79C3C34C52B45572883A05D425EB0F82
Resolution CNS No. 466/2012 on Guidelines and Rules for Research Involving humans Subject
https://conselho.saude.gov.br/resolucoes/2012/466_english.pdf
http://leaux.net/URLS/ConvertAPI Text Files/9660B9AAD6114E319E418531977EB6A1.en.txt
Examining the file media/Synopses/9660B9AAD6114E319E418531977EB6A1.html:
This file was generated: 2020-12-01 09:00:33
| 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 / Criminal Convictions
Searching for indicator prisoners:
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p.(None): IV.6 – In the event where there is any restriction to freedom or explanation required to the appropriate consent, the
p.(None): following shall be complied with as well:
p.(None): a) researches involving children and adolescents, individuals mentally disturbed or ill and those who
p.(None): have their capacity to consent substantially reduced, shall include in the protocol unquestionable
p.(None): justification for the choice of such individuals approved by CEP, and by CONEP, and comply with all requirements of
p.(None): informed consent statement by means of their legal representatives and the research participant, to the fullest extent
p.(None): of his/her capacity, is guaranteed the right to information;
p.(None): b) freedom to consent shall be specifically guaranteed to those individuals that, although fully capable, are
p.(None): exposed to specific conditioning or authority influence, featuring situations restricting their autonomy,
p.(None): specially students, members of the armed forces, employees, prisoners rehabilitation, shelters, nursing
p.(None): homes or religious associations interns and alike, in addition to be free to decide whether or not to participate
p.(None): in the research, with no retaliation of any kind;
p.(None): c) researches with individuals diagnosed with encephalic death may comply with the following
p.(None): requirements:
p.(None): c.1) documentary evidence of encephalic death;
p.(None):
p.(None): c.2) a written consent from family members and/or legal representative or documentary evidence of
p.(None): individual’s will to participate in researches;
p.(None): c.3) respect to human dignity;
p.(None): c.4) no additional economic-financial burden to the family;
p.(None): c.5) no prejudice to other patients awaiting hospitalization or treatment; and
p.(None): c.6) likely to acquire new, relevant scientific knowledge which cannot be so acquired any other way;
p.(None): d) the existence of an official government communication channel to clarify doubts to all those involved in the
p.(None): research projects, as well as for those cases of encephalic death diagnosis; and
p.(None): e) in group culture communities recognizing the leader’s authority or the collectiveness upon the
p.(None): individual, the authorization for the research should respect such feature, without the prejudice of
p.(None): individual consent, when possible and desirable. The authorization for the research should be granted in advance by
...
Political / Indigenous
Searching for indicator indigenous:
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p.(None): in the research, with no retaliation of any kind;
p.(None): c) researches with individuals diagnosed with encephalic death may comply with the following
p.(None): requirements:
p.(None): c.1) documentary evidence of encephalic death;
p.(None):
p.(None): c.2) a written consent from family members and/or legal representative or documentary evidence of
p.(None): individual’s will to participate in researches;
p.(None): c.3) respect to human dignity;
p.(None): c.4) no additional economic-financial burden to the family;
p.(None): c.5) no prejudice to other patients awaiting hospitalization or treatment; and
p.(None): c.6) likely to acquire new, relevant scientific knowledge which cannot be so acquired any other way;
p.(None): d) the existence of an official government communication channel to clarify doubts to all those involved in the
p.(None): research projects, as well as for those cases of encephalic death diagnosis; and
p.(None): e) in group culture communities recognizing the leader’s authority or the collectiveness upon the
p.(None): individual, the authorization for the research should respect such feature, without the prejudice of
p.(None): individual consent, when possible and desirable. The authorization for the research should be granted in advance by
p.(None): government bodies when the Brazilian Legislation rules upon their competence, like it is the case of the National
p.(None): Indian Foundation (FUNAI), where indigenous communities are under their own responsibility.
p.(None): IV.7 – The research depending on restriction to information to the research participants, such restriction shall be
p.(None): fully explained and justified by the leading researcher and submitted to the CEP/CONEP. Data collected from the
p.(None): research participants may not be used for any other purposes other than those specified in the protocol and/or informed
p.(None): consent statement.
p.(None): IV.8 – In cases where unfeasible to obtain the Informed Consent Form or that its obtaining may imply to substantial
p.(None): risks to the privacy and confidentiality of the research participant’s data or to the bonds of trust
p.(None): between investigator and investigated, the dismissal of such Statement Form must be rightly requested by the
p.(None): investigator to the CEP/CONEP System, for evaluation, without prejudice to the subsequent clarification process.
p.(None):
p.(None): V - RISKS AND BENEFITS
p.(None): Every research with human beings is considered to involve risks of different types. The bigger and more evident the
p.(None): risks, the bigger should be the care offered by CEP/CONEP to minimize them and protect the research
p.(None): participants. Possibilities for immediate or further damages must be analyzed at an individual and
p.(None): collective level. The analysis of risks is an indispensable part to the ethical analysis which generates
p.(None): the monitoring plan that shall be offered by the CEP/CONEP System in each specific case.
p.(None): V.1 – Researches involving human beings will be admissible when:
...
p.(None): guided, among others, by the impersonality, transparency, reasonability, proportionality and efficiency principles
p.(None): within deadlines laid down by operational standards, avoiding redundancies that may result in slowing down the
p.(None): analysis;
p.(None): 1. human genetics, when the project may involve:
p.(None): 1.1 shipments of human genetics overseas or any other human biological material for obtaining genetic material, except
p.(None): in those cases where there is cooperation with the Brazilian Government;
p.(None): 1.2 storage of biological material or human genetic data abroad and within the country, when part of an agreement with
p.(None): foreign institutions or with commercial institutions;
p.(None): 1.3 changes in the genetic structure of human cells for in vivo use;
p.(None): 1.4 researches in genetics of human reproduction (reprogenetics);
p.(None): 1.5 researches of genetics in behavior; and
p.(None): 1.6 researches in which irreversible dissociation of research participant’s data is expected;
p.(None): 2. human reproduction: researches interested in the functioning of the reproductive system, procreation and factors
p.(None): affecting the human reproductive health, shall consider as “research participant’s” all those who are
p.(None): affected by the procedures thereof. It will be up to CONEP to analyze the project when it involves:
p.(None): 2.1 – assisted reproduction;
p.(None): 2.2 – gametes, pre-embryos, embryos and fetus manipulation; and
p.(None): 2.3 – fetal medicine, when involving invasive procedures;
p.(None): 3. therapy equipments and devices, new or not registered in the country;
p.(None): 4. new invasive therapy procedures;
p.(None): 5. studies with indigenous populations;
p.(None): 6. research projects involving genetically modified organisms (GMOs), embryonic stem cells and organisms
p.(None): representing high collective risk, including organisms related to them, in areas of: experimentation,
p.(None): construction, growing, manipulation, transportation, transfer, import, export, storage, release into the environment
p.(None): and disposal;
p.(None): 7. setting up and functioning protocols of biobanks for research purposes;
p.(None): 8. researches with coordination and/or sponsorship originated outside Brazil, except those with the
p.(None): Brazilian Government co-sponsorship; and
p.(None): 9. projects that, at the discretion of CEP and duly justified, were judged as worthy of analysis by
p.(None): CONEP;
p.(None):
p.(None): IX.5 – strengthen the participation of CEPs through a continuous process of training, qualification and
p.(None): accreditation;
p.(None): IX.6 – coordinate the CEPs accreditation process, appointing them responsibilities originally from CONEP,
p.(None): according to their skill levels;
p.(None): IX.7 – analyze and monitor, directly and indirectly, within the standards deadline, the research protocols that may
p.(None): involve needs for a higher protection related to their research participants, specially the risks thereof.
p.(None): Within such scope, it shall always be considered as first priority and, or in association, the national interests in
p.(None): the scientific and technological development, as the basis for determining the relevance and opportunity
p.(None): for performing such researches;
...
Political / political affiliation
Searching for indicator political:
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p.(None): human behavior upon real and virtual means available changing and innovating at a continuous and fast pace;
p.(None): Considering the progress of science and technology, which may imply in current and potential benefits to the human
p.(None): being, the community in which he/she is inserted and the national and universal society, making it possible to
p.(None): promote well-being and quality of life, and promoting the protection and preservation of the environment
p.(None): for the current and future generations;
p.(None): Considering the ethical grounds subjects raised by the progress and growth of science and technology, rooted in all
p.(None): areas of human knowledge;
p.(None): Considering that all growth and progress must always respect the dignity, freedom and autonomy of the human being;
p.(None): Considering the documents that form the pillars of recognition and affirming dignity, freedom and autonomy
p.(None): of the human being, such as Nuremberg Code, from 1947, and the Universal Declaration of Human Rights, from 1948;
p.(None): Considering recent international documents, a reflection from the great scientific and technological
p.(None): discoveries from the XX and XXI centuries, particularly the Helsinque Declaration, adopted in 1964 and
p.(None): its versions from 1975, 1983, 1989, 1996 and 2000; the International Pact regarding Economical, Social
p.(None): and Cultural Rights, from 1966; the International Pact regarding Civil and Political Laws, from 1966; the
p.(None): Universal Declaration regarding Human Genoma and Human Rights, from 1997; the International Declaration
p.(None): regarding Human Genes Data, from 2003; and the Universal Declaration regarding Bioethics and Human Rights,
p.(None): from 2004;
p.(None): Considering the Federal Constitution of the Federal Republic of Brazil, which objectives and foundations of
p.(None): sovereignty, citizenship, human dignity, labor and free enterprise social values and political pluralism and the
p.(None): objectives of building a free, fair and caring society, to ensure national development, to end poverty
p.(None): and marginalization and to reduce social and regional inequalities and to promote the well being of all, without any
p.(None): type of prejudice or discrimination, are consistent with the international documents of ethics, human rights and
p.(None): development;
p.(None): Considering the related and relevant Brazilian Legislation; and
p.(None): Considering the Resolution no. 196/96, of the National Council of Health, from the Ministry of Health, that states
p.(None): periodic reviews to it according to the needs on techno-scientific and ethical areas.
p.(None):
p.(None): D E C I D E S:
p.(None): To approve the following guidelines and standards regulating researches involving human beings: I – PRELIMINARY
p.(None): PROVISIONS
p.(None): This Resolution consolidates bioethical benchmarks from the view point of the individual and the
p.(None): communities, such as autonomy, non maleficence, beneficence, justice and equity, among others, and it seeks to
p.(None):
p.(None): ensure the rights and duties that refer to the participants of the research, to the scientific community and the
p.(None): State.
p.(None): Projects of research involving human beings must attend to this Resolution.
p.(None):
p.(None): II – TERMS AND DEFINITIONS
p.(None): This Resolution adopts the following definitions:
p.(None): II.1 – research findings – facts or information met by the investigator along the study and considered as relevant to
p.(None): the participants or communities involved;
...
Political / vulnerable
Searching for indicator vulnerable:
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p.(None): d) always seek for the expected benefits to prevail regarding risks and/or foreseeable discomforts;
p.(None): e) use the appropriate methodology to answer the studied subjects specifying if a qualitative, quantitative or
p.(None): quali-quantitative investigation;
p.(None):
p.(None): f) if there is a need to allocate the research participants randomly into experimental and control groups, ensure
p.(None): beforehand that it is not possible to establish the advantages of a procedure over another, by reviewing literature,
p.(None): observation methods or methods that do not involve human beings;
p.(None): g) obtain a deliberate consent statement from the research participant and/or his/her legal
p.(None): representative, including on cases where, due to their nature, the researches imply in posteriori consent;
p.(None): h) count on human resources and materials necessary to ensure the research participant’s wellbeing, and the
p.(None): investigator(s) must have appropriate professional capability to develop his/her function in the proposed project;
p.(None): i) provide procedures ensuring confidentiality and privacy, image protection and avoiding stigmatization of the
p.(None): research participants, and to guarantee the non-use of information to the detriment of people and/or communities,
p.(None): including in terms of self-esteem, prestige and/or economic and financial aspects;
p.(None): j) to be preferably developed on individuals with full autonomy. Individuals or vulnerable groups shall not
p.(None): participate in the research when the expected information may be obtained with participants fully capable,
p.(None): unless the research may bring benefits to the individuals or vulnerable groups.
p.(None): k) always respect cultural, social, moral, religious and ethical values, as well as habits and practices,
p.(None): when involving communities in researches;
p.(None): l) ensure, wherever possible, that researches within communities become beneficial to their effects and continue
p.(None): after their conclusion. When there is a real benefit to motivate or stimulate changes of habits or behaviors for the
p.(None): sake of the community, the research protocol shall include, wherever possible, willingness to communicate such
p.(None): advantage to the people and/or community;
p.(None): m) communicate the competent authorities, as well as to the bodies legitimized by the Social Control, the results
p.(None): and/or findings of the research, every time they can contribute to improving living conditions of the community,
p.(None): preserving, however, the image and ensuring that the research participants will not be stigmatized;
p.(None): n) ensure the benefits resulting from the project to the research participants, whether in terms of social return,
p.(None): access to procedures, products or research agents;
p.(None): o) ensure the monitoring conditions, treatment, full assistance and guidance to the research participants, according
p.(None): to the case, while needed, including those in tracking researches;
p.(None): p) present evidence of commitments and advantages to the research participants and Brazil resulting from the
p.(None): performance thereof for researches carried out abroad or with foreign cooperation. In these cases, the investigator and
...
Searching for indicator vulnerability:
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p.(None): II.20 – partial report – the one presented during the research showing relevant facts and partial results of its
p.(None): development;
p.(None): II.21 – indemnification – material compensation dedicated exclusively for expenses related to
p.(None): transportation and meal for the research participant and his/her companion(s), whenever necessary;
p.(None): II.22 – research risks – possible damage to the human being physical, psychic, moral, intellectual, social, cultural or
p.(None): spiritual dimension, caused by and from any research;
p.(None): II.23 – Informed Consent Form (ICF) – a document specifying the research participant and/or his/her legal
p.(None): representative's consent statement, in the form of a written consent, and it must contain all necessary
p.(None): information, in a clear and objective language, so the participant and/or his legal representative
p.(None): clearly understand about the research to which he/she is willing to participate;
p.(None): II.24 – Consent Term – a document prepared for minors or legally incapable for their easy understanding allowing them,
p.(None): after being clearly informed about the research, to state their will to participate in the research without prejudice
p.(None): to the consent of their legal representatives; and
p.(None): II.25 – vulnerability – the condition of individuals or groups that, for any reason whatsoever, have their
p.(None): self-judgment capability reduced or disabled, or by any means they are prevented to resist to the opposition,
p.(None): especially when it comes to the informed consent form.
p.(None):
p.(None): III – ETHICAL ASPECTS OF RESEARCHES INVOLVING HUMAN BEINGS
p.(None): The researches involving human beings must attend to the relevant ethical and scientific grounds.
p.(None): III.1 – Ethics of research involve:
p.(None): a) respect the research participant’s dignity and autonomy, recognizing his/her vulnerability, ensuring
p.(None): his/her will to contribute and remain, or not, in the research, by means of express, free and informed statement;
p.(None): b) balance known and potential, individual or collective, risks and benefits committing to the maximum of benefits
p.(None): and to the minimum of risks and damages;
p.(None): c) ensure that known damages will be avoided; and
p.(None): d) social relevance of investigation, ensuring the equated weighting of interests involved with no loss to the sense
p.(None): of its social-humanitarian purpose.
p.(None): III.2 – In any area of knowledge involving human beings, the researches shall comply with the following demands:
p.(None): a) shall be appropriate to the scientific values that justifies it and with concrete possibilities of responding to
p.(None): uncertainties;
p.(None): b) shall be founded in scientific grounds, previous testing and/or appropriate assumptions to the specific area of
p.(None): investigation;
p.(None): c) shall be performed only when the expected knowledge cannot be obtained through other means;
p.(None): d) always seek for the expected benefits to prevail regarding risks and/or foreseeable discomforts;
p.(None): e) use the appropriate methodology to answer the studied subjects specifying if a qualitative, quantitative or
p.(None): quali-quantitative investigation;
p.(None):
p.(None): f) if there is a need to allocate the research participants randomly into experimental and control groups, ensure
p.(None): beforehand that it is not possible to establish the advantages of a procedure over another, by reviewing literature,
p.(None): observation methods or methods that do not involve human beings;
p.(None): g) obtain a deliberate consent statement from the research participant and/or his/her legal
...
Health / Drug Dependence
Searching for indicator dependence:
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p.(None): type of prejudice or discrimination, are consistent with the international documents of ethics, human rights and
p.(None): development;
p.(None): Considering the related and relevant Brazilian Legislation; and
p.(None): Considering the Resolution no. 196/96, of the National Council of Health, from the Ministry of Health, that states
p.(None): periodic reviews to it according to the needs on techno-scientific and ethical areas.
p.(None):
p.(None): D E C I D E S:
p.(None): To approve the following guidelines and standards regulating researches involving human beings: I – PRELIMINARY
p.(None): PROVISIONS
p.(None): This Resolution consolidates bioethical benchmarks from the view point of the individual and the
p.(None): communities, such as autonomy, non maleficence, beneficence, justice and equity, among others, and it seeks to
p.(None):
p.(None): ensure the rights and duties that refer to the participants of the research, to the scientific community and the
p.(None): State.
p.(None): Projects of research involving human beings must attend to this Resolution.
p.(None):
p.(None): II – TERMS AND DEFINITIONS
p.(None): This Resolution adopts the following definitions:
p.(None): II.1 – research findings – facts or information met by the investigator along the study and considered as relevant to
p.(None): the participants or communities involved;
p.(None): II.2 – informed consent agreement – an agreement of the research participant, child, teenager or legally unable, free
p.(None): of vice (simulation, fraud or error), dependence, subordination or intimidation. Such research participants
p.(None): must be clarified about the nature of research, its objectives, methods, expected benefits, potential risks and the
p.(None): discomfort that it might occur by reason of said investigation, according to their comprehension and respecting their
p.(None): singularities;
p.(None): II.3 – assistance to the research participant:
p.(None): II.3.1 – immediate assistance – considered as an emergency and with no cost of any kind to the research participant, in
p.(None): situations that he/she may need it; and
p.(None): II.3.2 – full assistance – that provided to attend complications and damages caused directly or indirectly by the
p.(None): research;
p.(None): II.4 – research benefits – immediate or posterior, direct or indirect profit, attained by the participant and/or
p.(None): his/her community caused by his/her participation in the research;
p.(None): II.5 – informed consent form – an agreement from the research participant and/or from his/her legal
p.(None): representative, free of vice (simulation, fraud or error), dependence, subordination or intimidation
p.(None): following a complete and detailed explanation of the nature of the research, its objectives, methods,
p.(None): expected benefits, potential risks and discomfort that might occur by reason of said investigation;
p.(None): II.6 – damage related to or caused by the research – immediate or posterior, direct or indirect offense, to the
p.(None): individual or community, caused by the research;
p.(None): II.7 – compensation – material coverage for compensating damages caused by the research to its
p.(None): participants;
p.(None): II.8 – research applicant institution – public or private organization, legitimated and qualified, to which the leading
p.(None): researcher is linked to;
p.(None): II.9 – research co-participating institution – public or private organization, legitimated and qualified,
p.(None): in which some of the stages or steps of the research are developed;
p.(None): II.10 – research participant – the individual who accepts to be studied on a voluntary and informed basis or under
p.(None): the clarification and authorization of his/her legal representatives. The participation must be free of
p.(None): charge, except Phase I or Bioequivalence clinical researches;
p.(None): II.11 – sponsor – public or private individual or legal entity that supports the research, throughout financial shares,
p.(None): infrastructure, human resources or institutional support;
p.(None): II.12 – research – a formal and systematic process which aims at the production, at the advancement of knowledge and/or
p.(None): at obtaining answers to problems by using a scientific methodology;
p.(None): II.13 – research in human reproduction – researches engaged with the functions of the reproductive
p.(None): system, procreation and factors that affect the reproductive health of humans, considering as “research
...
Health / Drug Usage
Searching for indicator influence:
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p.(None): in the research, or by his/her legal representative, as well as by the leading researcher or those delegated by
p.(None): him/her, and with all signed pages on the same sheet. Both copies shall state the address and contact number or
p.(None): other of those responsible for the research, of the local CEP and CONEP, when applicable.
p.(None): IV.6 – In the event where there is any restriction to freedom or explanation required to the appropriate consent, the
p.(None): following shall be complied with as well:
p.(None): a) researches involving children and adolescents, individuals mentally disturbed or ill and those who
p.(None): have their capacity to consent substantially reduced, shall include in the protocol unquestionable
p.(None): justification for the choice of such individuals approved by CEP, and by CONEP, and comply with all requirements of
p.(None): informed consent statement by means of their legal representatives and the research participant, to the fullest extent
p.(None): of his/her capacity, is guaranteed the right to information;
p.(None): b) freedom to consent shall be specifically guaranteed to those individuals that, although fully capable, are
p.(None): exposed to specific conditioning or authority influence, featuring situations restricting their autonomy,
p.(None): specially students, members of the armed forces, employees, prisoners rehabilitation, shelters, nursing
p.(None): homes or religious associations interns and alike, in addition to be free to decide whether or not to participate
p.(None): in the research, with no retaliation of any kind;
p.(None): c) researches with individuals diagnosed with encephalic death may comply with the following
p.(None): requirements:
p.(None): c.1) documentary evidence of encephalic death;
p.(None):
p.(None): c.2) a written consent from family members and/or legal representative or documentary evidence of
p.(None): individual’s will to participate in researches;
p.(None): c.3) respect to human dignity;
p.(None): c.4) no additional economic-financial burden to the family;
p.(None): c.5) no prejudice to other patients awaiting hospitalization or treatment; and
p.(None): c.6) likely to acquire new, relevant scientific knowledge which cannot be so acquired any other way;
p.(None): d) the existence of an official government communication channel to clarify doubts to all those involved in the
p.(None): research projects, as well as for those cases of encephalic death diagnosis; and
p.(None): e) in group culture communities recognizing the leader’s authority or the collectiveness upon the
...
Health / Mentally Disabled
Searching for indicator disabled:
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p.(None): II.21 – indemnification – material compensation dedicated exclusively for expenses related to
p.(None): transportation and meal for the research participant and his/her companion(s), whenever necessary;
p.(None): II.22 – research risks – possible damage to the human being physical, psychic, moral, intellectual, social, cultural or
p.(None): spiritual dimension, caused by and from any research;
p.(None): II.23 – Informed Consent Form (ICF) – a document specifying the research participant and/or his/her legal
p.(None): representative's consent statement, in the form of a written consent, and it must contain all necessary
p.(None): information, in a clear and objective language, so the participant and/or his legal representative
p.(None): clearly understand about the research to which he/she is willing to participate;
p.(None): II.24 – Consent Term – a document prepared for minors or legally incapable for their easy understanding allowing them,
p.(None): after being clearly informed about the research, to state their will to participate in the research without prejudice
p.(None): to the consent of their legal representatives; and
p.(None): II.25 – vulnerability – the condition of individuals or groups that, for any reason whatsoever, have their
p.(None): self-judgment capability reduced or disabled, or by any means they are prevented to resist to the opposition,
p.(None): especially when it comes to the informed consent form.
p.(None):
p.(None): III – ETHICAL ASPECTS OF RESEARCHES INVOLVING HUMAN BEINGS
p.(None): The researches involving human beings must attend to the relevant ethical and scientific grounds.
p.(None): III.1 – Ethics of research involve:
p.(None): a) respect the research participant’s dignity and autonomy, recognizing his/her vulnerability, ensuring
p.(None): his/her will to contribute and remain, or not, in the research, by means of express, free and informed statement;
p.(None): b) balance known and potential, individual or collective, risks and benefits committing to the maximum of benefits
p.(None): and to the minimum of risks and damages;
p.(None): c) ensure that known damages will be avoided; and
p.(None): d) social relevance of investigation, ensuring the equated weighting of interests involved with no loss to the sense
p.(None): of its social-humanitarian purpose.
p.(None): III.2 – In any area of knowledge involving human beings, the researches shall comply with the following demands:
p.(None): a) shall be appropriate to the scientific values that justifies it and with concrete possibilities of responding to
p.(None): uncertainties;
p.(None): b) shall be founded in scientific grounds, previous testing and/or appropriate assumptions to the specific area of
p.(None): investigation;
p.(None): c) shall be performed only when the expected knowledge cannot be obtained through other means;
p.(None): d) always seek for the expected benefits to prevail regarding risks and/or foreseeable discomforts;
...
Searching for indicator mentally:
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p.(None): legal rights, including the right to procure indemnification for potential damages.
p.(None): IV.5 – The Informed Consent Form should also:
p.(None): a) contain a statement of the leading researcher expressing the compliance with the requirements
p.(None): specified on items IV.3 and, where applicable, IV.4;
p.(None): b) be adapted to the ethical rules and to the local culture, by the leading researcher, on researches with foreign
p.(None): cooperation elaborated abroad, with clear and accessible language to all and particularly to the participants of the
p.(None): research, taking special care for easy reading and understanding;
p.(None): c) be approved by CEP to which the project was presented and by CONEP, when applicable; and
p.(None): d) be elaborated in 2 copies and with all pages initialed and signed at the end by the guest invited to participate
p.(None): in the research, or by his/her legal representative, as well as by the leading researcher or those delegated by
p.(None): him/her, and with all signed pages on the same sheet. Both copies shall state the address and contact number or
p.(None): other of those responsible for the research, of the local CEP and CONEP, when applicable.
p.(None): IV.6 – In the event where there is any restriction to freedom or explanation required to the appropriate consent, the
p.(None): following shall be complied with as well:
p.(None): a) researches involving children and adolescents, individuals mentally disturbed or ill and those who
p.(None): have their capacity to consent substantially reduced, shall include in the protocol unquestionable
p.(None): justification for the choice of such individuals approved by CEP, and by CONEP, and comply with all requirements of
p.(None): informed consent statement by means of their legal representatives and the research participant, to the fullest extent
p.(None): of his/her capacity, is guaranteed the right to information;
p.(None): b) freedom to consent shall be specifically guaranteed to those individuals that, although fully capable, are
p.(None): exposed to specific conditioning or authority influence, featuring situations restricting their autonomy,
p.(None): specially students, members of the armed forces, employees, prisoners rehabilitation, shelters, nursing
p.(None): homes or religious associations interns and alike, in addition to be free to decide whether or not to participate
p.(None): in the research, with no retaliation of any kind;
p.(None): c) researches with individuals diagnosed with encephalic death may comply with the following
p.(None): requirements:
p.(None): c.1) documentary evidence of encephalic death;
p.(None):
...
Health / Mentally Incapacitated
Searching for indicator incapable:
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p.(None): II.18 – previous material compensation – material compensation dedicated exclusively for expenses related to
p.(None): transportation and meal for the research participant and his/her companion(s), and if necessary, prior to his/her
p.(None): participation in the research;
p.(None): II.19 – final report – the one presented after the closure of the research, totaling its results;
p.(None): II.20 – partial report – the one presented during the research showing relevant facts and partial results of its
p.(None): development;
p.(None): II.21 – indemnification – material compensation dedicated exclusively for expenses related to
p.(None): transportation and meal for the research participant and his/her companion(s), whenever necessary;
p.(None): II.22 – research risks – possible damage to the human being physical, psychic, moral, intellectual, social, cultural or
p.(None): spiritual dimension, caused by and from any research;
p.(None): II.23 – Informed Consent Form (ICF) – a document specifying the research participant and/or his/her legal
p.(None): representative's consent statement, in the form of a written consent, and it must contain all necessary
p.(None): information, in a clear and objective language, so the participant and/or his legal representative
p.(None): clearly understand about the research to which he/she is willing to participate;
p.(None): II.24 – Consent Term – a document prepared for minors or legally incapable for their easy understanding allowing them,
p.(None): after being clearly informed about the research, to state their will to participate in the research without prejudice
p.(None): to the consent of their legal representatives; and
p.(None): II.25 – vulnerability – the condition of individuals or groups that, for any reason whatsoever, have their
p.(None): self-judgment capability reduced or disabled, or by any means they are prevented to resist to the opposition,
p.(None): especially when it comes to the informed consent form.
p.(None):
p.(None): III – ETHICAL ASPECTS OF RESEARCHES INVOLVING HUMAN BEINGS
p.(None): The researches involving human beings must attend to the relevant ethical and scientific grounds.
p.(None): III.1 – Ethics of research involve:
p.(None): a) respect the research participant’s dignity and autonomy, recognizing his/her vulnerability, ensuring
p.(None): his/her will to contribute and remain, or not, in the research, by means of express, free and informed statement;
p.(None): b) balance known and potential, individual or collective, risks and benefits committing to the maximum of benefits
p.(None): and to the minimum of risks and damages;
p.(None): c) ensure that known damages will be avoided; and
p.(None): d) social relevance of investigation, ensuring the equated weighting of interests involved with no loss to the sense
p.(None): of its social-humanitarian purpose.
...
Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.(None): justified analysis from the doctor assisting the research participant.
p.(None):
p.(None): IV – PROCESS OF INFORMED CONSENT FORM
p.(None): Due respect to human dignity requires that every research be carried out after subjects, individuals or groups,
p.(None): or their legal representatives have given the respective informed consent form expressing their agreement
p.(None): to participate in the research.
p.(None): The Process of the Informed Consent Form refers to all steps the guests need to observe to participate in a research
p.(None): and to be able to manifest themselves as autonomous, conscientious, free and informed.
p.(None): IV.1 – The first step of the Process of the Informed Consent Form refers to clarify the guests about their
p.(None): participation in the research, where the investigator or person delegated by him/her or under
p.(None): his/her responsibility should:
p.(None): a) look for the right moment, condition or place to carry out the clarification taking into account
p.(None): the guests’ peculiarities and privacy to participate in the research;
p.(None): b) provide clear and accessible information using the most appropriate strategies referred to the culture, age,
p.(None): socio-economic conditions and autonomy of the subjects participating in the research; and
p.(None): c) grant the appropriate time so that the subjects participating in the research could think and consult, if
p.(None): necessary, their family or other people to help them take an informed consent decision.
p.(None): IV.2 – Once the first step of clarification is completed, the investigator or person delegated by him/her shall
p.(None): submit the Informed Consent Form to the guest participating in the research, or to his/her legal
p.(None): representative, to be read and understood before the concession of the consent statement.
p.(None): IV.3 – The Informed Consent must contain:
p.(None): a) justification, objectives and procedures that will be used in the research detailing the methods applied,
p.(None): notifying the possibility of their inclusion into control or experimental group, when applicable;
p.(None): b) explanation of potential discomforts and risks resulting from participating in the research, besides the benefits
p.(None): expected from such participation and presenting measures and cautions to avoid and/or lower effects and
p.(None): adverse conditions that may cause damage, taking into account characteristics and context of the research participant;
p.(None): c) clarification regarding monitoring and assistance that the research participants are entitled to,
p.(None): including the benefits and monitoring following the closure and/or interruption of the research;
p.(None):
p.(None): d) granting of total freedom to the research participant to refuse to participate or to remove his/her
p.(None): consent at any stage of the research, with no penalty;
p.(None): e) granting of maintaining confidentiality and privacy of all research participants during all stages of
p.(None): research;
...
p.(None): justification for the choice of such individuals approved by CEP, and by CONEP, and comply with all requirements of
p.(None): informed consent statement by means of their legal representatives and the research participant, to the fullest extent
p.(None): of his/her capacity, is guaranteed the right to information;
p.(None): b) freedom to consent shall be specifically guaranteed to those individuals that, although fully capable, are
p.(None): exposed to specific conditioning or authority influence, featuring situations restricting their autonomy,
p.(None): specially students, members of the armed forces, employees, prisoners rehabilitation, shelters, nursing
p.(None): homes or religious associations interns and alike, in addition to be free to decide whether or not to participate
p.(None): in the research, with no retaliation of any kind;
p.(None): c) researches with individuals diagnosed with encephalic death may comply with the following
p.(None): requirements:
p.(None): c.1) documentary evidence of encephalic death;
p.(None):
p.(None): c.2) a written consent from family members and/or legal representative or documentary evidence of
p.(None): individual’s will to participate in researches;
p.(None): c.3) respect to human dignity;
p.(None): c.4) no additional economic-financial burden to the family;
p.(None): c.5) no prejudice to other patients awaiting hospitalization or treatment; and
p.(None): c.6) likely to acquire new, relevant scientific knowledge which cannot be so acquired any other way;
p.(None): d) the existence of an official government communication channel to clarify doubts to all those involved in the
p.(None): research projects, as well as for those cases of encephalic death diagnosis; and
p.(None): e) in group culture communities recognizing the leader’s authority or the collectiveness upon the
p.(None): individual, the authorization for the research should respect such feature, without the prejudice of
p.(None): individual consent, when possible and desirable. The authorization for the research should be granted in advance by
p.(None): government bodies when the Brazilian Legislation rules upon their competence, like it is the case of the National
p.(None): Indian Foundation (FUNAI), where indigenous communities are under their own responsibility.
p.(None): IV.7 – The research depending on restriction to information to the research participants, such restriction shall be
p.(None): fully explained and justified by the leading researcher and submitted to the CEP/CONEP. Data collected from the
p.(None): research participants may not be used for any other purposes other than those specified in the protocol and/or informed
p.(None): consent statement.
p.(None): IV.8 – In cases where unfeasible to obtain the Informed Consent Form or that its obtaining may imply to substantial
...
Health / Pregnant
Searching for indicator pregnant:
(return to top)
p.(None): n) ensure the benefits resulting from the project to the research participants, whether in terms of social return,
p.(None): access to procedures, products or research agents;
p.(None): o) ensure the monitoring conditions, treatment, full assistance and guidance to the research participants, according
p.(None): to the case, while needed, including those in tracking researches;
p.(None): p) present evidence of commitments and advantages to the research participants and Brazil resulting from the
p.(None): performance thereof for researches carried out abroad or with foreign cooperation. In these cases, the investigator and
p.(None): national institution responsible for the research in Brazil must be identified. The studies sponsored abroad must
p.(None): also respond, when applicable, to the needs of transferring knowledge and technology to the Brazilian
p.(None): team and, in case of developing new drugs, their registration in Brazil are mandatory, if safety and
p.(None): effectiveness are proven;
p.(None): q) use the material and data obtained from the research solely for the purposes identified in its protocol or
p.(None): according to the participant’s consent statement;
p.(None): r) consider evaluating risks and benefits and eventual interferences regarding fertility, pregnancy, embryo
p.(None): or fetus, childbirth, puerperium, lactation and newborn in researches carried out in pregnant women or those in the
p.(None): childbearing age;
p.(None): s) consider that the researches carried out in pregnant women must be performed before those carried out in women
p.(None): after their gestational period, except for researches to which pregnancy is the main purpose;
p.(None): t) women who declare themselves with no risk of pregnancy, whether by sexual relation or by no means of
p.(None): reproduction, guarantee the right to participate on es without the compulsory use of contraceptives; and
p.(None):
p.(None): u) discontinue research only after analysis of reasons for such discontinuation by
p.(None): the CEP/CONEP/CNS/MS System approving such study, unless in cases of justified urgency to the benefit of
p.(None): their participants.
p.(None): III.3 – The researches using experimental methodologies in the biomedical area, involving human beings, besides that
p.(None): recommended in item III.2, shall:
p.(None): a) be founded on previous experimentation carried out in labs using animals or other experimental models
p.(None): and scientific evidence, when appropriate;
p.(None): b) when using placebo, such use shall be fully justified as to its non maleficence and methodology
p.(None): requirements, where the benefits, risks, difficulties and effectiveness of a new therapeutic method shall
p.(None): be tested, comparing it to the best current prophylactic, diagnostic and therapeutic methods. It is not included the
p.(None): use of placebo or any other treatment to studies where there are no proven methods of prophylaxis, diagnosis or
p.(None): treatment;
...
Health / ill
Searching for indicator ill:
(return to top)
p.(None): legal rights, including the right to procure indemnification for potential damages.
p.(None): IV.5 – The Informed Consent Form should also:
p.(None): a) contain a statement of the leading researcher expressing the compliance with the requirements
p.(None): specified on items IV.3 and, where applicable, IV.4;
p.(None): b) be adapted to the ethical rules and to the local culture, by the leading researcher, on researches with foreign
p.(None): cooperation elaborated abroad, with clear and accessible language to all and particularly to the participants of the
p.(None): research, taking special care for easy reading and understanding;
p.(None): c) be approved by CEP to which the project was presented and by CONEP, when applicable; and
p.(None): d) be elaborated in 2 copies and with all pages initialed and signed at the end by the guest invited to participate
p.(None): in the research, or by his/her legal representative, as well as by the leading researcher or those delegated by
p.(None): him/her, and with all signed pages on the same sheet. Both copies shall state the address and contact number or
p.(None): other of those responsible for the research, of the local CEP and CONEP, when applicable.
p.(None): IV.6 – In the event where there is any restriction to freedom or explanation required to the appropriate consent, the
p.(None): following shall be complied with as well:
p.(None): a) researches involving children and adolescents, individuals mentally disturbed or ill and those who
p.(None): have their capacity to consent substantially reduced, shall include in the protocol unquestionable
p.(None): justification for the choice of such individuals approved by CEP, and by CONEP, and comply with all requirements of
p.(None): informed consent statement by means of their legal representatives and the research participant, to the fullest extent
p.(None): of his/her capacity, is guaranteed the right to information;
p.(None): b) freedom to consent shall be specifically guaranteed to those individuals that, although fully capable, are
p.(None): exposed to specific conditioning or authority influence, featuring situations restricting their autonomy,
p.(None): specially students, members of the armed forces, employees, prisoners rehabilitation, shelters, nursing
p.(None): homes or religious associations interns and alike, in addition to be free to decide whether or not to participate
p.(None): in the research, with no retaliation of any kind;
p.(None): c) researches with individuals diagnosed with encephalic death may comply with the following
p.(None): requirements:
p.(None): c.1) documentary evidence of encephalic death;
p.(None):
...
Health / of childbearing age/fertile
Searching for indicator childbearing age:
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p.(None): access to procedures, products or research agents;
p.(None): o) ensure the monitoring conditions, treatment, full assistance and guidance to the research participants, according
p.(None): to the case, while needed, including those in tracking researches;
p.(None): p) present evidence of commitments and advantages to the research participants and Brazil resulting from the
p.(None): performance thereof for researches carried out abroad or with foreign cooperation. In these cases, the investigator and
p.(None): national institution responsible for the research in Brazil must be identified. The studies sponsored abroad must
p.(None): also respond, when applicable, to the needs of transferring knowledge and technology to the Brazilian
p.(None): team and, in case of developing new drugs, their registration in Brazil are mandatory, if safety and
p.(None): effectiveness are proven;
p.(None): q) use the material and data obtained from the research solely for the purposes identified in its protocol or
p.(None): according to the participant’s consent statement;
p.(None): r) consider evaluating risks and benefits and eventual interferences regarding fertility, pregnancy, embryo
p.(None): or fetus, childbirth, puerperium, lactation and newborn in researches carried out in pregnant women or those in the
p.(None): childbearing age;
p.(None): s) consider that the researches carried out in pregnant women must be performed before those carried out in women
p.(None): after their gestational period, except for researches to which pregnancy is the main purpose;
p.(None): t) women who declare themselves with no risk of pregnancy, whether by sexual relation or by no means of
p.(None): reproduction, guarantee the right to participate on es without the compulsory use of contraceptives; and
p.(None):
p.(None): u) discontinue research only after analysis of reasons for such discontinuation by
p.(None): the CEP/CONEP/CNS/MS System approving such study, unless in cases of justified urgency to the benefit of
p.(None): their participants.
p.(None): III.3 – The researches using experimental methodologies in the biomedical area, involving human beings, besides that
p.(None): recommended in item III.2, shall:
p.(None): a) be founded on previous experimentation carried out in labs using animals or other experimental models
p.(None): and scientific evidence, when appropriate;
p.(None): b) when using placebo, such use shall be fully justified as to its non maleficence and methodology
p.(None): requirements, where the benefits, risks, difficulties and effectiveness of a new therapeutic method shall
p.(None): be tested, comparing it to the best current prophylactic, diagnostic and therapeutic methods. It is not included the
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.(None): including in terms of self-esteem, prestige and/or economic and financial aspects;
p.(None): j) to be preferably developed on individuals with full autonomy. Individuals or vulnerable groups shall not
p.(None): participate in the research when the expected information may be obtained with participants fully capable,
p.(None): unless the research may bring benefits to the individuals or vulnerable groups.
p.(None): k) always respect cultural, social, moral, religious and ethical values, as well as habits and practices,
p.(None): when involving communities in researches;
p.(None): l) ensure, wherever possible, that researches within communities become beneficial to their effects and continue
p.(None): after their conclusion. When there is a real benefit to motivate or stimulate changes of habits or behaviors for the
p.(None): sake of the community, the research protocol shall include, wherever possible, willingness to communicate such
p.(None): advantage to the people and/or community;
p.(None): m) communicate the competent authorities, as well as to the bodies legitimized by the Social Control, the results
p.(None): and/or findings of the research, every time they can contribute to improving living conditions of the community,
p.(None): preserving, however, the image and ensuring that the research participants will not be stigmatized;
p.(None): n) ensure the benefits resulting from the project to the research participants, whether in terms of social return,
p.(None): access to procedures, products or research agents;
p.(None): o) ensure the monitoring conditions, treatment, full assistance and guidance to the research participants, according
p.(None): to the case, while needed, including those in tracking researches;
p.(None): p) present evidence of commitments and advantages to the research participants and Brazil resulting from the
p.(None): performance thereof for researches carried out abroad or with foreign cooperation. In these cases, the investigator and
p.(None): national institution responsible for the research in Brazil must be identified. The studies sponsored abroad must
p.(None): also respond, when applicable, to the needs of transferring knowledge and technology to the Brazilian
p.(None): team and, in case of developing new drugs, their registration in Brazil are mandatory, if safety and
p.(None): effectiveness are proven;
p.(None): q) use the material and data obtained from the research solely for the purposes identified in its protocol or
p.(None): according to the participant’s consent statement;
p.(None): r) consider evaluating risks and benefits and eventual interferences regarding fertility, pregnancy, embryo
p.(None): or fetus, childbirth, puerperium, lactation and newborn in researches carried out in pregnant women or those in the
p.(None): childbearing age;
...
p.(None): reproduction, guarantee the right to participate on es without the compulsory use of contraceptives; and
p.(None):
p.(None): u) discontinue research only after analysis of reasons for such discontinuation by
p.(None): the CEP/CONEP/CNS/MS System approving such study, unless in cases of justified urgency to the benefit of
p.(None): their participants.
p.(None): III.3 – The researches using experimental methodologies in the biomedical area, involving human beings, besides that
p.(None): recommended in item III.2, shall:
p.(None): a) be founded on previous experimentation carried out in labs using animals or other experimental models
p.(None): and scientific evidence, when appropriate;
p.(None): b) when using placebo, such use shall be fully justified as to its non maleficence and methodology
p.(None): requirements, where the benefits, risks, difficulties and effectiveness of a new therapeutic method shall
p.(None): be tested, comparing it to the best current prophylactic, diagnostic and therapeutic methods. It is not included the
p.(None): use of placebo or any other treatment to studies where there are no proven methods of prophylaxis, diagnosis or
p.(None): treatment;
p.(None): c) use the biological material and data obtained from the study solely to that intended purpose in the protocol, or
p.(None): according to the consent granted by the research participant; and
p.(None): d) guarantee to all participants, at the end of the study and for unlimited time, free access to the best
p.(None): prophylactic, diagnostic and therapeutic methods that have proven their efficiency;
p.(None): d.1) the access will also be guaranteed in the interval between the end of the individual’s participation and the end
p.(None): of the study, in which case this guarantee could be granted by means of an extension study, according to a duly
p.(None): justified analysis from the doctor assisting the research participant.
p.(None):
p.(None): IV – PROCESS OF INFORMED CONSENT FORM
p.(None): Due respect to human dignity requires that every research be carried out after subjects, individuals or groups,
p.(None): or their legal representatives have given the respective informed consent form expressing their agreement
p.(None): to participate in the research.
p.(None): The Process of the Informed Consent Form refers to all steps the guests need to observe to participate in a research
p.(None): and to be able to manifest themselves as autonomous, conscientious, free and informed.
p.(None): IV.1 – The first step of the Process of the Informed Consent Form refers to clarify the guests about their
p.(None): participation in the research, where the investigator or person delegated by him/her or under
p.(None): his/her responsibility should:
p.(None): a) look for the right moment, condition or place to carry out the clarification taking into account
p.(None): the guests’ peculiarities and privacy to participate in the research;
p.(None): b) provide clear and accessible information using the most appropriate strategies referred to the culture, age,
p.(None): socio-economic conditions and autonomy of the subjects participating in the research; and
...
Social / Age
Searching for indicator age:
(return to top)
p.(None): d.1) the access will also be guaranteed in the interval between the end of the individual’s participation and the end
p.(None): of the study, in which case this guarantee could be granted by means of an extension study, according to a duly
p.(None): justified analysis from the doctor assisting the research participant.
p.(None):
p.(None): IV – PROCESS OF INFORMED CONSENT FORM
p.(None): Due respect to human dignity requires that every research be carried out after subjects, individuals or groups,
p.(None): or their legal representatives have given the respective informed consent form expressing their agreement
p.(None): to participate in the research.
p.(None): The Process of the Informed Consent Form refers to all steps the guests need to observe to participate in a research
p.(None): and to be able to manifest themselves as autonomous, conscientious, free and informed.
p.(None): IV.1 – The first step of the Process of the Informed Consent Form refers to clarify the guests about their
p.(None): participation in the research, where the investigator or person delegated by him/her or under
p.(None): his/her responsibility should:
p.(None): a) look for the right moment, condition or place to carry out the clarification taking into account
p.(None): the guests’ peculiarities and privacy to participate in the research;
p.(None): b) provide clear and accessible information using the most appropriate strategies referred to the culture, age,
p.(None): socio-economic conditions and autonomy of the subjects participating in the research; and
p.(None): c) grant the appropriate time so that the subjects participating in the research could think and consult, if
p.(None): necessary, their family or other people to help them take an informed consent decision.
p.(None): IV.2 – Once the first step of clarification is completed, the investigator or person delegated by him/her shall
p.(None): submit the Informed Consent Form to the guest participating in the research, or to his/her legal
p.(None): representative, to be read and understood before the concession of the consent statement.
p.(None): IV.3 – The Informed Consent must contain:
p.(None): a) justification, objectives and procedures that will be used in the research detailing the methods applied,
p.(None): notifying the possibility of their inclusion into control or experimental group, when applicable;
p.(None): b) explanation of potential discomforts and risks resulting from participating in the research, besides the benefits
p.(None): expected from such participation and presenting measures and cautions to avoid and/or lower effects and
p.(None): adverse conditions that may cause damage, taking into account characteristics and context of the research participant;
p.(None): c) clarification regarding monitoring and assistance that the research participants are entitled to,
p.(None): including the benefits and monitoring following the closure and/or interruption of the research;
p.(None):
...
Social / Child
Searching for indicator child:
(return to top)
p.(None): and marginalization and to reduce social and regional inequalities and to promote the well being of all, without any
p.(None): type of prejudice or discrimination, are consistent with the international documents of ethics, human rights and
p.(None): development;
p.(None): Considering the related and relevant Brazilian Legislation; and
p.(None): Considering the Resolution no. 196/96, of the National Council of Health, from the Ministry of Health, that states
p.(None): periodic reviews to it according to the needs on techno-scientific and ethical areas.
p.(None):
p.(None): D E C I D E S:
p.(None): To approve the following guidelines and standards regulating researches involving human beings: I – PRELIMINARY
p.(None): PROVISIONS
p.(None): This Resolution consolidates bioethical benchmarks from the view point of the individual and the
p.(None): communities, such as autonomy, non maleficence, beneficence, justice and equity, among others, and it seeks to
p.(None):
p.(None): ensure the rights and duties that refer to the participants of the research, to the scientific community and the
p.(None): State.
p.(None): Projects of research involving human beings must attend to this Resolution.
p.(None):
p.(None): II – TERMS AND DEFINITIONS
p.(None): This Resolution adopts the following definitions:
p.(None): II.1 – research findings – facts or information met by the investigator along the study and considered as relevant to
p.(None): the participants or communities involved;
p.(None): II.2 – informed consent agreement – an agreement of the research participant, child, teenager or legally unable, free
p.(None): of vice (simulation, fraud or error), dependence, subordination or intimidation. Such research participants
p.(None): must be clarified about the nature of research, its objectives, methods, expected benefits, potential risks and the
p.(None): discomfort that it might occur by reason of said investigation, according to their comprehension and respecting their
p.(None): singularities;
p.(None): II.3 – assistance to the research participant:
p.(None): II.3.1 – immediate assistance – considered as an emergency and with no cost of any kind to the research participant, in
p.(None): situations that he/she may need it; and
p.(None): II.3.2 – full assistance – that provided to attend complications and damages caused directly or indirectly by the
p.(None): research;
p.(None): II.4 – research benefits – immediate or posterior, direct or indirect profit, attained by the participant and/or
p.(None): his/her community caused by his/her participation in the research;
p.(None): II.5 – informed consent form – an agreement from the research participant and/or from his/her legal
p.(None): representative, free of vice (simulation, fraud or error), dependence, subordination or intimidation
p.(None): following a complete and detailed explanation of the nature of the research, its objectives, methods,
p.(None): expected benefits, potential risks and discomfort that might occur by reason of said investigation;
p.(None): II.6 – damage related to or caused by the research – immediate or posterior, direct or indirect offense, to the
p.(None): individual or community, caused by the research;
...
Searching for indicator children:
(return to top)
p.(None): Informed Consent Form shall not include any liability disclaim nor imply waiver by the research participant of his/her
p.(None): legal rights, including the right to procure indemnification for potential damages.
p.(None): IV.5 – The Informed Consent Form should also:
p.(None): a) contain a statement of the leading researcher expressing the compliance with the requirements
p.(None): specified on items IV.3 and, where applicable, IV.4;
p.(None): b) be adapted to the ethical rules and to the local culture, by the leading researcher, on researches with foreign
p.(None): cooperation elaborated abroad, with clear and accessible language to all and particularly to the participants of the
p.(None): research, taking special care for easy reading and understanding;
p.(None): c) be approved by CEP to which the project was presented and by CONEP, when applicable; and
p.(None): d) be elaborated in 2 copies and with all pages initialed and signed at the end by the guest invited to participate
p.(None): in the research, or by his/her legal representative, as well as by the leading researcher or those delegated by
p.(None): him/her, and with all signed pages on the same sheet. Both copies shall state the address and contact number or
p.(None): other of those responsible for the research, of the local CEP and CONEP, when applicable.
p.(None): IV.6 – In the event where there is any restriction to freedom or explanation required to the appropriate consent, the
p.(None): following shall be complied with as well:
p.(None): a) researches involving children and adolescents, individuals mentally disturbed or ill and those who
p.(None): have their capacity to consent substantially reduced, shall include in the protocol unquestionable
p.(None): justification for the choice of such individuals approved by CEP, and by CONEP, and comply with all requirements of
p.(None): informed consent statement by means of their legal representatives and the research participant, to the fullest extent
p.(None): of his/her capacity, is guaranteed the right to information;
p.(None): b) freedom to consent shall be specifically guaranteed to those individuals that, although fully capable, are
p.(None): exposed to specific conditioning or authority influence, featuring situations restricting their autonomy,
p.(None): specially students, members of the armed forces, employees, prisoners rehabilitation, shelters, nursing
p.(None): homes or religious associations interns and alike, in addition to be free to decide whether or not to participate
p.(None): in the research, with no retaliation of any kind;
p.(None): c) researches with individuals diagnosed with encephalic death may comply with the following
...
Social / Fetus/Neonate
Searching for indicator fetus:
(return to top)
p.(None): preserving, however, the image and ensuring that the research participants will not be stigmatized;
p.(None): n) ensure the benefits resulting from the project to the research participants, whether in terms of social return,
p.(None): access to procedures, products or research agents;
p.(None): o) ensure the monitoring conditions, treatment, full assistance and guidance to the research participants, according
p.(None): to the case, while needed, including those in tracking researches;
p.(None): p) present evidence of commitments and advantages to the research participants and Brazil resulting from the
p.(None): performance thereof for researches carried out abroad or with foreign cooperation. In these cases, the investigator and
p.(None): national institution responsible for the research in Brazil must be identified. The studies sponsored abroad must
p.(None): also respond, when applicable, to the needs of transferring knowledge and technology to the Brazilian
p.(None): team and, in case of developing new drugs, their registration in Brazil are mandatory, if safety and
p.(None): effectiveness are proven;
p.(None): q) use the material and data obtained from the research solely for the purposes identified in its protocol or
p.(None): according to the participant’s consent statement;
p.(None): r) consider evaluating risks and benefits and eventual interferences regarding fertility, pregnancy, embryo
p.(None): or fetus, childbirth, puerperium, lactation and newborn in researches carried out in pregnant women or those in the
p.(None): childbearing age;
p.(None): s) consider that the researches carried out in pregnant women must be performed before those carried out in women
p.(None): after their gestational period, except for researches to which pregnancy is the main purpose;
p.(None): t) women who declare themselves with no risk of pregnancy, whether by sexual relation or by no means of
p.(None): reproduction, guarantee the right to participate on es without the compulsory use of contraceptives; and
p.(None):
p.(None): u) discontinue research only after analysis of reasons for such discontinuation by
p.(None): the CEP/CONEP/CNS/MS System approving such study, unless in cases of justified urgency to the benefit of
p.(None): their participants.
p.(None): III.3 – The researches using experimental methodologies in the biomedical area, involving human beings, besides that
p.(None): recommended in item III.2, shall:
p.(None): a) be founded on previous experimentation carried out in labs using animals or other experimental models
p.(None): and scientific evidence, when appropriate;
p.(None): b) when using placebo, such use shall be fully justified as to its non maleficence and methodology
...
p.(None): protecting the research participants in Brazil;
p.(None): IX.3 – register and supervise the operation and cancel the registry of any other CEP that may form the CEP/CONEP
p.(None): System;
p.(None): IX.4 - evaluate protocols of research involving human beings, providing a duly justified opinion, always
p.(None): guided, among others, by the impersonality, transparency, reasonability, proportionality and efficiency principles
p.(None): within deadlines laid down by operational standards, avoiding redundancies that may result in slowing down the
p.(None): analysis;
p.(None): 1. human genetics, when the project may involve:
p.(None): 1.1 shipments of human genetics overseas or any other human biological material for obtaining genetic material, except
p.(None): in those cases where there is cooperation with the Brazilian Government;
p.(None): 1.2 storage of biological material or human genetic data abroad and within the country, when part of an agreement with
p.(None): foreign institutions or with commercial institutions;
p.(None): 1.3 changes in the genetic structure of human cells for in vivo use;
p.(None): 1.4 researches in genetics of human reproduction (reprogenetics);
p.(None): 1.5 researches of genetics in behavior; and
p.(None): 1.6 researches in which irreversible dissociation of research participant’s data is expected;
p.(None): 2. human reproduction: researches interested in the functioning of the reproductive system, procreation and factors
p.(None): affecting the human reproductive health, shall consider as “research participant’s” all those who are
p.(None): affected by the procedures thereof. It will be up to CONEP to analyze the project when it involves:
p.(None): 2.1 – assisted reproduction;
p.(None): 2.2 – gametes, pre-embryos, embryos and fetus manipulation; and
p.(None): 2.3 – fetal medicine, when involving invasive procedures;
p.(None): 3. therapy equipments and devices, new or not registered in the country;
p.(None): 4. new invasive therapy procedures;
p.(None): 5. studies with indigenous populations;
p.(None): 6. research projects involving genetically modified organisms (GMOs), embryonic stem cells and organisms
p.(None): representing high collective risk, including organisms related to them, in areas of: experimentation,
p.(None): construction, growing, manipulation, transportation, transfer, import, export, storage, release into the environment
p.(None): and disposal;
p.(None): 7. setting up and functioning protocols of biobanks for research purposes;
p.(None): 8. researches with coordination and/or sponsorship originated outside Brazil, except those with the
p.(None): Brazilian Government co-sponsorship; and
p.(None): 9. projects that, at the discretion of CEP and duly justified, were judged as worthy of analysis by
p.(None): CONEP;
p.(None):
p.(None): IX.5 – strengthen the participation of CEPs through a continuous process of training, qualification and
p.(None): accreditation;
p.(None): IX.6 – coordinate the CEPs accreditation process, appointing them responsibilities originally from CONEP,
p.(None): according to their skill levels;
p.(None): IX.7 – analyze and monitor, directly and indirectly, within the standards deadline, the research protocols that may
p.(None): involve needs for a higher protection related to their research participants, specially the risks thereof.
...
Social / Linguistic Proficiency
Searching for indicator language:
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p.(None): integrity and welfare of all participants of the research;
p.(None): II.17 – research protocol – a set of documents describing the research regarding its fundamental aspects and the
p.(None): information related to the research participants, the researcher’s qualification and all responsible bodies;
p.(None): II.18 – previous material compensation – material compensation dedicated exclusively for expenses related to
p.(None): transportation and meal for the research participant and his/her companion(s), and if necessary, prior to his/her
p.(None): participation in the research;
p.(None): II.19 – final report – the one presented after the closure of the research, totaling its results;
p.(None): II.20 – partial report – the one presented during the research showing relevant facts and partial results of its
p.(None): development;
p.(None): II.21 – indemnification – material compensation dedicated exclusively for expenses related to
p.(None): transportation and meal for the research participant and his/her companion(s), whenever necessary;
p.(None): II.22 – research risks – possible damage to the human being physical, psychic, moral, intellectual, social, cultural or
p.(None): spiritual dimension, caused by and from any research;
p.(None): II.23 – Informed Consent Form (ICF) – a document specifying the research participant and/or his/her legal
p.(None): representative's consent statement, in the form of a written consent, and it must contain all necessary
p.(None): information, in a clear and objective language, so the participant and/or his legal representative
p.(None): clearly understand about the research to which he/she is willing to participate;
p.(None): II.24 – Consent Term – a document prepared for minors or legally incapable for their easy understanding allowing them,
p.(None): after being clearly informed about the research, to state their will to participate in the research without prejudice
p.(None): to the consent of their legal representatives; and
p.(None): II.25 – vulnerability – the condition of individuals or groups that, for any reason whatsoever, have their
p.(None): self-judgment capability reduced or disabled, or by any means they are prevented to resist to the opposition,
p.(None): especially when it comes to the informed consent form.
p.(None):
p.(None): III – ETHICAL ASPECTS OF RESEARCHES INVOLVING HUMAN BEINGS
p.(None): The researches involving human beings must attend to the relevant ethical and scientific grounds.
p.(None): III.1 – Ethics of research involve:
p.(None): a) respect the research participant’s dignity and autonomy, recognizing his/her vulnerability, ensuring
p.(None): his/her will to contribute and remain, or not, in the research, by means of express, free and informed statement;
p.(None): b) balance known and potential, individual or collective, risks and benefits committing to the maximum of benefits
p.(None): and to the minimum of risks and damages;
...
p.(None): thereof;
p.(None): h) explanation of the indemnification guarantee in the case of eventual damages caused by the research.
p.(None): IV.4 – The Informed Consent Form used in researches adopting experimental methodologies in the biomedical
p.(None): area, involving human beings, besides that expected on item IV.3 above, must contain, necessarily, the following:
p.(None): a) explanation, where appropriate, of the existing alternative treatment methods;
p.(None): b) clarification , where appropriate, regarding the possibility of including the participant into a
p.(None): control group or placebo, clearly explaining the significance of that possibility; and
p.(None): c) do not demand from the research participant, under any justification, a waiver of indemnification for damages. The
p.(None): Informed Consent Form shall not include any liability disclaim nor imply waiver by the research participant of his/her
p.(None): legal rights, including the right to procure indemnification for potential damages.
p.(None): IV.5 – The Informed Consent Form should also:
p.(None): a) contain a statement of the leading researcher expressing the compliance with the requirements
p.(None): specified on items IV.3 and, where applicable, IV.4;
p.(None): b) be adapted to the ethical rules and to the local culture, by the leading researcher, on researches with foreign
p.(None): cooperation elaborated abroad, with clear and accessible language to all and particularly to the participants of the
p.(None): research, taking special care for easy reading and understanding;
p.(None): c) be approved by CEP to which the project was presented and by CONEP, when applicable; and
p.(None): d) be elaborated in 2 copies and with all pages initialed and signed at the end by the guest invited to participate
p.(None): in the research, or by his/her legal representative, as well as by the leading researcher or those delegated by
p.(None): him/her, and with all signed pages on the same sheet. Both copies shall state the address and contact number or
p.(None): other of those responsible for the research, of the local CEP and CONEP, when applicable.
p.(None): IV.6 – In the event where there is any restriction to freedom or explanation required to the appropriate consent, the
p.(None): following shall be complied with as well:
p.(None): a) researches involving children and adolescents, individuals mentally disturbed or ill and those who
p.(None): have their capacity to consent substantially reduced, shall include in the protocol unquestionable
p.(None): justification for the choice of such individuals approved by CEP, and by CONEP, and comply with all requirements of
p.(None): informed consent statement by means of their legal representatives and the research participant, to the fullest extent
p.(None): of his/her capacity, is guaranteed the right to information;
...
Social / Religion
Searching for indicator religious:
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p.(None): observation methods or methods that do not involve human beings;
p.(None): g) obtain a deliberate consent statement from the research participant and/or his/her legal
p.(None): representative, including on cases where, due to their nature, the researches imply in posteriori consent;
p.(None): h) count on human resources and materials necessary to ensure the research participant’s wellbeing, and the
p.(None): investigator(s) must have appropriate professional capability to develop his/her function in the proposed project;
p.(None): i) provide procedures ensuring confidentiality and privacy, image protection and avoiding stigmatization of the
p.(None): research participants, and to guarantee the non-use of information to the detriment of people and/or communities,
p.(None): including in terms of self-esteem, prestige and/or economic and financial aspects;
p.(None): j) to be preferably developed on individuals with full autonomy. Individuals or vulnerable groups shall not
p.(None): participate in the research when the expected information may be obtained with participants fully capable,
p.(None): unless the research may bring benefits to the individuals or vulnerable groups.
p.(None): k) always respect cultural, social, moral, religious and ethical values, as well as habits and practices,
p.(None): when involving communities in researches;
p.(None): l) ensure, wherever possible, that researches within communities become beneficial to their effects and continue
p.(None): after their conclusion. When there is a real benefit to motivate or stimulate changes of habits or behaviors for the
p.(None): sake of the community, the research protocol shall include, wherever possible, willingness to communicate such
p.(None): advantage to the people and/or community;
p.(None): m) communicate the competent authorities, as well as to the bodies legitimized by the Social Control, the results
p.(None): and/or findings of the research, every time they can contribute to improving living conditions of the community,
p.(None): preserving, however, the image and ensuring that the research participants will not be stigmatized;
p.(None): n) ensure the benefits resulting from the project to the research participants, whether in terms of social return,
p.(None): access to procedures, products or research agents;
p.(None): o) ensure the monitoring conditions, treatment, full assistance and guidance to the research participants, according
p.(None): to the case, while needed, including those in tracking researches;
p.(None): p) present evidence of commitments and advantages to the research participants and Brazil resulting from the
p.(None): performance thereof for researches carried out abroad or with foreign cooperation. In these cases, the investigator and
p.(None): national institution responsible for the research in Brazil must be identified. The studies sponsored abroad must
p.(None): also respond, when applicable, to the needs of transferring knowledge and technology to the Brazilian
...
p.(None): following shall be complied with as well:
p.(None): a) researches involving children and adolescents, individuals mentally disturbed or ill and those who
p.(None): have their capacity to consent substantially reduced, shall include in the protocol unquestionable
p.(None): justification for the choice of such individuals approved by CEP, and by CONEP, and comply with all requirements of
p.(None): informed consent statement by means of their legal representatives and the research participant, to the fullest extent
p.(None): of his/her capacity, is guaranteed the right to information;
p.(None): b) freedom to consent shall be specifically guaranteed to those individuals that, although fully capable, are
p.(None): exposed to specific conditioning or authority influence, featuring situations restricting their autonomy,
p.(None): specially students, members of the armed forces, employees, prisoners rehabilitation, shelters, nursing
p.(None): homes or religious associations interns and alike, in addition to be free to decide whether or not to participate
p.(None): in the research, with no retaliation of any kind;
p.(None): c) researches with individuals diagnosed with encephalic death may comply with the following
p.(None): requirements:
p.(None): c.1) documentary evidence of encephalic death;
p.(None):
p.(None): c.2) a written consent from family members and/or legal representative or documentary evidence of
p.(None): individual’s will to participate in researches;
p.(None): c.3) respect to human dignity;
p.(None): c.4) no additional economic-financial burden to the family;
p.(None): c.5) no prejudice to other patients awaiting hospitalization or treatment; and
p.(None): c.6) likely to acquire new, relevant scientific knowledge which cannot be so acquired any other way;
p.(None): d) the existence of an official government communication channel to clarify doubts to all those involved in the
p.(None): research projects, as well as for those cases of encephalic death diagnosis; and
p.(None): e) in group culture communities recognizing the leader’s authority or the collectiveness upon the
p.(None): individual, the authorization for the research should respect such feature, without the prejudice of
p.(None): individual consent, when possible and desirable. The authorization for the research should be granted in advance by
p.(None): government bodies when the Brazilian Legislation rules upon their competence, like it is the case of the National
...
Social / Threat of Stigma
Searching for indicator stigmatization:
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p.(None): a) shall be appropriate to the scientific values that justifies it and with concrete possibilities of responding to
p.(None): uncertainties;
p.(None): b) shall be founded in scientific grounds, previous testing and/or appropriate assumptions to the specific area of
p.(None): investigation;
p.(None): c) shall be performed only when the expected knowledge cannot be obtained through other means;
p.(None): d) always seek for the expected benefits to prevail regarding risks and/or foreseeable discomforts;
p.(None): e) use the appropriate methodology to answer the studied subjects specifying if a qualitative, quantitative or
p.(None): quali-quantitative investigation;
p.(None):
p.(None): f) if there is a need to allocate the research participants randomly into experimental and control groups, ensure
p.(None): beforehand that it is not possible to establish the advantages of a procedure over another, by reviewing literature,
p.(None): observation methods or methods that do not involve human beings;
p.(None): g) obtain a deliberate consent statement from the research participant and/or his/her legal
p.(None): representative, including on cases where, due to their nature, the researches imply in posteriori consent;
p.(None): h) count on human resources and materials necessary to ensure the research participant’s wellbeing, and the
p.(None): investigator(s) must have appropriate professional capability to develop his/her function in the proposed project;
p.(None): i) provide procedures ensuring confidentiality and privacy, image protection and avoiding stigmatization of the
p.(None): research participants, and to guarantee the non-use of information to the detriment of people and/or communities,
p.(None): including in terms of self-esteem, prestige and/or economic and financial aspects;
p.(None): j) to be preferably developed on individuals with full autonomy. Individuals or vulnerable groups shall not
p.(None): participate in the research when the expected information may be obtained with participants fully capable,
p.(None): unless the research may bring benefits to the individuals or vulnerable groups.
p.(None): k) always respect cultural, social, moral, religious and ethical values, as well as habits and practices,
p.(None): when involving communities in researches;
p.(None): l) ensure, wherever possible, that researches within communities become beneficial to their effects and continue
p.(None): after their conclusion. When there is a real benefit to motivate or stimulate changes of habits or behaviors for the
p.(None): sake of the community, the research protocol shall include, wherever possible, willingness to communicate such
p.(None): advantage to the people and/or community;
p.(None): m) communicate the competent authorities, as well as to the bodies legitimized by the Social Control, the results
p.(None): and/or findings of the research, every time they can contribute to improving living conditions of the community,
p.(None): preserving, however, the image and ensuring that the research participants will not be stigmatized;
...
Searching for indicator stigmatized:
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p.(None): research participants, and to guarantee the non-use of information to the detriment of people and/or communities,
p.(None): including in terms of self-esteem, prestige and/or economic and financial aspects;
p.(None): j) to be preferably developed on individuals with full autonomy. Individuals or vulnerable groups shall not
p.(None): participate in the research when the expected information may be obtained with participants fully capable,
p.(None): unless the research may bring benefits to the individuals or vulnerable groups.
p.(None): k) always respect cultural, social, moral, religious and ethical values, as well as habits and practices,
p.(None): when involving communities in researches;
p.(None): l) ensure, wherever possible, that researches within communities become beneficial to their effects and continue
p.(None): after their conclusion. When there is a real benefit to motivate or stimulate changes of habits or behaviors for the
p.(None): sake of the community, the research protocol shall include, wherever possible, willingness to communicate such
p.(None): advantage to the people and/or community;
p.(None): m) communicate the competent authorities, as well as to the bodies legitimized by the Social Control, the results
p.(None): and/or findings of the research, every time they can contribute to improving living conditions of the community,
p.(None): preserving, however, the image and ensuring that the research participants will not be stigmatized;
p.(None): n) ensure the benefits resulting from the project to the research participants, whether in terms of social return,
p.(None): access to procedures, products or research agents;
p.(None): o) ensure the monitoring conditions, treatment, full assistance and guidance to the research participants, according
p.(None): to the case, while needed, including those in tracking researches;
p.(None): p) present evidence of commitments and advantages to the research participants and Brazil resulting from the
p.(None): performance thereof for researches carried out abroad or with foreign cooperation. In these cases, the investigator and
p.(None): national institution responsible for the research in Brazil must be identified. The studies sponsored abroad must
p.(None): also respond, when applicable, to the needs of transferring knowledge and technology to the Brazilian
p.(None): team and, in case of developing new drugs, their registration in Brazil are mandatory, if safety and
p.(None): effectiveness are proven;
p.(None): q) use the material and data obtained from the research solely for the purposes identified in its protocol or
p.(None): according to the participant’s consent statement;
p.(None): r) consider evaluating risks and benefits and eventual interferences regarding fertility, pregnancy, embryo
p.(None): or fetus, childbirth, puerperium, lactation and newborn in researches carried out in pregnant women or those in the
...
Social / Victim of Abuse
Searching for indicator abuse:
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p.(None): such as those that contribute to the public health, justice and reduction of social inequalities and technological
p.(None): premises, upon request of the Ministry of Health or other organization of Public Administration, or even at the
p.(None): discretion of CONEP/CNS Plenary.
p.(None):
p.(None): X – ETHICAL ANALYSYS PROCEDURES
p.(None): X.1 – CEPs ETHICAL ANALYSIS DUTIES:
p.(None): 1. it is CEP’s responsibility to issue, after analysis, a duly reasoned opinion in which the collegiate
p.(None): decision is presented in a clear, objective and detailed manner, respecting the deadline laid down in the
p.(None): operating standard;
p.(None): 2. forward CONEP’s duties protocols after an informed analysis, according to the current operating
p.(None): standards taking special care of all documentation that must follow such forwarding, including the detailed proof
p.(None): of expenses and the financing resources necessary for the research;
p.(None): 3. CEP shall also be responsible for:
p.(None): a) keeping the confidential custody of all data obtained while on duty and filing the complete
p.(None): protocol;
p.(None): b) monitoring the project’s development through biannual reports from investigators and other monitoring
p.(None): strategies, according to the risk inherent to the research;
p.(None): c) CEP shall keep the project, protocol and corresponding reports filed for a five-year period after the closure of
p.(None): the study, and such filing may be digitally processed.
p.(None): d) receiving complaints of abuse and notifications about adverse facts that might alter the study’s regular course,
p.(None): deciding on the continuation, modification or discontinuation of the research, requesting, if applicable, the change of
p.(None): the Statement Consent;
p.(None): e) requiring the opening of a research to the institution’s and/or organization’s board, or to the public competent
p.(None): bodies, if known any case of complaints of irregularities in the researches involving human beings and, if proved the
p.(None): existence of such complaints, communicate the fact to CONEP and, where applicable, to other authorities; and
p.(None): f) maintain a regular and ongoing communication with CONEP, through its Executive Secretariat.
p.(None): X.2 – PROCEDURE OF CONEP’s ETHICAL ANALYSIS:
p.(None): 1. it is CONEP’s responsibility to issue a duly reasoned opinion, respecting the deadline to be laid down in the
p.(None): Operating Standard, with a clear, objective and detailed analysis of all elements and documents of the project;
p.(None):
p.(None): 2. CONEP shall also be responsible for the direct or indirect monitoring of all research protocols within its duties;
p.(None): and
p.(None): 3. the provisions about the Procedures of CEP’s Ethical Analysis are applied to CONEP in cases where it operates as
p.(None): CEP.
p.(None): X.3 – COMMON PROVISIONS TO CEP AND CONEP:
p.(None): 1. members of CEP/CONEP shall exempt themselves from the case’s analysis and discussion, as well as from
p.(None): decision-making, when involved in the research;
p.(None): 2. CEPs and CONEP may count on ad hoc consultants, people belonging to or not, an
p.(None): institution/organization, with the purpose of providing technical support;
p.(None): 3. a research lacking its protocol shall not be analyzed;
...
Social / Women
Searching for indicator women:
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p.(None): n) ensure the benefits resulting from the project to the research participants, whether in terms of social return,
p.(None): access to procedures, products or research agents;
p.(None): o) ensure the monitoring conditions, treatment, full assistance and guidance to the research participants, according
p.(None): to the case, while needed, including those in tracking researches;
p.(None): p) present evidence of commitments and advantages to the research participants and Brazil resulting from the
p.(None): performance thereof for researches carried out abroad or with foreign cooperation. In these cases, the investigator and
p.(None): national institution responsible for the research in Brazil must be identified. The studies sponsored abroad must
p.(None): also respond, when applicable, to the needs of transferring knowledge and technology to the Brazilian
p.(None): team and, in case of developing new drugs, their registration in Brazil are mandatory, if safety and
p.(None): effectiveness are proven;
p.(None): q) use the material and data obtained from the research solely for the purposes identified in its protocol or
p.(None): according to the participant’s consent statement;
p.(None): r) consider evaluating risks and benefits and eventual interferences regarding fertility, pregnancy, embryo
p.(None): or fetus, childbirth, puerperium, lactation and newborn in researches carried out in pregnant women or those in the
p.(None): childbearing age;
p.(None): s) consider that the researches carried out in pregnant women must be performed before those carried out in women
p.(None): after their gestational period, except for researches to which pregnancy is the main purpose;
p.(None): t) women who declare themselves with no risk of pregnancy, whether by sexual relation or by no means of
p.(None): reproduction, guarantee the right to participate on es without the compulsory use of contraceptives; and
p.(None):
p.(None): u) discontinue research only after analysis of reasons for such discontinuation by
p.(None): the CEP/CONEP/CNS/MS System approving such study, unless in cases of justified urgency to the benefit of
p.(None): their participants.
p.(None): III.3 – The researches using experimental methodologies in the biomedical area, involving human beings, besides that
p.(None): recommended in item III.2, shall:
p.(None): a) be founded on previous experimentation carried out in labs using animals or other experimental models
p.(None): and scientific evidence, when appropriate;
p.(None): b) when using placebo, such use shall be fully justified as to its non maleficence and methodology
p.(None): requirements, where the benefits, risks, difficulties and effectiveness of a new therapeutic method shall
p.(None): be tested, comparing it to the best current prophylactic, diagnostic and therapeutic methods. It is not included the
p.(None): use of placebo or any other treatment to studies where there are no proven methods of prophylaxis, diagnosis or
p.(None): treatment;
p.(None): c) use the biological material and data obtained from the study solely to that intended purpose in the protocol, or
p.(None): according to the consent granted by the research participant; and
...
Social / education
Searching for indicator educational:
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p.(None): consent statement and resulting from his/her participation shall be entitled to indemnification on the part of the
p.(None): investigator, sponsor and institutions involved in the different stages of the research.
p.(None):
p.(None): VI – RESEARCH PROTOCOL
p.(None): The protocol to be submitted to ethical review will only be subject to examination if accompanied with all
p.(None): documentation required by the CEP/CONEP System, considering the nature and specificities of each research. Plataforma
p.(None): BRASIL is the official system for launching researches for the CEP/CONEP System analysis and monitoring.
p.(None):
p.(None): VII – CEP/CONEP SYSTEM
p.(None): It is integrated by the National Commission of Ethics in Research – CONEP/CNS/MS of the National Council
p.(None): of Health and by the Committees of Ethic in Research – CEP – composing a system using mechanisms, tools and proper
p.(None): instruments of inter-relationship, cooperatively, aiming especially the protection of Brazil’s research
p.(None): participants, in a coordinated and decentralized manner by means of an accreditation process.
p.(None): VII.1 – Researches involving human beings shall be submitted to the CEP/CONEP System evaluation, which by analyzing
p.(None): and deciding, it becomes the co-responsible for guaranteeing protection to all research participants.
p.(None): VII.2 – The CEP are interdisciplinary and independent groups of a public function and advisory,
p.(None): deliberate, and educational nature, established to protect the interests of all research participants in their
p.(None): integrity and dignity and to contribute to the research development according to ethical standards:
p.(None): VII.2.1 – institutions and/or organizations performing researches involving human beings shall establish one or more
p.(None): Committees of Ethic in Researches – CEP, according to their own needs, and meeting the normative
p.(None): criteria; and
p.(None): VII.2.2 – in case of a non existing CEP in the applicant institution or in case of an investigator with no
p.(None): institutional affiliation, it shall be CONEP’s responsibility to indicate a CEP to perform the analysis of the research
p.(None): among those presenting the best conditions for monitoring such research.
p.(None): VII.3 – CONEP is a collegiate body that is advisory, deliberative, legislative, educational and independent in nature
p.(None): and is linked to the National Council of Health/MS.
p.(None): VII.4 – The ethical review of projects involving human beings shall be associated to its scientific analysis.
p.(None): VII.5 – Members of CEP/CONEP System shall be fully independent to make any decision they deem
p.(None): appropriate in the discharge of their duties, safeguarding the confidentiality of the information received. Hence, they
p.(None): shall not be subject to any pressure whatsoever on the part of higher-ranked personnel or third
p.(None): parties interested in a certain research. They should avoid taking decisions when involved in the
p.(None): research under analysis.
p.(None): VII.6 – Members of CEP and CONEP may not receive any compensation for the discharge of their duties, and may only
p.(None): receive reimbursement of expenses related to transportation, lodging and meal. It is recommended,
p.(None): however, that during the regular working hours at CEP, or at CONEP, they are dismissed from their other obligations
p.(None): in the institutions and/or organizations to which they render services given the public relevance of the
p.(None): function.
p.(None):
p.(None): VIII – COMMITTEES OF ETHIC IN RESEARCH (CEP) DUTIES:
p.(None): VIII.1 – evaluate protocols of research involving human beings, with priority given to subjects related to public
p.(None): relevance and strategic interests for the Unified Health System (SUS) priorities’ agenda, based on the
p.(None): epidemiological indicators providing a duly justified opinion, always guided, among others, by the impersonality,
p.(None):
p.(None): transparency, reasonability, proportionality and efficiency principles within deadlines laid down by
p.(None): operational standards, avoiding redundancies that may result in slowing down the analysis;
p.(None): VIII.2 – perform an advisory and educational role in matters related to ethics; and
p.(None): VIII.3 – elaborate its Bylaws.
p.(None):
p.(None): IX – NATIONAL COMISSION OF ETHICS IN RESEARCHES (CONEP) DUTIES:
p.(None): IX.1 – examine all ethical aspects of researches involving human beings, as well as to adapt and update all applicable
p.(None): rules, for which purpose they may refer to the society whenever they judge necessary;
p.(None): IX.2 – promote popular participation in initiatives of Social Control in Researches with Human Beings,
p.(None): besides establishing institutional CEP and other bodies, whenever such creation may imply in the strengthening of
p.(None): protecting the research participants in Brazil;
p.(None): IX.3 – register and supervise the operation and cancel the registry of any other CEP that may form the CEP/CONEP
p.(None): System;
p.(None): IX.4 - evaluate protocols of research involving human beings, providing a duly justified opinion, always
p.(None): guided, among others, by the impersonality, transparency, reasonability, proportionality and efficiency principles
p.(None): within deadlines laid down by operational standards, avoiding redundancies that may result in slowing down the
p.(None): analysis;
p.(None): 1. human genetics, when the project may involve:
p.(None): 1.1 shipments of human genetics overseas or any other human biological material for obtaining genetic material, except
p.(None): in those cases where there is cooperation with the Brazilian Government;
p.(None): 1.2 storage of biological material or human genetic data abroad and within the country, when part of an agreement with
p.(None): foreign institutions or with commercial institutions;
...
Social / embryo
Searching for indicator embryo:
(return to top)
p.(None): and/or findings of the research, every time they can contribute to improving living conditions of the community,
p.(None): preserving, however, the image and ensuring that the research participants will not be stigmatized;
p.(None): n) ensure the benefits resulting from the project to the research participants, whether in terms of social return,
p.(None): access to procedures, products or research agents;
p.(None): o) ensure the monitoring conditions, treatment, full assistance and guidance to the research participants, according
p.(None): to the case, while needed, including those in tracking researches;
p.(None): p) present evidence of commitments and advantages to the research participants and Brazil resulting from the
p.(None): performance thereof for researches carried out abroad or with foreign cooperation. In these cases, the investigator and
p.(None): national institution responsible for the research in Brazil must be identified. The studies sponsored abroad must
p.(None): also respond, when applicable, to the needs of transferring knowledge and technology to the Brazilian
p.(None): team and, in case of developing new drugs, their registration in Brazil are mandatory, if safety and
p.(None): effectiveness are proven;
p.(None): q) use the material and data obtained from the research solely for the purposes identified in its protocol or
p.(None): according to the participant’s consent statement;
p.(None): r) consider evaluating risks and benefits and eventual interferences regarding fertility, pregnancy, embryo
p.(None): or fetus, childbirth, puerperium, lactation and newborn in researches carried out in pregnant women or those in the
p.(None): childbearing age;
p.(None): s) consider that the researches carried out in pregnant women must be performed before those carried out in women
p.(None): after their gestational period, except for researches to which pregnancy is the main purpose;
p.(None): t) women who declare themselves with no risk of pregnancy, whether by sexual relation or by no means of
p.(None): reproduction, guarantee the right to participate on es without the compulsory use of contraceptives; and
p.(None):
p.(None): u) discontinue research only after analysis of reasons for such discontinuation by
p.(None): the CEP/CONEP/CNS/MS System approving such study, unless in cases of justified urgency to the benefit of
p.(None): their participants.
p.(None): III.3 – The researches using experimental methodologies in the biomedical area, involving human beings, besides that
p.(None): recommended in item III.2, shall:
p.(None): a) be founded on previous experimentation carried out in labs using animals or other experimental models
p.(None): and scientific evidence, when appropriate;
...
Social / employees
Searching for indicator employees:
(return to top)
p.(None): other of those responsible for the research, of the local CEP and CONEP, when applicable.
p.(None): IV.6 – In the event where there is any restriction to freedom or explanation required to the appropriate consent, the
p.(None): following shall be complied with as well:
p.(None): a) researches involving children and adolescents, individuals mentally disturbed or ill and those who
p.(None): have their capacity to consent substantially reduced, shall include in the protocol unquestionable
p.(None): justification for the choice of such individuals approved by CEP, and by CONEP, and comply with all requirements of
p.(None): informed consent statement by means of their legal representatives and the research participant, to the fullest extent
p.(None): of his/her capacity, is guaranteed the right to information;
p.(None): b) freedom to consent shall be specifically guaranteed to those individuals that, although fully capable, are
p.(None): exposed to specific conditioning or authority influence, featuring situations restricting their autonomy,
p.(None): specially students, members of the armed forces, employees, prisoners rehabilitation, shelters, nursing
p.(None): homes or religious associations interns and alike, in addition to be free to decide whether or not to participate
p.(None): in the research, with no retaliation of any kind;
p.(None): c) researches with individuals diagnosed with encephalic death may comply with the following
p.(None): requirements:
p.(None): c.1) documentary evidence of encephalic death;
p.(None):
p.(None): c.2) a written consent from family members and/or legal representative or documentary evidence of
p.(None): individual’s will to participate in researches;
p.(None): c.3) respect to human dignity;
p.(None): c.4) no additional economic-financial burden to the family;
p.(None): c.5) no prejudice to other patients awaiting hospitalization or treatment; and
p.(None): c.6) likely to acquire new, relevant scientific knowledge which cannot be so acquired any other way;
p.(None): d) the existence of an official government communication channel to clarify doubts to all those involved in the
p.(None): research projects, as well as for those cases of encephalic death diagnosis; and
p.(None): e) in group culture communities recognizing the leader’s authority or the collectiveness upon the
p.(None): individual, the authorization for the research should respect such feature, without the prejudice of
p.(None): individual consent, when possible and desirable. The authorization for the research should be granted in advance by
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.(None): VII.3 – CONEP is a collegiate body that is advisory, deliberative, legislative, educational and independent in nature
p.(None): and is linked to the National Council of Health/MS.
p.(None): VII.4 – The ethical review of projects involving human beings shall be associated to its scientific analysis.
p.(None): VII.5 – Members of CEP/CONEP System shall be fully independent to make any decision they deem
p.(None): appropriate in the discharge of their duties, safeguarding the confidentiality of the information received. Hence, they
p.(None): shall not be subject to any pressure whatsoever on the part of higher-ranked personnel or third
p.(None): parties interested in a certain research. They should avoid taking decisions when involved in the
p.(None): research under analysis.
p.(None): VII.6 – Members of CEP and CONEP may not receive any compensation for the discharge of their duties, and may only
p.(None): receive reimbursement of expenses related to transportation, lodging and meal. It is recommended,
p.(None): however, that during the regular working hours at CEP, or at CONEP, they are dismissed from their other obligations
p.(None): in the institutions and/or organizations to which they render services given the public relevance of the
p.(None): function.
p.(None):
p.(None): VIII – COMMITTEES OF ETHIC IN RESEARCH (CEP) DUTIES:
p.(None): VIII.1 – evaluate protocols of research involving human beings, with priority given to subjects related to public
p.(None): relevance and strategic interests for the Unified Health System (SUS) priorities’ agenda, based on the
p.(None): epidemiological indicators providing a duly justified opinion, always guided, among others, by the impersonality,
p.(None):
p.(None): transparency, reasonability, proportionality and efficiency principles within deadlines laid down by
p.(None): operational standards, avoiding redundancies that may result in slowing down the analysis;
p.(None): VIII.2 – perform an advisory and educational role in matters related to ethics; and
p.(None): VIII.3 – elaborate its Bylaws.
p.(None):
p.(None): IX – NATIONAL COMISSION OF ETHICS IN RESEARCHES (CONEP) DUTIES:
p.(None): IX.1 – examine all ethical aspects of researches involving human beings, as well as to adapt and update all applicable
p.(None): rules, for which purpose they may refer to the society whenever they judge necessary;
p.(None): IX.2 – promote popular participation in initiatives of Social Control in Researches with Human Beings,
p.(None): besides establishing institutional CEP and other bodies, whenever such creation may imply in the strengthening of
p.(None): protecting the research participants in Brazil;
p.(None): IX.3 – register and supervise the operation and cancel the registry of any other CEP that may form the CEP/CONEP
p.(None): System;
p.(None): IX.4 - evaluate protocols of research involving human beings, providing a duly justified opinion, always
p.(None): guided, among others, by the impersonality, transparency, reasonability, proportionality and efficiency principles
p.(None): within deadlines laid down by operational standards, avoiding redundancies that may result in slowing down the
p.(None): analysis;
p.(None): 1. human genetics, when the project may involve:
p.(None): 1.1 shipments of human genetics overseas or any other human biological material for obtaining genetic material, except
p.(None): in those cases where there is cooperation with the Brazilian Government;
p.(None): 1.2 storage of biological material or human genetic data abroad and within the country, when part of an agreement with
p.(None): foreign institutions or with commercial institutions;
p.(None): 1.3 changes in the genetic structure of human cells for in vivo use;
p.(None): 1.4 researches in genetics of human reproduction (reprogenetics);
p.(None): 1.5 researches of genetics in behavior; and
p.(None): 1.6 researches in which irreversible dissociation of research participant’s data is expected;
p.(None): 2. human reproduction: researches interested in the functioning of the reproductive system, procreation and factors
p.(None): affecting the human reproductive health, shall consider as “research participant’s” all those who are
p.(None): affected by the procedures thereof. It will be up to CONEP to analyze the project when it involves:
p.(None): 2.1 – assisted reproduction;
p.(None): 2.2 – gametes, pre-embryos, embryos and fetus manipulation; and
p.(None): 2.3 – fetal medicine, when involving invasive procedures;
p.(None): 3. therapy equipments and devices, new or not registered in the country;
p.(None): 4. new invasive therapy procedures;
p.(None): 5. studies with indigenous populations;
...
p.(None):
p.(None): IX.5 – strengthen the participation of CEPs through a continuous process of training, qualification and
p.(None): accreditation;
p.(None): IX.6 – coordinate the CEPs accreditation process, appointing them responsibilities originally from CONEP,
p.(None): according to their skill levels;
p.(None): IX.7 – analyze and monitor, directly and indirectly, within the standards deadline, the research protocols that may
p.(None): involve needs for a higher protection related to their research participants, specially the risks thereof.
p.(None): Within such scope, it shall always be considered as first priority and, or in association, the national interests in
p.(None): the scientific and technological development, as the basis for determining the relevance and opportunity
p.(None): for performing such researches;
p.(None): IX.8 – analyze and monitor, directly and indirectly, research protocols with conflict of interests that make
p.(None): the fair local analysis difficult and not viable;
p.(None): IX.9 – rightly analyze any CEP/CONEP System protocol, whenever appropriate; and
p.(None): IX.10 – analyze, urgently and with special processing, research protocols with relevant public interest
p.(None): such as those that contribute to the public health, justice and reduction of social inequalities and technological
p.(None): premises, upon request of the Ministry of Health or other organization of Public Administration, or even at the
p.(None): discretion of CONEP/CNS Plenary.
p.(None):
p.(None): X – ETHICAL ANALYSYS PROCEDURES
p.(None): X.1 – CEPs ETHICAL ANALYSIS DUTIES:
p.(None): 1. it is CEP’s responsibility to issue, after analysis, a duly reasoned opinion in which the collegiate
p.(None): decision is presented in a clear, objective and detailed manner, respecting the deadline laid down in the
p.(None): operating standard;
p.(None): 2. forward CONEP’s duties protocols after an informed analysis, according to the current operating
p.(None): standards taking special care of all documentation that must follow such forwarding, including the detailed proof
p.(None): of expenses and the financing resources necessary for the research;
p.(None): 3. CEP shall also be responsible for:
p.(None): a) keeping the confidential custody of all data obtained while on duty and filing the complete
p.(None): protocol;
p.(None): b) monitoring the project’s development through biannual reports from investigators and other monitoring
p.(None): strategies, according to the risk inherent to the research;
p.(None): c) CEP shall keep the project, protocol and corresponding reports filed for a five-year period after the closure of
p.(None): the study, and such filing may be digitally processed.
p.(None): d) receiving complaints of abuse and notifications about adverse facts that might alter the study’s regular course,
p.(None): deciding on the continuation, modification or discontinuation of the research, requesting, if applicable, the change of
p.(None): the Statement Consent;
p.(None): e) requiring the opening of a research to the institution’s and/or organization’s board, or to the public competent
p.(None): bodies, if known any case of complaints of irregularities in the researches involving human beings and, if proved the
p.(None): existence of such complaints, communicate the fact to CONEP and, where applicable, to other authorities; and
p.(None): f) maintain a regular and ongoing communication with CONEP, through its Executive Secretariat.
p.(None): X.2 – PROCEDURE OF CONEP’s ETHICAL ANALYSIS:
p.(None): 1. it is CONEP’s responsibility to issue a duly reasoned opinion, respecting the deadline to be laid down in the
p.(None): Operating Standard, with a clear, objective and detailed analysis of all elements and documents of the project;
p.(None):
p.(None): 2. CONEP shall also be responsible for the direct or indirect monitoring of all research protocols within its duties;
p.(None): and
p.(None): 3. the provisions about the Procedures of CEP’s Ethical Analysis are applied to CONEP in cases where it operates as
p.(None): CEP.
p.(None): X.3 – COMMON PROVISIONS TO CEP AND CONEP:
p.(None): 1. members of CEP/CONEP shall exempt themselves from the case’s analysis and discussion, as well as from
p.(None): decision-making, when involved in the research;
p.(None): 2. CEPs and CONEP may count on ad hoc consultants, people belonging to or not, an
p.(None): institution/organization, with the purpose of providing technical support;
p.(None): 3. a research lacking its protocol shall not be analyzed;
p.(None): 4. any approved research that becomes discontinued by the leading researcher, without an acceptable
p.(None): justification satisfactory to the CEP or CONEP, approving such research shall be considered an unethical
p.(None): investigation;
p.(None): 5. CEP’s review shall be completed upon its classification under one of the following categories:
p.(None): a) approved;
p.(None): b) outstanding: when CEP considers the correction of the presented protocol as necessary, and requests specific
p.(None): review, change or relevant information, which shall be performed within the deadline laid down in operating
p.(None): standard; and
p.(None): c) not approved;
p.(None): 6. CEP may request, if judged as convenient and appropriate while performing the ethical review, information,
p.(None): documents and others needed for the well understanding of the issues, and discontinue the procedure until
...
Economic / Economic/Poverty
Searching for indicator poverty:
(return to top)
p.(None): areas of human knowledge;
p.(None): Considering that all growth and progress must always respect the dignity, freedom and autonomy of the human being;
p.(None): Considering the documents that form the pillars of recognition and affirming dignity, freedom and autonomy
p.(None): of the human being, such as Nuremberg Code, from 1947, and the Universal Declaration of Human Rights, from 1948;
p.(None): Considering recent international documents, a reflection from the great scientific and technological
p.(None): discoveries from the XX and XXI centuries, particularly the Helsinque Declaration, adopted in 1964 and
p.(None): its versions from 1975, 1983, 1989, 1996 and 2000; the International Pact regarding Economical, Social
p.(None): and Cultural Rights, from 1966; the International Pact regarding Civil and Political Laws, from 1966; the
p.(None): Universal Declaration regarding Human Genoma and Human Rights, from 1997; the International Declaration
p.(None): regarding Human Genes Data, from 2003; and the Universal Declaration regarding Bioethics and Human Rights,
p.(None): from 2004;
p.(None): Considering the Federal Constitution of the Federal Republic of Brazil, which objectives and foundations of
p.(None): sovereignty, citizenship, human dignity, labor and free enterprise social values and political pluralism and the
p.(None): objectives of building a free, fair and caring society, to ensure national development, to end poverty
p.(None): and marginalization and to reduce social and regional inequalities and to promote the well being of all, without any
p.(None): type of prejudice or discrimination, are consistent with the international documents of ethics, human rights and
p.(None): development;
p.(None): Considering the related and relevant Brazilian Legislation; and
p.(None): Considering the Resolution no. 196/96, of the National Council of Health, from the Ministry of Health, that states
p.(None): periodic reviews to it according to the needs on techno-scientific and ethical areas.
p.(None):
p.(None): D E C I D E S:
p.(None): To approve the following guidelines and standards regulating researches involving human beings: I – PRELIMINARY
p.(None): PROVISIONS
p.(None): This Resolution consolidates bioethical benchmarks from the view point of the individual and the
p.(None): communities, such as autonomy, non maleficence, beneficence, justice and equity, among others, and it seeks to
p.(None):
p.(None): ensure the rights and duties that refer to the participants of the research, to the scientific community and the
p.(None): State.
p.(None): Projects of research involving human beings must attend to this Resolution.
p.(None):
p.(None): II – TERMS AND DEFINITIONS
p.(None): This Resolution adopts the following definitions:
p.(None): II.1 – research findings – facts or information met by the investigator along the study and considered as relevant to
p.(None): the participants or communities involved;
p.(None): II.2 – informed consent agreement – an agreement of the research participant, child, teenager or legally unable, free
...
General/Other / Impaired Autonomy
Searching for indicator autonomy:
(return to top)
p.(None): RESOLUTION No. 466, OF 12 DECEMBER 2012
p.(None):
p.(None):
p.(None): During session of the National Council of Health at its 240th General Meeting held on December 11 and 12, 2012, in the
p.(None): discharge of its official authorities and duties, conferred upon it by Law 8080 of September 19, 1990, and Law 8142 of
p.(None): December 28, 1990, and
p.(None): Considering the respect for human dignity and the special protection to the members of the scientific
p.(None): researches involving human beings;
p.(None): Considering the development and ethical commitment, inherent to the techno-scientific development;
p.(None): Considering the evolution of science and technology which unveiled another perception of life and its
p.(None): ways of living, with impacts not only in conception and in lengthening of the human life span, as in costumes, culture,
p.(None): human behavior upon real and virtual means available changing and innovating at a continuous and fast pace;
p.(None): Considering the progress of science and technology, which may imply in current and potential benefits to the human
p.(None): being, the community in which he/she is inserted and the national and universal society, making it possible to
p.(None): promote well-being and quality of life, and promoting the protection and preservation of the environment
p.(None): for the current and future generations;
p.(None): Considering the ethical grounds subjects raised by the progress and growth of science and technology, rooted in all
p.(None): areas of human knowledge;
p.(None): Considering that all growth and progress must always respect the dignity, freedom and autonomy of the human being;
p.(None): Considering the documents that form the pillars of recognition and affirming dignity, freedom and autonomy
p.(None): of the human being, such as Nuremberg Code, from 1947, and the Universal Declaration of Human Rights, from 1948;
p.(None): Considering recent international documents, a reflection from the great scientific and technological
p.(None): discoveries from the XX and XXI centuries, particularly the Helsinque Declaration, adopted in 1964 and
p.(None): its versions from 1975, 1983, 1989, 1996 and 2000; the International Pact regarding Economical, Social
p.(None): and Cultural Rights, from 1966; the International Pact regarding Civil and Political Laws, from 1966; the
p.(None): Universal Declaration regarding Human Genoma and Human Rights, from 1997; the International Declaration
p.(None): regarding Human Genes Data, from 2003; and the Universal Declaration regarding Bioethics and Human Rights,
p.(None): from 2004;
p.(None): Considering the Federal Constitution of the Federal Republic of Brazil, which objectives and foundations of
p.(None): sovereignty, citizenship, human dignity, labor and free enterprise social values and political pluralism and the
p.(None): objectives of building a free, fair and caring society, to ensure national development, to end poverty
p.(None): and marginalization and to reduce social and regional inequalities and to promote the well being of all, without any
p.(None): type of prejudice or discrimination, are consistent with the international documents of ethics, human rights and
p.(None): development;
p.(None): Considering the related and relevant Brazilian Legislation; and
p.(None): Considering the Resolution no. 196/96, of the National Council of Health, from the Ministry of Health, that states
p.(None): periodic reviews to it according to the needs on techno-scientific and ethical areas.
p.(None):
p.(None): D E C I D E S:
p.(None): To approve the following guidelines and standards regulating researches involving human beings: I – PRELIMINARY
p.(None): PROVISIONS
p.(None): This Resolution consolidates bioethical benchmarks from the view point of the individual and the
p.(None): communities, such as autonomy, non maleficence, beneficence, justice and equity, among others, and it seeks to
p.(None):
p.(None): ensure the rights and duties that refer to the participants of the research, to the scientific community and the
p.(None): State.
p.(None): Projects of research involving human beings must attend to this Resolution.
p.(None):
p.(None): II – TERMS AND DEFINITIONS
p.(None): This Resolution adopts the following definitions:
p.(None): II.1 – research findings – facts or information met by the investigator along the study and considered as relevant to
p.(None): the participants or communities involved;
p.(None): II.2 – informed consent agreement – an agreement of the research participant, child, teenager or legally unable, free
p.(None): of vice (simulation, fraud or error), dependence, subordination or intimidation. Such research participants
p.(None): must be clarified about the nature of research, its objectives, methods, expected benefits, potential risks and the
p.(None): discomfort that it might occur by reason of said investigation, according to their comprehension and respecting their
p.(None): singularities;
p.(None): II.3 – assistance to the research participant:
p.(None): II.3.1 – immediate assistance – considered as an emergency and with no cost of any kind to the research participant, in
p.(None): situations that he/she may need it; and
p.(None): II.3.2 – full assistance – that provided to attend complications and damages caused directly or indirectly by the
p.(None): research;
p.(None): II.4 – research benefits – immediate or posterior, direct or indirect profit, attained by the participant and/or
...
p.(None): representative's consent statement, in the form of a written consent, and it must contain all necessary
p.(None): information, in a clear and objective language, so the participant and/or his legal representative
p.(None): clearly understand about the research to which he/she is willing to participate;
p.(None): II.24 – Consent Term – a document prepared for minors or legally incapable for their easy understanding allowing them,
p.(None): after being clearly informed about the research, to state their will to participate in the research without prejudice
p.(None): to the consent of their legal representatives; and
p.(None): II.25 – vulnerability – the condition of individuals or groups that, for any reason whatsoever, have their
p.(None): self-judgment capability reduced or disabled, or by any means they are prevented to resist to the opposition,
p.(None): especially when it comes to the informed consent form.
p.(None):
p.(None): III – ETHICAL ASPECTS OF RESEARCHES INVOLVING HUMAN BEINGS
p.(None): The researches involving human beings must attend to the relevant ethical and scientific grounds.
p.(None): III.1 – Ethics of research involve:
p.(None): a) respect the research participant’s dignity and autonomy, recognizing his/her vulnerability, ensuring
p.(None): his/her will to contribute and remain, or not, in the research, by means of express, free and informed statement;
p.(None): b) balance known and potential, individual or collective, risks and benefits committing to the maximum of benefits
p.(None): and to the minimum of risks and damages;
p.(None): c) ensure that known damages will be avoided; and
p.(None): d) social relevance of investigation, ensuring the equated weighting of interests involved with no loss to the sense
p.(None): of its social-humanitarian purpose.
p.(None): III.2 – In any area of knowledge involving human beings, the researches shall comply with the following demands:
p.(None): a) shall be appropriate to the scientific values that justifies it and with concrete possibilities of responding to
p.(None): uncertainties;
p.(None): b) shall be founded in scientific grounds, previous testing and/or appropriate assumptions to the specific area of
p.(None): investigation;
p.(None): c) shall be performed only when the expected knowledge cannot be obtained through other means;
p.(None): d) always seek for the expected benefits to prevail regarding risks and/or foreseeable discomforts;
p.(None): e) use the appropriate methodology to answer the studied subjects specifying if a qualitative, quantitative or
p.(None): quali-quantitative investigation;
p.(None):
p.(None): f) if there is a need to allocate the research participants randomly into experimental and control groups, ensure
p.(None): beforehand that it is not possible to establish the advantages of a procedure over another, by reviewing literature,
p.(None): observation methods or methods that do not involve human beings;
p.(None): g) obtain a deliberate consent statement from the research participant and/or his/her legal
p.(None): representative, including on cases where, due to their nature, the researches imply in posteriori consent;
p.(None): h) count on human resources and materials necessary to ensure the research participant’s wellbeing, and the
p.(None): investigator(s) must have appropriate professional capability to develop his/her function in the proposed project;
p.(None): i) provide procedures ensuring confidentiality and privacy, image protection and avoiding stigmatization of the
p.(None): research participants, and to guarantee the non-use of information to the detriment of people and/or communities,
p.(None): including in terms of self-esteem, prestige and/or economic and financial aspects;
p.(None): j) to be preferably developed on individuals with full autonomy. Individuals or vulnerable groups shall not
p.(None): participate in the research when the expected information may be obtained with participants fully capable,
p.(None): unless the research may bring benefits to the individuals or vulnerable groups.
p.(None): k) always respect cultural, social, moral, religious and ethical values, as well as habits and practices,
p.(None): when involving communities in researches;
p.(None): l) ensure, wherever possible, that researches within communities become beneficial to their effects and continue
p.(None): after their conclusion. When there is a real benefit to motivate or stimulate changes of habits or behaviors for the
p.(None): sake of the community, the research protocol shall include, wherever possible, willingness to communicate such
p.(None): advantage to the people and/or community;
p.(None): m) communicate the competent authorities, as well as to the bodies legitimized by the Social Control, the results
p.(None): and/or findings of the research, every time they can contribute to improving living conditions of the community,
p.(None): preserving, however, the image and ensuring that the research participants will not be stigmatized;
p.(None): n) ensure the benefits resulting from the project to the research participants, whether in terms of social return,
p.(None): access to procedures, products or research agents;
p.(None): o) ensure the monitoring conditions, treatment, full assistance and guidance to the research participants, according
...
p.(None): of the study, in which case this guarantee could be granted by means of an extension study, according to a duly
p.(None): justified analysis from the doctor assisting the research participant.
p.(None):
p.(None): IV – PROCESS OF INFORMED CONSENT FORM
p.(None): Due respect to human dignity requires that every research be carried out after subjects, individuals or groups,
p.(None): or their legal representatives have given the respective informed consent form expressing their agreement
p.(None): to participate in the research.
p.(None): The Process of the Informed Consent Form refers to all steps the guests need to observe to participate in a research
p.(None): and to be able to manifest themselves as autonomous, conscientious, free and informed.
p.(None): IV.1 – The first step of the Process of the Informed Consent Form refers to clarify the guests about their
p.(None): participation in the research, where the investigator or person delegated by him/her or under
p.(None): his/her responsibility should:
p.(None): a) look for the right moment, condition or place to carry out the clarification taking into account
p.(None): the guests’ peculiarities and privacy to participate in the research;
p.(None): b) provide clear and accessible information using the most appropriate strategies referred to the culture, age,
p.(None): socio-economic conditions and autonomy of the subjects participating in the research; and
p.(None): c) grant the appropriate time so that the subjects participating in the research could think and consult, if
p.(None): necessary, their family or other people to help them take an informed consent decision.
p.(None): IV.2 – Once the first step of clarification is completed, the investigator or person delegated by him/her shall
p.(None): submit the Informed Consent Form to the guest participating in the research, or to his/her legal
p.(None): representative, to be read and understood before the concession of the consent statement.
p.(None): IV.3 – The Informed Consent must contain:
p.(None): a) justification, objectives and procedures that will be used in the research detailing the methods applied,
p.(None): notifying the possibility of their inclusion into control or experimental group, when applicable;
p.(None): b) explanation of potential discomforts and risks resulting from participating in the research, besides the benefits
p.(None): expected from such participation and presenting measures and cautions to avoid and/or lower effects and
p.(None): adverse conditions that may cause damage, taking into account characteristics and context of the research participant;
p.(None): c) clarification regarding monitoring and assistance that the research participants are entitled to,
p.(None): including the benefits and monitoring following the closure and/or interruption of the research;
p.(None):
p.(None): d) granting of total freedom to the research participant to refuse to participate or to remove his/her
...
p.(None): him/her, and with all signed pages on the same sheet. Both copies shall state the address and contact number or
p.(None): other of those responsible for the research, of the local CEP and CONEP, when applicable.
p.(None): IV.6 – In the event where there is any restriction to freedom or explanation required to the appropriate consent, the
p.(None): following shall be complied with as well:
p.(None): a) researches involving children and adolescents, individuals mentally disturbed or ill and those who
p.(None): have their capacity to consent substantially reduced, shall include in the protocol unquestionable
p.(None): justification for the choice of such individuals approved by CEP, and by CONEP, and comply with all requirements of
p.(None): informed consent statement by means of their legal representatives and the research participant, to the fullest extent
p.(None): of his/her capacity, is guaranteed the right to information;
p.(None): b) freedom to consent shall be specifically guaranteed to those individuals that, although fully capable, are
p.(None): exposed to specific conditioning or authority influence, featuring situations restricting their autonomy,
p.(None): specially students, members of the armed forces, employees, prisoners rehabilitation, shelters, nursing
p.(None): homes or religious associations interns and alike, in addition to be free to decide whether or not to participate
p.(None): in the research, with no retaliation of any kind;
p.(None): c) researches with individuals diagnosed with encephalic death may comply with the following
p.(None): requirements:
p.(None): c.1) documentary evidence of encephalic death;
p.(None):
p.(None): c.2) a written consent from family members and/or legal representative or documentary evidence of
p.(None): individual’s will to participate in researches;
p.(None): c.3) respect to human dignity;
p.(None): c.4) no additional economic-financial burden to the family;
p.(None): c.5) no prejudice to other patients awaiting hospitalization or treatment; and
p.(None): c.6) likely to acquire new, relevant scientific knowledge which cannot be so acquired any other way;
p.(None): d) the existence of an official government communication channel to clarify doubts to all those involved in the
p.(None): research projects, as well as for those cases of encephalic death diagnosis; and
p.(None): e) in group culture communities recognizing the leader’s authority or the collectiveness upon the
p.(None): individual, the authorization for the research should respect such feature, without the prejudice of
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.(None):
p.(None): D E C I D E S:
p.(None): To approve the following guidelines and standards regulating researches involving human beings: I – PRELIMINARY
p.(None): PROVISIONS
p.(None): This Resolution consolidates bioethical benchmarks from the view point of the individual and the
p.(None): communities, such as autonomy, non maleficence, beneficence, justice and equity, among others, and it seeks to
p.(None):
p.(None): ensure the rights and duties that refer to the participants of the research, to the scientific community and the
p.(None): State.
p.(None): Projects of research involving human beings must attend to this Resolution.
p.(None):
p.(None): II – TERMS AND DEFINITIONS
p.(None): This Resolution adopts the following definitions:
p.(None): II.1 – research findings – facts or information met by the investigator along the study and considered as relevant to
p.(None): the participants or communities involved;
p.(None): II.2 – informed consent agreement – an agreement of the research participant, child, teenager or legally unable, free
p.(None): of vice (simulation, fraud or error), dependence, subordination or intimidation. Such research participants
p.(None): must be clarified about the nature of research, its objectives, methods, expected benefits, potential risks and the
p.(None): discomfort that it might occur by reason of said investigation, according to their comprehension and respecting their
p.(None): singularities;
p.(None): II.3 – assistance to the research participant:
p.(None): II.3.1 – immediate assistance – considered as an emergency and with no cost of any kind to the research participant, in
p.(None): situations that he/she may need it; and
p.(None): II.3.2 – full assistance – that provided to attend complications and damages caused directly or indirectly by the
p.(None): research;
p.(None): II.4 – research benefits – immediate or posterior, direct or indirect profit, attained by the participant and/or
p.(None): his/her community caused by his/her participation in the research;
p.(None): II.5 – informed consent form – an agreement from the research participant and/or from his/her legal
p.(None): representative, free of vice (simulation, fraud or error), dependence, subordination or intimidation
p.(None): following a complete and detailed explanation of the nature of the research, its objectives, methods,
p.(None): expected benefits, potential risks and discomfort that might occur by reason of said investigation;
p.(None): II.6 – damage related to or caused by the research – immediate or posterior, direct or indirect offense, to the
p.(None): individual or community, caused by the research;
p.(None): II.7 – compensation – material coverage for compensating damages caused by the research to its
p.(None): participants;
p.(None): II.8 – research applicant institution – public or private organization, legitimated and qualified, to which the leading
p.(None): researcher is linked to;
p.(None): II.9 – research co-participating institution – public or private organization, legitimated and qualified,
p.(None): in which some of the stages or steps of the research are developed;
p.(None): II.10 – research participant – the individual who accepts to be studied on a voluntary and informed basis or under
...
p.(None): investigator to the CEP/CONEP System, for evaluation, without prejudice to the subsequent clarification process.
p.(None):
p.(None): V - RISKS AND BENEFITS
p.(None): Every research with human beings is considered to involve risks of different types. The bigger and more evident the
p.(None): risks, the bigger should be the care offered by CEP/CONEP to minimize them and protect the research
p.(None): participants. Possibilities for immediate or further damages must be analyzed at an individual and
p.(None): collective level. The analysis of risks is an indispensable part to the ethical analysis which generates
p.(None): the monitoring plan that shall be offered by the CEP/CONEP System in each specific case.
p.(None): V.1 – Researches involving human beings will be admissible when:
p.(None): a) the risk is justified by the expected benefit; and
p.(None): b) in case of experimental researches referred to health, the benefit is bigger, or, at least, equal to the already
p.(None): established options for prevention, diagnosis and treatment.
p.(None): V.2 – Researches with solely indirect benefits to their participants are admissible as long as their
p.(None): physical, psychological, moral, intellectual, social, cultural and spiritual dimensions are considered.
p.(None): V.3 – The leading researcher must immediately communicate to the CEP/CONEP System any significant risk or damage the
p.(None): research participant may suffer, stated or not in the Informed Consent Form and evaluate as an emergency the need to
p.(None): adjust or suspend the study.
p.(None): V.4 – In the health area researches, the researcher shall evaluate the need to adjust or suspend the
p.(None): ongoing study as soon as the significant superiority of an intervention over other comparative(s) are recognized,
p.(None): aiming at offering all subjects the benefits of the best regimen.
p.(None): V.5 – The CEP/CONEP System shall be informed of any relevant fact that may change the regular course of the studies
p.(None): approved by it and, specifically, in those researches related to health, to be informed of the adverse
p.(None): effects and the significant superiority of a research upon other or other comparatives.
p.(None): V.6 – The investigator, the sponsor and the institutions and/or organizations involved in different stages of the
p.(None): researches shall provide immediate assistance, in terms of item II.3, as well as to be responsible for
p.(None): the complete assistance to all subjects when referred to complications and damages caused by such research.
p.(None):
p.(None): V.7 – Every research subject who come to suffer any damages whatsoever in the future, whether or not indicated in the
p.(None): consent statement and resulting from his/her participation shall be entitled to indemnification on the part of the
p.(None): investigator, sponsor and institutions involved in the different stages of the research.
p.(None):
p.(None): VI – RESEARCH PROTOCOL
p.(None): The protocol to be submitted to ethical review will only be subject to examination if accompanied with all
p.(None): documentation required by the CEP/CONEP System, considering the nature and specificities of each research. Plataforma
p.(None): BRASIL is the official system for launching researches for the CEP/CONEP System analysis and monitoring.
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.(None): in the research, or by his/her legal representative, as well as by the leading researcher or those delegated by
p.(None): him/her, and with all signed pages on the same sheet. Both copies shall state the address and contact number or
p.(None): other of those responsible for the research, of the local CEP and CONEP, when applicable.
p.(None): IV.6 – In the event where there is any restriction to freedom or explanation required to the appropriate consent, the
p.(None): following shall be complied with as well:
p.(None): a) researches involving children and adolescents, individuals mentally disturbed or ill and those who
p.(None): have their capacity to consent substantially reduced, shall include in the protocol unquestionable
p.(None): justification for the choice of such individuals approved by CEP, and by CONEP, and comply with all requirements of
p.(None): informed consent statement by means of their legal representatives and the research participant, to the fullest extent
p.(None): of his/her capacity, is guaranteed the right to information;
p.(None): b) freedom to consent shall be specifically guaranteed to those individuals that, although fully capable, are
p.(None): exposed to specific conditioning or authority influence, featuring situations restricting their autonomy,
p.(None): specially students, members of the armed forces, employees, prisoners rehabilitation, shelters, nursing
p.(None): homes or religious associations interns and alike, in addition to be free to decide whether or not to participate
p.(None): in the research, with no retaliation of any kind;
p.(None): c) researches with individuals diagnosed with encephalic death may comply with the following
p.(None): requirements:
p.(None): c.1) documentary evidence of encephalic death;
p.(None):
p.(None): c.2) a written consent from family members and/or legal representative or documentary evidence of
p.(None): individual’s will to participate in researches;
p.(None): c.3) respect to human dignity;
p.(None): c.4) no additional economic-financial burden to the family;
p.(None): c.5) no prejudice to other patients awaiting hospitalization or treatment; and
p.(None): c.6) likely to acquire new, relevant scientific knowledge which cannot be so acquired any other way;
p.(None): d) the existence of an official government communication channel to clarify doubts to all those involved in the
p.(None): research projects, as well as for those cases of encephalic death diagnosis; and
p.(None): e) in group culture communities recognizing the leader’s authority or the collectiveness upon the
p.(None): individual, the authorization for the research should respect such feature, without the prejudice of
p.(None): individual consent, when possible and desirable. The authorization for the research should be granted in advance by
p.(None): government bodies when the Brazilian Legislation rules upon their competence, like it is the case of the National
p.(None): Indian Foundation (FUNAI), where indigenous communities are under their own responsibility.
p.(None): IV.7 – The research depending on restriction to information to the research participants, such restriction shall be
p.(None): fully explained and justified by the leading researcher and submitted to the CEP/CONEP. Data collected from the
p.(None): research participants may not be used for any other purposes other than those specified in the protocol and/or informed
p.(None): consent statement.
p.(None): IV.8 – In cases where unfeasible to obtain the Informed Consent Form or that its obtaining may imply to substantial
p.(None): risks to the privacy and confidentiality of the research participant’s data or to the bonds of trust
p.(None): between investigator and investigated, the dismissal of such Statement Form must be rightly requested by the
p.(None): investigator to the CEP/CONEP System, for evaluation, without prejudice to the subsequent clarification process.
p.(None):
p.(None): V - RISKS AND BENEFITS
p.(None): Every research with human beings is considered to involve risks of different types. The bigger and more evident the
...
p.(None):
p.(None): XIII – RESOLUTIONS AND SPECIFIC RULES
p.(None): XIII.1 – The assessment procedures of research protocols, as well as the specific aspects of registry,
p.(None): like concession, renewal or cancellation and, also accreditation of Ethical Committees in Research shall be
p.(None): regulated by Resolution from the National Council of Health.
p.(None): XIII.2 – The accreditation process of Ethical Committees in Research that form the CEP/CONEP System shall be treated by
p.(None): a Resolution from CNS.
p.(None): XIII.3 – Ethical research specificities in social and human science and others adopting
p.(None): methodologies from those areas shall be addressed in complementary resolution, given their
p.(None): particularities.
p.(None): XIII.4 – Ethical research specificities with strategic interest for SUS shall be addressed in specific complementary
p.(None): Resolution.
p.(None): XIII.5 – Procedural and administrative aspects of CEP/CONEP System shall be treated in Operating Standard
p.(None): from CNS.
p.(None): XIII.6 – Risk typification and gradation in different research methodologies shall be defined by the National Council
p.(None): of Health own rule.
p.(None):
p.(None): XIV – FINAL PROVISIONS
p.(None): Resolutions CNS no. 196/96, 303/2000 and 404/2008 are hereby repealed. This Resolution shall come into force upon
p.(None): publication.
p.(None):
p.(None):
p.(None):
p.(None): ALEXANDRE ROCHA SANTOS PADILHA
p.(None): President of the National Council of Health
p.(None):
p.(None):
p.(None): I approve the Resolution CNS no. 466 of December 12, 2012, pursuant to the terms of the Decree of Delegation of
p.(None): Authority dated November 12, 1991.
p.(None):
p.(None):
p.(None): ALEXANDRE ROCHA SANTOS PADILHA
p.(None): Ministry of State for Health
p.(None):
p.(None):
p.(None):
...
General/Other / participants in a control group
Searching for indicator control group:
(return to top)
p.(None): expected from such participation and presenting measures and cautions to avoid and/or lower effects and
p.(None): adverse conditions that may cause damage, taking into account characteristics and context of the research participant;
p.(None): c) clarification regarding monitoring and assistance that the research participants are entitled to,
p.(None): including the benefits and monitoring following the closure and/or interruption of the research;
p.(None):
p.(None): d) granting of total freedom to the research participant to refuse to participate or to remove his/her
p.(None): consent at any stage of the research, with no penalty;
p.(None): e) granting of maintaining confidentiality and privacy of all research participants during all stages of
p.(None): research;
p.(None): f) granting the research participant a copy of the Informed Consent Form;
p.(None): g) explanation of the reimbursement guarantee and how will the expenses of the research participants be covered and
p.(None): thereof;
p.(None): h) explanation of the indemnification guarantee in the case of eventual damages caused by the research.
p.(None): IV.4 – The Informed Consent Form used in researches adopting experimental methodologies in the biomedical
p.(None): area, involving human beings, besides that expected on item IV.3 above, must contain, necessarily, the following:
p.(None): a) explanation, where appropriate, of the existing alternative treatment methods;
p.(None): b) clarification , where appropriate, regarding the possibility of including the participant into a
p.(None): control group or placebo, clearly explaining the significance of that possibility; and
p.(None): c) do not demand from the research participant, under any justification, a waiver of indemnification for damages. The
p.(None): Informed Consent Form shall not include any liability disclaim nor imply waiver by the research participant of his/her
p.(None): legal rights, including the right to procure indemnification for potential damages.
p.(None): IV.5 – The Informed Consent Form should also:
p.(None): a) contain a statement of the leading researcher expressing the compliance with the requirements
p.(None): specified on items IV.3 and, where applicable, IV.4;
p.(None): b) be adapted to the ethical rules and to the local culture, by the leading researcher, on researches with foreign
p.(None): cooperation elaborated abroad, with clear and accessible language to all and particularly to the participants of the
p.(None): research, taking special care for easy reading and understanding;
p.(None): c) be approved by CEP to which the project was presented and by CONEP, when applicable; and
p.(None): d) be elaborated in 2 copies and with all pages initialed and signed at the end by the guest invited to participate
p.(None): in the research, or by his/her legal representative, as well as by the leading researcher or those delegated by
p.(None): him/her, and with all signed pages on the same sheet. Both copies shall state the address and contact number or
p.(None): other of those responsible for the research, of the local CEP and CONEP, when applicable.
...
Searching for indicator placebo:
(return to top)
p.(None): or fetus, childbirth, puerperium, lactation and newborn in researches carried out in pregnant women or those in the
p.(None): childbearing age;
p.(None): s) consider that the researches carried out in pregnant women must be performed before those carried out in women
p.(None): after their gestational period, except for researches to which pregnancy is the main purpose;
p.(None): t) women who declare themselves with no risk of pregnancy, whether by sexual relation or by no means of
p.(None): reproduction, guarantee the right to participate on es without the compulsory use of contraceptives; and
p.(None):
p.(None): u) discontinue research only after analysis of reasons for such discontinuation by
p.(None): the CEP/CONEP/CNS/MS System approving such study, unless in cases of justified urgency to the benefit of
p.(None): their participants.
p.(None): III.3 – The researches using experimental methodologies in the biomedical area, involving human beings, besides that
p.(None): recommended in item III.2, shall:
p.(None): a) be founded on previous experimentation carried out in labs using animals or other experimental models
p.(None): and scientific evidence, when appropriate;
p.(None): b) when using placebo, such use shall be fully justified as to its non maleficence and methodology
p.(None): requirements, where the benefits, risks, difficulties and effectiveness of a new therapeutic method shall
p.(None): be tested, comparing it to the best current prophylactic, diagnostic and therapeutic methods. It is not included the
p.(None): use of placebo or any other treatment to studies where there are no proven methods of prophylaxis, diagnosis or
p.(None): treatment;
p.(None): c) use the biological material and data obtained from the study solely to that intended purpose in the protocol, or
p.(None): according to the consent granted by the research participant; and
p.(None): d) guarantee to all participants, at the end of the study and for unlimited time, free access to the best
p.(None): prophylactic, diagnostic and therapeutic methods that have proven their efficiency;
p.(None): d.1) the access will also be guaranteed in the interval between the end of the individual’s participation and the end
p.(None): of the study, in which case this guarantee could be granted by means of an extension study, according to a duly
p.(None): justified analysis from the doctor assisting the research participant.
p.(None):
p.(None): IV – PROCESS OF INFORMED CONSENT FORM
p.(None): Due respect to human dignity requires that every research be carried out after subjects, individuals or groups,
p.(None): or their legal representatives have given the respective informed consent form expressing their agreement
p.(None): to participate in the research.
p.(None): The Process of the Informed Consent Form refers to all steps the guests need to observe to participate in a research
p.(None): and to be able to manifest themselves as autonomous, conscientious, free and informed.
...
p.(None): adverse conditions that may cause damage, taking into account characteristics and context of the research participant;
p.(None): c) clarification regarding monitoring and assistance that the research participants are entitled to,
p.(None): including the benefits and monitoring following the closure and/or interruption of the research;
p.(None):
p.(None): d) granting of total freedom to the research participant to refuse to participate or to remove his/her
p.(None): consent at any stage of the research, with no penalty;
p.(None): e) granting of maintaining confidentiality and privacy of all research participants during all stages of
p.(None): research;
p.(None): f) granting the research participant a copy of the Informed Consent Form;
p.(None): g) explanation of the reimbursement guarantee and how will the expenses of the research participants be covered and
p.(None): thereof;
p.(None): h) explanation of the indemnification guarantee in the case of eventual damages caused by the research.
p.(None): IV.4 – The Informed Consent Form used in researches adopting experimental methodologies in the biomedical
p.(None): area, involving human beings, besides that expected on item IV.3 above, must contain, necessarily, the following:
p.(None): a) explanation, where appropriate, of the existing alternative treatment methods;
p.(None): b) clarification , where appropriate, regarding the possibility of including the participant into a
p.(None): control group or placebo, clearly explaining the significance of that possibility; and
p.(None): c) do not demand from the research participant, under any justification, a waiver of indemnification for damages. The
p.(None): Informed Consent Form shall not include any liability disclaim nor imply waiver by the research participant of his/her
p.(None): legal rights, including the right to procure indemnification for potential damages.
p.(None): IV.5 – The Informed Consent Form should also:
p.(None): a) contain a statement of the leading researcher expressing the compliance with the requirements
p.(None): specified on items IV.3 and, where applicable, IV.4;
p.(None): b) be adapted to the ethical rules and to the local culture, by the leading researcher, on researches with foreign
p.(None): cooperation elaborated abroad, with clear and accessible language to all and particularly to the participants of the
p.(None): research, taking special care for easy reading and understanding;
p.(None): c) be approved by CEP to which the project was presented and by CONEP, when applicable; and
p.(None): d) be elaborated in 2 copies and with all pages initialed and signed at the end by the guest invited to participate
p.(None): in the research, or by his/her legal representative, as well as by the leading researcher or those delegated by
p.(None): him/her, and with all signed pages on the same sheet. Both copies shall state the address and contact number or
p.(None): other of those responsible for the research, of the local CEP and CONEP, when applicable.
p.(None): IV.6 – In the event where there is any restriction to freedom or explanation required to the appropriate consent, the
...
Orphaned Trigger Words
p.(None): II.7 – compensation – material coverage for compensating damages caused by the research to its
p.(None): participants;
p.(None): II.8 – research applicant institution – public or private organization, legitimated and qualified, to which the leading
p.(None): researcher is linked to;
p.(None): II.9 – research co-participating institution – public or private organization, legitimated and qualified,
p.(None): in which some of the stages or steps of the research are developed;
p.(None): II.10 – research participant – the individual who accepts to be studied on a voluntary and informed basis or under
p.(None): the clarification and authorization of his/her legal representatives. The participation must be free of
p.(None): charge, except Phase I or Bioequivalence clinical researches;
p.(None): II.11 – sponsor – public or private individual or legal entity that supports the research, throughout financial shares,
p.(None): infrastructure, human resources or institutional support;
p.(None): II.12 – research – a formal and systematic process which aims at the production, at the advancement of knowledge and/or
p.(None): at obtaining answers to problems by using a scientific methodology;
p.(None): II.13 – research in human reproduction – researches engaged with the functions of the reproductive
p.(None): system, procreation and factors that affect the reproductive health of humans, considering as “research
p.(None): participants” all those who were affected by its procedures;
p.(None): II.14 – research involving human beings – researches involving, individually or collectively and directly or
p.(None): indirectly, human beings as a whole or part thereof, including handling of his/her data, information or biological
p.(None): materials;
p.(None): II.15 –investigator – a member of the research team, co-responsible for the integrity and welfare of all participants
p.(None): of the research;
p.(None):
p.(None): II.16 – leading researcher – a person in charge of the coordination of the research and co-responsible for the
p.(None): integrity and welfare of all participants of the research;
p.(None): II.17 – research protocol – a set of documents describing the research regarding its fundamental aspects and the
p.(None): information related to the research participants, the researcher’s qualification and all responsible bodies;
p.(None): II.18 – previous material compensation – material compensation dedicated exclusively for expenses related to
p.(None): transportation and meal for the research participant and his/her companion(s), and if necessary, prior to his/her
p.(None): participation in the research;
p.(None): II.19 – final report – the one presented after the closure of the research, totaling its results;
p.(None): II.20 – partial report – the one presented during the research showing relevant facts and partial results of its
p.(None): development;
p.(None): II.21 – indemnification – material compensation dedicated exclusively for expenses related to
p.(None): transportation and meal for the research participant and his/her companion(s), whenever necessary;
p.(None): II.22 – research risks – possible damage to the human being physical, psychic, moral, intellectual, social, cultural or
p.(None): spiritual dimension, caused by and from any research;
p.(None): II.23 – Informed Consent Form (ICF) – a document specifying the research participant and/or his/her legal
...
p.(None): review, change or relevant information, which shall be performed within the deadline laid down in operating
p.(None): standard; and
p.(None): c) not approved;
p.(None): 6. CEP may request, if judged as convenient and appropriate while performing the ethical review, information,
p.(None): documents and others needed for the well understanding of the issues, and discontinue the procedure until
p.(None): confirming the receipt of said elements;
p.(None): 7. should the decision be not approved, it shall be CEP and/or CONEP’s responsibility to appeal, within 30 days,
p.(None): whenever a new fact is presented to substantiate the need for a reevaluation;
p.(None): 8. CEPs and CONEP shall determine the research protocol filing in cases where the leading researcher did
p.(None): not meet the requests addressed to him/her within the stated deadline. They shall also consider the withdrawn protocol
p.(None): when requested by the leading researcher;
p.(None): 9. once the project is approved, CEP, or CONEP in situations acting as a CEP or under the operation of
p.(None): its original duties, it becomes the co-responsible for that referred to the research’s ethical aspects; and
p.(None): 10. shall be considered as authorized for implementation those projects approved by CEP, or by CONEP when in situations
p.(None): acting originally as a CEP or under the operation of its duties.
p.(None):
p.(None): XI – LEADING RESEARCHER
p.(None): XI.1 – The researcher has a non transferable, indeclinable responsibility which includes the following
p.(None): ethical and legal aspects:
p.(None): XI.2 – The investigator is required to:
p.(None): a) submit the duly guided protocol to CEP and CONEP, awaiting for the ethical approval decision before
p.(None): starting the research;
p.(None): b) elaborate the Informed Consent Form;
p.(None): c) develop project as designed;
p.(None): d) prepare and submit interim and final reports;
p.(None): e) submit all data requested at any time by CEP or CONEP;
p.(None): f) keep under his/her custody and responsibility for 5 years, records of all research data, physical or
p.(None): digital, after the closure of such research;
p.(None): g) forward all results for publication, including the respective acknowledgments concerning associate
p.(None): investigators and technical staff participating in the project; and
p.(None):
p.(None): h) submit to the relevant CEO or CONEP reasonable, acceptable explanation for discontinuation of a project or non
p.(None): publication of any results.
p.(None):
p.(None): XII – OTHER PROVISIONS
p.(None): XII.1 – Every area of research and each research modality, in addition to abide by the provisions
p.(None): contained in this Resolution, shall comply with all branch requirements and specific regulations.
p.(None): XII.2 – Research promotion agencies and editorial staff of scientific journals shall require documentary evidence of
p.(None): project’s approval by the CEP/CONEP System.
p.(None): XII.3 – By virtue of the contextual nature of all considerations contained herein, this Resolution will be subject to
p.(None): regular reviews to meet the requirements of the technical-scientific and ethical areas.
p.(None):
p.(None): XIII – RESOLUTIONS AND SPECIFIC RULES
p.(None): XIII.1 – The assessment procedures of research protocols, as well as the specific aspects of registry,
p.(None): like concession, renewal or cancellation and, also accreditation of Ethical Committees in Research shall be
p.(None): regulated by Resolution from the National Council of Health.
p.(None): XIII.2 – The accreditation process of Ethical Committees in Research that form the CEP/CONEP System shall be treated by
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| abuse | Victim of Abuse |
| access | Access to Social Goods |
| age | Age |
| authority | Relationship to Authority |
| autonomy | Impaired Autonomy |
| child | Child |
| childbearing age | of childbearing age/fertile |
| children | Child |
| control group | participants in a control group |
| dependence | Drug Dependence |
| disabled | Mentally Disabled |
| educational | education |
| embryo | embryo |
| emergency | Public Emergency |
| employees | employees |
| family | Motherhood/Family |
| fetus | Fetus/Neonate |
| ill | ill |
| incapable | Mentally Incapacitated |
| indigenous | Indigenous |
| influence | Drug Usage |
| language | Linguistic Proficiency |
| mentally | Mentally Disabled |
| opinion | philosophical differences/differences of opinion |
| placebo | participants in a control group |
| political | political affiliation |
| poverty | Economic/Poverty |
| pregnant | Pregnant |
| prisoners | Criminal Convictions |
| religious | Religion |
| stigmatization | Threat of Stigma |
| stigmatized | Threat of Stigma |
| vulnerability | vulnerable |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| child | ['children'] |
| children | ['child'] |
| control group | ['placebo'] |
| disabled | ['mentally'] |
| mentally | ['disabled'] |
| placebo | ['controlXgroup'] |
| stigmatization | ['stigmatized'] |
| stigmatized | ['stigmatization'] |
| vulnerability | ['vulnerable'] |
| vulnerable | ['vulnerability'] |
Trigger Words
capacity
consent
cultural
developing
ethics
justice
protect
protection
risk
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input