RESOLUTION No. 506, OF FEBRUARY 3, 2016.
The Plenary of the National Health Council, at its Twenty-seventy-seventh regular meeting,
held on January 2nd and 3rd, 2016, in the use of its regimental competences and attributions
conferred by Law No. 8,080, of September 19, 1990, by Law No. 8,142, of December 28, 1990, by Decree No.
5,839, of July 11, 2006, and in compliance with the provisions of the Constitution of the Federative Republic of Brazil
1988 and related Brazilian legislation; and considering the provisions of CNS Resolution No. 466 of 2012,
in its items XIII.1 and XIII.2;
R E S O L V E:
Approve the following Resolution regarding the accreditation process for Research Ethics Committees (CEP)
that make up the CEP / Conep System.
Chapter I
PRELIMINARY PROVISIONS
1st. This Resolution establishes the criteria for the CEP accreditation process of the System
CEP / Conep, in public and private institutions. The processing of the protocol will be based on the gradation and
risk classification defined in a specific rule, with criteria established by the National Commission
Research Ethics (Conep), resulting from research activities involving human beings.
2nd Art. The accreditation process aims to reinforce the decentralization of the CEP / Conep System,
maintaining the uniformity of the analysis criteria established by the CNS, in line with the
current regulations.
3rd. Conep is responsible for evaluating, deliberating and granting accreditation to CEPs, in accordance with
in this Resolution.
Chapter II
TERMS AND DEFINITIONS
Art. 4 This Resolution adopts the following definitions:
I. ACCREDITATION: voluntary conformity assessment process, with a view to certification
granted by Conep to CEP for the ethical analysis of high risk protocols involving human beings.
II. CERTIFICATE OF ACCREDITATION: document granted by Conep that formalizes the condition of CEP accredited to the
committee that has its accreditation proposal selected and presents a performance considered satisfactory in the
pre-accreditation period.
III. ACCREDITED RESEARCH ETHICS COMMITTEE: CEP which, besides being accredited in the CEP / Conep System, is certified
by Conep for the analysis of high risk protocols.
IV. ACCREDITED RESEARCH ETHICS COMMITTEE: CEP that meets the operating conditions established in the
guidelines of the CEP / Conep System and has its registration granted by Conep. It can act as the CEP of the proposing institution,
participant or co-participant.
V. RESEARCH RISK GRADATION: classification of a research in one of the degrees of risk established in
own standard.
SAW. REPORTING: evaluation of the protocol carried out by the rapporteur, in accordance with CNS Resolutions and
relevant Brazilian regulations.
V I I. INSTITUTIONAL RESPONSIBLE: person with greater authority in the institution or, in their impossibility,
someone who officially represents you.
V I I I. RESEARCH RISK TIPIFICATION: process by which the degree of risk of a research is defined.
It is based on the possibility of damage resulting from it, the magnitude of these and the
consequences for the integrity of research participants in all its dimensions.
Chapter III
STEPS FOR ACCREDITATION OF RESEARCH ETHICS COMMITTEES
5th. The accreditation process consists of three distinct and sequential steps:
I. Selection of proposals: The Executive Secretariat of Conep will launch a public call containing the
selection and evaluation criteria, according to the needs identified by Conep and the respective
regional specificities. CEPs accredited in the CEP / Conep System may apply for the process
accreditation, according to the specifications of each call;
I I. Pre-accreditation: The number of CEPs selected for the pre-accreditation phase will be defined in the
public call. The CEP that has its proposal selected will go through a pre-accreditation period with a duration of
6 months, which can be extended for another 6 months, if necessary. At this stage, the CEP will have its activities
monitored and evaluated by Conep. CEP will not be accredited if it does not fulfill the requirements set out in this
Resolution and the current public call;
III. Accreditation: Upon completion of the pre-accreditation period, the CEP that meets the requirements,
according to the criteria established by Conep, you will receive the Accreditation Certificate.
Chapter IV
SELECTION OF PROPOSALS FOR ACCREDITATION
6th. The selection of proposals will be carried out by analyzing the documents required in this Resolution,
in addition to those eventually requested by the current public call. This analysis will be carried out by Conep.
Art. 7 The accreditation proposal will be accompanied by a statement issued by the person responsible
institutional framework, which ensures the commitment to analyze high-risk protocols, which may be
institution itself as well as other institutions not linked to the one that houses the CEP, when forwarded by the
Conep, through the Brazil Platform.
Art. 8 The institutional officer must present a document describing, in detail, the policy
institution to:
I. Provide financial resources for the maintenance and continuous investment in the CEP, covering
training and improvement of human resources (collegiate and secretariat), secretariat and infrastructure,
aiming to guarantee quality in the ethical evaluation of protocols involving human beings;
II. To guarantee CEP members full independence in making decisions in the exercise of their duties
ethical analysis functions, without suffering any form of pressure or interference from managers
institutional, by their hierarchical superiors or by those interested in a particular research;
III. Ensure CEP members are exempt from their institutional activities during meetings or other
events related to CEP, without prejudice to their remuneration;
IV. Guarantee to CEP members the cost of expenses incurred due to participation in
CEP meetings or other events.
Art. 9 The accreditation proposal must also be accompanied by documentation issued by the CEP, signed
by its coordinator and with the knowledge of the institutional responsible, including:
I. Formal request justifying the request for CEP accreditation;
II. Current Internal Regulations of the CEP;
III. Description of the current operation and infrastructure of the EP;
IV. Proposal for the minimum number of high-risk protocols from other institutions that the CEP
undertakes to evaluate monthly, after obtaining the Accreditation Certificate;
V. CEP activity report for the three years prior to the date of publication of the public call, in which
contain at least:
a) Total number of substantiated opinions issued, highlighting quantitatively those that were
forwarded for analysis by Conep or accredited CEP;
b) Description of the training and capacity building activities of its members;
c) Description of activities to disseminate knowledge of research ethics to users, researchers,
community, among others;
d) Composition of the CEP collegiate body in the last three years;
e) Frequency of holding meetings for ethical deliberation of research protocols through presentation of
respective minutes;
f) Frequency of each member of the CEP to meetings for ethical deliberation and compliance with the minimum quorum.
Art. 10. Proposals that present the documentation of articles 7, 8 and 9, and are suitable for the
eligibility requirements for the current public call. Through documentary analysis, proposals will be evaluated,
the CEP must:
I. Demonstrate the ability to evaluate and issue substantiated opinions related to
high risk, in a number not less than the minimum defined in the current public call, within the deadlines stipulated by the
norms of the CEP / Conep System;
II. Present a multidisciplinary composition, with no more than half of its members
belonging to the same professional category, with people of both sexes participating. CEP must have in its
composition, preferably at least one member with curricular experience in bioethics
or research ethics. Curricular experience is understood as an individual who has a background in bioethics or
ethics (lato or stricto sensu graduate); or who is a teacher in the field of bioethics or ethics in
search; or that has a publication in the area of ​​bioethics or research ethics;
III. To prove the effective and continuous participation of the users' representative in the three years prior to the
date of publication of the public call;
IV. Have obtained, at least, a renewal of registration with Conep, totaling uninterrupted period of operation
at least four years;
V. Not having a history of suspension or practice inconsistent with the System guidelines
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
publication of the public call.
Chapter V
PRE-ACCREDITATION
Art. 11. The pre-accreditation stage will include activities related to the on-site visit, training
and monitoring of CEP activities by Conep.
I. The on-site visit aims to assess the CEP's infrastructure, and confirm the commitments and guarantees
institutional, in addition to other information contained in the proposal submitted during the public call
current;
II. The training aims at harmonizing ethical analysis between opinions
substantiated by CEP and Conep, considering compliance with Resolutions and other regulations of the
CNS;
III. The monitoring of CEP activities will be carried out with the aim of improving
and correction of any inadequacies identified by Conep.
IV. During this stage, the CEP in accreditation may request access to the Technical Notes prepared by the
Conep for the high risk protocols you are analyzing.
Art. 12. During the training and monitoring period, there will be:
I. Simultaneous and distinct ethical analysis by CEP in accreditation and by Conep. Only the opinion of Conep
it will be valid and issued to the researcher during the pre-accreditation period;
II. Qualitative analysis by Conep, by comparison, of the corresponding substantiated opinions
Conep and CEP in accreditation, in accordance with CNS regulations.
Chapter VI
ACCREDITATION
Art. 13. The Accreditation Certificate, when granted, will be valid for three years and may be renewed upon
request by CEP itself and evaluation by Conep.
§ 1. The CEP registration will be renewed concurrently with the issuance or renewal of the Accreditation Certificate.
§ 2. Renewal of the CEP Accreditation Certificate must be requested from 60 days before, up to 60 days after registration.
expiration date of the certificate, and will be effected upon presentation, and evaluation by Conep, of the
documents listed in Art. 9, item V (items "a" to "f") of this Resolution.
§ 3. Once the term has elapsed and the Renewal Certificate has not been requested,
will be canceled automatically.
§ 4. The Accreditation Certificate may be canceled, at any time, at the request of the CEP, upon
presentation of justification in writing, without prejudice to loss of your registration.
§ 5. In the absence of compliance with the current regulations of the CNS, Conep will cancel the Accreditation Certificate,
substantiating its decision in an opinion.
§ 6. In the case of cancellation of accreditation by Conep, an appeal may be filed by the CEP. During the period
analysis of the resource, the accredited CEP will maintain the prerogatives conferred by the Certificate of
Accreditation.
Art. 14. When granting the Accreditation Certificate, CEP will ensure, through a document signed by
its coordinator, the commitment to evaluate high risk protocols in numbers at least equal to the
proposal presented, complying with the deadlines defined in the current operating standard and the ethical criteria
established in the CNS Resolutions.
Art. 15. During the validity of the accreditation, there will be:
I. Issuance of the opinion substantiated by the accredited CEP to the responsible researcher;
II. Periodic monitoring by Conep of the substantiated opinions issued by the accredited CEP, in accordance with
with CNS regulations;
III. Inspection visits to the accredited CEP.
Chapter VII
OF THE ASSIGNMENTS OF THE ETHICS COMMITTEES IN RESEARCH AND CONEP IN THE ANALYSIS OF HIGH RISK PROTOCOLS
Art. 16. The accredited CEP will analyze the high risk protocols.
§ 1º. The high-risk protocols will be distributed by Conep among accredited CEPs.
§ 2. High risk protocols will preferably be analyzed by the accredited CEP of the
proposing institution itself.
§ 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
Conep this responsibility.
Art. 17.The processing of high risk protocols in the CEP / Conep System will occur as follows:
I. The protocol will be forwarded to the accredited CEP, after submission by the researcher to Plataforma Brasil.
After approval by the accredited CEP, the protocol will be forwarded to the CEP of the proposing institutions,
participant (s) or co-participant (s), if any.
II.The document verification process will be performed by the accredited CEP;
III. Once the documentation has been checked and found to be satisfactory, the ethical analysis of the protocol will be
performed by the accredited CEP;
IV. During the period of analysis of the protocol by the accredited CEP, all related documentation will be available
for verification, without the possibility of editing, to the CEP linked to the proposing institution, participant (s)
and co-participant (s), if any. In the case of multicenter studies, it will also be available to other CEPs
involved;
V. After approval of the protocol by the accredited CEP, it will be evaluated, simultaneously, by the CEP
linked to the proposing institution and other CEP involved with the protocol;
SAW. The accredited CEPs involved with the protocol will assess the local aspects
pertinent to research at the institution, which include:
a) analysis of local documents;
b) local adaptations of the Free and Informed Consent Term, in the fields where editing is allowed (data from the
researcher, institution and CEP);
c) analysis of the institutional conditions and the competence of the researcher responsible at the institution;
d) questions that can generate pending indicating the need for further clarification. However, these
generated disputes will not be able to determine changes in the detailed project or in the fields where it is not allowed
edition in the Informed Consent Form. If the pending issue is not satisfactorily resolved
and if the CEP considers it relevant, it may not approve the realization of the protocol in the linked institution;
VII. Accredited CEPs have the prerogative to approve or not the protocol at their institution, even if approved
accredited CEP. In case of non-approval by the accredited CEP, the research cannot be carried out at the
institution linked to this CEP, and the consolidated opinion will be sent to the accredited CEP and also to Conep;
VIII. The accredited CEP involved in the protocol is responsible for communicating to the accredited CEP information
impact on the safety and well-being of research participants;
IX. The reception of complaints, doubts and complaints is the responsibility of all those involved in the
CEP / Conep System;
X. The deadlines for documentary checking, issuing a substantiated opinion, the researcher's response and
resource request will be defined in its own operational norm;
XI. The amendments and notifications of the high-risk protocols will begin the procedure by the accredited CEP.
Art. 18. The first appellate body will be the CEP in which the protocol is not approved. Conep will be the next
and last resort.
Art. 19. Once the operational capacity of accredited CEPs has been exceeded, Conep will be responsible for
analysis of surplus high risk protocols.
Chapter VIII
TRANSITIONAL PROVISIONS
Art. 20. For the purposes of this Resolution, the protocols that fall within the areas provided for in item IX.4 of
CNS Resolution No. 466 of 2012 will be considered high risk, until the publication of the standard related to typification and
gradation of research risk.
Art. 21. After the publication of this Resolution, and as long as there is no CEP accredited in the System, Conep will be
responsible for the ethical assessment of high risk protocols.
Art. 22. The aspects related to the necessary modifications in the Platform Brazil will come into force when
updating this electronic system.
Art. 23. Instance instituted within the scope of Conep will implement and monitor the accreditation process
CEP and the proposal for a continuing education program.
Chapter IX
FINAL PROVISIONS
Art. 24. Omitted cases will be resolved by Conep.
Art. 25. This Resolution takes effect on the date of its publication.
RONALD FERREIRA DOS SANTOS
President of the National Health Council
I ratify CNS Resolution No. 506, of February 3, 2016, under the terms of the Decree of Delegation of Competence of 12
November 1991.
MARCELO COSTA E CASTRO
Minister of State for Health