C661DEC5EFCA0F83910449083B33AEF8
Resolution CNS No. 346/2005 on Multicenter Research
http://conselho.saude.gov.br/resolucoes/2005/Res346_en.pdf
http://leaux.net/URLS/ConvertAPI Text Files/2B5CCFC532A54C1EAF6279161700CDAB.en.txt
Examining the file media/Synopses/2B5CCFC532A54C1EAF6279161700CDAB.html:
This file was generated: 2020-04-18 01:44:38
| 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
| Vulnerability Type | Vulnerability | Indicator | # Matches |
|---|
| Health | Health | health | 4 |
Health / Health
Searching for indicator health:
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p.(None): NATIONAL HEALTH COUNCIL RESOLUTION N° 346 OF 13th JANUARY 2005
p.(None): National Health Council Plenary Assembly, in its One Hundredth Fiftieth Ordinary Meeting, held on January
p.(None): the 11th,12th and 13th 2005, in the use of its regimental competencies and granted attributions by Law nº
p.(None): 8.080 from 19th September 1990 and by the Law nº 8.142, from 28th December 1990, and considering the accumulated
p.(None): experience in the National Committee for Ethics in Research – CONEP in the appreciation of multicentric
p.(None): research projects and aiming at simplifying the formalization, establishes the following regulation for
p.(None): multicentric research projects formalization in the Committees for Ethics in Research -CEPs- CONEP system.
p.(None):
p.(None): DECIDES:
p.(None):
p.(None): I- Term definition:
p.(None): Multicentric project – research project to be led according to unique protocol in several research centers and,
p.(None): therefore, to be carried out by a responsible researcher in each center, who may follow the same procedures.
p.(None):
p.(None): II- Formalization of multicentric research protocols:
p.(None): The multicentric research protocols that must receive report from CONEP, through Resolution HNC nº
p.(None): 196/96 and its complementary resolutions shall be formalized according to the following procedure:
p.(None):
p.(None): 1. CONEP shall analyze only the first protocol, sent by one of the centers, along with a list of the implicated centers
p.(None): and the fundamented report from CEP. CONEP, after eventual rearrangements have been made, shall send the final report
p.(None): to such CEP and the other centers implicated;
p.(None):
p.(None): a) In case of there be a national coordinator of the research, the CEP that shall receive the protocol and send it to
...
p.(None):
p.(None): a) Eventual modifications or additional material referring to responses to the requests of CONEP report
p.(None): shall be presented separately, well identified, added to the protocol after the documents above.
p.(None):
p.(None): 4. CONEP shall delegate to the other CEPs the final approbation of the projects cited in the item 3 above, maintained
p.(None): the prerogative of the CEP to approve or not the protocol in its institution, having always:
p.(None):
p.(None): a) to verify the suitability of the protocol with the institutional conditions and with the competence of
p.(None): the responsible researcher in the institution;
p.(None):
p.(None): b) to require the accomplishment of eventual modifications approved by the CONEP and the requests of the CEP; and
p.(None):
p.(None): c) to send the fundamented report to CONEP, in case of non final approbation by the CEP.
p.(None):
p.(None): 5. Only the CEP of the first center may be in charge of sending the notifications to CONEP in case of serious adverse
p.(None): events occurring in foreign centers, interruption of the researches or relevant modifications, being necessary that
p.(None): each researcher send the notifications to the local CEP.
p.(None):
p.(None): a) In case of adverse event occurring in the country, the responsible researcher of the center where it occurred, after
p.(None): analyzing it, must notify the CEP and this, in case of serious adverse event, to the CONEP.
p.(None):
p.(None): 6. The regulation of 8th August 2002 of Resolution HNC nº 292/99 remains revoked, upon delegation for researches with
p.(None): foreign cooperation, keeping the Resolution HNC nº 292/99 of the 8th July 1999 in its integrality.
p.(None):
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 346, of 13th January 2005, in the terms of the Competency Delegation Decree of 12th
p.(None): November 1991.
p.(None):
p.(None): HUMBERTO COSTA
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| health | Health |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
ethics
Applicable Type / Vulnerability / Indicator Overlay for this Input
| Vulnerability Type | Vulnerability | Indicator | # Matches |
|---|
| Health | Health | health | 4 |