REGULATION OF PROJECTS IN HEALTH RESEARCH
Ministerial Agreement 66
Official Registry 292 of 11-Mar.-2008 Status: Current
THE MINISTER OF PUBLIC HEALTH
Considering:
That the Political Constitution of the Republic provides in Article 44 that "The State shall formulate the National Policy of
Health and will monitor your application; will control the operation of the entities of the sector will recognize respect and
promote the development of traditional and alternative medicines, the exercise of which will be regulated by law, and
will promote scientific and technological progress in the area of ​​health, subject to bioethical principles ";
That Article 42 of the Magna Carta, provides that "the State shall guarantee the right to Health, as well as the
possibility of permanent and uninterrupted access to health services, in accordance with the principles of
equity, universality solidarity, quality and efficiency ";
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
the national health authority who regulates scientific research and development activities
health technology; as well as the same Organic Law, in its Chapter II articles 209 to 214, regulates in
general form the powers of the Ministry of Public Health (MSP), in the standardization, regulation and control of the
human genetics;
That the development of research and technology for health must meet ethical aspects that guarantee the
dignity and well-being of the person under investigation;
That the development of health research requires the establishment of technical criteria to regulate
the application of procedures related to the correct use of the resources allocated to it;
That without restricting the freedom of researchers, in the particular case of research carried out on beings
human and of which use materials or procedures that carry risk, it is necessary to adhere to the principles
fundamental scientific and ethical; of autonomy, beneficence, justice and security standards
universally accepted;
That research in health sciences is justified as long as cash is achieved with it
benefit of the participants in an investigation, and also, effectively contribute to the relief of suffering, to
improve the quality of life and the prolongation worthy of it;
That the investigation of new prophylactic, diagnostic and rehabilitation resources must be subject to
to control to obtain greater efficiency and avoid risks to people's health;
That with memorandum No. PCYT.222-519 of October 16, 2007, the Director of the Science Process and
Technology (PCYT) of the Ministry of Public Health, requests the preparation of this ministerial agreement;
Y,
In exercise of the powers granted by articles 176 and 179 of the Political Constitution of the Republic and
Article 17 of the Statute of the Administrative Legal Regime of the Executive Function.
Agree:
REGULATION OF PROJECTS IN HEALTH RESEARCH - Page 1
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Issue the Regulations for the approval, monitoring, follow-up, evaluation of health research projects
that relate to the areas relevant to the Ministry of Public Health.
Art. 1.- The Ministry of Public Health, through the Directorate of the Science and Technology Process, shall approve the
protocols, projects and / or health research programs whose objectives and purposes are developed within the
Biomedical research areas (controlled clinical studies), predictive, preventive and curative.
Art. 2.- The institutions that execute projects or programs of investigation in health must precautionary
compliance with standards that relate to protocols, researchers and groups of people
participants must contribute to the quality of science and ethics of biomedical research and
they must have the following characteristics: political and institutional independence, be multidisciplinary,
multisectoral, with scientific experience and of a pluralistic nature and free from prejudices.
Art. 3.- Of the objectives and / or purposes of health research protocols, projects or programs:
a) Contribute to the development of health science and technology with high quality and ethical constancy;
b) Safeguard the dignity and respect of people, security rights, confidentiality and good conduct of
the biomedical research of the institution, as well as the right to be informed and consent
willingly to participate in an investigation; Y,
c) Know, apply and comply with all the standards that have been accepted internationally and that have
relation with the observance of all the technical, scientific and ethical aspects that the responsibility entails
personal and institutional for the execution of health research.
Art. 4.- On the constitution, organization and participation of institutional bioethics committees:
These must comply with the provisions detailed in Ministerial Agreement No. 000099 of July 13, 2006,
published in the Official Registry 361 of September 21, 2006.
Art. 5.- Repeal all the provisions that oppose this ministerial agreement.
Art. 6.- Of the application and execution of the present ministerial agreement, which will come into effect from the date of
its publication in the Official Registry, be entrusted to the General Directorate of Health through the Science Process and
Technology.
Given in the Metropolitan District of Quito, February 8, 2008. f.) Dr. Caroline Chang Campos, Minister of Health
Public
It is a faithful copy of the document that appears in the file of the General Secretariat, to which I refer if necessary.
I certify.- Quito, February 27, 2008.
f.) Dr. Nelly Cecilia Mendoza Orquera, General Secretary of the Ministry of Public Health.
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