79C3C34C52B45572883A05D425EB0F82
Resolution CNS Nº 506/2016 Accreditation of CEP
http://conselho.saude.gov.br/resolucoes/2016/Reso_506.pdf
http://leaux.net/URLS/ConvertAPI Text Files/378F027C80C1B3A1AA6697BA509CEDFD.en.txt
Examining the file media/Synopses/378F027C80C1B3A1AA6697BA509CEDFD.html:
This file was generated: 2020-12-01 09:02:28
| 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 / Access to Social Goods
Searching for indicator access:
(return to top)
p.(None): ethics (lato or stricto sensu graduate); or who is a teacher in the field of bioethics or ethics in
p.(None): search; or that has a publication in the area of bioethics or research ethics;
p.(None): III. To prove the effective and continuous participation of the users' representative in the three years prior to the
p.(None): date of publication of the public call;
p.(None): IV. Have obtained, at least, a renewal of registration with Conep, totaling uninterrupted period of operation
p.(None): at least four years;
p.(None): V. Not having a history of suspension or practice inconsistent with the System guidelines
p.(None): CEP / Conep according to the investigation of the complaint or other means of informing the fact, in the six years prior to the date of
p.(None): publication of the public call.
p.(None): Chapter V
p.(None): PRE-ACCREDITATION
p.(None): Art. 11. The pre-accreditation stage will include activities related to the on-site visit, training
p.(None): and monitoring of CEP activities by Conep.
p.(None): I. The on-site visit aims to assess the CEP's infrastructure, and confirm the commitments and guarantees
p.(None): institutional, in addition to other information contained in the proposal submitted during the public call
p.(None): current;
p.(None): II. The training aims at harmonizing ethical analysis between opinions
p.(None): substantiated by CEP and Conep, considering compliance with Resolutions and other regulations of the
p.(None): CNS;
p.(None): III. The monitoring of CEP activities will be carried out with the aim of improving
p.(None): and correction of any inadequacies identified by Conep.
p.(None): IV. During this stage, the CEP in accreditation may request access to the Technical Notes prepared by the
p.(None): Conep for the high risk protocols you are analyzing.
p.(None): Art. 12. During the training and monitoring period, there will be:
p.(None): I. Simultaneous and distinct ethical analysis by CEP in accreditation and by Conep. Only the opinion of Conep
p.(None): it will be valid and issued to the researcher during the pre-accreditation period;
p.(None): II. Qualitative analysis by Conep, by comparison, of the corresponding substantiated opinions
p.(None): Conep and CEP in accreditation, in accordance with CNS regulations.
p.(None): Chapter VI
p.(None): ACCREDITATION
p.(None): Art. 13. The Accreditation Certificate, when granted, will be valid for three years and may be renewed upon
p.(None): request by CEP itself and evaluation by Conep.
p.(None): § 1. The CEP registration will be renewed concurrently with the issuance or renewal of the Accreditation Certificate.
p.(None): § 2. Renewal of the CEP Accreditation Certificate must be requested from 60 days before, up to 60 days after registration.
p.(None): expiration date of the certificate, and will be effected upon presentation, and evaluation by Conep, of the
p.(None): documents listed in Art. 9, item V (items "a" to "f") of this Resolution.
p.(None): § 3. Once the term has elapsed and the Renewal Certificate has not been requested,
p.(None): will be canceled automatically.
p.(None): § 4. The Accreditation Certificate may be canceled, at any time, at the request of the CEP, upon
p.(None): presentation of justification in writing, without prejudice to loss of your registration.
p.(None): § 5. In the absence of compliance with the current regulations of the CNS, Conep will cancel the Accreditation Certificate,
...
Social / Police Officer
Searching for indicator officer:
(return to top)
p.(None): selection and evaluation criteria, according to the needs identified by Conep and the respective
p.(None): regional specificities. CEPs accredited in the CEP / Conep System may apply for the process
p.(None): accreditation, according to the specifications of each call;
p.(None): I I. Pre-accreditation: The number of CEPs selected for the pre-accreditation phase will be defined in the
p.(None): public call. The CEP that has its proposal selected will go through a pre-accreditation period with a duration of
p.(None): 6 months, which can be extended for another 6 months, if necessary. At this stage, the CEP will have its activities
p.(None): monitored and evaluated by Conep. CEP will not be accredited if it does not fulfill the requirements set out in this
p.(None): Resolution and the current public call;
p.(None): III. Accreditation: Upon completion of the pre-accreditation period, the CEP that meets the requirements,
p.(None): according to the criteria established by Conep, you will receive the Accreditation Certificate.
p.(None): Chapter IV
p.(None): SELECTION OF PROPOSALS FOR ACCREDITATION
p.(None): 6th. The selection of proposals will be carried out by analyzing the documents required in this Resolution,
p.(None): in addition to those eventually requested by the current public call. This analysis will be carried out by Conep.
p.(None): Art. 7 The accreditation proposal will be accompanied by a statement issued by the person responsible
p.(None): institutional framework, which ensures the commitment to analyze high-risk protocols, which may be
p.(None): institution itself as well as other institutions not linked to the one that houses the CEP, when forwarded by the
p.(None): Conep, through the Brazil Platform.
p.(None): Art. 8 The institutional officer must present a document describing, in detail, the policy
p.(None): institution to:
p.(None): I. Provide financial resources for the maintenance and continuous investment in the CEP, covering
p.(None): training and improvement of human resources (collegiate and secretariat), secretariat and infrastructure,
p.(None): aiming to guarantee quality in the ethical evaluation of protocols involving human beings;
p.(None): II. To guarantee CEP members full independence in making decisions in the exercise of their duties
p.(None): ethical analysis functions, without suffering any form of pressure or interference from managers
p.(None): institutional, by their hierarchical superiors or by those interested in a particular research;
p.(None): III. Ensure CEP members are exempt from their institutional activities during meetings or other
p.(None): events related to CEP, without prejudice to their remuneration;
p.(None): IV. Guarantee to CEP members the cost of expenses incurred due to participation in
p.(None): CEP meetings or other events.
p.(None): Art. 9 The accreditation proposal must also be accompanied by documentation issued by the CEP, signed
p.(None): by its coordinator and with the knowledge of the institutional responsible, including:
p.(None): I. Formal request justifying the request for CEP accreditation;
p.(None): II. Current Internal Regulations of the CEP;
p.(None): III. Description of the current operation and infrastructure of the EP;
p.(None): IV. Proposal for the minimum number of high-risk protocols from other institutions that the CEP
p.(None): undertakes to evaluate monthly, after obtaining the Accreditation Certificate;
p.(None): V. CEP activity report for the three years prior to the date of publication of the public call, in which
p.(None): contain at least:
...
Social / education
Searching for indicator education:
(return to top)
p.(None): resource request will be defined in its own operational norm;
p.(None): XI. The amendments and notifications of the high-risk protocols will begin the procedure by the accredited CEP.
p.(None): Art. 18. The first appellate body will be the CEP in which the protocol is not approved. Conep will be the next
p.(None): and last resort.
p.(None): Art. 19. Once the operational capacity of accredited CEPs has been exceeded, Conep will be responsible for
p.(None): analysis of surplus high risk protocols.
p.(None): Chapter VIII
p.(None): TRANSITIONAL PROVISIONS
p.(None): Art. 20. For the purposes of this Resolution, the protocols that fall within the areas provided for in item IX.4 of
p.(None): CNS Resolution No. 466 of 2012 will be considered high risk, until the publication of the standard related to typification and
p.(None): gradation of research risk.
p.(None): Art. 21. After the publication of this Resolution, and as long as there is no CEP accredited in the System, Conep will be
p.(None): responsible for the ethical assessment of high risk protocols.
p.(None): Art. 22. The aspects related to the necessary modifications in the Platform Brazil will come into force when
p.(None): updating this electronic system.
p.(None): Art. 23. Instance instituted within the scope of Conep will implement and monitor the accreditation process
p.(None): CEP and the proposal for a continuing education program.
p.(None): Chapter IX
p.(None): FINAL PROVISIONS
p.(None): Art. 24. Omitted cases will be resolved by Conep.
p.(None): Art. 25. This Resolution takes effect on the date of its publication.
p.(None): RONALD FERREIRA DOS SANTOS
p.(None): President of the National Health Council
p.(None): I ratify CNS Resolution No. 506, of February 3, 2016, under the terms of the Decree of Delegation of Competence of 12
p.(None): November 1991.
p.(None): MARCELO COSTA E CASTRO
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.(None): date of publication of the public call;
p.(None): IV. Have obtained, at least, a renewal of registration with Conep, totaling uninterrupted period of operation
p.(None): at least four years;
p.(None): V. Not having a history of suspension or practice inconsistent with the System guidelines
p.(None): CEP / Conep according to the investigation of the complaint or other means of informing the fact, in the six years prior to the date of
p.(None): publication of the public call.
p.(None): Chapter V
p.(None): PRE-ACCREDITATION
p.(None): Art. 11. The pre-accreditation stage will include activities related to the on-site visit, training
p.(None): and monitoring of CEP activities by Conep.
p.(None): I. The on-site visit aims to assess the CEP's infrastructure, and confirm the commitments and guarantees
p.(None): institutional, in addition to other information contained in the proposal submitted during the public call
p.(None): current;
p.(None): II. The training aims at harmonizing ethical analysis between opinions
p.(None): substantiated by CEP and Conep, considering compliance with Resolutions and other regulations of the
p.(None): CNS;
p.(None): III. The monitoring of CEP activities will be carried out with the aim of improving
p.(None): and correction of any inadequacies identified by Conep.
p.(None): IV. During this stage, the CEP in accreditation may request access to the Technical Notes prepared by the
p.(None): Conep for the high risk protocols you are analyzing.
p.(None): Art. 12. During the training and monitoring period, there will be:
p.(None): I. Simultaneous and distinct ethical analysis by CEP in accreditation and by Conep. Only the opinion of Conep
p.(None): it will be valid and issued to the researcher during the pre-accreditation period;
p.(None): II. Qualitative analysis by Conep, by comparison, of the corresponding substantiated opinions
p.(None): Conep and CEP in accreditation, in accordance with CNS regulations.
p.(None): Chapter VI
p.(None): ACCREDITATION
p.(None): Art. 13. The Accreditation Certificate, when granted, will be valid for three years and may be renewed upon
p.(None): request by CEP itself and evaluation by Conep.
p.(None): § 1. The CEP registration will be renewed concurrently with the issuance or renewal of the Accreditation Certificate.
p.(None): § 2. Renewal of the CEP Accreditation Certificate must be requested from 60 days before, up to 60 days after registration.
p.(None): expiration date of the certificate, and will be effected upon presentation, and evaluation by Conep, of the
p.(None): documents listed in Art. 9, item V (items "a" to "f") of this Resolution.
p.(None): § 3. Once the term has elapsed and the Renewal Certificate has not been requested,
p.(None): will be canceled automatically.
p.(None): § 4. The Accreditation Certificate may be canceled, at any time, at the request of the CEP, upon
p.(None): presentation of justification in writing, without prejudice to loss of your registration.
p.(None): § 5. In the absence of compliance with the current regulations of the CNS, Conep will cancel the Accreditation Certificate,
p.(None): substantiating its decision in an opinion.
p.(None): § 6. In the case of cancellation of accreditation by Conep, an appeal may be filed by the CEP. During the period
p.(None): analysis of the resource, the accredited CEP will maintain the prerogatives conferred by the Certificate of
p.(None): Accreditation.
p.(None): Art. 14. When granting the Accreditation Certificate, CEP will ensure, through a document signed by
p.(None): its coordinator, the commitment to evaluate high risk protocols in numbers at least equal to the
p.(None): proposal presented, complying with the deadlines defined in the current operating standard and the ethical criteria
p.(None): established in the CNS Resolutions.
p.(None): Art. 15. During the validity of the accreditation, there will be:
p.(None): I. Issuance of the opinion substantiated by the accredited CEP to the responsible researcher;
p.(None): II. Periodic monitoring by Conep of the substantiated opinions issued by the accredited CEP, in accordance with
p.(None): with CNS regulations;
p.(None): III. Inspection visits to the accredited CEP.
p.(None): Chapter VII
p.(None): OF THE ASSIGNMENTS OF THE ETHICS COMMITTEES IN RESEARCH AND CONEP IN THE ANALYSIS OF HIGH RISK PROTOCOLS
p.(None): Art. 16. The accredited CEP will analyze the high risk protocols.
p.(None): § 1º. The high-risk protocols will be distributed by Conep among accredited CEPs.
p.(None): § 2. High risk protocols will preferably be analyzed by the accredited CEP of the
p.(None): proposing institution itself.
p.(None): § 3. In the event that there is no availability of accredited CEP for the analysis of high risk protocol, it will be up to the
p.(None): Conep this responsibility.
p.(None): Art. 17.The processing of high risk protocols in the CEP / Conep System will occur as follows:
p.(None): I. The protocol will be forwarded to the accredited CEP, after submission by the researcher to Plataforma Brasil.
p.(None): After approval by the accredited CEP, the protocol will be forwarded to the CEP of the proposing institutions,
p.(None): participant (s) or co-participant (s), if any.
p.(None): II.The document verification process will be performed by the accredited CEP;
p.(None): III. Once the documentation has been checked and found to be satisfactory, the ethical analysis of the protocol will be
p.(None): performed by the accredited CEP;
...
p.(None): for verification, without the possibility of editing, to the CEP linked to the proposing institution, participant (s)
p.(None): and co-participant (s), if any. In the case of multicenter studies, it will also be available to other CEPs
p.(None): involved;
p.(None): V. After approval of the protocol by the accredited CEP, it will be evaluated, simultaneously, by the CEP
p.(None): linked to the proposing institution and other CEP involved with the protocol;
p.(None): SAW. The accredited CEPs involved with the protocol will assess the local aspects
p.(None): pertinent to research at the institution, which include:
p.(None): a) analysis of local documents;
p.(None): b) local adaptations of the Free and Informed Consent Term, in the fields where editing is allowed (data from the
p.(None): researcher, institution and CEP);
p.(None): c) analysis of the institutional conditions and the competence of the researcher responsible at the institution;
p.(None): d) questions that can generate pending indicating the need for further clarification. However, these
p.(None): generated disputes will not be able to determine changes in the detailed project or in the fields where it is not allowed
p.(None): edition in the Informed Consent Form. If the pending issue is not satisfactorily resolved
p.(None): and if the CEP considers it relevant, it may not approve the realization of the protocol in the linked institution;
p.(None): VII. Accredited CEPs have the prerogative to approve or not the protocol at their institution, even if approved
p.(None): accredited CEP. In case of non-approval by the accredited CEP, the research cannot be carried out at the
p.(None): institution linked to this CEP, and the consolidated opinion will be sent to the accredited CEP and also to Conep;
p.(None): VIII. The accredited CEP involved in the protocol is responsible for communicating to the accredited CEP information
p.(None): impact on the safety and well-being of research participants;
p.(None): IX. The reception of complaints, doubts and complaints is the responsibility of all those involved in the
p.(None): CEP / Conep System;
p.(None): X. The deadlines for documentary checking, issuing a substantiated opinion, the researcher's response and
p.(None): resource request will be defined in its own operational norm;
p.(None): XI. The amendments and notifications of the high-risk protocols will begin the procedure by the accredited CEP.
p.(None): Art. 18. The first appellate body will be the CEP in which the protocol is not approved. Conep will be the next
p.(None): and last resort.
p.(None): Art. 19. Once the operational capacity of accredited CEPs has been exceeded, Conep will be responsible for
p.(None): analysis of surplus high risk protocols.
p.(None): Chapter VIII
p.(None): TRANSITIONAL PROVISIONS
p.(None): Art. 20. For the purposes of this Resolution, the protocols that fall within the areas provided for in item IX.4 of
p.(None): CNS Resolution No. 466 of 2012 will be considered high risk, until the publication of the standard related to typification and
p.(None): gradation of research risk.
p.(None): Art. 21. After the publication of this Resolution, and as long as there is no CEP accredited in the System, Conep will be
p.(None): responsible for the ethical assessment of high risk protocols.
p.(None): Art. 22. The aspects related to the necessary modifications in the Platform Brazil will come into force when
p.(None): updating this electronic system.
p.(None): Art. 23. Instance instituted within the scope of Conep will implement and monitor the accreditation process
p.(None): CEP and the proposal for a continuing education program.
p.(None): Chapter IX
p.(None): FINAL PROVISIONS
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.(None): in this Resolution.
p.(None): Chapter II
p.(None): TERMS AND DEFINITIONS
p.(None): Art. 4 This Resolution adopts the following definitions:
p.(None): I. ACCREDITATION: voluntary conformity assessment process, with a view to certification
p.(None): granted by Conep to CEP for the ethical analysis of high risk protocols involving human beings.
p.(None): II. CERTIFICATE OF ACCREDITATION: document granted by Conep that formalizes the condition of CEP accredited to the
p.(None): committee that has its accreditation proposal selected and presents a performance considered satisfactory in the
p.(None): pre-accreditation period.
p.(None): III. ACCREDITED RESEARCH ETHICS COMMITTEE: CEP which, besides being accredited in the CEP / Conep System, is certified
p.(None): by Conep for the analysis of high risk protocols.
p.(None): IV. ACCREDITED RESEARCH ETHICS COMMITTEE: CEP that meets the operating conditions established in the
p.(None): guidelines of the CEP / Conep System and has its registration granted by Conep. It can act as the CEP of the proposing institution,
p.(None): participant or co-participant.
p.(None): V. RESEARCH RISK GRADATION: classification of a research in one of the degrees of risk established in
p.(None): own standard.
p.(None): SAW. REPORTING: evaluation of the protocol carried out by the rapporteur, in accordance with CNS Resolutions and
p.(None): relevant Brazilian regulations.
p.(None): V I I. INSTITUTIONAL RESPONSIBLE: person with greater authority in the institution or, in their impossibility,
p.(None): someone who officially represents you.
p.(None): V I I I. RESEARCH RISK TIPIFICATION: process by which the degree of risk of a research is defined.
p.(None): It is based on the possibility of damage resulting from it, the magnitude of these and the
p.(None): consequences for the integrity of research participants in all its dimensions.
p.(None): Chapter III
p.(None): STEPS FOR ACCREDITATION OF RESEARCH ETHICS COMMITTEES
p.(None): 5th. The accreditation process consists of three distinct and sequential steps:
p.(None): I. Selection of proposals: The Executive Secretariat of Conep will launch a public call containing the
p.(None): selection and evaluation criteria, according to the needs identified by Conep and the respective
p.(None): regional specificities. CEPs accredited in the CEP / Conep System may apply for the process
p.(None): accreditation, according to the specifications of each call;
p.(None): I I. Pre-accreditation: The number of CEPs selected for the pre-accreditation phase will be defined in the
p.(None): public call. The CEP that has its proposal selected will go through a pre-accreditation period with a duration of
p.(None): 6 months, which can be extended for another 6 months, if necessary. At this stage, the CEP will have its activities
p.(None): monitored and evaluated by Conep. CEP will not be accredited if it does not fulfill the requirements set out in this
p.(None): Resolution and the current public call;
p.(None): III. Accreditation: Upon completion of the pre-accreditation period, the CEP that meets the requirements,
p.(None): according to the criteria established by Conep, you will receive the Accreditation Certificate.
p.(None): Chapter IV
...
Orphaned Trigger Words
p.(None): own standard.
p.(None): SAW. REPORTING: evaluation of the protocol carried out by the rapporteur, in accordance with CNS Resolutions and
p.(None): relevant Brazilian regulations.
p.(None): V I I. INSTITUTIONAL RESPONSIBLE: person with greater authority in the institution or, in their impossibility,
p.(None): someone who officially represents you.
p.(None): V I I I. RESEARCH RISK TIPIFICATION: process by which the degree of risk of a research is defined.
p.(None): It is based on the possibility of damage resulting from it, the magnitude of these and the
p.(None): consequences for the integrity of research participants in all its dimensions.
p.(None): Chapter III
p.(None): STEPS FOR ACCREDITATION OF RESEARCH ETHICS COMMITTEES
p.(None): 5th. The accreditation process consists of three distinct and sequential steps:
p.(None): I. Selection of proposals: The Executive Secretariat of Conep will launch a public call containing the
p.(None): selection and evaluation criteria, according to the needs identified by Conep and the respective
p.(None): regional specificities. CEPs accredited in the CEP / Conep System may apply for the process
p.(None): accreditation, according to the specifications of each call;
p.(None): I I. Pre-accreditation: The number of CEPs selected for the pre-accreditation phase will be defined in the
p.(None): public call. The CEP that has its proposal selected will go through a pre-accreditation period with a duration of
p.(None): 6 months, which can be extended for another 6 months, if necessary. At this stage, the CEP will have its activities
p.(None): monitored and evaluated by Conep. CEP will not be accredited if it does not fulfill the requirements set out in this
p.(None): Resolution and the current public call;
p.(None): III. Accreditation: Upon completion of the pre-accreditation period, the CEP that meets the requirements,
p.(None): according to the criteria established by Conep, you will receive the Accreditation Certificate.
p.(None): Chapter IV
p.(None): SELECTION OF PROPOSALS FOR ACCREDITATION
p.(None): 6th. The selection of proposals will be carried out by analyzing the documents required in this Resolution,
p.(None): in addition to those eventually requested by the current public call. This analysis will be carried out by Conep.
p.(None): Art. 7 The accreditation proposal will be accompanied by a statement issued by the person responsible
p.(None): institutional framework, which ensures the commitment to analyze high-risk protocols, which may be
p.(None): institution itself as well as other institutions not linked to the one that houses the CEP, when forwarded by the
p.(None): Conep, through the Brazil Platform.
p.(None): Art. 8 The institutional officer must present a document describing, in detail, the policy
p.(None): institution to:
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| authority | Relationship to Authority |
| education | education |
| officer | Police Officer |
| opinion | philosophical differences/differences of opinion |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
capacity
consent
ethics
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input