79C3C34C52B45572883A05D425EB0F82

Regulation on the General Health Law in the Matter of Health Research

http://www.salud.gob.mx/unidades/cdi/nom/compi/rlgsmis.html

http://leaux.net/URLS/ConvertAPI Text Files/E7AC01CC76848FE9369FF8C597AC75A1.en.txt

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This file was generated: 2020-12-01 05:30:17

Indicators in focus are typically shown highlighted in yellow;

Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink;

"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green;

Trigger Words/Phrases are shown highlighted in gray.

Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability Type	Vulnerability	Indicator	# Matches
Political	political affiliation	political	2
Health	Drug Dependence	dependence	1
Health	Drug Dependence	dependency	2
Health	Drug Usage	drug	10
Health	Mentally Disabled	disabled	2
Health	Mentally Incapacitated	incapable	8
Health	Physically Disabled	illness	2
Health	Physically Ill	sick	1
Health	Pregnant	pregnant	15
Health	breastfeeding	breastfeeding	3
Health	hospitalized patients	hospitalized	2
Health	of childbearing age/fertile	childbearing age	3
Health	of childbearing age/fertile	fertile	1
Health	patients in emergency situations	emergencies	1
Social	Access to Social Goods	access	1
Social	Age	age	3
Social	Child	child	1
Social	Child	children	1
Social	Fetus/Neonate	fetus	14
Social	Fetus/Neonate	fetuses	3
Social	Fetus/Neonate	neonates	1
Social	Incarcerated	restricted	1
Social	Infant	infant	1
Social	Marital Status	single	2
Social	Property Ownership	property	1
Social	Soldier	armed forces	1
Social	Soldier	military	1
Social	Unemployment	unemployment	1
Social	Women	women	18
Social	Youth/Minors	minor	9
Social	education	education	6
Social	education	educational	4
Social	embryo	embryo	7
Social	employees	employees	2
Social	philosophical differences/differences of opinion	opinion	10
General/Other	Impaired Autonomy	autonomy	1
General/Other	Incapacitated	incapacitated	2
General/Other	Incapacitated	incapacity	1
General/Other	Public Emergency	emergency	2
General/Other	Relationship to Authority	authority	7

Political / political affiliation

Searching for indicator political:

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p.(None): REGULATION of the General Health Law on Health Research
p.(None):
p.(None):
p.(None):
p.(None): On the margin a seal with the National Shield, which says: United Mexican States.- Presidency of the Republic.
p.(None):
p.(None): MIGUEL DE LA MADRID H. , Constitutional President of the United Mexican States, in exercise of the power conferred on the Federal Executive by section I of Article 89 of the Political Constitution of the United Mexican States and based on articles 1, 2 ., fraction VII, 3rd. section IX, 4th, 7th, 13 section "A" fractions I, IX, X, section "B" fractions I and VI, 96, 97, 98, 99, 100, 101, 102, 103 and others related to the General Health Law, and
p.(None):
p.(None): CONSIDERING
p.(None):
p.(None): That under the Decree by which Article 4 was added. Constitutional, published in the Official Gazette of the Federation dated February 3, 1983, the Right to Health Protection was established as a social guarantee;
p.(None):
p.(None): That on February 7, 1984 , the General Health Law was published in the Official Gazette of the Federation , regulating the third paragraph of Article 4. of the Political Constitution of the United Mexican States, beginning its validity on the 1st. July of the same year;
p.(None):
p.(None): 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 Federal Entities in General Health Matters, so it is pertinent to have the instruments regulations necessary for the effective exercise of its powers;
p.(None):
p.(None): That within the programs provided for in the National Development Plan 1983-1988, is that of Health, which, as strategic guidelines, completes five major policy areas, the last being "Training, Training and Research" aimed primarily at impulse of the biomedical, medical-social and health services areas hence the National Health Program 1984-1988 develops the Health Research Program, among others, as support for the consolidation of the National Health System in aspects substantial, with the specific objective of contributing to national scientific and technological development aimed at finding practical solutions to prevent, address and control priority health problems, increase productivity and technological efficiency abroad.
p.(None):
p.(None): That the General Health Law has established the guidelines and principles to which scientific and technological research for health, corresponding to the Ministry of Health, should guide its development;
p.(None):
p.(None): That research for health is a determining factor to improve actions aimed at protecting, promoting and restoring the health of the individual and society in general; to develop Mexican technology in health services and to increase its productivity, in accordance with the bases established in said Law;
p.(None):
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Health / Drug Dependence

Searching for indicator dependence:

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p.(None):
p.(None): ARTICLE 22 .- The informed consent must be formulated in writing and must be formulated in writing and must meet the following requirements:
p.(None):
p.(None): I. It will be prepared by the principal investigator, indicating the information indicated in the previous article and in accordance with the technical norm issued by the Secretariat;
p.(None):
p.(None): II.- It will be reviewed and, where appropriate, approved by the Ethics Commission of the health care institution;
p.(None):
p.(None): III.- Indicate the names and addresses of two witnesses and their relationship with the subject of investigation;
p.(None):
p.(None): IV. It must be signed by two witnesses and by the investigative subject or his legal representative, if applicable. If the investigation subject does not know how to sign, he will print his fingerprint and in his name he will sign another person he designates, and
p.(None):
p.(None): V. It will be extended in duplicate, leaving a copy in the possession of the subject of investigation or its legal representative.
p.(None):
p.(None): ARTICLE 23 .- In the case of investigations with minimal risk, the Ethics Commission, for justified reasons, may authorize that the informed consent be obtained without written formulation, and in the case of investigations without risk, the investigator may be granted the obtaining of the informed consent.
p.(None):
p.(None): ARTICLE 24 .- If there is any type of dependence, ancestry or subordination of the research subject to the investigator, which prevents him from freely granting his consent, this must be obtained by another member of the research team, completely independent of the investigator-subject relationship .
p.(None):
p.(None): ARTICLE 25.- When it is necessary to determine the mental capacity of an individual to grant his consent, the principal investigator must evaluate his capacity for understanding, reasoning and logic, according to the parameters approved by the Ethics Commission.
p.(None):
p.(None): ARTICLE 26 .- When it is presumed that the mental capacity of a subject has varied over time, the informed consent of the subject or, where appropriate, of his legal representative, must be endorsed by a group of professionals of recognized scientific and moral capacity in the specific fields of the investigation as well as of an observer who has no relation to the investigation, to ensure the suitability of the mechanism for obtaining consent, as well as its validity during the course of the investigation.
p.(None):
p.(None): ARTICLE 27 .- When a psychiatric patient is admitted to an institution for being subject to interdiction, in addition to complying with the provisions of the preceding articles, it will be necessary to obtain prior approval from the authority that knows the case.
p.(None):
p.(None): CHAPTER II
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Searching for indicator dependency:

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p.(None):
p.(None): ARTICLE 95.- Studies involving the exposure of the research subject to radiation shall:
p.(None):
p.(None): I. Justify yourself because it is not possible to obtain the same information at a lower risk through investigations that use other techniques
p.(None):
p.(None): II. Be designed optimizing the protection of the subject, so that the radiation it receives is minimized reasonable to allow obtaining the information sought.
p.(None):
p.(None): ARTICLE 96.- In investigations without direct benefit to the research subject, the equivalent dose limits, secondary limits, the derived limits as well as authorized limits, must be specified in the research projects, taking into account whether it is external, internal radiation , tissues with adherence to the biosafety standard which must match the standards of the National Commission for Nuclear Safety and Safeguards.
p.(None):
p.(None): Research that includes exposure of pregnant women to radioactive materials or ionizing radiation generating devices is prohibited.
p.(None):
p.(None): ARTICLE 97.- Investigations with direct benefit to the research subject, the criteria for limiting radiation doses should be the same as that applied for other exposures required for medical reasons, such as those due to diagnostic and treatment procedures.
p.(None):
p.(None): FIFTH TITLE
p.(None):
p.(None): Of the Internal Commissions in Health Institutions
p.(None):
p.(None): ONLY CHAPTER
p.(None):
p.(None): ARTICLE 98.- For the purposes of this Regulation, it is considered as a health institution where health research is carried out, any organically structured unit belonging to a dependency or entity of the Public Administration, or a social or private institution where carry out one or more of the activities established in article 5. of this Regulation.
p.(None):
p.(None): 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 applicable provisions, the following shall be continued:
p.(None):
p.(None): I. An Ethics Commission in the event that they conduct research in human beings;
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p.(None): II. A Biosafety Commission if research is carried out involving the use of ionizing and electromagnetic, radioactive isotopes, pathogenic microorganisms, recombinant nucleic acids or other similar procedures that may pose a health risk, and
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p.(None): III. A commission of investigation, whose integration will be mandatory for health care institutions and other institutions according to their internal regulations.
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p.(None): ARTICLE 100 .- The main purposes of the commissions that are constituted in the health institutions will be the following:
p.(None):
p.(None): I. Provide advice to the owners or managers of the institution, which supports the decision on the authorization for the development of researchers;
p.(None):
p.(None): II. Assist researchers for the optimal performance of their studies, and
p.(None):
p.(None): III. Monitor the application of these Regulations and other applicable provisions.
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p.(None): ARTICLE 101 .- The holders of the health institutions will register the commissions before the Secretariat, which will determine the characteristics and the periodicity of the reports that they will have to provide.
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p.(None): ARTICLE 102.- The Head of the health institution, based on the opinions of the Research Commission, will decide whether to authorize the proposed research, except in the case of investigations that require the specific authorization of the Secretariat, as indicated in articles 31, 62, 69, 71, 73 and 88 of these Regulations.
p.(None):
p.(None): ARTICLE 103 .- The commissions are integrated with a minimum of three scientists each, with research experience.
p.(None):
p.(None): ARTICLE 104 .- To constitute the Ethics Commission, members of both sexes must be included. It will be advisable that at least one of them does not belong to the health institution and includes medical professionals with the capacity to represent the moral, cultural and social values of the research groups.
p.(None):
p.(None): ARTICLE 105 .- To constitute the Biosafety Commission, scientists with extensive experience or knowledge in this field, whether or not members of the health institution staff, shall be included to ensure that research activities are carried out under appropriate biosafety measures.
p.(None):
p.(None): ARTICLE 106 .- To establish the Research Commission, preference will be given to members of the health institution with knowledge and experience in scientific methodology.
p.(None):
p.(None): ARTICLE 107 .- When within the institution it is not possible to gather the right people to establish the commissions, the respective holder may request the support and advice of the commissions constituted at the immediate superior level of his or her own dependency or outside of it, on condition that the aforementioned requirements are met.
p.(None):
p.(None): ARTICLE 108 .- The members of the commissions will remain in office for a period of three years, being able to be ratified for an equal period and will be relieved of their functions during the evaluation and opinion of their own investigations. The operation of each commission will be subject to the technical norms that the Secretariat dictates for this purpose, as well as to the internal regulations formulated by the commission itself and approved by the corresponding authority in the institution.
p.(None):
p.(None): ARTICLE 109 .- It is the responsibility of the Ethics Commission to issue the technical opinion on the ethical aspects of the proposed investigations, by reviewing the risks, benefits and the letter of consent in the protocols and their competent authorities, to guarantee the well-being and Rights of research subjects.
p.(None):
p.(None): ARTICLE 110.- It is the responsibility of the Biosafety Commission to issue the technical opinion of the biosafety aspects of the proposed investigations, by reviewing the facilities, in order to guarantee the protection of the biological physical integrity of the occupational personnel exposed, as well as of research subjects, the community and the environment.
p.(None):
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Health / Drug Usage

Searching for indicator drug:

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p.(None):
p.(None): III.- The principal investigator, the Ethics Commission, the authorized officials of the health care institution concerned or the Secretariat, must suspend or cancel the investigation in the presence of any adverse effect that is impediment from the point ethical view to continue the study;
p.(None):
p.(None): IV. The health care institution shall submit to the Secretariat a report within 15 business days following the date on which the suspension or cancellation of the study has been agreed, specifying the effect warned, the measures adopted and sequelae produced, and
p.(None):
p.(None): V. The others that indicate the technical standards issued by the Secretariat for this purpose.
p.(None):
p.(None): CHAPTER II
p.(None):
p.(None): Of Pharmacological Research
p.(None):
p.(None): ARTICLE 65 .- For the purposes of this Regulation, pharmacological research is understood as scientific activities aimed at the study of drugs and biological products for use in humans, in respect of which there is no previous experience in the country, which have not been Registered by the Secretariat and, therefore, are not distributed commercially, as well as the medicines registered and approved for sale, when your case is investigated with modalities, indications, doses or routes of administration different from those established, including in Use in combinations.
p.(None):
p.(None): ARTICLE 66 .- The investigation of drugs in clinical pharmacology includes the sequence of studies that are carried out from the first time they are administered to humans until data on their efficacy and therapeutic safety are obtained in large population groups. For this purpose, the following phases are considered:
p.(None):
p.(None): PHASE I.- It is the administration for the first time of a research drug to the healthy human being, without diagnostic or therapeutic benefit, in single or multiple doses, in small hospitalized groups, to establish initial pharmacological parameters in man;
p.(None):
p.(None): PHASE II.- It is the administration of a research drug of a sick human being, in single or multiple doses, in small hospitalized groups, to determine its initial efficacy and other pharmacological parameters in the diseased organism;
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p.(None): PHASE III.- It is the administration of a research drug to large groups of patients (usually external), to define its therapeutic usefulness and identify adverse reactions, interactions and external factors that may alter the pharmacological effect, and
p.(None):
p.(None): PHASE IV.- These studies are carried out after the registration and authorization of the medication is granted new information on the safety of the medication during its generalized and prolonged use.
p.(None):
p.(None): ARTICLE 67.- All the investigations in clinical pharmacology that are carried out, must be preceded by complete preclinical studies that include physicochemical characteristics, pharmacological activity, toxicity, pharmacokinetics, absorption, distribution, metabolism and excretion of the drug in different species of animals; frequencies, routes of administration and duration of the doses studied that can serve as a basis for the safety of their administration in humans; mutagenesis, teratogenesis and carcinogenesis studies will also be required.
p.(None):
p.(None): ARTICLE 68.- The preclinical toxicology studies required for each drug will be a function of this particular, of the known potential toxicology of others with similar chemical structure and of the route and time of administration that are intended to be used in humans.
p.(None):
p.(None): ARTICLE 69.- The use in human beings of investigational medicines during their evaluation through phases I to IV of clinical pharmacological research, will be done with the authorization of the Secretariat. For this purpose, the institutions must present the documentation indicated in Article 62 of that Regulation, in addition to the following:
p.(None):
p.(None): I. the basic and preclinical pharmacological information of the medicine, and
p.(None):
p.(None): II. Information previously obtained on clinical pharmacology, in cases of phases II, III and IV and availability tests when required.
p.(None):
p.(None): ARTICLE 70.- The studies of phase I clinical pharmacology, new antineoplastic drugs and others with a very low therapeutic index will be allowed, when:
p.(None):
p.(None): I. They are based on preclinical studies that demonstrate the pharmacological activity of the drug and clearly indicate the characteristics of its toxicity;
p.(None):
p.(None): II. They are carried out only in voluntary subjects with the specific advanced disease confirmed by additional diagnostic means, which have not presented a therapeutic response to any other available treatment and in whom the new drug could offer a therapeutic benefit, and
p.(None):
p.(None): III. Do not incur expenses to the patient.
p.(None):
p.(None): ARTICLE 71 .- In the emergency treatment in conditions that threaten the life of a person, when it is considered necessary to use investigational drugs or a known medication using indications, doses and routes of administration different from those established, the doctor must obtain the opinion favorable of the Commission of Investigation of the institution of attention to the health and the letter of informed consent of the subject of the subject of investigation or, in his case, of his legal representative, according to allow the circumstances, according to the following bases:
p.(None):
p.(None): I. The Research and Ethics Commissions will be informed of the use of the research drug in advance if the investigator can foresee the need for its use in urgent situations. In retrospect, if the use of the drug, the indication, doses or new routes of administration arise as unforeseen needs. In both cases the commissions will issue the opinion in favor or against approving the planned use or the repetition of the unforeseen use of the medicine and the head of the health care institution, the physician will be responsible for requiring the Secretariat to authorize such uses, and
p.(None):
p.(None): II. The status of informed consent will be obtained from the investigating subject, where appropriate, from his legal representative or the closest relative in the bond, except when the condition of the subject incapacitates or prevents him from granting it, the legal representative or the relative is not available and the stop using the investigational drug represents an almost absolute risk of death.
p.(None):
p.(None): CHAPTER III
p.(None):
p.(None): From the Research of Other New Resources
p.(None):
p.(None): ARTICLE 72 .- For the purposes of this Regulation, it is understood by investigation of other new resources or modalities different from those established, to the scientific activities aimed at the study of materials, grafts, transplants, prostheses, physical, chemical and surgical procedures and others prevention, diagnosis, treatment and rehabilitation methods that are carried out in humans or in their biological products, except pharmacological ones.
p.(None):
p.(None): ARTICLE 73.- All research referred to in this Chapter must have the authorization of the Secretariat. For this purpose, the institutions must present the documentation indicated in Article 62 of these Regulations, in addition to the following:
p.(None):
p.(None): I. The scientific foundations, information on previous experimentation in animals, in the laboratory, and
p.(None):
p.(None): II. Previous clinical research studies, if any.
p.(None):
p.(None): ARTICLE 74 .- All investigations on grafts and transplants must observe, in addition to the applicable provisions of this Regulation, the stipulations of sanitary control of the disposition of organs, tissues, and corpses of human beings.
p.(None):
p.(None): FOURTH TITLE
p.(None):
p.(None): On the Biosafety of Investigations
p.(None):
p.(None): CHAPTER I
p.(None):
p.(None): From Research with Pathogenic Microorganisms or Biological Material that may Contain them
p.(None):
p.(None): 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, shall:
p.(None):
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Health / Mentally Disabled

Searching for indicator disabled:

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p.(None):
p.(None): When two persons exercise the parental rights of a minor, the consent of one of them will only be admissible if there is irrefutable or manifest impossibility of the other to provide it or in case of imminent risk to the health or life of the minor or incapable.
p.(None):
p.(None): ARTICLE 37 .- When the mental capacity and psychological state of the minor or incapable permit, it must also obtain their acceptance to be the subject of investigation, after explaining what they intend to do. The Ethics Commission may waive compliance with these requirements for justified reasons.
p.(None):
p.(None): ARTICLE 38. - The investigations classified as of risk and with probability of direct benefit for the minor or the incapable one, will be admissible when;
p.(None):
p.(None): I.- The risk is justified by the importance of the benefit that the minor or the disabled will receive, and
p.(None):
p.(None): II.- The benefit is equal to or greater than other alternatives already established for diagnosis and treatment.
p.(None):
p.(None): ARTICLE 39.- Investigations classified as risk and without direct benefit to the minor or the incapable, shall be admissible according to the following considerations:
p.(None):
p.(None): I. When the risk is minimal:
p.(None):
p.(None): TO). The intervention or procedure must represent for the minor or the incapable a reasonable experience and comparable with those inherent in their current or expected medical, psychological, social or educational situation, and
p.(None):
p.(None): B). The intervention of the procedure should have a high probability of obtaining generalizable knowledge about the condition or disease of the minor or the incapable, that are of great importance to understand the disorder or to achieve its improvement in other subjects.
p.(None):
p.(None): II. When the risk is greater than the minimum:
p.(None):
p.(None): TO). Research should offer a high probability of understanding, preventing or alleviating a serious problem that affects the health and well-being of children or the disabled, and
p.(None):
p.(None): B). The head of the health care institution will establish strict supervision to determine whether the magnitude of the anticipated risks increases or others arise and will suspend the investigation at the time the risk could affect the biological, psychological or social well-being of the child or of the incapable
p.(None):
p.(None): CHAPTER IV
p.(None):
p.(None): From research in Women of Fertile Age, Pregnant Women, during Labor, Childbirth, Lactation and Newborns; of the use of Embryos, Obitos and Fetos and of Assisted Fertilization.
p.(None):
p.(None): ARTICLE 40 .- For the purposes of this Regulation, it is understood as:
p.(None):
p.(None): I. Women of childbearing age.- From the beginning of puberty until the onset of menopause;
p.(None):
p.(None): II. Pregnancy.- It is the period from the fertilization of the ovum (evidenced by any presumptive sign or symptom of pregnancy, as a suspension of menstruation or positive proof of medically accepted pregnancy) until the expulsion or removal of the fetus and its annexes.
p.(None):
p.(None): III. Embryo.- The product of conception from the fertilization of the ovum until the end of the twelfth week of management;
p.(None):
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Health / Mentally Incapacitated

Searching for indicator incapable:

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p.(None):
p.(None): Areas 3.- In any community investigation, the ethical considerations applicable to research on individuals must be extrapolated to the communal context in the pertinent aspects.
p.(None):
p.(None): CHAPTER III
p.(None):
p.(None): On Research in Minors or Disabilities
p.(None):
p.(None): ARTICLE 34.- In addition to the general provisions of ethics that must be complied with in any investigation in human beings, that which is carried out in minors or incapacitated persons must satisfy what is established in this chapter, except in the case of emancipated persons over 16 years of age.
p.(None):
p.(None): ARTICLE 35 .- When it is intended to carry out investigations in minors, it must be ensured that similar studies have previously been carried out in persons of May age and immature animals, except when it comes to studying conditions that are typical of the neonatal stage or specific conditions of certain ages.
p.(None):
p.(None): ARTICLE 36.- In order to carry out investigations in minors or incapacitated persons, in any case, the written informed consent must be obtained from those who exercise parental authority or the legal representation of the minor or incapable person in question.
p.(None):
p.(None): When two persons exercise the parental rights of a minor, the consent of one of them will only be admissible if there is irrefutable or manifest impossibility of the other to provide it or in case of imminent risk to the health or life of the minor or incapable.
p.(None):
p.(None): ARTICLE 37 .- When the mental capacity and psychological state of the minor or incapable permit, it must also obtain their acceptance to be the subject of investigation, after explaining what they intend to do. The Ethics Commission may waive compliance with these requirements for justified reasons.
p.(None):
p.(None): ARTICLE 38. - The investigations classified as of risk and with probability of direct benefit for the minor or the incapable one, will be admissible when;
p.(None):
p.(None): I.- The risk is justified by the importance of the benefit that the minor or the disabled will receive, and
p.(None):
p.(None): II.- The benefit is equal to or greater than other alternatives already established for diagnosis and treatment.
p.(None):
p.(None): ARTICLE 39.- Investigations classified as risk and without direct benefit to the minor or the incapable, shall be admissible according to the following considerations:
p.(None):
p.(None): I. When the risk is minimal:
p.(None):
p.(None): TO). The intervention or procedure must represent for the minor or the incapable a reasonable experience and comparable with those inherent in their current or expected medical, psychological, social or educational situation, and
p.(None):
p.(None): B). The intervention of the procedure should have a high probability of obtaining generalizable knowledge about the condition or disease of the minor or the incapable, that are of great importance to understand the disorder or to achieve its improvement in other subjects.
p.(None):
p.(None): II. When the risk is greater than the minimum:
p.(None):
p.(None): TO). Research should offer a high probability of understanding, preventing or alleviating a serious problem that affects the health and well-being of children or the disabled, and
p.(None):
p.(None): B). The head of the health care institution will establish strict supervision to determine whether the magnitude of the anticipated risks increases or others arise and will suspend the investigation at the time the risk could affect the biological, psychological or social well-being of the child or of the incapable
p.(None):
p.(None): CHAPTER IV
p.(None):
p.(None): From research in Women of Fertile Age, Pregnant Women, during Labor, Childbirth, Lactation and Newborns; of the use of Embryos, Obitos and Fetos and of Assisted Fertilization.
p.(None):
p.(None): ARTICLE 40 .- For the purposes of this Regulation, it is understood as:
p.(None):
p.(None): I. Women of childbearing age.- From the beginning of puberty until the onset of menopause;
p.(None):
p.(None): II. Pregnancy.- It is the period from the fertilization of the ovum (evidenced by any presumptive sign or symptom of pregnancy, as a suspension of menstruation or positive proof of medically accepted pregnancy) until the expulsion or removal of the fetus and its annexes.
p.(None):
p.(None): III. Embryo.- The product of conception from the fertilization of the ovum until the end of the twelfth week of management;
p.(None):
p.(None): IV. Fetus.- The product of conception from the beginning of the thirteenth week of gestation until its expulsion or extraction;
p.(None):
p.(None): V. Fetal Obito.- The death of the fetus in the womb;
p.(None):
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Health / Physically Disabled

Searching for indicator illness:

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p.(None):
p.(None): That without restricting the freedom of researchers, in the particular case of research carried out on human beings and of which use materials or procedures that carry a risk, it is necessary to adhere to scientific, ethical principles and safety standards generally accepted, and
p.(None):
p.(None): That the investigation in human beings of new prophylactic, diagnostic, therapeutic and rehabilitation resources, must be subject to a control to obtain a greater efficiency and avoid risks to the health of the people, I have been good to issue the following
p.(None):
p.(None): REGULATION OF THE GENERAL HEALTH LAW IN HEALTH RESEARCH
p.(None):
p.(None): FIRST TITLE
p.(None):
p.(None): General disposition
p.(None):
p.(None): ONLY CHAPTER
p.(None):
p.(None): ARTICLE 1 .- This Ordinance is intended to provide, in the administrative sphere, compliance with the General Health Law in relation to research for health in the public, social and private sectors. It is applicable throughout the national territory and its provisions are of public order and social interest.
p.(None):
p.(None): ARTICLE 2 .- For the purposes of this Regulation, when mention is made of the "Law" to the "Secretariat" and to the "Research", it shall be understood as referring to the General Law of Health, the Ministry of Health and Research for Health, respectively.
p.(None):
p.(None): ARTICLE 3.- Research for health includes the development of actions that contribute:
p.(None):
p.(None): I. To the knowledge of the biological and psychological processes in human beings;
p.(None):
p.(None): II. To the knowledge of the links between the causes of illness, medical practice and social structure;
p.(None):
p.(None): III. To the prevention and control of health problems;
p.(None):
p.(None): IV. To knowledge and evaluation of the harmful effects of the environment on health;
p.(None):
p.(None): V. To the study of the techniques and methods that are recommended or used for the provision of health services, and
p.(None):
p.(None): SAW. To the production of health supplies.
p.(None):
p.(None): ARTICLE 4 .- The application of these Regulations corresponds to the Secretariat and to the governments of the federal entities; including the Federal District, within the scope of their respective competences and in the terms of the Coordination Agreements that are signed to formalize the actions aimed at promoting and promoting the development of the investigation.
p.(None):
p.(None): ARTICLE 5 .- The powers referred to in the previous article will be distributed according to the following:
p.(None):
p.(None): A. It corresponds to the Secretariat:
p.(None):
p.(None): I. Issue the technical norms to which, throughout the national territory, they will be subject to health research and verify their compliance;
p.(None):
p.(None): II.- Organize and operate research activities in their administrative units;
p.(None):
p.(None): III.- Promote, guide, encourage and support research activities carried out by the governments of federal entities;
p.(None):
p.(None): IV. Carry out, as far as it is concerned and in coordination with the corresponding Dependencies and Entities, the general evaluation of research activities throughout the national territory, and
p.(None):
p.(None): V.- Coordinate research within the framework of the National Health system.
p.(None):
...

p.(None):
p.(None): ARTICLE 80 .- Microorganisms that are classified in risk groups I and II must be handled in basic microbiology laboratories, using safety cabinets when deemed necessary.
p.(None):
p.(None): ARTICLE 81 .- Microorganisms that are classified in risk group III must be handled in microbiological safety laboratories.
p.(None):
p.(None): ARTICLE 82 .- The microorganisms that are classified in the risk group IV must be handled in laboratories of maximum microbiology safety, under the authorization and control of the corresponding health authorities referred to in article 4. of the law.
p.(None):
p.(None): ARTICLE 83 .- During the development of the investigations referred to in this Chapter, the principal investigator shall be responsible:
p.(None):
p.(None): I. Determine the real and potential risks of the proposed research and, if approved by the health institution commissions, make them known to the associated researchers and other personnel who will participate in the research;
p.(None):
p.(None): II. Determine the appropriate level of physical containment, select the appropriate microbiological practices and design procedures to deal with possible accidents during the investigation and instruct the participating staff on these aspects;
p.(None):
p.(None): III. Ensure that participating personnel comply with the requirements of medical prophylaxis, vaccinations or serological tests;
p.(None):
p.(None): IV. Supervise that the transport of infectious materials is done in an appropriate manner, in accordance with the technical standards issued by the Secretariat;
p.(None):
p.(None): V. Inform the Biosafety Commission about the occurrence of illness among the personnel participating in the investigation, which could be attributed to the transcutaneous inoculation, ingestion or inhalation of infectious materials, as well as accidents that cause contamination that may affect the personnel or the environment , Y
p.(None):
p.(None): SAW. Report to the Biosafety Commission the difficulties or failures in the implementation of safety procedures, correct work errors that could cause the release of infectious material and ensure the integrity of physical containment measures.
p.(None):
p.(None): ARTICLE 84 .- The Biosafety Commissions of the health institutions must make visits as often as they determine, to evaluate compliance with the measures and to recommend compliance with the measures and to recommend modifications to laboratory practices, including Temporary or definitive suspension of research that represents an uncontrolled risk or co-risk for laboratory workers, the community or the environment.
p.(None):
p.(None): CHAPTER II
p.(None):
p.(None): From Research that involves construction and management of recombinant nucleic acids
p.(None):
p.(None): ARTICLE 85.- For the purposes of this Regulation, recombinant nucleic acids shall be understood as the new combinations of genetic material obtained outside a current cell, through the insertion of natural or synthetic segments of deoxyribonucleic acid in a virus, bacterial plasmid or other deoxibonucleic acid molecules, which serve as a vector system, to allow their incorporation into a host cell, in which they are not found naturally, but in which they will be able to replicate. Also included are deoxyribonucleic acid molecules that result from such replication.
p.(None):
...

Health / Physically Ill

Searching for indicator sick:

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p.(None):
p.(None): V. The others that indicate the technical standards issued by the Secretariat for this purpose.
p.(None):
p.(None): CHAPTER II
p.(None):
p.(None): Of Pharmacological Research
p.(None):
p.(None): ARTICLE 65 .- For the purposes of this Regulation, pharmacological research is understood as scientific activities aimed at the study of drugs and biological products for use in humans, in respect of which there is no previous experience in the country, which have not been Registered by the Secretariat and, therefore, are not distributed commercially, as well as the medicines registered and approved for sale, when your case is investigated with modalities, indications, doses or routes of administration different from those established, including in Use in combinations.
p.(None):
p.(None): ARTICLE 66 .- The investigation of drugs in clinical pharmacology includes the sequence of studies that are carried out from the first time they are administered to humans until data on their efficacy and therapeutic safety are obtained in large population groups. For this purpose, the following phases are considered:
p.(None):
p.(None): PHASE I.- It is the administration for the first time of a research drug to the healthy human being, without diagnostic or therapeutic benefit, in single or multiple doses, in small hospitalized groups, to establish initial pharmacological parameters in man;
p.(None):
p.(None): PHASE II.- It is the administration of a research drug of a sick human being, in single or multiple doses, in small hospitalized groups, to determine its initial efficacy and other pharmacological parameters in the diseased organism;
p.(None):
p.(None): PHASE III.- It is the administration of a research drug to large groups of patients (usually external), to define its therapeutic usefulness and identify adverse reactions, interactions and external factors that may alter the pharmacological effect, and
p.(None):
p.(None): PHASE IV.- These studies are carried out after the registration and authorization of the medication is granted new information on the safety of the medication during its generalized and prolonged use.
p.(None):
p.(None): ARTICLE 67.- All the investigations in clinical pharmacology that are carried out, must be preceded by complete preclinical studies that include physicochemical characteristics, pharmacological activity, toxicity, pharmacokinetics, absorption, distribution, metabolism and excretion of the drug in different species of animals; frequencies, routes of administration and duration of the doses studied that can serve as a basis for the safety of their administration in humans; mutagenesis, teratogenesis and carcinogenesis studies will also be required.
p.(None):
p.(None): ARTICLE 68.- The preclinical toxicology studies required for each drug will be a function of this particular, of the known potential toxicology of others with similar chemical structure and of the route and time of administration that are intended to be used in humans.
p.(None):
...

Health / Pregnant

Searching for indicator pregnant:

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p.(None):
p.(None): B). The intervention of the procedure should have a high probability of obtaining generalizable knowledge about the condition or disease of the minor or the incapable, that are of great importance to understand the disorder or to achieve its improvement in other subjects.
p.(None):
p.(None): II. When the risk is greater than the minimum:
p.(None):
p.(None): TO). Research should offer a high probability of understanding, preventing or alleviating a serious problem that affects the health and well-being of children or the disabled, and
p.(None):
p.(None): B). The head of the health care institution will establish strict supervision to determine whether the magnitude of the anticipated risks increases or others arise and will suspend the investigation at the time the risk could affect the biological, psychological or social well-being of the child or of the incapable
p.(None):
p.(None): CHAPTER IV
p.(None):
p.(None): From research in Women of Fertile Age, Pregnant Women, during Labor, Childbirth, Lactation and Newborns; of the use of Embryos, Obitos and Fetos and of Assisted Fertilization.
p.(None):
p.(None): ARTICLE 40 .- For the purposes of this Regulation, it is understood as:
p.(None):
p.(None): I. Women of childbearing age.- From the beginning of puberty until the onset of menopause;
p.(None):
p.(None): II. Pregnancy.- It is the period from the fertilization of the ovum (evidenced by any presumptive sign or symptom of pregnancy, as a suspension of menstruation or positive proof of medically accepted pregnancy) until the expulsion or removal of the fetus and its annexes.
p.(None):
p.(None): III. Embryo.- The product of conception from the fertilization of the ovum until the end of the twelfth week of management;
p.(None):
p.(None): IV. Fetus.- The product of conception from the beginning of the thirteenth week of gestation until its expulsion or extraction;
p.(None):
p.(None): V. Fetal Obito.- The death of the fetus in the womb;
p.(None):
p.(None): VI.- Live birth.- It is the expulsion or complete extraction of the product of conception, from the maternal breast, when after such separation the heart breathes and beats, the umbilical cord has been cut or not and the placenta is detached;
p.(None):
p.(None): VII.- Dead Birth.- is the expulsion or complete extraction of the product of conception, from the maternal breast, when after said separation the heart does not breathe or beat, the umbilical cord has been cut or not and the placenta is detached or not ;
p.(None):
p.(None): VIII.- Labor.- It is the period from the start of uterine contractions (with progressive characteristics of intensity, irrigation and duration) and that ends with the expulsion or extraction of the fetus and its annexes;
p.(None):
p.(None): IX. Puerperio.- It is the period that begins with the expulsion or extraction of the fetus and its annexes until the involution of gestational changes is achieved (approximately for 42 days)
p.(None):
p.(None): X. Breastfeeding.- It is a physiological phenomenon in which dairy secretion occurs from the expulsion or extraction of the fetus and its annexes, and
p.(None):
p.(None): XI Assisted fertilization.- It is one in which the insemination is artificial (homologous or heterologous) and includes in vitro fertilization.
p.(None):
p.(None): ARTICLE 41.- In addition to the general provisions of ethics that must be complied with in any investigation in human beings, those that include the subjects referred to in this chapter must satisfy what is established in articles 42 to 56 of these Regulations.
p.(None):
p.(None): ARTICLE 42.- In investigations classified as irrigation greater than the minimum that are carried out in women of childbearing age, measures shall be taken to:
p.(None):
p.(None): I. Certify that women are not pregnant, prior to their acceptance as research subjects, and
p.(None):
p.(None): II. Reduce as much as possible the chances of pregnancy during the investigation.
p.(None):
p.(None): ARTICLE 43 .- To carry out research in pregnant women, during labor, postpartum and lactation; in live or dead births; of use of embryos, deaths or fetuses; and for assisted fertilization, it is required to obtain the letter of informed consent from the woman and her spouse or concubinary in accordance with the provisions of articles 21 and 22 of these Regulations, prior information on the possible risks to the embryo, fetus or Newborn in your case.
p.(None):
p.(None): The consent of the spouse or concubinary can only be waived in case of incapacity or irrefutable or manifest impossibility to provide it; because the concubinary does not take care of the woman, or, when there is imminent risk to the health or life of the woman, embryo, fetus or newborn.
p.(None):
p.(None): ARTICLE 44.- The investigations carried out in pregnant women must be preceded by studies carried out in non-pregnant women that demonstrate their safety, except for specific studies that require said condition.
p.(None):
p.(None): ARTICLE 45. - The investigations in pregnant women, whose objective is to obtain generalizable knowledge about pregnancy, should not represent a risk greater than the minimum for the woman, the embryo or the fetus.
p.(None):
p.(None): ARTICLE 46.- Investigations in pregnant women that imply an intervention or experimental procedure not related to pregnancy, but with therapeutic benefit for women, as it would be in cases of gravidarum toxemia, diabetes, hypertension and malignancies, among others, should not expose embryo or the fetus at a greater than minimum risk, except when the use of the intervention or procedure is justified to save the woman's life.
p.(None):
p.(None): ARTICLE 47 .- Research in pregnant women, with therapeutic benefit related to pregnancy, will be allowed when:
p.(None):
p.(None): I. Aim to improve the health of the pregnant woman with a minimal risk to the embryo or fetus, or
p.(None):
p.(None): II.- Are aimed at increasing the viability of the fetus, with a minimal risk to the pregnant woman.
p.(None):
p.(None): ARTICLE 48 .- During the execution of investigations in pregnant women:
p.(None):
p.(None): I. Investigators will not have the authority to decide on the time, method or procedure used to terminate the pregnancy, nor will they participate in decisions on the viability of the fetus;
p.(None):
p.(None): II. Only with the authorization of the Ethics Commission can the method to terminate the pregnancy be modified for research purposes, when such modifications represent a minimal risk to the mother's health and do not represent any risk for the survival of the fetus, and
p.(None):
p.(None): III. In any case, it is strictly forbidden to grant monetary or other stimuli to terminate the pregnancy, for the interest of the investigation or for other reasons.
p.(None):
p.(None): ARTICLE 49 .- The informed consent letter for investigations during labor, must be obtained in accordance with the provisions of articles 21, 22, and 43 of these Regulations, before it is initiated and duly expressly state that the consent It can be withdrawn at any time during labor.
p.(None):
p.(None): ARTICLE 50.- Investigations in women in the puerperium will be allowed when they do not interfere with the health of the mother and the newborn.
p.(None):
p.(None): ARTICLE 51.- Investigations in women during breastfeeding will be authorized when there is no risk for the infant or when the mother decides not to breastfeed, her diet is assured by another method and the informed consent letter is obtained in accordance with the provisions of the Articles 21, 22, and 43 of this Regulation.
p.(None):
p.(None): ARTICLE 52 .- Fetuses will be subject to investigation only if the techniques and means used provide maximum security for them and the pregnant woman.
p.(None):
p.(None): ARTICLE 53 .- Newborns will not be subject to investigation until it has been established with certainty whether or not they are live births, except when the investigation is intended to increase their probability of survival until the viability phase, the study procedures 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 otherwise.
p.(None):
p.(None): ARTICLE 54 .- Live births may be subject to investigation if the provisions on investigation in minors, indicated in these Regulations are complied with.
p.(None):
p.(None): ARTICLE 55.- Investigations with embryos, deaths, fetuses, dead births, macerated fetal matter, cells, tissues and organs extracted from them will be carried out in accordance with the provisions of Title Fourteenth of the Law and these Regulations.
p.(None):
p.(None): ARTICLE 56.- The investigation on assisted fertilization will only be admissible when it is applied to the solution of sterility problems that cannot be solved in any other way, respecting the moral, cultural and social point of view of the couple, even if it differs with the researcher
p.(None):
p.(None): CHAPTER V
p.(None):
p.(None): On Subordinate Group Research
p.(None):
...

p.(None):
p.(None): III. Train staff on work procedures and the characteristics of the laboratory and equipment.
p.(None):
p.(None): ARTICLE 92.- All personnel directly or indirectly involved in this type of research must be adequately informed, by the person responsible for the radiological and physical safety, of the health risks represented by the radiation doses to which they are exposed and should know the basic principles of radiology protection, such as: Shielding, exposure time, distance and control of pollution and radioactive waste, among others, in order to ensure an accurate knowledge of radiation protection measures, such as: Shielding , exposure time, distance and control of pollution and radioactive waste, among others,in order to ensure an accurate knowledge of the radiological protection measures that ensure the biosecurity of the procedures used in the investigation, with the participation that corresponds to the Ministry of Energy, Mines and Parastatal Industry.
p.(None):
p.(None): ARTICLE 93 .- In these investigations, the occupational exposed personnel must be over 18 years. When such a person is a woman of childbearing age, the exposures should be distributed as evenly as possible in time, in order to protect, if necessary, the embryo during the organogenesis period, before the pregnancy diagnosis is made.
p.(None):
p.(None): Pregnant women will only be able to continue the work that exposes them occupationally, if it is ensured that the exposures will be distributed as evenly as possible in time and when it is unlikely that they will receive a third of the equivalent annual dose that should be specified in the biosafety regulations of according to the specific radioactive energy. Pregnant or breastfeeding women should not work in places where there is a risk of incorporation of radioactive materials.
p.(None):
p.(None): ARTICLE 94 .- The health institution where research is conducted with radioactive materials must appoint a doctor or health care institution that will be responsible for conducting medical examinations to the occupational exposed personnel, in order to:
p.(None):
p.(None): I. Determine their aptitude, from the point of view of their health, to perform the work considered, before they are exposed to radiation.
p.(None):
p.(None): II. Identify changes in your health that could result from radiation exposure during the performance of your work, and
p.(None):
p.(None): III. Detect late effects of radiation, even after exposure has ceased.
p.(None):
p.(None): ARTICLE 95.- Studies involving the exposure of the research subject to radiation shall:
p.(None):
p.(None): I. Justify yourself because it is not possible to obtain the same information at a lower risk through investigations that use other techniques
p.(None):
p.(None): II. Be designed optimizing the protection of the subject, so that the radiation it receives is minimized reasonable to allow obtaining the information sought.
p.(None):
p.(None): ARTICLE 96.- In investigations without direct benefit to the research subject, the equivalent dose limits, secondary limits, the derived limits as well as authorized limits, must be specified in the research projects, taking into account whether it is external, internal radiation , tissues with adherence to the biosafety standard which must match the standards of the National Commission for Nuclear Safety and Safeguards.
p.(None):
p.(None): Research that includes exposure of pregnant women to radioactive materials or ionizing radiation generating devices is prohibited.
p.(None):
p.(None): ARTICLE 97.- Investigations with direct benefit to the research subject, the criteria for limiting radiation doses should be the same as that applied for other exposures required for medical reasons, such as those due to diagnostic and treatment procedures.
p.(None):
p.(None): FIFTH TITLE
p.(None):
p.(None): Of the Internal Commissions in Health Institutions
p.(None):
p.(None): ONLY CHAPTER
p.(None):
p.(None): ARTICLE 98.- For the purposes of this Regulation, it is considered as a health institution where health research is carried out, any organically structured unit belonging to a dependency or entity of the Public Administration, or a social or private institution where carry out one or more of the activities established in article 5. of this Regulation.
p.(None):
p.(None): 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 applicable provisions, the following shall be continued:
p.(None):
p.(None): I. An Ethics Commission in the event that they conduct research in human beings;
p.(None):
p.(None): II. A Biosafety Commission if research is carried out involving the use of ionizing and electromagnetic, radioactive isotopes, pathogenic microorganisms, recombinant nucleic acids or other similar procedures that may pose a health risk, and
p.(None):
p.(None): III. A commission of investigation, whose integration will be mandatory for health care institutions and other institutions according to their internal regulations.
p.(None):
...

Health / breastfeeding

Searching for indicator breastfeeding:

(return to top)
p.(None):
p.(None): III. Embryo.- The product of conception from the fertilization of the ovum until the end of the twelfth week of management;
p.(None):
p.(None): IV. Fetus.- The product of conception from the beginning of the thirteenth week of gestation until its expulsion or extraction;
p.(None):
p.(None): V. Fetal Obito.- The death of the fetus in the womb;
p.(None):
p.(None): VI.- Live birth.- It is the expulsion or complete extraction of the product of conception, from the maternal breast, when after such separation the heart breathes and beats, the umbilical cord has been cut or not and the placenta is detached;
p.(None):
p.(None): VII.- Dead Birth.- is the expulsion or complete extraction of the product of conception, from the maternal breast, when after said separation the heart does not breathe or beat, the umbilical cord has been cut or not and the placenta is detached or not ;
p.(None):
p.(None): VIII.- Labor.- It is the period from the start of uterine contractions (with progressive characteristics of intensity, irrigation and duration) and that ends with the expulsion or extraction of the fetus and its annexes;
p.(None):
p.(None): IX. Puerperio.- It is the period that begins with the expulsion or extraction of the fetus and its annexes until the involution of gestational changes is achieved (approximately for 42 days)
p.(None):
p.(None): X. Breastfeeding.- It is a physiological phenomenon in which dairy secretion occurs from the expulsion or extraction of the fetus and its annexes, and
p.(None):
p.(None): XI Assisted fertilization.- It is one in which the insemination is artificial (homologous or heterologous) and includes in vitro fertilization.
p.(None):
p.(None): ARTICLE 41.- In addition to the general provisions of ethics that must be complied with in any investigation in human beings, those that include the subjects referred to in this chapter must satisfy what is established in articles 42 to 56 of these Regulations.
p.(None):
p.(None): ARTICLE 42.- In investigations classified as irrigation greater than the minimum that are carried out in women of childbearing age, measures shall be taken to:
p.(None):
p.(None): I. Certify that women are not pregnant, prior to their acceptance as research subjects, and
p.(None):
p.(None): II. Reduce as much as possible the chances of pregnancy during the investigation.
p.(None):
...

p.(None):
p.(None): I. Investigators will not have the authority to decide on the time, method or procedure used to terminate the pregnancy, nor will they participate in decisions on the viability of the fetus;
p.(None):
p.(None): II. Only with the authorization of the Ethics Commission can the method to terminate the pregnancy be modified for research purposes, when such modifications represent a minimal risk to the mother's health and do not represent any risk for the survival of the fetus, and
p.(None):
p.(None): III. In any case, it is strictly forbidden to grant monetary or other stimuli to terminate the pregnancy, for the interest of the investigation or for other reasons.
p.(None):
p.(None): ARTICLE 49 .- The informed consent letter for investigations during labor, must be obtained in accordance with the provisions of articles 21, 22, and 43 of these Regulations, before it is initiated and duly expressly state that the consent It can be withdrawn at any time during labor.
p.(None):
p.(None): ARTICLE 50.- Investigations in women in the puerperium will be allowed when they do not interfere with the health of the mother and the newborn.
p.(None):
p.(None): ARTICLE 51.- Investigations in women during breastfeeding will be authorized when there is no risk for the infant or when the mother decides not to breastfeed, her diet is assured by another method and the informed consent letter is obtained in accordance with the provisions of the Articles 21, 22, and 43 of this Regulation.
p.(None):
p.(None): ARTICLE 52 .- Fetuses will be subject to investigation only if the techniques and means used provide maximum security for them and the pregnant woman.
p.(None):
p.(None): ARTICLE 53 .- Newborns will not be subject to investigation until it has been established with certainty whether or not they are live births, except when the investigation is intended to increase their probability of survival until the viability phase, the study procedures 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 otherwise.
p.(None):
p.(None): ARTICLE 54 .- Live births may be subject to investigation if the provisions on investigation in minors, indicated in these Regulations are complied with.
p.(None):
p.(None): ARTICLE 55.- Investigations with embryos, deaths, fetuses, dead births, macerated fetal matter, cells, tissues and organs extracted from them will be carried out in accordance with the provisions of Title Fourteenth of the Law and these Regulations.
p.(None):
...

p.(None):
p.(None): ARTICLE 93 .- In these investigations, the occupational exposed personnel must be over 18 years. When such a person is a woman of childbearing age, the exposures should be distributed as evenly as possible in time, in order to protect, if necessary, the embryo during the organogenesis period, before the pregnancy diagnosis is made.
p.(None):
p.(None): Pregnant women will only be able to continue the work that exposes them occupationally, if it is ensured that the exposures will be distributed as evenly as possible in time and when it is unlikely that they will receive a third of the equivalent annual dose that should be specified in the biosafety regulations of according to the specific radioactive energy. Pregnant or breastfeeding women should not work in places where there is a risk of incorporation of radioactive materials.
p.(None):
p.(None): ARTICLE 94 .- The health institution where research is conducted with radioactive materials must appoint a doctor or health care institution that will be responsible for conducting medical examinations to the occupational exposed personnel, in order to:
p.(None):
p.(None): I. Determine their aptitude, from the point of view of their health, to perform the work considered, before they are exposed to radiation.
p.(None):
p.(None): II. Identify changes in your health that could result from radiation exposure during the performance of your work, and
p.(None):
p.(None): III. Detect late effects of radiation, even after exposure has ceased.
p.(None):
p.(None): ARTICLE 95.- Studies involving the exposure of the research subject to radiation shall:
p.(None):
p.(None): I. Justify yourself because it is not possible to obtain the same information at a lower risk through investigations that use other techniques
p.(None):
p.(None): II. Be designed optimizing the protection of the subject, so that the radiation it receives is minimized reasonable to allow obtaining the information sought.
p.(None):
p.(None): ARTICLE 96.- In investigations without direct benefit to the research subject, the equivalent dose limits, secondary limits, the derived limits as well as authorized limits, must be specified in the research projects, taking into account whether it is external, internal radiation , tissues with adherence to the biosafety standard which must match the standards of the National Commission for Nuclear Safety and Safeguards.
p.(None):
...

Health / hospitalized patients

Searching for indicator hospitalized:

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p.(None):
p.(None): IV. The health care institution shall submit to the Secretariat a report within 15 business days following the date on which the suspension or cancellation of the study has been agreed, specifying the effect warned, the measures adopted and sequelae produced, and
p.(None):
p.(None): V. The others that indicate the technical standards issued by the Secretariat for this purpose.
p.(None):
p.(None): CHAPTER II
p.(None):
p.(None): Of Pharmacological Research
p.(None):
p.(None): ARTICLE 65 .- For the purposes of this Regulation, pharmacological research is understood as scientific activities aimed at the study of drugs and biological products for use in humans, in respect of which there is no previous experience in the country, which have not been Registered by the Secretariat and, therefore, are not distributed commercially, as well as the medicines registered and approved for sale, when your case is investigated with modalities, indications, doses or routes of administration different from those established, including in Use in combinations.
p.(None):
p.(None): ARTICLE 66 .- The investigation of drugs in clinical pharmacology includes the sequence of studies that are carried out from the first time they are administered to humans until data on their efficacy and therapeutic safety are obtained in large population groups. For this purpose, the following phases are considered:
p.(None):
p.(None): PHASE I.- It is the administration for the first time of a research drug to the healthy human being, without diagnostic or therapeutic benefit, in single or multiple doses, in small hospitalized groups, to establish initial pharmacological parameters in man;
p.(None):
p.(None): PHASE II.- It is the administration of a research drug of a sick human being, in single or multiple doses, in small hospitalized groups, to determine its initial efficacy and other pharmacological parameters in the diseased organism;
p.(None):
p.(None): PHASE III.- It is the administration of a research drug to large groups of patients (usually external), to define its therapeutic usefulness and identify adverse reactions, interactions and external factors that may alter the pharmacological effect, and
p.(None):
p.(None): PHASE IV.- These studies are carried out after the registration and authorization of the medication is granted new information on the safety of the medication during its generalized and prolonged use.
p.(None):
p.(None): ARTICLE 67.- All the investigations in clinical pharmacology that are carried out, must be preceded by complete preclinical studies that include physicochemical characteristics, pharmacological activity, toxicity, pharmacokinetics, absorption, distribution, metabolism and excretion of the drug in different species of animals; frequencies, routes of administration and duration of the doses studied that can serve as a basis for the safety of their administration in humans; mutagenesis, teratogenesis and carcinogenesis studies will also be required.
p.(None):
p.(None): ARTICLE 68.- The preclinical toxicology studies required for each drug will be a function of this particular, of the known potential toxicology of others with similar chemical structure and of the route and time of administration that are intended to be used in humans.
p.(None):
...

Health / of childbearing age/fertile

Searching for indicator childbearing age:

(return to top)
p.(None):
p.(None): II. When the risk is greater than the minimum:
p.(None):
p.(None): TO). Research should offer a high probability of understanding, preventing or alleviating a serious problem that affects the health and well-being of children or the disabled, and
p.(None):
p.(None): B). The head of the health care institution will establish strict supervision to determine whether the magnitude of the anticipated risks increases or others arise and will suspend the investigation at the time the risk could affect the biological, psychological or social well-being of the child or of the incapable
p.(None):
p.(None): CHAPTER IV
p.(None):
p.(None): From research in Women of Fertile Age, Pregnant Women, during Labor, Childbirth, Lactation and Newborns; of the use of Embryos, Obitos and Fetos and of Assisted Fertilization.
p.(None):
p.(None): ARTICLE 40 .- For the purposes of this Regulation, it is understood as:
p.(None):
p.(None): I. Women of childbearing age.- From the beginning of puberty until the onset of menopause;
p.(None):
p.(None): II. Pregnancy.- It is the period from the fertilization of the ovum (evidenced by any presumptive sign or symptom of pregnancy, as a suspension of menstruation or positive proof of medically accepted pregnancy) until the expulsion or removal of the fetus and its annexes.
p.(None):
p.(None): III. Embryo.- The product of conception from the fertilization of the ovum until the end of the twelfth week of management;
p.(None):
p.(None): IV. Fetus.- The product of conception from the beginning of the thirteenth week of gestation until its expulsion or extraction;
p.(None):
p.(None): V. Fetal Obito.- The death of the fetus in the womb;
p.(None):
p.(None): VI.- Live birth.- It is the expulsion or complete extraction of the product of conception, from the maternal breast, when after such separation the heart breathes and beats, the umbilical cord has been cut or not and the placenta is detached;
p.(None):
p.(None): VII.- Dead Birth.- is the expulsion or complete extraction of the product of conception, from the maternal breast, when after said separation the heart does not breathe or beat, the umbilical cord has been cut or not and the placenta is detached or not ;
p.(None):
p.(None): VIII.- Labor.- It is the period from the start of uterine contractions (with progressive characteristics of intensity, irrigation and duration) and that ends with the expulsion or extraction of the fetus and its annexes;
p.(None):
p.(None): IX. Puerperio.- It is the period that begins with the expulsion or extraction of the fetus and its annexes until the involution of gestational changes is achieved (approximately for 42 days)
p.(None):
p.(None): X. Breastfeeding.- It is a physiological phenomenon in which dairy secretion occurs from the expulsion or extraction of the fetus and its annexes, and
p.(None):
p.(None): XI Assisted fertilization.- It is one in which the insemination is artificial (homologous or heterologous) and includes in vitro fertilization.
p.(None):
p.(None): ARTICLE 41.- In addition to the general provisions of ethics that must be complied with in any investigation in human beings, those that include the subjects referred to in this chapter must satisfy what is established in articles 42 to 56 of these Regulations.
p.(None):
p.(None): ARTICLE 42.- In investigations classified as irrigation greater than the minimum that are carried out in women of childbearing age, measures shall be taken to:
p.(None):
p.(None): I. Certify that women are not pregnant, prior to their acceptance as research subjects, and
p.(None):
p.(None): II. Reduce as much as possible the chances of pregnancy during the investigation.
p.(None):
p.(None): ARTICLE 43 .- To carry out research in pregnant women, during labor, postpartum and lactation; in live or dead births; of use of embryos, deaths or fetuses; and for assisted fertilization, it is required to obtain the letter of informed consent from the woman and her spouse or concubinary in accordance with the provisions of articles 21 and 22 of these Regulations, prior information on the possible risks to the embryo, fetus or Newborn in your case.
p.(None):
p.(None): The consent of the spouse or concubinary can only be waived in case of incapacity or irrefutable or manifest impossibility to provide it; because the concubinary does not take care of the woman, or, when there is imminent risk to the health or life of the woman, embryo, fetus or newborn.
p.(None):
...

p.(None):
p.(None): III. Train staff on work procedures and the characteristics of the laboratory and equipment.
p.(None):
p.(None): ARTICLE 92.- All personnel directly or indirectly involved in this type of research must be adequately informed, by the person responsible for the radiological and physical safety, of the health risks represented by the radiation doses to which they are exposed and should know the basic principles of radiology protection, such as: Shielding, exposure time, distance and control of pollution and radioactive waste, among others, in order to ensure an accurate knowledge of radiation protection measures, such as: Shielding , exposure time, distance and control of pollution and radioactive waste, among others,in order to ensure an accurate knowledge of the radiological protection measures that ensure the biosecurity of the procedures used in the investigation, with the participation that corresponds to the Ministry of Energy, Mines and Parastatal Industry.
p.(None):
p.(None): ARTICLE 93 .- In these investigations, the occupational exposed personnel must be over 18 years. When such a person is a woman of childbearing age, the exposures should be distributed as evenly as possible in time, in order to protect, if necessary, the embryo during the organogenesis period, before the pregnancy diagnosis is made.
p.(None):
p.(None): Pregnant women will only be able to continue the work that exposes them occupationally, if it is ensured that the exposures will be distributed as evenly as possible in time and when it is unlikely that they will receive a third of the equivalent annual dose that should be specified in the biosafety regulations of according to the specific radioactive energy. Pregnant or breastfeeding women should not work in places where there is a risk of incorporation of radioactive materials.
p.(None):
p.(None): ARTICLE 94 .- The health institution where research is conducted with radioactive materials must appoint a doctor or health care institution that will be responsible for conducting medical examinations to the occupational exposed personnel, in order to:
p.(None):
p.(None): I. Determine their aptitude, from the point of view of their health, to perform the work considered, before they are exposed to radiation.
p.(None):
p.(None): II. Identify changes in your health that could result from radiation exposure during the performance of your work, and
p.(None):
p.(None): III. Detect late effects of radiation, even after exposure has ceased.
p.(None):
p.(None): ARTICLE 95.- Studies involving the exposure of the research subject to radiation shall:
p.(None):
...

Searching for indicator fertile:

Health / patients in emergency situations

Searching for indicator emergencies:

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p.(None):
p.(None): THIRD TITLE
p.(None):
p.(None): On the investigation of new Prophylactic, Diagnostic, Therapeutic and Rehabilitation Resources.
p.(None):
p.(None): CHAPTER I
p.(None):
p.(None): Common Provisions
p.(None):
p.(None): ARTICLE 61 .- When research is carried out on human beings, on new prophylactic, diagnostic, therapeutic and rehabilitation resources or it is intended to modify those already known, the provisions of the preceding articles must be observed and, as applicable, meet the requirements set forth in This Title
p.(None):
p.(None): ARTICLE 62.- The corresponding authorities of the health care institutions that carry out these investigations must obtain authorization from the Secretariat. For this purpose, they will present the following documentation:
p.(None):
p.(None): I.- Research protocol that must contain an objective and complete analysis of the risks involved, compared with the risks of established diagnostic and treatment methods and the expectation of the subject's living conditions with and without the proposed procedure or treatment ;
p.(None):
p.(None): II.- Letter of acceptance from the head of the institution where the investigation would be carried out;
p.(None):
p.(None): III.- Favorable opinion of the Commissions of Investigation, Ethics and, where appropriate, biosafety;
p.(None):
p.(None): IV.- Description of available resources, including areas, equipment and auxiliary services of laboratories and cabinets;
p.(None):
p.(None): V.- Description of the resources available for the management of medical emergencies,
p.(None):
p.(None): VI.- Professional history of the principal investigator, which includes his academic preparation, representative scientific production and clinical practice or experience in the area of the proposed research;
p.(None):
p.(None): VII.- Academic preparation and experience of medical, paramedical and other experts who will participate in the research activities;
p.(None):
p.(None): VIII.- The requirements indicated in articles 69 and 73 of these Regulations, if applicable, and
p.(None):
p.(None): IX.- The others that indicate the technical standards issued by the Secretariat for this purpose.
p.(None):
p.(None): ARTICLE 63.- When there is sponsorship or other forms of remuneration, the necessary measures must be established to prevent them from causing 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 resources.
p.(None):
p.(None): ARTICLE 64.- In the development of the investigations contemplated in this Title the following obligations must be fulfilled:
p.(None):
p.(None): I.- The principal investigator will inform the Ethics Commission of any probable adverse effects or directly related to the investigation;
p.(None):
p.(None): II.- The head of the institution, in turn, will notify the Secretariat of the presence of any adverse effect, within a maximum period of 15 business days following its presentation;
p.(None):
...

Searching for indicator access:

Searching for indicator age:

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p.(None):
p.(None): 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 to the attributions that correspond to other dependencies of the Federal Executive, and have complied, where appropriate. , with toxicity studies, according to the characteristics of the products and the risk they imply for human health.
p.(None):
p.(None): ARTICLE 32 .- In all research in communities, the experimental design must offer practical measures of protection for individuals and ensure that valid results will be obtained, involving the minimum number of subjects that are representative.
p.(None):
p.(None): Areas 3.- In any community investigation, the ethical considerations applicable to research on individuals must be extrapolated to the communal context in the pertinent aspects.
p.(None):
p.(None): CHAPTER III
p.(None):
p.(None): On Research in Minors or Disabilities
p.(None):
p.(None): ARTICLE 34.- In addition to the general provisions of ethics that must be complied with in any investigation in human beings, that which is carried out in minors or incapacitated persons must satisfy what is established in this chapter, except in the case of emancipated persons over 16 years of age.
p.(None):
p.(None): ARTICLE 35 .- When it is intended to carry out investigations in minors, it must be ensured that similar studies have previously been carried out in persons of May age and immature animals, except when it comes to studying conditions that are typical of the neonatal stage or specific conditions of certain ages.
p.(None):
p.(None): ARTICLE 36.- In order to carry out investigations in minors or incapacitated persons, in any case, the written informed consent must be obtained from those who exercise parental authority or the legal representation of the minor or incapable person in question.
p.(None):
p.(None): When two persons exercise the parental rights of a minor, the consent of one of them will only be admissible if there is irrefutable or manifest impossibility of the other to provide it or in case of imminent risk to the health or life of the minor or incapable.
p.(None):
p.(None): ARTICLE 37 .- When the mental capacity and psychological state of the minor or incapable permit, it must also obtain their acceptance to be the subject of investigation, after explaining what they intend to do. The Ethics Commission may waive compliance with these requirements for justified reasons.
p.(None):
...

p.(None):
p.(None): B). The intervention of the procedure should have a high probability of obtaining generalizable knowledge about the condition or disease of the minor or the incapable, that are of great importance to understand the disorder or to achieve its improvement in other subjects.
p.(None):
p.(None): II. When the risk is greater than the minimum:
p.(None):
p.(None): TO). Research should offer a high probability of understanding, preventing or alleviating a serious problem that affects the health and well-being of children or the disabled, and
p.(None):
p.(None): B). The head of the health care institution will establish strict supervision to determine whether the magnitude of the anticipated risks increases or others arise and will suspend the investigation at the time the risk could affect the biological, psychological or social well-being of the child or of the incapable
p.(None):
p.(None): CHAPTER IV
p.(None):
p.(None): From research in Women of Fertile Age, Pregnant Women, during Labor, Childbirth, Lactation and Newborns; of the use of Embryos, Obitos and Fetos and of Assisted Fertilization.
p.(None):
p.(None): ARTICLE 40 .- For the purposes of this Regulation, it is understood as:
p.(None):
p.(None): I. Women of childbearing age.- From the beginning of puberty until the onset of menopause;
p.(None):
p.(None): II. Pregnancy.- It is the period from the fertilization of the ovum (evidenced by any presumptive sign or symptom of pregnancy, as a suspension of menstruation or positive proof of medically accepted pregnancy) until the expulsion or removal of the fetus and its annexes.
p.(None):
p.(None): III. Embryo.- The product of conception from the fertilization of the ovum until the end of the twelfth week of management;
p.(None):
p.(None): IV. Fetus.- The product of conception from the beginning of the thirteenth week of gestation until its expulsion or extraction;
p.(None):
p.(None): V. Fetal Obito.- The death of the fetus in the womb;
p.(None):
p.(None): VI.- Live birth.- It is the expulsion or complete extraction of the product of conception, from the maternal breast, when after such separation the heart breathes and beats, the umbilical cord has been cut or not and the placenta is detached;
p.(None):
...

Searching for indicator child:

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p.(None):
p.(None): I. When the risk is minimal:
p.(None):
p.(None): TO). The intervention or procedure must represent for the minor or the incapable a reasonable experience and comparable with those inherent in their current or expected medical, psychological, social or educational situation, and
p.(None):
p.(None): B). The intervention of the procedure should have a high probability of obtaining generalizable knowledge about the condition or disease of the minor or the incapable, that are of great importance to understand the disorder or to achieve its improvement in other subjects.
p.(None):
p.(None): II. When the risk is greater than the minimum:
p.(None):
p.(None): TO). Research should offer a high probability of understanding, preventing or alleviating a serious problem that affects the health and well-being of children or the disabled, and
p.(None):
p.(None): B). The head of the health care institution will establish strict supervision to determine whether the magnitude of the anticipated risks increases or others arise and will suspend the investigation at the time the risk could affect the biological, psychological or social well-being of the child or of the incapable
p.(None):
p.(None): CHAPTER IV
p.(None):
p.(None): From research in Women of Fertile Age, Pregnant Women, during Labor, Childbirth, Lactation and Newborns; of the use of Embryos, Obitos and Fetos and of Assisted Fertilization.
p.(None):
p.(None): ARTICLE 40 .- For the purposes of this Regulation, it is understood as:
p.(None):
p.(None): I. Women of childbearing age.- From the beginning of puberty until the onset of menopause;
p.(None):
p.(None): II. Pregnancy.- It is the period from the fertilization of the ovum (evidenced by any presumptive sign or symptom of pregnancy, as a suspension of menstruation or positive proof of medically accepted pregnancy) until the expulsion or removal of the fetus and its annexes.
p.(None):
p.(None): III. Embryo.- The product of conception from the fertilization of the ovum until the end of the twelfth week of management;
p.(None):
p.(None): IV. Fetus.- The product of conception from the beginning of the thirteenth week of gestation until its expulsion or extraction;
p.(None):
p.(None): V. Fetal Obito.- The death of the fetus in the womb;
p.(None):
...

Searching for indicator children:

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p.(None):
p.(None): II.- The benefit is equal to or greater than other alternatives already established for diagnosis and treatment.
p.(None):
p.(None): ARTICLE 39.- Investigations classified as risk and without direct benefit to the minor or the incapable, shall be admissible according to the following considerations:
p.(None):
p.(None): I. When the risk is minimal:
p.(None):
p.(None): TO). The intervention or procedure must represent for the minor or the incapable a reasonable experience and comparable with those inherent in their current or expected medical, psychological, social or educational situation, and
p.(None):
p.(None): B). The intervention of the procedure should have a high probability of obtaining generalizable knowledge about the condition or disease of the minor or the incapable, that are of great importance to understand the disorder or to achieve its improvement in other subjects.
p.(None):
p.(None): II. When the risk is greater than the minimum:
p.(None):
p.(None): TO). Research should offer a high probability of understanding, preventing or alleviating a serious problem that affects the health and well-being of children or the disabled, and
p.(None):
p.(None): B). The head of the health care institution will establish strict supervision to determine whether the magnitude of the anticipated risks increases or others arise and will suspend the investigation at the time the risk could affect the biological, psychological or social well-being of the child or of the incapable
p.(None):
p.(None): CHAPTER IV
p.(None):
p.(None): From research in Women of Fertile Age, Pregnant Women, during Labor, Childbirth, Lactation and Newborns; of the use of Embryos, Obitos and Fetos and of Assisted Fertilization.
p.(None):
p.(None): ARTICLE 40 .- For the purposes of this Regulation, it is understood as:
p.(None):
p.(None): I. Women of childbearing age.- From the beginning of puberty until the onset of menopause;
p.(None):
p.(None): II. Pregnancy.- It is the period from the fertilization of the ovum (evidenced by any presumptive sign or symptom of pregnancy, as a suspension of menstruation or positive proof of medically accepted pregnancy) until the expulsion or removal of the fetus and its annexes.
p.(None):
...

Searching for indicator fetus:

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p.(None):
p.(None): B). The head of the health care institution will establish strict supervision to determine whether the magnitude of the anticipated risks increases or others arise and will suspend the investigation at the time the risk could affect the biological, psychological or social well-being of the child or of the incapable
p.(None):
p.(None): CHAPTER IV
p.(None):
p.(None): From research in Women of Fertile Age, Pregnant Women, during Labor, Childbirth, Lactation and Newborns; of the use of Embryos, Obitos and Fetos and of Assisted Fertilization.
p.(None):
p.(None): ARTICLE 40 .- For the purposes of this Regulation, it is understood as:
p.(None):
p.(None): I. Women of childbearing age.- From the beginning of puberty until the onset of menopause;
p.(None):
p.(None): II. Pregnancy.- It is the period from the fertilization of the ovum (evidenced by any presumptive sign or symptom of pregnancy, as a suspension of menstruation or positive proof of medically accepted pregnancy) until the expulsion or removal of the fetus and its annexes.
p.(None):
p.(None): III. Embryo.- The product of conception from the fertilization of the ovum until the end of the twelfth week of management;
p.(None):
p.(None): IV. Fetus.- The product of conception from the beginning of the thirteenth week of gestation until its expulsion or extraction;
p.(None):
p.(None): V. Fetal Obito.- The death of the fetus in the womb;
p.(None):
p.(None): VI.- Live birth.- It is the expulsion or complete extraction of the product of conception, from the maternal breast, when after such separation the heart breathes and beats, the umbilical cord has been cut or not and the placenta is detached;
p.(None):
p.(None): VII.- Dead Birth.- is the expulsion or complete extraction of the product of conception, from the maternal breast, when after said separation the heart does not breathe or beat, the umbilical cord has been cut or not and the placenta is detached or not ;
p.(None):
p.(None): VIII.- Labor.- It is the period from the start of uterine contractions (with progressive characteristics of intensity, irrigation and duration) and that ends with the expulsion or extraction of the fetus and its annexes;
p.(None):
p.(None): IX. Puerperio.- It is the period that begins with the expulsion or extraction of the fetus and its annexes until the involution of gestational changes is achieved (approximately for 42 days)
p.(None):
p.(None): X. Breastfeeding.- It is a physiological phenomenon in which dairy secretion occurs from the expulsion or extraction of the fetus and its annexes, and
p.(None):
p.(None): XI Assisted fertilization.- It is one in which the insemination is artificial (homologous or heterologous) and includes in vitro fertilization.
p.(None):
p.(None): ARTICLE 41.- In addition to the general provisions of ethics that must be complied with in any investigation in human beings, those that include the subjects referred to in this chapter must satisfy what is established in articles 42 to 56 of these Regulations.
p.(None):
p.(None): ARTICLE 42.- In investigations classified as irrigation greater than the minimum that are carried out in women of childbearing age, measures shall be taken to:
p.(None):
p.(None): I. Certify that women are not pregnant, prior to their acceptance as research subjects, and
p.(None):
p.(None): II. Reduce as much as possible the chances of pregnancy during the investigation.
p.(None):
p.(None): ARTICLE 43 .- To carry out research in pregnant women, during labor, postpartum and lactation; in live or dead births; of use of embryos, deaths or fetuses; and for assisted fertilization, it is required to obtain the letter of informed consent from the woman and her spouse or concubinary in accordance with the provisions of articles 21 and 22 of these Regulations, prior information on the possible risks to the embryo, fetus or Newborn in your case.
p.(None):
p.(None): The consent of the spouse or concubinary can only be waived in case of incapacity or irrefutable or manifest impossibility to provide it; because the concubinary does not take care of the woman, or, when there is imminent risk to the health or life of the woman, embryo, fetus or newborn.
p.(None):
p.(None): ARTICLE 44.- The investigations carried out in pregnant women must be preceded by studies carried out in non-pregnant women that demonstrate their safety, except for specific studies that require said condition.
p.(None):
p.(None): ARTICLE 45. - The investigations in pregnant women, whose objective is to obtain generalizable knowledge about pregnancy, should not represent a risk greater than the minimum for the woman, the embryo or the fetus.
p.(None):
p.(None): ARTICLE 46.- Investigations in pregnant women that imply an intervention or experimental procedure not related to pregnancy, but with therapeutic benefit for women, as it would be in cases of gravidarum toxemia, diabetes, hypertension and malignancies, among others, should not expose embryo or the fetus at a greater than minimum risk, except when the use of the intervention or procedure is justified to save the woman's life.
p.(None):
p.(None): ARTICLE 47 .- Research in pregnant women, with therapeutic benefit related to pregnancy, will be allowed when:
p.(None):
p.(None): I. Aim to improve the health of the pregnant woman with a minimal risk to the embryo or fetus, or
p.(None):
p.(None): II.- Are aimed at increasing the viability of the fetus, with a minimal risk to the pregnant woman.
p.(None):
p.(None): ARTICLE 48 .- During the execution of investigations in pregnant women:
p.(None):
p.(None): I. Investigators will not have the authority to decide on the time, method or procedure used to terminate the pregnancy, nor will they participate in decisions on the viability of the fetus;
p.(None):
p.(None): II. Only with the authorization of the Ethics Commission can the method to terminate the pregnancy be modified for research purposes, when such modifications represent a minimal risk to the mother's health and do not represent any risk for the survival of the fetus, and
p.(None):
p.(None): III. In any case, it is strictly forbidden to grant monetary or other stimuli to terminate the pregnancy, for the interest of the investigation or for other reasons.
p.(None):
p.(None): ARTICLE 49 .- The informed consent letter for investigations during labor, must be obtained in accordance with the provisions of articles 21, 22, and 43 of these Regulations, before it is initiated and duly expressly state that the consent It can be withdrawn at any time during labor.
p.(None):
p.(None): ARTICLE 50.- Investigations in women in the puerperium will be allowed when they do not interfere with the health of the mother and the newborn.
p.(None):
p.(None): ARTICLE 51.- Investigations in women during breastfeeding will be authorized when there is no risk for the infant or when the mother decides not to breastfeed, her diet is assured by another method and the informed consent letter is obtained in accordance with the provisions of the Articles 21, 22, and 43 of this Regulation.
p.(None):
p.(None): ARTICLE 52 .- Fetuses will be subject to investigation only if the techniques and means used provide maximum security for them and the pregnant woman.
p.(None):
...

Searching for indicator fetuses:

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p.(None):
p.(None): X. Breastfeeding.- It is a physiological phenomenon in which dairy secretion occurs from the expulsion or extraction of the fetus and its annexes, and
p.(None):
p.(None): XI Assisted fertilization.- It is one in which the insemination is artificial (homologous or heterologous) and includes in vitro fertilization.
p.(None):
p.(None): ARTICLE 41.- In addition to the general provisions of ethics that must be complied with in any investigation in human beings, those that include the subjects referred to in this chapter must satisfy what is established in articles 42 to 56 of these Regulations.
p.(None):
p.(None): ARTICLE 42.- In investigations classified as irrigation greater than the minimum that are carried out in women of childbearing age, measures shall be taken to:
p.(None):
p.(None): I. Certify that women are not pregnant, prior to their acceptance as research subjects, and
p.(None):
p.(None): II. Reduce as much as possible the chances of pregnancy during the investigation.
p.(None):
p.(None): ARTICLE 43 .- To carry out research in pregnant women, during labor, postpartum and lactation; in live or dead births; of use of embryos, deaths or fetuses; and for assisted fertilization, it is required to obtain the letter of informed consent from the woman and her spouse or concubinary in accordance with the provisions of articles 21 and 22 of these Regulations, prior information on the possible risks to the embryo, fetus or Newborn in your case.
p.(None):
p.(None): The consent of the spouse or concubinary can only be waived in case of incapacity or irrefutable or manifest impossibility to provide it; because the concubinary does not take care of the woman, or, when there is imminent risk to the health or life of the woman, embryo, fetus or newborn.
p.(None):
p.(None): ARTICLE 44.- The investigations carried out in pregnant women must be preceded by studies carried out in non-pregnant women that demonstrate their safety, except for specific studies that require said condition.
p.(None):
...

p.(None):
p.(None): III. In any case, it is strictly forbidden to grant monetary or other stimuli to terminate the pregnancy, for the interest of the investigation or for other reasons.
p.(None):
p.(None): ARTICLE 49 .- The informed consent letter for investigations during labor, must be obtained in accordance with the provisions of articles 21, 22, and 43 of these Regulations, before it is initiated and duly expressly state that the consent It can be withdrawn at any time during labor.
p.(None):
p.(None): ARTICLE 50.- Investigations in women in the puerperium will be allowed when they do not interfere with the health of the mother and the newborn.
p.(None):
p.(None): ARTICLE 51.- Investigations in women during breastfeeding will be authorized when there is no risk for the infant or when the mother decides not to breastfeed, her diet is assured by another method and the informed consent letter is obtained in accordance with the provisions of the Articles 21, 22, and 43 of this Regulation.
p.(None):
p.(None): ARTICLE 52 .- Fetuses will be subject to investigation only if the techniques and means used provide maximum security for them and the pregnant woman.
p.(None):
p.(None): ARTICLE 53 .- Newborns will not be subject to investigation until it has been established with certainty whether or not they are live births, except when the investigation is intended to increase their probability of survival until the viability phase, the study procedures 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 otherwise.
p.(None):
p.(None): ARTICLE 54 .- Live births may be subject to investigation if the provisions on investigation in minors, indicated in these Regulations are complied with.
p.(None):
p.(None): ARTICLE 55.- Investigations with embryos, deaths, fetuses, dead births, macerated fetal matter, cells, tissues and organs extracted from them will be carried out in accordance with the provisions of Title Fourteenth of the Law and these Regulations.
p.(None):
p.(None): ARTICLE 56.- The investigation on assisted fertilization will only be admissible when it is applied to the solution of sterility problems that cannot be solved in any other way, respecting the moral, cultural and social point of view of the couple, even if it differs with the researcher
p.(None):
p.(None): CHAPTER V
p.(None):
p.(None): On Subordinate Group Research
p.(None):
p.(None): ARTICLE 57. - Subordinate groups are understood as the following: students, laboratory and hospital workers, employees, members of the armed forces, inmates in prisons or social rehabilitation centers and other special groups of the population, in which Informed consent may be influenced by some authority.
p.(None):
p.(None): ARTICLE 58 .- When conducting research in subordinate groups, one or more members of the population under study must participate in the Ethics Commission, capable of representing the moral, cultural and social values of the group in question and monitor:
p.(None):
...

Searching for indicator neonates:

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p.(None):
p.(None): II. Research with minimal risk: Prospective studies that use the risk of data through common procedures in physical or psychological examinations of routine diagnoses or treatment, among which are considered: weighing the subject, tests of auditory acuity; electrocardiogram, thermography, collection of excreta and external secretions, obtaining placenta during childbirth, collection of amniotic fluid when the membranes rupture, obtaining saliva, deciduous teeth and permanent teeth extracted by therapeutic indication, dental plaque and stones removed by prophylactic procedure not invaders, haircut and nails without causing disfigurement, blood collection by venous puncture in adults in good health, with a maximum frequency of twice a week and a maximum volume of 450 ml. in two months,
p.(None):
p.(None): III.- Research with risk greater than the minimum: These are those in which the probabilities of affecting the subject are significant, among which are considered: radiological and microwave studies, trials with the medications and modalities defined in article 65 of this Regulation, trials with new devices, studies that include surgical procedures, blood draw 2% of the circulating volume in neonates, amniocentesis and other invasive techniques or major procedures, those that employ random methods of allocation to therapeutic schemes and those that have control with Placebos, among others.
p.(None):
p.(None): ARTICLE 18. - The principal investigator shall suspend the investigation immediately, when noticing any risk or damage to the health of the subject in whom the investigation is carried out. Likewise, it will be suspended immediately when the subject of investigation indicates it.
p.(None):
p.(None): ARTICLE 19 .- It is the responsibility of the health care institution to provide medical care to the subject that suffers any damage, if it is directly related to the investigation, without prejudice to the compensation that legally corresponds.
p.(None):
p.(None): ARTICLE 20 .- Informed consent means the written agreement, whereby the subject of investigation or, where appropriate, his legal representative authorizes his participation in the investigation, with full knowledge of the nature of the procedures and risks to the that will be submitted, with the capacity of free choice and without any coercion.
p.(None):
p.(None): ARTICLE 21 .- For the informed consent to be considered existing, the research subject or, where appropriate, his legal representatives must receive a full and clear explanation, so that he can understand it, at least, on the following aspects:
p.(None):
p.(None): I. The justification and objectives of the investigation;
p.(None):
p.(None): II. The procedures to be used and their purpose, including the identification of the procedures that are experimental;
p.(None):
...

Searching for indicator restricted:

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p.(None):
p.(None): CHAPTER III
p.(None):
p.(None): Research with radioactive isotopes and devices and generators of ionizing and electromagnetic radiation
p.(None):
p.(None): ARTICULO 89.- Las investigaciones que impliquen el uso en seres humanos para fines médicos de isótopos radiactivos y dispositivos generadores de radiaciones ionizantes y electromagnéticas de radiaciones ionizantes y electromagnéticas deberán realizarse de conformidad con las leyes, reglamentos y normas sobre seguridad radiológica, así como las disposiciones que emita la Secretaría, y en los ámbitos respectivos de su competencia, las Secretarías de Energía, Minas e Industria Paraestatal; Comunicaciones y Transportes; Trabajo y Previsión Social y Desarrollo Urbano y Ecología.
p.(None):
p.(None): ARTICLE 90.- In the health institutions where these investigations are carried out, the Biosafety Commission shall ensure that for each study the person responsible for radiological and physical safety is identified before the National Nuclear Safety and Safeguards Commission, for compliance with the requirements and obligations as responsible for radiological safety.
p.(None):
p.(None): ARTICLE 91 .- The responsible person referred to in the previous article must:
p.(None):
p.(None): I. Define, implement and monitor compliance with radiological and physical safety measures;
p.(None):
p.(None): II. Prepare, in the terms of the Regulatory Law of Constitutional Article 27 on Nuclear Matters, a manual of procedures available to all personnel, which will describe the procedures for identification and control of radiation sources; permitted and restricted areas; registration and control of the dose equivalent of occupationally exposed personnel and the environment; training and medical examinations to the occupational exposed personnel; emergency plan in cases of accidents that contaminate personnel or the environment, among others, and
p.(None):
p.(None): III. Train staff on work procedures and the characteristics of the laboratory and equipment.
p.(None):
p.(None): ARTICLE 92.- All personnel directly or indirectly involved in this type of research must be adequately informed, by the person responsible for the radiological and physical safety, of the health risks represented by the radiation doses to which they are exposed and should know the basic principles of radiology protection, such as: Shielding, exposure time, distance and control of pollution and radioactive waste, among others, in order to ensure an accurate knowledge of radiation protection measures, such as: Shielding , exposure time, distance and control of pollution and radioactive waste, among others,in order to ensure an accurate knowledge of the radiological protection measures that ensure the biosecurity of the procedures used in the investigation, with the participation that corresponds to the Ministry of Energy, Mines and Parastatal Industry.
p.(None):
...

Searching for indicator infant:

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p.(None):
p.(None): II. Only with the authorization of the Ethics Commission can the method to terminate the pregnancy be modified for research purposes, when such modifications represent a minimal risk to the mother's health and do not represent any risk for the survival of the fetus, and
p.(None):
p.(None): III. In any case, it is strictly forbidden to grant monetary or other stimuli to terminate the pregnancy, for the interest of the investigation or for other reasons.
p.(None):
p.(None): ARTICLE 49 .- The informed consent letter for investigations during labor, must be obtained in accordance with the provisions of articles 21, 22, and 43 of these Regulations, before it is initiated and duly expressly state that the consent It can be withdrawn at any time during labor.
p.(None):
p.(None): ARTICLE 50.- Investigations in women in the puerperium will be allowed when they do not interfere with the health of the mother and the newborn.
p.(None):
p.(None): ARTICLE 51.- Investigations in women during breastfeeding will be authorized when there is no risk for the infant or when the mother decides not to breastfeed, her diet is assured by another method and the informed consent letter is obtained in accordance with the provisions of the Articles 21, 22, and 43 of this Regulation.
p.(None):
p.(None): ARTICLE 52 .- Fetuses will be subject to investigation only if the techniques and means used provide maximum security for them and the pregnant woman.
p.(None):
p.(None): ARTICLE 53 .- Newborns will not be subject to investigation until it has been established with certainty whether or not they are live births, except when the investigation is intended to increase their probability of survival until the viability phase, the study procedures 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 otherwise.
p.(None):
p.(None): ARTICLE 54 .- Live births may be subject to investigation if the provisions on investigation in minors, indicated in these Regulations are complied with.
p.(None):
p.(None): ARTICLE 55.- Investigations with embryos, deaths, fetuses, dead births, macerated fetal matter, cells, tissues and organs extracted from them will be carried out in accordance with the provisions of Title Fourteenth of the Law and these Regulations.
p.(None):
p.(None): ARTICLE 56.- The investigation on assisted fertilization will only be admissible when it is applied to the solution of sterility problems that cannot be solved in any other way, respecting the moral, cultural and social point of view of the couple, even if it differs with the researcher
...

Searching for indicator single:

Searching for indicator property:

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p.(None):
p.(None): ARTICLE 126 .- The head of the health institution where research is carried out referred to in this Chapter, shall establish and monitor compliance with safety measures for the care and management of animals, as well as prophylaxis measures and vaccination necessary for the protection of occupationally exposed personnel.
p.(None):
p.(None): EIGHTH TITLE
p.(None):
p.(None): About security measures
p.(None):
p.(None): ONLY CHAPTER
p.(None):
p.(None): ARTICLE 127 .- The publication of security measures and their procedure, in matters of investigation, shall be subject to the order in chapters I and III of the Eighteenth Title of the Law and to the provisions of this Regulation.
p.(None):
p.(None): ARTICLE 128.- It is the responsibility of the health authorities, within the scope of their respective powers, to order or execute the following security measures:
p.(None):
p.(None): I. The isolation;
p.(None):
p.(None): II.The quarantine;
p.(None):
p.(None): III. Personal observation;
p.(None):
p.(None): IV. The vaccination of people;
p.(None):
p.(None): V. The vaccination of animals, as long as it refers to human health;
p.(None):
p.(None): SAW. The destruction or control of insects and other transmitting and harmful fauna, insofar as it refers to human health,
p.(None):
p.(None): VII. The suspension of work or services;
p.(None):
p.(None): VIII. The assurance and destruction of objects, products or substances;
p.(None):
p.(None): IX. Unemployment or eviction of houses, buildings, establishments and, in general, of any property;
p.(None):
p.(None): X. The prohibition of acts of use, and
p.(None):
p.(None): XI The others of competent sanitary nature, that can avoid that they are caused or continue causing risks or damages to the health.
p.(None):
p.(None): NINTH TITLE
p.(None):
p.(None): Monitoring and Observance
p.(None):
p.(None): ONLY CHAPTER
p.(None):
p.(None): ARTICLE 129. -It corresponds to the sanitary authorities, within the scope of their respective competences, the follow-up and observance of these Regulations and other applicable provisions, in accordance with the provisions of the Seventh Title of the Law.
p.(None):
p.(None): ARTICLE 130 .- Who conducts health research that includes the use of human beings, as well as the use of pathogenic microorganisms or biological material that contains them, construction and management of recombinant nucleic acids, radioactive isotopes and devices generating ionizing and electromagnetic radiation , in contravention of the provisions of the Law and these Regulations, will be entitled to the sanctions that the Law indicates in this regard, to the detriment of those established in the Regulatory Law of Constitutional Article 27 on Nuclear Matters and of the penalties that could be incurred when they constitute crimes.
p.(None):
p.(None): ARTICLE 131 .- The competent authority may revoke the sanitary authorizations that it has granted to carry out health investigations, when they comply with the provisions contained in the Law, these Regulations and other provisions derived therefrom. For the Substantiation of the procedure for the revocation of authorizations, the provisions of Chapter II of the Sixteenth Title of the Law shall be observed.
p.(None):
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Searching for indicator armed forces:

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p.(None):
p.(None): ARTICLE 53 .- Newborns will not be subject to investigation until it has been established with certainty whether or not they are live births, except when the investigation is intended to increase their probability of survival until the viability phase, the study procedures 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 otherwise.
p.(None):
p.(None): ARTICLE 54 .- Live births may be subject to investigation if the provisions on investigation in minors, indicated in these Regulations are complied with.
p.(None):
p.(None): ARTICLE 55.- Investigations with embryos, deaths, fetuses, dead births, macerated fetal matter, cells, tissues and organs extracted from them will be carried out in accordance with the provisions of Title Fourteenth of the Law and these Regulations.
p.(None):
p.(None): ARTICLE 56.- The investigation on assisted fertilization will only be admissible when it is applied to the solution of sterility problems that cannot be solved in any other way, respecting the moral, cultural and social point of view of the couple, even if it differs with the researcher
p.(None):
p.(None): CHAPTER V
p.(None):
p.(None): On Subordinate Group Research
p.(None):
p.(None): ARTICLE 57. - Subordinate groups are understood as the following: students, laboratory and hospital workers, employees, members of the armed forces, inmates in prisons or social rehabilitation centers and other special groups of the population, in which Informed consent may be influenced by some authority.
p.(None):
p.(None): ARTICLE 58 .- When conducting research in subordinate groups, one or more members of the population under study must participate in the Ethics Commission, capable of representing the moral, cultural and social values of the group in question and monitor:
p.(None):
p.(None): I. That the participation, the rejection of the subjects to intervene or withdrawal of their consent during the study, does not affect their school, work, military situation or that related to the judicial process to which they were subject and the conditions of compliance with sentence, in your case:
p.(None):
p.(None): II.- That the results of the investigation are not used to the detriment of the participating individuals, and
p.(None):
p.(None): III.- That the health care institution and, the sponsors are responsible for the medical treatment of the damages caused and, where appropriate, for the compensation that legally corresponds for the harmful consequences of the investigation.
p.(None):
p.(None): CHAPTER VI
p.(None):
p.(None): Of Research in Organs, Tissues and their Derivatives, Products and Corpse of Human Beings.
p.(None):
...

Searching for indicator military:

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p.(None):
p.(None): ARTICLE 56.- The investigation on assisted fertilization will only be admissible when it is applied to the solution of sterility problems that cannot be solved in any other way, respecting the moral, cultural and social point of view of the couple, even if it differs with the researcher
p.(None):
p.(None): CHAPTER V
p.(None):
p.(None): On Subordinate Group Research
p.(None):
p.(None): ARTICLE 57. - Subordinate groups are understood as the following: students, laboratory and hospital workers, employees, members of the armed forces, inmates in prisons or social rehabilitation centers and other special groups of the population, in which Informed consent may be influenced by some authority.
p.(None):
p.(None): ARTICLE 58 .- When conducting research in subordinate groups, one or more members of the population under study must participate in the Ethics Commission, capable of representing the moral, cultural and social values of the group in question and monitor:
p.(None):
p.(None): I. That the participation, the rejection of the subjects to intervene or withdrawal of their consent during the study, does not affect their school, work, military situation or that related to the judicial process to which they were subject and the conditions of compliance with sentence, in your case:
p.(None):
p.(None): II.- That the results of the investigation are not used to the detriment of the participating individuals, and
p.(None):
p.(None): III.- That the health care institution and, the sponsors are responsible for the medical treatment of the damages caused and, where appropriate, for the compensation that legally corresponds for the harmful consequences of the investigation.
p.(None):
p.(None): CHAPTER VI
p.(None):
p.(None): Of Research in Organs, Tissues and their Derivatives, Products and Corpse of Human Beings.
p.(None):
p.(None): ARTICLE 59.- The investigation referred to in this Chapter includes that which includes the use of organs, tissues and their derivatives, products and bodies of human beings, as well as the set of activities related to their obtaining, conservation, use, preparation, Supply and final destination.
p.(None):
p.(None): ARTICLE 60.- This investigation must observe, in addition to due respect for the human corpse, the applicable provisions stipulated in this ordinance and what is established in the Fourteenth Title of the Law and its Regulation on Health Control Matters of the disposal of Organs, Tissues and Corpses of Human Beings.
p.(None):
p.(None): THIRD TITLE
p.(None):
p.(None): On the investigation of new Prophylactic, Diagnostic, Therapeutic and Rehabilitation Resources.
p.(None):
p.(None): CHAPTER I
p.(None):
p.(None): Common Provisions
p.(None):
p.(None): ARTICLE 61 .- When research is carried out on human beings, on new prophylactic, diagnostic, therapeutic and rehabilitation resources or it is intended to modify those already known, the provisions of the preceding articles must be observed and, as applicable, meet the requirements set forth in This Title
p.(None):
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Searching for indicator unemployment:

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p.(None):
p.(None): ARTICLE 125 .- The bioterios of production or chronic maintenance shall be supervised by qualified and competent professionals in the field and shall allow the growth, maturation, reproduction and normal behavior of the animals, in accordance with the standards issued by the institution itself.
p.(None):
p.(None): ARTICLE 126 .- The head of the health institution where research is carried out referred to in this Chapter, shall establish and monitor compliance with safety measures for the care and management of animals, as well as prophylaxis measures and vaccination necessary for the protection of occupationally exposed personnel.
p.(None):
p.(None): EIGHTH TITLE
p.(None):
p.(None): About security measures
p.(None):
p.(None): ONLY CHAPTER
p.(None):
p.(None): ARTICLE 127 .- The publication of security measures and their procedure, in matters of investigation, shall be subject to the order in chapters I and III of the Eighteenth Title of the Law and to the provisions of this Regulation.
p.(None):
p.(None): ARTICLE 128.- It is the responsibility of the health authorities, within the scope of their respective powers, to order or execute the following security measures:
p.(None):
p.(None): I. The isolation;
p.(None):
p.(None): II.The quarantine;
p.(None):
p.(None): III. Personal observation;
p.(None):
p.(None): IV. The vaccination of people;
p.(None):
p.(None): V. The vaccination of animals, as long as it refers to human health;
p.(None):
p.(None): SAW. The destruction or control of insects and other transmitting and harmful fauna, insofar as it refers to human health,
p.(None):
p.(None): VII. The suspension of work or services;
p.(None):
p.(None): VIII. The assurance and destruction of objects, products or substances;
p.(None):
p.(None): IX. Unemployment or eviction of houses, buildings, establishments and, in general, of any property;
p.(None):
p.(None): X. The prohibition of acts of use, and
p.(None):
p.(None): XI The others of competent sanitary nature, that can avoid that they are caused or continue causing risks or damages to the health.
p.(None):
p.(None): NINTH TITLE
p.(None):
p.(None): Monitoring and Observance
p.(None):
p.(None): ONLY CHAPTER
p.(None):
p.(None): ARTICLE 129. -It corresponds to the sanitary authorities, within the scope of their respective competences, the follow-up and observance of these Regulations and other applicable provisions, in accordance with the provisions of the Seventh Title of the Law.
p.(None):
p.(None): ARTICLE 130 .- Who conducts health research that includes the use of human beings, as well as the use of pathogenic microorganisms or biological material that contains them, construction and management of recombinant nucleic acids, radioactive isotopes and devices generating ionizing and electromagnetic radiation , in contravention of the provisions of the Law and these Regulations, will be entitled to the sanctions that the Law indicates in this regard, to the detriment of those established in the Regulatory Law of Constitutional Article 27 on Nuclear Matters and of the penalties that could be incurred when they constitute crimes.
p.(None):
p.(None): ARTICLE 131 .- The competent authority may revoke the sanitary authorizations that it has granted to carry out health investigations, when they comply with the provisions contained in the Law, these Regulations and other provisions derived therefrom. For the Substantiation of the procedure for the revocation of authorizations, the provisions of Chapter II of the Sixteenth Title of the Law shall be observed.
p.(None):
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Searching for indicator women:

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p.(None):
p.(None): TO). The intervention or procedure must represent for the minor or the incapable a reasonable experience and comparable with those inherent in their current or expected medical, psychological, social or educational situation, and
p.(None):
p.(None): B). The intervention of the procedure should have a high probability of obtaining generalizable knowledge about the condition or disease of the minor or the incapable, that are of great importance to understand the disorder or to achieve its improvement in other subjects.
p.(None):
p.(None): II. When the risk is greater than the minimum:
p.(None):
p.(None): TO). Research should offer a high probability of understanding, preventing or alleviating a serious problem that affects the health and well-being of children or the disabled, and
p.(None):
p.(None): B). The head of the health care institution will establish strict supervision to determine whether the magnitude of the anticipated risks increases or others arise and will suspend the investigation at the time the risk could affect the biological, psychological or social well-being of the child or of the incapable
p.(None):
p.(None): CHAPTER IV
p.(None):
p.(None): From research in Women of Fertile Age, Pregnant Women, during Labor, Childbirth, Lactation and Newborns; of the use of Embryos, Obitos and Fetos and of Assisted Fertilization.
p.(None):
p.(None): ARTICLE 40 .- For the purposes of this Regulation, it is understood as:
p.(None):
p.(None): I. Women of childbearing age.- From the beginning of puberty until the onset of menopause;
p.(None):
p.(None): II. Pregnancy.- It is the period from the fertilization of the ovum (evidenced by any presumptive sign or symptom of pregnancy, as a suspension of menstruation or positive proof of medically accepted pregnancy) until the expulsion or removal of the fetus and its annexes.
p.(None):
p.(None): III. Embryo.- The product of conception from the fertilization of the ovum until the end of the twelfth week of management;
p.(None):
p.(None): IV. Fetus.- The product of conception from the beginning of the thirteenth week of gestation until its expulsion or extraction;
p.(None):
p.(None): V. Fetal Obito.- The death of the fetus in the womb;
p.(None):
p.(None): VI.- Live birth.- It is the expulsion or complete extraction of the product of conception, from the maternal breast, when after such separation the heart breathes and beats, the umbilical cord has been cut or not and the placenta is detached;
p.(None):
p.(None): VII.- Dead Birth.- is the expulsion or complete extraction of the product of conception, from the maternal breast, when after said separation the heart does not breathe or beat, the umbilical cord has been cut or not and the placenta is detached or not ;
p.(None):
p.(None): VIII.- Labor.- It is the period from the start of uterine contractions (with progressive characteristics of intensity, irrigation and duration) and that ends with the expulsion or extraction of the fetus and its annexes;
p.(None):
p.(None): IX. Puerperio.- It is the period that begins with the expulsion or extraction of the fetus and its annexes until the involution of gestational changes is achieved (approximately for 42 days)
p.(None):
p.(None): X. Breastfeeding.- It is a physiological phenomenon in which dairy secretion occurs from the expulsion or extraction of the fetus and its annexes, and
p.(None):
p.(None): XI Assisted fertilization.- It is one in which the insemination is artificial (homologous or heterologous) and includes in vitro fertilization.
p.(None):
p.(None): ARTICLE 41.- In addition to the general provisions of ethics that must be complied with in any investigation in human beings, those that include the subjects referred to in this chapter must satisfy what is established in articles 42 to 56 of these Regulations.
p.(None):
p.(None): ARTICLE 42.- In investigations classified as irrigation greater than the minimum that are carried out in women of childbearing age, measures shall be taken to:
p.(None):
p.(None): I. Certify that women are not pregnant, prior to their acceptance as research subjects, and
p.(None):
p.(None): II. Reduce as much as possible the chances of pregnancy during the investigation.
p.(None):
p.(None): ARTICLE 43 .- To carry out research in pregnant women, during labor, postpartum and lactation; in live or dead births; of use of embryos, deaths or fetuses; and for assisted fertilization, it is required to obtain the letter of informed consent from the woman and her spouse or concubinary in accordance with the provisions of articles 21 and 22 of these Regulations, prior information on the possible risks to the embryo, fetus or Newborn in your case.
p.(None):
p.(None): The consent of the spouse or concubinary can only be waived in case of incapacity or irrefutable or manifest impossibility to provide it; because the concubinary does not take care of the woman, or, when there is imminent risk to the health or life of the woman, embryo, fetus or newborn.
p.(None):
p.(None): ARTICLE 44.- The investigations carried out in pregnant women must be preceded by studies carried out in non-pregnant women that demonstrate their safety, except for specific studies that require said condition.
p.(None):
p.(None): ARTICLE 45. - The investigations in pregnant women, whose objective is to obtain generalizable knowledge about pregnancy, should not represent a risk greater than the minimum for the woman, the embryo or the fetus.
p.(None):
p.(None): ARTICLE 46.- Investigations in pregnant women that imply an intervention or experimental procedure not related to pregnancy, but with therapeutic benefit for women, as it would be in cases of gravidarum toxemia, diabetes, hypertension and malignancies, among others, should not expose embryo or the fetus at a greater than minimum risk, except when the use of the intervention or procedure is justified to save the woman's life.
p.(None):
p.(None): ARTICLE 47 .- Research in pregnant women, with therapeutic benefit related to pregnancy, will be allowed when:
p.(None):
p.(None): I. Aim to improve the health of the pregnant woman with a minimal risk to the embryo or fetus, or
p.(None):
p.(None): II.- Are aimed at increasing the viability of the fetus, with a minimal risk to the pregnant woman.
p.(None):
p.(None): ARTICLE 48 .- During the execution of investigations in pregnant women:
p.(None):
p.(None): I. Investigators will not have the authority to decide on the time, method or procedure used to terminate the pregnancy, nor will they participate in decisions on the viability of the fetus;
p.(None):
p.(None): II. Only with the authorization of the Ethics Commission can the method to terminate the pregnancy be modified for research purposes, when such modifications represent a minimal risk to the mother's health and do not represent any risk for the survival of the fetus, and
p.(None):
p.(None): III. In any case, it is strictly forbidden to grant monetary or other stimuli to terminate the pregnancy, for the interest of the investigation or for other reasons.
p.(None):
p.(None): ARTICLE 49 .- The informed consent letter for investigations during labor, must be obtained in accordance with the provisions of articles 21, 22, and 43 of these Regulations, before it is initiated and duly expressly state that the consent It can be withdrawn at any time during labor.
p.(None):
p.(None): ARTICLE 50.- Investigations in women in the puerperium will be allowed when they do not interfere with the health of the mother and the newborn.
p.(None):
p.(None): ARTICLE 51.- Investigations in women during breastfeeding will be authorized when there is no risk for the infant or when the mother decides not to breastfeed, her diet is assured by another method and the informed consent letter is obtained in accordance with the provisions of the Articles 21, 22, and 43 of this Regulation.
p.(None):
p.(None): ARTICLE 52 .- Fetuses will be subject to investigation only if the techniques and means used provide maximum security for them and the pregnant woman.
p.(None):
p.(None): ARTICLE 53 .- Newborns will not be subject to investigation until it has been established with certainty whether or not they are live births, except when the investigation is intended to increase their probability of survival until the viability phase, the study procedures 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 otherwise.
p.(None):
p.(None): ARTICLE 54 .- Live births may be subject to investigation if the provisions on investigation in minors, indicated in these Regulations are complied with.
p.(None):
p.(None): ARTICLE 55.- Investigations with embryos, deaths, fetuses, dead births, macerated fetal matter, cells, tissues and organs extracted from them will be carried out in accordance with the provisions of Title Fourteenth of the Law and these Regulations.
p.(None):
...

p.(None):
p.(None): III. Train staff on work procedures and the characteristics of the laboratory and equipment.
p.(None):
p.(None): ARTICLE 92.- All personnel directly or indirectly involved in this type of research must be adequately informed, by the person responsible for the radiological and physical safety, of the health risks represented by the radiation doses to which they are exposed and should know the basic principles of radiology protection, such as: Shielding, exposure time, distance and control of pollution and radioactive waste, among others, in order to ensure an accurate knowledge of radiation protection measures, such as: Shielding , exposure time, distance and control of pollution and radioactive waste, among others,in order to ensure an accurate knowledge of the radiological protection measures that ensure the biosecurity of the procedures used in the investigation, with the participation that corresponds to the Ministry of Energy, Mines and Parastatal Industry.
p.(None):
p.(None): ARTICLE 93 .- In these investigations, the occupational exposed personnel must be over 18 years. When such a person is a woman of childbearing age, the exposures should be distributed as evenly as possible in time, in order to protect, if necessary, the embryo during the organogenesis period, before the pregnancy diagnosis is made.
p.(None):
p.(None): Pregnant women will only be able to continue the work that exposes them occupationally, if it is ensured that the exposures will be distributed as evenly as possible in time and when it is unlikely that they will receive a third of the equivalent annual dose that should be specified in the biosafety regulations of according to the specific radioactive energy. Pregnant or breastfeeding women should not work in places where there is a risk of incorporation of radioactive materials.
p.(None):
p.(None): ARTICLE 94 .- The health institution where research is conducted with radioactive materials must appoint a doctor or health care institution that will be responsible for conducting medical examinations to the occupational exposed personnel, in order to:
p.(None):
p.(None): I. Determine their aptitude, from the point of view of their health, to perform the work considered, before they are exposed to radiation.
p.(None):
p.(None): II. Identify changes in your health that could result from radiation exposure during the performance of your work, and
p.(None):
p.(None): III. Detect late effects of radiation, even after exposure has ceased.
p.(None):
p.(None): ARTICLE 95.- Studies involving the exposure of the research subject to radiation shall:
p.(None):
p.(None): I. Justify yourself because it is not possible to obtain the same information at a lower risk through investigations that use other techniques
p.(None):
p.(None): II. Be designed optimizing the protection of the subject, so that the radiation it receives is minimized reasonable to allow obtaining the information sought.
p.(None):
p.(None): ARTICLE 96.- In investigations without direct benefit to the research subject, the equivalent dose limits, secondary limits, the derived limits as well as authorized limits, must be specified in the research projects, taking into account whether it is external, internal radiation , tissues with adherence to the biosafety standard which must match the standards of the National Commission for Nuclear Safety and Safeguards.
p.(None):
p.(None): Research that includes exposure of pregnant women to radioactive materials or ionizing radiation generating devices is prohibited.
p.(None):
p.(None): ARTICLE 97.- Investigations with direct benefit to the research subject, the criteria for limiting radiation doses should be the same as that applied for other exposures required for medical reasons, such as those due to diagnostic and treatment procedures.
p.(None):
p.(None): FIFTH TITLE
p.(None):
p.(None): Of the Internal Commissions in Health Institutions
p.(None):
p.(None): ONLY CHAPTER
p.(None):
p.(None): ARTICLE 98.- For the purposes of this Regulation, it is considered as a health institution where health research is carried out, any organically structured unit belonging to a dependency or entity of the Public Administration, or a social or private institution where carry out one or more of the activities established in article 5. of this Regulation.
p.(None):
p.(None): 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 applicable provisions, the following shall be continued:
p.(None):
p.(None): I. An Ethics Commission in the event that they conduct research in human beings;
p.(None):
p.(None): II. A Biosafety Commission if research is carried out involving the use of ionizing and electromagnetic, radioactive isotopes, pathogenic microorganisms, recombinant nucleic acids or other similar procedures that may pose a health risk, and
p.(None):
p.(None): III. A commission of investigation, whose integration will be mandatory for health care institutions and other institutions according to their internal regulations.
p.(None):
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Searching for indicator minor:

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p.(None): ARTICLE 32 .- In all research in communities, the experimental design must offer practical measures of protection for individuals and ensure that valid results will be obtained, involving the minimum number of subjects that are representative.
p.(None):
p.(None): Areas 3.- In any community investigation, the ethical considerations applicable to research on individuals must be extrapolated to the communal context in the pertinent aspects.
p.(None):
p.(None): CHAPTER III
p.(None):
p.(None): On Research in Minors or Disabilities
p.(None):
p.(None): ARTICLE 34.- In addition to the general provisions of ethics that must be complied with in any investigation in human beings, that which is carried out in minors or incapacitated persons must satisfy what is established in this chapter, except in the case of emancipated persons over 16 years of age.
p.(None):
p.(None): ARTICLE 35 .- When it is intended to carry out investigations in minors, it must be ensured that similar studies have previously been carried out in persons of May age and immature animals, except when it comes to studying conditions that are typical of the neonatal stage or specific conditions of certain ages.
p.(None):
p.(None): ARTICLE 36.- In order to carry out investigations in minors or incapacitated persons, in any case, the written informed consent must be obtained from those who exercise parental authority or the legal representation of the minor or incapable person in question.
p.(None):
p.(None): When two persons exercise the parental rights of a minor, the consent of one of them will only be admissible if there is irrefutable or manifest impossibility of the other to provide it or in case of imminent risk to the health or life of the minor or incapable.
p.(None):
p.(None): ARTICLE 37 .- When the mental capacity and psychological state of the minor or incapable permit, it must also obtain their acceptance to be the subject of investigation, after explaining what they intend to do. The Ethics Commission may waive compliance with these requirements for justified reasons.
p.(None):
p.(None): ARTICLE 38. - The investigations classified as of risk and with probability of direct benefit for the minor or the incapable one, will be admissible when;
p.(None):
p.(None): I.- The risk is justified by the importance of the benefit that the minor or the disabled will receive, and
p.(None):
p.(None): II.- The benefit is equal to or greater than other alternatives already established for diagnosis and treatment.
p.(None):
p.(None): ARTICLE 39.- Investigations classified as risk and without direct benefit to the minor or the incapable, shall be admissible according to the following considerations:
p.(None):
p.(None): I. When the risk is minimal:
p.(None):
p.(None): TO). The intervention or procedure must represent for the minor or the incapable a reasonable experience and comparable with those inherent in their current or expected medical, psychological, social or educational situation, and
p.(None):
p.(None): B). The intervention of the procedure should have a high probability of obtaining generalizable knowledge about the condition or disease of the minor or the incapable, that are of great importance to understand the disorder or to achieve its improvement in other subjects.
p.(None):
p.(None): II. When the risk is greater than the minimum:
p.(None):
p.(None): TO). Research should offer a high probability of understanding, preventing or alleviating a serious problem that affects the health and well-being of children or the disabled, and
p.(None):
p.(None): B). The head of the health care institution will establish strict supervision to determine whether the magnitude of the anticipated risks increases or others arise and will suspend the investigation at the time the risk could affect the biological, psychological or social well-being of the child or of the incapable
p.(None):
p.(None): CHAPTER IV
p.(None):
p.(None): From research in Women of Fertile Age, Pregnant Women, during Labor, Childbirth, Lactation and Newborns; of the use of Embryos, Obitos and Fetos and of Assisted Fertilization.
p.(None):
p.(None): ARTICLE 40 .- For the purposes of this Regulation, it is understood as:
p.(None):
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Searching for indicator education:

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p.(None):
p.(None): ARTICLE 5 .- The powers referred to in the previous article will be distributed according to the following:
p.(None):
p.(None): A. It corresponds to the Secretariat:
p.(None):
p.(None): I. Issue the technical norms to which, throughout the national territory, they will be subject to health research and verify their compliance;
p.(None):
p.(None): II.- Organize and operate research activities in their administrative units;
p.(None):
p.(None): III.- Promote, guide, encourage and support research activities carried out by the governments of federal entities;
p.(None):
p.(None): IV. Carry out, as far as it is concerned and in coordination with the corresponding Dependencies and Entities, the general evaluation of research activities throughout the national territory, and
p.(None):
p.(None): V.- Coordinate research within the framework of the National Health system.
p.(None):
p.(None): B. In matters of General Health, as local authorities, it corresponds to the governments of the federal entities, within their respective territorial jurisdictions and in accordance with the applicable provisions:
p.(None):
p.(None): I. Organize, operate, supervise and evaluate health research activities;
p.(None):
p.(None): II. Formulate and develop their research programs;
p.(None):
p.(None): III. Prepare and provide research information requested by the competent federal authorities;
p.(None):
p.(None): IV. Monitor compliance with the Laws, Regulations and Technical Standards that refer to research, and
p.(None):
p.(None): V. Collaborate with the coordination of research within the framework of the National Health System.
p.(None):
p.(None): ARTICLE 6.- The Secretaries of Health and Public Education, in the sphere of their respective competences, may enter into collaboration or agreement agreements with educational institutions that carry out health research, so that they, without prejudice to autonomy that by law corresponds to them contribute to the said Dependencies in the development of actions aimed at promoting health research, as well as for compliance with the provisions of Title Five of the Law.
p.(None):
p.(None): ARTICLE 7.- The coordination of the investigation, within the framework of the National Health System, will be in charge of the Secretariat, to whom it will correspond:
p.(None):
p.(None): I. Establish and conduct the national policy on Health Research, under the terms of the applicable Laws, these Regulations and other provisions;
p.(None):
p.(None): II. Promote research activities within the institutions that make up the National Health System;
p.(None):
p.(None): III.- Promote the deconcentration and decentralization of research activities;
p.(None):
p.(None): IV.- Determine the periodicity and characteristics of information on health research that must be provided by the agencies and entities that carry it out;
p.(None):
p.(None): V. Support coordination between health and educational institutions to boost research activities;
p.(None):
p.(None): SAW. Contribute with the competent agencies to the regulation and control of technology transfer in the area of health;
p.(None):
p.(None): VII. Contribute to the training and distribution of human resources for research is consistent with the priorities of the National Health System;
p.(None):
p.(None): VIII. Promote and promote community participation in the development of research programs;
p.(None):
p.(None): IX. Promote the permanent updating of the legal provisions regarding research, and
p.(None):
p.(None): X. The other attributions related to the previous ones that are required for the fulfillment of the research objectives of the National Health System.
p.(None):
p.(None): ARTICLE 8 - In the formulation of research policies and in the coordination of actions for their execution and development, the Ministry of Public Education and the Secretariat will have as consultation body the Inter-Institutional Commission for Health Research.
p.(None):
p.(None): ARTICLE 9.- The Secretariat, in coordination with the Ministry 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 updated the national research inventory in the area of its competence.
p.(None):
p.(None): ARTICLE 10 .- For the purposes indicated in the previous article and in the terms of the Law to Coordinate and Promote Scientific and Technological Development, a National System of Registry of Research and Technological Development will be established, and the Secretariat will issue the technical standards corresponding to the institutions that carry it out, for the registration and monitoring of projects.
p.(None):
p.(None): ARTICLE 11 .- The Secretariat shall establish, in accordance with the participants, the inter-institutional and intersectoral coordination bases, as well as those of a technical nature of international research conventions and treaties.
p.(None):
p.(None): Of these instruments, a report will be sent to the Secretariat, which must include, among other points, the origin and destination of the financial resources involved, including those of sponsored research that are related to the development of inputs, technologies and other application processes , susceptible to patents or commercial development, among others, that are carried out in human beings.
p.(None):
p.(None): Those that involve higher education institutions and the National Science and Technology Council in which they will proceed by consensus of the subscribers are exempted from the foregoing.
p.(None):
p.(None): ARTICLE 12 .- The General Health Council shall have the power to issue the complementary provisions on areas or modalities of the investigation in which it considers it necessary, as well as to give an opinion on research programs and projects.
p.(None):
p.(None): SECOND TITLE
p.(None):
p.(None): On the Ethical Aspects of Research in Human Beings
p.(None):
p.(None): CHAPTER I
p.(None):
p.(None): Common Provisions
p.(None):
p.(None): ARTICLE 13. -In any investigation in which the human being is the subject of study, the criterion of respect for his dignity and the protection of his rights and well-being shall prevail.
p.(None):
p.(None): ARTICLE 14 .- The Research carried out in human beings must be carried out according to the following bases:
p.(None):
p.(None): I. It will conform to the scientific and ethical principles that justify it;
p.(None):
p.(None): II.- It will be based on the previous experimentation carried out in animals, in laboratories or in other scientific facts.
p.(None):
p.(None): III.- It should be done only when the knowledge that is intended to be produced cannot be obtained by another suitable means;
p.(None):
p.(None): IV.- The probabilities of the expected beneficiaries must always prevail over the predictable risks;
p.(None):
p.(None): V.- You will have the informed and written consent of the research subject or his legal representative, with the exceptions that these Regulations indicate;
p.(None):
...

p.(None):
p.(None): ARTICLE 152 .- Against acts and resolutions of the health authorities that, on the occasion of the application of this Regulation, terminate an instance or resolve a file, the interested parties may file a complaint of disagreement, which will be substantiated in the terms of the law.
p.(None):
p.(None): TRANSITORY
p.(None):
p.(None): FIRST .- This Regulation shall enter into force on the day of its publication in the Official Gazette of the Federation .
p.(None):
p.(None): SECOND .- The Agreement for the creation of the Commissions of Research and Ethics, of December twenty-three thousand nine hundred and eighty-one, published in the Official Gazette of the Federation on January twenty-sixteen nineteen eighty-two, and the Decree of the Biosafety Commissions, dated July 8, nineteen eighty-two, published in the Official Gazette of the Federation on August 4 of the same year. Likewise, other provisions on the matter that oppose this ordinance are repealed.
p.(None):
...

Searching for indicator educational:

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p.(None):
p.(None): A. It corresponds to the Secretariat:
p.(None):
p.(None): I. Issue the technical norms to which, throughout the national territory, they will be subject to health research and verify their compliance;
p.(None):
p.(None): II.- Organize and operate research activities in their administrative units;
p.(None):
p.(None): III.- Promote, guide, encourage and support research activities carried out by the governments of federal entities;
p.(None):
p.(None): IV. Carry out, as far as it is concerned and in coordination with the corresponding Dependencies and Entities, the general evaluation of research activities throughout the national territory, and
p.(None):
p.(None): V.- Coordinate research within the framework of the National Health system.
p.(None):
p.(None): B. In matters of General Health, as local authorities, it corresponds to the governments of the federal entities, within their respective territorial jurisdictions and in accordance with the applicable provisions:
p.(None):
p.(None): I. Organize, operate, supervise and evaluate health research activities;
p.(None):
p.(None): II. Formulate and develop their research programs;
p.(None):
p.(None): III. Prepare and provide research information requested by the competent federal authorities;
p.(None):
p.(None): IV. Monitor compliance with the Laws, Regulations and Technical Standards that refer to research, and
p.(None):
p.(None): V. Collaborate with the coordination of research within the framework of the National Health System.
p.(None):
p.(None): ARTICLE 6.- The Secretaries of Health and Public Education, in the sphere of their respective competences, may enter into collaboration or agreement agreements with educational institutions that carry out health research, so that they, without prejudice to autonomy that by law corresponds to them contribute to the said Dependencies in the development of actions aimed at promoting health research, as well as for compliance with the provisions of Title Five of the Law.
p.(None):
p.(None): ARTICLE 7.- The coordination of the investigation, within the framework of the National Health System, will be in charge of the Secretariat, to whom it will correspond:
p.(None):
p.(None): I. Establish and conduct the national policy on Health Research, under the terms of the applicable Laws, these Regulations and other provisions;
p.(None):
p.(None): II. Promote research activities within the institutions that make up the National Health System;
p.(None):
p.(None): III.- Promote the deconcentration and decentralization of research activities;
p.(None):
p.(None): IV.- Determine the periodicity and characteristics of information on health research that must be provided by the agencies and entities that carry it out;
p.(None):
p.(None): V. Support coordination between health and educational institutions to boost research activities;
p.(None):
p.(None): SAW. Contribute with the competent agencies to the regulation and control of technology transfer in the area of health;
p.(None):
p.(None): VII. Contribute to the training and distribution of human resources for research is consistent with the priorities of the National Health System;
p.(None):
p.(None): VIII. Promote and promote community participation in the development of research programs;
p.(None):
p.(None): IX. Promote the permanent updating of the legal provisions regarding research, and
p.(None):
p.(None): X. The other attributions related to the previous ones that are required for the fulfillment of the research objectives of the National Health System.
p.(None):
p.(None): ARTICLE 8 - In the formulation of research policies and in the coordination of actions for their execution and development, the Ministry of Public Education and the Secretariat will have as consultation body the Inter-Institutional Commission for Health Research.
p.(None):
p.(None): ARTICLE 9.- The Secretariat, in coordination with the Ministry 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 updated the national research inventory in the area of its competence.
p.(None):
...

p.(None):
p.(None): ARTICLE 38. - The investigations classified as of risk and with probability of direct benefit for the minor or the incapable one, will be admissible when;
p.(None):
p.(None): I.- The risk is justified by the importance of the benefit that the minor or the disabled will receive, and
p.(None):
p.(None): II.- The benefit is equal to or greater than other alternatives already established for diagnosis and treatment.
p.(None):
p.(None): ARTICLE 39.- Investigations classified as risk and without direct benefit to the minor or the incapable, shall be admissible according to the following considerations:
p.(None):
p.(None): I. When the risk is minimal:
p.(None):
p.(None): TO). The intervention or procedure must represent for the minor or the incapable a reasonable experience and comparable with those inherent in their current or expected medical, psychological, social or educational situation, and
p.(None):
p.(None): B). The intervention of the procedure should have a high probability of obtaining generalizable knowledge about the condition or disease of the minor or the incapable, that are of great importance to understand the disorder or to achieve its improvement in other subjects.
p.(None):
p.(None): II. When the risk is greater than the minimum:
p.(None):
p.(None): TO). Research should offer a high probability of understanding, preventing or alleviating a serious problem that affects the health and well-being of children or the disabled, and
p.(None):
p.(None): B). The head of the health care institution will establish strict supervision to determine whether the magnitude of the anticipated risks increases or others arise and will suspend the investigation at the time the risk could affect the biological, psychological or social well-being of the child or of the incapable
p.(None):
p.(None): CHAPTER IV
p.(None):
p.(None): From research in Women of Fertile Age, Pregnant Women, during Labor, Childbirth, Lactation and Newborns; of the use of Embryos, Obitos and Fetos and of Assisted Fertilization.
p.(None):
...

p.(None):
p.(None): ARTICLE 111.- It is the responsibility of the Research Commission to evaluate the technical quality and scientific merit of the proposed research, formulating the corresponding opinion, and issue the opinion of the Ethics and Biosafety Commissions.
p.(None):
p.(None): ARTICLE 112. - The commissions and the authorities to which they report will maintain confidentiality about the reports they receive from the researchers, mainly if the investigations are related to the development of inputs, technology and other application processes susceptible to patents or commercial development.
p.(None):
p.(None): SIXTH TITLE
p.(None):
p.(None): On the Execution of Research in Healthcare Institutions
p.(None):
p.(None): ONLY CHAPTER
p.(None):
p.(None): ARTICLE 113. - The conduction of the investigation will be in charge of a principal investigator, who must be a health professional and have the appropriate academic training and experience for the direction of the work to be performed, in addition to being members of the care institution to health and have the authorization of the head responsible for the ascription area
p.(None):
p.(None): ARTICLE 114 .- For the purposes of this Regulation, those whose activities related to medicine, dentistry, veterinary medicine, biology, bacteriology, nursing, social work, chemistry, psychology, sanitary engineering, nutrition, dietology, pathology and health professionals are considered its branches and the others that establish applicable legal provisions require a professional degree or certificate of specialization legally issued and registered by the competent educational authorities.
p.(None):
p.(None): ARTICLE 115.- The investigations will be carried out in accordance with a protocol, which will be prepared in accordance with the technical norm issued by the Secretariat for this purpose and will include the elements that allow the evaluation of the study that is proposed to be carried out.
p.(None):
p.(None): ARTICLE 116. - The principal investigator will be in charge of the technical direction of the study and will have the following attributions:
p.(None):
p.(None): I. Prepare the research protocol;
p.(None):
p.(None): II. Comply with the procedures indicated in the protocol and request authorization for modification in the necessary cases on aspects of ethics and biosafety;
p.(None):
p.(None): III. Document and record all data generated during the study;
p.(None):
p.(None): IV. Form a file on the study that will contain the protocol, the modifications to it, the authorities, the data generated, the final report and all the documentary and biological material that can be stored, related to the research;
p.(None):
p.(None): V. Select the personnel participating in the study and provide the information and training necessary to carry out their function, as well as keep them informed of the data generated and the results;
p.(None):
p.(None): SAW. Prepare and present partial and final research reports, and
p.(None):
p.(None): VII. The related works that are necessary to comply with the technical direction of the investigation.
p.(None):
p.(None): ARTICLE 117 .- The principal investigator will select the researchers associated with the appropriate academic training and experience in the scientific disciplines that are required to participate in the study.
p.(None):
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Searching for indicator embryo:

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p.(None):
p.(None): B). The head of the health care institution will establish strict supervision to determine whether the magnitude of the anticipated risks increases or others arise and will suspend the investigation at the time the risk could affect the biological, psychological or social well-being of the child or of the incapable
p.(None):
p.(None): CHAPTER IV
p.(None):
p.(None): From research in Women of Fertile Age, Pregnant Women, during Labor, Childbirth, Lactation and Newborns; of the use of Embryos, Obitos and Fetos and of Assisted Fertilization.
p.(None):
p.(None): ARTICLE 40 .- For the purposes of this Regulation, it is understood as:
p.(None):
p.(None): I. Women of childbearing age.- From the beginning of puberty until the onset of menopause;
p.(None):
p.(None): II. Pregnancy.- It is the period from the fertilization of the ovum (evidenced by any presumptive sign or symptom of pregnancy, as a suspension of menstruation or positive proof of medically accepted pregnancy) until the expulsion or removal of the fetus and its annexes.
p.(None):
p.(None): III. Embryo.- The product of conception from the fertilization of the ovum until the end of the twelfth week of management;
p.(None):
p.(None): IV. Fetus.- The product of conception from the beginning of the thirteenth week of gestation until its expulsion or extraction;
p.(None):
p.(None): V. Fetal Obito.- The death of the fetus in the womb;
p.(None):
p.(None): VI.- Live birth.- It is the expulsion or complete extraction of the product of conception, from the maternal breast, when after such separation the heart breathes and beats, the umbilical cord has been cut or not and the placenta is detached;
p.(None):
p.(None): VII.- Dead Birth.- is the expulsion or complete extraction of the product of conception, from the maternal breast, when after said separation the heart does not breathe or beat, the umbilical cord has been cut or not and the placenta is detached or not ;
p.(None):
p.(None): VIII.- Labor.- It is the period from the start of uterine contractions (with progressive characteristics of intensity, irrigation and duration) and that ends with the expulsion or extraction of the fetus and its annexes;
p.(None):
p.(None): IX. Puerperio.- It is the period that begins with the expulsion or extraction of the fetus and its annexes until the involution of gestational changes is achieved (approximately for 42 days)
p.(None):
p.(None): X. Breastfeeding.- It is a physiological phenomenon in which dairy secretion occurs from the expulsion or extraction of the fetus and its annexes, and
p.(None):
p.(None): XI Assisted fertilization.- It is one in which the insemination is artificial (homologous or heterologous) and includes in vitro fertilization.
p.(None):
p.(None): ARTICLE 41.- In addition to the general provisions of ethics that must be complied with in any investigation in human beings, those that include the subjects referred to in this chapter must satisfy what is established in articles 42 to 56 of these Regulations.
p.(None):
p.(None): ARTICLE 42.- In investigations classified as irrigation greater than the minimum that are carried out in women of childbearing age, measures shall be taken to:
p.(None):
p.(None): I. Certify that women are not pregnant, prior to their acceptance as research subjects, and
p.(None):
p.(None): II. Reduce as much as possible the chances of pregnancy during the investigation.
p.(None):
p.(None): ARTICLE 43 .- To carry out research in pregnant women, during labor, postpartum and lactation; in live or dead births; of use of embryos, deaths or fetuses; and for assisted fertilization, it is required to obtain the letter of informed consent from the woman and her spouse or concubinary in accordance with the provisions of articles 21 and 22 of these Regulations, prior information on the possible risks to the embryo, fetus or Newborn in your case.
p.(None):
p.(None): The consent of the spouse or concubinary can only be waived in case of incapacity or irrefutable or manifest impossibility to provide it; because the concubinary does not take care of the woman, or, when there is imminent risk to the health or life of the woman, embryo, fetus or newborn.
p.(None):
p.(None): ARTICLE 44.- The investigations carried out in pregnant women must be preceded by studies carried out in non-pregnant women that demonstrate their safety, except for specific studies that require said condition.
p.(None):
p.(None): ARTICLE 45. - The investigations in pregnant women, whose objective is to obtain generalizable knowledge about pregnancy, should not represent a risk greater than the minimum for the woman, the embryo or the fetus.
p.(None):
p.(None): ARTICLE 46.- Investigations in pregnant women that imply an intervention or experimental procedure not related to pregnancy, but with therapeutic benefit for women, as it would be in cases of gravidarum toxemia, diabetes, hypertension and malignancies, among others, should not expose embryo or the fetus at a greater than minimum risk, except when the use of the intervention or procedure is justified to save the woman's life.
p.(None):
p.(None): ARTICLE 47 .- Research in pregnant women, with therapeutic benefit related to pregnancy, will be allowed when:
p.(None):
p.(None): I. Aim to improve the health of the pregnant woman with a minimal risk to the embryo or fetus, or
p.(None):
p.(None): II.- Are aimed at increasing the viability of the fetus, with a minimal risk to the pregnant woman.
p.(None):
p.(None): ARTICLE 48 .- During the execution of investigations in pregnant women:
p.(None):
p.(None): I. Investigators will not have the authority to decide on the time, method or procedure used to terminate the pregnancy, nor will they participate in decisions on the viability of the fetus;
p.(None):
p.(None): II. Only with the authorization of the Ethics Commission can the method to terminate the pregnancy be modified for research purposes, when such modifications represent a minimal risk to the mother's health and do not represent any risk for the survival of the fetus, and
p.(None):
p.(None): III. In any case, it is strictly forbidden to grant monetary or other stimuli to terminate the pregnancy, for the interest of the investigation or for other reasons.
p.(None):
...

p.(None):
p.(None): III. Train staff on work procedures and the characteristics of the laboratory and equipment.
p.(None):
p.(None): ARTICLE 92.- All personnel directly or indirectly involved in this type of research must be adequately informed, by the person responsible for the radiological and physical safety, of the health risks represented by the radiation doses to which they are exposed and should know the basic principles of radiology protection, such as: Shielding, exposure time, distance and control of pollution and radioactive waste, among others, in order to ensure an accurate knowledge of radiation protection measures, such as: Shielding , exposure time, distance and control of pollution and radioactive waste, among others,in order to ensure an accurate knowledge of the radiological protection measures that ensure the biosecurity of the procedures used in the investigation, with the participation that corresponds to the Ministry of Energy, Mines and Parastatal Industry.
p.(None):
p.(None): ARTICLE 93 .- In these investigations, the occupational exposed personnel must be over 18 years. When such a person is a woman of childbearing age, the exposures should be distributed as evenly as possible in time, in order to protect, if necessary, the embryo during the organogenesis period, before the pregnancy diagnosis is made.
p.(None):
p.(None): Pregnant women will only be able to continue the work that exposes them occupationally, if it is ensured that the exposures will be distributed as evenly as possible in time and when it is unlikely that they will receive a third of the equivalent annual dose that should be specified in the biosafety regulations of according to the specific radioactive energy. Pregnant or breastfeeding women should not work in places where there is a risk of incorporation of radioactive materials.
p.(None):
p.(None): ARTICLE 94 .- The health institution where research is conducted with radioactive materials must appoint a doctor or health care institution that will be responsible for conducting medical examinations to the occupational exposed personnel, in order to:
p.(None):
p.(None): I. Determine their aptitude, from the point of view of their health, to perform the work considered, before they are exposed to radiation.
p.(None):
p.(None): II. Identify changes in your health that could result from radiation exposure during the performance of your work, and
p.(None):
p.(None): III. Detect late effects of radiation, even after exposure has ceased.
p.(None):
p.(None): ARTICLE 95.- Studies involving the exposure of the research subject to radiation shall:
p.(None):
p.(None): I. Justify yourself because it is not possible to obtain the same information at a lower risk through investigations that use other techniques
p.(None):
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p.(None):
p.(None): ARTICLE 52 .- Fetuses will be subject to investigation only if the techniques and means used provide maximum security for them and the pregnant woman.
p.(None):
p.(None): ARTICLE 53 .- Newborns will not be subject to investigation until it has been established with certainty whether or not they are live births, except when the investigation is intended to increase their probability of survival until the viability phase, the study procedures 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 otherwise.
p.(None):
p.(None): ARTICLE 54 .- Live births may be subject to investigation if the provisions on investigation in minors, indicated in these Regulations are complied with.
p.(None):
p.(None): ARTICLE 55.- Investigations with embryos, deaths, fetuses, dead births, macerated fetal matter, cells, tissues and organs extracted from them will be carried out in accordance with the provisions of Title Fourteenth of the Law and these Regulations.
p.(None):
p.(None): ARTICLE 56.- The investigation on assisted fertilization will only be admissible when it is applied to the solution of sterility problems that cannot be solved in any other way, respecting the moral, cultural and social point of view of the couple, even if it differs with the researcher
p.(None):
p.(None): CHAPTER V
p.(None):
p.(None): On Subordinate Group Research
p.(None):
p.(None): ARTICLE 57. - Subordinate groups are understood as the following: students, laboratory and hospital workers, employees, members of the armed forces, inmates in prisons or social rehabilitation centers and other special groups of the population, in which Informed consent may be influenced by some authority.
p.(None):
p.(None): ARTICLE 58 .- When conducting research in subordinate groups, one or more members of the population under study must participate in the Ethics Commission, capable of representing the moral, cultural and social values of the group in question and monitor:
p.(None):
p.(None): I. That the participation, the rejection of the subjects to intervene or withdrawal of their consent during the study, does not affect their school, work, military situation or that related to the judicial process to which they were subject and the conditions of compliance with sentence, in your case:
p.(None):
p.(None): II.- That the results of the investigation are not used to the detriment of the participating individuals, and
p.(None):
p.(None): III.- That the health care institution and, the sponsors are responsible for the medical treatment of the damages caused and, where appropriate, for the compensation that legally corresponds for the harmful consequences of the investigation.
p.(None):
p.(None): CHAPTER VI
p.(None):
p.(None): Of Research in Organs, Tissues and their Derivatives, Products and Corpse of Human Beings.
p.(None):
...

p.(None):
p.(None): I. Have laboratory facilities and equipment in accordance with the technical standards issued for this purpose by the Secretariat, which guarantee adequate physical containment for the safe handling of such germs;
p.(None):
p.(None): II. Prepare a manual of procedures for microbiology laboratories and make it available to staff, service and maintenance technician;
p.(None):
p.(None): III.- Train personnel on the handling, transport, use, decontamination and disposal of waste;
p.(None):
p.(None): IV. Determine the need for medical surveillance of personnel involved in the investigations and, where appropriate, implement it;
p.(None):
p.(None): V. Establish a safety supervision and monitoring program in microbiology laboratories;
p.(None):
p.(None): SAW. Have an updated bibliography and an archive on equipment safety, availability of containment systems, rules and regulations, risks involved and other related aspects, and
p.(None):
p.(None): VII. Comply with the other provisions determined by the Secretariat
p.(None):
p.(None): ARTICLE 76 .- In the health institutions mentioned in the previous article, the microbiology laboratories will comply with the requirements set forth in the technical standards issued by the Secretariat and will be classified into three types:
p.(None):
p.(None): I. Basic Laboratory of Microbiology;
p.(None):
p.(None): II. Microbiological Safety Laboratory, and
p.(None):
p.(None): III. Laboratory of Maximum Microbiological Safety.
p.(None):
p.(None): ARTICLE 77 .- The Manual of Procedures referred to in article 75 section II, of these Regulations, will describe the following aspects:
p.(None):
p.(None): I. Laboratory practices;
p.(None):
p.(None): II. Personal security of employees;
p.(None):
p.(None): III. Management and maintenance of sunstroke and equipment;
p.(None):
p.(None): IV. Urgent situations;
p.(None):
p.(None): V. Entry and transit restrictions;
p.(None):
p.(None): SAW. Reception of transport of biological materials;
p.(None):
p.(None): VII. Waste provisions;
p.(None):
p.(None): VIII. Decontamination, and
p.(None):
p.(None): IX. The others considered necessary to achieve microbiological safety.
p.(None):
p.(None): ARTICLE 78.- The principal investigator, according to a superior, the Biosafety Commission and the head of the institution, will determine, in accordance with the technical standards issued by the Secretariat, the type of laboratory in which the proposed investigations must be carried out. , as well as the respective procedures, taking into account the degree of risk of infection presented by the microorganisms to be used.
p.(None):
p.(None): ARTICLE 79 .- To assess the degree of infection risk referred to in the previous article, the Secretariat will issue the corresponding technical standard and classify microorganisms into four Groups, according to the following criteria:
p.(None):
p.(None): Risk Group I:
p.(None):
p.(None): Microorganisms that represent little risk for the individual and the community;
p.(None):
p.(None): Risk Group II;
p.(None):
p.(None): Microorganisms that represent moderate risk for the individual and limited for the community;
p.(None):
p.(None): Risk Group III;
p.(None):
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p.(None):
p.(None): ARTICLE 10 .- For the purposes indicated in the previous article and in the terms of the Law to Coordinate and Promote Scientific and Technological Development, a National System of Registry of Research and Technological Development will be established, and the Secretariat will issue the technical standards corresponding to the institutions that carry it out, for the registration and monitoring of projects.
p.(None):
p.(None): ARTICLE 11 .- The Secretariat shall establish, in accordance with the participants, the inter-institutional and intersectoral coordination bases, as well as those of a technical nature of international research conventions and treaties.
p.(None):
p.(None): Of these instruments, a report will be sent to the Secretariat, which must include, among other points, the origin and destination of the financial resources involved, including those of sponsored research that are related to the development of inputs, technologies and other application processes , susceptible to patents or commercial development, among others, that are carried out in human beings.
p.(None):
p.(None): Those that involve higher education institutions and the National Science and Technology Council in which they will proceed by consensus of the subscribers are exempted from the foregoing.
p.(None):
p.(None): ARTICLE 12 .- The General Health Council shall have the power to issue the complementary provisions on areas or modalities of the investigation in which it considers it necessary, as well as to give an opinion on research programs and projects.
p.(None):
p.(None): SECOND TITLE
p.(None):
p.(None): On the Ethical Aspects of Research in Human Beings
p.(None):
p.(None): CHAPTER I
p.(None):
p.(None): Common Provisions
p.(None):
p.(None): ARTICLE 13. -In any investigation in which the human being is the subject of study, the criterion of respect for his dignity and the protection of his rights and well-being shall prevail.
p.(None):
p.(None): ARTICLE 14 .- The Research carried out in human beings must be carried out according to the following bases:
p.(None):
p.(None): I. It will conform to the scientific and ethical principles that justify it;
p.(None):
p.(None): II.- It will be based on the previous experimentation carried out in animals, in laboratories or in other scientific facts.
p.(None):
p.(None): III.- It should be done only when the knowledge that is intended to be produced cannot be obtained by another suitable means;
p.(None):
p.(None): IV.- The probabilities of the expected beneficiaries must always prevail over the predictable risks;
p.(None):
p.(None): V.- You will have the informed and written consent of the research subject or his legal representative, with the exceptions that these Regulations indicate;
p.(None):
p.(None): VI.- It must be carried out by health professionals referred to in article 114 of this Regulation, with knowledge and experience to take care of the integrity of the human being, under the responsibility of a health care institution that acts under the supervision of the competent health authorities and that it has the necessary human and material resources that guarantee the well-being of the research subject;
p.(None):
p.(None): VII. It will have the favorable opinion of the Commissions of Investigation, Ethics and Biosafety, where appropriate, and
p.(None):
p.(None): VIII. It will be carried out when authorized by the head of the health care institution and, where appropriate, by the Secretariat, in accordance with articles 31, 62, 69, 71, 73, and 88 of these Regulations.
p.(None):
p.(None): ARTICLE 15.- When the experimental design of an investigation that is carried out in human beings includes several groups, random selection methods will be used to obtain an impartial allocation of the participants in each group and the pertinent measures must be taken to avoid any risk or damage. to research subjects.
p.(None):
p.(None): ARTICLE 16.- In the investigations in human beings, the privacy of the individual subject of investigation will be protected, identifying it only when the results require it and this authorizes it.
p.(None):
p.(None): ARTICLE 17 .- The risk of the investigation is considered to be the probability that the research subject will suffer some damage as an immediate or late consequence of the study. For purposes of this Regulation, investigations are classified into the following categories;
p.(None):
p.(None): I.- Risk-free research: These are studies that employ retrospective documentary research techniques and methods and those in which no intervention or intentional modification is made in the physiological, psychological and social variables of the individuals participating in the study, among the which are considered: questionnaires, interviews, review of clinical records and others, in which he is not identified or sensitive aspects of his behavior are treated;
p.(None):
...

p.(None):
p.(None): ARTICLE 60.- This investigation must observe, in addition to due respect for the human corpse, the applicable provisions stipulated in this ordinance and what is established in the Fourteenth Title of the Law and its Regulation on Health Control Matters of the disposal of Organs, Tissues and Corpses of Human Beings.
p.(None):
p.(None): THIRD TITLE
p.(None):
p.(None): On the investigation of new Prophylactic, Diagnostic, Therapeutic and Rehabilitation Resources.
p.(None):
p.(None): CHAPTER I
p.(None):
p.(None): Common Provisions
p.(None):
p.(None): ARTICLE 61 .- When research is carried out on human beings, on new prophylactic, diagnostic, therapeutic and rehabilitation resources or it is intended to modify those already known, the provisions of the preceding articles must be observed and, as applicable, meet the requirements set forth in This Title
p.(None):
p.(None): ARTICLE 62.- The corresponding authorities of the health care institutions that carry out these investigations must obtain authorization from the Secretariat. For this purpose, they will present the following documentation:
p.(None):
p.(None): I.- Research protocol that must contain an objective and complete analysis of the risks involved, compared with the risks of established diagnostic and treatment methods and the expectation of the subject's living conditions with and without the proposed procedure or treatment ;
p.(None):
p.(None): II.- Letter of acceptance from the head of the institution where the investigation would be carried out;
p.(None):
p.(None): III.- Favorable opinion of the Commissions of Investigation, Ethics and, where appropriate, biosafety;
p.(None):
p.(None): IV.- Description of available resources, including areas, equipment and auxiliary services of laboratories and cabinets;
p.(None):
p.(None): V.- Description of the resources available for the management of medical emergencies,
p.(None):
p.(None): VI.- Professional history of the principal investigator, which includes his academic preparation, representative scientific production and clinical practice or experience in the area of the proposed research;
p.(None):
p.(None): VII.- Academic preparation and experience of medical, paramedical and other experts who will participate in the research activities;
p.(None):
p.(None): VIII.- The requirements indicated in articles 69 and 73 of these Regulations, if applicable, and
p.(None):
p.(None): IX.- The others that indicate the technical standards issued by the Secretariat for this purpose.
p.(None):
p.(None): ARTICLE 63.- When there is sponsorship or other forms of remuneration, the necessary measures must be established to prevent them from causing 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 resources.
p.(None):
p.(None): ARTICLE 64.- In the development of the investigations contemplated in this Title the following obligations must be fulfilled:
p.(None):
p.(None): I.- The principal investigator will inform the Ethics Commission of any probable adverse effects or directly related to the investigation;
p.(None):
...

p.(None):
p.(None): ARTICLE 69.- The use in human beings of investigational medicines during their evaluation through phases I to IV of clinical pharmacological research, will be done with the authorization of the Secretariat. For this purpose, the institutions must present the documentation indicated in Article 62 of that Regulation, in addition to the following:
p.(None):
p.(None): I. the basic and preclinical pharmacological information of the medicine, and
p.(None):
p.(None): II. Information previously obtained on clinical pharmacology, in cases of phases II, III and IV and availability tests when required.
p.(None):
p.(None): ARTICLE 70.- The studies of phase I clinical pharmacology, new antineoplastic drugs and others with a very low therapeutic index will be allowed, when:
p.(None):
p.(None): I. They are based on preclinical studies that demonstrate the pharmacological activity of the drug and clearly indicate the characteristics of its toxicity;
p.(None):
p.(None): II. They are carried out only in voluntary subjects with the specific advanced disease confirmed by additional diagnostic means, which have not presented a therapeutic response to any other available treatment and in whom the new drug could offer a therapeutic benefit, and
p.(None):
p.(None): III. Do not incur expenses to the patient.
p.(None):
p.(None): ARTICLE 71 .- In the emergency treatment in conditions that threaten the life of a person, when it is considered necessary to use investigational drugs or a known medication using indications, doses and routes of administration different from those established, the doctor must obtain the opinion favorable of the Commission of Investigation of the institution of attention to the health and the letter of informed consent of the subject of the subject of investigation or, in his case, of his legal representative, according to allow the circumstances, according to the following bases:
p.(None):
p.(None): I. The Research and Ethics Commissions will be informed of the use of the research drug in advance if the investigator can foresee the need for its use in urgent situations. In retrospect, if the use of the drug, the indication, doses or new routes of administration arise as unforeseen needs. In both cases the commissions will issue the opinion in favor or against approving the planned use or the repetition of the unforeseen use of the medicine and the head of the health care institution, the physician will be responsible for requiring the Secretariat to authorize such uses, and
p.(None):
p.(None): II. The status of informed consent will be obtained from the investigating subject, where appropriate, from his legal representative or the closest relative in the bond, except when the condition of the subject incapacitates or prevents him from granting it, the legal representative or the relative is not available and the stop using the investigational drug represents an almost absolute risk of death.
p.(None):
p.(None): CHAPTER III
p.(None):
p.(None): From the Research of Other New Resources
p.(None):
p.(None): ARTICLE 72 .- For the purposes of this Regulation, it is understood by investigation of other new resources or modalities different from those established, to the scientific activities aimed at the study of materials, grafts, transplants, prostheses, physical, chemical and surgical procedures and others prevention, diagnosis, treatment and rehabilitation methods that are carried out in humans or in their biological products, except pharmacological ones.
p.(None):
p.(None): ARTICLE 73.- All research referred to in this Chapter must have the authorization of the Secretariat. For this purpose, the institutions must present the documentation indicated in Article 62 of these Regulations, in addition to the following:
p.(None):
p.(None): I. The scientific foundations, information on previous experimentation in animals, in the laboratory, and
p.(None):
p.(None): II. Previous clinical research studies, if any.
p.(None):
...

p.(None):
p.(None): ARTICLE 103 .- The commissions are integrated with a minimum of three scientists each, with research experience.
p.(None):
p.(None): ARTICLE 104 .- To constitute the Ethics Commission, members of both sexes must be included. It will be advisable that at least one of them does not belong to the health institution and includes medical professionals with the capacity to represent the moral, cultural and social values of the research groups.
p.(None):
p.(None): ARTICLE 105 .- To constitute the Biosafety Commission, scientists with extensive experience or knowledge in this field, whether or not members of the health institution staff, shall be included to ensure that research activities are carried out under appropriate biosafety measures.
p.(None):
p.(None): ARTICLE 106 .- To establish the Research Commission, preference will be given to members of the health institution with knowledge and experience in scientific methodology.
p.(None):
p.(None): ARTICLE 107 .- When within the institution it is not possible to gather the right people to establish the commissions, the respective holder may request the support and advice of the commissions constituted at the immediate superior level of his or her own dependency or outside of it, on condition that the aforementioned requirements are met.
p.(None):
p.(None): ARTICLE 108 .- The members of the commissions will remain in office for a period of three years, being able to be ratified for an equal period and will be relieved of their functions during the evaluation and opinion of their own investigations. The operation of each commission will be subject to the technical norms that the Secretariat dictates for this purpose, as well as to the internal regulations formulated by the commission itself and approved by the corresponding authority in the institution.
p.(None):
p.(None): ARTICLE 109 .- It is the responsibility of the Ethics Commission to issue the technical opinion on the ethical aspects of the proposed investigations, by reviewing the risks, benefits and the letter of consent in the protocols and their competent authorities, to guarantee the well-being and Rights of research subjects.
p.(None):
p.(None): ARTICLE 110.- It is the responsibility of the Biosafety Commission to issue the technical opinion of the biosafety aspects of the proposed investigations, by reviewing the facilities, in order to guarantee the protection of the biological physical integrity of the occupational personnel exposed, as well as of research subjects, the community and the environment.
p.(None):
p.(None): ARTICLE 111.- It is the responsibility of the Research Commission to evaluate the technical quality and scientific merit of the proposed research, formulating the corresponding opinion, and issue the opinion of the Ethics and Biosafety Commissions.
p.(None):
p.(None): ARTICLE 112. - The commissions and the authorities to which they report will maintain confidentiality about the reports they receive from the researchers, mainly if the investigations are related to the development of inputs, technology and other application processes susceptible to patents or commercial development.
p.(None):
p.(None): SIXTH TITLE
p.(None):
p.(None): On the Execution of Research in Healthcare Institutions
p.(None):
p.(None): ONLY CHAPTER
p.(None):
p.(None): ARTICLE 113. - The conduction of the investigation will be in charge of a principal investigator, who must be a health professional and have the appropriate academic training and experience for the direction of the work to be performed, in addition to being members of the care institution to health and have the authorization of the head responsible for the ascription area
p.(None):
p.(None): ARTICLE 114 .- For the purposes of this Regulation, those whose activities related to medicine, dentistry, veterinary medicine, biology, bacteriology, nursing, social work, chemistry, psychology, sanitary engineering, nutrition, dietology, pathology and health professionals are considered its branches and the others that establish applicable legal provisions require a professional degree or certificate of specialization legally issued and registered by the competent educational authorities.
p.(None):
p.(None): ARTICLE 115.- The investigations will be carried out in accordance with a protocol, which will be prepared in accordance with the technical norm issued by the Secretariat for this purpose and will include the elements that allow the evaluation of the study that is proposed to be carried out.
p.(None):
...

General/Other / Impaired Autonomy

Searching for indicator autonomy:

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p.(None):
p.(None): I. Issue the technical norms to which, throughout the national territory, they will be subject to health research and verify their compliance;
p.(None):
p.(None): II.- Organize and operate research activities in their administrative units;
p.(None):
p.(None): III.- Promote, guide, encourage and support research activities carried out by the governments of federal entities;
p.(None):
p.(None): IV. Carry out, as far as it is concerned and in coordination with the corresponding Dependencies and Entities, the general evaluation of research activities throughout the national territory, and
p.(None):
p.(None): V.- Coordinate research within the framework of the National Health system.
p.(None):
p.(None): B. In matters of General Health, as local authorities, it corresponds to the governments of the federal entities, within their respective territorial jurisdictions and in accordance with the applicable provisions:
p.(None):
p.(None): I. Organize, operate, supervise and evaluate health research activities;
p.(None):
p.(None): II. Formulate and develop their research programs;
p.(None):
p.(None): III. Prepare and provide research information requested by the competent federal authorities;
p.(None):
p.(None): IV. Monitor compliance with the Laws, Regulations and Technical Standards that refer to research, and
p.(None):
p.(None): V. Collaborate with the coordination of research within the framework of the National Health System.
p.(None):
p.(None): ARTICLE 6.- The Secretaries of Health and Public Education, in the sphere of their respective competences, may enter into collaboration or agreement agreements with educational institutions that carry out health research, so that they, without prejudice to autonomy that by law corresponds to them contribute to the said Dependencies in the development of actions aimed at promoting health research, as well as for compliance with the provisions of Title Five of the Law.
p.(None):
p.(None): ARTICLE 7.- The coordination of the investigation, within the framework of the National Health System, will be in charge of the Secretariat, to whom it will correspond:
p.(None):
p.(None): I. Establish and conduct the national policy on Health Research, under the terms of the applicable Laws, these Regulations and other provisions;
p.(None):
p.(None): II. Promote research activities within the institutions that make up the National Health System;
p.(None):
p.(None): III.- Promote the deconcentration and decentralization of research activities;
p.(None):
p.(None): IV.- Determine the periodicity and characteristics of information on health research that must be provided by the agencies and entities that carry it out;
p.(None):
p.(None): V. Support coordination between health and educational institutions to boost research activities;
p.(None):
p.(None): SAW. Contribute with the competent agencies to the regulation and control of technology transfer in the area of health;
p.(None):
p.(None): VII. Contribute to the training and distribution of human resources for research is consistent with the priorities of the National Health System;
p.(None):
p.(None): VIII. Promote and promote community participation in the development of research programs;
p.(None):
p.(None): IX. Promote the permanent updating of the legal provisions regarding research, and
p.(None):
p.(None): X. The other attributions related to the previous ones that are required for the fulfillment of the research objectives of the National Health System.
p.(None):
...

General/Other / Incapacitated

Searching for indicator incapacitated:

Searching for indicator incapacity:

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p.(None):
p.(None): ARTICLE 42.- In investigations classified as irrigation greater than the minimum that are carried out in women of childbearing age, measures shall be taken to:
p.(None):
p.(None): I. Certify that women are not pregnant, prior to their acceptance as research subjects, and
p.(None):
p.(None): II. Reduce as much as possible the chances of pregnancy during the investigation.
p.(None):
p.(None): ARTICLE 43 .- To carry out research in pregnant women, during labor, postpartum and lactation; in live or dead births; of use of embryos, deaths or fetuses; and for assisted fertilization, it is required to obtain the letter of informed consent from the woman and her spouse or concubinary in accordance with the provisions of articles 21 and 22 of these Regulations, prior information on the possible risks to the embryo, fetus or Newborn in your case.
p.(None):
p.(None): The consent of the spouse or concubinary can only be waived in case of incapacity or irrefutable or manifest impossibility to provide it; because the concubinary does not take care of the woman, or, when there is imminent risk to the health or life of the woman, embryo, fetus or newborn.
p.(None):
p.(None): ARTICLE 44.- The investigations carried out in pregnant women must be preceded by studies carried out in non-pregnant women that demonstrate their safety, except for specific studies that require said condition.
p.(None):
p.(None): ARTICLE 45. - The investigations in pregnant women, whose objective is to obtain generalizable knowledge about pregnancy, should not represent a risk greater than the minimum for the woman, the embryo or the fetus.
p.(None):
...

General/Other / Public Emergency

Searching for indicator emergency:

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p.(None):
p.(None): ARTICLE 68.- The preclinical toxicology studies required for each drug will be a function of this particular, of the known potential toxicology of others with similar chemical structure and of the route and time of administration that are intended to be used in humans.
p.(None):
p.(None): ARTICLE 69.- The use in human beings of investigational medicines during their evaluation through phases I to IV of clinical pharmacological research, will be done with the authorization of the Secretariat. For this purpose, the institutions must present the documentation indicated in Article 62 of that Regulation, in addition to the following:
p.(None):
p.(None): I. the basic and preclinical pharmacological information of the medicine, and
p.(None):
p.(None): II. Information previously obtained on clinical pharmacology, in cases of phases II, III and IV and availability tests when required.
p.(None):
p.(None): ARTICLE 70.- The studies of phase I clinical pharmacology, new antineoplastic drugs and others with a very low therapeutic index will be allowed, when:
p.(None):
p.(None): I. They are based on preclinical studies that demonstrate the pharmacological activity of the drug and clearly indicate the characteristics of its toxicity;
p.(None):
p.(None): II. They are carried out only in voluntary subjects with the specific advanced disease confirmed by additional diagnostic means, which have not presented a therapeutic response to any other available treatment and in whom the new drug could offer a therapeutic benefit, and
p.(None):
p.(None): III. Do not incur expenses to the patient.
p.(None):
p.(None): ARTICLE 71 .- In the emergency treatment in conditions that threaten the life of a person, when it is considered necessary to use investigational drugs or a known medication using indications, doses and routes of administration different from those established, the doctor must obtain the opinion favorable of the Commission of Investigation of the institution of attention to the health and the letter of informed consent of the subject of the subject of investigation or, in his case, of his legal representative, according to allow the circumstances, according to the following bases:
p.(None):
p.(None): I. The Research and Ethics Commissions will be informed of the use of the research drug in advance if the investigator can foresee the need for its use in urgent situations. In retrospect, if the use of the drug, the indication, doses or new routes of administration arise as unforeseen needs. In both cases the commissions will issue the opinion in favor or against approving the planned use or the repetition of the unforeseen use of the medicine and the head of the health care institution, the physician will be responsible for requiring the Secretariat to authorize such uses, and
p.(None):
...

p.(None):
p.(None): CHAPTER III
p.(None):
p.(None): Research with radioactive isotopes and devices and generators of ionizing and electromagnetic radiation
p.(None):
p.(None): ARTICULO 89.- Las investigaciones que impliquen el uso en seres humanos para fines médicos de isótopos radiactivos y dispositivos generadores de radiaciones ionizantes y electromagnéticas de radiaciones ionizantes y electromagnéticas deberán realizarse de conformidad con las leyes, reglamentos y normas sobre seguridad radiológica, así como las disposiciones que emita la Secretaría, y en los ámbitos respectivos de su competencia, las Secretarías de Energía, Minas e Industria Paraestatal; Comunicaciones y Transportes; Trabajo y Previsión Social y Desarrollo Urbano y Ecología.
p.(None):
p.(None): ARTICLE 90.- In the health institutions where these investigations are carried out, the Biosafety Commission shall ensure that for each study the person responsible for radiological and physical safety is identified before the National Nuclear Safety and Safeguards Commission, for compliance with the requirements and obligations as responsible for radiological safety.
p.(None):
p.(None): ARTICLE 91 .- The responsible person referred to in the previous article must:
p.(None):
p.(None): I. Define, implement and monitor compliance with radiological and physical safety measures;
p.(None):
p.(None): II. Prepare, in the terms of the Regulatory Law of Constitutional Article 27 on Nuclear Matters, a manual of procedures available to all personnel, which will describe the procedures for identification and control of radiation sources; permitted and restricted areas; registration and control of the dose equivalent of occupationally exposed personnel and the environment; training and medical examinations to the occupational exposed personnel; emergency plan in cases of accidents that contaminate personnel or the environment, among others, and
p.(None):
p.(None): III. Train staff on work procedures and the characteristics of the laboratory and equipment.
p.(None):
p.(None): ARTICLE 92.- All personnel directly or indirectly involved in this type of research must be adequately informed, by the person responsible for the radiological and physical safety, of the health risks represented by the radiation doses to which they are exposed and should know the basic principles of radiology protection, such as: Shielding, exposure time, distance and control of pollution and radioactive waste, among others, in order to ensure an accurate knowledge of radiation protection measures, such as: Shielding , exposure time, distance and control of pollution and radioactive waste, among others,in order to ensure an accurate knowledge of the radiological protection measures that ensure the biosecurity of the procedures used in the investigation, with the participation that corresponds to the Ministry of Energy, Mines and Parastatal Industry.
p.(None):
p.(None): ARTICLE 93 .- In these investigations, the occupational exposed personnel must be over 18 years. When such a person is a woman of childbearing age, the exposures should be distributed as evenly as possible in time, in order to protect, if necessary, the embryo during the organogenesis period, before the pregnancy diagnosis is made.
p.(None):
...

General/Other / Relationship to Authority

Searching for indicator authority:

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p.(None):
p.(None): ARTICLE 25.- When it is necessary to determine the mental capacity of an individual to grant his consent, the principal investigator must evaluate his capacity for understanding, reasoning and logic, according to the parameters approved by the Ethics Commission.
p.(None):
p.(None): ARTICLE 26 .- When it is presumed that the mental capacity of a subject has varied over time, the informed consent of the subject or, where appropriate, of his legal representative, must be endorsed by a group of professionals of recognized scientific and moral capacity in the specific fields of the investigation as well as of an observer who has no relation to the investigation, to ensure the suitability of the mechanism for obtaining consent, as well as its validity during the course of the investigation.
p.(None):
p.(None): ARTICLE 27 .- When a psychiatric patient is admitted to an institution for being subject to interdiction, in addition to complying with the provisions of the preceding articles, it will be necessary to obtain prior approval from the authority that knows the case.
p.(None):
p.(None): CHAPTER II
p.(None):
p.(None): On Community Research
p.(None):
p.(None): ARTICLE 28. - The investigations referred to the human health in communities will be admissible when the expected benefit for this one is reasonably assured and when the studies carried out in small scale have not produced conclusive results.
p.(None):
p.(None): ARTICLE 29. - In the investigations in communities, the principal investigator must obtain the approval of the health authorities and other civil authorities of the community to study, in addition to obtaining the letter of informed consent of the individuals included in the study, informing them of the information referred to in articles 21 and 22 of this Regulation.
p.(None):
p.(None): ARTICLE 30 .- When the individuals that make up a community do not have the capacity to understand the implications of participating in an investigation, the Ethics Commission of the institution to which the principal investigator belongs may or may not authorize the written informed consent form. The subjects are obtained through a reliable person with moral authority over the community. If the Commission is not authorized, the investigation will not be carried out. On the other hand, the participation of individuals will be entirely voluntary and each one will be free to abstain or stop participating at any time during the study.
p.(None):
p.(None): 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 to the attributions that correspond to other dependencies of the Federal Executive, and have complied, where appropriate. , with toxicity studies, according to the characteristics of the products and the risk they imply for human health.
p.(None):
p.(None): ARTICLE 32 .- In all research in communities, the experimental design must offer practical measures of protection for individuals and ensure that valid results will be obtained, involving the minimum number of subjects that are representative.
p.(None):
p.(None): Areas 3.- In any community investigation, the ethical considerations applicable to research on individuals must be extrapolated to the communal context in the pertinent aspects.
p.(None):
p.(None): CHAPTER III
p.(None):
p.(None): On Research in Minors or Disabilities
p.(None):
p.(None): ARTICLE 34.- In addition to the general provisions of ethics that must be complied with in any investigation in human beings, that which is carried out in minors or incapacitated persons must satisfy what is established in this chapter, except in the case of emancipated persons over 16 years of age.
p.(None):
p.(None): ARTICLE 35 .- When it is intended to carry out investigations in minors, it must be ensured that similar studies have previously been carried out in persons of May age and immature animals, except when it comes to studying conditions that are typical of the neonatal stage or specific conditions of certain ages.
p.(None):
p.(None): ARTICLE 36.- In order to carry out investigations in minors or incapacitated persons, in any case, the written informed consent must be obtained from those who exercise parental authority or the legal representation of the minor or incapable person in question.
p.(None):
p.(None): When two persons exercise the parental rights of a minor, the consent of one of them will only be admissible if there is irrefutable or manifest impossibility of the other to provide it or in case of imminent risk to the health or life of the minor or incapable.
p.(None):
p.(None): ARTICLE 37 .- When the mental capacity and psychological state of the minor or incapable permit, it must also obtain their acceptance to be the subject of investigation, after explaining what they intend to do. The Ethics Commission may waive compliance with these requirements for justified reasons.
p.(None):
p.(None): ARTICLE 38. - The investigations classified as of risk and with probability of direct benefit for the minor or the incapable one, will be admissible when;
p.(None):
p.(None): I.- The risk is justified by the importance of the benefit that the minor or the disabled will receive, and
p.(None):
...

p.(None):
p.(None): ARTICLE 47 .- Research in pregnant women, with therapeutic benefit related to pregnancy, will be allowed when:
p.(None):
p.(None): I. Aim to improve the health of the pregnant woman with a minimal risk to the embryo or fetus, or
p.(None):
p.(None): II.- Are aimed at increasing the viability of the fetus, with a minimal risk to the pregnant woman.
p.(None):
p.(None): ARTICLE 48 .- During the execution of investigations in pregnant women:
p.(None):
p.(None): I. Investigators will not have the authority to decide on the time, method or procedure used to terminate the pregnancy, nor will they participate in decisions on the viability of the fetus;
p.(None):
p.(None): II. Only with the authorization of the Ethics Commission can the method to terminate the pregnancy be modified for research purposes, when such modifications represent a minimal risk to the mother's health and do not represent any risk for the survival of the fetus, and
p.(None):
p.(None): III. In any case, it is strictly forbidden to grant monetary or other stimuli to terminate the pregnancy, for the interest of the investigation or for other reasons.
p.(None):
p.(None): ARTICLE 49 .- The informed consent letter for investigations during labor, must be obtained in accordance with the provisions of articles 21, 22, and 43 of these Regulations, before it is initiated and duly expressly state that the consent It can be withdrawn at any time during labor.
p.(None):
p.(None): ARTICLE 50.- Investigations in women in the puerperium will be allowed when they do not interfere with the health of the mother and the newborn.
p.(None):
...

p.(None):
p.(None): ARTICLE 54 .- Live births may be subject to investigation if the provisions on investigation in minors, indicated in these Regulations are complied with.
p.(None):
p.(None): ARTICLE 55.- Investigations with embryos, deaths, fetuses, dead births, macerated fetal matter, cells, tissues and organs extracted from them will be carried out in accordance with the provisions of Title Fourteenth of the Law and these Regulations.
p.(None):
p.(None): ARTICLE 56.- The investigation on assisted fertilization will only be admissible when it is applied to the solution of sterility problems that cannot be solved in any other way, respecting the moral, cultural and social point of view of the couple, even if it differs with the researcher
p.(None):
p.(None): CHAPTER V
p.(None):
p.(None): On Subordinate Group Research
p.(None):
p.(None): ARTICLE 57. - Subordinate groups are understood as the following: students, laboratory and hospital workers, employees, members of the armed forces, inmates in prisons or social rehabilitation centers and other special groups of the population, in which Informed consent may be influenced by some authority.
p.(None):
p.(None): ARTICLE 58 .- When conducting research in subordinate groups, one or more members of the population under study must participate in the Ethics Commission, capable of representing the moral, cultural and social values of the group in question and monitor:
p.(None):
p.(None): I. That the participation, the rejection of the subjects to intervene or withdrawal of their consent during the study, does not affect their school, work, military situation or that related to the judicial process to which they were subject and the conditions of compliance with sentence, in your case:
p.(None):
p.(None): II.- That the results of the investigation are not used to the detriment of the participating individuals, and
p.(None):
p.(None): III.- That the health care institution and, the sponsors are responsible for the medical treatment of the damages caused and, where appropriate, for the compensation that legally corresponds for the harmful consequences of the investigation.
p.(None):
p.(None): CHAPTER VI
p.(None):
p.(None): Of Research in Organs, Tissues and their Derivatives, Products and Corpse of Human Beings.
p.(None):
p.(None): ARTICLE 59.- The investigation referred to in this Chapter includes that which includes the use of organs, tissues and their derivatives, products and bodies of human beings, as well as the set of activities related to their obtaining, conservation, use, preparation, Supply and final destination.
p.(None):
...

p.(None):
p.(None): ARTICLE 105 .- To constitute the Biosafety Commission, scientists with extensive experience or knowledge in this field, whether or not members of the health institution staff, shall be included to ensure that research activities are carried out under appropriate biosafety measures.
p.(None):
p.(None): ARTICLE 106 .- To establish the Research Commission, preference will be given to members of the health institution with knowledge and experience in scientific methodology.
p.(None):
p.(None): ARTICLE 107 .- When within the institution it is not possible to gather the right people to establish the commissions, the respective holder may request the support and advice of the commissions constituted at the immediate superior level of his or her own dependency or outside of it, on condition that the aforementioned requirements are met.
p.(None):
p.(None): ARTICLE 108 .- The members of the commissions will remain in office for a period of three years, being able to be ratified for an equal period and will be relieved of their functions during the evaluation and opinion of their own investigations. The operation of each commission will be subject to the technical norms that the Secretariat dictates for this purpose, as well as to the internal regulations formulated by the commission itself and approved by the corresponding authority in the institution.
p.(None):
p.(None): ARTICLE 109 .- It is the responsibility of the Ethics Commission to issue the technical opinion on the ethical aspects of the proposed investigations, by reviewing the risks, benefits and the letter of consent in the protocols and their competent authorities, to guarantee the well-being and Rights of research subjects.
p.(None):
p.(None): ARTICLE 110.- It is the responsibility of the Biosafety Commission to issue the technical opinion of the biosafety aspects of the proposed investigations, by reviewing the facilities, in order to guarantee the protection of the biological physical integrity of the occupational personnel exposed, as well as of research subjects, the community and the environment.
p.(None):
p.(None): ARTICLE 111.- It is the responsibility of the Research Commission to evaluate the technical quality and scientific merit of the proposed research, formulating the corresponding opinion, and issue the opinion of the Ethics and Biosafety Commissions.
p.(None):
p.(None): ARTICLE 112. - The commissions and the authorities to which they report will maintain confidentiality about the reports they receive from the researchers, mainly if the investigations are related to the development of inputs, technology and other application processes susceptible to patents or commercial development.
p.(None):
p.(None): SIXTH TITLE
p.(None):
p.(None): On the Execution of Research in Healthcare Institutions
p.(None):
p.(None): ONLY CHAPTER
...

p.(None):
p.(None): SAW. The destruction or control of insects and other transmitting and harmful fauna, insofar as it refers to human health,
p.(None):
p.(None): VII. The suspension of work or services;
p.(None):
p.(None): VIII. The assurance and destruction of objects, products or substances;
p.(None):
p.(None): IX. Unemployment or eviction of houses, buildings, establishments and, in general, of any property;
p.(None):
p.(None): X. The prohibition of acts of use, and
p.(None):
p.(None): XI The others of competent sanitary nature, that can avoid that they are caused or continue causing risks or damages to the health.
p.(None):
p.(None): NINTH TITLE
p.(None):
p.(None): Monitoring and Observance
p.(None):
p.(None): ONLY CHAPTER
p.(None):
p.(None): ARTICLE 129. -It corresponds to the sanitary authorities, within the scope of their respective competences, the follow-up and observance of these Regulations and other applicable provisions, in accordance with the provisions of the Seventh Title of the Law.
p.(None):
p.(None): ARTICLE 130 .- Who conducts health research that includes the use of human beings, as well as the use of pathogenic microorganisms or biological material that contains them, construction and management of recombinant nucleic acids, radioactive isotopes and devices generating ionizing and electromagnetic radiation , in contravention of the provisions of the Law and these Regulations, will be entitled to the sanctions that the Law indicates in this regard, to the detriment of those established in the Regulatory Law of Constitutional Article 27 on Nuclear Matters and of the penalties that could be incurred when they constitute crimes.
p.(None):
p.(None): ARTICLE 131 .- The competent authority may revoke the sanitary authorizations that it has granted to carry out health investigations, when they comply with the provisions contained in the Law, these Regulations and other provisions derived therefrom. For the Substantiation of the procedure for the revocation of authorizations, the provisions of Chapter II of the Sixteenth Title of the Law shall be observed.
p.(None):
p.(None): ARTICLE 152 .- Against acts and resolutions of the health authorities that, on the occasion of the application of this Regulation, terminate an instance or resolve a file, the interested parties may file a complaint of disagreement, which will be substantiated in the terms of the law.
p.(None):
p.(None): TRANSITORY
p.(None):
p.(None): FIRST .- This Regulation shall enter into force on the day of its publication in the Official Gazette of the Federation .
p.(None):
p.(None): SECOND .- The Agreement for the creation of the Commissions of Research and Ethics, of December twenty-three thousand nine hundred and eighty-one, published in the Official Gazette of the Federation on January twenty-sixteen nineteen eighty-two, and the Decree of the Biosafety Commissions, dated July 8, nineteen eighty-two, published in the Official Gazette of the Federation on August 4 of the same year. Likewise, other provisions on the matter that oppose this ordinance are repealed.
p.(None):
...

Orphaned Trigger Words

p.(None):
p.(None): ARTICLE 19 .- It is the responsibility of the health care institution to provide medical care to the subject that suffers any damage, if it is directly related to the investigation, without prejudice to the compensation that legally corresponds.
p.(None):
p.(None): ARTICLE 20 .- Informed consent means the written agreement, whereby the subject of investigation or, where appropriate, his legal representative authorizes his participation in the investigation, with full knowledge of the nature of the procedures and risks to the that will be submitted, with the capacity of free choice and without any coercion.
p.(None):
p.(None): ARTICLE 21 .- For the informed consent to be considered existing, the research subject or, where appropriate, his legal representatives must receive a full and clear explanation, so that he can understand it, at least, on the following aspects:
p.(None):
p.(None): I. The justification and objectives of the investigation;
p.(None):
p.(None): II. The procedures to be used and their purpose, including the identification of the procedures that are experimental;
p.(None):
p.(None): III. The inconvenience or expected risks;
p.(None):
p.(None): IV. The benefits that can be observed;
p.(None):
p.(None): V. Alternative procedures that may be advantageous for the subject;
p.(None):
p.(None): SAW. The guarantee of receiving an answer to any question and clarification of any doubt about the procedures, risks, benefits and other matters related to the investigation and treatment of the subject;
p.(None):
p.(None): VII. The freedom to withdraw your consent at any time and stop participating in the study, without creating prejudices to continue your care and treatment;
p.(None):
p.(None): VIII. The assurance that the subject will not be identified and that the confidentiality of information related to their privacy will be maintained;
p.(None):
p.(None): IX. The commitment to provide updated information obtained during the study although this could affect the subject's willingness to continue participating;
p.(None):
p.(None): X. The availability of medical treatment and the compensation that would legally be entitled, by the health care institution, in the case of damages that warrant it, directly caused by the investigation, and
p.(None):
p.(None): XI That if there are additional expenses, these will be absorbed by the research budget.
p.(None):
p.(None): ARTICLE 22 .- The informed consent must be formulated in writing and must be formulated in writing and must meet the following requirements:
p.(None):
p.(None): I. It will be prepared by the principal investigator, indicating the information indicated in the previous article and in accordance with the technical norm issued by the Secretariat;
p.(None):
p.(None): II.- It will be reviewed and, where appropriate, approved by the Ethics Commission of the health care institution;
p.(None):
p.(None): III.- Indicate the names and addresses of two witnesses and their relationship with the subject of investigation;
p.(None):
p.(None): IV. It must be signed by two witnesses and by the investigative subject or his legal representative, if applicable. If the investigation subject does not know how to sign, he will print his fingerprint and in his name he will sign another person he designates, and
p.(None): ...

p.(None):
p.(None): III. Management and maintenance of sunstroke and equipment;
p.(None):
p.(None): IV. Urgent situations;
p.(None):
p.(None): V. Entry and transit restrictions;
p.(None):
p.(None): SAW. Reception of transport of biological materials;
p.(None):
p.(None): VII. Waste provisions;
p.(None):
p.(None): VIII. Decontamination, and
p.(None):
p.(None): IX. The others considered necessary to achieve microbiological safety.
p.(None):
p.(None): ARTICLE 78.- The principal investigator, according to a superior, the Biosafety Commission and the head of the institution, will determine, in accordance with the technical standards issued by the Secretariat, the type of laboratory in which the proposed investigations must be carried out. , as well as the respective procedures, taking into account the degree of risk of infection presented by the microorganisms to be used.
p.(None):
p.(None): ARTICLE 79 .- To assess the degree of infection risk referred to in the previous article, the Secretariat will issue the corresponding technical standard and classify microorganisms into four Groups, according to the following criteria:
p.(None):
p.(None): Risk Group I:
p.(None):
p.(None): Microorganisms that represent little risk for the individual and the community;
p.(None):
p.(None): Risk Group II;
p.(None):
p.(None): Microorganisms that represent moderate risk for the individual and limited for the community;
p.(None):
p.(None): Risk Group III;
p.(None):
p.(None): Microorganisms that represent high risk for the individual and low for the community, and
p.(None):
p.(None): Risk Group IV;
p.(None):
p.(None): Microorganisms that represent high risk for the individual and for the community.
p.(None):
p.(None): ARTICLE 80 .- Microorganisms that are classified in risk groups I and II must be handled in basic microbiology laboratories, using safety cabinets when deemed necessary.
p.(None):
p.(None): ARTICLE 81 .- Microorganisms that are classified in risk group III must be handled in microbiological safety laboratories.
p.(None):
p.(None): ARTICLE 82 .- The microorganisms that are classified in the risk group IV must be handled in laboratories of maximum microbiology safety, under the authorization and control of the corresponding health authorities referred to in article 4. of the law.
p.(None):
p.(None): ARTICLE 83 .- During the development of the investigations referred to in this Chapter, the principal investigator shall be responsible:
p.(None):
p.(None): I. Determine the real and potential risks of the proposed research and, if approved by the health institution commissions, make them known to the associated researchers and other personnel who will participate in the research;
p.(None):
p.(None): II. Determine the appropriate level of physical containment, select the appropriate microbiological practices and design procedures to deal with possible accidents during the investigation and instruct the participating staff on these aspects;
p.(None):
p.(None): III. Ensure that participating personnel comply with the requirements of medical prophylaxis, vaccinations or serological tests;
p.(None):
p.(None): IV. Supervise that the transport of infectious materials is done in an appropriate manner, in accordance with the technical standards issued by the Secretariat; ...

p.(None):
p.(None): CHAPTER II
p.(None):
p.(None): From Research that involves construction and management of recombinant nucleic acids
p.(None):
p.(None): ARTICLE 85.- For the purposes of this Regulation, recombinant nucleic acids shall be understood as the new combinations of genetic material obtained outside a current cell, through the insertion of natural or synthetic segments of deoxyribonucleic acid in a virus, bacterial plasmid or other deoxibonucleic acid molecules, which serve as a vector system, to allow their incorporation into a host cell, in which they are not found naturally, but in which they will be able to replicate. Also included are deoxyribonucleic acid molecules that result from such replication.
p.(None):
p.(None): ARTICLE 86.- Investigations with recombined nucleic acids shall be designed in such a way that the maximum level of biological containment is achieved, selecting suitable host and vector systems that decrease 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.
p.(None):
p.(None): ARTICLE 87.- The principal investigator, in agreement with his superior, with the Biosafety Commission and with the head of the health institution, will determine, according to the technical standards issued by the Secretariat, the type of microbiology laboratory in the one that will carry out the experiments referred to in this Chapter, taking into account the origin of the genetic material that is intended to be replicated.
p.(None):
p.(None): ARTICLE 88.- The authorization of the Secretariat is required to initiate the following types of experimentation:
p.(None):
p.(None): I. Formation of recombinant deoxyribonucleic acid derived from pathogenic microorganisms that are classified in risk groups III and IV referred to in Article 79 of this Regulation, as well as the formation of recombinant genetic material derived from cells that are infected by such agents, regardless of the host and vector system used,
p.(None):
p.(None): II. Intentional construction of recombinant nucleic acids to induce the biosynthesis of potent toxins for vertebrates;
p.(None):
p.(None): III. International release into the environment of any microorganism that carries recombinant nucleic acids;
p.(None):
p.(None): IV. Transfer of antibiotic resistance to microorganisms that do not acquire it in nature, if such a transfer could adversely affect the use of the antibiotic in human medicine, and
p.(None):
p.(None): V. Experiments with microorganisms with recombinant nucleic acids in cultures larger than 10 liters, because their physical and biological containment is more difficult, unless the recombined molecules have been rigorously characterized and the absence of dangerous genes in them is demonstrated. Those industrial and agricultural processes not directly and specifically related to the activities established in Article 3 are excluded. of this Regulation.
p.(None):
p.(None): CHAPTER III
p.(None):
p.(None): Research with radioactive isotopes and devices and generators of ionizing and electromagnetic radiation
p.(None):
p.(None): ARTICULO 89.- Las investigaciones que impliquen el uso en seres humanos para fines médicos de isótopos radiactivos y dispositivos generadores de radiaciones ionizantes y electromagnéticas de radiaciones ionizantes y electromagnéticas deberán realizarse de conformidad con las leyes, reglamentos y normas sobre seguridad radiológica, así como las disposiciones que emita la Secretaría, y en los ámbitos respectivos de su competencia, las Secretarías de Energía, Minas e Industria Paraestatal; Comunicaciones y Transportes; Trabajo y Previsión Social y Desarrollo Urbano y Ecología.
p.(None): ...

Appendix

Indicator List

Indicator	Vulnerability
access	Access to Social Goods
age	Age
armed forces	Soldier
authority	Relationship to Authority
autonomy	Impaired Autonomy
breastfeeding	breastfeeding
child	Child
childbearing age	of childbearing age/fertile
children	Child
dependence	Drug Dependence
dependency	Drug Dependence
disabled	Mentally Disabled
drug	Drug Usage
education	education
educational	education
embryo	embryo
emergencies	patients in emergency situations
emergency	Public Emergency
employees	employees
fertile	of childbearing age/fertile
fetus	Fetus/Neonate
fetuses	Fetus/Neonate
hospitalized	hospitalized patients
illness	Physically Disabled
incapable	Mentally Incapacitated
incapacitated	Incapacitated
incapacity	Incapacitated
infant	Infant
military	Soldier
minor	Youth/Minors
neonates	Fetus/Neonate
opinion	philosophical differences/differences of opinion
political	political affiliation
pregnant	Pregnant
property	Property Ownership
restricted	Incarcerated
sick	Physically Ill
single	Marital Status
unemployment	Unemployment
women	Women

Indicator Peers (Indicators in Same Vulnerability)

Indicator	Peers
armed forces	['military']
child	['children']
childbearing age	['fertile']
children	['child']
dependence	['dependency']
dependency	['dependence']
education	['educational']
educational	['education']
fertile	['childbearingXage']
fetus	['fetuses', 'neonates']
fetuses	['fetus', 'neonates']
incapacitated	['incapacity']
incapacity	['incapacitated']
military	['armedXforces']
neonates	['fetus', 'fetuses']

Trigger Words

capacity

coercion

consent

cultural

ethics

protect

protection

risk

sensitive

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability Type	Vulnerability	Indicator	# Matches
Political	political affiliation	political	2
Health	Drug Dependence	dependence	1
Health	Drug Dependence	dependency	2
Health	Drug Usage	drug	10
Health	Mentally Disabled	disabled	2
Health	Mentally Incapacitated	incapable	8
Health	Physically Disabled	illness	2
Health	Physically Ill	sick	1
Health	Pregnant	pregnant	15
Health	breastfeeding	breastfeeding	3
Health	hospitalized patients	hospitalized	2
Health	of childbearing age/fertile	childbearing age	3
Health	of childbearing age/fertile	fertile	1
Health	patients in emergency situations	emergencies	1
Social	Access to Social Goods	access	1
Social	Age	age	3
Social	Child	child	1
Social	Child	children	1
Social	Fetus/Neonate	fetus	14
Social	Fetus/Neonate	fetuses	3
Social	Fetus/Neonate	neonates	1
Social	Incarcerated	restricted	1
Social	Infant	infant	1
Social	Marital Status	single	2
Social	Property Ownership	property	1
Social	Soldier	armed forces	1
Social	Soldier	military	1
Social	Unemployment	unemployment	1
Social	Women	women	18
Social	Youth/Minors	minor	9
Social	education	education	6
Social	education	educational	4
Social	embryo	embryo	7
Social	employees	employees	2
Social	philosophical differences/differences of opinion	opinion	10
General/Other	Impaired Autonomy	autonomy	1
General/Other	Incapacitated	incapacitated	2
General/Other	Incapacitated	incapacity	1
General/Other	Public Emergency	emergency	2
General/Other	Relationship to Authority	authority	7

Regulation on the General Health Law in the Matter of Health Research

Applicable Type / Vulnerability / Indicator Overlay for this Input

Political / political affiliation

Health / Drug Dependence

Health / Drug Usage

Health / Mentally Disabled

Health / Mentally Incapacitated

Health / Physically Disabled

Health / Physically Ill

Health / Pregnant

Health / breastfeeding

Health / hospitalized patients

Health / of childbearing age/fertile

Health / patients in emergency situations

Social / Access to Social Goods

Social / Age

Social / Child

Social / Fetus/Neonate

Social / Incarcerated

Social / Infant

Social / Marital Status

Social / Property Ownership

Social / Soldier

Social / Unemployment

Social / Women

Social / Youth/Minors

Social / education

Social / embryo

Social / employees

Social / philosophical differences/differences of opinion

General/Other / Impaired Autonomy

General/Other / Incapacitated

General/Other / Public Emergency

General/Other / Relationship to Authority

Orphaned Trigger Words

Appendix

Indicator List

Indicator Peers (Indicators in Same Vulnerability)

Trigger Words

Applicable Type / Vulnerability / Indicator Overlay for this Input