Bioethics Commission. 14.2 Declaration of Helsinki of the World Medical Association on ethical principles for medical research in Humans. Adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964 and amended by the 59th General Assembly, Seoul, Korea, October 2008. Available at: Bioethics Documentation Center. 14.3 Integration and Functioning Guides of the Research Ethics Committees and Bioethics Hospital Committees of the National Bioethics Commission. 14.5 Federal Law on Transparency and Access to Government Public Information. 14.6 Federal Law on Protection of Personal Data Held by Private Parties. 14.7 Industrial Property Law. 14.8 Méndez Ramírez: "The Research Protocol" Ed. Trillas, Mexico 1990. Cap. I, p. 11-27. 14.9 Office of the United Nations High Commissioner for Human Rights. Istanbul Protocol: Manual for Effective investigation and documentation of torture and other cruel, inhuman or degrading treatment or punishment. Nations United, New York and Geneva, 2001. 14.10 Regulation of the General Health Law on Health Research. 14.11 Internal Regulations of the Interinstitutional Commission for Health Research. 15. Surveillance The monitoring of the application of this norm corresponds to the Ministry of Health and the governments of the entities federation within the scope of their respective competences. 16. Validity This rule will enter into force 60 calendar days from the date of its publication in the Official Gazette of the Federation. Effective suffrage. No reelection. Mexico, D.F., on November 26, 2012.- The Undersecretary of Integration and Development of the Health Sector and President of the National Consultative Committee for the Standardization of Innovation, Development, Technologies and Information in Health, Germán Enrique Fajardo Dolci.- Rubric. In the document you are viewing there may be text, characters or objects that are not displayed due to format conversion HTML, so we recommend that you always take the digitized image of the DOF or the PDF file of the edition as a reference. Official Journal of the Federation Amazon River No. 62, Col. Cuauhtémoc, C.P 06500, Mexico City Tel. (55) 5093-3200, where you can access our service menu E-mail address: www.dof.gob.mx 113 LEGAL NOTICE | SOME RIGHTS RESERVED © 2019