79C3C34C52B45572883A05D425EB0F82
http://abracro.org.br/images/legislacao/Reso292.pdf
http://abracro.org.br/images/legislacao/Reso292.pdf
http://leaux.net/URLS/ConvertAPI Text Files/F6B8B38A733A0C0163F7999BCE7CAB79.en.txt
Examining the file media/Synopses/F6B8B38A733A0C0163F7999BCE7CAB79.html:
This file was generated: 2021-01-08 22:56:04
| 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
Social / Property Ownership
Searching for indicator property:
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p.(None): a) the collaboration of foreign individuals or legal entities, whether public or private;
p.(None): b) sending and / or receiving biological materials from humans;
p.(None): c) sending and / or receiving data and information collected for aggregation in the results of the
p.(None): search;
p.(None): d) international multicenter studies.
p.(None): I.1 - Respecting the conditions above, the following are not included in this thematic area:
p.(None): a) research entirely carried out in the country by a foreign researcher who belongs to the
p.(None): national entity technician;
p.(None): b) research carried out by a multinational based in the country.
p.(None): II - In all surveys, the following must be done:
p.(None): II.1 - prove the Brazilian participation and identify the researcher and co-national institution
p.(None): responsible;
p.(None): II.2 - explain the responsibilities, rights and obligations, by agreement between the parties
p.(None): involved.
p.(None): III - This Resolution incorporates all the provisions contained in Resolution No. 196/96 of the Council
p.(None): Of Health, on Regulatory Guidelines and Norms for Research Involving Human Beings, of which this is
p.(None): complementary part of the specific thematic area.
p.(None): III.1 - CNS resolutions referring to other thematic areas simultaneously contemplated in the research, must be
p.(None): fulfilled, as appropriate.
p.(None): IV - The costs and benefits arising from the investigation process and the results of the research must be distributed
p.(None): fairly between the parties involved, and should be explained in the protocol.
p.(None): V - The researcher and the national institution must pay attention to the rules and legal provisions on the shipment of
p.(None): material abroad and those that protect industrial property and / or technological transfer (Law nº 9.279 of
p.(None): 05/14/96 that regulates rights and obligations related to industrial property, Decree nº 2.553 / 98 that regulates it
p.(None): and Law 9.610 / 98 on copyright), explaining, when applicable, the agreements established, in addition to the
p.(None): current legal rules on the sending of biological material abroad.
p.(None): VI - During the course of the research, sponsors and researchers must communicate to the Ethics Committees
p.(None): in Research - CEP, relevant information of public interest, regardless of the planned periodic reports.
p.(None): VII - In preparing the protocol, special care must be taken to present the following
p.(None): items:
p.(None): VII.1 - Approval document issued by the Research Ethics Committee or equivalent of
p.(None): institution of the country of origin, which will promote or which will also execute the project.
p.(None): VII.2 - When the development of the project in the country of origin is not foreseen, the justification must be placed
p.(None): in the protocol for appreciation of the CEP of the Brazilian institution.
p.(None): VII.3 - Details of the financial resources involved: sources (if international and foreign and if there are
p.(None): national / institutional counterpart), form and value of the researcher's remuneration and other resources
p.(None): expenses with infrastructure and impact on the routine of the health service of the institution where it will take place. It should be
p.(None): avoid, as far as possible, that the contribution of financial resources creates situations of discrimination between
p.(None): professionals and / or between users, since these resources can lead to benefits
p.(None): extraordinary for research participants and subjects.
p.(None): VII.4 - Declaration by the promoter or sponsor, if any, of a commitment to comply with the terms of the resolutions of the
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
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p.(None): in Research - CEP, relevant information of public interest, regardless of the planned periodic reports.
p.(None): VII - In preparing the protocol, special care must be taken to present the following
p.(None): items:
p.(None): VII.1 - Approval document issued by the Research Ethics Committee or equivalent of
p.(None): institution of the country of origin, which will promote or which will also execute the project.
p.(None): VII.2 - When the development of the project in the country of origin is not foreseen, the justification must be placed
p.(None): in the protocol for appreciation of the CEP of the Brazilian institution.
p.(None): VII.3 - Details of the financial resources involved: sources (if international and foreign and if there are
p.(None): national / institutional counterpart), form and value of the researcher's remuneration and other resources
p.(None): expenses with infrastructure and impact on the routine of the health service of the institution where it will take place. It should be
p.(None): avoid, as far as possible, that the contribution of financial resources creates situations of discrimination between
p.(None): professionals and / or between users, since these resources can lead to benefits
p.(None): extraordinary for research participants and subjects.
p.(None): VII.4 - Declaration by the promoter or sponsor, if any, of a commitment to comply with the terms of the resolutions of the
p.(None): CNS concerning ethics in research involving human beings.
p.(None): VII.5 - Declaration on the use of biological material and the data and information collected
p.(None): exclusively for the purposes foreseen in the protocol, of all those who will handle the material.
p.(None): VII.6 - Opinion of the researcher on the protocol, if it was impossible to participate in the design of the
p.(None): project.
p.(None): VIII - Within the attributions provided for in item VIII.4.c.8 of Resolution No. 196/96, it is up to CONEP, after the
p.(None): approval of the institutional CEP, to appreciate the researches framed in this thematic area,
p.(None): simultaneously framed in others.
p.(None): VIII.1 - The omitted cases, regarding the ethical aspects of the research, will be resolved by the Commission
p.(None): National Research Ethics Committee.
p.(None): JOSÉ SERRA
p.(None): President of the National Health Council
p.(None): I ratify CNS Resolution No. 292, of July 8, 1999, under the terms of the Decree of Delegation of Competence of 12
p.(None): November 1991.
p.(None): JOSÉ SERRA
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| opinion | philosophical differences/differences of opinion |
| property | Property Ownership |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
ethics
protect
Applicable Type / Vulnerability / Indicator Overlay for this Input