79C3C34C52B45572883A05D425EB0F82
Supreme Decree Nº 30/2013 Regulation on Law Nº20.120 Modifying Supreme decree Nº114/2010, Regulation on Law No. 20.120 Regarding Scientific Research in Human Beings, the Genome, and the Prohibition of Human Cloning
https://www.leychile.cl/Navegar?idNorma=1048008&
http://leaux.net/URLS/ConvertAPI Text Files/0610E6BD505FB9E36F3469EC714ED752.en.txt
Examining the file media/Synopses/0610E6BD505FB9E36F3469EC714ED752.html:
This file was generated: 2020-12-01 09:05:34
| 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): Camera of
p.(None): Senate Deputies Transparency Contact / Suggestions
p.(None): BCN Chile Law Territorial Information Observatory Political History Civic Formation
p.(None): History of the
p.(None): Search engine Highlights Standards Treaties Law Take it Personalize Help
p.(None): Me
p.(None): Enter selection
p.(None): Home> Browse Standard> Dto 30 Having trouble correctly displaying the
p.(None): rule?
p.(None): Like 0
p.(None): Navigation mode: MODIFY DECREE N ° 114, OF 2010, WHICH APPROVES REGULATION OF LAW N ° 20.120,
p.(None): full text per article ON SCIENTIFIC RESEARCH IN THE HUMAN BEING, ITS GENOME AND PROHIBITS THE
p.(None): HUMAN CLONATION
p.(None): Expand Collapse
p.(None): Send briefcase Clean short URL: Click to generate ...
p.(None): Exp. Standard Back Next Standard: Decree 30 Version: Unique From: JAN 14, 2013 Publication Date: JAN 14, 2013 Promulgation Date: Jul 5, 2012
p.(None): Agency: MINISTRY OF HEALTH; UNDERSECRETARIAT OF PUBLIC HEALTH
p.(None): DECREE 30
p.(None): HEADER
p.(None): ARTICLE
p.(None): PROMULGATION Text | SEARCH CLEAN
p.(None): Text Versions Options Data
p.(None): CHANGES DECREE N ° 114, OF 2010, WHICH APPROVES REGULATION OF
p.(None): LAW No. 20,120, ON SCIENTIFIC INVESTIGATION IN THE BEING
p.(None): HUMAN, ITS GENOME AND PROHIBITS HUMAN CLONING
p.(None): No. 30.- Santiago, July 5, 2012.- Seen: The provisions of Law No.
p.(None): 20.120, on scientific research on humans, their genome, and prohibits
p.(None): human cloning, published in the Official Gazette of September 22,
p.(None): 2006; in decree No. 114 of 2010, Regulation of the aforementioned regulations; at
p.(None): DFL N ° 1, of 2005, of the Ministry of Health, which fixes the consolidated text,
p.(None): coordinated and systematized of the decree law N ° 2.763, of 1979, and of the laws N °
p.(None): 18,933 and No. 18,469; in articles 7 and 8 of decree No. 136 of 2004,
p.(None): Organic Regulation of the Ministry of Health; in resolution No. 1,600 of
p.(None): 2008, from the Comptroller General of the Republic, and
p.(None): Considering:
p.(None): 1. That the Ministry of Health is responsible for exercising the corresponding function
p.(None): The State to guarantee free and equal access to promotional actions,
p.(None): protection and recovery of the health and rehabilitation of the sick person;
p.(None): as well as coordinate, control and, when appropriate, execute such actions.
p.(None): 2. That, in accordance with the foregoing, it corresponds to this Secretary of State
p.(None): formulate, set and control health policies, for which it has, among others
p.(None): functions, the power to issue general standards in technical matters to which
p.(None): the organisms and entities of the System must adhere, to execute activities
p.(None): prevention and health protection.
p.(None): 3. That, in this order of ideas, the President of the Republic, through the
p.(None): Ministry of Health, issued decree No. 114 of 2010, which approves the
p.(None): Regulation of Law No. 20,120, on scientific research in the being
p.(None): human, its genome, and prohibits human cloning.
p.(None): 4.- That, on April 24, 2012, Law No.
p.(None): 20.584 that "Regulates the Rights and Duties that People have in
p.(None): Relationship with Actions Linked to Your Health Care "that regulates matters
p.(None): related to this regulation, which implies the need to update
p.(None): its standards.
p.(None): Bearing in mind: The powers granted to me by Articles 32 No. 6 and
p.(None): 35 of the Political Constitution of the Republic, I dictate the following:
p.(None): Decree:
p.(None): Decree No. 114 of 2010, which approves the Regulations of the law, is amended
p.(None): No. 20,120, on scientific research in humans, their genome, and
p.(None): prohibits human cloning, as follows:
p.(None): 1.- Replace article 1 with the following:
p.(None): "Article 1 .- The purpose of these Regulations is to establish the
p.(None): standards that complement and develop the provisions in force in
p.(None): Law No. 20,120 and the relevant ones of Law No. 20,584, regarding
p.(None): biomedical scientific research in humans and its clinical applications,
p.(None): within the framework of the protection of life, physical and mental integrity of the
p.(None): individual and his diversity and genetic identity. "
p.(None): 2.- Add in the second paragraph of article 6, after the
p.(None): word investigation and preceded by a comma (,) the expression "diagnosis".
p.(None): 3.- Make in article 8 the following modifications:
p.(None): A) Replace letter a) with the following:
p.(None): "a) Biomedical scientific research in humans: all research
p.(None): that implies a physical or psychic intervention or interaction with beings
p.(None): human, with the aim of improving prevention, diagnosis, treatment,
p.(None): management and rehabilitation of people's health or to increase the
p.(None): biological knowledge of the human being. Biomedical scientific research in
p.(None): human beings includes the use of human material or available information
p.(None): identifiable; ".
p.(None): B) Add a new letter b.1) of the following tenor:
p.(None): "b.1) Contract Research Organization (OIC; CRO): Person
p.(None): natural or legal, commercial, academic or otherwise, hired as
p.(None): intermediary by the sponsor, to carry out one or more of the tasks and
...
p.(None): Entry, update processes, Chile Law offers a better time Remember that the deployment speed and performance
p.(None): integration and response of response queries with Google Chrome, of Chile Law, depends on the browser you use and the
p.(None): according to ISO 9001: 2015 Apple Safari or Mozilla Firefox, characteristics of your computer (1 Gb of RAM
p.(None): browsers with a minimum engine and processing speed over 1 GHz.)
p.(None): javascript optimized.
p.(None): Display optimized for screen resolution
p.(None): 1024x768 pixels minimum
p.(None): PORTAL BCN LAW CHILE OBSERVATORY INFORMATION HISTORY POLITICS CIVIC FORMATION
p.(None): TERRITORIAL
p.(None): About the Americas Search Engine About Home
p.(None): Library History of the Law Asia Pacific Elections Constitutions Legislative Bulletin
p.(None): Advice Easy Law Bioethics Historical policies BCN
p.(None): Parliamentarians Take it with you Contact Daily Statistics of Delibera Sessions
p.(None): Territorial Catalog and Interventions Documents and
p.(None): Featured Standards
p.(None): Bookstore Digital Map Library Parliamentary Books
p.(None): Customize
p.(None): Parliamentary Work Our Country Biographical Reviews Evolution
p.(None): Parliamentary Treaties
p.(None): BCN Parliamentary Publications 2017 Constitutional
p.(None): Help Interviews ex
p.(None): Transparency Reports Training Guide
p.(None): Civic Parliamentary Statistics Contact
p.(None): Senate
p.(None): The Congress Teaching Resources
p.(None): National Chamber and its
p.(None): Contact Contact
p.(None): buildings
p.(None): Processes
p.(None): electioneers
p.(None): Matches,
p.(None): movements and
p.(None): coalitions
p.(None): Books and brochures
p.(None): about history
p.(None): politics
p.(None): Historical archives
p.(None): digital
p.(None): Teaching resources
p.(None): Documenting the
p.(None): political history
p.(None): Contact
p.(None): Transparent BCN
...
Health / Physically Ill
Searching for indicator sick:
(return to top)
p.(None): HUMAN CLONATION
p.(None): Expand Collapse
p.(None): Send briefcase Clean short URL: Click to generate ...
p.(None): Exp. Standard Back Next Standard: Decree 30 Version: Unique From: JAN 14, 2013 Publication Date: JAN 14, 2013 Promulgation Date: Jul 5, 2012
p.(None): Agency: MINISTRY OF HEALTH; UNDERSECRETARIAT OF PUBLIC HEALTH
p.(None): DECREE 30
p.(None): HEADER
p.(None): ARTICLE
p.(None): PROMULGATION Text | SEARCH CLEAN
p.(None): Text Versions Options Data
p.(None): CHANGES DECREE N ° 114, OF 2010, WHICH APPROVES REGULATION OF
p.(None): LAW No. 20,120, ON SCIENTIFIC INVESTIGATION IN THE BEING
p.(None): HUMAN, ITS GENOME AND PROHIBITS HUMAN CLONING
p.(None): No. 30.- Santiago, July 5, 2012.- Seen: The provisions of Law No.
p.(None): 20.120, on scientific research on humans, their genome, and prohibits
p.(None): human cloning, published in the Official Gazette of September 22,
p.(None): 2006; in decree No. 114 of 2010, Regulation of the aforementioned regulations; at
p.(None): DFL N ° 1, of 2005, of the Ministry of Health, which fixes the consolidated text,
p.(None): coordinated and systematized of the decree law N ° 2.763, of 1979, and of the laws N °
p.(None): 18,933 and No. 18,469; in articles 7 and 8 of decree No. 136 of 2004,
p.(None): Organic Regulation of the Ministry of Health; in resolution No. 1,600 of
p.(None): 2008, from the Comptroller General of the Republic, and
p.(None): Considering:
p.(None): 1. That the Ministry of Health is responsible for exercising the corresponding function
p.(None): The State to guarantee free and equal access to promotional actions,
p.(None): protection and recovery of the health and rehabilitation of the sick person;
p.(None): as well as coordinate, control and, when appropriate, execute such actions.
p.(None): 2. That, in accordance with the foregoing, it corresponds to this Secretary of State
p.(None): formulate, set and control health policies, for which it has, among others
p.(None): functions, the power to issue general standards in technical matters to which
p.(None): the organisms and entities of the System must adhere, to execute activities
p.(None): prevention and health protection.
p.(None): 3. That, in this order of ideas, the President of the Republic, through the
p.(None): Ministry of Health, issued decree No. 114 of 2010, which approves the
p.(None): Regulation of Law No. 20,120, on scientific research in the being
p.(None): human, its genome, and prohibits human cloning.
p.(None): 4.- That, on April 24, 2012, Law No.
p.(None): 20.584 that "Regulates the Rights and Duties that People have in
p.(None): Relationship with Actions Linked to Your Health Care "that regulates matters
p.(None): related to this regulation, which implies the need to update
p.(None): its standards.
p.(None): Bearing in mind: The powers granted to me by Articles 32 No. 6 and
p.(None): 35 of the Political Constitution of the Republic, I dictate the following:
p.(None): Decree:
p.(None): Decree No. 114 of 2010, which approves the Regulations of the law, is amended
p.(None): No. 20,120, on scientific research in humans, their genome, and
p.(None): prohibits human cloning, as follows:
p.(None): 1.- Replace article 1 with the following:
p.(None): "Article 1 .- The purpose of these Regulations is to establish the
p.(None): standards that complement and develop the provisions in force in
p.(None): Law No. 20,120 and the relevant ones of Law No. 20,584, regarding
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.(None): rule?
p.(None): Like 0
p.(None): Navigation mode: MODIFY DECREE N ° 114, OF 2010, WHICH APPROVES REGULATION OF LAW N ° 20.120,
p.(None): full text per article ON SCIENTIFIC RESEARCH IN THE HUMAN BEING, ITS GENOME AND PROHIBITS THE
p.(None): HUMAN CLONATION
p.(None): Expand Collapse
p.(None): Send briefcase Clean short URL: Click to generate ...
p.(None): Exp. Standard Back Next Standard: Decree 30 Version: Unique From: JAN 14, 2013 Publication Date: JAN 14, 2013 Promulgation Date: Jul 5, 2012
p.(None): Agency: MINISTRY OF HEALTH; UNDERSECRETARIAT OF PUBLIC HEALTH
p.(None): DECREE 30
p.(None): HEADER
p.(None): ARTICLE
p.(None): PROMULGATION Text | SEARCH CLEAN
p.(None): Text Versions Options Data
p.(None): CHANGES DECREE N ° 114, OF 2010, WHICH APPROVES REGULATION OF
p.(None): LAW No. 20,120, ON SCIENTIFIC INVESTIGATION IN THE BEING
p.(None): HUMAN, ITS GENOME AND PROHIBITS HUMAN CLONING
p.(None): No. 30.- Santiago, July 5, 2012.- Seen: The provisions of Law No.
p.(None): 20.120, on scientific research on humans, their genome, and prohibits
p.(None): human cloning, published in the Official Gazette of September 22,
p.(None): 2006; in decree No. 114 of 2010, Regulation of the aforementioned regulations; at
p.(None): DFL N ° 1, of 2005, of the Ministry of Health, which fixes the consolidated text,
p.(None): coordinated and systematized of the decree law N ° 2.763, of 1979, and of the laws N °
p.(None): 18,933 and No. 18,469; in articles 7 and 8 of decree No. 136 of 2004,
p.(None): Organic Regulation of the Ministry of Health; in resolution No. 1,600 of
p.(None): 2008, from the Comptroller General of the Republic, and
p.(None): Considering:
p.(None): 1. That the Ministry of Health is responsible for exercising the corresponding function
p.(None): The State to guarantee free and equal access to promotional actions,
p.(None): protection and recovery of the health and rehabilitation of the sick person;
p.(None): as well as coordinate, control and, when appropriate, execute such actions.
p.(None): 2. That, in accordance with the foregoing, it corresponds to this Secretary of State
p.(None): formulate, set and control health policies, for which it has, among others
p.(None): functions, the power to issue general standards in technical matters to which
p.(None): the organisms and entities of the System must adhere, to execute activities
p.(None): prevention and health protection.
p.(None): 3. That, in this order of ideas, the President of the Republic, through the
p.(None): Ministry of Health, issued decree No. 114 of 2010, which approves the
p.(None): Regulation of Law No. 20,120, on scientific research in the being
p.(None): human, its genome, and prohibits human cloning.
p.(None): 4.- That, on April 24, 2012, Law No.
p.(None): 20.584 that "Regulates the Rights and Duties that People have in
p.(None): Relationship with Actions Linked to Your Health Care "that regulates matters
p.(None): related to this regulation, which implies the need to update
p.(None): its standards.
p.(None): Bearing in mind: The powers granted to me by Articles 32 No. 6 and
p.(None): 35 of the Political Constitution of the Republic, I dictate the following:
p.(None): Decree:
p.(None): Decree No. 114 of 2010, which approves the Regulations of the law, is amended
p.(None): No. 20,120, on scientific research in humans, their genome, and
p.(None): prohibits human cloning, as follows:
p.(None): 1.- Replace article 1 with the following:
p.(None): "Article 1 .- The purpose of these Regulations is to establish the
...
p.(None): physical and mental health and integrity. The minor's refusal to participate or
p.(None): continuing the investigation must be respected. "
p.(None): 6.- Replace article 12 by the following:
p.(None): "Article 12.- Informed consent is understood as acquiescence
p.(None): achieved through a communication process and formalized through a
p.(None): written record, issued by the person in whom the investigation will be conducted or by
p.(None): your legal representative, in which explicit mention is made of the knowledge that
p.(None): it has about the essential aspects of the research, especially its
p.(None): purpose, potential benefits and risks, and procedures or
p.(None): alternative treatments.
p.(None): In relation to scientific research with subjects with mental disabilities
p.(None): or intellectual, you must take into account the provisions of Law No. 20,584 and its
p.(None): pertinent regulations, as appropriate. "
p.(None): 7.- Replace article 16 with the following:
p.(None): "Article 16.- The Scientific Ethical Committees, hereinafter the Committees, are
p.(None): collegiate entities, constituted in public or private institutions in
p.(None): conformity to the standards established in these Regulations, which have
p.(None): essential responsibility to protect the rights, safety and well-being of
p.(None): research subjects.
p.(None): The Committees must be accredited by the Health Authority.
p.(None): Corresponds to the superior authority of the entity in which they are constituted
p.(None): ensure the access of its members to scientific and technical information of the
p.(None): matters related to ethics and biomedical research and ensuring support
p.(None): of resources necessary for its proper functioning, in terms of
p.(None): infrastructure and facilities that facilitate their work, guarantee the
p.(None): confidentiality of the treated subjects as well as to provide the personnel
p.(None): administrative and logistical support that this entails. "
p.(None): 8.- In article 18 make the following modifications:
p.(None): A) In the first paragraph, after the expressions "Ethical Committees
p.(None): Scientists ", add the word" accredited: "
p.(None): B) Add the following numerals:
p.(None): "3) Observe the development of the protocols in progress, in order to
p.(None): recommend any modifications that may be necessary for protection
p.(None): of people participating in the research.
p.(None): 9.- Add a new article 18 bis, the tenor of which is as follows:
p.(None): "Article 18 bis.- The Committee must request from each of its members a
p.(None): declaration of the interests that could affect their participation in order to
p.(None): avoid conflicts of interest. In the event that a member declares a conflict of
p.(None): Interest regarding the protocol to be evaluated, must be withdrawn from its review.
p.(None): Also, at the time that a researcher or group of researchers
p.(None): present for review to a Committee a research project must reveal
p.(None): before it, potential or apparent conflicts of interest. "
p.(None): 10.- Replace article 25 with the following:
p.(None): "Article 25.- It will correspond to the sponsor, by itself or through its
p.(None): intermediary choose suitable researchers with experience and qualification
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.(None): that implies a physical or psychic intervention or interaction with beings
p.(None): human, with the aim of improving prevention, diagnosis, treatment,
p.(None): management and rehabilitation of people's health or to increase the
p.(None): biological knowledge of the human being. Biomedical scientific research in
p.(None): human beings includes the use of human material or available information
p.(None): identifiable; ".
p.(None): B) Add a new letter b.1) of the following tenor:
p.(None): "b.1) Contract Research Organization (OIC; CRO): Person
p.(None): natural or legal, commercial, academic or otherwise, hired as
p.(None): intermediary by the sponsor, to carry out one or more of the tasks and
p.(None): Functions of the sponsor related to the clinical trial. "
p.(None): C) Replace letter e) by the following:
p.(None): "e) Establishment or research site: physical place or geographic space
p.(None): where the researcher plans to contact potential participants and / or where
p.(None): the intervention (s) it includes is carried out. "
p.(None): D) Replace letter g) with the following:
p.(None): "g) Research or multicenter study: biomedical research conducted
p.(None): according to the same protocol that involves two or more establishments or
p.(None): research sites. "
p.(None): 4.- Replace article 10 with the following articles 10 and 10 bis:
p.(None): "Article 10.- All scientific research in human beings to be carried out in
p.(None): the country can only be carried out if it has a favorable review and report
p.(None): of a Scientific Ethical Committee accredited by the Health Authority and
p.(None): independent of the research team.
p.(None): In the cases of multicenter studies, the scientific and ethical review is
p.(None): will be carried out by a single accredited committee, and must be complemented by a
p.(None): local assessment related to researchers and institutions involved
p.(None): at that level to verify the feasibility of the study in their communities,
p.(None): including infrastructure, level of training and considerations
p.(None): significant local ethics. "
p.(None): "Article 10 bis: All scientific research to be carried out on human beings
p.(None): You must have the express authorization of the director or directors of the
p.(None): establishments within which it is carried out, which will be evacuated within
p.(None): of the term of 20 working days counted from the conformity evaluation of the Committee
p.(None): Relevant Scientific Ethics and the Institute of Public Health in the case of the article
p.(None): 7th, second paragraph; the refusal of this authorization must be founded.
p.(None): Said authorization will become effective once the terms in which
p.(None): will carry out the research by the sponsor and its intermediary in its
p.(None): case, and of the investigators, person in charge or main participant, depending on
p.(None): relevant.
p.(None): Any serious adverse event that occurs in the course of the
p.(None): investigation, must be informed promptly by the investigator
p.(None): responsible to the Director of the establishment where the
p.(None): investigation and to the Committee as appropriate. "
p.(None): 5.- Replace the first paragraph of article 11 by the following:
p.(None): "Article 11.- All scientific research carried out with human beings
p.(None): You must have the prior, express, free, informed, personal and
p.(None): written. In the case of minors, it must be ensured that their participation in the
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.(None): including infrastructure, level of training and considerations
p.(None): significant local ethics. "
p.(None): "Article 10 bis: All scientific research to be carried out on human beings
p.(None): You must have the express authorization of the director or directors of the
p.(None): establishments within which it is carried out, which will be evacuated within
p.(None): of the term of 20 working days counted from the conformity evaluation of the Committee
p.(None): Relevant Scientific Ethics and the Institute of Public Health in the case of the article
p.(None): 7th, second paragraph; the refusal of this authorization must be founded.
p.(None): Said authorization will become effective once the terms in which
p.(None): will carry out the research by the sponsor and its intermediary in its
p.(None): case, and of the investigators, person in charge or main participant, depending on
p.(None): relevant.
p.(None): Any serious adverse event that occurs in the course of the
p.(None): investigation, must be informed promptly by the investigator
p.(None): responsible to the Director of the establishment where the
p.(None): investigation and to the Committee as appropriate. "
p.(None): 5.- Replace the first paragraph of article 11 by the following:
p.(None): "Article 11.- All scientific research carried out with human beings
p.(None): You must have the prior, express, free, informed, personal and
p.(None): written. In the case of minors, it must be ensured that their participation in the
p.(None): study does not violate your essential rights or constitute a risk to your
p.(None): physical and mental health and integrity. The minor's refusal to participate or
p.(None): continuing the investigation must be respected. "
p.(None): 6.- Replace article 12 by the following:
p.(None): "Article 12.- Informed consent is understood as acquiescence
p.(None): achieved through a communication process and formalized through a
p.(None): written record, issued by the person in whom the investigation will be conducted or by
p.(None): your legal representative, in which explicit mention is made of the knowledge that
p.(None): it has about the essential aspects of the research, especially its
p.(None): purpose, potential benefits and risks, and procedures or
p.(None): alternative treatments.
p.(None): In relation to scientific research with subjects with mental disabilities
p.(None): or intellectual, you must take into account the provisions of Law No. 20,584 and its
p.(None): pertinent regulations, as appropriate. "
p.(None): 7.- Replace article 16 with the following:
p.(None): "Article 16.- The Scientific Ethical Committees, hereinafter the Committees, are
p.(None): collegiate entities, constituted in public or private institutions in
p.(None): conformity to the standards established in these Regulations, which have
p.(None): essential responsibility to protect the rights, safety and well-being of
p.(None): research subjects.
p.(None): The Committees must be accredited by the Health Authority.
p.(None): Corresponds to the superior authority of the entity in which they are constituted
p.(None): ensure the access of its members to scientific and technical information of the
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.(None): word investigation and preceded by a comma (,) the expression "diagnosis".
p.(None): 3.- Make in article 8 the following modifications:
p.(None): A) Replace letter a) with the following:
p.(None): "a) Biomedical scientific research in humans: all research
p.(None): that implies a physical or psychic intervention or interaction with beings
p.(None): human, with the aim of improving prevention, diagnosis, treatment,
p.(None): management and rehabilitation of people's health or to increase the
p.(None): biological knowledge of the human being. Biomedical scientific research in
p.(None): human beings includes the use of human material or available information
p.(None): identifiable; ".
p.(None): B) Add a new letter b.1) of the following tenor:
p.(None): "b.1) Contract Research Organization (OIC; CRO): Person
p.(None): natural or legal, commercial, academic or otherwise, hired as
p.(None): intermediary by the sponsor, to carry out one or more of the tasks and
p.(None): Functions of the sponsor related to the clinical trial. "
p.(None): C) Replace letter e) by the following:
p.(None): "e) Establishment or research site: physical place or geographic space
p.(None): where the researcher plans to contact potential participants and / or where
p.(None): the intervention (s) it includes is carried out. "
p.(None): D) Replace letter g) with the following:
p.(None): "g) Research or multicenter study: biomedical research conducted
p.(None): according to the same protocol that involves two or more establishments or
p.(None): research sites. "
p.(None): 4.- Replace article 10 with the following articles 10 and 10 bis:
p.(None): "Article 10.- All scientific research in human beings to be carried out in
p.(None): the country can only be carried out if it has a favorable review and report
p.(None): of a Scientific Ethical Committee accredited by the Health Authority and
p.(None): independent of the research team.
p.(None): In the cases of multicenter studies, the scientific and ethical review is
p.(None): will be carried out by a single accredited committee, and must be complemented by a
p.(None): local assessment related to researchers and institutions involved
p.(None): at that level to verify the feasibility of the study in their communities,
p.(None): including infrastructure, level of training and considerations
p.(None): significant local ethics. "
p.(None): "Article 10 bis: All scientific research to be carried out on human beings
p.(None): You must have the express authorization of the director or directors of the
p.(None): establishments within which it is carried out, which will be evacuated within
p.(None): of the term of 20 working days counted from the conformity evaluation of the Committee
p.(None): Relevant Scientific Ethics and the Institute of Public Health in the case of the article
p.(None): 7th, second paragraph; the refusal of this authorization must be founded.
p.(None): Said authorization will become effective once the terms in which
p.(None): will carry out the research by the sponsor and its intermediary in its
p.(None): case, and of the investigators, person in charge or main participant, depending on
p.(None): relevant.
p.(None): Any serious adverse event that occurs in the course of the
p.(None): investigation, must be informed promptly by the investigator
p.(None): responsible to the Director of the establishment where the
p.(None): investigation and to the Committee as appropriate. "
p.(None): 5.- Replace the first paragraph of article 11 by the following:
p.(None): "Article 11.- All scientific research carried out with human beings
p.(None): You must have the prior, express, free, informed, personal and
p.(None): written. In the case of minors, it must be ensured that their participation in the
p.(None): study does not violate your essential rights or constitute a risk to your
p.(None): physical and mental health and integrity. The minor's refusal to participate or
p.(None): continuing the investigation must be respected. "
p.(None): 6.- Replace article 12 by the following:
p.(None): "Article 12.- Informed consent is understood as acquiescence
p.(None): achieved through a communication process and formalized through a
p.(None): written record, issued by the person in whom the investigation will be conducted or by
p.(None): your legal representative, in which explicit mention is made of the knowledge that
p.(None): it has about the essential aspects of the research, especially its
p.(None): purpose, potential benefits and risks, and procedures or
p.(None): alternative treatments.
p.(None): In relation to scientific research with subjects with mental disabilities
p.(None): or intellectual, you must take into account the provisions of Law No. 20,584 and its
p.(None): pertinent regulations, as appropriate. "
p.(None): 7.- Replace article 16 with the following:
p.(None): "Article 16.- The Scientific Ethical Committees, hereinafter the Committees, are
p.(None): collegiate entities, constituted in public or private institutions in
p.(None): conformity to the standards established in these Regulations, which have
p.(None): essential responsibility to protect the rights, safety and well-being of
p.(None): research subjects.
p.(None): The Committees must be accredited by the Health Authority.
p.(None): Corresponds to the superior authority of the entity in which they are constituted
p.(None): ensure the access of its members to scientific and technical information of the
p.(None): matters related to ethics and biomedical research and ensuring support
p.(None): of resources necessary for its proper functioning, in terms of
p.(None): infrastructure and facilities that facilitate their work, guarantee the
p.(None): confidentiality of the treated subjects as well as to provide the personnel
p.(None): administrative and logistical support that this entails. "
p.(None): 8.- In article 18 make the following modifications:
p.(None): A) In the first paragraph, after the expressions "Ethical Committees
p.(None): Scientists ", add the word" accredited: "
p.(None): B) Add the following numerals:
p.(None): "3) Observe the development of the protocols in progress, in order to
p.(None): recommend any modifications that may be necessary for protection
p.(None): of people participating in the research.
p.(None): 9.- Add a new article 18 bis, the tenor of which is as follows:
p.(None): "Article 18 bis.- The Committee must request from each of its members a
p.(None): declaration of the interests that could affect their participation in order to
p.(None): avoid conflicts of interest. In the event that a member declares a conflict of
p.(None): Interest regarding the protocol to be evaluated, must be withdrawn from its review.
p.(None): Also, at the time that a researcher or group of researchers
p.(None): present for review to a Committee a research project must reveal
p.(None): before it, potential or apparent conflicts of interest. "
p.(None): 10.- Replace article 25 with the following:
p.(None): "Article 25.- It will correspond to the sponsor, by itself or through its
...
Orphaned Trigger Words
p.(None): of resources necessary for its proper functioning, in terms of
p.(None): infrastructure and facilities that facilitate their work, guarantee the
p.(None): confidentiality of the treated subjects as well as to provide the personnel
p.(None): administrative and logistical support that this entails. "
p.(None): 8.- In article 18 make the following modifications:
p.(None): A) In the first paragraph, after the expressions "Ethical Committees
p.(None): Scientists ", add the word" accredited: "
p.(None): B) Add the following numerals:
p.(None): "3) Observe the development of the protocols in progress, in order to
p.(None): recommend any modifications that may be necessary for protection
p.(None): of people participating in the research.
p.(None): 9.- Add a new article 18 bis, the tenor of which is as follows:
p.(None): "Article 18 bis.- The Committee must request from each of its members a
p.(None): declaration of the interests that could affect their participation in order to
p.(None): avoid conflicts of interest. In the event that a member declares a conflict of
p.(None): Interest regarding the protocol to be evaluated, must be withdrawn from its review.
p.(None): Also, at the time that a researcher or group of researchers
p.(None): present for review to a Committee a research project must reveal
p.(None): before it, potential or apparent conflicts of interest. "
p.(None): 10.- Replace article 25 with the following:
p.(None): "Article 25.- It will correspond to the sponsor, by itself or through its
p.(None): intermediary choose suitable researchers with experience and qualification
p.(None): professional according to the level of complexity of the research and adopt the
p.(None): receipts that appear in the protocol of the investigation. In said protocol
p.(None): The necessary safeguards must be expressly stated to protect
p.(None): through the appropriate insurance and guarantees, the adverse events that
p.(None): could foresee or that without being foreseeable cause harm to the person. "
p.(None): Sign up, take reason and publish yourself.- SEBASTIÁN PIÑERA ECHENIQUE,
p.(None): President of the Republic.- Jaime Mañalich Muxi, Minister of Health.
p.(None): I am transcribing for your knowledge affection decree No. 30 of 07-05-2012.-
p.(None): Yours sincerely, Jorge Díaz Anaiz, Undersecretary of Public Health.
p.(None): Rise
p.(None): Entry, update processes, Chile Law offers a better time Remember that the deployment speed and performance
p.(None): integration and response of response queries with Google Chrome, of Chile Law, depends on the browser you use and the
p.(None): according to ISO 9001: 2015 Apple Safari or Mozilla Firefox, characteristics of your computer (1 Gb of RAM
p.(None): browsers with a minimum engine and processing speed over 1 GHz.)
p.(None): javascript optimized.
p.(None): Display optimized for screen resolution
p.(None): 1024x768 pixels minimum
p.(None): PORTAL BCN LAW CHILE OBSERVATORY INFORMATION HISTORY POLITICS CIVIC FORMATION
p.(None): TERRITORIAL
p.(None): About the Americas Search Engine About Home
p.(None): Library History of the Law Asia Pacific Elections Constitutions Legislative Bulletin
p.(None): Advice Easy Law Bioethics Historical policies BCN
p.(None): Parliamentarians Take it with you Contact Daily Statistics of Delibera Sessions
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p.(None): Customize
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p.(None): National Chamber and its
p.(None): Contact Contact
p.(None): buildings
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| authority | Relationship to Authority |
| minor | Youth/Minors |
| political | political affiliation |
| sick | Physically Ill |
| single | Marital Status |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
consent
ethics
harm
protect
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input