0A4F4F9BD490A749D5437F821CF06DF1
Regulation on Research, Ministerial Agreement No. 0066, Public Registry No. 292
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This file was generated: 2020-07-15 04:40:20
| 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 / political affiliation
Searching for indicator political:
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p.(None): REGULATION OF PROJECTS IN HEALTH RESEARCH
p.(None): Ministerial Agreement 66
p.(None): Official Registry 292 of 11-Mar.-2008 Status: Current
p.(None): THE MINISTER OF PUBLIC HEALTH
p.(None): Considering:
p.(None): That the Political Constitution of the Republic provides in Article 44 that "The State shall formulate the National Policy of
p.(None): Health and will monitor your application; will control the operation of the entities of the sector will recognize respect and
p.(None): promote the development of traditional and alternative medicines, the exercise of which will be regulated by law, and
p.(None): will promote scientific and technological progress in the area of health, subject to bioethical principles ";
p.(None): That Article 42 of the Magna Carta, provides that "the State shall guarantee the right to Health, as well as the
p.(None): possibility of permanent and uninterrupted access to health services, in accordance with the principles of
p.(None): equity, universality solidarity, quality and efficiency ";
p.(None): That the Organic Law of Health in the Fifth Book, Sole Title, Chapter I in its articles 207 and 208 provides that it shall be
p.(None): the national health authority who regulates scientific research and development activities
p.(None): health technology; as well as the same Organic Law, in its Chapter II articles 209 to 214, regulates in
p.(None): general form the powers of the Ministry of Public Health (MSP), in the standardization, regulation and control of the
p.(None): human genetics;
p.(None): That the development of research and technology for health must meet ethical aspects that guarantee the
p.(None): dignity and well-being of the person under investigation;
p.(None): That the development of health research requires the establishment of technical criteria to regulate
p.(None): the application of procedures related to the correct use of the resources allocated to it;
p.(None): That without restricting the freedom of researchers, in the particular case of research carried out on beings
p.(None): human and of which use materials or procedures that carry risk, it is necessary to adhere to the principles
p.(None): fundamental scientific and ethical; of autonomy, beneficence, justice and security standards
p.(None): universally accepted;
p.(None): That research in health sciences is justified as long as cash is achieved with it
p.(None): benefit of the participants in an investigation, and also, effectively contribute to the relief of suffering, to
p.(None): improve the quality of life and the prolongation worthy of it;
p.(None): That the investigation of new prophylactic, diagnostic and rehabilitation resources must be subject to
p.(None): to control to obtain greater efficiency and avoid risks to people's health;
p.(None): That with memorandum No. PCYT.222-519 of October 16, 2007, the Director of the Science Process and
p.(None): Technology (PCYT) of the Ministry of Public Health, requests the preparation of this ministerial agreement;
p.(None): Y,
p.(None): In exercise of the powers granted by articles 176 and 179 of the Political Constitution of the Republic and
p.(None): Article 17 of the Statute of the Administrative Legal Regime of the Executive Function.
p.(None): Agree:
p.(None): REGULATION OF PROJECTS IN HEALTH RESEARCH - Page 1
p.(None): LEXIS FINDER - www.lexis.com.ec
p.(None): Issue the Regulations for the approval, monitoring, follow-up, evaluation of health research projects
p.(None): that relate to the areas relevant to the Ministry of Public Health.
p.(None): Art. 1.- The Ministry of Public Health, through the Directorate of the Science and Technology Process, shall approve the
p.(None): protocols, projects and / or health research programs whose objectives and purposes are developed within the
p.(None): Biomedical research areas (controlled clinical studies), predictive, preventive and curative.
p.(None): Art. 2.- The institutions that execute projects or programs of investigation in health must precautionary
p.(None): compliance with standards that relate to protocols, researchers and groups of people
p.(None): participants must contribute to the quality of science and ethics of biomedical research and
p.(None): they must have the following characteristics: political and institutional independence, be multidisciplinary,
p.(None): multisectoral, with scientific experience and of a pluralistic nature and free from prejudices.
p.(None): Art. 3.- Of the objectives and / or purposes of health research protocols, projects or programs:
p.(None): a) Contribute to the development of health science and technology with high quality and ethical constancy;
p.(None): b) Safeguard the dignity and respect of people, security rights, confidentiality and good conduct of
p.(None): the biomedical research of the institution, as well as the right to be informed and consent
p.(None): willingly to participate in an investigation; Y,
p.(None): c) Know, apply and comply with all the standards that have been accepted internationally and that have
p.(None): relation with the observance of all the technical, scientific and ethical aspects that the responsibility entails
p.(None): personal and institutional for the execution of health research.
p.(None): Art. 4.- On the constitution, organization and participation of institutional bioethics committees:
p.(None): These must comply with the provisions detailed in Ministerial Agreement No. 000099 of July 13, 2006,
p.(None): published in the Official Registry 361 of September 21, 2006.
p.(None): Art. 5.- Repeal all the provisions that oppose this ministerial agreement.
p.(None): Art. 6.- Of the application and execution of the present ministerial agreement, which will come into effect from the date of
p.(None): its publication in the Official Registry, be entrusted to the General Directorate of Health through the Science Process and
p.(None): Technology.
p.(None): Given in the Metropolitan District of Quito, February 8, 2008. f.) Dr. Caroline Chang Campos, Minister of Health
p.(None): Public
p.(None): It is a faithful copy of the document that appears in the file of the General Secretariat, to which I refer if necessary.
...
Social / Access to Social Goods
Searching for indicator access:
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p.(None): REGULATION OF PROJECTS IN HEALTH RESEARCH
p.(None): Ministerial Agreement 66
p.(None): Official Registry 292 of 11-Mar.-2008 Status: Current
p.(None): THE MINISTER OF PUBLIC HEALTH
p.(None): Considering:
p.(None): That the Political Constitution of the Republic provides in Article 44 that "The State shall formulate the National Policy of
p.(None): Health and will monitor your application; will control the operation of the entities of the sector will recognize respect and
p.(None): promote the development of traditional and alternative medicines, the exercise of which will be regulated by law, and
p.(None): will promote scientific and technological progress in the area of health, subject to bioethical principles ";
p.(None): That Article 42 of the Magna Carta, provides that "the State shall guarantee the right to Health, as well as the
p.(None): possibility of permanent and uninterrupted access to health services, in accordance with the principles of
p.(None): equity, universality solidarity, quality and efficiency ";
p.(None): That the Organic Law of Health in the Fifth Book, Sole Title, Chapter I in its articles 207 and 208 provides that it shall be
p.(None): the national health authority who regulates scientific research and development activities
p.(None): health technology; as well as the same Organic Law, in its Chapter II articles 209 to 214, regulates in
p.(None): general form the powers of the Ministry of Public Health (MSP), in the standardization, regulation and control of the
p.(None): human genetics;
p.(None): That the development of research and technology for health must meet ethical aspects that guarantee the
p.(None): dignity and well-being of the person under investigation;
p.(None): That the development of health research requires the establishment of technical criteria to regulate
p.(None): the application of procedures related to the correct use of the resources allocated to it;
p.(None): That without restricting the freedom of researchers, in the particular case of research carried out on beings
p.(None): human and of which use materials or procedures that carry risk, it is necessary to adhere to the principles
p.(None): fundamental scientific and ethical; of autonomy, beneficence, justice and security standards
p.(None): universally accepted;
p.(None): That research in health sciences is justified as long as cash is achieved with it
p.(None): benefit of the participants in an investigation, and also, effectively contribute to the relief of suffering, to
p.(None): improve the quality of life and the prolongation worthy of it;
...
General/Other / Impaired Autonomy
Searching for indicator autonomy:
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p.(None): will promote scientific and technological progress in the area of health, subject to bioethical principles ";
p.(None): That Article 42 of the Magna Carta, provides that "the State shall guarantee the right to Health, as well as the
p.(None): possibility of permanent and uninterrupted access to health services, in accordance with the principles of
p.(None): equity, universality solidarity, quality and efficiency ";
p.(None): That the Organic Law of Health in the Fifth Book, Sole Title, Chapter I in its articles 207 and 208 provides that it shall be
p.(None): the national health authority who regulates scientific research and development activities
p.(None): health technology; as well as the same Organic Law, in its Chapter II articles 209 to 214, regulates in
p.(None): general form the powers of the Ministry of Public Health (MSP), in the standardization, regulation and control of the
p.(None): human genetics;
p.(None): That the development of research and technology for health must meet ethical aspects that guarantee the
p.(None): dignity and well-being of the person under investigation;
p.(None): That the development of health research requires the establishment of technical criteria to regulate
p.(None): the application of procedures related to the correct use of the resources allocated to it;
p.(None): That without restricting the freedom of researchers, in the particular case of research carried out on beings
p.(None): human and of which use materials or procedures that carry risk, it is necessary to adhere to the principles
p.(None): fundamental scientific and ethical; of autonomy, beneficence, justice and security standards
p.(None): universally accepted;
p.(None): That research in health sciences is justified as long as cash is achieved with it
p.(None): benefit of the participants in an investigation, and also, effectively contribute to the relief of suffering, to
p.(None): improve the quality of life and the prolongation worthy of it;
p.(None): That the investigation of new prophylactic, diagnostic and rehabilitation resources must be subject to
p.(None): to control to obtain greater efficiency and avoid risks to people's health;
p.(None): That with memorandum No. PCYT.222-519 of October 16, 2007, the Director of the Science Process and
p.(None): Technology (PCYT) of the Ministry of Public Health, requests the preparation of this ministerial agreement;
p.(None): Y,
p.(None): In exercise of the powers granted by articles 176 and 179 of the Political Constitution of the Republic and
p.(None): Article 17 of the Statute of the Administrative Legal Regime of the Executive Function.
p.(None): Agree:
p.(None): REGULATION OF PROJECTS IN HEALTH RESEARCH - Page 1
p.(None): LEXIS FINDER - www.lexis.com.ec
p.(None): Issue the Regulations for the approval, monitoring, follow-up, evaluation of health research projects
p.(None): that relate to the areas relevant to the Ministry of Public Health.
p.(None): Art. 1.- The Ministry of Public Health, through the Directorate of the Science and Technology Process, shall approve the
p.(None): protocols, projects and / or health research programs whose objectives and purposes are developed within the
p.(None): Biomedical research areas (controlled clinical studies), predictive, preventive and curative.
p.(None): Art. 2.- The institutions that execute projects or programs of investigation in health must precautionary
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.(None): REGULATION OF PROJECTS IN HEALTH RESEARCH
p.(None): Ministerial Agreement 66
p.(None): Official Registry 292 of 11-Mar.-2008 Status: Current
p.(None): THE MINISTER OF PUBLIC HEALTH
p.(None): Considering:
p.(None): That the Political Constitution of the Republic provides in Article 44 that "The State shall formulate the National Policy of
p.(None): Health and will monitor your application; will control the operation of the entities of the sector will recognize respect and
p.(None): promote the development of traditional and alternative medicines, the exercise of which will be regulated by law, and
p.(None): will promote scientific and technological progress in the area of health, subject to bioethical principles ";
p.(None): That Article 42 of the Magna Carta, provides that "the State shall guarantee the right to Health, as well as the
p.(None): possibility of permanent and uninterrupted access to health services, in accordance with the principles of
p.(None): equity, universality solidarity, quality and efficiency ";
p.(None): That the Organic Law of Health in the Fifth Book, Sole Title, Chapter I in its articles 207 and 208 provides that it shall be
p.(None): the national health authority who regulates scientific research and development activities
p.(None): health technology; as well as the same Organic Law, in its Chapter II articles 209 to 214, regulates in
p.(None): general form the powers of the Ministry of Public Health (MSP), in the standardization, regulation and control of the
p.(None): human genetics;
p.(None): That the development of research and technology for health must meet ethical aspects that guarantee the
p.(None): dignity and well-being of the person under investigation;
p.(None): That the development of health research requires the establishment of technical criteria to regulate
p.(None): the application of procedures related to the correct use of the resources allocated to it;
p.(None): That without restricting the freedom of researchers, in the particular case of research carried out on beings
p.(None): human and of which use materials or procedures that carry risk, it is necessary to adhere to the principles
p.(None): fundamental scientific and ethical; of autonomy, beneficence, justice and security standards
p.(None): universally accepted;
p.(None): That research in health sciences is justified as long as cash is achieved with it
p.(None): benefit of the participants in an investigation, and also, effectively contribute to the relief of suffering, to
p.(None): improve the quality of life and the prolongation worthy of it;
p.(None): That the investigation of new prophylactic, diagnostic and rehabilitation resources must be subject to
p.(None): to control to obtain greater efficiency and avoid risks to people's health;
p.(None): That with memorandum No. PCYT.222-519 of October 16, 2007, the Director of the Science Process and
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| authority | Relationship to Authority |
| autonomy | Impaired Autonomy |
| political | political affiliation |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
ethics
justice
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input