79C3C34C52B45572883A05D425EB0F82
Resolution CNS No 580/2018 on Research of Strategic Interest for the Unified Health System (SUS)
http://conselho.saude.gov.br/resolucoes/2018/Reso580.pdf
http://leaux.net/URLS/ConvertAPI Text Files/DD492F53306145FDB8D50832599BAEEF.en.txt
Examining the file media/Synopses/DD492F53306145FDB8D50832599BAEEF.html:
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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
Health / patients in emergency situations
Searching for indicator emergencies:
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p.(None): person he delegates;
p.(None): VI - co-participant research institution: organization, public or private, legitimately constituted and qualified,
p.(None): in which any of the research phases or stages takes place, without necessarily having the indication of a researcher
p.(None): responsible in the institution;
p.(None): VII - institution participating in the research: organization, public or private, legitimately constituted and
p.(None): who participates in a multicenter study and where the research project is conducted according to
p.(None): single protocol with a responsible researcher at the center;
p.(None): VIII - institution proposing the research: organization, public or private, legitimately constituted and
p.(None): enabled, to which the responsible researcher is linked;
p.(None): IX - SUS member institution: federal, state and municipal public bodies and institutions, of the
p.(None): direct and indirect administration and of the foundations maintained by the Public Power. Also included are
p.(None): federal, state and municipal public institutions for quality control, research and production of inputs,
p.(None): medicines, including blood and blood products, and health equipment. The private sector may participate
p.(None): SUS, in a complementary character, as provided for in article 24, of Law No. 8,080, of September 19, 1990;
p.(None): X - human biological material: specimens, samples and aliquots of original material and its fractionated components;
p.(None): XI - research of strategic interest to SUS: protocols that contribute to public health, justice, reduction
p.(None): social inequalities and technological dependencies, as well as public health emergencies, referred to the
p.(None): appreciation of CONEP upon request from the Secretariat of Science, Technology and Strategic Inputs
p.(None): the Ministry of Health (SCTIE / MS);
p.(None): XII - researcher: member of the research team, co-responsible for the integrity and well-being of the participants
p.(None): research;
p.(None): XIII - responsible researcher: person responsible for coordinating the research and co-responsible for
p.(None): integrity and well-being of research participants;
p.(None): XIV - Unified Health System: public health promotion, protection and recovery system, created by
p.(None): Federal Constitution of 1,988 and regulated by Law 8,080, of September 19, 1990, and Law 8,142, of 28
p.(None): December 1990, in the form of services that integrate health protection and promotion, prevention and assistance,
p.(None): provided by federal, state and municipal public agencies, direct administration and
p.(None): indirectly, foundations maintained by the Public Power and by private institutions, on a complementary basis;
p.(None): XV - Term of Institutional Consent (TAI): document of consent to the conduct of research in
p.(None): institution, which must describe the activities to be developed, being signed by the manager
p.(None): institutional or person delegated by him, with identification of position / function and respective signature;
...
p.(None): Art. 8 The project must present the budget in accordance with the current regulations.
p.(None): Art. 9. It is the duty of the researcher to disclose the results of the research to the participants and institutions where the data
p.(None): were collected at the end of the study.
p.(None): Art. 10. The ethical appraisal of studies carried out in services that are part of SUS must be carried out in CEP
p.(None): linked to the institution where the research participants will be recruited, without prejudice to the flow defined by the
p.(None): other CNS resolutions. If there is no CEP in the institution, the flow defined by CONEP must be followed.
p.(None): §1 In the case of carrying out the study in an institution that is classified as a participant or co-participant in the
p.(None): research, the Institutional Consent Term must be signed by the director of the institution and will compose the set
p.(None): documentary for the ethical appreciation of research.
p.(None): Paragraph 2. In the case of research using the institution's collection, the researcher must inform the
p.(None): procedures that will be adopted to guarantee the confidentiality, privacy and confidentiality of the participant's data
p.(None): of research.
p.(None): CHAPTER III
p.(None): From Strategic Research to SUS
p.(None): Art. 11. Research considered to be of strategic interest to SUS by the Ministry of Health will be forwarded to
p.(None): initial appraisal at CONEP (as CEP of the Ministry of Health) and may be processed in a special
p.(None): urgency.
p.(None): §1º The Ministry of Health will define which research protocols should be prioritized, through
p.(None): justified, for urgent procedure at CONEP.
p.(None): §2º Research protocols that respond to health emergencies will be processed as a matter of urgency.
p.(None): and / or subsidize the implementation of health policies, actions, programs and services, in order to respond
p.(None): timely to issues of public interest in the area of health.
p.(None): Paragraph 3. The request from the Ministry of Health for urgency and special procedures at CONEP will be made through
p.(None): specific document for each referral project of the Secretary for Science, Technology and Inputs
p.(None): Of the Ministry of Health.
p.(None): Art. 12. The projects considered as strategic research and submitted by the Ministry of
p.(None): Health, as a matter of urgency for special procedures at CONEP, will have their first evaluation in up to 10
p.(None): (ten) working days, with the appreciation of at least five sitting members, one of whom is a member of
p.(None): Coordination of CONEP.
p.(None): CHAPTER IV
p.(None): Research with cooperation or co-sponsorship of the Brazilian government
p.(None): Art. 13. For the processing of research projects with cooperation or co-sponsorship with the Brazilian Government,
p.(None): as expressed in item IX.4, points 1.1 and 8, of CNS Resolution No. 466, of December 12, 2012, must be attached
p.(None): the referral document of the Secretary of the Secretariat for Science, Technology and Strategic Inputs of the
p.(None): Ministry of Health, project specific, in the protocol.
p.(None): Single paragraph. In such cases, the assessment will be carried out by the CEP of the proposing institution and
p.(None): participants, if applicable, without the need for processing at CONEP.
p.(None): Art. 14. The other current ethical standards apply, when there is no prejudice to the provisions of this Resolution.
p.(None): Art. 15. This Resolution takes effect on the date of its publication.
p.(None): RONALD FERREIRA DOS SANTOS
...
Social / Access to Social Goods
Searching for indicator access:
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p.(None): research;
p.(None): XIII - responsible researcher: person responsible for coordinating the research and co-responsible for
p.(None): integrity and well-being of research participants;
p.(None): XIV - Unified Health System: public health promotion, protection and recovery system, created by
p.(None): Federal Constitution of 1,988 and regulated by Law 8,080, of September 19, 1990, and Law 8,142, of 28
p.(None): December 1990, in the form of services that integrate health protection and promotion, prevention and assistance,
p.(None): provided by federal, state and municipal public agencies, direct administration and
p.(None): indirectly, foundations maintained by the Public Power and by private institutions, on a complementary basis;
p.(None): XV - Term of Institutional Consent (TAI): document of consent to the conduct of research in
p.(None): institution, which must describe the activities to be developed, being signed by the manager
p.(None): institutional or person delegated by him, with identification of position / function and respective signature;
p.(None): XVI - Health worker: employees (public employees, statutory employees, employees, outsourced workers, among others)
p.(None): institutions that are part of the SUS, in the exercise of their professional functions; and
p.(None): XVII - health user: person who has access to ordered and organized goods and services for the prevention of
p.(None): disease and health promotion, protection, treatment and recovery;
p.(None): CHAPTER II
p.(None): Ethical aspects of research with human beings in institutions
p.(None): SUS
p.(None): Art. 2 The researches carried out in institutions that are members of SUS must comply with ethical and
p.(None): public service responsibility and social interest, and should not be confused with
p.(None): health care.
p.(None): Art. 3 The use for research purposes of human collections and / or biological material resulting from research activities
p.(None): health care can only be carried out with the due appreciation and ethical approval of the CEP / CONEP System.
p.(None): Art. 4 It is the duty of the responsible researcher, or person delegated by him to the research team, to explain, in the
p.(None): process of obtaining consent, to the research participant recruited from a health service linked to the
p.(None): SUS (health service user), the difference between the research procedure and the routine service of the service.
p.(None): Single paragraph. User service should not be harmed, regardless of your decision to
p.(None): participate or not participate in the research, and this guarantee must be explicit in the consent process and in the
p.(None): Free and Informed Consent (ICF) when applicable.
p.(None): Art. 5 The research procedures should not interfere with the routine of health care services,
p.(None): unless the purpose of the study justifies it, and is expressly authorized by the institution's director.
...
Social / Marital Status
Searching for indicator single:
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p.(None): Considering the provisions of CNS Resolution No. 466, of December 12, 2012, which establishes the guidelines and
p.(None): regulatory standards for research involving human beings; and
p.(None): Considering what was set out in CNS Resolution No. 553, of August 9, 2017, which provides for the charter of rights and duties
p.(None): health user.
p.(None): RESOLVES:
p.(None): Regulate the provision in item XIII.4 of CNS Resolution No. 466, of December 12, 2012, which establishes that the
p.(None): ethical specificities of research of strategic interest to the Unified Health System (SUS) will be
p.(None): contemplated in specific Resolution, and gives other measures.
p.(None): CHAPTER I
p.(None): Terms and definitions
p.(None): Art. 1 For the purposes of this Resolution, the following terms and definitions are adopted:
p.(None): I - collection: organized set of documents, in physical or electronic format, which can serve as a source
p.(None): for the collection of information for the constitution of a database for the purpose of scientific research;
p.(None): II - health care: set of health actions and services articulated at levels of increasing complexity, with the
p.(None): purpose of guaranteeing comprehensive health care;
p.(None): III - director of the co-participant institution: legally responsible for the institution, public or private, legitimately
p.(None): constituted and qualified, in which some of the research phases or stages are developed, or person delegated by him;
p.(None): IV - director of the participating research institution: legally responsible for the institution, public or private,
p.(None): legitimately constituted and qualified, participating in a multicenter study and where the research project is
p.(None): conducted according to a single protocol and with a responsible researcher at the center;
p.(None): V - director of the proposing research institution: legally responsible for the institution, public or
p.(None): private, legitimately constituted and qualified, to which the responsible researcher is linked, or
p.(None): person he delegates;
p.(None): VI - co-participant research institution: organization, public or private, legitimately constituted and qualified,
p.(None): in which any of the research phases or stages takes place, without necessarily having the indication of a researcher
p.(None): responsible in the institution;
p.(None): VII - institution participating in the research: organization, public or private, legitimately constituted and
p.(None): who participates in a multicenter study and where the research project is conducted according to
p.(None): single protocol with a responsible researcher at the center;
p.(None): VIII - institution proposing the research: organization, public or private, legitimately constituted and
p.(None): enabled, to which the responsible researcher is linked;
p.(None): IX - SUS member institution: federal, state and municipal public bodies and institutions, of the
p.(None): direct and indirect administration and of the foundations maintained by the Public Power. Also included are
p.(None): federal, state and municipal public institutions for quality control, research and production of inputs,
p.(None): medicines, including blood and blood products, and health equipment. The private sector may participate
p.(None): SUS, in a complementary character, as provided for in article 24, of Law No. 8,080, of September 19, 1990;
p.(None): X - human biological material: specimens, samples and aliquots of original material and its fractionated components;
p.(None): XI - research of strategic interest to SUS: protocols that contribute to public health, justice, reduction
p.(None): social inequalities and technological dependencies, as well as public health emergencies, referred to the
p.(None): appreciation of CONEP upon request from the Secretariat of Science, Technology and Strategic Inputs
p.(None): the Ministry of Health (SCTIE / MS);
p.(None): XII - researcher: member of the research team, co-responsible for the integrity and well-being of the participants
p.(None): research;
p.(None): XIII - responsible researcher: person responsible for coordinating the research and co-responsible for
p.(None): integrity and well-being of research participants;
p.(None): XIV - Unified Health System: public health promotion, protection and recovery system, created by
...
p.(None): XVI - Health worker: employees (public employees, statutory employees, employees, outsourced workers, among others)
p.(None): institutions that are part of the SUS, in the exercise of their professional functions; and
p.(None): XVII - health user: person who has access to ordered and organized goods and services for the prevention of
p.(None): disease and health promotion, protection, treatment and recovery;
p.(None): CHAPTER II
p.(None): Ethical aspects of research with human beings in institutions
p.(None): SUS
p.(None): Art. 2 The researches carried out in institutions that are members of SUS must comply with ethical and
p.(None): public service responsibility and social interest, and should not be confused with
p.(None): health care.
p.(None): Art. 3 The use for research purposes of human collections and / or biological material resulting from research activities
p.(None): health care can only be carried out with the due appreciation and ethical approval of the CEP / CONEP System.
p.(None): Art. 4 It is the duty of the responsible researcher, or person delegated by him to the research team, to explain, in the
p.(None): process of obtaining consent, to the research participant recruited from a health service linked to the
p.(None): SUS (health service user), the difference between the research procedure and the routine service of the service.
p.(None): Single paragraph. User service should not be harmed, regardless of your decision to
p.(None): participate or not participate in the research, and this guarantee must be explicit in the consent process and in the
p.(None): Free and Informed Consent (ICF) when applicable.
p.(None): Art. 5 The research procedures should not interfere with the routine of health care services,
p.(None): unless the purpose of the study justifies it, and is expressly authorized by the institution's director.
p.(None): Art. 6 The research carried out in an institution that is part of SUS should not interfere in the activities
p.(None): professionals of the workers in the service, except when justified the need, and can only be
p.(None): carried out when duly authorized by the head of the institution.
p.(None): Art. 7 The research that includes health workers as participants must respect the precepts
p.(None): administrative and legal aspects of the institution, without prejudice to its functional activities.
p.(None): Art. 8 The project must present the budget in accordance with the current regulations.
p.(None): Art. 9. It is the duty of the researcher to disclose the results of the research to the participants and institutions where the data
p.(None): were collected at the end of the study.
p.(None): Art. 10. The ethical appraisal of studies carried out in services that are part of SUS must be carried out in CEP
p.(None): linked to the institution where the research participants will be recruited, without prejudice to the flow defined by the
p.(None): other CNS resolutions. If there is no CEP in the institution, the flow defined by CONEP must be followed.
p.(None): §1 In the case of carrying out the study in an institution that is classified as a participant or co-participant in the
...
p.(None): initial appraisal at CONEP (as CEP of the Ministry of Health) and may be processed in a special
p.(None): urgency.
p.(None): §1º The Ministry of Health will define which research protocols should be prioritized, through
p.(None): justified, for urgent procedure at CONEP.
p.(None): §2º Research protocols that respond to health emergencies will be processed as a matter of urgency.
p.(None): and / or subsidize the implementation of health policies, actions, programs and services, in order to respond
p.(None): timely to issues of public interest in the area of health.
p.(None): Paragraph 3. The request from the Ministry of Health for urgency and special procedures at CONEP will be made through
p.(None): specific document for each referral project of the Secretary for Science, Technology and Inputs
p.(None): Of the Ministry of Health.
p.(None): Art. 12. The projects considered as strategic research and submitted by the Ministry of
p.(None): Health, as a matter of urgency for special procedures at CONEP, will have their first evaluation in up to 10
p.(None): (ten) working days, with the appreciation of at least five sitting members, one of whom is a member of
p.(None): Coordination of CONEP.
p.(None): CHAPTER IV
p.(None): Research with cooperation or co-sponsorship of the Brazilian government
p.(None): Art. 13. For the processing of research projects with cooperation or co-sponsorship with the Brazilian Government,
p.(None): as expressed in item IX.4, points 1.1 and 8, of CNS Resolution No. 466, of December 12, 2012, must be attached
p.(None): the referral document of the Secretary of the Secretariat for Science, Technology and Strategic Inputs of the
p.(None): Ministry of Health, project specific, in the protocol.
p.(None): Single paragraph. In such cases, the assessment will be carried out by the CEP of the proposing institution and
p.(None): participants, if applicable, without the need for processing at CONEP.
p.(None): Art. 14. The other current ethical standards apply, when there is no prejudice to the provisions of this Resolution.
p.(None): Art. 15. This Resolution takes effect on the date of its publication.
p.(None): RONALD FERREIRA DOS SANTOS
p.(None): President of the National Health Council
p.(None): I ratify CNS Resolution No. 580, of March 22, 2018, pursuant to the Decree of Delegation of Competence of December 12, 2018
p.(None): November 1991.
p.(None): GILBERTO OCCHI
p.(None): Minister of State for Health
...
Social / Threat of Stigma
Searching for indicator stigmatized:
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p.(None): Constitution of the Federative Republic of Brazil of 1988, of the related Brazilian legislation; and
p.(None): Considering the provisions of Law No. 8,080, of September 19, 1990, which provides, among others, about the conditions for
p.(None): the promotion, protection and recovery of health, the organization and functioning of the corresponding services;
p.(None): Considering that research and technological development activities in health, in compliance with the provisions of article 32,
p.(None): Paragraph 5 of Law 8,080, of September 19, 1990, must be included in the respective Health Plans,
p.(None): approved by the Health Councils in the respective spheres (municipal, state and national);
p.(None): Considering the regulation of Law 8,142, of December 28, 1990, which provides for community participation in the
p.(None): SUS management and intergovernmental transfers of financial resources in the health area, as well as
p.(None): other measures;
p.(None): Considering the provisions of Decree No. 7.508, of June 28, 2011, published in the Federal Official Gazette
p.(None): of June 29, 2011, which regulates Law No. 8,080, of September 19, 1990, which provides for the organization of the
p.(None): Unified Health System (SUS), with regard to health planning, health care and coordination
p.(None): interfederativa, and gives other measures;
p.(None): Considering that it is an ethical requirement that the results and / or findings of the research are communicated to the authorities
p.(None): competent bodies, as well as the bodies legitimized by Social Control, especially those that can
p.(None): contribute to the improvement of the community's living conditions, preserving, however, the image and ensuring
p.(None): that research participants are not stigmatized;
p.(None): Considering that health care is the reason and objective of the Unified Health System and that health
p.(None): users seek SUS services for disease prevention, health promotion and recovery, as well as
p.(None): need to standardize the conduct of research projects of strategic interest to SUS;
p.(None): Considering the need to articulate the Research Ethics Committees System (CEP) and the National Ethics Commission
p.(None): Research Center of the National Health Council - CNS (CEP / CONEP-CNS System) in the various spheres of SUS management, for the
p.(None): ethical assessment and monitoring of approved research;
p.(None): Considering the proposals of the SUS Strategic Research Working Group, from CONEP / CNS,
p.(None): which drafted proposals and systematized the contributions of the public consultation to society held from July 17 to
p.(None): August 15, 2017, in protecting the ethical specificities of research of strategic interest to SUS;
p.(None): Considering the provisions of CNS Resolution No. 466, of December 12, 2012, which establishes the guidelines and
p.(None): regulatory standards for research involving human beings; and
p.(None): Considering what was set out in CNS Resolution No. 553, of August 9, 2017, which provides for the charter of rights and duties
p.(None): health user.
p.(None): RESOLVES:
p.(None): Regulate the provision in item XIII.4 of CNS Resolution No. 466, of December 12, 2012, which establishes that the
p.(None): ethical specificities of research of strategic interest to the Unified Health System (SUS) will be
p.(None): contemplated in specific Resolution, and gives other measures.
p.(None): CHAPTER I
p.(None): Terms and definitions
p.(None): Art. 1 For the purposes of this Resolution, the following terms and definitions are adopted:
...
Social / employees
Searching for indicator employees:
(return to top)
p.(None): social inequalities and technological dependencies, as well as public health emergencies, referred to the
p.(None): appreciation of CONEP upon request from the Secretariat of Science, Technology and Strategic Inputs
p.(None): the Ministry of Health (SCTIE / MS);
p.(None): XII - researcher: member of the research team, co-responsible for the integrity and well-being of the participants
p.(None): research;
p.(None): XIII - responsible researcher: person responsible for coordinating the research and co-responsible for
p.(None): integrity and well-being of research participants;
p.(None): XIV - Unified Health System: public health promotion, protection and recovery system, created by
p.(None): Federal Constitution of 1,988 and regulated by Law 8,080, of September 19, 1990, and Law 8,142, of 28
p.(None): December 1990, in the form of services that integrate health protection and promotion, prevention and assistance,
p.(None): provided by federal, state and municipal public agencies, direct administration and
p.(None): indirectly, foundations maintained by the Public Power and by private institutions, on a complementary basis;
p.(None): XV - Term of Institutional Consent (TAI): document of consent to the conduct of research in
p.(None): institution, which must describe the activities to be developed, being signed by the manager
p.(None): institutional or person delegated by him, with identification of position / function and respective signature;
p.(None): XVI - Health worker: employees (public employees, statutory employees, employees, outsourced workers, among others)
p.(None): institutions that are part of the SUS, in the exercise of their professional functions; and
p.(None): XVII - health user: person who has access to ordered and organized goods and services for the prevention of
p.(None): disease and health promotion, protection, treatment and recovery;
p.(None): CHAPTER II
p.(None): Ethical aspects of research with human beings in institutions
p.(None): SUS
p.(None): Art. 2 The researches carried out in institutions that are members of SUS must comply with ethical and
p.(None): public service responsibility and social interest, and should not be confused with
p.(None): health care.
p.(None): Art. 3 The use for research purposes of human collections and / or biological material resulting from research activities
p.(None): health care can only be carried out with the due appreciation and ethical approval of the CEP / CONEP System.
p.(None): Art. 4 It is the duty of the responsible researcher, or person delegated by him to the research team, to explain, in the
p.(None): process of obtaining consent, to the research participant recruited from a health service linked to the
p.(None): SUS (health service user), the difference between the research procedure and the routine service of the service.
p.(None): Single paragraph. User service should not be harmed, regardless of your decision to
p.(None): participate or not participate in the research, and this guarantee must be explicit in the consent process and in the
p.(None): Free and Informed Consent (ICF) when applicable.
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| emergencies | patients in emergency situations |
| employees | employees |
| single | Marital Status |
| stigmatized | Threat of Stigma |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
consent
ethics
justice
protection
Applicable Type / Vulnerability / Indicator Overlay for this Input