79C3C34C52B45572883A05D425EB0F82
Resolution N#304
https://conselho.saude.gov.br/resolucoes/2000/Res304_en.pdf
http://leaux.net/URLS/ConvertAPI Text Files/215B23AE35E35C47D59A71333ADBEA39.en.txt
Examining the file media/Synopses/215B23AE35E35C47D59A71333ADBEA39.html:
This file was generated: 2020-12-01 09:01:31
| 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): NATIONAL HEALTH COUNCIL RESOLUTION N#304, 9TH AUGUST 2000
p.(None):
p.(None):
p.(None): The Plenary Assembly of the National Health Council , in its 100th Ordinary Meeting, ocurred on 9-10 August 2002,
p.(None): in the use of its regimental competencies and granted attributions by the Law n# 8.080, of 19 November 1990 and
p.(None): by the Law n# 8.142, of 28 December 1990, considering:
p.(None): - The need of a complementar regulation of Resolution CNS n# 196/96 (Guidelines and Regulating Norms of Research
p.(None): Involving Human Beings), attributions of the CONEP accordingly to item VIII.4.d of the same Resolution,
p.(None): regarding the special thematic area “indigenous populations” (item VIII.4.c.6).
p.(None): Decides:
p.(None): - To approve the following Rules to Researches Involving Human Beings – Area of Indigenous Peoples.
p.(None): I – Introduction
p.(None): This resolution attempts to assert the just respect rights of the indigenous peoples, concerning the practical and
p.(None): theoretical development of research in human beings that involves life, territory, culture and natural resources
p.(None): of the indigenous peoples from Brazil. It also recognizes the rights of the indigenous to participate in the
p.(None): decisions that affect them.
p.(None): These rules incorporate the guidelines foreseen in Resolution 196/96 of the National Health Council , and based
p.(None): on the principal internacional documents on UN’s human rights, particularly the Convention 169 on Indigenous and
p.(None): Tribal Peoples in Independent Countries and Resolution on Action of ILO – International Labour Organization, concerning
p.(None): the Indigenous and Tribal Peoples, of 1989, of the Constitution of the Federal Republic of Brazil ( Title VIII, Article
p.(None): VIII of Indigenous peoples) and of all national legislation of support and respect to the rights of Indigenous Peoples
p.(None): while individual and collective subjects of research.
p.(None): Researches involving indigenous communities or individuals correspond to and consider the ethical and
p.(None): cientific requirements indicated in Resolution CNS 196/96 that contains the guidelines and regulating Norms of
p.(None): research involving human beings and its complementary rules. Particular attention should be also given to Resolution
p.(None): CNS 292/99 on research with foreign cooperation, besides other CNS resolutions on ethics in research, Decrees 86715
p.(None): of 10/12/81 and 96830, of 15/01/90 that regulate the temporary visa to foreigners.
p.(None): II – Expressions and Definitions
p.(None): This resolution adopts in its scope the following definitions:
p.(None): 1 – Indigenous Peoples – peoples with proper organizations and identities, owing to the awareness of their historic
p.(None): continuity as pre-colombian societies.
p.(None): 2 – Indigenous – one who considers him/herself as part of an indigenous community and is recognized as a
p.(None): member by this community.
p.(None): 3 – Isolated Indigenous – Individuals or groups who avoid or are not in contact with the involving society.
p.(None):
p.(None): III – Ethical aspects of research involving indigenous peoples.
p.(None): Researches involving indigenous peoples should also obey the bioethics referencial, considering the peculiarities of
p.(None): each people and/or community.
p.(None): 1 – The benefits and advantages resulting from the development of research should consider the need of targeted
p.(None): individuals and groups of the study, or similar societies and/or national societies, taking into account the
p.(None): promotion and maintanance of welfare, preservation and protection of biological and cultural diversity,
p.(None): collective and invividual health and the contribuition to the development of knownledge and own technology.
p.(None): 2 – Any research involving the indigenous or his/her community should:
p.(None): 2.1 – Respect view of the world, the costumes, estheticts attitudes, religious beliefs, social organization, peculiar
p.(None): philosophies, linguistics differences and political structure;
p.(None): 2.2 – Not allow physical, mental, pshycological or intellectual and social exploration of the indigenous;
p.(None): 2.3 – Not allow situations that can put at risk the integrity and the physical, mental and social welfare of the
p.(None): indigenous;
p.(None): 2.4 – Have the agreement of the targeted community which can be obtained through the respective indigenous
p.(None): organizations or local councils, respecting the individual consent, which in common agreement with the
p.(None): referred communities will designate the mediator to the contact between the researcher and the community.
p.(None): 2.5 – Guarantee equality of consideration of the involved interests, taking into account the vunerability of
p.(None): the group in question.
p.(None): 3 – It is recommended, preferencially, not to do researches in isolated indegenous communities. In special cases, there
p.(None): should be presented detailed justification.
p.(None): 4 – It will be considered ethically unacceptable to patent , by somebody else, chemical products and
p.(None): biological material of any kind, obtained from researches with indigenous peoples.
p.(None): 5 – The formation of DNA banks, of cell lineage or any other biological material related to indegenous
p.(None): peoples, is not admited without the explicit agreement of the involved community, without the presentation
p.(None): of a detailed proposal in the research protocol to be submited to the Committee for Ethics in Research – CEP
p.(None): (in Portuguese) and to the National Committee for Ethics in Research – CONEP (in Portuguese), and the formal approval
p.(None): of these Committees.
p.(None): 6 – The non-observance of any of those itens above should be communicated to the institucional CEP and to the CONEP of
p.(None): the National Health Council, to take appropriated steps.
p.(None): IV – The Research Protocol
p.(None): The protocol to be submited to ethical evaluation should consider item VI of Resolution 196/96, adding:
p.(None): 1 - The commitment of obtaining the approvement of the involved communities as foreseen in item III Article 2 of
p.(None): this rule, describing the procedures to obtain the approvement.
p.(None): 2 – Description of the process to obtain and register the Freely given and Informed Consent Term – TCLE (in
p.(None): Portuguese), assuring the adjustment to cultural and linguistic peculiarities of the involved ones.
p.(None): V – Protection
p.(None): 1 – The research can be interrupted at any time, obeying the rule in item III.3.z of Resolution 196/96, since:
p.(None): 1.1 – The indegenous community that is being studied asks for it;
p.(None):
p.(None): 1.2 – the research that is being developted generates conflicts and/or any kind of uneasiness inside the community;
p.(None): 1.3 - there is violation of the organization and survival form of the indigenous community, especially the one related
p.(None): to subects’ lives, to human resources, phytogenetics resources, to knowledge of properties of the soil, subsoil, fauna
p.(None): and flora, to oral traditions and all artistic expressions of that community.
p.(None): VI – Attributtions of CONEP
p.(None): 1 – Within the foreseen attibuitions in item VIII.4.c.6 of Resolution CNS 196/96, CONEP is in the charge of, after the
p.(None): institutional approval of CEP, evaluating the researches fitted in this thematic area, even when they are fitted in
p.(None): another one.
p.(None): 2 – A report of the Intersectorial Committee for Indegenous Health (CISI), (in Portuguese), when consultancy is needed,
p.(None): can be requested by CONEP. – National Comission for Ethics in Research.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): JOSÉ SERRA
p.(None): President of the Nacional Health Council
p.(None):
p.(None):
p.(None): I ratify the Resolution CNS n# 304, of 10 August 2000, in the terms of the Competency Delegation Decree of
p.(None): 12 November 1991
p.(None):
p.(None):
p.(None): JOSÉ SERRA
...
Political / political affiliation
Searching for indicator political:
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p.(None): 2 – Indigenous – one who considers him/herself as part of an indigenous community and is recognized as a
p.(None): member by this community.
p.(None): 3 – Isolated Indigenous – Individuals or groups who avoid or are not in contact with the involving society.
p.(None):
p.(None): III – Ethical aspects of research involving indigenous peoples.
p.(None): Researches involving indigenous peoples should also obey the bioethics referencial, considering the peculiarities of
p.(None): each people and/or community.
p.(None): 1 – The benefits and advantages resulting from the development of research should consider the need of targeted
p.(None): individuals and groups of the study, or similar societies and/or national societies, taking into account the
p.(None): promotion and maintanance of welfare, preservation and protection of biological and cultural diversity,
p.(None): collective and invividual health and the contribuition to the development of knownledge and own technology.
p.(None): 2 – Any research involving the indigenous or his/her community should:
p.(None): 2.1 – Respect view of the world, the costumes, estheticts attitudes, religious beliefs, social organization, peculiar
p.(None): philosophies, linguistics differences and political structure;
p.(None): 2.2 – Not allow physical, mental, pshycological or intellectual and social exploration of the indigenous;
p.(None): 2.3 – Not allow situations that can put at risk the integrity and the physical, mental and social welfare of the
p.(None): indigenous;
p.(None): 2.4 – Have the agreement of the targeted community which can be obtained through the respective indigenous
p.(None): organizations or local councils, respecting the individual consent, which in common agreement with the
p.(None): referred communities will designate the mediator to the contact between the researcher and the community.
p.(None): 2.5 – Guarantee equality of consideration of the involved interests, taking into account the vunerability of
p.(None): the group in question.
p.(None): 3 – It is recommended, preferencially, not to do researches in isolated indegenous communities. In special cases, there
p.(None): should be presented detailed justification.
p.(None): 4 – It will be considered ethically unacceptable to patent , by somebody else, chemical products and
p.(None): biological material of any kind, obtained from researches with indigenous peoples.
p.(None): 5 – The formation of DNA banks, of cell lineage or any other biological material related to indegenous
p.(None): peoples, is not admited without the explicit agreement of the involved community, without the presentation
...
Social / Access to Social Goods
Searching for indicator social welfare:
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p.(None):
p.(None): III – Ethical aspects of research involving indigenous peoples.
p.(None): Researches involving indigenous peoples should also obey the bioethics referencial, considering the peculiarities of
p.(None): each people and/or community.
p.(None): 1 – The benefits and advantages resulting from the development of research should consider the need of targeted
p.(None): individuals and groups of the study, or similar societies and/or national societies, taking into account the
p.(None): promotion and maintanance of welfare, preservation and protection of biological and cultural diversity,
p.(None): collective and invividual health and the contribuition to the development of knownledge and own technology.
p.(None): 2 – Any research involving the indigenous or his/her community should:
p.(None): 2.1 – Respect view of the world, the costumes, estheticts attitudes, religious beliefs, social organization, peculiar
p.(None): philosophies, linguistics differences and political structure;
p.(None): 2.2 – Not allow physical, mental, pshycological or intellectual and social exploration of the indigenous;
p.(None): 2.3 – Not allow situations that can put at risk the integrity and the physical, mental and social welfare of the
p.(None): indigenous;
p.(None): 2.4 – Have the agreement of the targeted community which can be obtained through the respective indigenous
p.(None): organizations or local councils, respecting the individual consent, which in common agreement with the
p.(None): referred communities will designate the mediator to the contact between the researcher and the community.
p.(None): 2.5 – Guarantee equality of consideration of the involved interests, taking into account the vunerability of
p.(None): the group in question.
p.(None): 3 – It is recommended, preferencially, not to do researches in isolated indegenous communities. In special cases, there
p.(None): should be presented detailed justification.
p.(None): 4 – It will be considered ethically unacceptable to patent , by somebody else, chemical products and
p.(None): biological material of any kind, obtained from researches with indigenous peoples.
p.(None): 5 – The formation of DNA banks, of cell lineage or any other biological material related to indegenous
p.(None): peoples, is not admited without the explicit agreement of the involved community, without the presentation
p.(None): of a detailed proposal in the research protocol to be submited to the Committee for Ethics in Research – CEP
p.(None): (in Portuguese) and to the National Committee for Ethics in Research – CONEP (in Portuguese), and the formal approval
p.(None): of these Committees.
...
Social / Linguistic Proficiency
Searching for indicator linguistic:
(return to top)
p.(None): should be presented detailed justification.
p.(None): 4 – It will be considered ethically unacceptable to patent , by somebody else, chemical products and
p.(None): biological material of any kind, obtained from researches with indigenous peoples.
p.(None): 5 – The formation of DNA banks, of cell lineage or any other biological material related to indegenous
p.(None): peoples, is not admited without the explicit agreement of the involved community, without the presentation
p.(None): of a detailed proposal in the research protocol to be submited to the Committee for Ethics in Research – CEP
p.(None): (in Portuguese) and to the National Committee for Ethics in Research – CONEP (in Portuguese), and the formal approval
p.(None): of these Committees.
p.(None): 6 – The non-observance of any of those itens above should be communicated to the institucional CEP and to the CONEP of
p.(None): the National Health Council, to take appropriated steps.
p.(None): IV – The Research Protocol
p.(None): The protocol to be submited to ethical evaluation should consider item VI of Resolution 196/96, adding:
p.(None): 1 - The commitment of obtaining the approvement of the involved communities as foreseen in item III Article 2 of
p.(None): this rule, describing the procedures to obtain the approvement.
p.(None): 2 – Description of the process to obtain and register the Freely given and Informed Consent Term – TCLE (in
p.(None): Portuguese), assuring the adjustment to cultural and linguistic peculiarities of the involved ones.
p.(None): V – Protection
p.(None): 1 – The research can be interrupted at any time, obeying the rule in item III.3.z of Resolution 196/96, since:
p.(None): 1.1 – The indegenous community that is being studied asks for it;
p.(None):
p.(None): 1.2 – the research that is being developted generates conflicts and/or any kind of uneasiness inside the community;
p.(None): 1.3 - there is violation of the organization and survival form of the indigenous community, especially the one related
p.(None): to subects’ lives, to human resources, phytogenetics resources, to knowledge of properties of the soil, subsoil, fauna
p.(None): and flora, to oral traditions and all artistic expressions of that community.
p.(None): VI – Attributtions of CONEP
p.(None): 1 – Within the foreseen attibuitions in item VIII.4.c.6 of Resolution CNS 196/96, CONEP is in the charge of, after the
p.(None): institutional approval of CEP, evaluating the researches fitted in this thematic area, even when they are fitted in
p.(None): another one.
p.(None): 2 – A report of the Intersectorial Committee for Indegenous Health (CISI), (in Portuguese), when consultancy is needed,
p.(None): can be requested by CONEP. – National Comission for Ethics in Research.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): JOSÉ SERRA
p.(None): President of the Nacional Health Council
p.(None):
p.(None):
p.(None): I ratify the Resolution CNS n# 304, of 10 August 2000, in the terms of the Competency Delegation Decree of
p.(None): 12 November 1991
p.(None):
p.(None):
p.(None): JOSÉ SERRA
...
Social / Religion
Searching for indicator religious:
(return to top)
p.(None): continuity as pre-colombian societies.
p.(None): 2 – Indigenous – one who considers him/herself as part of an indigenous community and is recognized as a
p.(None): member by this community.
p.(None): 3 – Isolated Indigenous – Individuals or groups who avoid or are not in contact with the involving society.
p.(None):
p.(None): III – Ethical aspects of research involving indigenous peoples.
p.(None): Researches involving indigenous peoples should also obey the bioethics referencial, considering the peculiarities of
p.(None): each people and/or community.
p.(None): 1 – The benefits and advantages resulting from the development of research should consider the need of targeted
p.(None): individuals and groups of the study, or similar societies and/or national societies, taking into account the
p.(None): promotion and maintanance of welfare, preservation and protection of biological and cultural diversity,
p.(None): collective and invividual health and the contribuition to the development of knownledge and own technology.
p.(None): 2 – Any research involving the indigenous or his/her community should:
p.(None): 2.1 – Respect view of the world, the costumes, estheticts attitudes, religious beliefs, social organization, peculiar
p.(None): philosophies, linguistics differences and political structure;
p.(None): 2.2 – Not allow physical, mental, pshycological or intellectual and social exploration of the indigenous;
p.(None): 2.3 – Not allow situations that can put at risk the integrity and the physical, mental and social welfare of the
p.(None): indigenous;
p.(None): 2.4 – Have the agreement of the targeted community which can be obtained through the respective indigenous
p.(None): organizations or local councils, respecting the individual consent, which in common agreement with the
p.(None): referred communities will designate the mediator to the contact between the researcher and the community.
p.(None): 2.5 – Guarantee equality of consideration of the involved interests, taking into account the vunerability of
p.(None): the group in question.
p.(None): 3 – It is recommended, preferencially, not to do researches in isolated indegenous communities. In special cases, there
p.(None): should be presented detailed justification.
p.(None): 4 – It will be considered ethically unacceptable to patent , by somebody else, chemical products and
p.(None): biological material of any kind, obtained from researches with indigenous peoples.
p.(None): 5 – The formation of DNA banks, of cell lineage or any other biological material related to indegenous
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| indigenous | Indigenous |
| linguistic | Linguistic Proficiency |
| political | political affiliation |
| religious | Religion |
| social welfare | Access to Social Goods |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
consent
cultural
ethics
protection
risk
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input