79C3C34C52B45572883A05D425EB0F82
Establishing Criteria for the Conduct of Health Research Projects
https://dof.gob.mx/nota_detalle.php?codigo=5284148&fecha=04/01/2013
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| 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
Political / Illegal Activity
Searching for indicator crime:
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p.000113: research, as well as for the analysis of the results; Y
p.000113: 7.4.1.6 The annexes that the investigator considers necessary for the sustenance of the technical-descriptive report or those required
p.000113: the institution or establishment where the investigation is carried out.
p.000113: 7.4.2 The principal investigator shall submit to the Secretariat a partial or final technical-descriptive report as appropriate,
p.000113: of the progress of the investigation and will have the responsibility of delivering a copy of each report to the head of the Committees
p.000113: of Research, Ethics in Research and, where appropriate, Biosafety, of the institution or establishment where the
p.000113: investigation.
p.000113: 7.4.3 The Secretariat has the power to request additional information or rethink the investigation, when
p.000113: consider that the information provided is insufficient, not clear or does not meet the requirements established by the Law
p.000113: General de Salud, the Regulation, this and other Mexican Official Norms, as well as the other legal systems
p.000113: applicable.
p.000113: 7.4.4 When the information contained in the technical-descriptive reports or the confirmation of the fact, it is possible to
p.000113: verify that the investigation has not been carried out in accordance with the initial research project or protocol, which served as the basis
p.000113: for the issuance of the original authorization, the health authority must establish an administrative procedure against the
p.000113: principal investigator and, where appropriate, may revoke said authorization and suspend the investigation, without prejudice to the sanctions
p.000113: that correspond to the facts possibly constituting a crime.
p.000113: 7.4.5 In the event that the research is sponsored by any public or private body, it must be ensured that it does not
p.000113: will generate conflicts of interest that may cause the interruption of the treatment for the research subject, for which
p.000113: a detailed explanation of the resources available and the form must be attached to the research project or protocol
p.000113: in which they will be provided and distributed.
p.000113: 8. Of the institutions or establishments where an investigation is carried out
p.000113: 8.1 All research in human beings must be carried out in an institution or establishment, which must have the
p.000113: infrastructure and sufficient resolution capacity to provide adequate medical care or, where appropriate, through
p.000113: third parties, in the presence of any adverse effect of the experimental maneuver expressed in the project or protocol of
p.000113: Authorized investigation
p.000113: 8.2 The head of the institution or establishment and the corresponding Health Research Committees,
p.000113: they must act impartially and objectively, with strict adherence to ethical and scientific principles, in all matters that are
p.000113: detach from the investigation that is being carried out in their facilities, especially when it comes to attending the
p.000113: Complaints made by research subjects, by themselves or through their legal representatives.
p.000113: 8.3 Authorizations or consent regarding research projects or protocols issued by the owner of the
p.000113: institution or establishment or their respective Committees, must be prepared and signed separately.
p.000113: 8.4 Every institution or establishment in whose facilities an investigation is conducted, you must supervise and ensure that
...
Political / political affiliation
Searching for indicator party:
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p.000113: she in her facilities;
p.000113: 6.3.2.7 If applicable, letter of express acceptance of the position of the research sponsor, in which it is required to be
p.000113: The obligations and rights that the research project or protocol imposes on the sponsor are indicated and accepted. In the
p.000113: In the case of legal persons, the position must be accepted by the person empowered to do so or by their legal representative, of
p.000113: according to its organic structure or constitutive regime;
p.000113: 6.3.2.8 Favorable opinion of the Research and Ethics Committees in Research of the institution or establishment in
p.000113: The investigation will be carried out. In case the use of ionizing radiation or engineering techniques is included
p.000113: genetic, the favorable opinion of the Biosafety Committee will also be necessary;
p.000113: 6.3.2.9 Generic description of the resources available for the management of medical emergencies, according to the type
p.000113: of research study that develops. Medical care must be provided with own resources or through third parties,
p.000113: this fact must be recorded in the content of the generic description referred to in this numeral; Y
p.000113: 6.3.2.10 Model informed consent letter on research.
p.000113: 6.3.2.11 Where appropriate, interested parties may submit with their application for authorization of the project or protocol of
p.000113: investigation, opinion issued by a third party authorized for this purpose by the Ministry of Health, under the terms of article 102
p.000113: of the General Health Law.
p.000113: 6.4 The authorization of a research for human health does not authorize the commercialization of
p.000113: medications, procedures or resulting devices, even when the conclusion of the investigation has been made official,
p.000113: by delivery and acknowledgment of receipt of the final report.
p.000113: 7. The follow-up of the investigation and the technical-descriptive reports
p.000113: 7.1 Follow-up tasks are considered: the preparation and delivery to the Secretariat of a technical-descriptive report of
p.000113: partial, with respect to the progress of the investigation in question and at the end of the investigation, one of a final nature, which describes
p.000113: The results obtained.
p.000113: 7.1.1 When results are obtained with technological applications, the area in which the contributions will be provided must be indicated
p.000113: knowledge gained, among which the following stand out: the methodological, technical, clinical procedures area,
p.000113: epidemiological, new medications or improvement of existing ones, biological products for use in humans, medical equipment,
p.000113: prostheses, orthotics and functional aids, healing material, surgical and hygienic products, diagnostic agents or others.
p.000113: 7.2 The head of the institution or establishment, the Research Committees, Research Ethics or Biosafety, the
p.000113: Principal investigator and, where appropriate, the sponsor, will be responsible in accordance with their field of competence in matters of:
p.000113: a) Research follow-up;
p.000113: b) Health damage arising from the development of research; as well as those damages derived from the interruption or
...
p.000113: Authorized investigation
p.000113: 8.2 The head of the institution or establishment and the corresponding Health Research Committees,
p.000113: they must act impartially and objectively, with strict adherence to ethical and scientific principles, in all matters that are
p.000113: detach from the investigation that is being carried out in their facilities, especially when it comes to attending the
p.000113: Complaints made by research subjects, by themselves or through their legal representatives.
p.000113: 8.3 Authorizations or consent regarding research projects or protocols issued by the owner of the
p.000113: institution or establishment or their respective Committees, must be prepared and signed separately.
p.000113: 8.4 Every institution or establishment in whose facilities an investigation is conducted, you must supervise and ensure that
p.000113: its development is in charge of health professionals, with adherence to the scientific and ethical principles that guide the practice
p.000113: medical and that research subjects are not exposed to damage or unnecessary risks or greater than the benefits
p.000113: expected
p.000113: 8.5 Health care cannot be conditioned on a person in exchange for giving consent
p.000113: to participate or continue participating in an investigation.
p.000113: 8.6 Every institution or establishment, in which an investigation is carried out or intended to be carried out, must have a
p.000113: service for medical emergency care. In your case, you must have an agreement signed with an establishment
p.000113: for medical care with greater resolution capacity, which, as a third party, provides such emergency care.
p.000113: 8.7 The head of the institution or establishment must notify the Secretariat of any adverse effects arising from the
p.000113: experimental maneuver, within a maximum period of 15 working days from its presentation, which includes the measures of
p.000113: care taken, the sequelae identified, as well as a detailed report on the physical condition of the patient, in which
p.000113: Mention if you are free from all risks until the time of notification.
p.000113: 8.8 The head of the institution or establishment, the Research Committees, Research Ethics, Biosecurity or the
p.000113: principal investigator, must order the immediate suspension or cancellation of the investigation, in the presence of any
p.000113: severe adverse effect, which constitutes an ethical or technical impediment to continue the study, about which, you must
p.000113: Notify the Secretariat, in detail, with the opportunity indicated in paragraph 8.7. In that case, the resumption of the
p.000113: Research will require a new authorization.
p.000113: 8.9 The principal investigator must inform the Committee of Ethics in the Investigation of any probable adverse effects or
p.000113: directly related to the investigation. Likewise, it must inform said Committee as frequently as it
p.000113: establish, on the absence of adverse effects on research projects or protocols that are under its
p.000113: responsibility.
p.000113: 8.10 Serious or lethal adverse reactions or effects should be reported immediately to the Secretariat. In the cases
p.000113: If there is a suspicion of adverse effects due to medications, the Mexican Official Standard, referred to in the
p.000113: Section 3.2 of this standard.
...
Health / Drug Dependence
Searching for indicator dependence:
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p.000113: administrative that will participate in the investigation, so it will be jointly responsible for the proceeding and their expertise in relation
p.000113: with the investigation, so you must have broad powers to, where appropriate, request the head of the institution or
p.000113: establishment, which suspends the participation of any of them.
p.000113: 10.4.1 For each principal or associate researcher, specify if they are attached to the institution or establishment, position or
p.000113: function, hours / week that you will dedicate to the research project or protocol, maximum academic degree, place and institution in
p.000113: that was obtained (national or foreign) as well as discipline; if applicable, category in the National System of Researchers
p.000113: (national researcher or candidate).
p.000113: 10.5 The investigator is responsible for suspending the investigation, in accordance with the provisions of section VI of the
p.000113: Article 100 of the General Health Law.
p.000113: 10.6 In formulating the informed consent letter regarding research, the investigator must ensure that
p.000113: it complies with the requirements and assumptions indicated in the Regulation, taking care that the gratuity is made explicit for
p.000113: the subject of investigation, the compensation to which he will be entitled in case of suffering damage to his health directly attributable to the
p.000113: research and the availability of free medical treatment for it, even if you decide to withdraw from it
p.000113: investigation, before it concludes.
p.000113: 10.7 The investigator must refrain from personally obtaining the informed consent of those subjects of
p.000113: research that are linked to it by some kind of dependence, ancestry or subordination.
p.000113: 10.8 It is the responsibility of the principal investigator to inform the research subject, family member, guardian or legal representative,
p.000113: during the development of the research, about the implications of each experimental maneuver and the characteristics of
p.000113: your condition Likewise, you must inform the appropriateness of taking a therapeutic option appropriate to your case.
p.000113: Its particular characteristics.
p.000113: 10.9 The researcher must inform the Committee of Ethics in the Investigation of any adverse effects likely or directly
p.000113: Research related.
p.000113: 10.10 The principal investigator must prepare and submit to the Secretariat the technical, descriptive, partial or final reports
p.000113: corresponding, referred to in paragraph 7.4.1, of this standard.
p.000113: 11. The physical and legal security of the subject of investigation
p.000113: 11.1 The safety of the research subject regarding the development of the experimental maneuver, responsibility of the
p.000113: institution or establishment, of the principal investigator and of the sponsor, in the terms of numeral 7.2, of this norm.
p.000113: 11.2 The research subject, his family, guardian or legal representative, have the right to withdraw, at any time, their
p.000113: consent to stop participating in the investigation in question, at the time requested. When this
p.000113: happen, the principal investigator must ensure that the research subject continues to receive care and treatment without
p.000113: any cost, until it is certain that there was no damage directly related to the investigation.
...
Health / Mentally Disabled
Searching for indicator disabled:
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p.000113: Health, research for human health and the institution or establishment where research is conducted for
p.000113: health, respectively.
p.000113: 5.2 Any research project or protocol for the use of medicines or materials, for which they have not yet
p.000113: there is sufficient scientific evidence of their therapeutic or rehabilitative efficacy or the modification of the
p.000113: therapeutic indications of already known products, you must have authorization from the Secretariat before starting your
p.000113: development
p.000113: 5.3 The Secretariat, for the granting of the authorization of an investigation for health in human beings according to the
p.000113: objective and field of application of this standard, you must confirm that in the research oprotocol project, the
p.000113: criteria of respect for the dignity of the research subject, the protection of their rights, mainly that of the protection of
p.000113: health, as well as the well-being and conservation of their physical integrity.
p.000113: 5.4 It is the power of the Secretariat, within the scope of its competence, and in accordance with the applicable legal provisions,
p.000113: monitoring and control of research projects or protocols authorized according to the objective and scope of application of
p.000113: This standard, which must conform to the scientific and ethical principles that guide medical practice.
p.000113: 5.5 All research must ensure that it does not expose the research subject to unnecessary risks and that the benefits
p.000113: Expected are greater than the predictable risks inherent in the experimental maneuver.
p.000113: In the case of investigations in minors or disabled persons, the provisions of articles 38 and 39 of the
p.000113: Regulation. In pregnant women, what is specified in article 44 of the same system must be taken into account.
p.000113: 5.6 For the authorization of an investigation, according to the objective and field of application of this standard, the project or
p.000113: Research protocol should fully describe the elements and conditions that allow the Secretariat to evaluate the
p.000113: Safety assurance of the research subjects, where appropriate, may observe Good Clinical Research Practices.
p.000113: 5.7 All research must ensure in a clear, objective and explicit way, the free of the experimental maneuver for the
p.000113: research subject, which should be considered in the research budget, in accordance with the numeral
p.000113: 10.6, of this standard.
p.000113: 5.8 In any research project or protocol, its duration should be estimated, so it is necessary that the
p.000113: tentative start and end dates, as well as the period calculated for its development.
p.000113: 5.9 The conditions described in the research project or protocol, including the estimated start and end dates,
p.000113: as well as the necessary number of research subjects, will be considered indispensable requirements for the authorization of
p.000113: a research for health in humans.
p.000113: 5.10 The justification of the research projects or protocols presented with the request for authorization of a
p.000113: Human health research should include: sufficient information and technical elements to suppose that the
p.000113: knowledge that is intended to be acquired, it is not possible to obtain them by other means.
p.000113: 5.11 The principal investigator, as well as other health professionals and technicians involved in an investigation,
...
Health / Motherhood/Family
Searching for indicator family:
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p.000113: with the investigation, so you must have broad powers to, where appropriate, request the head of the institution or
p.000113: establishment, which suspends the participation of any of them.
p.000113: 10.4.1 For each principal or associate researcher, specify if they are attached to the institution or establishment, position or
p.000113: function, hours / week that you will dedicate to the research project or protocol, maximum academic degree, place and institution in
p.000113: that was obtained (national or foreign) as well as discipline; if applicable, category in the National System of Researchers
p.000113: (national researcher or candidate).
p.000113: 10.5 The investigator is responsible for suspending the investigation, in accordance with the provisions of section VI of the
p.000113: Article 100 of the General Health Law.
p.000113: 10.6 In formulating the informed consent letter regarding research, the investigator must ensure that
p.000113: it complies with the requirements and assumptions indicated in the Regulation, taking care that the gratuity is made explicit for
p.000113: the subject of investigation, the compensation to which he will be entitled in case of suffering damage to his health directly attributable to the
p.000113: research and the availability of free medical treatment for it, even if you decide to withdraw from it
p.000113: investigation, before it concludes.
p.000113: 10.7 The investigator must refrain from personally obtaining the informed consent of those subjects of
p.000113: research that are linked to it by some kind of dependence, ancestry or subordination.
p.000113: 10.8 It is the responsibility of the principal investigator to inform the research subject, family member, guardian or legal representative,
p.000113: during the development of the research, about the implications of each experimental maneuver and the characteristics of
p.000113: your condition Likewise, you must inform the appropriateness of taking a therapeutic option appropriate to your case.
p.000113: Its particular characteristics.
p.000113: 10.9 The researcher must inform the Committee of Ethics in the Investigation of any adverse effects likely or directly
p.000113: Research related.
p.000113: 10.10 The principal investigator must prepare and submit to the Secretariat the technical, descriptive, partial or final reports
p.000113: corresponding, referred to in paragraph 7.4.1, of this standard.
p.000113: 11. The physical and legal security of the subject of investigation
p.000113: 11.1 The safety of the research subject regarding the development of the experimental maneuver, responsibility of the
p.000113: institution or establishment, of the principal investigator and of the sponsor, in the terms of numeral 7.2, of this norm.
p.000113: 11.2 The research subject, his family, guardian or legal representative, have the right to withdraw, at any time, their
p.000113: consent to stop participating in the investigation in question, at the time requested. When this
p.000113: happen, the principal investigator must ensure that the research subject continues to receive care and treatment without
p.000113: any cost, until it is certain that there was no damage directly related to the investigation.
p.000113: 11.2.1 Where appropriate, the principal investigator may also withdraw the research subject so that he may participate in it,
p.000113: if you consider that during the development of said investigation, the risk is greater than the benefit and for that reason obliges your
p.000113: retirement.
p.000113: 11.2.2 To ensure the safety of the research subject, at the end of the investigation, the principal investigator
p.000113: You must provide what is necessary to continue the treatment and care, in order to avoid any effects
p.000113: secondary derived from the suspension of the experimental maneuver that has been practiced.
p.000113: 11.3 The informed consent letter is an essential requirement to request the authorization of a project or protocol
p.000113: of investigation, so you must comply with the speci fi cations established in articles 20, 21 and 22 of the
p.000113: Regulation.
p.000113: In cases of investigations without risk or with minimal risk, the informed consent letter will be a requirement
p.000113: to request authorization of the research project or protocol.
...
Health / Pregnant
Searching for indicator pregnant:
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p.000113: health, respectively.
p.000113: 5.2 Any research project or protocol for the use of medicines or materials, for which they have not yet
p.000113: there is sufficient scientific evidence of their therapeutic or rehabilitative efficacy or the modification of the
p.000113: therapeutic indications of already known products, you must have authorization from the Secretariat before starting your
p.000113: development
p.000113: 5.3 The Secretariat, for the granting of the authorization of an investigation for health in human beings according to the
p.000113: objective and field of application of this standard, you must confirm that in the research oprotocol project, the
p.000113: criteria of respect for the dignity of the research subject, the protection of their rights, mainly that of the protection of
p.000113: health, as well as the well-being and conservation of their physical integrity.
p.000113: 5.4 It is the power of the Secretariat, within the scope of its competence, and in accordance with the applicable legal provisions,
p.000113: monitoring and control of research projects or protocols authorized according to the objective and scope of application of
p.000113: This standard, which must conform to the scientific and ethical principles that guide medical practice.
p.000113: 5.5 All research must ensure that it does not expose the research subject to unnecessary risks and that the benefits
p.000113: Expected are greater than the predictable risks inherent in the experimental maneuver.
p.000113: In the case of investigations in minors or disabled persons, the provisions of articles 38 and 39 of the
p.000113: Regulation. In pregnant women, what is specified in article 44 of the same system must be taken into account.
p.000113: 5.6 For the authorization of an investigation, according to the objective and field of application of this standard, the project or
p.000113: Research protocol should fully describe the elements and conditions that allow the Secretariat to evaluate the
p.000113: Safety assurance of the research subjects, where appropriate, may observe Good Clinical Research Practices.
p.000113: 5.7 All research must ensure in a clear, objective and explicit way, the free of the experimental maneuver for the
p.000113: research subject, which should be considered in the research budget, in accordance with the numeral
p.000113: 10.6, of this standard.
p.000113: 5.8 In any research project or protocol, its duration should be estimated, so it is necessary that the
p.000113: tentative start and end dates, as well as the period calculated for its development.
p.000113: 5.9 The conditions described in the research project or protocol, including the estimated start and end dates,
p.000113: as well as the necessary number of research subjects, will be considered indispensable requirements for the authorization of
p.000113: a research for health in humans.
p.000113: 5.10 The justification of the research projects or protocols presented with the request for authorization of a
p.000113: Human health research should include: sufficient information and technical elements to suppose that the
p.000113: knowledge that is intended to be acquired, it is not possible to obtain them by other means.
p.000113: 5.11 The principal investigator, as well as other health professionals and technicians involved in an investigation,
p.000113: they must comply ethically and professionally with the obligations imposed by the General Health Law and the Regulations, as well
p.000113: Like this norm
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Health / patients in emergency situations
Searching for indicator emergencies:
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p.000113: for the development of research.
p.000113: 6.3.2.3 Type of investigation in question;
p.000113: 6.3.2.4 External support: name of the institution or establishment and type of support (human, material, financial resources,
p.000113: advice, information and others);
p.000113: 6.3.2.5 Simple copy of the registration form of the Research Committees, Research Ethics and, where appropriate, of
p.000113: Biosafety, with acknowledgment of receipt from the Secretariat.
p.000113: 6.3.2.6 Letter of authorization from the head of the institution or establishment to carry out the investigation or part of
p.000113: she in her facilities;
p.000113: 6.3.2.7 If applicable, letter of express acceptance of the position of the research sponsor, in which it is required to be
p.000113: The obligations and rights that the research project or protocol imposes on the sponsor are indicated and accepted. In the
p.000113: In the case of legal persons, the position must be accepted by the person empowered to do so or by their legal representative, of
p.000113: according to its organic structure or constitutive regime;
p.000113: 6.3.2.8 Favorable opinion of the Research and Ethics Committees in Research of the institution or establishment in
p.000113: The investigation will be carried out. In case the use of ionizing radiation or engineering techniques is included
p.000113: genetic, the favorable opinion of the Biosafety Committee will also be necessary;
p.000113: 6.3.2.9 Generic description of the resources available for the management of medical emergencies, according to the type
p.000113: of research study that develops. Medical care must be provided with own resources or through third parties,
p.000113: this fact must be recorded in the content of the generic description referred to in this numeral; Y
p.000113: 6.3.2.10 Model informed consent letter on research.
p.000113: 6.3.2.11 Where appropriate, interested parties may submit with their application for authorization of the project or protocol of
p.000113: investigation, opinion issued by a third party authorized for this purpose by the Ministry of Health, under the terms of article 102
p.000113: of the General Health Law.
p.000113: 6.4 The authorization of a research for human health does not authorize the commercialization of
p.000113: medications, procedures or resulting devices, even when the conclusion of the investigation has been made official,
p.000113: by delivery and acknowledgment of receipt of the final report.
p.000113: 7. The follow-up of the investigation and the technical-descriptive reports
p.000113: 7.1 Follow-up tasks are considered: the preparation and delivery to the Secretariat of a technical-descriptive report of
p.000113: partial, with respect to the progress of the investigation in question and at the end of the investigation, one of a final nature, which describes
p.000113: The results obtained.
p.000113: 7.1.1 When results are obtained with technological applications, the area in which the contributions will be provided must be indicated
p.000113: knowledge gained, among which the following stand out: the methodological, technical, clinical procedures area,
p.000113: epidemiological, new medications or improvement of existing ones, biological products for use in humans, medical equipment,
...
Social / Access to Social Goods
Searching for indicator access:
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p.000113: of investigation, so you must comply with the speci fi cations established in articles 20, 21 and 22 of the
p.000113: Regulation.
p.000113: In cases of investigations without risk or with minimal risk, the informed consent letter will be a requirement
p.000113: to request authorization of the research project or protocol.
p.000113: 11.4 When the investigation involves the combined application of a procedure in experimental phase with another method already
p.000113: proven, the responsibility for the safety of the individual, because of his character of patient-subject of investigation, will be
p.000113: joint between the researcher and the doctor responsible for the method tested.
p.000113: 11.5 In the investigation, it is prohibited to charge recovery fees to the research subjects, their relatives or
p.000113: legal representative, for participating in it.
p.000113: 11.6 If during the development of a research project or protocol, the subject participating in it, presents signs and
p.000113: symptoms of an unintended pathology (comorbidity), which is not a consequence of the experimental maneuver and that could
p.000113: get to generate damage to your health or complicate as a result of such experimental maneuver, the principal investigator must
p.000113: evaluate the desirability of the subject continuing or being excluded from the investigation, in accordance with 11.2.1, of
p.000113: this norm. The decision and its justification must be recorded in the clinical file of the research subject.
p.000113: 11.7 All research subjects have the right to the protection of their personal data from access, rectification and cancellation
p.000113: of the same, as well as to express their opposition, in the terms established by the law, which will establish the cases of exception
p.000113: to the principles that fix the data processing, for reasons of national security, public order provisions, security and
p.000113: public health to protect the rights of third parties.
p.000113: 12. Of the information involved in investigations
p.000113: 12.1 The information related to any investigation that the principal investigator submits to the Secretariat will be
p.000113: classified as con fi dential. The Committees on health research of institutions or establishments in the
p.000113: For research to be conducted, they must be fully confidential regarding the reports and reports they receive from the researcher
p.000113: principal, in particular, in the case of investigations whose results are subject to patent or development and
p.000113: commercial exploitation.
p.000113: 12.2 The members of the Committees on health research of the institutions or establishments in the
p.000113: For research to be conducted, they must be fully confidential regarding the reports and reports they receive from the researcher
p.000113: principal, especially in the case of investigations whose results are subject to patent or development and
p.000113: commercial exploitation.
p.000113: 12.3 The principal investigator and the Health Research Committees of the institution or establishment must
p.000113: protect the identity and personal data of the research subjects, whether during the development of an investigation,
p.000113: as in the stages of publication or dissemination of the results thereof, adhering to the applicable legislation speci fi ed in
p.000113: The matter.
p.000113: 13. Concordance with international and Mexican standards
p.000113: This standard partially agrees with the following international standards:
p.000113: Helsinki Declaration of the World Medical Association on ethical principles for medical research on beings
p.000113: humans, and
p.000113: Istanbul Protocol: Manual for the effective investigation and documentation of torture and other cruel cruel punishment,
p.000113: Inhuman or degrading.
p.000113: It does not match any Mexican norm.
p.000113: 14. Bibliography
p.000113: 14.1 Decree establishing the decentralized body called the National Bioethics Commission.
p.000113: 14.2 Declaration of Helsinki of the World Medical Association on ethical principles for medical research in
p.000113: Humans. Adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964 and amended by the 59th
p.000113: General Assembly, Seoul, Korea, October 2008. Available at: Bioethics Documentation Center.
p.000113: 14.3 Integration and Functioning Guides of the Research Ethics Committees and Bioethics Hospital Committees
p.000113: of the National Bioethics Commission.
p.000113: 14.5 Federal Law on Transparency and Access to Government Public Information.
p.000113: 14.6 Federal Law on Protection of Personal Data Held by Private Parties.
p.000113: 14.7 Industrial Property Law.
p.000113: 14.8 Méndez Ramírez: "The Research Protocol" Ed. Trillas, Mexico 1990. Cap. I, p. 11-27.
p.000113: 14.9 Office of the United Nations High Commissioner for Human Rights. Istanbul Protocol: Manual for
p.000113: Effective investigation and documentation of torture and other cruel, inhuman or degrading treatment or punishment. Nations
p.000113: United, New York and Geneva, 2001.
p.000113: 14.10 Regulation of the General Health Law on Health Research.
p.000113: 14.11 Internal Regulations of the Interinstitutional Commission for Health Research.
p.000113: 15. Surveillance
p.000113: The monitoring of the application of this norm corresponds to the Ministry of Health and the governments of the entities
p.000113: federation within the scope of their respective competences.
p.000113: 16. Validity
p.000113: This rule will enter into force 60 calendar days from the date of its publication in the Official Gazette of the
p.000113: Federation.
p.000113: Effective suffrage. No reelection.
p.000113: Mexico, D.F., on November 26, 2012.- The Undersecretary of Integration and Development of the Health Sector and President of the
p.000113: National Consultative Committee for the Standardization of Innovation, Development, Technologies and Information in Health, Germán Enrique
p.000113: Fajardo Dolci.- Rubric.
p.000113: In the document you are viewing there may be text, characters or objects that are not displayed due to format conversion
p.000113: HTML, so we recommend that you always take the digitized image of the DOF or the PDF file of the edition as a reference.
p.000113: Official Journal of the Federation
p.000113: Amazon River No. 62, Col. Cuauhtémoc, C.P 06500, Mexico City
p.000113: Tel. (55) 5093-3200, where you can access our service menu
p.000113: E-mail address: www.dof.gob.mx
p.000113: 113
...
Social / Police Officer
Searching for indicator officer:
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p.000113: as well as the necessary number of research subjects, will be considered indispensable requirements for the authorization of
p.000113: a research for health in humans.
p.000113: 5.10 The justification of the research projects or protocols presented with the request for authorization of a
p.000113: Human health research should include: sufficient information and technical elements to suppose that the
p.000113: knowledge that is intended to be acquired, it is not possible to obtain them by other means.
p.000113: 5.11 The principal investigator, as well as other health professionals and technicians involved in an investigation,
p.000113: they must comply ethically and professionally with the obligations imposed by the General Health Law and the Regulations, as well
p.000113: Like this norm
p.000113: 5.12 In any investigation, the files of the research subjects will be considered clinical records, so
p.000113: that must comply with the provisions of the Official Mexican Standard, referred to in paragraph 3.1 of this standard.
p.000113: 5.13 Whoever conducts an investigation without complying with the provisions of this standard, will become creditor to the sanctions that
p.000113: establishes the General Health Law and its Regulations.
p.000113: 5.14 The availability of a financial fund should be included in the research budget, as well as the mechanisms
p.000113: to guarantee the continuity of medical treatment and compensation to which the subject of law will legally be entitled
p.000113: investigation, in case of suffering damages directly related to it; where appropriate, this financial fund can be
p.000113: covered with study insurance.
p.000113: 5.15 In establishments in the public, social and private sectors, where projects or protocols for development are developed
p.000113: research for human health, the health officer, legal representative or person empowered to do so,
p.000113: may request conformity assessment with respect to this standard, before the accredited and approved bodies for said standard
p.000113: purpose.
p.000113: 6. The presentation and authorization of research projects or protocols
p.000113: 6.1 In order to request the authorization of a research for health in human beings, in accordance with the objective and
p.000113: Field of application of this standard, interested parties must complete the procedure before the Secretariat, using the format
p.000113: correspondent.
p.000113: 6.2 Annex to the authorization request format, the research project or protocol must contain at least
p.000113: following elements:
p.000113: 6.2.1 Project title or research protocol;
p.000113: 6.2.2 Theoretical framework;
p.000113: 6.2.3 Definition of the problem;
p.000113: 6.2.4 Background;
p.000113: 6.2.5 Justification;
p.000113: 6.2.6 Hypothesis (if applicable);
p.000113: 6.2.7 General objective (where appropriate, specific objectives);
p.000113: 6.2.8 Material and methods;
p.000113: 6.2.9 Design: inclusion and exclusion criteria, capture, processing, analysis and interpretation of information;
p.000113: 6.2.10 Bibliographic references;
p.000113: 6.2.11 Names and signatures of the principal investigator and associated investigators (indicate a maximum of 5, in order of
p.000113: research participation); Y
p.000113: 6.2.12 Other documents related to the research project or protocol.
p.000113: 6.3 To the application form for the authorization of a research project or protocol, a free writing must be attached,
p.000113: containing the following information:
p.000113: 6.3.1 Identification data, which integrates the title of the research project or protocol, name of the researcher and
...
Social / Property Ownership
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p.000113: Custom search
p.000113: User Password User ••••• Login Login
p.000113: Forgot your password?
p.000113: Forgot your username?
p.000113: Home | Directory | Contact | Site Map | Help
p.000113: .
p.000113: Copy of today Procedures Services Laws and Regulations Search Search ...
p.000113: Frequent questions
p.000113: DOF: 04/01/2013
p.000113: Mexican Official NOM-012-SSA3-2012, which establishes the criteria for the execution of projects of
p.000113: research for health in humans.
p.000113: On the margin a seal with the National Shield, which says: United Mexican States.- Ministry of Health.
p.000113: GERMAN ENRIQUE FAJARDO DOLCI, Under Secretary of Integration and Development of the Health Sector and Chairman of the Committee
p.000113: National Consultative Standardization of Innovation, Development, Technologies and Information in Health, based on the
p.000113: provided by articles 39 of the Organic Law of the Federal Public Administration; 4th. of the Federal Procedure Law
p.000113: Administrative, 3rd. fraction XI, 38 fraction II, 40 fractions III and XI, 41, 43, 47 fractions III and IV of the Federal Law on Metrology
p.000113: and Normalization; 2nd. fraction VII, 3rd. fractions I, II and IX, 13 section A fractions I, II and IX, 45, 48, 78, 79, 81, 96, 98, 99, 100,
p.000113: 101, 102 and 103 of the General Health Law; 28 and 34 of the Regulation of the Federal Law on Metrology and Standardization; 3rd, 4th,
p.000113: 5th, 22, 62, 78, 108, 115, 116 and 119 of the Regulations of the General Health Law on Health Research; 2nd.
p.000113: section A fraction I, 8th. fraction V and 9o. section IV Bis of the Internal Regulations of the Ministry of Health, may I order the
p.000113: publication in the Official Gazette of the Federation of Mexican Official Standard NOM-012-SSA3-2012, which establishes the criteria
p.000113: for the execution of research projects for human health.
p.000113: CONSIDERING
p.000113: That on November 5, 2009, the draft of this standard was published in the Official Gazette of the Federation, in
...
Searching for indicator property:
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p.000113: as in the stages of publication or dissemination of the results thereof, adhering to the applicable legislation speci fi ed in
p.000113: The matter.
p.000113: 13. Concordance with international and Mexican standards
p.000113: This standard partially agrees with the following international standards:
p.000113: Helsinki Declaration of the World Medical Association on ethical principles for medical research on beings
p.000113: humans, and
p.000113: Istanbul Protocol: Manual for the effective investigation and documentation of torture and other cruel cruel punishment,
p.000113: Inhuman or degrading.
p.000113: It does not match any Mexican norm.
p.000113: 14. Bibliography
p.000113: 14.1 Decree establishing the decentralized body called the National Bioethics Commission.
p.000113: 14.2 Declaration of Helsinki of the World Medical Association on ethical principles for medical research in
p.000113: Humans. Adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964 and amended by the 59th
p.000113: General Assembly, Seoul, Korea, October 2008. Available at: Bioethics Documentation Center.
p.000113: 14.3 Integration and Functioning Guides of the Research Ethics Committees and Bioethics Hospital Committees
p.000113: of the National Bioethics Commission.
p.000113: 14.5 Federal Law on Transparency and Access to Government Public Information.
p.000113: 14.6 Federal Law on Protection of Personal Data Held by Private Parties.
p.000113: 14.7 Industrial Property Law.
p.000113: 14.8 Méndez Ramírez: "The Research Protocol" Ed. Trillas, Mexico 1990. Cap. I, p. 11-27.
p.000113: 14.9 Office of the United Nations High Commissioner for Human Rights. Istanbul Protocol: Manual for
p.000113: Effective investigation and documentation of torture and other cruel, inhuman or degrading treatment or punishment. Nations
p.000113: United, New York and Geneva, 2001.
p.000113: 14.10 Regulation of the General Health Law on Health Research.
p.000113: 14.11 Internal Regulations of the Interinstitutional Commission for Health Research.
p.000113: 15. Surveillance
p.000113: The monitoring of the application of this norm corresponds to the Ministry of Health and the governments of the entities
p.000113: federation within the scope of their respective competences.
p.000113: 16. Validity
p.000113: This rule will enter into force 60 calendar days from the date of its publication in the Official Gazette of the
p.000113: Federation.
p.000113: Effective suffrage. No reelection.
p.000113: Mexico, D.F., on November 26, 2012.- The Undersecretary of Integration and Development of the Health Sector and President of the
p.000113: National Consultative Committee for the Standardization of Innovation, Development, Technologies and Information in Health, Germán Enrique
p.000113: Fajardo Dolci.- Rubric.
p.000113: In the document you are viewing there may be text, characters or objects that are not displayed due to format conversion
p.000113: HTML, so we recommend that you always take the digitized image of the DOF or the PDF file of the edition as a reference.
p.000113: Official Journal of the Federation
p.000113: Amazon River No. 62, Col. Cuauhtémoc, C.P 06500, Mexico City
p.000113: Tel. (55) 5093-3200, where you can access our service menu
p.000113: E-mail address: www.dof.gob.mx
p.000113: 113
...
Social / Soldier
Searching for indicator military:
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p.000113: Standardization of Innovation, Development, Technologies and Health Information, the following is issued:
p.000113: OFFICIAL MEXICAN STANDARD NOM-012-SSA3-2012, ESTABLISHING CRITERIA FOR THE
p.000113: EXECUTION OF RESEARCH PROJECTS FOR HEALTH IN HUMAN BEINGS
p.000113: PREFACE
p.000113: In the elaboration of this norm they participated:
p.000113: GENERAL HEALTH COUNCIL
p.000113: HEALTH SECRETARY
p.000113: Undersecretariat of Integration and Development of the Health Sector
p.000113: General Directorate of Quality and Health Education
p.000113: Coordinating Commission of National Institutes of Health and High Specialty Hospitals
p.000113: Ignacio Chavez National Institute of Cardiology
p.000113: National Institute of Medical Sciences and Nutrition Salvador Zubirán
p.000113: National Institute of Respiratory Diseases Ismael Cosío Villegas
p.000113: National Institute of Neurology and Neurosurgery Manuel Velasco Suárez
p.000113: National institute of pediatrics
p.000113: National Institute of Perinatology Isidro Espinosa de los Reyes
p.000113: National Institute of Psychiatry Ramón de la Fuente Muñiz
p.000113: National Institute of Rehabilitation
p.000113: National Institute of Genomic Medicine
p.000113: National Institute of Public Health
p.000113: General Hospital of Mexico
p.000113: Dr. Manuel Gea González General Hospital
p.000113: Children's Hospital of Mexico Federico Gómez
p.000113: Juarez Hospital of Mexico
p.000113: Federal Commission for Protection against Health Risks
p.000113: National Medical Arbitration Commission
p.000113: National Health Council
p.000113: INSTITUTE OF SECURITY AND SOCIAL SERVICES OF STATE WORKERS
p.000113: Medical address
p.000113: SECRETARY OF NATIONAL DEFENSE
p.000113: General Directorate of Military Health
p.000113: NATIONAL INSTITUTE OF STATISTICS, GEOGRAPHY AND INFORMATICS
p.000113: SECRETARY OF PUBLIC EDUCATION
p.000113: CHECK FOR
p.000113: DATE
p.000113: Undersecretary of Higher Education
p.000113: General Directorate of Higher University Education Jan 2013
p.000113: NATIONAL SCIENCE AND TECHNOLOGY COUNCIL Do Lu Ma Mi Ju Vi Sá
p.000113: AUTONOMO NATIONAL UNIVERSITY OF MEXICO 1 2 3 4 5
p.000113: Faculty of Medicine 6 7 8 9 10 11 12
p.000113: NATIONAL POLITECHNICAL INSTITUTE 13 14 15 16 17 18 19
p.000113: Higher School of Medicine 20 21 22 23 24 25 26
p.000113: National School of Medicine and Homeopathy 27 28 29 30 31
p.000113: ANAHUAC UNIVERSITY
p.000113: Medical School Create User
p.000113: LA SALLE UNIVERSITY
p.000113: Advanced search
p.000113: School of Medicine
p.000113: ASOCIACION NACIONAL DE HOSPITALES PRIVADOS, A.C. News
p.000113: NATIONAL CHAMBER OF INDUSTRY FARMACEUTICA, A.C. Top Notes
p.000113: MEXICAN FOUNDATION FOR HEALTH, A.C.
p.000113: Complaints and suggestions
p.000113: HOSPITAL ANGELES DE LAS LOMAS, S.A. OF C.V.
p.000113: AMERICAN BRITISH COWDRAY HOSPITAL, I.A.P. Get Copy of DOF
p.000113: HOSPITAL MEDICA SUR, S.A. OF C.V. Publications
p.000113: Relevant
p.000113: SOCIEDAD DE LA BENEFICENCIA ESPAÑOLA, I.A.P. Verify DOF Copy
p.000113: INDEX
p.000113: Relevant Links
p.000113: 0. Introduction
p.000113: 1. Objective
p.000113: Contact Us
p.000113: 2. Application field RSS filters
p.000113: 3. References History of the Official Gazette
p.000113: 4. Definitions
p.000113: Statistics
p.000113: 5. General
p.000113: Government Vacancies
p.000113: 6. The presentation and authorization of research projects or protocols
p.000113: 7. The follow-up of the investigation and the technical-descriptive reports
...
Social / Women
Searching for indicator women:
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p.000113: health, respectively.
p.000113: 5.2 Any research project or protocol for the use of medicines or materials, for which they have not yet
p.000113: there is sufficient scientific evidence of their therapeutic or rehabilitative efficacy or the modification of the
p.000113: therapeutic indications of already known products, you must have authorization from the Secretariat before starting your
p.000113: development
p.000113: 5.3 The Secretariat, for the granting of the authorization of an investigation for health in human beings according to the
p.000113: objective and field of application of this standard, you must confirm that in the research oprotocol project, the
p.000113: criteria of respect for the dignity of the research subject, the protection of their rights, mainly that of the protection of
p.000113: health, as well as the well-being and conservation of their physical integrity.
p.000113: 5.4 It is the power of the Secretariat, within the scope of its competence, and in accordance with the applicable legal provisions,
p.000113: monitoring and control of research projects or protocols authorized according to the objective and scope of application of
p.000113: This standard, which must conform to the scientific and ethical principles that guide medical practice.
p.000113: 5.5 All research must ensure that it does not expose the research subject to unnecessary risks and that the benefits
p.000113: Expected are greater than the predictable risks inherent in the experimental maneuver.
p.000113: In the case of investigations in minors or disabled persons, the provisions of articles 38 and 39 of the
p.000113: Regulation. In pregnant women, what is specified in article 44 of the same system must be taken into account.
p.000113: 5.6 For the authorization of an investigation, according to the objective and field of application of this standard, the project or
p.000113: Research protocol should fully describe the elements and conditions that allow the Secretariat to evaluate the
p.000113: Safety assurance of the research subjects, where appropriate, may observe Good Clinical Research Practices.
p.000113: 5.7 All research must ensure in a clear, objective and explicit way, the free of the experimental maneuver for the
p.000113: research subject, which should be considered in the research budget, in accordance with the numeral
p.000113: 10.6, of this standard.
p.000113: 5.8 In any research project or protocol, its duration should be estimated, so it is necessary that the
p.000113: tentative start and end dates, as well as the period calculated for its development.
p.000113: 5.9 The conditions described in the research project or protocol, including the estimated start and end dates,
p.000113: as well as the necessary number of research subjects, will be considered indispensable requirements for the authorization of
p.000113: a research for health in humans.
p.000113: 5.10 The justification of the research projects or protocols presented with the request for authorization of a
p.000113: Human health research should include: sufficient information and technical elements to suppose that the
p.000113: knowledge that is intended to be acquired, it is not possible to obtain them by other means.
p.000113: 5.11 The principal investigator, as well as other health professionals and technicians involved in an investigation,
p.000113: they must comply ethically and professionally with the obligations imposed by the General Health Law and the Regulations, as well
p.000113: Like this norm
...
Social / education
Searching for indicator education:
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p.000113: CONSIDERING
p.000113: That on November 5, 2009, the draft of this standard was published in the Official Gazette of the Federation, in
p.000113: compliance with its approval by the National Consultative Committee for the Standardization of Innovation, Development,
p.000113: Technologies and Information in Health; in accordance with the provisions of article 47 section I of the Federal Law on Metrology
p.000113: and Standardization, so that in the following 60 calendar days after said publication, the interested parties will submit
p.000113: your comments to the National Consultative Committee for the Standardization of Innovation, Development, Technologies and Information in
p.000113: Health.
p.000113: That during the 60-day Public Consultation period, which ended on January 5, 2010, were received at the headquarters of the
p.000113: mentioned Committee, comments regarding the Draft Mexican Official Standard, why they were previously dated
p.000113: published in the Official Gazette of the Federation the answers to the comments received by the aforementioned Committee, in the
p.000113: terms of article 47 section III of the Federal Law on Metrology and Standardization.
p.000113: That in view of the above considerations, with the approval of the National Advisory Committee of
p.000113: Standardization of Innovation, Development, Technologies and Health Information, the following is issued:
p.000113: OFFICIAL MEXICAN STANDARD NOM-012-SSA3-2012, ESTABLISHING CRITERIA FOR THE
p.000113: EXECUTION OF RESEARCH PROJECTS FOR HEALTH IN HUMAN BEINGS
p.000113: PREFACE
p.000113: In the elaboration of this norm they participated:
p.000113: GENERAL HEALTH COUNCIL
p.000113: HEALTH SECRETARY
p.000113: Undersecretariat of Integration and Development of the Health Sector
p.000113: General Directorate of Quality and Health Education
p.000113: Coordinating Commission of National Institutes of Health and High Specialty Hospitals
p.000113: Ignacio Chavez National Institute of Cardiology
p.000113: National Institute of Medical Sciences and Nutrition Salvador Zubirán
p.000113: National Institute of Respiratory Diseases Ismael Cosío Villegas
p.000113: National Institute of Neurology and Neurosurgery Manuel Velasco Suárez
p.000113: National institute of pediatrics
p.000113: National Institute of Perinatology Isidro Espinosa de los Reyes
p.000113: National Institute of Psychiatry Ramón de la Fuente Muñiz
p.000113: National Institute of Rehabilitation
p.000113: National Institute of Genomic Medicine
p.000113: National Institute of Public Health
p.000113: General Hospital of Mexico
p.000113: Dr. Manuel Gea González General Hospital
p.000113: Children's Hospital of Mexico Federico Gómez
p.000113: Juarez Hospital of Mexico
p.000113: Federal Commission for Protection against Health Risks
p.000113: National Medical Arbitration Commission
p.000113: National Health Council
p.000113: INSTITUTE OF SECURITY AND SOCIAL SERVICES OF STATE WORKERS
p.000113: Medical address
p.000113: SECRETARY OF NATIONAL DEFENSE
p.000113: General Directorate of Military Health
p.000113: NATIONAL INSTITUTE OF STATISTICS, GEOGRAPHY AND INFORMATICS
p.000113: SECRETARY OF PUBLIC EDUCATION
p.000113: CHECK FOR
p.000113: DATE
p.000113: Undersecretary of Higher Education
p.000113: General Directorate of Higher University Education Jan 2013
p.000113: NATIONAL SCIENCE AND TECHNOLOGY COUNCIL Do Lu Ma Mi Ju Vi Sá
p.000113: AUTONOMO NATIONAL UNIVERSITY OF MEXICO 1 2 3 4 5
p.000113: Faculty of Medicine 6 7 8 9 10 11 12
p.000113: NATIONAL POLITECHNICAL INSTITUTE 13 14 15 16 17 18 19
p.000113: Higher School of Medicine 20 21 22 23 24 25 26
p.000113: National School of Medicine and Homeopathy 27 28 29 30 31
p.000113: ANAHUAC UNIVERSITY
p.000113: Medical School Create User
p.000113: LA SALLE UNIVERSITY
p.000113: Advanced search
p.000113: School of Medicine
p.000113: ASOCIACION NACIONAL DE HOSPITALES PRIVADOS, A.C. News
p.000113: NATIONAL CHAMBER OF INDUSTRY FARMACEUTICA, A.C. Top Notes
p.000113: MEXICAN FOUNDATION FOR HEALTH, A.C.
p.000113: Complaints and suggestions
p.000113: HOSPITAL ANGELES DE LAS LOMAS, S.A. OF C.V.
p.000113: AMERICAN BRITISH COWDRAY HOSPITAL, I.A.P. Get Copy of DOF
p.000113: HOSPITAL MEDICA SUR, S.A. OF C.V. Publications
p.000113: Relevant
p.000113: SOCIEDAD DE LA BENEFICENCIA ESPAÑOLA, I.A.P. Verify DOF Copy
p.000113: INDEX
p.000113: Relevant Links
p.000113: 0. Introduction
p.000113: 1. Objective
p.000113: Contact Us
p.000113: 2. Application field RSS filters
p.000113: 3. References History of the Official Gazette
p.000113: 4. Definitions
p.000113: Statistics
p.000113: 5. General
p.000113: Government Vacancies
p.000113: 6. The presentation and authorization of research projects or protocols
p.000113: 7. The follow-up of the investigation and the technical-descriptive reports
p.000113: Former workers
p.000113: Migratory
p.000113: 8. Of the institutions or establishments where an investigation is carried out
p.000113: 9. On the constitution, registration and operation of the Research, Ethics in Research and Biosafety Committees
p.000113: 10. From the Principal Investigator
p.000113: INDICATORS
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
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p.000113: institution or establishment where the research will be carried out, as well as, where appropriate, the unit, department or services to the
p.000113: That will be attached.
p.000113: 6.3.2 List of documents, among which at least the following will be delivered:
p.000113: 6.3.2.1 Description of the risk level of the study, in accordance with Article 17 of the Regulation.
p.000113: 6.3.2.2 Expected duration: indicating month and year, of the estimated start and end dates, as well as the calculated period
p.000113: for the development of research.
p.000113: 6.3.2.3 Type of investigation in question;
p.000113: 6.3.2.4 External support: name of the institution or establishment and type of support (human, material, financial resources,
p.000113: advice, information and others);
p.000113: 6.3.2.5 Simple copy of the registration form of the Research Committees, Research Ethics and, where appropriate, of
p.000113: Biosafety, with acknowledgment of receipt from the Secretariat.
p.000113: 6.3.2.6 Letter of authorization from the head of the institution or establishment to carry out the investigation or part of
p.000113: she in her facilities;
p.000113: 6.3.2.7 If applicable, letter of express acceptance of the position of the research sponsor, in which it is required to be
p.000113: The obligations and rights that the research project or protocol imposes on the sponsor are indicated and accepted. In the
p.000113: In the case of legal persons, the position must be accepted by the person empowered to do so or by their legal representative, of
p.000113: according to its organic structure or constitutive regime;
p.000113: 6.3.2.8 Favorable opinion of the Research and Ethics Committees in Research of the institution or establishment in
p.000113: The investigation will be carried out. In case the use of ionizing radiation or engineering techniques is included
p.000113: genetic, the favorable opinion of the Biosafety Committee will also be necessary;
p.000113: 6.3.2.9 Generic description of the resources available for the management of medical emergencies, according to the type
p.000113: of research study that develops. Medical care must be provided with own resources or through third parties,
p.000113: this fact must be recorded in the content of the generic description referred to in this numeral; Y
p.000113: 6.3.2.10 Model informed consent letter on research.
p.000113: 6.3.2.11 Where appropriate, interested parties may submit with their application for authorization of the project or protocol of
p.000113: investigation, opinion issued by a third party authorized for this purpose by the Ministry of Health, under the terms of article 102
p.000113: of the General Health Law.
p.000113: 6.4 The authorization of a research for human health does not authorize the commercialization of
p.000113: medications, procedures or resulting devices, even when the conclusion of the investigation has been made official,
p.000113: by delivery and acknowledgment of receipt of the final report.
p.000113: 7. The follow-up of the investigation and the technical-descriptive reports
p.000113: 7.1 Follow-up tasks are considered: the preparation and delivery to the Secretariat of a technical-descriptive report of
p.000113: partial, with respect to the progress of the investigation in question and at the end of the investigation, one of a final nature, which describes
p.000113: The results obtained.
p.000113: 7.1.1 When results are obtained with technological applications, the area in which the contributions will be provided must be indicated
p.000113: knowledge gained, among which the following stand out: the methodological, technical, clinical procedures area,
p.000113: epidemiological, new medications or improvement of existing ones, biological products for use in humans, medical equipment,
p.000113: prostheses, orthotics and functional aids, healing material, surgical and hygienic products, diagnostic agents or others.
p.000113: 7.2 The head of the institution or establishment, the Research Committees, Research Ethics or Biosafety, the
p.000113: Principal investigator and, where appropriate, the sponsor, will be responsible in accordance with their field of competence in matters of:
p.000113: a) Research follow-up;
p.000113: b) Health damage arising from the development of research; as well as those damages derived from the interruption or
...
p.000113: request the support of other Committees constituted at the immediate superior level of their own institution or in institutions or
p.000113: external health facilities.
p.000113: 9.1.4 The head of the institution or establishment must register the Research Committees, Research Ethics and
p.000113: Biosafety, as appropriate, before the Secretariat, to inform about the modification, designation or replacement of any of
p.000113: its members and deliver an annual report of their activities, referring to the evaluation of projects according to the objective and
p.000113: Field of application of this standard.
p.000113: 9.2 On the functioning of the Research Committees, Research Ethics and Biosafety
p.000113: 9.2.1 The constitution and operation of the Committees shall be subject to the provisions of current legislation and, where appropriate, to the
p.000113: criteria referred to in article 41 Bis of the General Health Law.
p.000113: 9.2.2 The members of the Committees shall remain in office for the time established in the installation minutes,
p.000113: being able to be ratified at the end of each period, if necessary replaced in a staggered manner, which should be
p.000113: documentary evidence. The operation and activities of the Committees must be described in the Rules of Operation
p.000113: of the Committee, which are issued in accordance with the provisions of current legislation and, where appropriate, in accordance with
p.000113: criteria referred to in article 41 Bis of the General Health Law.
p.000113: 9.2.3 The members of the Research Committees, Research Ethics and Biosafety shall refrain from participating
p.000113: in the evaluation and opinion of their own investigations.
p.000113: 9.2.4 Each Committee shall designate the person who will occupy the position of president, who will be responsible to the head of
p.000113: the institution or establishment of the activities developed by said Committee.
p.000113: 9.2.5 The secretary of each Committee shall take the necessary steps to develop the activities of the Committee of
p.000113: in question, so it must be provided with the administrative management powers for the exercise of its functions.
p.000113: 9.2.6 The Research and Biosafety Committees shall have at least four members representing each of the
p.000113: The areas related to the subject matter of the research project or protocol in the opinion phase may include medical personnel from
p.000113: nursing, administrative of the institution or establishment itself, as well as of other sectors that integrate said Committee.
p.000113: 9.2.7 In the sessions of each Committee, members of external Committees may participate or have the support of advisers
p.000113: external, which will have a voice but no vote. In these cases, the researchers themselves may participate
p.000113: institution or establishment, as long as they work in areas related to the subject of the research project or protocol in
p.000113: opinion phase
p.000113: 9.2.8 The Research Ethics Committee should evaluate at the beginning and periodically that the projects or protocols of
p.000113: investigation, adhere to the ethical principles and applicable regulations in accordance with the internal regulations
p.000113: that each Committee has prepared. Also, within its scope of responsibility, it will have the power to approve or not, such
p.000113: research projects or protocols, which will be submitted for authorization by the Secretariat.
p.000113: 9.2.9 The Research Ethics Committee will be responsible for reviewing and, where appropriate, approving the consent letter
p.000113: informed in the field of research, formulated by the principal investigator.
p.000113: 9.2.10 The Research Ethics Committee must propose to the head of the institution or establishment where it is carried out
p.000113: health investigation, that the investigation be suspended or canceled in the presence of any adverse effects that may be
p.000113: impediment from an ethical or technical point of view, to continue with the study.
p.000113: 9.2.11 The Biosafety Committee will monitor that for each study, as the case may be, with toxic, infectious or contagious risks
p.000113: radiology must meet the requirements for its realization, including that there is a person in charge of
p.000113: radiation safety, which must be registered with the National Commission for Nuclear Safety and Safeguards.
p.000113: 9.2.12 It is the responsibility of the Committees, to issue the technical opinion regarding research, ethics and biosafety in their field of
p.000113: competence, according to the nature of the proposed investigations.
p.000113: 10. From the Principal Investigator
p.000113: 10.1 The conduct of any investigation in accordance with this standard will be the responsibility of the principal investigator, who
p.000113: You must be a health professional with academic training and proven experience in the field, which will allow you to direct the
p.000113: research you intend to perform.
p.000113: 10.2 The principal investigator may plan and prepare the research project or protocol and must direct it in
p.000113: adherence to the methodological, ethical and safety aspects of the research subject.
p.000113: 10.3 When the principal investigator wishes to make amendments in the methodological design of the project or protocol of
p.000113: initial investigation, which served as the basis for the issuance of the original authorization of a
p.000113: Human health research, in accordance with this standard, should request a new Secretariat from the Secretariat
p.000113: authorization, prior favorable opinion of the Committee that validated the initial project or protocol, in the terms of section 4.6, of
p.000113: of definitions. In cases where the life of the research subjects is in danger, the amendments may be
p.000113: applied immediately, with the prior approval of the Research Ethics Committee and subsequently with the authorization of the
p.000113: Secretariat, of all of which, must be documented.
p.000113: 10.4 It is the responsibility of the principal investigator to select and specify the number of participants: technical support staff and
p.000113: administrative that will participate in the investigation, so it will be jointly responsible for the proceeding and their expertise in relation
p.000113: with the investigation, so you must have broad powers to, where appropriate, request the head of the institution or
p.000113: establishment, which suspends the participation of any of them.
p.000113: 10.4.1 For each principal or associate researcher, specify if they are attached to the institution or establishment, position or
p.000113: function, hours / week that you will dedicate to the research project or protocol, maximum academic degree, place and institution in
p.000113: that was obtained (national or foreign) as well as discipline; if applicable, category in the National System of Researchers
p.000113: (national researcher or candidate).
p.000113: 10.5 The investigator is responsible for suspending the investigation, in accordance with the provisions of section VI of the
p.000113: Article 100 of the General Health Law.
p.000113: 10.6 In formulating the informed consent letter regarding research, the investigator must ensure that
p.000113: it complies with the requirements and assumptions indicated in the Regulation, taking care that the gratuity is made explicit for
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General/Other / Public Emergency
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p.000113: third parties, in the presence of any adverse effect of the experimental maneuver expressed in the project or protocol of
p.000113: Authorized investigation
p.000113: 8.2 The head of the institution or establishment and the corresponding Health Research Committees,
p.000113: they must act impartially and objectively, with strict adherence to ethical and scientific principles, in all matters that are
p.000113: detach from the investigation that is being carried out in their facilities, especially when it comes to attending the
p.000113: Complaints made by research subjects, by themselves or through their legal representatives.
p.000113: 8.3 Authorizations or consent regarding research projects or protocols issued by the owner of the
p.000113: institution or establishment or their respective Committees, must be prepared and signed separately.
p.000113: 8.4 Every institution or establishment in whose facilities an investigation is conducted, you must supervise and ensure that
p.000113: its development is in charge of health professionals, with adherence to the scientific and ethical principles that guide the practice
p.000113: medical and that research subjects are not exposed to damage or unnecessary risks or greater than the benefits
p.000113: expected
p.000113: 8.5 Health care cannot be conditioned on a person in exchange for giving consent
p.000113: to participate or continue participating in an investigation.
p.000113: 8.6 Every institution or establishment, in which an investigation is carried out or intended to be carried out, must have a
p.000113: service for medical emergency care. In your case, you must have an agreement signed with an establishment
p.000113: for medical care with greater resolution capacity, which, as a third party, provides such emergency care.
p.000113: 8.7 The head of the institution or establishment must notify the Secretariat of any adverse effects arising from the
p.000113: experimental maneuver, within a maximum period of 15 working days from its presentation, which includes the measures of
p.000113: care taken, the sequelae identified, as well as a detailed report on the physical condition of the patient, in which
p.000113: Mention if you are free from all risks until the time of notification.
p.000113: 8.8 The head of the institution or establishment, the Research Committees, Research Ethics, Biosecurity or the
p.000113: principal investigator, must order the immediate suspension or cancellation of the investigation, in the presence of any
p.000113: severe adverse effect, which constitutes an ethical or technical impediment to continue the study, about which, you must
p.000113: Notify the Secretariat, in detail, with the opportunity indicated in paragraph 8.7. In that case, the resumption of the
p.000113: Research will require a new authorization.
p.000113: 8.9 The principal investigator must inform the Committee of Ethics in the Investigation of any probable adverse effects or
p.000113: directly related to the investigation. Likewise, it must inform said Committee as frequently as it
p.000113: establish, on the absence of adverse effects on research projects or protocols that are under its
p.000113: responsibility.
p.000113: 8.10 Serious or lethal adverse reactions or effects should be reported immediately to the Secretariat. In the cases
p.000113: If there is a suspicion of adverse effects due to medications, the Mexican Official Standard, referred to in the
p.000113: Section 3.2 of this standard.
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General/Other / Relationship to Authority
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p.000113: Former workers
p.000113: Migratory
p.000113: 8. Of the institutions or establishments where an investigation is carried out
p.000113: 9. On the constitution, registration and operation of the Research, Ethics in Research and Biosafety Committees
p.000113: 10. From the Principal Investigator
p.000113: INDICATORS
p.000113: 11. The physical and legal security of the subject of investigation
p.000113: 12. Of the information involved in investigations Exchange Rate and Rates at
p.000113: 13. Concordance with international and Mexican standards 01/24/2020
p.000113: 14. Bibliography
p.000113: DOLAR UDIS
p.000113: 15. Surveillance 18.8018 6.432402
p.000113: 16. Validity
p.000113: 0. Introduction TIIE 28 DAYS TIIE 91 DAYS
p.000113: Scientific, clinical, biomedical, technological and biopsychosocial research in the field of health, are determining factors 7.5225% 7.4200%
p.000113: to improve actions aimed at protecting, promoting and restoring the health of the individual and society in general, so
p.000113: that it is essential to guide their development in specific matters and regulate their execution in human beings, in such a way
p.000113: so that the guarantee of the care of the ethical aspects, of the well-being and physical integrity of the person participating in a TIIE DE
p.000113: research project or protocol and respect for their dignity, become the rule of conduct for any FONDEO researcher
p.000113: from the health area. 7.20%
p.000113: This standard defines the minimum elements that must be compulsorily fulfilled by researchers who carry out this
p.000113: activity in human beings, in accordance with the provisions that in this matter are established on an indispensable basis to see
p.000113: the Ministry of Health as a health authority, as established by the General Law of Health itself and its Regulations in more
p.000113: of research for health.
p.000113: In this sense, once the mandatory provisions established by the legal framework have been fulfilled
p.000113: Mexican health, who conduct research for human health; they must adapt to the scientific principles
p.000113: and ethics that justify the medical research found in universally accepted international instruments and
p.000113: to the criteria that the National Bioethics Commission issues in the matter. SURVEYS
p.000113: 1. Objective
p.000113: This standard establishes the normative criteria of an administrative, ethical and methodological nature, which corresponds to the Did you like the new image
p.000113: General Health Law and the Regulation on health research, are mandatory to request the
p.000113: authorization of projects or protocols for research purposes, for the use in humans of medicines or of the Journal's website
p.000113: materials, for which there is still insufficient scientific evidence of its therapeutic or rehabilitative efficacy or is it an Official of the Federation?
p.000113: intend the modification of
p.000113: therapeutic indications of already known products, as well as for the execution and monitoring of said projects. No Yes
p.000113: 2. Field of application
p.000113: This rule is mandatory, for any health professional, institution or establishment for care
p.000113: medical of the public, social and private sectors that intend to carry out or conduct research activities for health
p.000113: in human beings, with the characteristics indicated in the objective of the present norm.
p.000113: 3. References
p.000113: Vote
p.000113: For the correct interpretation and application of this standard, it is necessary to consult the following Official Mexican Official Rules or
p.000113: those that replace them:
...
p.000113: 7.4.1.4 Conclusions, which should describe whether or not they were related to the hypothesis (s), as well as to the objectives
p.000113: raised in the research project or protocol;
p.000113: 7.4.1.5 Bibliographic references, only those that served as the basis for planning and execution of the
p.000113: research, as well as for the analysis of the results; Y
p.000113: 7.4.1.6 The annexes that the investigator considers necessary for the sustenance of the technical-descriptive report or those required
p.000113: the institution or establishment where the investigation is carried out.
p.000113: 7.4.2 The principal investigator shall submit to the Secretariat a partial or final technical-descriptive report as appropriate,
p.000113: of the progress of the investigation and will have the responsibility of delivering a copy of each report to the head of the Committees
p.000113: of Research, Ethics in Research and, where appropriate, Biosafety, of the institution or establishment where the
p.000113: investigation.
p.000113: 7.4.3 The Secretariat has the power to request additional information or rethink the investigation, when
p.000113: consider that the information provided is insufficient, not clear or does not meet the requirements established by the Law
p.000113: General de Salud, the Regulation, this and other Mexican Official Norms, as well as the other legal systems
p.000113: applicable.
p.000113: 7.4.4 When the information contained in the technical-descriptive reports or the confirmation of the fact, it is possible to
p.000113: verify that the investigation has not been carried out in accordance with the initial research project or protocol, which served as the basis
p.000113: for the issuance of the original authorization, the health authority must establish an administrative procedure against the
p.000113: principal investigator and, where appropriate, may revoke said authorization and suspend the investigation, without prejudice to the sanctions
p.000113: that correspond to the facts possibly constituting a crime.
p.000113: 7.4.5 In the event that the research is sponsored by any public or private body, it must be ensured that it does not
p.000113: will generate conflicts of interest that may cause the interruption of the treatment for the research subject, for which
p.000113: a detailed explanation of the resources available and the form must be attached to the research project or protocol
p.000113: in which they will be provided and distributed.
p.000113: 8. Of the institutions or establishments where an investigation is carried out
p.000113: 8.1 All research in human beings must be carried out in an institution or establishment, which must have the
p.000113: infrastructure and sufficient resolution capacity to provide adequate medical care or, where appropriate, through
p.000113: third parties, in the presence of any adverse effect of the experimental maneuver expressed in the project or protocol of
p.000113: Authorized investigation
p.000113: 8.2 The head of the institution or establishment and the corresponding Health Research Committees,
p.000113: they must act impartially and objectively, with strict adherence to ethical and scientific principles, in all matters that are
p.000113: detach from the investigation that is being carried out in their facilities, especially when it comes to attending the
p.000113: Complaints made by research subjects, by themselves or through their legal representatives.
...
General/Other / declaration of helsinki
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p.000113: to the principles that fix the data processing, for reasons of national security, public order provisions, security and
p.000113: public health to protect the rights of third parties.
p.000113: 12. Of the information involved in investigations
p.000113: 12.1 The information related to any investigation that the principal investigator submits to the Secretariat will be
p.000113: classified as con fi dential. The Committees on health research of institutions or establishments in the
p.000113: For research to be conducted, they must be fully confidential regarding the reports and reports they receive from the researcher
p.000113: principal, in particular, in the case of investigations whose results are subject to patent or development and
p.000113: commercial exploitation.
p.000113: 12.2 The members of the Committees on health research of the institutions or establishments in the
p.000113: For research to be conducted, they must be fully confidential regarding the reports and reports they receive from the researcher
p.000113: principal, especially in the case of investigations whose results are subject to patent or development and
p.000113: commercial exploitation.
p.000113: 12.3 The principal investigator and the Health Research Committees of the institution or establishment must
p.000113: protect the identity and personal data of the research subjects, whether during the development of an investigation,
p.000113: as in the stages of publication or dissemination of the results thereof, adhering to the applicable legislation speci fi ed in
p.000113: The matter.
p.000113: 13. Concordance with international and Mexican standards
p.000113: This standard partially agrees with the following international standards:
p.000113: Helsinki Declaration of the World Medical Association on ethical principles for medical research on beings
p.000113: humans, and
p.000113: Istanbul Protocol: Manual for the effective investigation and documentation of torture and other cruel cruel punishment,
p.000113: Inhuman or degrading.
p.000113: It does not match any Mexican norm.
p.000113: 14. Bibliography
p.000113: 14.1 Decree establishing the decentralized body called the National Bioethics Commission.
p.000113: 14.2 Declaration of Helsinki of the World Medical Association on ethical principles for medical research in
p.000113: Humans. Adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964 and amended by the 59th
p.000113: General Assembly, Seoul, Korea, October 2008. Available at: Bioethics Documentation Center.
p.000113: 14.3 Integration and Functioning Guides of the Research Ethics Committees and Bioethics Hospital Committees
p.000113: of the National Bioethics Commission.
p.000113: 14.5 Federal Law on Transparency and Access to Government Public Information.
p.000113: 14.6 Federal Law on Protection of Personal Data Held by Private Parties.
p.000113: 14.7 Industrial Property Law.
p.000113: 14.8 Méndez Ramírez: "The Research Protocol" Ed. Trillas, Mexico 1990. Cap. I, p. 11-27.
p.000113: 14.9 Office of the United Nations High Commissioner for Human Rights. Istanbul Protocol: Manual for
p.000113: Effective investigation and documentation of torture and other cruel, inhuman or degrading treatment or punishment. Nations
p.000113: United, New York and Geneva, 2001.
p.000113: 14.10 Regulation of the General Health Law on Health Research.
p.000113: 14.11 Internal Regulations of the Interinstitutional Commission for Health Research.
p.000113: 15. Surveillance
p.000113: The monitoring of the application of this norm corresponds to the Ministry of Health and the governments of the entities
p.000113: federation within the scope of their respective competences.
p.000113: 16. Validity
p.000113: This rule will enter into force 60 calendar days from the date of its publication in the Official Gazette of the
p.000113: Federation.
p.000113: Effective suffrage. No reelection.
p.000113: Mexico, D.F., on November 26, 2012.- The Undersecretary of Integration and Development of the Health Sector and President of the
...
Orphaned Trigger Words
p.000113: to the criteria that the National Bioethics Commission issues in the matter. SURVEYS
p.000113: 1. Objective
p.000113: This standard establishes the normative criteria of an administrative, ethical and methodological nature, which corresponds to the Did you like the new image
p.000113: General Health Law and the Regulation on health research, are mandatory to request the
p.000113: authorization of projects or protocols for research purposes, for the use in humans of medicines or of the Journal's website
p.000113: materials, for which there is still insufficient scientific evidence of its therapeutic or rehabilitative efficacy or is it an Official of the Federation?
p.000113: intend the modification of
p.000113: therapeutic indications of already known products, as well as for the execution and monitoring of said projects. No Yes
p.000113: 2. Field of application
p.000113: This rule is mandatory, for any health professional, institution or establishment for care
p.000113: medical of the public, social and private sectors that intend to carry out or conduct research activities for health
p.000113: in human beings, with the characteristics indicated in the objective of the present norm.
p.000113: 3. References
p.000113: Vote
p.000113: For the correct interpretation and application of this standard, it is necessary to consult the following Official Mexican Official Rules or
p.000113: those that replace them:
p.000113: 3.1 Official Mexican Standard NOM-004-SSA3-2012, Of the clinical file.
p.000113: 3.2 Official Mexican Standard NOM-220-SSA1-2002, Installation and operation of pharmacovigilance.
p.000113: 4. Definitions
p.000113: For the purposes of this standard, the following definitions shall apply:
p.000113: 4.1 Medical care, to the set of services provided to the individual in order to promote, protect and restore their
p.000113: Health.
p.000113: 4.2 Authorization of an investigation for the health in human beings, to the administrative act by means of which, the
p.000113: Ministry of Health allows the health professional to carry out health research activities, in which the
p.000113: human being is the research subject, for the use of medicines or materials according to the objective of this
p.000113: rule.
p.000113: 4.3 Informed consent letter on research, to the written document, signed by the researcher
p.000113: principal, the patient or his relative, guardian or legal representative and two witnesses, through which the subject of investigation accepts
p.000113: Participate voluntarily in an investigation and have an experimental maneuver applied once you have received the
p.000113: Sufficient, timely, clear and truthful information about the expected risks and benefits. The names of the
p.000113: witnesses, address and the relationship they have with the subject of investigation.
p.000113: 4.4 Committees on health research, to all professionals belonging to an institution or
p.000113: establishment where health research or other sectors are carried out, responsible for reviewing, approving and monitoring that
p.000113: research projects or protocols are carried out in accordance with the scientific principles of research, ethics in research
p.000113: and biosafety dictated by the medical lex artis and in accordance with the Mexican legal-health framework.
p.000113: 4.5 Adverse effect, to the set of signs and symptoms not calculated and unexpected that occur in a subject of
p.000113: research, as a result of the application of experimental maneuvers provided for in a protocol or project of
p.000113: research for health in humans and potentially representing a risk to their health.
p.000113: 4.6 Amendment, any change to a document that is part of the research project or protocol, derived from
p.000113: variations in the methodological structure, replacement of the principal investigator or in the identification of risks in the subjects of
p.000113: investigation. The documents subject to amendment are: project or protocol, informed consent letter, manual
p.000113: of the investigator, documents for the patient, measurement scales and schedule.
p.000113: 4.7 Sufficient scientific evidence, knowledge of which the validity of its content can be confirmed as true, with
p.000113: Certainty and without a doubt.
p.000113: 4.8 Annual report, to the document to be submitted by the Research Committees, Research Ethics and
p.000113: Biosafety to the Ministry of Health during the first 10 business days of the month of June of each year, on integration and
p.000113: activities of said Committees.
p.000113: 4.9 Final technical report, to the document presented by the principal investigator to the Ministry of Health,
p.000113: to communicate the final results of a research protocol or project in accordance with the objective and field of application of
p.000113: This rule, as well as, the main findings obtained at the beginning, during and at the end of the execution.
p.000113: 4.10 Partial technical report, to the document to be submitted by the principal investigator to the Ministry of Health in any
p.000113: time or at least once a year, to communicate the progress and partial results of an investigation, according to the objective and
p.000113: Field of application of this standard.
p.000113: 4.11 Institution or establishment where health research is carried out, to all those where they are provided
p.000113: health care services, belonging to the public, social or private sectors, whatever their denomination, which
p.000113: can carry out preventive, diagnostic, therapeutic and rehabilitation activities, by itself or subrogated, aimed at
p.000113: maintain or reintegrate people's health status and carry out training and staff development activities for the
p.000113: Health as well as research.
p.000113: 4.12 Research for health in human beings, in which the human being is the subject of research and who
p.000113: develops with the sole purpose of making scientific and technological contributions, to obtain new knowledge in
p.000113: health matter.
p.000113: 4.13 Principal investigator, the health professional, to whom the Ministry of Health authorizes a project or protocol for the
p.000113: execution of a research for health in human beings, in accordance with the objective and scope of this standard and is
...
p.000113: Sufficient science of its therapeutic or rehabilitative efficiency or the modification of the therapeutic indications of
p.000113: products already known, in a research subject, with the purpose of obtaining scientific information regarding the effectiveness of
p.000113: its use for preventive, diagnostic, therapeutic or rehabilitative purposes.
p.000113: 4.16 Medicines or materials, to the principles of phamacolological, chemical, biological, materials and medical devices,
p.000113: used or applied in human beings for scientific research purposes, for which there is no evidence
p.000113: scientific enough to prove its preventive, therapeutic or rehabilitative efficacy.
p.000113: 4.17 Modification, any change of administrative type that does not alter the research project or protocol, such as:
p.000113: change of address, business name, change in the integration of the researcher's team or work group, among others.
p.000113: 4.18 Sponsor, natural or legal person who accepts responsibilities that are expressed in writing, to participate and
p.000113: fully or partially finance a research project or protocol.
p.000113: 4.19 Invasive procedure, is one that uses one or several medical techniques that invade the body, with an end
p.000113: Diagnostic or therapeutic.
p.000113: 4.20 Research project or protocol for human health, to the document describing the proposal for
p.000113: an investigation for human health, in accordance with the objective and scope of this standard, integrated at least
p.000113: by the chapters of: planning, programming, organization and budgeting; methodologically structured and
p.000113: systematized in its different phases of work, which will be carried out under the responsibility, conduct and supervision of a
p.000113: principal investigator.
p.000113: 4.21 Subject of investigation, to the individual who gives his informed consent, by himself or by conduct of his
p.000113: legal representative, so that in his person certain procedures are carried out for research purposes
p.000113: Health in humans.
p.000113: 5. General
p.000113: 5.1 For the purposes of this standard, when mention is made of "Regulation", "Secretariat", "investigation" and "institution",
p.000113: will understand that it is the Regulation of the General Health Law regarding health research, the Secretariat of
p.000113: Health, research for human health and the institution or establishment where research is conducted for
p.000113: health, respectively.
p.000113: 5.2 Any research project or protocol for the use of medicines or materials, for which they have not yet
p.000113: there is sufficient scientific evidence of their therapeutic or rehabilitative efficacy or the modification of the
p.000113: therapeutic indications of already known products, you must have authorization from the Secretariat before starting your
p.000113: development
p.000113: 5.3 The Secretariat, for the granting of the authorization of an investigation for health in human beings according to the
p.000113: objective and field of application of this standard, you must confirm that in the research oprotocol project, the
p.000113: criteria of respect for the dignity of the research subject, the protection of their rights, mainly that of the protection of
p.000113: health, as well as the well-being and conservation of their physical integrity.
p.000113: 5.4 It is the power of the Secretariat, within the scope of its competence, and in accordance with the applicable legal provisions,
p.000113: monitoring and control of research projects or protocols authorized according to the objective and scope of application of
...
p.000113: 8.7 The head of the institution or establishment must notify the Secretariat of any adverse effects arising from the
p.000113: experimental maneuver, within a maximum period of 15 working days from its presentation, which includes the measures of
p.000113: care taken, the sequelae identified, as well as a detailed report on the physical condition of the patient, in which
p.000113: Mention if you are free from all risks until the time of notification.
p.000113: 8.8 The head of the institution or establishment, the Research Committees, Research Ethics, Biosecurity or the
p.000113: principal investigator, must order the immediate suspension or cancellation of the investigation, in the presence of any
p.000113: severe adverse effect, which constitutes an ethical or technical impediment to continue the study, about which, you must
p.000113: Notify the Secretariat, in detail, with the opportunity indicated in paragraph 8.7. In that case, the resumption of the
p.000113: Research will require a new authorization.
p.000113: 8.9 The principal investigator must inform the Committee of Ethics in the Investigation of any probable adverse effects or
p.000113: directly related to the investigation. Likewise, it must inform said Committee as frequently as it
p.000113: establish, on the absence of adverse effects on research projects or protocols that are under its
p.000113: responsibility.
p.000113: 8.10 Serious or lethal adverse reactions or effects should be reported immediately to the Secretariat. In the cases
p.000113: If there is a suspicion of adverse effects due to medications, the Mexican Official Standard, referred to in the
p.000113: Section 3.2 of this standard.
p.000113: 9. On the constitution, registration and operation of the Research Committees, Research Ethics and
p.000113: Biosafety
p.000113: 9.1 On the constitution and registration of the Research Committees, Research Ethics and Biosafety.
p.000113: 9.1.1 The establishment of the Research and Biosafety Committees, which are required in the institution or establishment,
p.000113: must be multidisciplinary, with health professionals of different specialties relevant to the issues on which
p.000113: Research in the institution, may or may not have experience in scientific methodology applied to research. They must include
p.000113: professionals from other disciplines, users and people from civil society, representing moral, cultural and
p.000113: The social characteristics of the research subjects may come from the institution itself or from other medical institutions.
p.000113: In the case of the Research Ethics Committees, the provisions of current legislation and the provisions of
p.000113: criteria referred to in article 41 Bis of the General Health Law.
p.000113: 9.1.2 The Research and Biosafety Committees shall be integrated with a minimum of three scientists, plus representatives of
p.000113: civil society deemed necessary, with a total of at least 6 members and a maximum of 20.
p.000113: 9.1.3 When it is not possible to set up a Research or Biosafety Committee, with its own staff the holder may
p.000113: request the support of other Committees constituted at the immediate superior level of their own institution or in institutions or
p.000113: external health facilities.
p.000113: 9.1.4 The head of the institution or establishment must register the Research Committees, Research Ethics and
p.000113: Biosafety, as appropriate, before the Secretariat, to inform about the modification, designation or replacement of any of
p.000113: its members and deliver an annual report of their activities, referring to the evaluation of projects according to the objective and
p.000113: Field of application of this standard.
p.000113: 9.2 On the functioning of the Research Committees, Research Ethics and Biosafety
p.000113: 9.2.1 The constitution and operation of the Committees shall be subject to the provisions of current legislation and, where appropriate, to the
p.000113: criteria referred to in article 41 Bis of the General Health Law.
p.000113: 9.2.2 The members of the Committees shall remain in office for the time established in the installation minutes,
p.000113: being able to be ratified at the end of each period, if necessary replaced in a staggered manner, which should be
p.000113: documentary evidence. The operation and activities of the Committees must be described in the Rules of Operation
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| authority | Relationship to Authority |
| crime | Illegal Activity |
| dependence | Drug Dependence |
| disabled | Mentally Disabled |
| education | education |
| emergencies | patients in emergency situations |
| emergency | Public Emergency |
| family | Motherhood/Family |
| helsinki | declaration of helsinki |
| home | Property Ownership |
| military | Soldier |
| officer | Police Officer |
| opinion | philosophical differences/differences of opinion |
| party | political affiliation |
| pregnant | Pregnant |
| property | Property Ownership |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| home | ['property'] |
| property | ['home'] |
Trigger Words
capacity
consent
cultural
ethics
protect
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input