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
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:
(return to top)
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:
(return to top)
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:
(return to top)
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:
(return to top)
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
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| authority | Relationship to Authority |
| autonomy | Impaired Autonomy |
| child | Child |
| children | Child |
| education | education |
| indigenous | Indigenous |
| language | Linguistic Proficiency |
| linguistic | Linguistic Proficiency |
| opinion | philosophical differences/differences of opinion |
| political | political affiliation |
| religious | Religion |
| single | Marital Status |
| stigma | Threat of Stigma |
| stigmatization | Threat of Stigma |
| vulnerability | vulnerable |
| vulnerable | vulnerable |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| 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