RESOLUTION No. 580, OF MARCH 22, 2018. The Plenary of the National Health Council (CNS), at its Thirty-third Regular Meeting, held in March 21st and 22nd, 2018, and in the use of its regimental powers and attributions conferred by Law nº 8,080, of September 19, 1990; by Law No. 8,142, of December 28, 1990; by Complementary Law No. 141, of January 13, 2012; by Decree No. 5,839, of July 11, 2006; complying with the provisions of Constitution of the Federative Republic of Brazil of 1988, of the related Brazilian legislation; and Considering the provisions of Law No. 8,080, of September 19, 1990, which provides, among others, about the conditions for the promotion, protection and recovery of health, the organization and functioning of the corresponding services; Considering that research and technological development activities in health, in compliance with the provisions of article 32, Paragraph 5 of Law 8,080, of September 19, 1990, must be included in the respective Health Plans, approved by the Health Councils in the respective spheres (municipal, state and national); Considering the regulation of Law 8,142, of December 28, 1990, which provides for community participation in the SUS management and intergovernmental transfers of financial resources in the health area, as well as other measures; Considering the provisions of Decree No. 7.508, of June 28, 2011, published in the Federal Official Gazette of June 29, 2011, which regulates Law No. 8,080, of September 19, 1990, which provides for the organization of the Unified Health System (SUS), with regard to health planning, health care and coordination interfederativa, and gives other measures; Considering that it is an ethical requirement that the results and / or findings of the research are communicated to the authorities competent bodies, as well as the bodies legitimized by Social Control, especially those that can contribute to the improvement of the community's living conditions, preserving, however, the image and ensuring that research participants are not stigmatized; Considering that health care is the reason and objective of the Unified Health System and that health users seek SUS services for disease prevention, health promotion and recovery, as well as need to standardize the conduct of research projects of strategic interest to SUS; Considering the need to articulate the Research Ethics Committees System (CEP) and the National Ethics Commission Research Center of the National Health Council - CNS (CEP / CONEP-CNS System) in the various spheres of SUS management, for the ethical assessment and monitoring of approved research; Considering the proposals of the SUS Strategic Research Working Group, from CONEP / CNS, which drafted proposals and systematized the contributions of the public consultation to society held from July 17 to August 15, 2017, in protecting the ethical specificities of research of strategic interest to SUS; Considering the provisions of CNS Resolution No. 466, of December 12, 2012, which establishes the guidelines and regulatory standards for research involving human beings; and Considering what was set out in CNS Resolution No. 553, of August 9, 2017, which provides for the charter of rights and duties health user. RESOLVES: Regulate the provision in item XIII.4 of CNS Resolution No. 466, of December 12, 2012, which establishes that the ethical specificities of research of strategic interest to the Unified Health System (SUS) will be contemplated in specific Resolution, and gives other measures. CHAPTER I Terms and definitions Art. 1 For the purposes of this Resolution, the following terms and definitions are adopted: I - collection: organized set of documents, in physical or electronic format, which can serve as a source for the collection of information for the constitution of a database for the purpose of scientific research; II - health care: set of health actions and services articulated at levels of increasing complexity, with the purpose of guaranteeing comprehensive health care; III - director of the co-participant institution: legally responsible for the institution, public or private, legitimately constituted and qualified, in which some of the research phases or stages are developed, or person delegated by him; IV - director of the participating research institution: legally responsible for the institution, public or private, legitimately constituted and qualified, participating in a multicenter study and where the research project is conducted according to a single protocol and with a responsible researcher at the center; V - director of the proposing research institution: legally responsible for the institution, public or private, legitimately constituted and qualified, to which the responsible researcher is linked, or person he delegates; VI - co-participant research institution: organization, public or private, legitimately constituted and qualified, in which any of the research phases or stages takes place, without necessarily having the indication of a researcher responsible in the institution; VII - institution participating in the research: organization, public or private, legitimately constituted and who participates in a multicenter study and where the research project is conducted according to single protocol with a responsible researcher at the center; VIII - institution proposing the research: organization, public or private, legitimately constituted and enabled, to which the responsible researcher is linked; IX - SUS member institution: federal, state and municipal public bodies and institutions, of the direct and indirect administration and of the foundations maintained by the Public Power. Also included are federal, state and municipal public institutions for quality control, research and production of inputs, medicines, including blood and blood products, and health equipment. The private sector may participate SUS, in a complementary character, as provided for in article 24, of Law No. 8,080, of September 19, 1990; X - human biological material: specimens, samples and aliquots of original material and its fractionated components; XI - research of strategic interest to SUS: protocols that contribute to public health, justice, reduction social inequalities and technological dependencies, as well as public health emergencies, referred to the appreciation of CONEP upon request from the Secretariat of Science, Technology and Strategic Inputs the Ministry of Health (SCTIE / MS); XII - researcher: member of the research team, co-responsible for the integrity and well-being of the participants research; XIII - responsible researcher: person responsible for coordinating the research and co-responsible for integrity and well-being of research participants; XIV - Unified Health System: public health promotion, protection and recovery system, created by Federal Constitution of 1,988 and regulated by Law 8,080, of September 19, 1990, and Law 8,142, of 28 December 1990, in the form of services that integrate health protection and promotion, prevention and assistance, provided by federal, state and municipal public agencies, direct administration and indirectly, foundations maintained by the Public Power and by private institutions, on a complementary basis; XV - Term of Institutional Consent (TAI): document of consent to the conduct of research in institution, which must describe the activities to be developed, being signed by the manager institutional or person delegated by him, with identification of position / function and respective signature; XVI - Health worker: employees (public employees, statutory employees, employees, outsourced workers, among others) institutions that are part of the SUS, in the exercise of their professional functions; and XVII - health user: person who has access to ordered and organized goods and services for the prevention of disease and health promotion, protection, treatment and recovery; CHAPTER II Ethical aspects of research with human beings in institutions SUS Art. 2 The researches carried out in institutions that are members of SUS must comply with ethical and public service responsibility and social interest, and should not be confused with health care. Art. 3 The use for research purposes of human collections and / or biological material resulting from research activities health care can only be carried out with the due appreciation and ethical approval of the CEP / CONEP System. Art. 4 It is the duty of the responsible researcher, or person delegated by him to the research team, to explain, in the process of obtaining consent, to the research participant recruited from a health service linked to the SUS (health service user), the difference between the research procedure and the routine service of the service. Single paragraph. User service should not be harmed, regardless of your decision to participate or not participate in the research, and this guarantee must be explicit in the consent process and in the Free and Informed Consent (ICF) when applicable. Art. 5 The research procedures should not interfere with the routine of health care services, unless the purpose of the study justifies it, and is expressly authorized by the institution's director. Art. 6 The research carried out in an institution that is part of SUS should not interfere in the activities professionals of the workers in the service, except when justified the need, and can only be carried out when duly authorized by the head of the institution. Art. 7 The research that includes health workers as participants must respect the precepts administrative and legal aspects of the institution, without prejudice to its functional activities. Art. 8 The project must present the budget in accordance with the current regulations. Art. 9. It is the duty of the researcher to disclose the results of the research to the participants and institutions where the data were collected at the end of the study. Art. 10. The ethical appraisal of studies carried out in services that are part of SUS must be carried out in CEP linked to the institution where the research participants will be recruited, without prejudice to the flow defined by the other CNS resolutions. If there is no CEP in the institution, the flow defined by CONEP must be followed. §1 In the case of carrying out the study in an institution that is classified as a participant or co-participant in the research, the Institutional Consent Term must be signed by the director of the institution and will compose the set documentary for the ethical appreciation of research. Paragraph 2. In the case of research using the institution's collection, the researcher must inform the procedures that will be adopted to guarantee the confidentiality, privacy and confidentiality of the participant's data of research. CHAPTER III From Strategic Research to SUS Art. 11. Research considered to be of strategic interest to SUS by the Ministry of Health will be forwarded to initial appraisal at CONEP (as CEP of the Ministry of Health) and may be processed in a special urgency. §1º The Ministry of Health will define which research protocols should be prioritized, through justified, for urgent procedure at CONEP. §2º Research protocols that respond to health emergencies will be processed as a matter of urgency. and / or subsidize the implementation of health policies, actions, programs and services, in order to respond timely to issues of public interest in the area of ​​health. Paragraph 3. The request from the Ministry of Health for urgency and special procedures at CONEP will be made through specific document for each referral project of the Secretary for Science, Technology and Inputs Of the Ministry of Health. Art. 12. The projects considered as strategic research and submitted by the Ministry of Health, as a matter of urgency for special procedures at CONEP, will have their first evaluation in up to 10 (ten) working days, with the appreciation of at least five sitting members, one of whom is a member of Coordination of CONEP. CHAPTER IV Research with cooperation or co-sponsorship of the Brazilian government Art. 13. For the processing of research projects with cooperation or co-sponsorship with the Brazilian Government, as expressed in item IX.4, points 1.1 and 8, of CNS Resolution No. 466, of December 12, 2012, must be attached the referral document of the Secretary of the Secretariat for Science, Technology and Strategic Inputs of the Ministry of Health, project specific, in the protocol. Single paragraph. In such cases, the assessment will be carried out by the CEP of the proposing institution and participants, if applicable, without the need for processing at CONEP. Art. 14. The other current ethical standards apply, when there is no prejudice to the provisions of this Resolution. Art. 15. This Resolution takes effect on the date of its publication. RONALD FERREIRA DOS SANTOS President of the National Health Council I ratify CNS Resolution No. 580, of March 22, 2018, pursuant to the Decree of Delegation of Competence of December 12, 2018 November 1991. GILBERTO OCCHI Minister of State for Health Published DOU Nº 135, Monday, July 16, 2018, section 1, page 55