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GENERAL HEALTH CARE LAW REGULATION IN THE FIELD OF HEALTH RESEARCH
Published in the DOF on January 6, 1987
Latest reform published in the DOF on April 2, 2014
On the sidelines a seal with the National Shield, which reads: United Mexican States.-Presidency of the Republic.
MIGUEL DE LA MADRID H., Constitutional President of the United Mexican States, in exercise of the faculty that confers on the Federal Executive the fraction I of Article 89 of the Political Constitution of the United Mexican States and based on articles 1o., 2o., fraction VII, 3o. Part IX, 4th, 7o., 13 paragraph "A" fractions I, IX, X, paragraph "B" fractions I and VI, 96, 97, 98, 99, 100, 101, 102, 103 and other relating to the General Health Law, and
CONSIDERING
That under the Decree for which Article 4 was added. Constitutional, published in the Official Journal of the Federation dated February 3, 1983, was enshrined as a social guarantee, the Right to Health Protection;
That on February 7, 1984 was published in the Official Journal of the Federation the General Law of Health, regulation of the third paragraph of Article 4. of the Political Constitution of the United Mexican States, beginning its term of office 1o. of July of the same year;
That the aforementioned law established and defined the bases and modalities for access to health services, as well as the distribution of competences between the Federation and the Federative Entities in General Health Matters, therefore it is appropriate to have the necessary regulatory instruments for the effective exercise of their privileges;
That within the programs provided for in the National Development Plan 1983-1988, the Health Plan is located, which, as a strategy guidelines, completes five major policy areas, the last of which is the "Training, Training and Research" aimed primarily at the promotion of the biomedical, medical-social and health services areas, hence the National Health Program 1984-1988 develops the Health Research Program, others, as supporting the consolidation of the National Health System in aspects substantial, having as a specific objective the contribution to the scientific and technological development of the national community to the search for practical solutions to prevent, to attend and to control the priority problems of health, to increase the productivity and efficiency of services and decrease the technological dependence of the foreign country;
That the General Health Law has established the guidelines and general principles to be submitted to scientific and technological research aimed at health, corresponding to the Secretariat of Health-oriented development;
That health research is a determining factor in improving actions to protect, promote and restore the health of the individual and of society in general; to develop technology Mexican health services and in order to increase their productivity, according to the bases established in that Law;
That the conduct of health research should address ethical aspects that ensure the dignity and well-being of the person subject to research;
That the development of health research requires the establishment of technical criteria to regulate the application of procedures regarding the correct use of resources. intended for it;
That without restricting the freedom of researchers, in the particular case of research performed in human beings and using materials or procedures that carry a risk, it is necessary to be subject to generally accepted scientific, ethical and safety standards, and
That human research of new prophylactic, diagnostic, therapeutic and rehabilitation resources should be subject to control to obtain greater efficacy and to avoid health risks. of people, I have had to issue the following
GENERAL HEALTH CARE LAW REGULATION IN THE FIELD OF HEALTH RESEARCH
TITLE FIRST
General Provisions
ONLY CHAPTER
ARTICLE 1o.- This Ordinance is intended to provide, in the administrative sphere, compliance with the General Health Law regarding health research in the public sectors, social and private. It is applicable throughout the national territory and its provisions are of public order and social interest.
ARTICLE 2o.- For the purposes of this Regulation, when the "Law" is mentioned to the "Secretariat" and to the "Investigation", the General Health Law, the Secretariat of Health and the Health Research, respectively.
ARTICLE 3o.- Health research includes the development of actions that contribute:
I. Knowledge of biological and psychological processes in humans;
II. Knowledge of the links between causes of disease, medical practice, and social structure;
III. For the prevention and control of health problems;
IV. Knowledge and assessment of the harmful effects of the environment on health;
V. Study of techniques and methods that are recommended or employed for the provision of health services, and
VI. To production of health inputs.
ARTICLE 4.- The application of this Regulation corresponds to the Secretariat and to the governments of the federal entities, including the Federal District, in the field of their respective competencies and in the terms of the Coordination Agreements which are signed in order to formalise actions aimed at promoting and promoting the development of research.
ARTICLE 5o.- The competencies referred to in the previous article will be distributed according to the following:
A. Corresponds to the Secretariat:
I. Issue the technical standards to be subject, throughout the national territory, to health research and to verify compliance;
II. Organize and operate research activities in your administrative units;
III. Promote, orient, encourage and support research activities by governments of federal entities;
IV. Perform, in what is competent and in coordination with the Dependencies and Entities concerned, the overall assessment of the research activities throughout the national territory, and
V. Coordinate research within the framework of the National Health System.
B. In the field of General Health, as local authorities, it is up to the governments of the federative entities, within their respective territorial jurisdictions and in accordance with the applicable provisions:
I. Organize, operate, monitor, and evaluate health research activities;
II. Formulate and develop your research programs;
III. Develop and provide the research information requested by the competent federal authorities;
IV. Vigil compliance with the Laws, Regulations, and Technical Standards that refer to research, and
V. Collaborate with the coordination of research within the framework of the National Health System.
ARTICLE 6o.- The Secretariats of Health and Public Education, in the sphere of their respective competences, may conclude agreements of collaboration or consultation with educational institutions to carry out research in health, so that they, without prejudice to the autonomy that the law corresponds to them, contribute to the expressed dependencies in the development of actions aimed at promoting health research, as well as for compliance with the provisions of Title V of the Law.
ARTICLE 7o.- The coordination of research, within the framework of the National Health System, will be carried out by the Secretariat, to whom it will be responsible:
I. Establish and conduct the national policy on Health Research, in the terms of the applicable Laws, of this Regulation and other provisions;
II. Promote research activities within the institutions that integrate the National Health System;
III. Driving the deconcentration and decentralization of research activities;
IV. Determine the periodicity and characteristics of health research information to be provided by the dependencies and entities that perform it;
V. Support coordination between health and educational institutions to drive research activities;
VI. Coassist with the competent dependencies to regulate and control technology transfer in the area of health;
VII. To help the formation and distribution of human resources for research be consistent with the priorities of the National Health System;
VIII. Promote and boost community participation in the development of research programs;
IX. Drive the permanent update of the legal provisions on investigation, and
X. Other privileges related to previous ones that are required for the fulfillment of the National Health System's research objectives.
ARTICLE 8.- In the formulation of research policies and in the coordination of actions for its implementation and development, the Secretariat of Public Education and the Secretariat will have as its organ consultation of the Inter-Agency Committee for Health Research.
ARTICLE 9o.- The Secretariat, in coordination with the Secretariat of Public Education and with the collaboration of the National Council of Science and Technology and the institutions of higher education, will carry out and keep the national research inventory in the area of its competence up to date.
ARTICLE 10.- For the purposes set out in the previous article and in the terms of Article 99 of the Law, the Secretariat shall carry out and keep up to date an inventory of the research carried out in the institutional system of the Secretariat, which will cover the registration of:
I. The centers where research is performed;
II. The researchers;
III. The scientific publications of the researchers, and
IV. The performance of the researchers.
ARTICLE 11.- The Secretariat shall establish, in accordance with the participants, the inter-institutional and inter-sectoral coordination bases, as well as the technical aspects of the agreements and international treaties on research.
Of these instruments, a report will be sent to the Secretariat, which will include, among other points, the origin and destination of the financial resources involved, including those of those investigations. sponsors that are related to the development of inputs, technologies, and other application processes, susceptible of patents or commercial development, among others, that are carried out in human beings.
Except for those involved in higher education institutions and the National Council for Science and Technology, where subscribers will be reached by consensus.
ARTICLE 12.- The General Health Council shall have the power to issue additional provisions on areas or modalities of the investigation in which it considers it necessary, as well as have an opinion on research programmes and projects.
TITLE SECOND
Of The Ethical Aspects of Research in Human Beings
CHAPTER I
Common Provisions
ARTICLE 13.- In any research in which the human being is a subject of study, the criterion of respect for their dignity and the protection of their rights and well-being must prevail.
ARTICLE 14.- The research performed on human beings should be developed according to the following bases:
I. It must be adapted to the scientific and ethical principles that justify medical research, especially as regards its possible contribution to the solution of health problems and the development of new fields of science medical;
II. It shall be based on prior experimentation performed on animals, laboratories or other scientific facts;
III. It must be performed only when the knowledge that is intended to be produced cannot be obtained by another suitable means;
IV. The probabilities of the expected benefits over predictable risks should always prevail;
V. It shall have the informed consent of the subject in whom the investigation will be carried out, or of its legal representative, in the event of legal incapacity of the person, in terms of the provisions of this Regulation and other legal provisions applicable;
VI. Must be performed by health professionals referred to in Article 114 of this Regulation, with knowledge and experience to care for the integrity of the human being, under the responsibility of an institution of care to the health that acts under the supervision of the competent health authorities and which has the necessary human and material resources to ensure the welfare of the research subject;
VII. Contara with the favorable opinion of the Research Committees, Ethics in Research and Biosafety, in the cases corresponding to each of them, in accordance with the provisions of this Regulation and other applicable legal provisions;
VIII. It will be performed when you have the authorization of the holder of the institution health care and, where appropriate, the Secretariat, in accordance with Articles 31, 62, 69, 71, 73 and 88 of this Regulation;
IX. The investigation shall be suspended immediately by the principal investigator, in the event of the risk of serious injury, disability or death of the subject in whom the investigation is conducted, as well as when requested, and
X. It will be the responsibility of the institution of health care in which the research is carried out to provide medical care to the research subject who suffers some damage, if it is directly related to the research, without damage to the compensation that is legally applicable.
ARTICLE 15.- When the experimental design of an investigation performed on human beings includes several groups, random selection methods will be used to obtain an impartial assignment of the participants in each group and the relevant measures shall be taken to avoid any risk or harm to the research subjects.
ARTICLE 16.- In human investigations, the privacy of the individual subject of investigation will be protected, identifying only when the results require it and this will be authorized.
ARTICLE 17.- It is considered as a risk of the investigation to the probability that the research subject will suffer some damage as an immediate or late consequence of the study. For the purposes of this Regulation, investigations are classified in the following categories
I. Risk-free research: These are studies that employ retrospective documentary research techniques and methods and those in which no intentional intervention or modification is performed in the physiological, psychological and social variables of the individuals involved in the study, among those considered: questionnaires, interviews, review of clinical records and others, in which no aspects are identified or addressed sensitive to their conduct;
II. Research with minimal risk: Prospective studies that employ data risk through common procedures in physical or psychological examinations of routine diagnosis or treatment, among those considered: weighing the subject, tests for hearing acuity; electrocardiogram, thermography, collection of excreta and external secretions, obtaining placenta during delivery, collection of amniotic fluid when the membranes were broken, obtaining saliva, deciduous teeth and permanent teeth removed by therapeutic indication, dental plaque and calculations removed by non-invasive prophylactic procedure, haircut and fingernails without causing disfiguration, blood removal by venous puncture in adults in good health, with maximum frequency twice a week and a maximum volume of 450 Ml. in two months, except during pregnancy, moderate exercise in healthy volunteers, psychological testing of individuals or groups in which the conduct of the subject is not manipulated, medicines for common use, large therapeutic margin, authorised for sale, using the indications, doses and routes of administration established and other than the investigational medicinal products as defined in Article 65 of this Regulation, inter alia, and
III.- Research at greater risk than the minimum: These are the ones in which the probabilities of affecting the subject are significant, among those considered: radiological and microwave studies, trials with the medicinal products and modalities defined in Article 65 of this Regulation, trials with new devices, studies including surgical procedures, blood extraction greater than 2% of the circulating volume in neonates, amniocentesis and other invasive techniques or procedures, those employing random methods of assignment to therapeutic schemes and those that have control with placebos, among others.
ARTICLE 18.- Repealed.
ARTICLE 19.- Repealed.
ARTICLE 20.- The written agreement is understood by informed consent, by which the subject of investigation or, if applicable, his legal representative authorizes his participation in the research, with full knowledge of the nature of the procedures and risks to which it will be subjected, with the ability to free choice and without any coercion.
ARTICLE 21.- In order for the informed consent to be considered to exist, the subject of investigation or, if appropriate, its legal representative must receive a clear and complete explanation, in such a way which can be understood by at least the following aspects:
I. The justification and objectives of the investigation;
II. The procedures to be used and their purpose, including the identification of the procedures that are experimental;
III. The expected inconvenience or risks;
IV. The benefits that can be obtained;
V. Alternative procedures that might be advantageous to the subject;
VI. The assurance of receiving a response to any questions and clarification to any doubt about the procedures, risks, benefits and other matters related to the investigation and treatment of the subject;
VII. The freedom to withdraw your consent at any time and to stop participating in the study, without creating prejudice to continue your care and treatment;
VIII. The security that the subject will not be identified and that the confidentiality of the information related to their privacy will be maintained;
IX. The commitment to provide you with up-to-date information obtained during the study even though it may affect the subject's will to continue participating;
X. The availability of medical treatment and the compensation to which legally it would be entitled, by the institution of health care, in the case of damages that merit it, directly caused by the investigation, and
XI. That if there are additional expenses, they will be absorbed by the research budget.
ARTICLE 22.- Informed consent must be made in writing and must meet the following requirements:
I. It shall be drawn up by the principal investigator, pointing out the information referred to in the previous Article and taking into account the other applicable legal provisions;
II. It will be reviewed and, if necessary, approved by the Research Ethics Committee of the health care institution;
III. Indicate the names and addresses of two witnesses and the relationship they have with the research subject;
IV. It must be signed by two witnesses and by the research subject or his legal representative, if any. If the research subject does not know how to sign, it will print its fingerprint and sign it to another person designated by it, and
V. It will be extended in duplicate, with a copy being held by the research subject or its legal representative.
ARTICLE 23.- Repealed.
ARTICLE 24.- If there were any kind of dependence, ancestry or subordination of the research subject towards the investigator, which would prevent him from freely granting his consent, this must be obtained by another member of the research team, completely independent of the research-subject relationship.
ARTICLE 25.- Repealed.
ARTICLE 26.- Repealed.
ARTICLE 27.- When a psychiatric patient is admitted to an institution for being subject to interdiction, in addition to complying with the above articles, it will be necessary to obtain the prior approval of the authority known to the case.
CHAPTER II
From Research to Communities
ARTICLE 28.- Investigations concerning human health in communities will be admissible when the expected benefit for this is reasonably assured and when the studies carried out in small scale have not produced conclusive results.
ARTICLE 29.- In community investigations, the principal investigator must obtain the approval of the health authorities and other civil authorities of the community to study, in addition to obtain the informed consent letter from the individuals included in the study, by giving them the information referred to in Articles 21 and 22 of this Regulation.
Dealing with communities that because of their economic or social conditions, are in a situation of vulnerability, among them, the indigenous communities and peoples, Furthermore, it will require that the Research Ethics Committee of the institution to which the principal investigator belongs, should make a positive view of the conduct of the research.
ARTICLE 30.- Repealed.
ARTICLE 31.- Experimental investigations in communities may only be carried out by establishments that have the prior authorization of the Secretariat to carry them out, without prejudice of the powers corresponding to other dependencies of the Federal Executive, and have, where appropriate, complied with the toxicity studies, in accordance with the characteristics of the products and the risk involved in human health.
ARTICLE 32.- In all community research, the experimental design must provide practical protective measures for individuals and ensure that valid results will be obtained, by making the minimum of subjects participate to be representative.
ARTICLE 33.- In any community research, the ethical considerations applicable to research on individuals should be extrapolated to the communal context in the relevant aspects.
CHAPTER III
From Child or Incapable Research
ARTICLE 34.- In addition to the general provisions of ethics that must be fulfilled in all research in human beings, that which is carried out in minors or incapable must satisfy what is established in this chapter, except in the case of more than 16 emancipated years.
ARTICLE 35.- When it is intended to conduct research on minors, it should be ensured that similar studies have been done previously in people of May and in immature animals, except in the case of studying conditions that are specific to the neonatal stage or specific conditions of certain ages.
ARTICLE 36.- For the conduct of investigations in minors or incapable, it shall in any case be obtained the written consent of those who exercise the parental authority or the legal representation of the child or the child concerned.
When two persons exercise the parental authority of a child, the consent of one of them shall be admissible only if there is no or manifest impossibility of the other to provide it or in the event of imminent risk to the health or life of the minor or incapable.
ARTICLE 37.- When the mental capacity and psychological state of the child or unable to permit it, it must be obtained, in addition, its acceptance to be a subject of research, after explaining what it is intended to do. The Research Ethics Committee may dispense with these requirements for justified reasons.
ARTICLE 38.- Investigations classified as risk and likely to be of direct benefit to the child or the child shall be admissible when:
I.- The risk is justified by the importance of the benefit that the child or the child will receive, and
II.- The benefit is equal to or greater than other alternatives already established for diagnosis and treatment.
ARTICLE 39.- Investigations classified as risk and without direct benefit to the minor or the incapable, shall be admissible according to the following considerations:
I. When the risk is minimal:
A). The intervention or procedure shall represent for the minor or the incapable a reasonable and comparable experience with those inherent in his current or expected medical, psychological, social or educational, and
B). The procedure intervention should be high likely to obtain generalizable knowledge about the condition or disease of the minor or the incapable, which are of great importance to understand the disorder or to achieve improvement in other subjects.
II. When the risk is greater than the minimum:
A). Research should offer great odds of understanding, preventing, or alleviating a serious problem that affects the health and well-being of children or those who are unable to do so, and
B). The health care institution holder will establish strict supervision to determine whether the magnitude of the anticipated risks increases or others arise and will suspend the investigation into the time when the risk could affect the biological, psychological or social well-being of the child or the child.
CHAPTER IV
Of research in Women in the Fertile Age, Pregnant, during Labor, Postpartum, Breastfeeding, and Newborn; from the use of Embrions, Obits, and Fetos and Fertilization Assisted
ARTICLE 40.- For the purposes of this Regulation it is understood by:
I. Women of childbearing age. -From the onset of puberty to the onset of menopause;
II. Pregnancy.-This is the period from the fertilisation of the egg (evidenced by any sign or presumptive symptom of pregnancy, such as suspension of menstruation or positive pregnancy test). medically accepted) until the removal or removal of the fetus and its attachments;
III. Embrion.-The product of conception from the fertilisation of the egg to the end of the twelfth week of management;
IV. Feto.-The product of conception from the beginning of the thirteenth week of gestation to its expulsion or extraction;
V. Obito Fetal.-The death of the fetus in the uterus;
VI. Live birth.-It is the complete removal or removal of the product from the conception, from the maternal breast, when after the separation breathes and can the heart, whether or not the cord has been cut umbilical and whether or not the placenta has been detached;
VII. Dead birth.-is the complete removal or removal of the product from conception, from the maternal breast, when after said separation does not breathe or can the heart, whether or not cut the umbilical cord and whether or not the placenta is detached;
VIII. Labor.-It is the period from the beginning of uterine contractions (with progressive characteristics of intensity, irrigation and duration) and ending with expulsion or removal of the fetus and its attachments;
IX. Puerperium.-It is the period that begins with the expulsion or extraction of the fetus and its attachments until the involution of the gestational changes (approximately 42 days);
X. Lactation.-It is a physiological phenomenon in which the milk secretion occurs from the expulsion or extraction of the fetus and its attachments, and
XI. Assisted fertilization. -It is the one in which insemination is artificial (homologous or heterologous) and includes in vitro fertilization.
ARTICLE 41.- In addition to the general provisions of ethics that must be complied with in all research in human beings, those that include the subjects referred to in this chapter shall be satisfy the requirements set out in Articles 42 to 56 of this Regulation.
ARTICLE 42.- In research classified as higher risk than the minimum, to be performed in women of childbearing potential, measures must be taken to:
I. To certify that women are not pregnant, prior to their acceptance as research subjects, and
II. Decrease the chances of pregnancy during the development of the research.
ARTICLE 43.- To conduct research on pregnant women, during labor, puerperium and lactation; in live or dead births; of the use of embryos, deaths or fetuses; and for assisted fertilization, it is necessary to obtain the letter of informed consent of the woman and her spouse or concubinaire in accordance with the provisions of Articles 21 and 22 of this Regulation, after information of the possible risks to the embryo, fetus or newborn in your case.
The consent of the spouse or concubinaire may be dispensed only in the event of incapacity or unfeasible or manifest failure to provide it; because the concubinaire does not take care of the woman or, or, where there is an imminent risk to the health or life of the woman, embryo, foetus or newborn.
ARTICLE 44.- Research in pregnant women should be preceded by studies in non-pregnant women who demonstrate their safety, with the exception of studies specific requirements for such a condition.
ARTICLE 45.- Research without therapeutic benefit in pregnant women, whose aim is to obtain generalizable knowledge about pregnancy, should not pose a greater risk to the minimum for the woman, the embryo or the fetus.
ARTICLE 46.- research in pregnant women involving an intervention or experimental procedure not related to pregnancy, but with therapeutic benefit for women, as it would be in cases of gravidic toxaemia, diabetes, hypertension and neoplasms, among others, must not expose the embryo or the foetus to a higher risk, except where the use of the intervention or procedure is justified in order to save the life of the woman.
ARTICLE 47.- Research in pregnant women, with therapeutic benefit related to pregnancy, will be allowed when:
I. To improve the health of pregnant women with minimal risk to the embryo or fetus, or
II. They are intended to increase the viability of the fetus, with minimal risk to the pregnant woman.
ARTICLE 48.- During the execution of investigations in pregnant women:
I. Researchers shall have no authority to decide on the time, method or procedure used to terminate the pregnancy, nor shall they participate in decisions on the quality of the fetus;
II. Only with the authorization of the Research Ethics Committee may the method to terminate pregnancy for research purposes, where such modifications mean a minimum risk to the health of the mother and do not pose a risk to the survival of the fetus; and
III. In any case, it is strictly forbidden to grant monetary or other stimuli to interrupt the pregnancy, in the interest of the investigation or for other reasons.
ARTICLE 49.- The informed consent letter for investigations during labor, must be obtained according to the provisions of Articles 21, 22, and 43 of this Regulation, before that the person starts and must expressly state that consent may be withdrawn at any time during labor.
ARTICLE 50.- Women's research during the puerperium will be allowed when they do not interfere with the health of the mother and the newborn.
ARTICLE 51.- Research in women during breast-feeding will be authorized when there is no risk to the infant or when the mother decides not to breast-feed it, the feeding is assured by another method and obtain the informed consent letter in accordance with Articles 21, 22 and 43 of this Regulation.
ARTICLE 52.- The fetuses will be subject to investigation only if the techniques and means used provide maximum security for them and the pregnant woman.
ARTICLE 53.- Newborn will not be subject to investigation until it has been established with certainty whether or not they are live births, except where the investigation is intended to increase their the probability of survival to the feasibility phase, the procedures of the study do not cause the cessation of their vital functions or when, without adding any risk, it is sought to obtain important generalizable knowledge that cannot be obtained from another mode.
ARTICLE 54.- Live births may be subject to investigation if the provisions on child research, as indicated in this Regulation, are met.
ARTICLE 55.- Research with embryos, deaths, fetuses, stillbirths, macerated fetal matter, cells, tissues and organs extracted from these, will be performed according to the provisions of the Title Tenth Fourth of the Law and in this Regulation.
ARTICLE 56.- Research on assisted fertilization will only be admissible when it is applied to the solution of sterility problems that cannot be resolved otherwise, respecting the moral, cultural and social view of the couple, even if it differs with that of the researcher.
CHAPTER V
From Research to Subordinate Groups
ARTICLE 57.- It is understood by groups subordinate to the following: students, laboratory workers and hospitals, employees, members of the armed forces, inmates in prisons or social rehabilitation centres and other special groups of the population, in which informed consent can be influenced by some authority.
ARTICLE 58.- When investigations are carried out in subordinate groups, representatives of the affected core or user persons participating in the Research Ethics Committee, in terms of the second paragraph of the Article 41 Bis of the Law, shall monitor:
I. That participation, the refusal of the subjects to intervene or withdraw their consent during the study, does not affect their school, work, military situation or the situation related to the judicial process to which they were subject and the terms of the sentence, if any;
II. That the results of the research are not used to the detriment of the participating individuals, and
III. That the health care institution and the sponsors be responsible for the medical treatment of the damages and, where appropriate, the compensation that is legally appropriate for the harmful consequences of the investigation.
CHAPTER VI
From Research on Organ, Tissue and its Derivatives, Products and Bodies of Human Beings
ARTICLE 59.- The investigation referred to in this Chapter includes the use of organs, tissues and their derivatives, products and bodies of human beings, as well as the assembly of activities related to their procurement, conservation, use, preparation, supply and final destination.
ARTICLE 60.- The investigation referred to in this Chapter must observe, in addition to the respect, dignity and consideration of the human body, the provisions of this Regulation and the provisions of the Title Tenth Fourth of the Law and other applicable legal provisions.
THIRD TITLE
From researching new Profilactic, Diagnostic, Therapeutic, and Rehabilitation Resources
CHAPTER I
Common Provisions
ARTICLE 61.- When research is carried out on human beings, on new prophylactic, diagnostic, therapeutic and rehabilitation resources or is intended to modify the already known ones, observe, as applicable, the provisions of the foregoing articles and satisfy the provisions of this Title.
ARTICLE 62.- Those interested in carrying out the investigations referred to in this Title shall obtain the authorization of the Secretariat. They shall submit their application in writing by appending the following documentation:
I. A research protocol that shall contain a complete and objective analysis of the risks involved, as compared to the risks of established diagnostic and treatment methods and the expectation of the living conditions of the subject to and without the proposed procedure or treatment;
II. Letter of acceptance of the holder of the institution where the investigation would be carried out, as well as the principal investigator responsible for the investigation;
III. favourable opinion of the Research and Ethics Committees in Research and, where appropriate, Biosafety;
IV. Description of the available resources, including areas, equipment, and auxiliary lab and cabinet services;
V. Description of the resources available for medical emergency management;
VI. Professional history of the principal investigator, including his academic preparation, representative scientific production, and clinical practice or experience in the area of the proposed research;
VII. The one that checks the academic preparation and experience of the medical, paramedical and other experts who will participate in the research activities;
VIII. The one with which, where appropriate, the information referred to in Articles 69 and 73 of this Regulation is accredited, and
IX. The other that points to the applicable legal provisions.
Interested parties may submit with their application for authorization the opinion issued by a third party authorized for this purpose by the Secretariat, which shall contain the technical report on the security and scientific validity of the relevant research protocol, in accordance with the applicable legal provisions, which shall be appraised by the Secretariat, in order to determine whether the authorisation. In this case, the Secretariat shall resolve the conduct, within 30 working days, from the day following the date of the filing of the application.
ARTICLE 63.- Where there is sponsorship or other forms of remuneration, the necessary measures must be put in place to prevent conflicts of interest to the principal investigator in the protection of the rights of the research subjects, even if they have given their consent in the preservation of the veracity of the results and in the allocation of the resources.
ARTICLE 64.- In the conduct of the investigations referred to in this Title, the following obligations shall be fulfilled:
I. The principal investigator will report to the Research Ethics Committee likely or directly related to the investigation;
II. The holder of the institution shall, in turn, notify the Secretariat of the presence of any adverse effects within a maximum of 15 working days following (sic DOF 06-01-1987) at his/her presentation;
III. The principal investigator, the Research Ethics Committee, the officials of the health care institution in question or the Secretariat, shall suspend or cancel the investigation in the presence of any adverse effect that is an ethical or technical impediment to continuing the study;
IV. The health care institution shall submit to the Secretariat a report within 15 working days following the one in which the suspension or cancellation of the study, specifying the warning effect, has been agreed upon, the measures taken and sequelae produced, and
V. The others that point to the applicable legal provisions.
CHAPTER II
From Pharmacologic Research
ARTICLE 65.- For the purposes of this Regulation, pharmacological research is understood to scientific activities aimed at the study of drugs and biological products for use in human, in respect of which there is no prior experience in the country, which have not been registered by the Secretariat and therefore are not distributed in a commercial manner, as well as the registered and parked medicines (sic DOF 06-01-1987) for sale, when their use is investigated with modalities, indications, different doses or routes of administration, including their use in combinations.
ARTICLE 66.- Clinical pharmacology research includes the sequence of studies that have been carried out since they are administered for the first time. human being until data is obtained on its efficacy, quality and therapeutic safety in large population groups. For this purpose the following phases are considered:
FASE I.- It is the first time administration of a research drug to a healthy human, without a diagnostic or therapeutic benefit, in single or multiple doses, in hospitalized small groups. , to establish initial pharmacological parameters in man;
PHASE II.- It is the administration of an investigational drug to the human being, in single or multiple doses, in hospitalized small groups, to determine its initial and other efficacy. pharmacological parameters in the diseased organism;
PHASE III.- It is the administration of a research drug to large groups of patients (usually external) to define their therapeutic utility and identify adverse reactions, interactions and external factors that may alter the pharmacological effect, and
PHASE IV.- These are studies that are performed after the drug is granted registration and authorization for sale, and aims to generate new information on the safety of the drug. during their widespread and prolonged employment.
ARTICLE 67.- All clinical pharmacology research to be performed must be preceded by complete preclinical studies including physico-chemical characteristics, pharmacology, toxicity, pharmacokinetics, absorption, distribution, metabolism and excretion of the medicinal product in different animal species; frequencies, routes of administration and duration of the studied doses which may serve as a basis for the safety of his administration in the human being; they will also be required studies on mutagenesis, teratogenesis and carcinogenesis.
ARTICLE 68.- The preclinical toxicology studies required for each drug will be based on this in particular, of the known potential toxicology of others with similar chemical structure and of the route and time of administration intended to be used in the human being.
ARTICLE 69.- The use in human beings of investigational medicinal products during their assessment through phases I to IV of clinical pharmacological research, will be done with the authorization of the Secretariat. For this purpose, the institutions shall submit the documentation referred to in Article 62 of that Regulation, in addition to the following:
I. The basic and preclinical pharmacology information of the drug, and
II. The information previously obtained on clinical pharmacology, in cases of Phase II, III and IV and availability tests when required.
ARTICLE 70.- Clinical pharmacology studies phase I, of new antineoplastic drugs and of others with very small therapeutic index, will be allowed when:
I. Based on preclinical studies demonstrating the pharmacological activity of the medicinal product and clearly indicating the characteristics of its toxicity;
II. Be performed only in subjects who are volunteers with the advanced specific disease, confirmed by additional diagnostic means, who have not presented therapeutic response to any other available treatment and in whom the new drug may offer a therapeutic benefit, and
III. Do not cause patient expenses.
ARTICLE 71.- In emergency treatment under conditions that threaten the life of a person, when it is deemed necessary to use a research drug or a medicinal product known using indications, doses and routes of administration other than those established, the treating physician must obtain the favourable opinion of the Research and Ethics Committees of the institution of health care, as well as the letter of informed consent of the the subject of investigation or, where appropriate, of his legal representative, as circumstances permit, according to the following bases:
I. Research and Research Ethics Committees will be informed of employment of the investigational medicinal product in advance if the investigator can provide for the need for use in emergency situations. Subsequently, if the use of the medicinal product, the indication, new doses or routes of administration were to be used as unforeseen needs. In both cases the Committees shall issue the opinion in favour of or against approving the planned use or repetition of the non-intended use of the medicinal product, and
II. The informed consent letter will be obtained from the research subject, in his or her (sic DOF 06-01-1987), from his or her legal representative or from the closest family member, except where the subject's condition incapacitated or prevents him from being It is not available to the legal representative or the family member, and the failure to use the investigational medicinal product represents an almost absolute risk of death.
CHAPTER III
From Research on Other New Resources
ARTICLE 72.- For the purposes of this Regulation, it is understood by research of other new resources or different modalities of the established ones, to the scientific activities tending to the study of materials, grafts, transplants, prostheses, physical, chemical and surgical procedures, instruments, apparatus, artificial organs and other methods of prevention, diagnosis, treatment and rehabilitation performed in human beings or in their biological products, except for pharmacological products.
ARTICLE 73.- Any investigation referred to in this Chapter shall have the authorization of the Secretariat. For this purpose, the institutions shall submit the documentation referred to in Article 62 of this Regulation in addition to the following:
I. Scientific fundamentals, information on prior experimentation performed on animals, in the laboratory, and
II. Previous studies of clinical research, when any.
ARTICLE 74.- Investigations related to the disposition of organs, tissues and cells, including blood and blood components, should be subject to provided for by the Act, this Regulation and the other applicable legal provisions.
TITLE THIRD BIS
Authorized Third Parties
ONLY CHAPTER
ARTICLE 74 BIS 1.- For the purposes of this Regulation, it is considered third-party authorized to the natural or moral person authorized by the Secretariat to issue the opinions referred to in the second paragraph of Article 102 of the Law.
ARTICLE 74 BIS 2.- The Secretariat shall publish in the Official Journal of the Federation the calls addressed to the natural and moral persons interested in serving as an authorised third party, in which the scope, requirements and conditions for their authorisation shall be established, inter alia.
ARTICLE 74 BIS 3.- The Secretariat shall form a technical committee composed of experts in the field of research in human beings, representatives of chambers and associations and, where appropriate, of the accreditation body, which shall have the function of having a technical opinion on applications for the granting of third-party authorisations.
The operation and operation of the technical committee referred to in the preceding paragraph shall be in accordance with the operating rules to be issued by that committee.
ARTICLE 74 BIS 4.- To obtain authorization as an authorized third party, the data subject must meet the following requirements:
I. Submit a request in the format set by the Secretariat. For this purpose, the Secretariat shall disclose the corresponding format by publication in the Official Journal of the Federation;
II. Accompanying the documentation that accredits the experience and legal, technical, material, human and financial to issue the opinions referred to in the second paragraph of Article 102 of the Law;
III. Contar with the facilities, equipment and technology to carry out the tests, studies and other activities necessary to deliver the opinions referred to in the second paragraph of Article 102 of the Law;
IV. Contar with standard operating procedures to ensure quality in the performance of their duties;
V. Accompanied me to point out in protest of telling the truth, that it is not subject to direct influence by any manufacturer, trader, natural or moral person, merchant of the research protocols to rule, and
VI. Submit your proposals for activities to rule on research protocols, as well as describe the services it intends to provide and the procedures to be used to deliver such opinions.
ARTICLE 74 BIS 5.- Submitted the application for authorization of the authorized third party, the Secretariat shall proceed to carry out the verification visits and, together with the committee referred to in Article 74 Bis 3 of this Regulation, shall carry out the assessments necessary to give an opinion on whether the requirements referred to in the previous Article are met.
If the opinion issued by the Secretariat is not favorable, a period of up to one hundred and eighty calendar days shall be granted to the applicant, counted from the day following which the opinion has been notified, in order to correct the anomalies detected. The period granted may be extended for an equal period, on a single occasion, where the applicant justifies the need for this.
If the applicant fails to correct the anomalies detected within the time limit given to him, in accordance with the provisions of the preceding paragraph, his/her request.
ARTICLE 74 BIS 6.- The authorization as a third party shall be valid for two years, which may be extended by equal time, at the request of the person concerned.
ARTICLE 74 BIS 7.- Authorized third parties must:
I. Comply with the provisions contained in the Act, this Regulation and other applicable legal provisions;
II. Refrain from providing services as an authorised third party, where they are shareholders, advisers, successors, proxies, advisers, commissioners, or any other type of relationship with the person applying for their services, which may mean a conflict of interest;
III. Inform the Secretariat immediately, of any irregularities or non-compliance with the health provisions that they identify during the evaluation of the research protocols that they carry out;
IV. Provide the Secretariat with reports on the opinions and technical recommendations they issue on the research protocols they evaluate, as well as providing the information required by such a dependency;
V. Assist the Secretariat in cases of health emergency, and
VI. Allow verification of your activities by the Secretariat and facilitate their verifiers free access to their facilities.
ARTICLE 74 BIS 8.- The result of the tests carried out by the authorized third party, shall be stated in an opinion to be signed, under its responsibility, by the person empowered to do so. Such opinions shall be valid before the Secretariat in accordance with the functions authorized to the third party.
ARTICLE 74 BIS 9.- The Secretariat may, at any time, carry out verification visits to authorized third parties to verify that the conditions under which were granted the corresponding authorization are fulfilled.
ARTICLE 74 BIS 10.- If derived from verification visits, the Secretariat warns that the conditions referred to in the previous article do not subsist, or either, the applicable legal provisions are not complied with, it shall prevent the person concerned to remedy the anomalies found and give him a period of up to one hundred and eighty days, counted from the day following that which was notified to him. such anomalies, to correct them. The above, without prejudice to the fact that when the detected irregularity involves a health risk, the Secretariat may order the temporary suspension of the activities carried out by the authorised third party.
If the authorized third party does not disregard the prevention, within the period prescribed in accordance with the provisions of the preceding paragraph, it shall be cause of suspension of the authorization granted, in terms of Article 412 of the Law, and the Secretariat will grant a new period of ninety days to correct such irregularities. In the event that the Secretariat does not comply with the above, the authorisation shall be revoked.
ARTICLE 74 BIS 11.- The Secretariat shall publish in the Official Journal of the Federation the relationship of the third parties authorized to rule on investigation, as well as the suspensions and revocations to those authorizations.
TITLE FOURTH
From the Biosecurity of Investigations
CHAPTER I
From Research with Pathogenic Microorganisms or Biological Material that Can Contain Them
ARTICLE 75.- The health institutions referred to in Article 98 of this Regulation, in which investigations are carried out with pathogenic microorganisms or biological material that may contain them, they must:
I. Contar with the laboratory facilities and equipment according to the technical standards that the Secretariat will issue, which guarantee the physical containment suitable for the safe handling of such germs;
II. Develop a manual of procedures for microbiology laboratories and make it available to professional, technical, service and maintenance personnel;
III. Add to staff on handling, transportation, utilization, decontamination, and waste disposal;
IV. Determine the need for medical surveillance of personnel involved in investigations and, where appropriate, implement it;
V. Establish a safety monitoring and monitoring program in microbiology labs;
VI. Dispose of updated bibliography and a file on the (sic DOF 06-01-1987) equipment security, availability of containment systems, rules and regulations, risks involved and other related aspects, and
VII. Meet other provisions as determined by the Secretariat.
ARTICLE 76.- In the health institutions referred to in the previous article, the microbiology laboratories shall comply with the requirements to indicate the technical standards that the Secretariat will dictate. Classify in three types:
I. Basic Microbiology Lab;
II. Microbiological Security Laboratory, and
III. Maximum Microbiological Safety Laboratory.
ARTICLE 77.- The Manual of Procedures referred to in Article 75 (II) of this Regulation will describe the following aspects:
I. Lab Practices;
II. Employees ' personal security;
III. Handling and maintenance of insolations and equipment;
IV. Emergency situations;
V. Entry and Transit Restrictions;
VI. Receiving and transporting biological materials;
VII. Waste provisions;
VIII. Discontamination, and
IX. Others deemed necessary to achieve microbiological safety.
ARTICLE 78.- The principal investigator, according to his superior, the Biosafety Committee and the head of the health care institution, determine, in accordance with the applicable provisions, the type of laboratory in which the proposed investigations are to be carried out, as well as the respective procedures, taking into account the degree of risk of infection presented by the micro-organisms to use.
ARTICLE 79.- To assess the degree of risk of infection referred to in the previous article, the Secretariat shall issue the appropriate technical standard and classify the micro-organisms within the four Groups, according to the following criteria:
Risk Group I:
Microorganisms that pose little risk to the individual and the community;
Risk Group II:
Microorganisms that represent moderate risk to the individual and limited to the community;
Risk Group III:
Microorganisms that pose high risk to the individual and scarce to the community, and
Risk Group IV:
Micro-organisms that pose high risk to the individual and to the community.
ARTICLE 80.- Micro-organisms that are classified in risk groups I and II must be handled in laboratories of basic type of microbiology, using safety cabinets when considered required.
ARTICLE 81.- The microorganisms that are classified in the risk group III must be handled in microbiological safety laboratories.
ARTICLE 82.- The microorganisms that are classified in the risk group IV must be handled in laboratories of maximum safety microbiology, under the authority and control of the authorities. The health of the Member State concerned 4. of the Law.
ARTICLE 83.- During the development of the investigations referred to in this Chapter, the principal investigator shall be responsible for:
I. To determine the actual and potential risks of the proposed research and, if approved by the Committees of the health institution, in accordance with its field of competence, to make them known to the associated researchers and the other personnel involved in the investigation;
II. Determine the appropriate level of physical containment, select suitable microbiological practices, and design procedures to address potential accidents during research and instruct participating personnel on these aspects;
III. Monitor that participating personnel comply with the requirements for medical prophylaxis, vaccinations, or serological tests;
IV. Monitor that the transportation of infectious materials is done appropriately, in accordance with applicable legal provisions;
V. Report to the Biosafety Committee on the occurrence of illness among personnel participant in the investigation, which may be attributed to the transcutaneous inoculation, ingestion or inhalation of infectious materials, as well as accidents causing contamination that may affect staff or the environment, and
VI. Report to the Biosafety Committee the difficulties or failures in the implementation of the security procedures, as well as correct working errors that could result in the release of infectious material and ensure the integrity of physical containment measures.
ARTICLE 84.- The Biosafety Committee of the health institutions must carry out visits with the periodicity that they determine, to evaluate the compliance with safety measures and to issue recommendations to laboratory practices, including the temporary or definitive suspension of investigations representing an uncontrolled risk of infection or contamination for the laboratory workers, the community or the environment.
CHAPTER II
From research involving the construction and management of recombinant nucleic acids
ARTICLE 85.- For the purposes of this Regulation, new combinations of genetic material obtained outside of a new combination of genetic material (sic DOF 06-01-1987) shall be understood The invention relates to a living cell, by means of the insertion of natural or synthetic segments of deoxyribonucleic acid into a virus, bacterial plasmid or other deoxyribonucleic acid molecules, which serve as a vector system to allow incorporation into a host cell, in which they are not found naturally, but in which will be able to replicate. The molecules of deoxyribonucleic acid resulting from such replication are also included.
ARTICLE 86.- Research with recombinant nucleic acids should be designed in such a way that the maximum level of biological containment is achieved by selecting the host and vector systems. Suitable for reducing the probability of dissemination outside the laboratory of recombinant molecules, taking into account the origin of the genetic material and the technical standards issued by the Secretariat.
ARTICLE 87.- The principal investigator, in accordance with his hierarchical superior, the Biosafety Committee and the head of the health institution, shall determine, in accordance with the applicable legal provisions, the type of microbiology laboratory in which the experiments referred to in this Chapter are to be carried out, taking into account the origin of the genetic material intended to be replicated.
ARTICLE 88.- The authorization of the Secretariat is required to initiate the following types of experimentation:
I. Recombinant deoxyribonucleic acid formation derived from pathogenic microorganisms that are classified in risk groups III and IV as referred to in Article 79 of this Regulation. Regulation as well as the formation of recombinant genetic material derived from cells that are infected by such agents, regardless of the host system and vector used;
II. Intintentional construction of recombinant nucleic acids to induce the biosynthesis of potent toxins for vertebrates;
III. International release (sic DOF 06-01-1987) to the environment of any microorganism that carries recombinant nucleic acids;
IV. Transfer of antibiotic resistance to microorganisms that do not acquire them in nature, if such a transfer could negatively affect the use of the antibiotic in human medicine, and
V. Experiments with microorganisms with recombinant nucleic acids in crops larger than 10 liters, because their physical and biological containment is more difficult, unless the molecules Recombinant products have been rigorously characterized and the absence of dangerous genes is demonstrated in them. Those processes of an industrial and agricultural nature not directly related and specifically to the activities laid down in Article 3o are excluded. of this Regulation.
CHAPTER III
From research with radioactive isotopes and ionising and electromagnetic radiation devices and generators
ARTICLE 89.- Investigations involving the use of radioactive isotopes and devices generating ionising and electromagnetic radiation in beings human for medical purposes, shall be carried out in accordance with applicable laws, regulations and other legal provisions.
ARTICLE 90.- In health institutions where the investigations referred to in this Chapter are carried out, the Biosafety Committee shall monitor that for each the person responsible for radiation safety by the National Nuclear Safety and Safeguards Commission is authorized to comply with the requirements and obligations arising from as the security officer radiological.
ARTICLE 91.- The person responsible referred to in the previous article must:
I. Define, implement, and monitor compliance with radiation and physical security measures;
II. To elaborate, in the terms of the Regulatory Law of Article 27 Constitutional on Nuclear Matter, a manual of procedures available to all personnel, in which the procedures for the identification and control of radiation sources; permitted and restricted areas; recording and monitoring of the dose equivalent of occupational exposure and the environment; training and medical examinations for staff occupational exposure; emergency plan in cases of accidents which pollute the personnel or the environment, among others, and
III. Add staff to work procedures and the characteristics of the lab and equipment.
ARTICLE 92.- The personnel directly or indirectly involved in the investigations referred to in this Chapter shall be adequately informed by the a person responsible for radiation safety, on the health risks posed by the radiation doses to which he is exposed, as well as the basic principles of radiation protection, such as: shielding, exposure time, distance and control of pollution and radioactive waste, inter alia, in order to ensure that accurate knowledge of the radiation protection measures is ensured to ensure the biosecurity of the procedures used in the investigation, with the participation of the Energy Secretariat.
ARTICLE 93.- In these investigations, the occupational staff exposed must be 18 years of age. Where such staff are women of childbearing potential, the exposures shall be distributed as evenly as possible over time in order to protect the embryo, where appropriate, during the period of organogenesis, before the diagnosis is made. pregnancy.
Pregnant women will only be able to continue the work that will expose them to them, if it is ensured that the exposures are distributed as evenly as possible over time and when it is unlikely that receive one third of the annual equivalent dose to be specified in the biosecurity standards according to the specific radioactive energy. Pregnant or breast-feeding women should not work in places where there is a risk of the incorporation of radioactive materials.
ARTICLE 94.- The health institution where research is conducted with radioactive materials should appoint a physician or health care institution that will be responsible for conducting examinations. medical staff to be exposed, in order to:
I. Determine your fitness, from the point of view of your health, to perform the work considered, before they are exposed to radiation.
II. Identify changes in your health that may result from exposure to radiation during the performance of your tasks, and
III. Detect late effects of radiation, including after exposure has ceased.
ARTICLE 95.- Studies involving the exposure of the research subject to radiation should:
I. Justified because it is not possible to obtain the same information with lower risk through research using other techniques, and
II. Being designed to optimize the protection of the subject, so that the radiation it receives is reduced to a reasonable minimum that allows obtaining the information sought.
ARTICLE 96.- In investigations without direct benefit to the research subject, the limits of equivalent doses, secondary limits, the limits derived as well as authorized limits, must be be specified in the research projects, taking into account whether it is external, internal radiation, the tissues attached to the biosafety standard which must match the standards of the National Nuclear Safety Commission and Safeguards.
Research involving the exposure of pregnant women to radioactive materials or ionizing radiation-generating devices is prohibited.
ARTICLE 97.- In research with direct benefit to the research subject, the criterion for limiting radiation doses should be the same as applied for other required exposures. for medical reasons, such as those due to diagnostic and treatment procedures.
TITLE FIFTH
From the Internal Committees in Health Institutions
ONLY CHAPTER
ARTICLE 98.- For the purposes of this Regulation, it is considered to be a health institution where health research is carried out, to any organically structured unit belonging to a (a) the institution or entity of the Public Administration, or to a social or private institution where one or more of the activities laid down in Article 5o is carried out. of this Regulation.
ARTICLE 99.- In any health institution where health research is carried out, under the responsibility of the respective directors or holders and in accordance with the provisions applicable, shall be constituted:
I. A Research Ethics Committee in the event that they conduct research on human beings;
II. A Biosafety Committee charged with determining and normalizing the interior of the the use of ionising radiation or genetic engineering techniques, based on the applicable legal provisions, and
III. A Research Committee, whose integration will be mandatory for institutions health care.
ARTICLE 100.- The general functions of the Committees referred to in the previous article shall be as follows:
I. Provide advice to the holders or managers of the institution to support the decision on authorization for research development;
II. Auxiliary researchers for optimal performance of their studies, and
III. Monitor the application of this Regulation and other applicable provisions.
ARTICLE 101.- The holders of the health institutions shall register the Committees referred to in Article 99 of this Regulation to the Secretariat, the which determines the characteristics and periodicity of the reports to be provided. In the case of the Research Ethics Committees, the registry will be registered with the National Bioethics Commission.
ARTICLE 102.- The head of the health institution, based on the opinions of the Research, Research Ethics and Biosafety Committees, according to shall decide whether to authorize the conduct of the investigations which are proposed, except in the case of investigations requiring the authorization of the Secretariat, in terms of Articles 31, 62, 69, 71, 73 and 88 of the Regulation.
For the purposes of the above paragraph, the Research, Research and Biosafety Ethics Committees may be jointly held.
ARTICLE 103.- The Research and Biosafety Committees will be integrated with a minimum of three scientists, with experience in the field of research.
ARTICLE 104.- The Research Ethics Committees will be integrated by medical personnel from different specialties and by people from the psychology professions, nursing, social work, sociology, anthropology, philosophy or law that have training in bioethics, it is essential to have representatives of the affected nucleus or users of the health services, up to the number agreed by its members in accordance with the provisions The General Secretariat shall be responsible for this.
ARTICLE 105.- To constitute the Biosafety Committee will include scientists with extensive experience or knowledge in this field, whether or not they are members of the personnel of the health institution, to ensure that the research activities are carried out under appropriate biosecurity measures.
ARTICLE 106.- To constitute the Research Committee preference will be given to the members of the health institution with knowledge and experience in the scientific methodology.
ARTICLE 107.- When the institution fails to meet the appropriate persons to constitute the Committees, the respective holder may request the support and advice of the Committees constituted at the immediate higher level of their own or external dependence, provided that the above requirements are met.
ARTICLE 108.- The members of the Committees shall remain in office for a period of three years, and may be ratified for an equal period. Members of the Committees shall also be excused from participating in the evaluation or issuance of opinions of investigations in which they have participated. The functioning of the Research and Biosafety Committees shall be subject to the general provisions which the Secretariat has to effect, as well as to the operating rules which these Committees shall make.
ARTICLE 109.- The Research Ethics Committee will evaluate and dictate the research protocols in human beings, formulating the recommendations of the the ethical nature of the investigation, for which it will review the risks and benefits of the investigation, as well as the letter of the informed consent of the subject that will be the subject of the investigation, among other elements, to guarantee the welfare and the rights of the research subjects, as well as follow up on those recommendations.
Also, the Research Ethics Committee will develop the guidelines and ethical guidelines for the research in human beings of the health institution which belong.
ARTICLE 110.- The Biosafety Committee will issue the technical opinion of the biosafety aspects of the proposed investigations, through the review of the facilities, materials and methods involved, among other elements, in order to ensure the safeguarding of the biological physical integrity of the occupational staff exposed, as well as of the research subjects, the community and the environment environment.
ARTICLE 111.- The Research Committee will assess the technical quality and scientific merit of the proposed research, formulating the relevant opinion, and shall deliver the opinion which, if appropriate, shall contain the opinion of the Research and Biosafety Ethics Committees.
ARTICLE 112.- The Committees referred to in this Chapter and the authorities to which they report shall maintain confidentiality regarding the reports they receive from researchers, mainly if the research is related to the development of inputs, technology and other application processes susceptible to patents or commercial development.
TITLE SIXTH
Implementing Research in Health Care Institutions
ONLY CHAPTER
ARTICLE 113.- The conduct of the research will be carried out by a principal investigator, who must be a health professional and have the appropriate academic training and experience for the In addition to being members of the institution of health care and having the authorization of the head responsible for the area, the work to be carried out, in addition to being members of the health care institution.
ARTICLE 114.- For the purposes of this Regulation, health professionals are considered to be persons whose activities related to medicine, dentistry, veterinary medicine, biology, bacteriology, nursing, social work, chemistry, psychology, health engineering, nutrition, dietology, pathology and its branches and others that establish other applicable legal provisions, require professional qualifications or certificate of specialization legally issued and registered by the educational authorities competent.
ARTICLE 115.- The investigations shall be carried out in accordance with a protocol, which shall be drawn up in accordance with the technical standard for the effect of the Secretariat and shall include the elements to assess the proposed study.
ARTICLE 116.- The principal investigator will be responsible for the technical direction of the study and will have the following attributions:
I. Prepare the investigation protocol;
II. Meet the procedures indicated in the protocol and request authorization for modification in the necessary cases on ethics and biosecurity aspects;
III. Document and record all data generated during the study;
IV. Forming a file on the study that will contain the protocol, modifications thereto, authorizations, generated data, final report and all documentary and biological material susceptible to be saved, related to research;
V. Select the participating staff in the study and provide you with the information and training needed to perform their function, as well as keep them abreast of the data generated and the results;
VI. Develop and present the partial and final reports of the investigation, and
VII. The other related ones that are required (sic DOF 06-01-1987) to meet the technical direction of the investigation.
ARTICLE 117.- The principal investigator will select the researchers associated with the appropriate academic training and experience in the scientific disciplines required to participate in the study. study.
ARTICLE 118.- The principal investigator will select the technical and support personnel with the necessary expertise to ensure their competence in carrying out the activities assigned to them and, in your case, care that they receive training and training to properly perform their tasks according to the level of supervision that will be available while driving the study.
ARTICLE 119.- At the end of the execution of the investigation, the principal investigator has the responsibility to present the Research Committee of the health care institution, a technical report including the elements to establish the applicable legal provisions.
ARTICLE 120.- The principal investigator may publish partial and final reports of the studies and disseminate their findings by other means, taking care that the confidentiality they have is respected. rights of the research subjects, as well as the one that has been agreed with the study's sponsors. In addition to giving due credit to the associated investigators and to the technical staff who would have participated in the investigation, they must submit a copy of these publications to the Directorate of the Institution.
TITLE SEVENTH
From Research that includes the use of experimental animals.
ONLY CHAPTER
ARTICLE 121.- In experimental animal research, referring to human health, the requirements that establish the standards of the health institutions themselves must be met. authorized by the Secretariat and satisfy the requirements of this Chapter.
ARTICLE 122.- Investigations will be designed to avoid maximum animal suffering.
ARTICLE 123.- When it is necessary to cull an animal from experimentation, a procedure shall be used to ensure as far as possible his death without suffering.
ARTICLE 124.- Biosafety must be in accordance with the species, body conformation, habits, postural preferences and characteristics of the animals, in order to provide them with comfort, except when the experimental variables justify other situations.
ARTICLE 125.- The production or chronic maintenance biosystems shall be supervised by qualified and competent professional in the field and shall permit the growth, maturation, reproduction and normal behaviour of the animals, in accordance with the rules which the institution itself issues.
ARTICLE 126.- The holder of the health institution in which this Chapter is conducted shall establish and monitor compliance with the security measures for the care and management of the animals, as well as the preventive and vaccination measures necessary for the protection of the occupational staff exposed.
TITLE EIGHTH
Of Security Measures
ONLY CHAPTER
ARTICLE 127.- The application of the security measures and their procedure, in the field of investigation, shall be subject to the provisions of Chapters I and III of Title Tenth Eighth of the Law and to the provided for in this Regulation.
ARTICLE 128.- It is for the health authorities, within the scope of their respective attributions, to order or execute the following security measures:
I. Isolation;
II. Quarantine;
III. Personal observation;
IV. People vaccination;
V. The vaccination of animals, as long as it relates to human health;
VI. The destruction or control of insects and other transmissive and noxious fauna, as far as human health is concerned,
VII. The suspension of jobs or services;
VIII. The securing and destruction of objects, products, or substances;
IX. The vacancy or eviction of homes, buildings, establishments, and, in general, any property;
X. The prohibition of use acts, and
XI. Other health conditions to be determined by the competent health authorities, which may prevent the cause or continue to cause risks or damage to health.
TITLE NINTH
From Tracking and Observance
ONLY CHAPTER
ARTICLE 129.- It is for the health authorities, within the scope of their respective powers, to monitor and comply with this Regulation and other applicable provisions, in accordance with the The provisions of Title Tenth of the Law.
ARTICLE 130.- Who conducts health research that includes the use of human beings, as well as the use of pathogenic microorganisms or biological material containing them, construction and The invention relates to the use of recombinant nucleic acids, radioactive isotopes and ionising and electromagnetic radiation generating devices, in contravention of the provisions of the Law and this Regulation. the Law, without prejudice to those established in the Regulatory Law of the Article 27 Constitutional on Nuclear Matter and the penalties in which it could incur when they were constituted of crimes.
ARTICLE 131.- The competent authority may revoke the health authorizations it has granted to carry out health investigations, when they do not comply with the provisions contained in the Law, this Regulation and other provisions deriving from it. For the substantiation of the procedure for the revocation of the authorizations, the provisions of Chapter II of the Law-Law Title shall be observed.
ARTICLE 132.- Against acts and resolutions of the health authorities which, in order to implement this Regulation, end an instance or resolve a file, the persons concerned may institute the application of non-conformity, which shall be substantial in terms of Chapter IV of Title Tenth Eighth of the Law.
ARTICLE 152 (sic DOF 02-04-2014).- Repealed.
TRANSIENT
FIRST.- This Regulation shall enter into force on the day following its publication in the Official Journal of the Federation.
SECOND.- The Agreement on the creation of the Research and Ethics Commissions, of the twenty-third of December of a thousand nine hundred and eighty-one, published in the Official Journal of the Federation, is opened. Twenty-six of January of a thousand nine hundred and eighty-two, and the Decree of creation of the Commissions of Biosafety, of the eight of July of one thousand nine hundred and eighty two, published in the Official Journal of the Federation on August 4 of the same year. The other provisions on matters which are contrary to this order shall also be repealed.
Given at the Federal Executive Branch, in Mexico City, Federal District, at the twenty-three days of the month of December of a thousand nine hundred and eighty-six.- Miguel de la Madrid H.- Heading.-The Secretary of Programming and Budget, Carlos Salinas de Gortari.-The Secretary of Energy, Mines and Parastate Industry, Alfredo del Mazo González.-Heading.-The Secretary of Public Education, Miguel Gonzalez Avelar.-Heading.-The Health Secretary, Guillermo Soberon Acevedo.- Heading.
ha Juan Lopez.-Heading.
