C661DEC5EFCA0F83910449083B33AEF8
Resolution CNS No. 340/2004: On Research on Human Genetics (2004)
http://conselho.saude.gov.br/resolucoes/2004/Res340_en.pdf
http://leaux.net/URLS/ConvertAPI Text Files/5129847F6DB51979B55F7AF388BB30DC.en.txt
Examining the file media/Synopses/5129847F6DB51979B55F7AF388BB30DC.html:
This file was generated: 2020-04-11 03:24:32
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Indigenous
Searching for indicator indigenous:
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p.(None): III.13 – In the case of human genetic data exchange among institutions, there shall be an agreement among themselves
p.(None): towards mutual cooperation and equal data access.
p.(None): III.14 – Human genetic data shall not be stored by individuals, requiring the participation of a responsible
p.(None): institution that ensures adequate protection.
p.(None): III.15 – The benefits of human genetic data utilization collected within the research scope, including
p.(None): populational genetic studies, shall be shared among the involved communities, on an international or national basis.
p.(None): III.16 – Researches for genome modification shall only be carried out with somatic cells. IV- Research Protocol:
p.(None): IV.1 – Researches on the area of human genetics shall be submitted to CEP evaluation as complete protocols and, if
p.(None): necessary, submitted also to CONEP, in accordance with chapter VI of Resolution CNS No 196/96, not being
p.(None): accepted as amendments, addends or sub-study of another area’s protocol. It shall also include:
p.(None): a) research justification;
p.(None): b) how genes, DNA and RNA segments or gene products in study are correlated with a possible condition of the research
p.(None): subject;
p.(None): c) clear explanation of exams and tests that will be carried out and the indication of genes, DNA and
p.(None): RNA segments or gene products that will be studied;
p.(None): d) justification for choice and size of the sample, particularly when it regards a vulnerable population
p.(None): or group and distinct cultures (for example, indigenous group);
p.(None): e) recruitment means of both the research subjects and controls, when necessary;
p.(None): f) careful analysis of potential and current risks and benefits for the individual, the group and future
p.(None): generations, when necessary;
p.(None): g) information regarding the use, storage or other destinations of biological material;
p.(None): h) measures and cares for assuring the privacy and avoiding stigmatization and discrimination of
p.(None): the research subject, the family and the group in any way;
p.(None): i) explanation of preexistent agreement related to the property of generated information as well as the industrial
p.(None): property, when necessary;
p.(None): j) description of the genetic advice planning and clinical surveillance, when indicated, including the names and
p.(None): contacts of the responsible professionals, approach type according to expected situations, consequences to
p.(None): subjects and foreseen conducts. The responsible professionals for the genetic advices and clinical surveillance
p.(None): must comply with the professional formation and certificates required by the professional councils and specialty
p.(None): societies;
p.(None):
p.(None): l) a justification for the transport of biological material and/or data to other institutions, national or foreign,
p.(None): with clear indication of material and/or data types as well as the
p.(None):
p.(None): listing of exams and tests to be carried out. It is also required to clarify the reasons why the exams or tests can not
p.(None): be performed in Brazil, if this is the case; and
...
Political / Political
Searching for indicator party:
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p.(None): individuals, families or groups’.
p.(None): III.3 – Researches involving predictive tests must be preceded by clarification, before material collecting,
p.(None): with respect to the meaning and possible usage of expected results.
p.(None): III.4 – It shall be offered to research subjects the option to choose whether or not they want to be informed of the
p.(None): results of their medical exams.
p.(None): III.5 – Research projects must contain a proposal for genetic advice, whenever the case.
p.(None): III.6 – It is the research subjects’ liability to authorize or not data storage and collection of materials within the
p.(None): scope of the research, after being informed about the procedures defined in the Resolution concerning storage of
p.(None): biological materials.
p.(None): III.7 – Every individual has access to his/her genetic data, as well as the right to retrieve them from banks where
p.(None): they are stored.
p.(None): III.8 – In order to have individual genetic data irreversibly dissociated from any identifiable individual,
p.(None): justification must be provided for such procedure so as to be evaluated by CEP and CONEP.
p.(None): III.9 - In the event of genetic data dissociation approval by CEP and CONEP, the research subject must be informed of
p.(None): advantages and disadvantages of such dissociation and a specific Term of Consent for this finality signed.
p.(None): III.10 –The item V.7 of Resolution CNS N°196/96 must be observed including a possible patent registration.
p.(None): III.11 – The resulting genetic data of a research associated to an identifiable individual shall not be divulged nor
p.(None): become accessible to a third party, particularly to employers, insurance companies and educational institutions. In
p.(None): addition to that, such resulting data shall not be provided for crossing with other stored data for
p.(None): judicial purposes or other finality, unless otherwise duly authorized by the research subject.
p.(None):
p.(None):
p.(None): III.12 – Human genetic data collected on researches with a predefined purpose shall only be used for a different
p.(None): purpose if duly authorized by the donor or his/her legal representative. It is also required a new research protocol
p.(None): duly approved by the Committee for Ethics in Research and, if necessary, by CONEP. In the event of not obtaining the
p.(None): TCLE, a formal justification shall be presented to CEP evaluation.
p.(None): III.13 – In the case of human genetic data exchange among institutions, there shall be an agreement among themselves
p.(None): towards mutual cooperation and equal data access.
p.(None): III.14 – Human genetic data shall not be stored by individuals, requiring the participation of a responsible
p.(None): institution that ensures adequate protection.
p.(None): III.15 – The benefits of human genetic data utilization collected within the research scope, including
p.(None): populational genetic studies, shall be shared among the involved communities, on an international or national basis.
p.(None): III.16 – Researches for genome modification shall only be carried out with somatic cells. IV- Research Protocol:
p.(None): IV.1 – Researches on the area of human genetics shall be submitted to CEP evaluation as complete protocols and, if
...
Health / Drug Usage
Searching for indicator usage:
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p.(None):
p.(None): NATIONAL HEALTH COUNCIL
p.(None):
p.(None): RESOLUTION Nº 340, 8TH JULY 2004
p.(None): The National Health Council Plenary Assembly, in its 144th Ordinary Meeting, held from the 7th to the 8th July 2004, in
p.(None): the use of its regimental competencies and granted attributions by the Law nº 8.080 of 19th September 1990 and by the
p.(None): Law nº 8.142, of 28th December 1990, and
p.(None): Considering the recent technical-scientific advance and its applications on human genetic research, requiring
p.(None): positioning of institutions, researchers and the Committees for Ethics in Research (CEP) on a national
p.(None): basis, thus requiring complementary regulation on Resolution (NHC) CNS N° 196/96 (Guidelines and Regulating
p.(None): Rules for Research Involving Human Beings) attribution of the National Commission for Ethics on Research (CONEP),
p.(None): in accordance with item VIII.4 of such Resolution;
p.(None): Considering the subsides received from the CEPs-CONEP system and the cumulated experience on research project
p.(None): analysis on this area up to the present moment; and
p.(None): Considering the need to observe the potential risks for health and the protection of human rights, fundamental
p.(None): freedom and the respect for human dignity upon collection, processing, usage and storage of data and human
p.(None): genetic materials,
p.(None): D E C I D E S:
p.(None): To approve the following Guidelines for the Ethical Analysis and the Evaluation of the Research Project on Human
p.(None): Genetic Special Thematic Area:
p.(None): I – Preamble
p.(None): The present Resolution incorporates all clauses stated in Resolution CNS N°196/96 of the National Health Council,
p.(None): concerning Directives and Adjustment Rules on Research Involving Human Beings, of which it is a complementary
p.(None): part of the specific thematic area, and includes also, whichever applies, if necessary, the dispositions of
p.(None): Resolutions CNS N° 251/97, 292/99, 303/2000 e 304/2000.
p.(None): II - Terms and Definitions
p.(None): II.1 – The human genetic research involves the production of genetic or proteomic data of human beings and may consist
p.(None): of different types:
p.(None): a) research on basic genetic mechanisms: studies on localization, structure, function and expression of human genes and
p.(None): chromosome organization;
p.(None): b) research on clinical genetics: research that consists of the descriptive study on subjects individually and/or on
p.(None): their families, aiming at elucidating conditions of probable genetic etiology which may involve clinical
p.(None): information analysis and genetic material tests;
p.(None): c) research on populational genetics: studies on normal or pathological genetic variability on groups of individuals,
p.(None): and the relationship among these groups and a particular condition;
p.(None): d) human molecular researches: researches that involve molecular assays whether or not associated to diseases; genetic
p.(None): or epigenetic studies on nucleic acids (DNA and RNA) or proteins aiming for novel treatments or the prevention
...
p.(None): somatic cells in vivo (gene therapy in vivo) or human somatic cells in vitro
p.(None):
p.(None): and transferring of these cells to an organism (gene therapy ex vivo) and researches with human stem cells with genetic
p.(None): modifications; e
p.(None): f) research on behavioral genetics: study aiming at establishing possible relationships between genetic
p.(None): characteristics and human behavior.
p.(None): II.2 – All procedures related to human genetics that have not been fully accepted in the scientific literature will
p.(None): be considered as research and, therefore, must comply with the guidelines set forth in this Resolution. It
p.(None): includes genetic procedures on assisted reproduction not yet regulated by the Federal Medicine Council.
p.(None): III – Ethical Aspects
p.(None): The main purpose of researches on genetics shall be related to scientific knowledge accumulation that
p.(None): promotes suffering relief and improves the health of individuals and humanity.
p.(None): III.1 – The genetic research produces a special data category by containing medical, scientific and
p.(None): personal information and thus, the knowledge impact shall be evaluated on the individual, family and the
p.(None): group to which he belongs.
p.(None): III.2 – Data protection means shall be anticipated in order to avoid the stigmatization and discrimination of
p.(None): individuals, families or groups’.
p.(None): III.3 – Researches involving predictive tests must be preceded by clarification, before material collecting,
p.(None): with respect to the meaning and possible usage of expected results.
p.(None): III.4 – It shall be offered to research subjects the option to choose whether or not they want to be informed of the
p.(None): results of their medical exams.
p.(None): III.5 – Research projects must contain a proposal for genetic advice, whenever the case.
p.(None): III.6 – It is the research subjects’ liability to authorize or not data storage and collection of materials within the
p.(None): scope of the research, after being informed about the procedures defined in the Resolution concerning storage of
p.(None): biological materials.
p.(None): III.7 – Every individual has access to his/her genetic data, as well as the right to retrieve them from banks where
p.(None): they are stored.
p.(None): III.8 – In order to have individual genetic data irreversibly dissociated from any identifiable individual,
p.(None): justification must be provided for such procedure so as to be evaluated by CEP and CONEP.
p.(None): III.9 - In the event of genetic data dissociation approval by CEP and CONEP, the research subject must be informed of
p.(None): advantages and disadvantages of such dissociation and a specific Term of Consent for this finality signed.
p.(None): III.10 –The item V.7 of Resolution CNS N°196/96 must be observed including a possible patent registration.
p.(None): III.11 – The resulting genetic data of a research associated to an identifiable individual shall not be divulged nor
p.(None): become accessible to a third party, particularly to employers, insurance companies and educational institutions. In
p.(None): addition to that, such resulting data shall not be provided for crossing with other stored data for
...
Health / Health
Searching for indicator health:
(return to top)
p.(None):
p.(None): NATIONAL HEALTH COUNCIL
p.(None):
p.(None): RESOLUTION Nº 340, 8TH JULY 2004
p.(None): The National Health Council Plenary Assembly, in its 144th Ordinary Meeting, held from the 7th to the 8th July 2004, in
p.(None): the use of its regimental competencies and granted attributions by the Law nº 8.080 of 19th September 1990 and by the
p.(None): Law nº 8.142, of 28th December 1990, and
p.(None): Considering the recent technical-scientific advance and its applications on human genetic research, requiring
p.(None): positioning of institutions, researchers and the Committees for Ethics in Research (CEP) on a national
p.(None): basis, thus requiring complementary regulation on Resolution (NHC) CNS N° 196/96 (Guidelines and Regulating
p.(None): Rules for Research Involving Human Beings) attribution of the National Commission for Ethics on Research (CONEP),
p.(None): in accordance with item VIII.4 of such Resolution;
p.(None): Considering the subsides received from the CEPs-CONEP system and the cumulated experience on research project
p.(None): analysis on this area up to the present moment; and
p.(None): Considering the need to observe the potential risks for health and the protection of human rights, fundamental
p.(None): freedom and the respect for human dignity upon collection, processing, usage and storage of data and human
p.(None): genetic materials,
p.(None): D E C I D E S:
p.(None): To approve the following Guidelines for the Ethical Analysis and the Evaluation of the Research Project on Human
p.(None): Genetic Special Thematic Area:
p.(None): I – Preamble
p.(None): The present Resolution incorporates all clauses stated in Resolution CNS N°196/96 of the National Health Council,
p.(None): concerning Directives and Adjustment Rules on Research Involving Human Beings, of which it is a complementary
p.(None): part of the specific thematic area, and includes also, whichever applies, if necessary, the dispositions of
p.(None): Resolutions CNS N° 251/97, 292/99, 303/2000 e 304/2000.
p.(None): II - Terms and Definitions
p.(None): II.1 – The human genetic research involves the production of genetic or proteomic data of human beings and may consist
p.(None): of different types:
p.(None): a) research on basic genetic mechanisms: studies on localization, structure, function and expression of human genes and
p.(None): chromosome organization;
p.(None): b) research on clinical genetics: research that consists of the descriptive study on subjects individually and/or on
p.(None): their families, aiming at elucidating conditions of probable genetic etiology which may involve clinical
p.(None): information analysis and genetic material tests;
p.(None): c) research on populational genetics: studies on normal or pathological genetic variability on groups of individuals,
p.(None): and the relationship among these groups and a particular condition;
p.(None): d) human molecular researches: researches that involve molecular assays whether or not associated to diseases; genetic
p.(None): or epigenetic studies on nucleic acids (DNA and RNA) or proteins aiming for novel treatments or the prevention
p.(None): of genetic disorders other pathologies or the identification of molecular variability;
p.(None): e) researches on gene and cellular therapy: introduction of recombinant DNA or RNA molecules in human
p.(None): somatic cells in vivo (gene therapy in vivo) or human somatic cells in vitro
p.(None):
p.(None): and transferring of these cells to an organism (gene therapy ex vivo) and researches with human stem cells with genetic
p.(None): modifications; e
p.(None): f) research on behavioral genetics: study aiming at establishing possible relationships between genetic
p.(None): characteristics and human behavior.
p.(None): II.2 – All procedures related to human genetics that have not been fully accepted in the scientific literature will
p.(None): be considered as research and, therefore, must comply with the guidelines set forth in this Resolution. It
p.(None): includes genetic procedures on assisted reproduction not yet regulated by the Federal Medicine Council.
p.(None): III – Ethical Aspects
p.(None): The main purpose of researches on genetics shall be related to scientific knowledge accumulation that
p.(None): promotes suffering relief and improves the health of individuals and humanity.
p.(None): III.1 – The genetic research produces a special data category by containing medical, scientific and
p.(None): personal information and thus, the knowledge impact shall be evaluated on the individual, family and the
p.(None): group to which he belongs.
p.(None): III.2 – Data protection means shall be anticipated in order to avoid the stigmatization and discrimination of
p.(None): individuals, families or groups’.
p.(None): III.3 – Researches involving predictive tests must be preceded by clarification, before material collecting,
p.(None): with respect to the meaning and possible usage of expected results.
p.(None): III.4 – It shall be offered to research subjects the option to choose whether or not they want to be informed of the
p.(None): results of their medical exams.
p.(None): III.5 – Research projects must contain a proposal for genetic advice, whenever the case.
p.(None): III.6 – It is the research subjects’ liability to authorize or not data storage and collection of materials within the
p.(None): scope of the research, after being informed about the procedures defined in the Resolution concerning storage of
p.(None): biological materials.
p.(None): III.7 – Every individual has access to his/her genetic data, as well as the right to retrieve them from banks where
p.(None): they are stored.
p.(None): III.8 – In order to have individual genetic data irreversibly dissociated from any identifiable individual,
p.(None): justification must be provided for such procedure so as to be evaluated by CEP and CONEP.
...
p.(None): information (chapter VI – Resolution CNS Nº 196/96, as well as chapters III and IV of the present Resolution).
p.(None): VI.3. It is CONEP’s duty the final approval on human genetic researches that include:
p.(None): a) the dispatch abroad of genetic material or any human biological material aiming at obtaining genetic
p.(None): material;
p.(None): b) the storage of biological material or human genetic data, abroad or in this country, when in
p.(None): partnership with foreign or commercial institutions;
p.(None): c) alterations of the genetic structure of human cells for in vivo utilization;
p.(None):
p.(None): d) researches on the area of human-reproduction genetics (repro-genetics);
p.(None): e) researches on behavioral genetics; and
p.(None): f) researches that anticipate irreversible dissociation of research subject and data.
p.(None): VI.4 – In the cases mentioned in VI.3 above, CEP must examine protocol, elaborate the fundamented report and send
p.(None): both to CONEP with the complete documentation according to Resolution CNS N° 196/96, items VII.13.a and
p.(None): b and VIII.4.c.1. The researcher shall be informed that he must await the report issued by CONEP so as to start
p.(None): up the project execution.
p.(None): VI.5 – It is delegated to CEP the final approval of human genetic projects that are not included in item VI.3
p.(None): above. In this case, CEP must send to CONEP the front page and the fundamented report, whether it has been
p.(None): approved or not.
p.(None): VI.6 – Dispatch of material abroad must obey the normative and legal rules of the country.
p.(None):
p.(None):
p.(None): HUMBERTO COSTA
p.(None): President of the National Health Council
p.(None):
p.(None):
p.(None): I ratify the Resolution CNS nº 340, of 8th July 2004, in the terms of the Competency Delegation Decree of 12th November
p.(None): 1991.
p.(None):
p.(None): HUMBERTO COSTA
...
Health / Motherhood/Family
Searching for indicator family:
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p.(None): and the relationship among these groups and a particular condition;
p.(None): d) human molecular researches: researches that involve molecular assays whether or not associated to diseases; genetic
p.(None): or epigenetic studies on nucleic acids (DNA and RNA) or proteins aiming for novel treatments or the prevention
p.(None): of genetic disorders other pathologies or the identification of molecular variability;
p.(None): e) researches on gene and cellular therapy: introduction of recombinant DNA or RNA molecules in human
p.(None): somatic cells in vivo (gene therapy in vivo) or human somatic cells in vitro
p.(None):
p.(None): and transferring of these cells to an organism (gene therapy ex vivo) and researches with human stem cells with genetic
p.(None): modifications; e
p.(None): f) research on behavioral genetics: study aiming at establishing possible relationships between genetic
p.(None): characteristics and human behavior.
p.(None): II.2 – All procedures related to human genetics that have not been fully accepted in the scientific literature will
p.(None): be considered as research and, therefore, must comply with the guidelines set forth in this Resolution. It
p.(None): includes genetic procedures on assisted reproduction not yet regulated by the Federal Medicine Council.
p.(None): III – Ethical Aspects
p.(None): The main purpose of researches on genetics shall be related to scientific knowledge accumulation that
p.(None): promotes suffering relief and improves the health of individuals and humanity.
p.(None): III.1 – The genetic research produces a special data category by containing medical, scientific and
p.(None): personal information and thus, the knowledge impact shall be evaluated on the individual, family and the
p.(None): group to which he belongs.
p.(None): III.2 – Data protection means shall be anticipated in order to avoid the stigmatization and discrimination of
p.(None): individuals, families or groups’.
p.(None): III.3 – Researches involving predictive tests must be preceded by clarification, before material collecting,
p.(None): with respect to the meaning and possible usage of expected results.
p.(None): III.4 – It shall be offered to research subjects the option to choose whether or not they want to be informed of the
p.(None): results of their medical exams.
p.(None): III.5 – Research projects must contain a proposal for genetic advice, whenever the case.
p.(None): III.6 – It is the research subjects’ liability to authorize or not data storage and collection of materials within the
p.(None): scope of the research, after being informed about the procedures defined in the Resolution concerning storage of
p.(None): biological materials.
p.(None): III.7 – Every individual has access to his/her genetic data, as well as the right to retrieve them from banks where
p.(None): they are stored.
p.(None): III.8 – In order to have individual genetic data irreversibly dissociated from any identifiable individual,
p.(None): justification must be provided for such procedure so as to be evaluated by CEP and CONEP.
p.(None): III.9 - In the event of genetic data dissociation approval by CEP and CONEP, the research subject must be informed of
p.(None): advantages and disadvantages of such dissociation and a specific Term of Consent for this finality signed.
p.(None): III.10 –The item V.7 of Resolution CNS N°196/96 must be observed including a possible patent registration.
...
p.(None): populational genetic studies, shall be shared among the involved communities, on an international or national basis.
p.(None): III.16 – Researches for genome modification shall only be carried out with somatic cells. IV- Research Protocol:
p.(None): IV.1 – Researches on the area of human genetics shall be submitted to CEP evaluation as complete protocols and, if
p.(None): necessary, submitted also to CONEP, in accordance with chapter VI of Resolution CNS No 196/96, not being
p.(None): accepted as amendments, addends or sub-study of another area’s protocol. It shall also include:
p.(None): a) research justification;
p.(None): b) how genes, DNA and RNA segments or gene products in study are correlated with a possible condition of the research
p.(None): subject;
p.(None): c) clear explanation of exams and tests that will be carried out and the indication of genes, DNA and
p.(None): RNA segments or gene products that will be studied;
p.(None): d) justification for choice and size of the sample, particularly when it regards a vulnerable population
p.(None): or group and distinct cultures (for example, indigenous group);
p.(None): e) recruitment means of both the research subjects and controls, when necessary;
p.(None): f) careful analysis of potential and current risks and benefits for the individual, the group and future
p.(None): generations, when necessary;
p.(None): g) information regarding the use, storage or other destinations of biological material;
p.(None): h) measures and cares for assuring the privacy and avoiding stigmatization and discrimination of
p.(None): the research subject, the family and the group in any way;
p.(None): i) explanation of preexistent agreement related to the property of generated information as well as the industrial
p.(None): property, when necessary;
p.(None): j) description of the genetic advice planning and clinical surveillance, when indicated, including the names and
p.(None): contacts of the responsible professionals, approach type according to expected situations, consequences to
p.(None): subjects and foreseen conducts. The responsible professionals for the genetic advices and clinical surveillance
p.(None): must comply with the professional formation and certificates required by the professional councils and specialty
p.(None): societies;
p.(None):
p.(None): l) a justification for the transport of biological material and/or data to other institutions, national or foreign,
p.(None): with clear indication of material and/or data types as well as the
p.(None):
p.(None): listing of exams and tests to be carried out. It is also required to clarify the reasons why the exams or tests can not
p.(None): be performed in Brazil, if this is the case; and
p.(None): m) in international cooperation projects the opportunities for technology transfer should be described.
p.(None):
p.(None): V - Freely Given and Informed Consent Term – TCLE
p.(None): V.1 – The TCLE must be elaborated according to the rule in chapter IV of Resolution CNS N° 196/96, with special
p.(None): emphasis on the following items:
p.(None): a) clear explanation of exams and tests that will be performed, the indication of genes, DNA and RNA segments or gene
p.(None): product that will be studied and their correlation with a possible condition of the research subject;
...
Social / Access to Social Goods
Searching for indicator access:
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p.(None): includes genetic procedures on assisted reproduction not yet regulated by the Federal Medicine Council.
p.(None): III – Ethical Aspects
p.(None): The main purpose of researches on genetics shall be related to scientific knowledge accumulation that
p.(None): promotes suffering relief and improves the health of individuals and humanity.
p.(None): III.1 – The genetic research produces a special data category by containing medical, scientific and
p.(None): personal information and thus, the knowledge impact shall be evaluated on the individual, family and the
p.(None): group to which he belongs.
p.(None): III.2 – Data protection means shall be anticipated in order to avoid the stigmatization and discrimination of
p.(None): individuals, families or groups’.
p.(None): III.3 – Researches involving predictive tests must be preceded by clarification, before material collecting,
p.(None): with respect to the meaning and possible usage of expected results.
p.(None): III.4 – It shall be offered to research subjects the option to choose whether or not they want to be informed of the
p.(None): results of their medical exams.
p.(None): III.5 – Research projects must contain a proposal for genetic advice, whenever the case.
p.(None): III.6 – It is the research subjects’ liability to authorize or not data storage and collection of materials within the
p.(None): scope of the research, after being informed about the procedures defined in the Resolution concerning storage of
p.(None): biological materials.
p.(None): III.7 – Every individual has access to his/her genetic data, as well as the right to retrieve them from banks where
p.(None): they are stored.
p.(None): III.8 – In order to have individual genetic data irreversibly dissociated from any identifiable individual,
p.(None): justification must be provided for such procedure so as to be evaluated by CEP and CONEP.
p.(None): III.9 - In the event of genetic data dissociation approval by CEP and CONEP, the research subject must be informed of
p.(None): advantages and disadvantages of such dissociation and a specific Term of Consent for this finality signed.
p.(None): III.10 –The item V.7 of Resolution CNS N°196/96 must be observed including a possible patent registration.
p.(None): III.11 – The resulting genetic data of a research associated to an identifiable individual shall not be divulged nor
p.(None): become accessible to a third party, particularly to employers, insurance companies and educational institutions. In
p.(None): addition to that, such resulting data shall not be provided for crossing with other stored data for
p.(None): judicial purposes or other finality, unless otherwise duly authorized by the research subject.
p.(None):
p.(None):
p.(None): III.12 – Human genetic data collected on researches with a predefined purpose shall only be used for a different
p.(None): purpose if duly authorized by the donor or his/her legal representative. It is also required a new research protocol
p.(None): duly approved by the Committee for Ethics in Research and, if necessary, by CONEP. In the event of not obtaining the
p.(None): TCLE, a formal justification shall be presented to CEP evaluation.
p.(None): III.13 – In the case of human genetic data exchange among institutions, there shall be an agreement among themselves
p.(None): towards mutual cooperation and equal data access.
p.(None): III.14 – Human genetic data shall not be stored by individuals, requiring the participation of a responsible
p.(None): institution that ensures adequate protection.
p.(None): III.15 – The benefits of human genetic data utilization collected within the research scope, including
p.(None): populational genetic studies, shall be shared among the involved communities, on an international or national basis.
p.(None): III.16 – Researches for genome modification shall only be carried out with somatic cells. IV- Research Protocol:
p.(None): IV.1 – Researches on the area of human genetics shall be submitted to CEP evaluation as complete protocols and, if
p.(None): necessary, submitted also to CONEP, in accordance with chapter VI of Resolution CNS No 196/96, not being
p.(None): accepted as amendments, addends or sub-study of another area’s protocol. It shall also include:
p.(None): a) research justification;
p.(None): b) how genes, DNA and RNA segments or gene products in study are correlated with a possible condition of the research
p.(None): subject;
p.(None): c) clear explanation of exams and tests that will be carried out and the indication of genes, DNA and
p.(None): RNA segments or gene products that will be studied;
p.(None): d) justification for choice and size of the sample, particularly when it regards a vulnerable population
p.(None): or group and distinct cultures (for example, indigenous group);
p.(None): e) recruitment means of both the research subjects and controls, when necessary;
p.(None): f) careful analysis of potential and current risks and benefits for the individual, the group and future
p.(None): generations, when necessary;
...
p.(None): j) description of the genetic advice planning and clinical surveillance, when indicated, including the names and
p.(None): contacts of the responsible professionals, approach type according to expected situations, consequences to
p.(None): subjects and foreseen conducts. The responsible professionals for the genetic advices and clinical surveillance
p.(None): must comply with the professional formation and certificates required by the professional councils and specialty
p.(None): societies;
p.(None):
p.(None): l) a justification for the transport of biological material and/or data to other institutions, national or foreign,
p.(None): with clear indication of material and/or data types as well as the
p.(None):
p.(None): listing of exams and tests to be carried out. It is also required to clarify the reasons why the exams or tests can not
p.(None): be performed in Brazil, if this is the case; and
p.(None): m) in international cooperation projects the opportunities for technology transfer should be described.
p.(None):
p.(None): V - Freely Given and Informed Consent Term – TCLE
p.(None): V.1 – The TCLE must be elaborated according to the rule in chapter IV of Resolution CNS N° 196/96, with special
p.(None): emphasis on the following items:
p.(None): a) clear explanation of exams and tests that will be performed, the indication of genes, DNA and RNA segments or gene
p.(None): product that will be studied and their correlation with a possible condition of the research subject;
p.(None): b) guarantee of secrecy, privacy and, when necessary, anonymity;
p.(None): c) the genetic advice planning and clinical surveillance, with the indication of the responsible people, without cost
p.(None): to the research subjects;
p.(None): d) kind and degree of access to results by the subject, with the option to acknowledge or not this
p.(None): information;
p.(None): e) in the case of material storage, the information should be included in the TCLE, explaining the possibility of
p.(None): utilization in a new research project. It must state that the subject will be contacted for further
p.(None): authorization for the use of the material in future projects and, when impossible to do so, the fact shall be
p.(None): justified to the CEP. In addition to that, it is also required to explain that the material will only be used upon
p.(None): approval of a new project by CEP and CONEP (when necessary);
p.(None): f) information on protection measures of individual data, exam and test results as well as the clinical report will
p.(None): only be accessed by the involved researchers and not by third parties (insurance companies, employers, hierarchical
p.(None): supervisors, etc);
p.(None): g) information on protection measures against any kind of individual or collective discrimination and/or
p.(None): stigmatization; and
p.(None): h) in investigations of families, it is required to obtain the Freely Given and Informed Consent Term of
p.(None): each individual of the study.
p.(None):
p.(None): VI – Operational:
p.(None): VI.1. It is CEP’s duty, based on chapter VII of the resolution CNS N° 196/96, to analyze research projects, assuming
p.(None): co-responsibility as far as ethical aspects are concerned.
p.(None): VI.2. It is CEP’s duty to promptly return to the researcher a protocol that does not contain all the relevant
p.(None): information (chapter VI – Resolution CNS Nº 196/96, as well as chapters III and IV of the present Resolution).
...
Social / Educational
Searching for indicator educational:
(return to top)
p.(None): with respect to the meaning and possible usage of expected results.
p.(None): III.4 – It shall be offered to research subjects the option to choose whether or not they want to be informed of the
p.(None): results of their medical exams.
p.(None): III.5 – Research projects must contain a proposal for genetic advice, whenever the case.
p.(None): III.6 – It is the research subjects’ liability to authorize or not data storage and collection of materials within the
p.(None): scope of the research, after being informed about the procedures defined in the Resolution concerning storage of
p.(None): biological materials.
p.(None): III.7 – Every individual has access to his/her genetic data, as well as the right to retrieve them from banks where
p.(None): they are stored.
p.(None): III.8 – In order to have individual genetic data irreversibly dissociated from any identifiable individual,
p.(None): justification must be provided for such procedure so as to be evaluated by CEP and CONEP.
p.(None): III.9 - In the event of genetic data dissociation approval by CEP and CONEP, the research subject must be informed of
p.(None): advantages and disadvantages of such dissociation and a specific Term of Consent for this finality signed.
p.(None): III.10 –The item V.7 of Resolution CNS N°196/96 must be observed including a possible patent registration.
p.(None): III.11 – The resulting genetic data of a research associated to an identifiable individual shall not be divulged nor
p.(None): become accessible to a third party, particularly to employers, insurance companies and educational institutions. In
p.(None): addition to that, such resulting data shall not be provided for crossing with other stored data for
p.(None): judicial purposes or other finality, unless otherwise duly authorized by the research subject.
p.(None):
p.(None):
p.(None): III.12 – Human genetic data collected on researches with a predefined purpose shall only be used for a different
p.(None): purpose if duly authorized by the donor or his/her legal representative. It is also required a new research protocol
p.(None): duly approved by the Committee for Ethics in Research and, if necessary, by CONEP. In the event of not obtaining the
p.(None): TCLE, a formal justification shall be presented to CEP evaluation.
p.(None): III.13 – In the case of human genetic data exchange among institutions, there shall be an agreement among themselves
p.(None): towards mutual cooperation and equal data access.
p.(None): III.14 – Human genetic data shall not be stored by individuals, requiring the participation of a responsible
p.(None): institution that ensures adequate protection.
p.(None): III.15 – The benefits of human genetic data utilization collected within the research scope, including
p.(None): populational genetic studies, shall be shared among the involved communities, on an international or national basis.
p.(None): III.16 – Researches for genome modification shall only be carried out with somatic cells. IV- Research Protocol:
p.(None): IV.1 – Researches on the area of human genetics shall be submitted to CEP evaluation as complete protocols and, if
p.(None): necessary, submitted also to CONEP, in accordance with chapter VI of Resolution CNS No 196/96, not being
...
Social / property
Searching for indicator property:
(return to top)
p.(None): III.16 – Researches for genome modification shall only be carried out with somatic cells. IV- Research Protocol:
p.(None): IV.1 – Researches on the area of human genetics shall be submitted to CEP evaluation as complete protocols and, if
p.(None): necessary, submitted also to CONEP, in accordance with chapter VI of Resolution CNS No 196/96, not being
p.(None): accepted as amendments, addends or sub-study of another area’s protocol. It shall also include:
p.(None): a) research justification;
p.(None): b) how genes, DNA and RNA segments or gene products in study are correlated with a possible condition of the research
p.(None): subject;
p.(None): c) clear explanation of exams and tests that will be carried out and the indication of genes, DNA and
p.(None): RNA segments or gene products that will be studied;
p.(None): d) justification for choice and size of the sample, particularly when it regards a vulnerable population
p.(None): or group and distinct cultures (for example, indigenous group);
p.(None): e) recruitment means of both the research subjects and controls, when necessary;
p.(None): f) careful analysis of potential and current risks and benefits for the individual, the group and future
p.(None): generations, when necessary;
p.(None): g) information regarding the use, storage or other destinations of biological material;
p.(None): h) measures and cares for assuring the privacy and avoiding stigmatization and discrimination of
p.(None): the research subject, the family and the group in any way;
p.(None): i) explanation of preexistent agreement related to the property of generated information as well as the industrial
p.(None): property, when necessary;
p.(None): j) description of the genetic advice planning and clinical surveillance, when indicated, including the names and
p.(None): contacts of the responsible professionals, approach type according to expected situations, consequences to
p.(None): subjects and foreseen conducts. The responsible professionals for the genetic advices and clinical surveillance
p.(None): must comply with the professional formation and certificates required by the professional councils and specialty
p.(None): societies;
p.(None):
p.(None): l) a justification for the transport of biological material and/or data to other institutions, national or foreign,
p.(None): with clear indication of material and/or data types as well as the
p.(None):
p.(None): listing of exams and tests to be carried out. It is also required to clarify the reasons why the exams or tests can not
p.(None): be performed in Brazil, if this is the case; and
p.(None): m) in international cooperation projects the opportunities for technology transfer should be described.
p.(None):
p.(None): V - Freely Given and Informed Consent Term – TCLE
p.(None): V.1 – The TCLE must be elaborated according to the rule in chapter IV of Resolution CNS N° 196/96, with special
p.(None): emphasis on the following items:
p.(None): a) clear explanation of exams and tests that will be performed, the indication of genes, DNA and RNA segments or gene
p.(None): product that will be studied and their correlation with a possible condition of the research subject;
p.(None): b) guarantee of secrecy, privacy and, when necessary, anonymity;
p.(None): c) the genetic advice planning and clinical surveillance, with the indication of the responsible people, without cost
p.(None): to the research subjects;
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| educational | Educational |
| family | Motherhood/Family |
| health | Health |
| indigenous | Indigenous |
| party | Political |
| property | property |
| usage | Drug Usage |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
consent
ethics
protection
vulnerable
Applicable Type / Vulnerability / Indicator Overlay for this Input