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Navigation mode: MODIFY DECREE N ° 114, OF 2010, WHICH APPROVES REGULATION OF LAW N ° 20.120,
full text per article ON SCIENTIFIC RESEARCH IN THE HUMAN BEING, ITS GENOME AND PROHIBITS THE
HUMAN CLONATION
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Exp. Standard Back Next Standard: Decree 30 Version: Unique From: JAN 14, 2013 Publication Date: JAN 14, 2013 Promulgation Date: Jul 5, 2012
Agency: MINISTRY OF HEALTH; UNDERSECRETARIAT OF PUBLIC HEALTH
DECREE 30
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CHANGES DECREE N ° 114, OF 2010, WHICH APPROVES REGULATION OF
LAW No. 20,120, ON SCIENTIFIC INVESTIGATION IN THE BEING
HUMAN, ITS GENOME AND PROHIBITS HUMAN CLONING
No. 30.- Santiago, July 5, 2012.- Seen: The provisions of Law No.
20.120, on scientific research on humans, their genome, and prohibits
human cloning, published in the Official Gazette of September 22,
2006; in decree No. 114 of 2010, Regulation of the aforementioned regulations; at
DFL N ° 1, of 2005, of the Ministry of Health, which fixes the consolidated text,
coordinated and systematized of the decree law N ° 2.763, of 1979, and of the laws N °
18,933 and No. 18,469; in articles 7 and 8 of decree No. 136 of 2004,
Organic Regulation of the Ministry of Health; in resolution No. 1,600 of
2008, from the Comptroller General of the Republic, and
Considering:
1. That the Ministry of Health is responsible for exercising the corresponding function
The State to guarantee free and equal access to promotional actions,
protection and recovery of the health and rehabilitation of the sick person;
as well as coordinate, control and, when appropriate, execute such actions.
2. That, in accordance with the foregoing, it corresponds to this Secretary of State
formulate, set and control health policies, for which it has, among others
functions, the power to issue general standards in technical matters to which
the organisms and entities of the System must adhere, to execute activities
prevention and health protection.
3. That, in this order of ideas, the President of the Republic, through the
Ministry of Health, issued decree No. 114 of 2010, which approves the
Regulation of Law No. 20,120, on scientific research in the being
human, its genome, and prohibits human cloning.
4.- That, on April 24, 2012, Law No.
20.584 that "Regulates the Rights and Duties that People have in
Relationship with Actions Linked to Your Health Care "that regulates matters
related to this regulation, which implies the need to update
its standards.
Bearing in mind: The powers granted to me by Articles 32 No. 6 and
35 of the Political Constitution of the Republic, I dictate the following:
Decree:
Decree No. 114 of 2010, which approves the Regulations of the law, is amended
No. 20,120, on scientific research in humans, their genome, and
prohibits human cloning, as follows:
1.- Replace article 1 with the following:
"Article 1 .- The purpose of these Regulations is to establish the
standards that complement and develop the provisions in force in
Law No. 20,120 and the relevant ones of Law No. 20,584, regarding
biomedical scientific research in humans and its clinical applications,
within the framework of the protection of life, physical and mental integrity of the
individual and his diversity and genetic identity. "
2.- Add in the second paragraph of article 6, after the
word investigation and preceded by a comma (,) the expression "diagnosis".
3.- Make in article 8 the following modifications:
A) Replace letter a) with the following:
"a) Biomedical scientific research in humans: all research
that implies a physical or psychic intervention or interaction with beings
human, with the aim of improving prevention, diagnosis, treatment,
management and rehabilitation of people's health or to increase the
biological knowledge of the human being. Biomedical scientific research in
human beings includes the use of human material or available information
identifiable; ".
B) Add a new letter b.1) of the following tenor:
"b.1) Contract Research Organization (OIC; CRO): Person
natural or legal, commercial, academic or otherwise, hired as
intermediary by the sponsor, to carry out one or more of the tasks and
Functions of the sponsor related to the clinical trial. "
C) Replace letter e) by the following:
"e) Establishment or research site: physical place or geographic space
where the researcher plans to contact potential participants and / or where
the intervention (s) it includes is carried out. "
D) Replace letter g) with the following:
"g) Research or multicenter study: biomedical research conducted
according to the same protocol that involves two or more establishments or
research sites. "
4.- Replace article 10 with the following articles 10 and 10 bis:
"Article 10.- All scientific research in human beings to be carried out in
the country can only be carried out if it has a favorable review and report
of a Scientific Ethical Committee accredited by the Health Authority and
independent of the research team.
In the cases of multicenter studies, the scientific and ethical review is
will be carried out by a single accredited committee, and must be complemented by a
local assessment related to researchers and institutions involved
at that level to verify the feasibility of the study in their communities,
including infrastructure, level of training and considerations
significant local ethics. "
"Article 10 bis: All scientific research to be carried out on human beings
You must have the express authorization of the director or directors of the
establishments within which it is carried out, which will be evacuated within
of the term of 20 working days counted from the conformity evaluation of the Committee
Relevant Scientific Ethics and the Institute of Public Health in the case of the article
7th, second paragraph; the refusal of this authorization must be founded.
Said authorization will become effective once the terms in which
will carry out the research by the sponsor and its intermediary in its
case, and of the investigators, person in charge or main participant, depending on
relevant.
Any serious adverse event that occurs in the course of the
investigation, must be informed promptly by the investigator
responsible to the Director of the establishment where the
investigation and to the Committee as appropriate. "
5.- Replace the first paragraph of article 11 by the following:
"Article 11.- All scientific research carried out with human beings
You must have the prior, express, free, informed, personal and
written. In the case of minors, it must be ensured that their participation in the
study does not violate your essential rights or constitute a risk to your
physical and mental health and integrity. The minor's refusal to participate or
continuing the investigation must be respected. "
6.- Replace article 12 by the following:
"Article 12.- Informed consent is understood as acquiescence
achieved through a communication process and formalized through a
written record, issued by the person in whom the investigation will be conducted or by
your legal representative, in which explicit mention is made of the knowledge that
it has about the essential aspects of the research, especially its
purpose, potential benefits and risks, and procedures or
alternative treatments.
In relation to scientific research with subjects with mental disabilities
or intellectual, you must take into account the provisions of Law No. 20,584 and its
pertinent regulations, as appropriate. "
7.- Replace article 16 with the following:
"Article 16.- The Scientific Ethical Committees, hereinafter the Committees, are
collegiate entities, constituted in public or private institutions in
conformity to the standards established in these Regulations, which have
essential responsibility to protect the rights, safety and well-being of
research subjects.
The Committees must be accredited by the Health Authority.
Corresponds to the superior authority of the entity in which they are constituted
ensure the access of its members to scientific and technical information of the
matters related to ethics and biomedical research and ensuring support
of resources necessary for its proper functioning, in terms of
infrastructure and facilities that facilitate their work, guarantee the
confidentiality of the treated subjects as well as to provide the personnel
administrative and logistical support that this entails. "
8.- In article 18 make the following modifications:
A) In the first paragraph, after the expressions "Ethical Committees
Scientists ", add the word" accredited: "
B) Add the following numerals:
"3) Observe the development of the protocols in progress, in order to
recommend any modifications that may be necessary for protection
of people participating in the research.
9.- Add a new article 18 bis, the tenor of which is as follows:
"Article 18 bis.- The Committee must request from each of its members a
declaration of the interests that could affect their participation in order to
avoid conflicts of interest. In the event that a member declares a conflict of
Interest regarding the protocol to be evaluated, must be withdrawn from its review.
Also, at the time that a researcher or group of researchers
present for review to a Committee a research project must reveal
before it, potential or apparent conflicts of interest. "
10.- Replace article 25 with the following:
"Article 25.- It will correspond to the sponsor, by itself or through its
intermediary choose suitable researchers with experience and qualification
professional according to the level of complexity of the research and adopt the
receipts that appear in the protocol of the investigation. In said protocol
The necessary safeguards must be expressly stated to protect
through the appropriate insurance and guarantees, the adverse events that
could foresee or that without being foreseeable cause harm to the person. "
Sign up, take reason and publish yourself.- SEBASTIÁN PIÑERA ECHENIQUE,
President of the Republic.- Jaime Mañalich Muxi, Minister of Health.
I am transcribing for your knowledge affection decree No. 30 of 07-05-2012.-
Yours sincerely, Jorge Díaz Anaiz, Undersecretary of Public Health.
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