RESOLUTION No. 510, OF APRIL 7, 2016
The Plenary of the National Health Council at its Fifty-ninth Extraordinary Meeting, held on 06 and 07
April 2016, in the use of its regimental powers and attributions conferred by Law 8,080, of September 19
1990, by Law No. 8,142, of December 28, 1990, by Decree No. 5,839, of July 11, 2006, and
Considering that ethics is a human construction, therefore historical, social and cultural;
Considering that research ethics implies respect for human dignity and the protection due to participants in
scientific research involving human beings;
Considering that the researcher's ethical action demands conscious and free action from the participant;
Whereas research in the humanities and social sciences requires respect and guarantees the full exercise of
participants' rights, and should be designed, evaluated and carried out in order to foresee and avoid possible
damage to participants;
Considering that the Human and Social Sciences have specificities in their conceptions and practices of
research, insofar as they have a pluralistic meaning of science from which the adoption
from multiple theoretical-methodological perspectives, as well as dealing with attributions of meaning,
practices and representations, without direct intervention in the human body, with specific nature and degree of risk;
Considering that the researcher-participant relationship is continuously built in the research process, being able to
be redefined at any time in the dialogue between subjectivities, implying reflexivity and building relationships
non-hierarchical;
Considering the documents that constitute the pillars of recognition and affirmation of dignity,
freedom and autonomy of human beings, such as the 1948 Universal Declaration of Human Rights and the
Inter-American Declaration of Human Rights and Duties, 1948;
Considering the existence of the system of Research Ethics Committees and the National Ethics Commission in
Search;
Considering that Resolution 466/12, in Article XIII.3, recognizes the ethical specificities of
research in Human and Social Sciences and others that use methodologies specific to these areas, given their
peculiarities;
Whereas scientific production must imply current or potential benefits for humans,
for the community in which it operates and for society, enabling the promotion of quality worthy of
life based on respect for civil, social, cultural rights and an ecologically balanced environment; and
Considering the importance of building a clear, precise and fully understandable regulatory framework for all
those involved in research activities in Human and Social Sciences, resolves:
Art. 1 This Resolution provides for the rules applicable to research in Human and Social Sciences whose procedures
methodological aspects involve the use of data directly obtained from the participants or information
identifiable or that may carry greater risks than those existing in everyday life, in the form
defined in this Resolution.
Single paragraph. The following shall not be recorded or evaluated by the CEP / CONEP system: I - public opinion survey with
unidentified participants;
II - research that uses information of public access, under the terms of Law No. 12,527, of November 18,
2011;
III - research that uses information in the public domain; IV - census research;
V - research with databases, whose information is aggregated, with no possibility of identification
individual; and
VI - research carried out exclusively with scientific texts to review the scientific literature;
VII - research that aims at the theoretical deepening of situations that emerge spontaneously and contingently in the
professional practice, as long as they do not reveal data that can identify the subject; and
VIII - activity carried out with the sole purpose of education, teaching or training without the purpose of
scientific research, of undergraduate students, of technical course, or of professionals in specialization.
Paragraph 1 The Course Conclusion Papers, monographs and
similar, in which case the research protocol must be submitted to the CEP / CONEP system;
§ 2 If, during the planning or execution of the education, teaching or training activity, the
intention to incorporate the results of these activities into a research project, mandatory
present the research protocol to the CEP / CONEP system.
Chapter I
TERMS AND DEFINITIONS
Art. 2 For the purposes of this Resolution, the following terms and definitions are adopted:
I - free and informed consent: consent of the research participant - child, adolescent or
individuals temporarily or otherwise prevented from consenting, to the extent of their understanding and respected their
singularities, after clarifying the nature of the research, justification, objectives, methods, potential
benefits and risks. Obtaining consent does not eliminate the need for consent from the person responsible;
II - assistance to the research participant: that which is provided to deal with immaterial damages arising, directly or
indirectly, from research;
III - benefits: current or potential contributions of research to the human being, to the community in which he is
inserted and for society, enabling the promotion of quality worthy of life, based on respect for human rights
civil, social, cultural and an ecologically balanced environment;
IV - confidentiality: it is the guarantee of safeguarding information given in confidence and protection against
its unauthorized disclosure;
V - free and informed consent: consent of the research participant or his legal representative, free
simulation, fraud, error or intimidation, after clarifying the nature of the research, its
justification, its objectives, methods, potential benefits and risks;
VI - publicly accessible information: data that can be used in the production of research and in the transmission of
knowledge and which are available without restriction to access by researchers and citizens in general,
not subject to limitations related to privacy, security or access control. These
information may be processed, or not, and contained in any medium, medium and format produced or managed by
public or private bodies;
VII - material damage: injury that affects the assets of the research participant due to the
characteristics or the results of the research process, imposing a monetary expense or decreasing its revenues
earned or that could be earned; VIII - immaterial damage: injury to the right or personality,
such as physical and psychological integrity, health, honor, image, and privacy, unlawfully
produced to the research participant by characteristics or results of the research
search;
IX - discrimination: characterization or social treatment of a person or group of people, with consequent violation
human dignity, human and social rights and fundamental freedoms of that person or group of
people;
X - clarification: clear and accessible presentation of the nature of the research, its justification,
its objectives, methods, potential benefits and risks, designed to the extent of the participant's understanding,
from their individual, social, economic and cultural characteristics, and because of the approaches
methodological applied. All of these elements determine whether the clarification will be given by document
written, by image or orally, registered or unregistered;
XI - stigmatization: attribution of negative content to one or more characteristics (stigma) of a
person or group of people, with consequent violation of human dignity, human rights and fundamental freedoms
that person or group of people;
XII - preliminary stages of a research: the activities that the researcher has to carry out are thus considered
to ascertain the conditions for the possibility of carrying out the research, including documentary and
direct contacts with possible participants, without their identification and without the public and formal registration of
information thus obtained; not to be confused with “exploratory studies” or “pilot research”, which
should be considered as research projects. Preliminary steps include visits to communities,
to services, conversations with community leaders, among others;
XIII - research participant: individual or group, who is not a member of the research team,
participates in an informed and voluntary manner, by granting consent and also, when
fit, in agreement, in the forms described in this resolution;
XIV - public opinion survey: verbal or written consultation of a punctual character, carried out through methodology
specific way, through which the participant is invited to express his preference, evaluation or
meaning that it attributes to themes, actions of people and organizations, or products and services; without
possibility of identifying the participant;
XV - covert research: research conducted without the participants being informed about objectives and
study procedures, and without your consent being obtained in advance or during the performance of the
search. Covert research is only justified in circumstances where information about
objectives and procedures would change the target behavior of the study or when the use of this method
presents the only way of conducting the study, and the procedure to be explained to the CEP should be explained
adopted by the researcher with the participant, with regard to risks, communication to the participant and use of
collected data, in addition to the commitment or not to confidentiality. Whenever feasible, consent
of the participants should be sought later;
XVI - research in human and social sciences: those that turn to knowledge, understanding of
conditions, existence, experience and knowledge of people and groups, in their social, institutional,
their cultural values, their historical and political orderings and their forms of subjectivity and
communication, directly or indirectly, including research modalities involving
intervention;
XVII - responsible researcher: person with at least a technologist, bachelor's or undergraduate degree,
responsible for coordinating and conducting the research and for the integrity and well-being of the participants in the
search. In the case of undergraduate students who carry out research for the preparation of the Conclusion Work
Course, the research will be registered at the CEP, under the responsibility of the respective TCC supervisor;
XVIII - prejudice: negative value attributed to a person or group of people, with consequent violation of
civil and political and economic, social and cultural rights;
XIX - privacy: the research participant's right to maintain control over their choices and personal information
and to safeguard your intimacy, your image and your personal data, being a guarantee that these life choices do not
will suffer undue invasions, by public control, state or non-state, and by social disapproval from the
characteristics or search results;
XX - consent and consent process: process based on the construction of a relationship of
trust between researcher and research participant, in accordance with their culture and continuously open
dialogue and questioning, the record of their obtaining not necessarily being written;
XXI - research protocol: set of documents including the cover page and the research project
with the description of the research in its fundamental aspects and the information related to the participant of the
research, the qualification of researchers and all responsible bodies. The provisions of
CNS operational norm in force or another that will replace it, as appropriate and when there is no loss in the
established in this Resolution;
XXII - registration of consent or assent: document in any medium, format or media, such as
paper, audio, filming, electronic and digital media, which records the granting of consent or consent
free and informed, the form of registration being chosen based on individual, social,
linguistic, economic and cultural aspects of the research participant and because of the
methodological applied;
XXIII - final report: it is the one presented at the end of the research, containing all its results;
XXIV - reimbursement: material compensation for expenses resulting from participation in the research, or
that is, expenses for the participant and their companions, such as transportation and food;
XXV - research risk: possibility of damage to the physical, mental, moral, intellectual, social dimension,
cultural aspect of the human being, at any stage of the research and resulting from it; and
XXVI - vulnerability: a situation in which a person or group of people has reduced the ability to take
decisions and oppose resistance in the research situation, due to individual, psychological,
economic, cultural, social or political.
Chapter II
OF ETHICAL PRINCIPLES OF RESEARCH IN HUMAN SCIENCES AND
SOCIAL
Art. 3 The ethical principles of research in Human and Social Sciences are:
I - recognition of the freedom and autonomy of everyone involved in the research process,
including scientific and academic freedom;
II - defense of human rights and refusal of arbitration and authoritarianism in relations involving
research processes;
III - respect for cultural, social, moral and religious values, as well as habits and customs, of
research participants;
IV - commitment to the expansion and consolidation of democracy through the socialization of the production of
knowledge resulting from the research, including in a format accessible to the group or population that was researched;
V - refusal of all forms of prejudice, encouraging respect for diversity,
participation of vulnerable and discriminated individuals and groups and differences in research processes;
VI - guarantee of consent or consent of the research participants, clarified about its meaning and
implications;
VII - guarantee of confidentiality of information, privacy of participants and protection
his identity, including the use of his image and voice;
VIII - guarantee that the researcher will not use the information obtained in research at a loss
of its participants;
IX - commitment by everyone involved in the research not to create, maintain or expand risk situations
or vulnerability to individuals and collectivities, nor to accentuate stigma, prejudice or discrimination; and
X - commitment to provide assistance to eventual material and immaterial damages, resulting from participation in the
research, as the case may be, as long as necessary.
Chapter III
THE CONSENT PROCESS AND FREE AND CONSENT
ENLIGHTENED
Art. 4 The process of consent and free and informed consent involves the establishment of
relationship of trust between researcher and participant, continually open to dialogue and questioning,
can be obtained or registered in any of the research execution phases, as well as removed from
any time, without prejudice to the participant.
Art. 5 The process of communicating consent and free and informed consent can be carried out by
through their oral, written, sign language or other forms that are appropriate,
the individual, social, economic and cultural characteristics of the person or group must be considered
of people participating in the research and applied methodological approaches.
§ 1 The process of communicating consent and free and informed consent must occur
spontaneously, clearly and objectively, and to avoid excessively formal modalities, in a climate
mutual trust, ensuring full and interactive communication.
§ 2 In the process of communicating consent and free and informed consent, the participant
you should have the opportunity to clarify your doubts, as well as have the time that is appropriate for
making an autonomous decision.
Art. 6 The researcher must seek the most appropriate time, condition and place for clarifications on the
research are carried out, considering, for this, the peculiarities of the guest to participate in the research, who will be
the right of refusal is guaranteed.
Art. 7 The researcher must ensure space for the participant to express his fears or
doubts during the research process, avoiding any form of imposition or constraint, respecting their
culture.
Art. 8 The information about the research must be transmitted in an accessible and transparent way to
that the guest invited to participate in a research, or his legal representative, can manifest himself, in a
autonomous, conscious, free and enlightened.
Art. 9 The rights of the participants are:
I - be informed about the research;
II - give up at any time to participate in the research, without any prejudice; III - have your privacy
respected;
IV - have the confidentiality of personal information guaranteed;
V - decide whether your identity will be disclosed and what, among the information you provided, can be treated
publicly;
VI - to be compensated for the damage resulting from the research, under the terms of the Law; and
VII - the reimbursement of expenses directly resulting from your participation in the research.
Section I
Obtaining consent and consent
Art. 10. The researcher must clarify the potential participant, to the extent of his understanding and respected his
singularities, about the nature of the research, its objectives, methods, rights, risks and potential benefits.
Art. 11. The consent of the research participant must be particularly guaranteed to the one who, although
fully capable, exposed to specific conditions, or subject to a relationship of authority or
dependency, characterizing situations that may limit autonomy.
Art. 12. There should be justification for choosing children, adolescents and people in situations of
decreased decision-making capacity in the protocol to be approved by the CEP / CONEP system.
Single paragraph. In the cases provided for in the caput, the consent of the
participant and free and informed consent, through the legal representatives of the participant of the
research, preserving the participant's right to information and autonomy, according to his capacity.
Art. 13. In communities whose culture recognizes the authority of the leader or the collective over the individual,
as is the case with some traditional, indigenous or religious communities, for example, obtaining
authorization for research must respect this particularity, without prejudice to individual consent, when
possible and desirable.
Art. 14. When the Free and Informed Consent process is not viable, the waiver of this
process must be justifiably requested by the researcher responsible to the CEP / CONEP System to
appreciation.
Section II
Registration of Consent and Assent
Art. 15. The Consent and Assent Register is the means by which consent is made explicit
free and informed consent of the participant or their legal guardian, in written, sound, imagery,
or in other forms that meet the characteristics of the research and the participants, and must contain
information in clear and easy to understand language for sufficient clarification about the research.
§ 1 When there is no record of consent and assent, the researcher must deliver
document to the participant that includes the information provided for the free and informed consent on the
search.
§ 2 The obtaining of consent can also be proven through a witness who does not compose the
research team and that accompanied the manifestation of consent.
Art. 16. The researcher must justify the most appropriate means of registration, considering, for this, the
degree of risk involved, the characteristics of the research process and the participant.
§ 1 The cases in which the Consent or Free Assent Registration is not feasible
Clarified or where this record means substantial risks to the privacy and confidentiality of the data of the
participant or to the bonds of trust between researcher and subject, the waiver must be
justified by the researcher responsible for the CEP / CONEP system.
§ 2 The waiver of registration of consent or consent does not exempt the researcher from the process
consent or consent, except in the cases provided for in this Resolution.
§ 3 The waiver of the Consent Registration must be evaluated and approved by the CEP / CONEP system.
Art. 17. The Free and Informed Consent Register, in its different formats, must contain
sufficient research clarification, including:
I - the justification, objectives and procedures that will be used in the research, with information
about methods to be used, in clear and accessible language, to the research participants, respecting the
nature of the research;
II - the explanation of the possible damages resulting from participation in the research, in addition to the presentation of
measures and precautions to be employed to avoid situations that may cause damage, considering the
characteristics of the research participant;
III - the guarantee of the research participant's full freedom to decide on their participation,
being able to withdraw their consent, at any stage of the research, without prejudice;
IV - the guarantee of maintaining the confidentiality and privacy of the research participants, whether person or
group of people, during all phases of the research, except when there is an explicit manifestation in
contrary sense, even after the end of the research;
V - information on the form of monitoring and assistance to which the participants of the
research, including considering benefits, if any;
VI - guaranteeing participants access to research results;
VII - explanation of the guarantee to the reimbursement participant and a description of the ways of covering expenses
performed by the participant resulting from the research, if any;
VIII - information on the address, e-mail and telephone contact of those responsible for the research;
IX - brief explanation of what the CEP is, as well as the address, email and telephone contact of the local CEP and, when
the case, from CONEP; and
X - the information that the participant will have access to the consent record whenever requested.
§ 1 In the cases where any of the items is not contemplated in the chosen registration modality, such information
must be delivered to the participant in a complementary document, in order to ensure that all items
above are informed to the participants.
Paragraph 2. In cases where the informed consent or consent is not registered in writing, the
participant may have access to the consent or consent record whenever requested.
Paragraph 3. In cases where the free or informed consent or consent is registered in writing
a copy, signed by the participant and the responsible researcher, must be delivered to the participant.
§ 4 The consent of the research participant must be included in the consent record.
CHAPTER IV RISKS
Art. 18. In research projects in Human and Social Sciences, the definition and gradation of risk result from the
appreciation of its methodological procedures and its potential to cause greater harm to the participant of the
than those existing in everyday life, in line with the procedural and dialogical character of these researches.
Art. 19. The researcher must always be aware of the risks that research may entail to participants in
due to its procedures, and precautionary and protective measures must be adopted in order to avoid
damage or mitigate its effects.
§ 1 When the researcher realizes any possibility of damage to the participant, resulting from
participation in the research, should discuss with the participants the appropriate measures, which can
include the end of the research and inform the CEP / CONEP system.
§ 2 The research participant who suffers any type of damage resulting from his participation in the research,
provided or not in the Free and Informed Consent Register, is entitled to assistance and to seek compensation.
Art. 20. The researcher must take all appropriate measures to protect the participant as a child,
adolescent, or any person whose autonomy is reduced or who is subject to a relationship of authority or
dependency that characterizes a situation of limited autonomy, recognizing its peculiar situation of
vulnerability, regardless of the level of risk of the research.
Art. 21. The risk provided for in the protocol will be graded at the minimum, low, moderate or high levels, considering
its magnitude according to the characteristics and circumstances of the project, as defined in Resolution
specific information on risk classification and grading and on the processing of protocols.
§ 1 The processing of protocols will be differentiated according to the gradation of
risk.
§ 2 The gradation of risk must distinguish different levels of precaution and protection in relation to the
research participant.
Chapter V
OF THE ETHICAL ANALYSIS PROCEDURE IN THE CEP / CONEP SYSTEM
Art. 22. The protocol to be submitted to ethical evaluation will only be assessed if the entire
documentation requested by the CEP / CONEP system, as described, in this respect, in the CNS operational norm
in force, when applicable and when there is no prejudice in the provisions of this Resolution,
considering the nature and specificities of each research.
Art. 23. Research projects will be enrolled in Plataforma Brasil, for their ethical evaluation, of
as provided for in this Resolution and in the specific Resolution for grading, risk classification and processing of
protocols.
Art. 24. All preliminary steps necessary for the researcher to elaborate his project are not subject to evaluation
CEP / CONEP system.
Art. 25. The evaluation to be made by the CEP / CONEP System will focus on the ethical aspects of the projects,
considering the risks and the due protection of the research participants' rights.
§1o. The scientific evaluation of the theoretical aspects of the projects submitted to this Resolution is the responsibility of the
specific academic institutions, such as academic research commissions, graduate boards, research institutions
fostering research, among others. The CEP / CONEP System is not responsible for analyzing the methodological design itself.
§ 2. The evaluation to be carried out by the CEP / CONEP System will focus only on the procedures
methodological measures that imply risks to the participants.
Art. 26. The ethical analysis of the research projects covered by this Resolution can only occur in the Research Committees
Research Ethics that include equal representation of members of the Human and Social Sciences,
the rapporteurs should be chosen from among the qualified members in this area of ​​knowledge.
Art. 27. The research carried out by undergraduate and graduate students, which is part of the project
advisor already approved by the CEP / Conep system, can be presented as an amendment to the approved project,
that does not contain essential changes in the objectives and methodology of the original project.
Chapter VI
RESPONSIBLE RESEARCHER
Art. 28. The researcher's responsibility is non-delegable and indeclinable and includes the ethical and
legal requirements, including:
I - present the protocol duly instructed to the CEP / Conep system, awaiting the decision of
ethical approval, before starting the research, as defined in a specific resolution for grading and grading
risk;
II - conduct the Free and Informed Consent and Consent process; III - present requested data
by CEP or Conep at any time;
IV - keep the research data on file, physical or digital, under your custody and responsibility, for a period
minimum of 5 (five) years after the end of the research; and
V - present in the final report that the project was developed as outlined, justifying, when
occurred, its change or interruption.
Chapter VII
TRANSITIONAL PROVISIONS
Art. 29. An instance will be instituted, within the scope of Conep, for implementation, monitoring, proposal of
update of this Resolution and the proper form for registration of protocols related to projects of the
Human and Social Sciences at Plataforma Brasil, as well as for proposing training and capacity building projects
in the area.
Single paragraph. The body foreseen in the caput will be composed of full members of the Humanities
and Social members of CONEP, representatives of the national scientific associations of Human Sciences and
Social, members of the CEP of Human and Social Sciences and users.
Art. 30. The admission of researchers and other professionals working in the Humanities and
Services in existing CEP collegiate bodies, as well as the creation of new CEPs, maintaining interdisciplinarity
in its composition.
Art. 31. Aspects related to the necessary modifications to the Brazil Platform will come into effect when
system update.
Chapter VIII
FINAL PROVISIONS
Art. 32. The provisions of items VII, VIII, IX and X of CNS Resolution No. 466, of December 12, 2012, are applied,
where applicable and when there is no prejudice to the provisions of this Resolution.
Single paragraph. In situations not covered by this Resolution, the principles will prevail
contained in CNS Resolution No. 466 of 2012.
Art. 33. The composition of Conep will respect the equity of the full and alternate members appointed by the CEP
between the Human and Social Sciences area and the other areas that compose it, guaranteeing the representation
balance of the different areas in the elaboration of norms and in the management of the CEP / CONEP System.
Art. 34. 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. 510, of April 7, 2016, under the terms of the Decree of Delegation of
Competency of November 12, 1991.
MARCELO CASTRO
Minister of State for Health
Published in DOU nº 98, Tuesday, May 24, 2016 - section 1, pages 44, 45, 46