79C3C34C52B45572883A05D425EB0F82

Resolution No. 510

http://conselho.saude.gov.br/resolucoes/2016/Reso510.pdf

http://leaux.net/URLS/ConvertAPI Text Files/D22AA79E54C172CDCD47463E5D367C58.en.txt

Examining the file media/Synopses/D22AA79E54C172CDCD47463E5D367C58.html:

This file was generated: 2020-12-01 09:11:57

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

Vulnerability TypeVulnerabilityIndicator# Matches
PoliticalIndigenousindigenous1
Politicalpolitical affiliationpolitical3
Politicalvulnerablevulnerable1
Politicalvulnerablevulnerability3
SocialAccess to Social Goodsaccess6
SocialChildchild2
SocialChildchildren1
SocialLinguistic Proficiencylanguage3
SocialLinguistic Proficiencylinguistic1
SocialMarital Statussingle4
SocialReligionreligious2
SocialThreat of Stigmastigma2
SocialThreat of Stigmastigmatization1
Socialeducationeducation2
Socialphilosophical differences/differences of opinionopinion2
General/OtherImpaired Autonomyautonomy6
General/OtherRelationship to Authorityauthority3

Political / Indigenous

Searching for indicator indigenous:

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p.(None): Art. 10. The researcher must clarify the potential participant, to the extent of his understanding and respected his
p.(None): singularities, about the nature of the research, its objectives, methods, rights, risks and potential benefits.
p.(None): Art. 11. The consent of the research participant must be particularly guaranteed to the one who, although
p.(None): fully capable, exposed to specific conditions, or subject to a relationship of authority or
p.(None): dependency, characterizing situations that may limit autonomy.
p.(None): Art. 12. There should be justification for choosing children, adolescents and people in situations of
p.(None): decreased decision-making capacity in the protocol to be approved by the CEP / CONEP system.
p.(None): Single paragraph. In the cases provided for in the caput, the consent of the
p.(None): participant and free and informed consent, through the legal representatives of the participant of the
p.(None): research, preserving the participant's right to information and autonomy, according to his capacity.
p.(None): Art. 13. In communities whose culture recognizes the authority of the leader or the collective over the individual,
p.(None): as is the case with some traditional, indigenous or religious communities, for example, obtaining
p.(None): authorization for research must respect this particularity, without prejudice to individual consent, when
p.(None): possible and desirable.
p.(None): Art. 14. When the Free and Informed Consent process is not viable, the waiver of this
p.(None): process must be justifiably requested by the researcher responsible to the CEP / CONEP System to
p.(None): appreciation.
p.(None): Section II
p.(None): Registration of Consent and Assent
p.(None): Art. 15. The Consent and Assent Register is the means by which consent is made explicit
p.(None): free and informed consent of the participant or their legal guardian, in written, sound, imagery,
p.(None): or in other forms that meet the characteristics of the research and the participants, and must contain
p.(None): information in clear and easy to understand language for sufficient clarification about the research.
p.(None): § 1 When there is no record of consent and assent, the researcher must deliver
p.(None): document to the participant that includes the information provided for the free and informed consent on the
p.(None): search.
p.(None): § 2 The obtaining of consent can also be proven through a witness who does not compose the
...

Political / political affiliation

Searching for indicator political:

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p.(None): fit, in agreement, in the forms described in this resolution;
p.(None): XIV - public opinion survey: verbal or written consultation of a punctual character, carried out through methodology
p.(None): specific way, through which the participant is invited to express his preference, evaluation or
p.(None): meaning that it attributes to themes, actions of people and organizations, or products and services; without
p.(None): possibility of identifying the participant;
p.(None): XV - covert research: research conducted without the participants being informed about objectives and
p.(None): study procedures, and without your consent being obtained in advance or during the performance of the
p.(None): search. Covert research is only justified in circumstances where information about
p.(None): objectives and procedures would change the target behavior of the study or when the use of this method
p.(None): presents the only way of conducting the study, and the procedure to be explained to the CEP should be explained
p.(None): adopted by the researcher with the participant, with regard to risks, communication to the participant and use of
p.(None): collected data, in addition to the commitment or not to confidentiality. Whenever feasible, consent
p.(None): of the participants should be sought later;
p.(None): XVI - research in human and social sciences: those that turn to knowledge, understanding of
p.(None): conditions, existence, experience and knowledge of people and groups, in their social, institutional,
p.(None): their cultural values, their historical and political orderings and their forms of subjectivity and
p.(None): communication, directly or indirectly, including research modalities involving
p.(None): intervention;
p.(None): XVII - responsible researcher: person with at least a technologist, bachelor's or undergraduate degree,
p.(None): responsible for coordinating and conducting the research and for the integrity and well-being of the participants in the
p.(None): search. In the case of undergraduate students who carry out research for the preparation of the Conclusion Work
p.(None): Course, the research will be registered at the CEP, under the responsibility of the respective TCC supervisor;
p.(None): XVIII - prejudice: negative value attributed to a person or group of people, with consequent violation of
p.(None): civil and political and economic, social and cultural rights;
p.(None): XIX - privacy: the research participant's right to maintain control over their choices and personal information
p.(None): and to safeguard your intimacy, your image and your personal data, being a guarantee that these life choices do not
p.(None): will suffer undue invasions, by public control, state or non-state, and by social disapproval from the
p.(None): characteristics or search results;
p.(None): XX - consent and consent process: process based on the construction of a relationship of
p.(None): trust between researcher and research participant, in accordance with their culture and continuously open
p.(None): dialogue and questioning, the record of their obtaining not necessarily being written;
p.(None): XXI - research protocol: set of documents including the cover page and the research project
p.(None): with the description of the research in its fundamental aspects and the information related to the participant of the
p.(None): research, the qualification of researchers and all responsible bodies. The provisions of
p.(None): CNS operational norm in force or another that will replace it, as appropriate and when there is no loss in the
p.(None): established in this Resolution;
p.(None): XXII - registration of consent or assent: document in any medium, format or media, such as
p.(None): paper, audio, filming, electronic and digital media, which records the granting of consent or consent
p.(None): free and informed, the form of registration being chosen based on individual, social,
p.(None): linguistic, economic and cultural aspects of the research participant and because of the
p.(None): methodological applied;
p.(None): XXIII - final report: it is the one presented at the end of the research, containing all its results;
p.(None): XXIV - reimbursement: material compensation for expenses resulting from participation in the research, or
p.(None): that is, expenses for the participant and their companions, such as transportation and food;
p.(None): XXV - research risk: possibility of damage to the physical, mental, moral, intellectual, social dimension,
p.(None): cultural aspect of the human being, at any stage of the research and resulting from it; and
p.(None): XXVI - vulnerability: a situation in which a person or group of people has reduced the ability to take
p.(None): decisions and oppose resistance in the research situation, due to individual, psychological,
p.(None): economic, cultural, social or political.
p.(None): Chapter II
p.(None): OF ETHICAL PRINCIPLES OF RESEARCH IN HUMAN SCIENCES AND
p.(None): SOCIAL
p.(None): Art. 3 The ethical principles of research in Human and Social Sciences are:
p.(None): I - recognition of the freedom and autonomy of everyone involved in the research process,
p.(None): including scientific and academic freedom;
p.(None): II - defense of human rights and refusal of arbitration and authoritarianism in relations involving
p.(None): research processes;
p.(None): III - respect for cultural, social, moral and religious values, as well as habits and customs, of
p.(None): research participants;
p.(None): IV - commitment to the expansion and consolidation of democracy through the socialization of the production of
p.(None): knowledge resulting from the research, including in a format accessible to the group or population that was researched;
p.(None): V - refusal of all forms of prejudice, encouraging respect for diversity,
p.(None): participation of vulnerable and discriminated individuals and groups and differences in research processes;
p.(None): VI - guarantee of consent or consent of the research participants, clarified about its meaning and
p.(None): implications;
p.(None): VII - guarantee of confidentiality of information, privacy of participants and protection
p.(None): his identity, including the use of his image and voice;
p.(None): VIII - guarantee that the researcher will not use the information obtained in research at a loss
p.(None): of its participants;
...

Political / vulnerable

Searching for indicator vulnerable:

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p.(None): cultural aspect of the human being, at any stage of the research and resulting from it; and
p.(None): XXVI - vulnerability: a situation in which a person or group of people has reduced the ability to take
p.(None): decisions and oppose resistance in the research situation, due to individual, psychological,
p.(None): economic, cultural, social or political.
p.(None): Chapter II
p.(None): OF ETHICAL PRINCIPLES OF RESEARCH IN HUMAN SCIENCES AND
p.(None): SOCIAL
p.(None): Art. 3 The ethical principles of research in Human and Social Sciences are:
p.(None): I - recognition of the freedom and autonomy of everyone involved in the research process,
p.(None): including scientific and academic freedom;
p.(None): II - defense of human rights and refusal of arbitration and authoritarianism in relations involving
p.(None): research processes;
p.(None): III - respect for cultural, social, moral and religious values, as well as habits and customs, of
p.(None): research participants;
p.(None): IV - commitment to the expansion and consolidation of democracy through the socialization of the production of
p.(None): knowledge resulting from the research, including in a format accessible to the group or population that was researched;
p.(None): V - refusal of all forms of prejudice, encouraging respect for diversity,
p.(None): participation of vulnerable and discriminated individuals and groups and differences in research processes;
p.(None): VI - guarantee of consent or consent of the research participants, clarified about its meaning and
p.(None): implications;
p.(None): VII - guarantee of confidentiality of information, privacy of participants and protection
p.(None): his identity, including the use of his image and voice;
p.(None): VIII - guarantee that the researcher will not use the information obtained in research at a loss
p.(None): of its participants;
p.(None): IX - commitment by everyone involved in the research not to create, maintain or expand risk situations
p.(None): or vulnerability to individuals and collectivities, nor to accentuate stigma, prejudice or discrimination; and
p.(None): X - commitment to provide assistance to eventual material and immaterial damages, resulting from participation in the
p.(None): research, as the case may be, as long as necessary.
p.(None): Chapter III
p.(None): THE CONSENT PROCESS AND FREE AND CONSENT
p.(None): ENLIGHTENED
p.(None): Art. 4 The process of consent and free and informed consent involves the establishment of
p.(None): relationship of trust between researcher and participant, continually open to dialogue and questioning,
...

Searching for indicator vulnerability:

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p.(None): XXI - research protocol: set of documents including the cover page and the research project
p.(None): with the description of the research in its fundamental aspects and the information related to the participant of the
p.(None): research, the qualification of researchers and all responsible bodies. The provisions of
p.(None): CNS operational norm in force or another that will replace it, as appropriate and when there is no loss in the
p.(None): established in this Resolution;
p.(None): XXII - registration of consent or assent: document in any medium, format or media, such as
p.(None): paper, audio, filming, electronic and digital media, which records the granting of consent or consent
p.(None): free and informed, the form of registration being chosen based on individual, social,
p.(None): linguistic, economic and cultural aspects of the research participant and because of the
p.(None): methodological applied;
p.(None): XXIII - final report: it is the one presented at the end of the research, containing all its results;
p.(None): XXIV - reimbursement: material compensation for expenses resulting from participation in the research, or
p.(None): that is, expenses for the participant and their companions, such as transportation and food;
p.(None): XXV - research risk: possibility of damage to the physical, mental, moral, intellectual, social dimension,
p.(None): cultural aspect of the human being, at any stage of the research and resulting from it; and
p.(None): XXVI - vulnerability: a situation in which a person or group of people has reduced the ability to take
p.(None): decisions and oppose resistance in the research situation, due to individual, psychological,
p.(None): economic, cultural, social or political.
p.(None): Chapter II
p.(None): OF ETHICAL PRINCIPLES OF RESEARCH IN HUMAN SCIENCES AND
p.(None): SOCIAL
p.(None): Art. 3 The ethical principles of research in Human and Social Sciences are:
p.(None): I - recognition of the freedom and autonomy of everyone involved in the research process,
p.(None): including scientific and academic freedom;
p.(None): II - defense of human rights and refusal of arbitration and authoritarianism in relations involving
p.(None): research processes;
p.(None): III - respect for cultural, social, moral and religious values, as well as habits and customs, of
p.(None): research participants;
p.(None): IV - commitment to the expansion and consolidation of democracy through the socialization of the production of
p.(None): knowledge resulting from the research, including in a format accessible to the group or population that was researched;
p.(None): V - refusal of all forms of prejudice, encouraging respect for diversity,
p.(None): participation of vulnerable and discriminated individuals and groups and differences in research processes;
p.(None): VI - guarantee of consent or consent of the research participants, clarified about its meaning and
p.(None): implications;
p.(None): VII - guarantee of confidentiality of information, privacy of participants and protection
p.(None): his identity, including the use of his image and voice;
p.(None): VIII - guarantee that the researcher will not use the information obtained in research at a loss
p.(None): of its participants;
p.(None): IX - commitment by everyone involved in the research not to create, maintain or expand risk situations
p.(None): or vulnerability to individuals and collectivities, nor to accentuate stigma, prejudice or discrimination; and
p.(None): X - commitment to provide assistance to eventual material and immaterial damages, resulting from participation in the
p.(None): research, as the case may be, as long as necessary.
p.(None): Chapter III
p.(None): THE CONSENT PROCESS AND FREE AND CONSENT
p.(None): ENLIGHTENED
p.(None): Art. 4 The process of consent and free and informed consent involves the establishment of
p.(None): relationship of trust between researcher and participant, continually open to dialogue and questioning,
p.(None): can be obtained or registered in any of the research execution phases, as well as removed from
p.(None): any time, without prejudice to the participant.
p.(None): Art. 5 The process of communicating consent and free and informed consent can be carried out by
p.(None): through their oral, written, sign language or other forms that are appropriate,
p.(None): the individual, social, economic and cultural characteristics of the person or group must be considered
p.(None): of people participating in the research and applied methodological approaches.
p.(None): § 1 The process of communicating consent and free and informed consent must occur
...

p.(None): appreciation of its methodological procedures and its potential to cause greater harm to the participant of the
p.(None): than those existing in everyday life, in line with the procedural and dialogical character of these researches.
p.(None): Art. 19. The researcher must always be aware of the risks that research may entail to participants in
p.(None): due to its procedures, and precautionary and protective measures must be adopted in order to avoid
p.(None): damage or mitigate its effects.
p.(None): § 1 When the researcher realizes any possibility of damage to the participant, resulting from
p.(None): participation in the research, should discuss with the participants the appropriate measures, which can
p.(None): include the end of the research and inform the CEP / CONEP system.
p.(None): § 2 The research participant who suffers any type of damage resulting from his participation in the research,
p.(None): provided or not in the Free and Informed Consent Register, is entitled to assistance and to seek compensation.
p.(None): Art. 20. The researcher must take all appropriate measures to protect the participant as a child,
p.(None): adolescent, or any person whose autonomy is reduced or who is subject to a relationship of authority or
p.(None): dependency that characterizes a situation of limited autonomy, recognizing its peculiar situation of
p.(None): vulnerability, regardless of the level of risk of the research.
p.(None): Art. 21. The risk provided for in the protocol will be graded at the minimum, low, moderate or high levels, considering
p.(None): its magnitude according to the characteristics and circumstances of the project, as defined in Resolution
p.(None): specific information on risk classification and grading and on the processing of protocols.
p.(None): § 1 The processing of protocols will be differentiated according to the gradation of
p.(None): risk.
p.(None): § 2 The gradation of risk must distinguish different levels of precaution and protection in relation to the
p.(None): research participant.
p.(None): Chapter V
p.(None): OF THE ETHICAL ANALYSIS PROCEDURE IN THE CEP / CONEP SYSTEM
p.(None): Art. 22. The protocol to be submitted to ethical evaluation will only be assessed if the entire
p.(None): documentation requested by the CEP / CONEP system, as described, in this respect, in the CNS operational norm
p.(None): in force, when applicable and when there is no prejudice in the provisions of this Resolution,
p.(None): considering the nature and specificities of each research.
p.(None): Art. 23. Research projects will be enrolled in Plataforma Brasil, for their ethical evaluation, of
p.(None): as provided for in this Resolution and in the specific Resolution for grading, risk classification and processing of
p.(None): protocols.
p.(None): Art. 24. All preliminary steps necessary for the researcher to elaborate his project are not subject to evaluation
...

Social / Access to Social Goods

Searching for indicator access:

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p.(None): Inter-American Declaration of Human Rights and Duties, 1948;
p.(None): Considering the existence of the system of Research Ethics Committees and the National Ethics Commission in
p.(None): Search;
p.(None): Considering that Resolution 466/12, in Article XIII.3, recognizes the ethical specificities of
p.(None): research in Human and Social Sciences and others that use methodologies specific to these areas, given their
p.(None): peculiarities;
p.(None): Whereas scientific production must imply current or potential benefits for humans,
p.(None): for the community in which it operates and for society, enabling the promotion of quality worthy of
p.(None): life based on respect for civil, social, cultural rights and an ecologically balanced environment; and
p.(None): Considering the importance of building a clear, precise and fully understandable regulatory framework for all
p.(None): those involved in research activities in Human and Social Sciences, resolves:
p.(None): Art. 1 This Resolution provides for the rules applicable to research in Human and Social Sciences whose procedures
p.(None): methodological aspects involve the use of data directly obtained from the participants or information
p.(None): identifiable or that may carry greater risks than those existing in everyday life, in the form
p.(None): defined in this Resolution.
p.(None): Single paragraph. The following shall not be recorded or evaluated by the CEP / CONEP system: I - public opinion survey with
p.(None): unidentified participants;
p.(None): II - research that uses information of public access, under the terms of Law No. 12,527, of November 18,
p.(None): 2011;
p.(None): III - research that uses information in the public domain; IV - census research;
p.(None): V - research with databases, whose information is aggregated, with no possibility of identification
p.(None): individual; and
p.(None): VI - research carried out exclusively with scientific texts to review the scientific literature;
p.(None): VII - research that aims at the theoretical deepening of situations that emerge spontaneously and contingently in the
p.(None): professional practice, as long as they do not reveal data that can identify the subject; and
p.(None): VIII - activity carried out with the sole purpose of education, teaching or training without the purpose of
p.(None): scientific research, of undergraduate students, of technical course, or of professionals in specialization.
p.(None): Paragraph 1 The Course Conclusion Papers, monographs and
p.(None): similar, in which case the research protocol must be submitted to the CEP / CONEP system;
p.(None): § 2 If, during the planning or execution of the education, teaching or training activity, the
p.(None): intention to incorporate the results of these activities into a research project, mandatory
p.(None): present the research protocol to the CEP / CONEP system.
p.(None): Chapter I
p.(None): TERMS AND DEFINITIONS
p.(None): Art. 2 For the purposes of this Resolution, the following terms and definitions are adopted:
p.(None): I - free and informed consent: consent of the research participant - child, adolescent or
p.(None): individuals temporarily or otherwise prevented from consenting, to the extent of their understanding and respected their
p.(None): singularities, after clarifying the nature of the research, justification, objectives, methods, potential
p.(None): benefits and risks. Obtaining consent does not eliminate the need for consent from the person responsible;
p.(None): II - assistance to the research participant: that which is provided to deal with immaterial damages arising, directly or
p.(None): indirectly, from research;
p.(None): III - benefits: current or potential contributions of research to the human being, to the community in which he is
p.(None): inserted and for society, enabling the promotion of quality worthy of life, based on respect for human rights
p.(None): civil, social, cultural and an ecologically balanced environment;
p.(None): IV - confidentiality: it is the guarantee of safeguarding information given in confidence and protection against
p.(None): its unauthorized disclosure;
p.(None): V - free and informed consent: consent of the research participant or his legal representative, free
p.(None): simulation, fraud, error or intimidation, after clarifying the nature of the research, its
p.(None): justification, its objectives, methods, potential benefits and risks;
p.(None): VI - publicly accessible information: data that can be used in the production of research and in the transmission of
p.(None): knowledge and which are available without restriction to access by researchers and citizens in general,
p.(None): not subject to limitations related to privacy, security or access control. These
p.(None): information may be processed, or not, and contained in any medium, medium and format produced or managed by
p.(None): public or private bodies;
p.(None): VII - material damage: injury that affects the assets of the research participant due to the
p.(None): characteristics or the results of the research process, imposing a monetary expense or decreasing its revenues
p.(None): earned or that could be earned; VIII - immaterial damage: injury to the right or personality,
p.(None): such as physical and psychological integrity, health, honor, image, and privacy, unlawfully
p.(None): produced to the research participant by characteristics or results of the research
p.(None): search;
p.(None): IX - discrimination: characterization or social treatment of a person or group of people, with consequent violation
p.(None): human dignity, human and social rights and fundamental freedoms of that person or group of
p.(None): people;
p.(None): X - clarification: clear and accessible presentation of the nature of the research, its justification,
p.(None): its objectives, methods, potential benefits and risks, designed to the extent of the participant's understanding,
p.(None): from their individual, social, economic and cultural characteristics, and because of the approaches
p.(None): methodological applied. All of these elements determine whether the clarification will be given by document
p.(None): written, by image or orally, registered or unregistered;
p.(None): XI - stigmatization: attribution of negative content to one or more characteristics (stigma) of a
p.(None): person or group of people, with consequent violation of human dignity, human rights and fundamental freedoms
p.(None): that person or group of people;
...

p.(None): § 3 The waiver of the Consent Registration must be evaluated and approved by the CEP / CONEP system.
p.(None): Art. 17. The Free and Informed Consent Register, in its different formats, must contain
p.(None): sufficient research clarification, including:
p.(None): I - the justification, objectives and procedures that will be used in the research, with information
p.(None): about methods to be used, in clear and accessible language, to the research participants, respecting the
p.(None): nature of the research;
p.(None): II - the explanation of the possible damages resulting from participation in the research, in addition to the presentation of
p.(None): measures and precautions to be employed to avoid situations that may cause damage, considering the
p.(None): characteristics of the research participant;
p.(None): III - the guarantee of the research participant's full freedom to decide on their participation,
p.(None): being able to withdraw their consent, at any stage of the research, without prejudice;
p.(None): IV - the guarantee of maintaining the confidentiality and privacy of the research participants, whether person or
p.(None): group of people, during all phases of the research, except when there is an explicit manifestation in
p.(None): contrary sense, even after the end of the research;
p.(None): V - information on the form of monitoring and assistance to which the participants of the
p.(None): research, including considering benefits, if any;
p.(None): VI - guaranteeing participants access to research results;
p.(None): VII - explanation of the guarantee to the reimbursement participant and a description of the ways of covering expenses
p.(None): performed by the participant resulting from the research, if any;
p.(None): VIII - information on the address, e-mail and telephone contact of those responsible for the research;
p.(None): IX - brief explanation of what the CEP is, as well as the address, email and telephone contact of the local CEP and, when
p.(None): the case, from CONEP; and
p.(None): X - the information that the participant will have access to the consent record whenever requested.
p.(None): § 1 In the cases where any of the items is not contemplated in the chosen registration modality, such information
p.(None): must be delivered to the participant in a complementary document, in order to ensure that all items
p.(None): above are informed to the participants.
p.(None): Paragraph 2. In cases where the informed consent or consent is not registered in writing, the
p.(None): participant may have access to the consent or consent record whenever requested.
p.(None): Paragraph 3. In cases where the free or informed consent or consent is registered in writing
p.(None): a copy, signed by the participant and the responsible researcher, must be delivered to the participant.
p.(None): § 4 The consent of the research participant must be included in the consent record.
p.(None): CHAPTER IV RISKS
p.(None): Art. 18. In research projects in Human and Social Sciences, the definition and gradation of risk result from the
p.(None): appreciation of its methodological procedures and its potential to cause greater harm to the participant of the
p.(None): than those existing in everyday life, in line with the procedural and dialogical character of these researches.
p.(None): Art. 19. The researcher must always be aware of the risks that research may entail to participants in
p.(None): due to its procedures, and precautionary and protective measures must be adopted in order to avoid
p.(None): damage or mitigate its effects.
p.(None): § 1 When the researcher realizes any possibility of damage to the participant, resulting from
p.(None): participation in the research, should discuss with the participants the appropriate measures, which can
p.(None): include the end of the research and inform the CEP / CONEP system.
p.(None): § 2 The research participant who suffers any type of damage resulting from his participation in the research,
...

Social / Child

Searching for indicator child:

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p.(None): II - research that uses information of public access, under the terms of Law No. 12,527, of November 18,
p.(None): 2011;
p.(None): III - research that uses information in the public domain; IV - census research;
p.(None): V - research with databases, whose information is aggregated, with no possibility of identification
p.(None): individual; and
p.(None): VI - research carried out exclusively with scientific texts to review the scientific literature;
p.(None): VII - research that aims at the theoretical deepening of situations that emerge spontaneously and contingently in the
p.(None): professional practice, as long as they do not reveal data that can identify the subject; and
p.(None): VIII - activity carried out with the sole purpose of education, teaching or training without the purpose of
p.(None): scientific research, of undergraduate students, of technical course, or of professionals in specialization.
p.(None): Paragraph 1 The Course Conclusion Papers, monographs and
p.(None): similar, in which case the research protocol must be submitted to the CEP / CONEP system;
p.(None): § 2 If, during the planning or execution of the education, teaching or training activity, the
p.(None): intention to incorporate the results of these activities into a research project, mandatory
p.(None): present the research protocol to the CEP / CONEP system.
p.(None): Chapter I
p.(None): TERMS AND DEFINITIONS
p.(None): Art. 2 For the purposes of this Resolution, the following terms and definitions are adopted:
p.(None): I - free and informed consent: consent of the research participant - child, adolescent or
p.(None): individuals temporarily or otherwise prevented from consenting, to the extent of their understanding and respected their
p.(None): singularities, after clarifying the nature of the research, justification, objectives, methods, potential
p.(None): benefits and risks. Obtaining consent does not eliminate the need for consent from the person responsible;
p.(None): II - assistance to the research participant: that which is provided to deal with immaterial damages arising, directly or
p.(None): indirectly, from research;
p.(None): III - benefits: current or potential contributions of research to the human being, to the community in which he is
p.(None): inserted and for society, enabling the promotion of quality worthy of life, based on respect for human rights
p.(None): civil, social, cultural and an ecologically balanced environment;
p.(None): IV - confidentiality: it is the guarantee of safeguarding information given in confidence and protection against
p.(None): its unauthorized disclosure;
p.(None): V - free and informed consent: consent of the research participant or his legal representative, free
p.(None): simulation, fraud, error or intimidation, after clarifying the nature of the research, its
p.(None): justification, its objectives, methods, potential benefits and risks;
p.(None): VI - publicly accessible information: data that can be used in the production of research and in the transmission of
...

p.(None): a copy, signed by the participant and the responsible researcher, must be delivered to the participant.
p.(None): § 4 The consent of the research participant must be included in the consent record.
p.(None): CHAPTER IV RISKS
p.(None): Art. 18. In research projects in Human and Social Sciences, the definition and gradation of risk result from the
p.(None): appreciation of its methodological procedures and its potential to cause greater harm to the participant of the
p.(None): than those existing in everyday life, in line with the procedural and dialogical character of these researches.
p.(None): Art. 19. The researcher must always be aware of the risks that research may entail to participants in
p.(None): due to its procedures, and precautionary and protective measures must be adopted in order to avoid
p.(None): damage or mitigate its effects.
p.(None): § 1 When the researcher realizes any possibility of damage to the participant, resulting from
p.(None): participation in the research, should discuss with the participants the appropriate measures, which can
p.(None): include the end of the research and inform the CEP / CONEP system.
p.(None): § 2 The research participant who suffers any type of damage resulting from his participation in the research,
p.(None): provided or not in the Free and Informed Consent Register, is entitled to assistance and to seek compensation.
p.(None): Art. 20. The researcher must take all appropriate measures to protect the participant as a child,
p.(None): adolescent, or any person whose autonomy is reduced or who is subject to a relationship of authority or
p.(None): dependency that characterizes a situation of limited autonomy, recognizing its peculiar situation of
p.(None): vulnerability, regardless of the level of risk of the research.
p.(None): Art. 21. The risk provided for in the protocol will be graded at the minimum, low, moderate or high levels, considering
p.(None): its magnitude according to the characteristics and circumstances of the project, as defined in Resolution
p.(None): specific information on risk classification and grading and on the processing of protocols.
p.(None): § 1 The processing of protocols will be differentiated according to the gradation of
p.(None): risk.
p.(None): § 2 The gradation of risk must distinguish different levels of precaution and protection in relation to the
p.(None): research participant.
p.(None): Chapter V
p.(None): OF THE ETHICAL ANALYSIS PROCEDURE IN THE CEP / CONEP SYSTEM
p.(None): Art. 22. The protocol to be submitted to ethical evaluation will only be assessed if the entire
p.(None): documentation requested by the CEP / CONEP system, as described, in this respect, in the CNS operational norm
p.(None): in force, when applicable and when there is no prejudice in the provisions of this Resolution,
...

Searching for indicator children:

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p.(None): that the guest invited to participate in a research, or his legal representative, can manifest himself, in a
p.(None): autonomous, conscious, free and enlightened.
p.(None): Art. 9 The rights of the participants are:
p.(None): I - be informed about the research;
p.(None): II - give up at any time to participate in the research, without any prejudice; III - have your privacy
p.(None): respected;
p.(None): IV - have the confidentiality of personal information guaranteed;
p.(None): V - decide whether your identity will be disclosed and what, among the information you provided, can be treated
p.(None): publicly;
p.(None): VI - to be compensated for the damage resulting from the research, under the terms of the Law; and
p.(None): VII - the reimbursement of expenses directly resulting from your participation in the research.
p.(None): Section I
p.(None): Obtaining consent and consent
p.(None): Art. 10. The researcher must clarify the potential participant, to the extent of his understanding and respected his
p.(None): singularities, about the nature of the research, its objectives, methods, rights, risks and potential benefits.
p.(None): Art. 11. The consent of the research participant must be particularly guaranteed to the one who, although
p.(None): fully capable, exposed to specific conditions, or subject to a relationship of authority or
p.(None): dependency, characterizing situations that may limit autonomy.
p.(None): Art. 12. There should be justification for choosing children, adolescents and people in situations of
p.(None): decreased decision-making capacity in the protocol to be approved by the CEP / CONEP system.
p.(None): Single paragraph. In the cases provided for in the caput, the consent of the
p.(None): participant and free and informed consent, through the legal representatives of the participant of the
p.(None): research, preserving the participant's right to information and autonomy, according to his capacity.
p.(None): Art. 13. In communities whose culture recognizes the authority of the leader or the collective over the individual,
p.(None): as is the case with some traditional, indigenous or religious communities, for example, obtaining
p.(None): authorization for research must respect this particularity, without prejudice to individual consent, when
p.(None): possible and desirable.
p.(None): Art. 14. When the Free and Informed Consent process is not viable, the waiver of this
p.(None): process must be justifiably requested by the researcher responsible to the CEP / CONEP System to
p.(None): appreciation.
p.(None): Section II
p.(None): Registration of Consent and Assent
...

Social / Linguistic Proficiency

Searching for indicator language:

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p.(None): his identity, including the use of his image and voice;
p.(None): VIII - guarantee that the researcher will not use the information obtained in research at a loss
p.(None): of its participants;
p.(None): IX - commitment by everyone involved in the research not to create, maintain or expand risk situations
p.(None): or vulnerability to individuals and collectivities, nor to accentuate stigma, prejudice or discrimination; and
p.(None): X - commitment to provide assistance to eventual material and immaterial damages, resulting from participation in the
p.(None): research, as the case may be, as long as necessary.
p.(None): Chapter III
p.(None): THE CONSENT PROCESS AND FREE AND CONSENT
p.(None): ENLIGHTENED
p.(None): Art. 4 The process of consent and free and informed consent involves the establishment of
p.(None): relationship of trust between researcher and participant, continually open to dialogue and questioning,
p.(None): can be obtained or registered in any of the research execution phases, as well as removed from
p.(None): any time, without prejudice to the participant.
p.(None): Art. 5 The process of communicating consent and free and informed consent can be carried out by
p.(None): through their oral, written, sign language or other forms that are appropriate,
p.(None): the individual, social, economic and cultural characteristics of the person or group must be considered
p.(None): of people participating in the research and applied methodological approaches.
p.(None): § 1 The process of communicating consent and free and informed consent must occur
p.(None): spontaneously, clearly and objectively, and to avoid excessively formal modalities, in a climate
p.(None): mutual trust, ensuring full and interactive communication.
p.(None): § 2 In the process of communicating consent and free and informed consent, the participant
p.(None): you should have the opportunity to clarify your doubts, as well as have the time that is appropriate for
p.(None): making an autonomous decision.
p.(None): Art. 6 The researcher must seek the most appropriate time, condition and place for clarifications on the
p.(None): research are carried out, considering, for this, the peculiarities of the guest to participate in the research, who will be
p.(None): the right of refusal is guaranteed.
p.(None): Art. 7 The researcher must ensure space for the participant to express his fears or
p.(None): doubts during the research process, avoiding any form of imposition or constraint, respecting their
p.(None): culture.
p.(None): Art. 8 The information about the research must be transmitted in an accessible and transparent way to
p.(None): that the guest invited to participate in a research, or his legal representative, can manifest himself, in a
p.(None): autonomous, conscious, free and enlightened.
p.(None): Art. 9 The rights of the participants are:
p.(None): I - be informed about the research;
...

p.(None): research, preserving the participant's right to information and autonomy, according to his capacity.
p.(None): Art. 13. In communities whose culture recognizes the authority of the leader or the collective over the individual,
p.(None): as is the case with some traditional, indigenous or religious communities, for example, obtaining
p.(None): authorization for research must respect this particularity, without prejudice to individual consent, when
p.(None): possible and desirable.
p.(None): Art. 14. When the Free and Informed Consent process is not viable, the waiver of this
p.(None): process must be justifiably requested by the researcher responsible to the CEP / CONEP System to
p.(None): appreciation.
p.(None): Section II
p.(None): Registration of Consent and Assent
p.(None): Art. 15. The Consent and Assent Register is the means by which consent is made explicit
p.(None): free and informed consent of the participant or their legal guardian, in written, sound, imagery,
p.(None): or in other forms that meet the characteristics of the research and the participants, and must contain
p.(None): information in clear and easy to understand language for sufficient clarification about the research.
p.(None): § 1 When there is no record of consent and assent, the researcher must deliver
p.(None): document to the participant that includes the information provided for the free and informed consent on the
p.(None): search.
p.(None): § 2 The obtaining of consent can also be proven through a witness who does not compose the
p.(None): research team and that accompanied the manifestation of consent.
p.(None): Art. 16. The researcher must justify the most appropriate means of registration, considering, for this, the
p.(None): degree of risk involved, the characteristics of the research process and the participant.
p.(None): § 1 The cases in which the Consent or Free Assent Registration is not feasible
p.(None): Clarified or where this record means substantial risks to the privacy and confidentiality of the data of the
p.(None): participant or to the bonds of trust between researcher and subject, the waiver must be
p.(None): justified by the researcher responsible for the CEP / CONEP system.
p.(None): § 2 The waiver of registration of consent or consent does not exempt the researcher from the process
p.(None): consent or consent, except in the cases provided for in this Resolution.
p.(None): § 3 The waiver of the Consent Registration must be evaluated and approved by the CEP / CONEP system.
p.(None): Art. 17. The Free and Informed Consent Register, in its different formats, must contain
p.(None): sufficient research clarification, including:
p.(None): I - the justification, objectives and procedures that will be used in the research, with information
p.(None): about methods to be used, in clear and accessible language, to the research participants, respecting the
p.(None): nature of the research;
p.(None): II - the explanation of the possible damages resulting from participation in the research, in addition to the presentation of
p.(None): measures and precautions to be employed to avoid situations that may cause damage, considering the
p.(None): characteristics of the research participant;
p.(None): III - the guarantee of the research participant's full freedom to decide on their participation,
p.(None): being able to withdraw their consent, at any stage of the research, without prejudice;
p.(None): IV - the guarantee of maintaining the confidentiality and privacy of the research participants, whether person or
p.(None): group of people, during all phases of the research, except when there is an explicit manifestation in
p.(None): contrary sense, even after the end of the research;
p.(None): V - information on the form of monitoring and assistance to which the participants of the
p.(None): research, including considering benefits, if any;
p.(None): VI - guaranteeing participants access to research results;
p.(None): VII - explanation of the guarantee to the reimbursement participant and a description of the ways of covering expenses
p.(None): performed by the participant resulting from the research, if any;
p.(None): VIII - information on the address, e-mail and telephone contact of those responsible for the research;
p.(None): IX - brief explanation of what the CEP is, as well as the address, email and telephone contact of the local CEP and, when
p.(None): the case, from CONEP; and
p.(None): X - the information that the participant will have access to the consent record whenever requested.
...

Searching for indicator linguistic:

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p.(None): XIX - privacy: the research participant's right to maintain control over their choices and personal information
p.(None): and to safeguard your intimacy, your image and your personal data, being a guarantee that these life choices do not
p.(None): will suffer undue invasions, by public control, state or non-state, and by social disapproval from the
p.(None): characteristics or search results;
p.(None): XX - consent and consent process: process based on the construction of a relationship of
p.(None): trust between researcher and research participant, in accordance with their culture and continuously open
p.(None): dialogue and questioning, the record of their obtaining not necessarily being written;
p.(None): XXI - research protocol: set of documents including the cover page and the research project
p.(None): with the description of the research in its fundamental aspects and the information related to the participant of the
p.(None): research, the qualification of researchers and all responsible bodies. The provisions of
p.(None): CNS operational norm in force or another that will replace it, as appropriate and when there is no loss in the
p.(None): established in this Resolution;
p.(None): XXII - registration of consent or assent: document in any medium, format or media, such as
p.(None): paper, audio, filming, electronic and digital media, which records the granting of consent or consent
p.(None): free and informed, the form of registration being chosen based on individual, social,
p.(None): linguistic, economic and cultural aspects of the research participant and because of the
p.(None): methodological applied;
p.(None): XXIII - final report: it is the one presented at the end of the research, containing all its results;
p.(None): XXIV - reimbursement: material compensation for expenses resulting from participation in the research, or
p.(None): that is, expenses for the participant and their companions, such as transportation and food;
p.(None): XXV - research risk: possibility of damage to the physical, mental, moral, intellectual, social dimension,
p.(None): cultural aspect of the human being, at any stage of the research and resulting from it; and
p.(None): XXVI - vulnerability: a situation in which a person or group of people has reduced the ability to take
p.(None): decisions and oppose resistance in the research situation, due to individual, psychological,
p.(None): economic, cultural, social or political.
p.(None): Chapter II
p.(None): OF ETHICAL PRINCIPLES OF RESEARCH IN HUMAN SCIENCES AND
p.(None): SOCIAL
p.(None): Art. 3 The ethical principles of research in Human and Social Sciences are:
p.(None): I - recognition of the freedom and autonomy of everyone involved in the research process,
p.(None): including scientific and academic freedom;
p.(None): II - defense of human rights and refusal of arbitration and authoritarianism in relations involving
p.(None): research processes;
...

Social / Marital Status

Searching for indicator single:

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p.(None): non-hierarchical;
p.(None): Considering the documents that constitute the pillars of recognition and affirmation of dignity,
p.(None): freedom and autonomy of human beings, such as the 1948 Universal Declaration of Human Rights and the
p.(None): Inter-American Declaration of Human Rights and Duties, 1948;
p.(None): Considering the existence of the system of Research Ethics Committees and the National Ethics Commission in
p.(None): Search;
p.(None): Considering that Resolution 466/12, in Article XIII.3, recognizes the ethical specificities of
p.(None): research in Human and Social Sciences and others that use methodologies specific to these areas, given their
p.(None): peculiarities;
p.(None): Whereas scientific production must imply current or potential benefits for humans,
p.(None): for the community in which it operates and for society, enabling the promotion of quality worthy of
p.(None): life based on respect for civil, social, cultural rights and an ecologically balanced environment; and
p.(None): Considering the importance of building a clear, precise and fully understandable regulatory framework for all
p.(None): those involved in research activities in Human and Social Sciences, resolves:
p.(None): Art. 1 This Resolution provides for the rules applicable to research in Human and Social Sciences whose procedures
p.(None): methodological aspects involve the use of data directly obtained from the participants or information
p.(None): identifiable or that may carry greater risks than those existing in everyday life, in the form
p.(None): defined in this Resolution.
p.(None): Single paragraph. The following shall not be recorded or evaluated by the CEP / CONEP system: I - public opinion survey with
p.(None): unidentified participants;
p.(None): II - research that uses information of public access, under the terms of Law No. 12,527, of November 18,
p.(None): 2011;
p.(None): III - research that uses information in the public domain; IV - census research;
p.(None): V - research with databases, whose information is aggregated, with no possibility of identification
p.(None): individual; and
p.(None): VI - research carried out exclusively with scientific texts to review the scientific literature;
p.(None): VII - research that aims at the theoretical deepening of situations that emerge spontaneously and contingently in the
p.(None): professional practice, as long as they do not reveal data that can identify the subject; and
p.(None): VIII - activity carried out with the sole purpose of education, teaching or training without the purpose of
p.(None): scientific research, of undergraduate students, of technical course, or of professionals in specialization.
p.(None): Paragraph 1 The Course Conclusion Papers, monographs and
p.(None): similar, in which case the research protocol must be submitted to the CEP / CONEP system;
p.(None): § 2 If, during the planning or execution of the education, teaching or training activity, the
p.(None): intention to incorporate the results of these activities into a research project, mandatory
p.(None): present the research protocol to the CEP / CONEP system.
p.(None): Chapter I
p.(None): TERMS AND DEFINITIONS
p.(None): Art. 2 For the purposes of this Resolution, the following terms and definitions are adopted:
...

p.(None): Art. 9 The rights of the participants are:
p.(None): I - be informed about the research;
p.(None): II - give up at any time to participate in the research, without any prejudice; III - have your privacy
p.(None): respected;
p.(None): IV - have the confidentiality of personal information guaranteed;
p.(None): V - decide whether your identity will be disclosed and what, among the information you provided, can be treated
p.(None): publicly;
p.(None): VI - to be compensated for the damage resulting from the research, under the terms of the Law; and
p.(None): VII - the reimbursement of expenses directly resulting from your participation in the research.
p.(None): Section I
p.(None): Obtaining consent and consent
p.(None): Art. 10. The researcher must clarify the potential participant, to the extent of his understanding and respected his
p.(None): singularities, about the nature of the research, its objectives, methods, rights, risks and potential benefits.
p.(None): Art. 11. The consent of the research participant must be particularly guaranteed to the one who, although
p.(None): fully capable, exposed to specific conditions, or subject to a relationship of authority or
p.(None): dependency, characterizing situations that may limit autonomy.
p.(None): Art. 12. There should be justification for choosing children, adolescents and people in situations of
p.(None): decreased decision-making capacity in the protocol to be approved by the CEP / CONEP system.
p.(None): Single paragraph. In the cases provided for in the caput, the consent of the
p.(None): participant and free and informed consent, through the legal representatives of the participant of the
p.(None): research, preserving the participant's right to information and autonomy, according to his capacity.
p.(None): Art. 13. In communities whose culture recognizes the authority of the leader or the collective over the individual,
p.(None): as is the case with some traditional, indigenous or religious communities, for example, obtaining
p.(None): authorization for research must respect this particularity, without prejudice to individual consent, when
p.(None): possible and desirable.
p.(None): Art. 14. When the Free and Informed Consent process is not viable, the waiver of this
p.(None): process must be justifiably requested by the researcher responsible to the CEP / CONEP System to
p.(None): appreciation.
p.(None): Section II
p.(None): Registration of Consent and Assent
p.(None): Art. 15. The Consent and Assent Register is the means by which consent is made explicit
p.(None): free and informed consent of the participant or their legal guardian, in written, sound, imagery,
...

p.(None): advisor already approved by the CEP / Conep system, can be presented as an amendment to the approved project,
p.(None): that does not contain essential changes in the objectives and methodology of the original project.
p.(None): Chapter VI
p.(None): RESPONSIBLE RESEARCHER
p.(None): Art. 28. The researcher's responsibility is non-delegable and indeclinable and includes the ethical and
p.(None): legal requirements, including:
p.(None): I - present the protocol duly instructed to the CEP / Conep system, awaiting the decision of
p.(None): ethical approval, before starting the research, as defined in a specific resolution for grading and grading
p.(None): risk;
p.(None): II - conduct the Free and Informed Consent and Consent process; III - present requested data
p.(None): by CEP or Conep at any time;
p.(None): IV - keep the research data on file, physical or digital, under your custody and responsibility, for a period
p.(None): minimum of 5 (five) years after the end of the research; and
p.(None): V - present in the final report that the project was developed as outlined, justifying, when
p.(None): occurred, its change or interruption.
p.(None): Chapter VII
p.(None): TRANSITIONAL PROVISIONS
p.(None): Art. 29. An instance will be instituted, within the scope of Conep, for implementation, monitoring, proposal of
p.(None): update of this Resolution and the proper form for registration of protocols related to projects of the
p.(None): Human and Social Sciences at Plataforma Brasil, as well as for proposing training and capacity building projects
p.(None): in the area.
p.(None): Single paragraph. The body foreseen in the caput will be composed of full members of the Humanities
p.(None): and Social members of CONEP, representatives of the national scientific associations of Human Sciences and
p.(None): Social, members of the CEP of Human and Social Sciences and users.
p.(None): Art. 30. The admission of researchers and other professionals working in the Humanities and
p.(None): Services in existing CEP collegiate bodies, as well as the creation of new CEPs, maintaining interdisciplinarity
p.(None): in its composition.
p.(None): Art. 31. Aspects related to the necessary modifications to the Brazil Platform will come into effect when
p.(None): system update.
p.(None): Chapter VIII
p.(None): FINAL PROVISIONS
p.(None): Art. 32. The provisions of items VII, VIII, IX and X of CNS Resolution No. 466, of December 12, 2012, are applied,
p.(None): where applicable and when there is no prejudice to the provisions of this Resolution.
p.(None): Single paragraph. In situations not covered by this Resolution, the principles will prevail
p.(None): contained in CNS Resolution No. 466 of 2012.
p.(None): Art. 33. The composition of Conep will respect the equity of the full and alternate members appointed by the CEP
p.(None): between the Human and Social Sciences area and the other areas that compose it, guaranteeing the representation
p.(None): balance of the different areas in the elaboration of norms and in the management of the CEP / CONEP System.
p.(None): Art. 34. 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. 510, of April 7, 2016, under the terms of the Decree of Delegation of
p.(None): Competency of November 12, 1991.
p.(None): MARCELO CASTRO
p.(None): Minister of State for Health
...

Social / Religion

Searching for indicator religious:

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p.(None): methodological applied;
p.(None): XXIII - final report: it is the one presented at the end of the research, containing all its results;
p.(None): XXIV - reimbursement: material compensation for expenses resulting from participation in the research, or
p.(None): that is, expenses for the participant and their companions, such as transportation and food;
p.(None): XXV - research risk: possibility of damage to the physical, mental, moral, intellectual, social dimension,
p.(None): cultural aspect of the human being, at any stage of the research and resulting from it; and
p.(None): XXVI - vulnerability: a situation in which a person or group of people has reduced the ability to take
p.(None): decisions and oppose resistance in the research situation, due to individual, psychological,
p.(None): economic, cultural, social or political.
p.(None): Chapter II
p.(None): OF ETHICAL PRINCIPLES OF RESEARCH IN HUMAN SCIENCES AND
p.(None): SOCIAL
p.(None): Art. 3 The ethical principles of research in Human and Social Sciences are:
p.(None): I - recognition of the freedom and autonomy of everyone involved in the research process,
p.(None): including scientific and academic freedom;
p.(None): II - defense of human rights and refusal of arbitration and authoritarianism in relations involving
p.(None): research processes;
p.(None): III - respect for cultural, social, moral and religious values, as well as habits and customs, of
p.(None): research participants;
p.(None): IV - commitment to the expansion and consolidation of democracy through the socialization of the production of
p.(None): knowledge resulting from the research, including in a format accessible to the group or population that was researched;
p.(None): V - refusal of all forms of prejudice, encouraging respect for diversity,
p.(None): participation of vulnerable and discriminated individuals and groups and differences in research processes;
p.(None): VI - guarantee of consent or consent of the research participants, clarified about its meaning and
p.(None): implications;
p.(None): VII - guarantee of confidentiality of information, privacy of participants and protection
p.(None): his identity, including the use of his image and voice;
p.(None): VIII - guarantee that the researcher will not use the information obtained in research at a loss
p.(None): of its participants;
p.(None): IX - commitment by everyone involved in the research not to create, maintain or expand risk situations
p.(None): or vulnerability to individuals and collectivities, nor to accentuate stigma, prejudice or discrimination; and
p.(None): X - commitment to provide assistance to eventual material and immaterial damages, resulting from participation in the
p.(None): research, as the case may be, as long as necessary.
p.(None): Chapter III
...

p.(None): singularities, about the nature of the research, its objectives, methods, rights, risks and potential benefits.
p.(None): Art. 11. The consent of the research participant must be particularly guaranteed to the one who, although
p.(None): fully capable, exposed to specific conditions, or subject to a relationship of authority or
p.(None): dependency, characterizing situations that may limit autonomy.
p.(None): Art. 12. There should be justification for choosing children, adolescents and people in situations of
p.(None): decreased decision-making capacity in the protocol to be approved by the CEP / CONEP system.
p.(None): Single paragraph. In the cases provided for in the caput, the consent of the
p.(None): participant and free and informed consent, through the legal representatives of the participant of the
p.(None): research, preserving the participant's right to information and autonomy, according to his capacity.
p.(None): Art. 13. In communities whose culture recognizes the authority of the leader or the collective over the individual,
p.(None): as is the case with some traditional, indigenous or religious communities, for example, obtaining
p.(None): authorization for research must respect this particularity, without prejudice to individual consent, when
p.(None): possible and desirable.
p.(None): Art. 14. When the Free and Informed Consent process is not viable, the waiver of this
p.(None): process must be justifiably requested by the researcher responsible to the CEP / CONEP System to
p.(None): appreciation.
p.(None): Section II
p.(None): Registration of Consent and Assent
p.(None): Art. 15. The Consent and Assent Register is the means by which consent is made explicit
p.(None): free and informed consent of the participant or their legal guardian, in written, sound, imagery,
p.(None): or in other forms that meet the characteristics of the research and the participants, and must contain
p.(None): information in clear and easy to understand language for sufficient clarification about the research.
p.(None): § 1 When there is no record of consent and assent, the researcher must deliver
p.(None): document to the participant that includes the information provided for the free and informed consent on the
p.(None): search.
p.(None): § 2 The obtaining of consent can also be proven through a witness who does not compose the
p.(None): research team and that accompanied the manifestation of consent.
...

Social / Threat of Stigma

Searching for indicator stigma:

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p.(None): not subject to limitations related to privacy, security or access control. These
p.(None): information may be processed, or not, and contained in any medium, medium and format produced or managed by
p.(None): public or private bodies;
p.(None): VII - material damage: injury that affects the assets of the research participant due to the
p.(None): characteristics or the results of the research process, imposing a monetary expense or decreasing its revenues
p.(None): earned or that could be earned; VIII - immaterial damage: injury to the right or personality,
p.(None): such as physical and psychological integrity, health, honor, image, and privacy, unlawfully
p.(None): produced to the research participant by characteristics or results of the research
p.(None): search;
p.(None): IX - discrimination: characterization or social treatment of a person or group of people, with consequent violation
p.(None): human dignity, human and social rights and fundamental freedoms of that person or group of
p.(None): people;
p.(None): X - clarification: clear and accessible presentation of the nature of the research, its justification,
p.(None): its objectives, methods, potential benefits and risks, designed to the extent of the participant's understanding,
p.(None): from their individual, social, economic and cultural characteristics, and because of the approaches
p.(None): methodological applied. All of these elements determine whether the clarification will be given by document
p.(None): written, by image or orally, registered or unregistered;
p.(None): XI - stigmatization: attribution of negative content to one or more characteristics (stigma) of a
p.(None): person or group of people, with consequent violation of human dignity, human rights and fundamental freedoms
p.(None): that person or group of people;
p.(None): XII - preliminary stages of a research: the activities that the researcher has to carry out are thus considered
p.(None): to ascertain the conditions for the possibility of carrying out the research, including documentary and
p.(None): direct contacts with possible participants, without their identification and without the public and formal registration of
p.(None): information thus obtained; not to be confused with “exploratory studies” or “pilot research”, which
p.(None): should be considered as research projects. Preliminary steps include visits to communities,
p.(None): to services, conversations with community leaders, among others;
p.(None): XIII - research participant: individual or group, who is not a member of the research team,
p.(None): participates in an informed and voluntary manner, by granting consent and also, when
p.(None): fit, in agreement, in the forms described in this resolution;
p.(None): XIV - public opinion survey: verbal or written consultation of a punctual character, carried out through methodology
p.(None): specific way, through which the participant is invited to express his preference, evaluation or
p.(None): meaning that it attributes to themes, actions of people and organizations, or products and services; without
p.(None): possibility of identifying the participant;
p.(None): XV - covert research: research conducted without the participants being informed about objectives and
p.(None): study procedures, and without your consent being obtained in advance or during the performance of the
...

p.(None): including scientific and academic freedom;
p.(None): II - defense of human rights and refusal of arbitration and authoritarianism in relations involving
p.(None): research processes;
p.(None): III - respect for cultural, social, moral and religious values, as well as habits and customs, of
p.(None): research participants;
p.(None): IV - commitment to the expansion and consolidation of democracy through the socialization of the production of
p.(None): knowledge resulting from the research, including in a format accessible to the group or population that was researched;
p.(None): V - refusal of all forms of prejudice, encouraging respect for diversity,
p.(None): participation of vulnerable and discriminated individuals and groups and differences in research processes;
p.(None): VI - guarantee of consent or consent of the research participants, clarified about its meaning and
p.(None): implications;
p.(None): VII - guarantee of confidentiality of information, privacy of participants and protection
p.(None): his identity, including the use of his image and voice;
p.(None): VIII - guarantee that the researcher will not use the information obtained in research at a loss
p.(None): of its participants;
p.(None): IX - commitment by everyone involved in the research not to create, maintain or expand risk situations
p.(None): or vulnerability to individuals and collectivities, nor to accentuate stigma, prejudice or discrimination; and
p.(None): X - commitment to provide assistance to eventual material and immaterial damages, resulting from participation in the
p.(None): research, as the case may be, as long as necessary.
p.(None): Chapter III
p.(None): THE CONSENT PROCESS AND FREE AND CONSENT
p.(None): ENLIGHTENED
p.(None): Art. 4 The process of consent and free and informed consent involves the establishment of
p.(None): relationship of trust between researcher and participant, continually open to dialogue and questioning,
p.(None): can be obtained or registered in any of the research execution phases, as well as removed from
p.(None): any time, without prejudice to the participant.
p.(None): Art. 5 The process of communicating consent and free and informed consent can be carried out by
p.(None): through their oral, written, sign language or other forms that are appropriate,
p.(None): the individual, social, economic and cultural characteristics of the person or group must be considered
p.(None): of people participating in the research and applied methodological approaches.
p.(None): § 1 The process of communicating consent and free and informed consent must occur
p.(None): spontaneously, clearly and objectively, and to avoid excessively formal modalities, in a climate
p.(None): mutual trust, ensuring full and interactive communication.
...

Searching for indicator stigmatization:

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p.(None): knowledge and which are available without restriction to access by researchers and citizens in general,
p.(None): not subject to limitations related to privacy, security or access control. These
p.(None): information may be processed, or not, and contained in any medium, medium and format produced or managed by
p.(None): public or private bodies;
p.(None): VII - material damage: injury that affects the assets of the research participant due to the
p.(None): characteristics or the results of the research process, imposing a monetary expense or decreasing its revenues
p.(None): earned or that could be earned; VIII - immaterial damage: injury to the right or personality,
p.(None): such as physical and psychological integrity, health, honor, image, and privacy, unlawfully
p.(None): produced to the research participant by characteristics or results of the research
p.(None): search;
p.(None): IX - discrimination: characterization or social treatment of a person or group of people, with consequent violation
p.(None): human dignity, human and social rights and fundamental freedoms of that person or group of
p.(None): people;
p.(None): X - clarification: clear and accessible presentation of the nature of the research, its justification,
p.(None): its objectives, methods, potential benefits and risks, designed to the extent of the participant's understanding,
p.(None): from their individual, social, economic and cultural characteristics, and because of the approaches
p.(None): methodological applied. All of these elements determine whether the clarification will be given by document
p.(None): written, by image or orally, registered or unregistered;
p.(None): XI - stigmatization: attribution of negative content to one or more characteristics (stigma) of a
p.(None): person or group of people, with consequent violation of human dignity, human rights and fundamental freedoms
p.(None): that person or group of people;
p.(None): XII - preliminary stages of a research: the activities that the researcher has to carry out are thus considered
p.(None): to ascertain the conditions for the possibility of carrying out the research, including documentary and
p.(None): direct contacts with possible participants, without their identification and without the public and formal registration of
p.(None): information thus obtained; not to be confused with “exploratory studies” or “pilot research”, which
p.(None): should be considered as research projects. Preliminary steps include visits to communities,
p.(None): to services, conversations with community leaders, among others;
p.(None): XIII - research participant: individual or group, who is not a member of the research team,
p.(None): participates in an informed and voluntary manner, by granting consent and also, when
p.(None): fit, in agreement, in the forms described in this resolution;
p.(None): XIV - public opinion survey: verbal or written consultation of a punctual character, carried out through methodology
p.(None): specific way, through which the participant is invited to express his preference, evaluation or
p.(None): meaning that it attributes to themes, actions of people and organizations, or products and services; without
p.(None): possibility of identifying the participant;
p.(None): XV - covert research: research conducted without the participants being informed about objectives and
...

Social / education

Searching for indicator education:

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p.(None): life based on respect for civil, social, cultural rights and an ecologically balanced environment; and
p.(None): Considering the importance of building a clear, precise and fully understandable regulatory framework for all
p.(None): those involved in research activities in Human and Social Sciences, resolves:
p.(None): Art. 1 This Resolution provides for the rules applicable to research in Human and Social Sciences whose procedures
p.(None): methodological aspects involve the use of data directly obtained from the participants or information
p.(None): identifiable or that may carry greater risks than those existing in everyday life, in the form
p.(None): defined in this Resolution.
p.(None): Single paragraph. The following shall not be recorded or evaluated by the CEP / CONEP system: I - public opinion survey with
p.(None): unidentified participants;
p.(None): II - research that uses information of public access, under the terms of Law No. 12,527, of November 18,
p.(None): 2011;
p.(None): III - research that uses information in the public domain; IV - census research;
p.(None): V - research with databases, whose information is aggregated, with no possibility of identification
p.(None): individual; and
p.(None): VI - research carried out exclusively with scientific texts to review the scientific literature;
p.(None): VII - research that aims at the theoretical deepening of situations that emerge spontaneously and contingently in the
p.(None): professional practice, as long as they do not reveal data that can identify the subject; and
p.(None): VIII - activity carried out with the sole purpose of education, teaching or training without the purpose of
p.(None): scientific research, of undergraduate students, of technical course, or of professionals in specialization.
p.(None): Paragraph 1 The Course Conclusion Papers, monographs and
p.(None): similar, in which case the research protocol must be submitted to the CEP / CONEP system;
p.(None): § 2 If, during the planning or execution of the education, teaching or training activity, the
p.(None): intention to incorporate the results of these activities into a research project, mandatory
p.(None): present the research protocol to the CEP / CONEP system.
p.(None): Chapter I
p.(None): TERMS AND DEFINITIONS
p.(None): Art. 2 For the purposes of this Resolution, the following terms and definitions are adopted:
p.(None): I - free and informed consent: consent of the research participant - child, adolescent or
p.(None): individuals temporarily or otherwise prevented from consenting, to the extent of their understanding and respected their
p.(None): singularities, after clarifying the nature of the research, justification, objectives, methods, potential
p.(None): benefits and risks. Obtaining consent does not eliminate the need for consent from the person responsible;
p.(None): II - assistance to the research participant: that which is provided to deal with immaterial damages arising, directly or
p.(None): indirectly, from research;
p.(None): III - benefits: current or potential contributions of research to the human being, to the community in which he is
p.(None): inserted and for society, enabling the promotion of quality worthy of life, based on respect for human rights
p.(None): civil, social, cultural and an ecologically balanced environment;
p.(None): IV - confidentiality: it is the guarantee of safeguarding information given in confidence and protection against
p.(None): its unauthorized disclosure;
...

Social / philosophical differences/differences of opinion

Searching for indicator opinion:

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p.(None): freedom and autonomy of human beings, such as the 1948 Universal Declaration of Human Rights and the
p.(None): Inter-American Declaration of Human Rights and Duties, 1948;
p.(None): Considering the existence of the system of Research Ethics Committees and the National Ethics Commission in
p.(None): Search;
p.(None): Considering that Resolution 466/12, in Article XIII.3, recognizes the ethical specificities of
p.(None): research in Human and Social Sciences and others that use methodologies specific to these areas, given their
p.(None): peculiarities;
p.(None): Whereas scientific production must imply current or potential benefits for humans,
p.(None): for the community in which it operates and for society, enabling the promotion of quality worthy of
p.(None): life based on respect for civil, social, cultural rights and an ecologically balanced environment; and
p.(None): Considering the importance of building a clear, precise and fully understandable regulatory framework for all
p.(None): those involved in research activities in Human and Social Sciences, resolves:
p.(None): Art. 1 This Resolution provides for the rules applicable to research in Human and Social Sciences whose procedures
p.(None): methodological aspects involve the use of data directly obtained from the participants or information
p.(None): identifiable or that may carry greater risks than those existing in everyday life, in the form
p.(None): defined in this Resolution.
p.(None): Single paragraph. The following shall not be recorded or evaluated by the CEP / CONEP system: I - public opinion survey with
p.(None): unidentified participants;
p.(None): II - research that uses information of public access, under the terms of Law No. 12,527, of November 18,
p.(None): 2011;
p.(None): III - research that uses information in the public domain; IV - census research;
p.(None): V - research with databases, whose information is aggregated, with no possibility of identification
p.(None): individual; and
p.(None): VI - research carried out exclusively with scientific texts to review the scientific literature;
p.(None): VII - research that aims at the theoretical deepening of situations that emerge spontaneously and contingently in the
p.(None): professional practice, as long as they do not reveal data that can identify the subject; and
p.(None): VIII - activity carried out with the sole purpose of education, teaching or training without the purpose of
p.(None): scientific research, of undergraduate students, of technical course, or of professionals in specialization.
p.(None): Paragraph 1 The Course Conclusion Papers, monographs and
p.(None): similar, in which case the research protocol must be submitted to the CEP / CONEP system;
p.(None): § 2 If, during the planning or execution of the education, teaching or training activity, the
p.(None): intention to incorporate the results of these activities into a research project, mandatory
p.(None): present the research protocol to the CEP / CONEP system.
p.(None): Chapter I
p.(None): TERMS AND DEFINITIONS
p.(None): Art. 2 For the purposes of this Resolution, the following terms and definitions are adopted:
...

p.(None): its objectives, methods, potential benefits and risks, designed to the extent of the participant's understanding,
p.(None): from their individual, social, economic and cultural characteristics, and because of the approaches
p.(None): methodological applied. All of these elements determine whether the clarification will be given by document
p.(None): written, by image or orally, registered or unregistered;
p.(None): XI - stigmatization: attribution of negative content to one or more characteristics (stigma) of a
p.(None): person or group of people, with consequent violation of human dignity, human rights and fundamental freedoms
p.(None): that person or group of people;
p.(None): XII - preliminary stages of a research: the activities that the researcher has to carry out are thus considered
p.(None): to ascertain the conditions for the possibility of carrying out the research, including documentary and
p.(None): direct contacts with possible participants, without their identification and without the public and formal registration of
p.(None): information thus obtained; not to be confused with “exploratory studies” or “pilot research”, which
p.(None): should be considered as research projects. Preliminary steps include visits to communities,
p.(None): to services, conversations with community leaders, among others;
p.(None): XIII - research participant: individual or group, who is not a member of the research team,
p.(None): participates in an informed and voluntary manner, by granting consent and also, when
p.(None): fit, in agreement, in the forms described in this resolution;
p.(None): XIV - public opinion survey: verbal or written consultation of a punctual character, carried out through methodology
p.(None): specific way, through which the participant is invited to express his preference, evaluation or
p.(None): meaning that it attributes to themes, actions of people and organizations, or products and services; without
p.(None): possibility of identifying the participant;
p.(None): XV - covert research: research conducted without the participants being informed about objectives and
p.(None): study procedures, and without your consent being obtained in advance or during the performance of the
p.(None): search. Covert research is only justified in circumstances where information about
p.(None): objectives and procedures would change the target behavior of the study or when the use of this method
p.(None): presents the only way of conducting the study, and the procedure to be explained to the CEP should be explained
p.(None): adopted by the researcher with the participant, with regard to risks, communication to the participant and use of
p.(None): collected data, in addition to the commitment or not to confidentiality. Whenever feasible, consent
p.(None): of the participants should be sought later;
p.(None): XVI - research in human and social sciences: those that turn to knowledge, understanding of
p.(None): conditions, existence, experience and knowledge of people and groups, in their social, institutional,
p.(None): their cultural values, their historical and political orderings and their forms of subjectivity and
p.(None): communication, directly or indirectly, including research modalities involving
p.(None): intervention;
...

General/Other / Impaired Autonomy

Searching for indicator autonomy:

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p.(None): Considering that ethics is a human construction, therefore historical, social and cultural;
p.(None): Considering that research ethics implies respect for human dignity and the protection due to participants in
p.(None): scientific research involving human beings;
p.(None): Considering that the researcher's ethical action demands conscious and free action from the participant;
p.(None): Whereas research in the humanities and social sciences requires respect and guarantees the full exercise of
p.(None): participants' rights, and should be designed, evaluated and carried out in order to foresee and avoid possible
p.(None): damage to participants;
p.(None): Considering that the Human and Social Sciences have specificities in their conceptions and practices of
p.(None): research, insofar as they have a pluralistic meaning of science from which the adoption
p.(None): from multiple theoretical-methodological perspectives, as well as dealing with attributions of meaning,
p.(None): practices and representations, without direct intervention in the human body, with specific nature and degree of risk;
p.(None): Considering that the researcher-participant relationship is continuously built in the research process, being able to
p.(None): be redefined at any time in the dialogue between subjectivities, implying reflexivity and building relationships
p.(None): non-hierarchical;
p.(None): Considering the documents that constitute the pillars of recognition and affirmation of dignity,
p.(None): freedom and autonomy of human beings, such as the 1948 Universal Declaration of Human Rights and the
p.(None): Inter-American Declaration of Human Rights and Duties, 1948;
p.(None): Considering the existence of the system of Research Ethics Committees and the National Ethics Commission in
p.(None): Search;
p.(None): Considering that Resolution 466/12, in Article XIII.3, recognizes the ethical specificities of
p.(None): research in Human and Social Sciences and others that use methodologies specific to these areas, given their
p.(None): peculiarities;
p.(None): Whereas scientific production must imply current or potential benefits for humans,
p.(None): for the community in which it operates and for society, enabling the promotion of quality worthy of
p.(None): life based on respect for civil, social, cultural rights and an ecologically balanced environment; and
p.(None): Considering the importance of building a clear, precise and fully understandable regulatory framework for all
p.(None): those involved in research activities in Human and Social Sciences, resolves:
p.(None): Art. 1 This Resolution provides for the rules applicable to research in Human and Social Sciences whose procedures
p.(None): methodological aspects involve the use of data directly obtained from the participants or information
p.(None): identifiable or that may carry greater risks than those existing in everyday life, in the form
p.(None): defined in this Resolution.
p.(None): Single paragraph. The following shall not be recorded or evaluated by the CEP / CONEP system: I - public opinion survey with
p.(None): unidentified participants;
...

p.(None): free and informed, the form of registration being chosen based on individual, social,
p.(None): linguistic, economic and cultural aspects of the research participant and because of the
p.(None): methodological applied;
p.(None): XXIII - final report: it is the one presented at the end of the research, containing all its results;
p.(None): XXIV - reimbursement: material compensation for expenses resulting from participation in the research, or
p.(None): that is, expenses for the participant and their companions, such as transportation and food;
p.(None): XXV - research risk: possibility of damage to the physical, mental, moral, intellectual, social dimension,
p.(None): cultural aspect of the human being, at any stage of the research and resulting from it; and
p.(None): XXVI - vulnerability: a situation in which a person or group of people has reduced the ability to take
p.(None): decisions and oppose resistance in the research situation, due to individual, psychological,
p.(None): economic, cultural, social or political.
p.(None): Chapter II
p.(None): OF ETHICAL PRINCIPLES OF RESEARCH IN HUMAN SCIENCES AND
p.(None): SOCIAL
p.(None): Art. 3 The ethical principles of research in Human and Social Sciences are:
p.(None): I - recognition of the freedom and autonomy of everyone involved in the research process,
p.(None): including scientific and academic freedom;
p.(None): II - defense of human rights and refusal of arbitration and authoritarianism in relations involving
p.(None): research processes;
p.(None): III - respect for cultural, social, moral and religious values, as well as habits and customs, of
p.(None): research participants;
p.(None): IV - commitment to the expansion and consolidation of democracy through the socialization of the production of
p.(None): knowledge resulting from the research, including in a format accessible to the group or population that was researched;
p.(None): V - refusal of all forms of prejudice, encouraging respect for diversity,
p.(None): participation of vulnerable and discriminated individuals and groups and differences in research processes;
p.(None): VI - guarantee of consent or consent of the research participants, clarified about its meaning and
p.(None): implications;
p.(None): VII - guarantee of confidentiality of information, privacy of participants and protection
p.(None): his identity, including the use of his image and voice;
p.(None): VIII - guarantee that the researcher will not use the information obtained in research at a loss
p.(None): of its participants;
p.(None): IX - commitment by everyone involved in the research not to create, maintain or expand risk situations
...

p.(None): culture.
p.(None): Art. 8 The information about the research must be transmitted in an accessible and transparent way to
p.(None): that the guest invited to participate in a research, or his legal representative, can manifest himself, in a
p.(None): autonomous, conscious, free and enlightened.
p.(None): Art. 9 The rights of the participants are:
p.(None): I - be informed about the research;
p.(None): II - give up at any time to participate in the research, without any prejudice; III - have your privacy
p.(None): respected;
p.(None): IV - have the confidentiality of personal information guaranteed;
p.(None): V - decide whether your identity will be disclosed and what, among the information you provided, can be treated
p.(None): publicly;
p.(None): VI - to be compensated for the damage resulting from the research, under the terms of the Law; and
p.(None): VII - the reimbursement of expenses directly resulting from your participation in the research.
p.(None): Section I
p.(None): Obtaining consent and consent
p.(None): Art. 10. The researcher must clarify the potential participant, to the extent of his understanding and respected his
p.(None): singularities, about the nature of the research, its objectives, methods, rights, risks and potential benefits.
p.(None): Art. 11. The consent of the research participant must be particularly guaranteed to the one who, although
p.(None): fully capable, exposed to specific conditions, or subject to a relationship of authority or
p.(None): dependency, characterizing situations that may limit autonomy.
p.(None): Art. 12. There should be justification for choosing children, adolescents and people in situations of
p.(None): decreased decision-making capacity in the protocol to be approved by the CEP / CONEP system.
p.(None): Single paragraph. In the cases provided for in the caput, the consent of the
p.(None): participant and free and informed consent, through the legal representatives of the participant of the
p.(None): research, preserving the participant's right to information and autonomy, according to his capacity.
p.(None): Art. 13. In communities whose culture recognizes the authority of the leader or the collective over the individual,
p.(None): as is the case with some traditional, indigenous or religious communities, for example, obtaining
p.(None): authorization for research must respect this particularity, without prejudice to individual consent, when
p.(None): possible and desirable.
p.(None): Art. 14. When the Free and Informed Consent process is not viable, the waiver of this
p.(None): process must be justifiably requested by the researcher responsible to the CEP / CONEP System to
p.(None): appreciation.
p.(None): Section II
p.(None): Registration of Consent and Assent
p.(None): Art. 15. The Consent and Assent Register is the means by which consent is made explicit
p.(None): free and informed consent of the participant or their legal guardian, in written, sound, imagery,
p.(None): or in other forms that meet the characteristics of the research and the participants, and must contain
p.(None): information in clear and easy to understand language for sufficient clarification about the research.
p.(None): § 1 When there is no record of consent and assent, the researcher must deliver
...

p.(None): § 4 The consent of the research participant must be included in the consent record.
p.(None): CHAPTER IV RISKS
p.(None): Art. 18. In research projects in Human and Social Sciences, the definition and gradation of risk result from the
p.(None): appreciation of its methodological procedures and its potential to cause greater harm to the participant of the
p.(None): than those existing in everyday life, in line with the procedural and dialogical character of these researches.
p.(None): Art. 19. The researcher must always be aware of the risks that research may entail to participants in
p.(None): due to its procedures, and precautionary and protective measures must be adopted in order to avoid
p.(None): damage or mitigate its effects.
p.(None): § 1 When the researcher realizes any possibility of damage to the participant, resulting from
p.(None): participation in the research, should discuss with the participants the appropriate measures, which can
p.(None): include the end of the research and inform the CEP / CONEP system.
p.(None): § 2 The research participant who suffers any type of damage resulting from his participation in the research,
p.(None): provided or not in the Free and Informed Consent Register, is entitled to assistance and to seek compensation.
p.(None): Art. 20. The researcher must take all appropriate measures to protect the participant as a child,
p.(None): adolescent, or any person whose autonomy is reduced or who is subject to a relationship of authority or
p.(None): dependency that characterizes a situation of limited autonomy, recognizing its peculiar situation of
p.(None): vulnerability, regardless of the level of risk of the research.
p.(None): Art. 21. The risk provided for in the protocol will be graded at the minimum, low, moderate or high levels, considering
p.(None): its magnitude according to the characteristics and circumstances of the project, as defined in Resolution
p.(None): specific information on risk classification and grading and on the processing of protocols.
p.(None): § 1 The processing of protocols will be differentiated according to the gradation of
p.(None): risk.
p.(None): § 2 The gradation of risk must distinguish different levels of precaution and protection in relation to the
p.(None): research participant.
p.(None): Chapter V
p.(None): OF THE ETHICAL ANALYSIS PROCEDURE IN THE CEP / CONEP SYSTEM
p.(None): Art. 22. The protocol to be submitted to ethical evaluation will only be assessed if the entire
p.(None): documentation requested by the CEP / CONEP system, as described, in this respect, in the CNS operational norm
p.(None): in force, when applicable and when there is no prejudice in the provisions of this Resolution,
p.(None): considering the nature and specificities of each research.
p.(None): Art. 23. Research projects will be enrolled in Plataforma Brasil, for their ethical evaluation, of
p.(None): as provided for in this Resolution and in the specific Resolution for grading, risk classification and processing of
p.(None): protocols.
...

General/Other / Relationship to Authority

Searching for indicator authority:

(return to top)
p.(None): Art. 7 The researcher must ensure space for the participant to express his fears or
p.(None): doubts during the research process, avoiding any form of imposition or constraint, respecting their
p.(None): culture.
p.(None): Art. 8 The information about the research must be transmitted in an accessible and transparent way to
p.(None): that the guest invited to participate in a research, or his legal representative, can manifest himself, in a
p.(None): autonomous, conscious, free and enlightened.
p.(None): Art. 9 The rights of the participants are:
p.(None): I - be informed about the research;
p.(None): II - give up at any time to participate in the research, without any prejudice; III - have your privacy
p.(None): respected;
p.(None): IV - have the confidentiality of personal information guaranteed;
p.(None): V - decide whether your identity will be disclosed and what, among the information you provided, can be treated
p.(None): publicly;
p.(None): VI - to be compensated for the damage resulting from the research, under the terms of the Law; and
p.(None): VII - the reimbursement of expenses directly resulting from your participation in the research.
p.(None): Section I
p.(None): Obtaining consent and consent
p.(None): Art. 10. The researcher must clarify the potential participant, to the extent of his understanding and respected his
p.(None): singularities, about the nature of the research, its objectives, methods, rights, risks and potential benefits.
p.(None): Art. 11. The consent of the research participant must be particularly guaranteed to the one who, although
p.(None): fully capable, exposed to specific conditions, or subject to a relationship of authority or
p.(None): dependency, characterizing situations that may limit autonomy.
p.(None): Art. 12. There should be justification for choosing children, adolescents and people in situations of
p.(None): decreased decision-making capacity in the protocol to be approved by the CEP / CONEP system.
p.(None): Single paragraph. In the cases provided for in the caput, the consent of the
p.(None): participant and free and informed consent, through the legal representatives of the participant of the
p.(None): research, preserving the participant's right to information and autonomy, according to his capacity.
p.(None): Art. 13. In communities whose culture recognizes the authority of the leader or the collective over the individual,
p.(None): as is the case with some traditional, indigenous or religious communities, for example, obtaining
p.(None): authorization for research must respect this particularity, without prejudice to individual consent, when
p.(None): possible and desirable.
p.(None): Art. 14. When the Free and Informed Consent process is not viable, the waiver of this
p.(None): process must be justifiably requested by the researcher responsible to the CEP / CONEP System to
p.(None): appreciation.
p.(None): Section II
p.(None): Registration of Consent and Assent
p.(None): Art. 15. The Consent and Assent Register is the means by which consent is made explicit
p.(None): free and informed consent of the participant or their legal guardian, in written, sound, imagery,
p.(None): or in other forms that meet the characteristics of the research and the participants, and must contain
p.(None): information in clear and easy to understand language for sufficient clarification about the research.
p.(None): § 1 When there is no record of consent and assent, the researcher must deliver
p.(None): document to the participant that includes the information provided for the free and informed consent on the
p.(None): search.
...

p.(None): CHAPTER IV RISKS
p.(None): Art. 18. In research projects in Human and Social Sciences, the definition and gradation of risk result from the
p.(None): appreciation of its methodological procedures and its potential to cause greater harm to the participant of the
p.(None): than those existing in everyday life, in line with the procedural and dialogical character of these researches.
p.(None): Art. 19. The researcher must always be aware of the risks that research may entail to participants in
p.(None): due to its procedures, and precautionary and protective measures must be adopted in order to avoid
p.(None): damage or mitigate its effects.
p.(None): § 1 When the researcher realizes any possibility of damage to the participant, resulting from
p.(None): participation in the research, should discuss with the participants the appropriate measures, which can
p.(None): include the end of the research and inform the CEP / CONEP system.
p.(None): § 2 The research participant who suffers any type of damage resulting from his participation in the research,
p.(None): provided or not in the Free and Informed Consent Register, is entitled to assistance and to seek compensation.
p.(None): Art. 20. The researcher must take all appropriate measures to protect the participant as a child,
p.(None): adolescent, or any person whose autonomy is reduced or who is subject to a relationship of authority or
p.(None): dependency that characterizes a situation of limited autonomy, recognizing its peculiar situation of
p.(None): vulnerability, regardless of the level of risk of the research.
p.(None): Art. 21. The risk provided for in the protocol will be graded at the minimum, low, moderate or high levels, considering
p.(None): its magnitude according to the characteristics and circumstances of the project, as defined in Resolution
p.(None): specific information on risk classification and grading and on the processing of protocols.
p.(None): § 1 The processing of protocols will be differentiated according to the gradation of
p.(None): risk.
p.(None): § 2 The gradation of risk must distinguish different levels of precaution and protection in relation to the
p.(None): research participant.
p.(None): Chapter V
p.(None): OF THE ETHICAL ANALYSIS PROCEDURE IN THE CEP / CONEP SYSTEM
p.(None): Art. 22. The protocol to be submitted to ethical evaluation will only be assessed if the entire
p.(None): documentation requested by the CEP / CONEP system, as described, in this respect, in the CNS operational norm
p.(None): in force, when applicable and when there is no prejudice in the provisions of this Resolution,
p.(None): considering the nature and specificities of each research.
p.(None): Art. 23. Research projects will be enrolled in Plataforma Brasil, for their ethical evaluation, of
...


Orphaned Trigger Words



p.(None): its magnitude according to the characteristics and circumstances of the project, as defined in Resolution
p.(None): specific information on risk classification and grading and on the processing of protocols.
p.(None): § 1 The processing of protocols will be differentiated according to the gradation of
p.(None): risk.
p.(None): § 2 The gradation of risk must distinguish different levels of precaution and protection in relation to the
p.(None): research participant.
p.(None): Chapter V
p.(None): OF THE ETHICAL ANALYSIS PROCEDURE IN THE CEP / CONEP SYSTEM
p.(None): Art. 22. The protocol to be submitted to ethical evaluation will only be assessed if the entire
p.(None): documentation requested by the CEP / CONEP system, as described, in this respect, in the CNS operational norm
p.(None): in force, when applicable and when there is no prejudice in the provisions of this Resolution,
p.(None): considering the nature and specificities of each research.
p.(None): Art. 23. Research projects will be enrolled in Plataforma Brasil, for their ethical evaluation, of
p.(None): as provided for in this Resolution and in the specific Resolution for grading, risk classification and processing of
p.(None): protocols.
p.(None): Art. 24. All preliminary steps necessary for the researcher to elaborate his project are not subject to evaluation
p.(None): CEP / CONEP system.
p.(None): Art. 25. The evaluation to be made by the CEP / CONEP System will focus on the ethical aspects of the projects,
p.(None): considering the risks and the due protection of the research participants' rights.
p.(None): §1o. The scientific evaluation of the theoretical aspects of the projects submitted to this Resolution is the responsibility of the
p.(None): specific academic institutions, such as academic research commissions, graduate boards, research institutions
p.(None): fostering research, among others. The CEP / CONEP System is not responsible for analyzing the methodological design itself.
p.(None): § 2. The evaluation to be carried out by the CEP / CONEP System will focus only on the procedures
p.(None): methodological measures that imply risks to the participants.
p.(None): Art. 26. The ethical analysis of the research projects covered by this Resolution can only occur in the Research Committees
p.(None): Research Ethics that include equal representation of members of the Human and Social Sciences,
p.(None): the rapporteurs should be chosen from among the qualified members in this area of ​​knowledge.
p.(None): Art. 27. The research carried out by undergraduate and graduate students, which is part of the project
p.(None): advisor already approved by the CEP / Conep system, can be presented as an amendment to the approved project,
p.(None): that does not contain essential changes in the objectives and methodology of the original project.
p.(None): Chapter VI
p.(None): RESPONSIBLE RESEARCHER
p.(None): Art. 28. The researcher's responsibility is non-delegable and indeclinable and includes the ethical and
p.(None): legal requirements, including:
p.(None): I - present the protocol duly instructed to the CEP / Conep system, awaiting the decision of
p.(None): ethical approval, before starting the research, as defined in a specific resolution for grading and grading
p.(None): risk;
p.(None): II - conduct the Free and Informed Consent and Consent process; III - present requested data
p.(None): by CEP or Conep at any time;
p.(None): IV - keep the research data on file, physical or digital, under your custody and responsibility, for a period
p.(None): minimum of 5 (five) years after the end of the research; and
p.(None): V - present in the final report that the project was developed as outlined, justifying, when
p.(None): occurred, its change or interruption.
p.(None): Chapter VII
p.(None): TRANSITIONAL PROVISIONS
p.(None): Art. 29. An instance will be instituted, within the scope of Conep, for implementation, monitoring, proposal of
p.(None): update of this Resolution and the proper form for registration of protocols related to projects of the ...

Appendix

Indicator List

IndicatorVulnerability
accessAccess to Social Goods
authorityRelationship to Authority
autonomyImpaired Autonomy
childChild
childrenChild
educationeducation
indigenousIndigenous
languageLinguistic Proficiency
linguisticLinguistic Proficiency
opinionphilosophical differences/differences of opinion
politicalpolitical affiliation
religiousReligion
singleMarital Status
stigmaThreat of Stigma
stigmatizationThreat of Stigma
vulnerabilityvulnerable
vulnerablevulnerable

Indicator Peers (Indicators in Same Vulnerability)

IndicatorPeers
child['children']
children['child']
language['linguistic']
linguistic['language']
stigma['stigmatization']
stigmatization['stigma']
vulnerability['vulnerable']
vulnerable['vulnerability']

Trigger Words

capacity

consent

cultural

ethics

harm

protect

protection

risk


Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability TypeVulnerabilityIndicator# Matches
PoliticalIndigenousindigenous1
Politicalpolitical affiliationpolitical3
Politicalvulnerablevulnerable1
Politicalvulnerablevulnerability3
SocialAccess to Social Goodsaccess6
SocialChildchild2
SocialChildchildren1
SocialLinguistic Proficiencylanguage3
SocialLinguistic Proficiencylinguistic1
SocialMarital Statussingle4
SocialReligionreligious2
SocialThreat of Stigmastigma2
SocialThreat of Stigmastigmatization1
Socialeducationeducation2
Socialphilosophical differences/differences of opinionopinion2
General/OtherImpaired Autonomyautonomy6
General/OtherRelationship to Authorityauthority3