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Research Ethics (CONEP)
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REGULATORY ACTS
Resolutions
Recommendations
Motions INTERNAL RULES OF CONEP / CNS
Resolutions
Legislation
(Version approved at the CONEP meeting of 05/24/01 and at the CNS Ordinary Meeting of 06/06/2001).
CHAPTER I
MEETINGS OF THE
ADVICE - NATURE AND PURPOSE -
Calendar Art. 1 - The National Research Ethics Commission - CONEP is a collegiate body with national scope,
Advisory, deliberative, within the scope of issuing opinions on research protocols, normative, in the context of
Minutes
propositional scope of CNS Resolutions, educational, autonomous, linked to the National Health Council - CNS,
created by CNS Resolution 196/96, of 10/10/96. Its purpose is to monitor research involving
human beings throughout the country, and institutional Research Ethics Committees, preserving ethical aspects
LIBRARY primarily in defense of the integrity and dignity of the research subjects, individually or collectively
Magazine considered, taking into account the moral pluralism of Brazilian society.
Newsletters
Sole Paragraph - CONEP will promote the development of social control over these surveys, contributing to the
Books
fulfillment of CNS duties.
Reporting
CHAPTER II
HEALTH EVENTS
- CONEP ORGANIZATION -
PLENARY COUNCILS Section I
PRESENTATION OF THE ACCOUNTS Composition
Art. 2 - CONEP will have a multi-professional and transdisciplinary composition, with people of both sexes, with 13
(thirteen) sitting members and their respective alternates, 05 (five) of them with outstanding performance in the field of
ethics in research and health and 08 (eight) personalities with outstanding performance in the theological, legal and
others, ensuring that at least one is from the health management area, which will be appointed by the Department
of Science and Technology in Health - DECIT, of the Health Policy Secretariat - SPS, and one of the representatives of
users. You can also count on consultants and "ad hoc" members.
Art. 3 - The members will be selected from a list prepared from indications of the CEP registered in the
CONEP, with 07 (seven) members and respective alternates being chosen by CNS and 06 (six) members and
respective alternates will be defined by lot, chaired by the CNS. Each CEP may make two nominations.
Art. 4 - The appointment of members will be made by CNS Resolution.
Art. 5 - The term of CONEP members will be 4 (four) years with alternate renewal every 2 (two) years,
seven or six of its members.
Art. 6 - The effective members, as well as consultants and "ad hoc" members of CONEP may not exercise
activities that may characterize conflict of interest.
Art. 7 - The alternate will be automatically summoned, in the absence of participation by the titular member.
Art. 8 - A member who, without prior notice, fails to attend three
consecutive or four meetings interspersed over a year.
Sole Paragraph - In the event of this article, the alternate will assume the title and a new indication of the
CNS plenary session for alternate, respecting the requirements of articles 2 and 3.
Art. 9 - CONEP will have a coordinator chosen by the CNS, among its Directors and two coordinators
deputies chosen from among their full members and designated by the CNS, with a term of 2 (two) years,
be reappointed.
Article 10 - CONEP will have an Executive Secretariat, exercised by a secretary appointed by the CNS.
First Paragraph - The logistical and administrative support to the Executive Secretariat of CONEP / CNS will be made possible by the
CNS.
Paragraph Two - The technical and administrative support from the CNS Executive Secretariat to CONEP will be shared
with DECIT / SPS / MS, within the scope of common interests, when the activities to be performed involve
jointly programmed actions between this body and the Executive Secretariat of CONEP.
Section II
CONEP's duties
Art. 11 - CONEP is responsible for examining the ethical aspects of research involving human beings, as well as
adequacy and updating of the relevant norms. CONEP will consult the company whenever it deems necessary,
including the following duties, among others:
I - encourage the creation of institutional CEPs and other entities;
II - register the institutional and other entities' CEPs;
III - review the research protocols within 60 (sixty) days and follow them up in the cases provided for;
IV - under the guidelines and approval of the CNS plenary, edit specific norms in the field of research ethics,
including in the special thematic areas, as well as recommendations for their application;
V - function as a final instance of resources, based on information provided systematically, on an
official or from complaints or requests from interested parties, and must manifest themselves within a period not
more than 60 (sixty) days;
VI - review responsibilities, prohibit or interrupt research, definitively or temporarily, and may request
protocols for ethical review, including those already approved by CEP and the National Health Surveillance Agency;
VII - constitute a system of information and monitoring of the ethical aspects of research involving human beings
throughout the national territory, keeping the databases updated;
VIII - organize a system for evaluating and monitoring CEP activities;
IX - inform and advise the CNS and other instances of SUS, as well as the government and society, on issues
ethics related to research in human beings, to maintain necessary contacts especially with the organs of
health surveillance;
X - disclose Res. CNS 196/96 and other norms related to research ethics involving human beings;
XI - establish, together with other sectors of the Ministry of Health, rules and criteria for the accreditation of
Research Center. This accreditation should be proposed by the sectors of the Ministry of Health, in accordance with
their needs, and approved by the National Health Council;
XII - upon approval by the CNS plenary, establish its own operating rules;
XIII - act as a consultative institution in matters of difficult ethical decision associated with research, issuing, if
necessary, comments and information to the public.
First Paragraph - In the cases provided for in the complementary rules of the thematic areas, in which there is delegation
the CEP responsible for issuing the final opinion, based on the research project, CONEP
will receive the referred opinion and the partial and final reports of the research, maintaining the prerogatives of item VI of this
article.
Second Paragraph - In the exercise of its duties, CONEP will not be able to specifically identify the
name (s) of the researcher (s), according to the ethical principle of confidentiality, except when under official request
the competent bodies of the Judiciary.
Art. 12 - CONEP will submit to the CNS for its deliberation:
I - proposed standards to be applied to research involving human beings;
II - annual work plan;
III - annual report of its activities, including summary of the established CEPs and of the analyzed, approved projects,
not approved or suspended, globally and by thematic areas, without specifying the specific (s)
researcher (s).
Sole Paragraph - The report referred to in item III must be available to the public.
Section III
Members' duties
Art. 13 - The Coordinator is responsible for directing, coordinating and supervising the activities of CONEP and specifically:
I - install and preside over its meetings.
II - elicit CONEP's pronouncement on issues related to research projects;
III - take part in the discussions and votes and, when applicable, exercise the right to the tiebreaker vote;
IV - appoint members to carry out studies, surveys and issue opinions necessary to achieve
the purpose of the commission, after hearing the plenary;
V - invite entities, scientists, technicians and personalities to collaborate in studies or participate as
"ad hoc" consultants in the assessment of matters submitted to CONEP, after hearing the plenary;
VI - propose steps considered essential to the examination of the matter, after hearing the plenary;
VII - forward an annual work plan and partial or at least annual reports to the CNS, after hearing the plenary;
VIII - Sign the final opinions on research projects, complaints or other matters relevant to CONEP,
according to the resolutions taken at the meeting.
IX - issue an "ad referendum" opinion on matters considered urgent, informing members to
deliberation at the next meeting.
Art. 14 - The Deputy Coordinators are responsible for:
I - replace the Coordinator in his absences or impediments;
II - provide advice to the Coordinator in terms of the organ's competence;
III - propose to the Plenary and coordinate the elaboration of communication vehicles for CONEP activities, with the objective
dissemination and education.
Art. 15 - The Executive Secretary is responsible for:
I - attend meetings;
II - forward and ensure compliance with CONEP's resolutions;
III - organize the agenda of the meetings;
IV - receive correspondence, projects, denunciations or other matters, giving the necessary referrals;
V - designate, according to criteria established and approved by the plenary, rapporteurs for the projects registered, and
send a copy of them for consideration, at least 10 (ten) days before the meeting;
VI - prepare, sign, distribute to members and keep the memory of the meetings on file;
VII - coordinate the activities of the Executive Secretariat, such as organizing a database, recording deliberations,
protocol and others;
VIII - maintain control of legal and regulatory deadlines related to the processes under analysis;
IX - prepare an annual report on the activities of the Commission to be sent to the CNS;
X - advise the members of CONEP on the relationship with the CNS and the Health System, and regarding the interface with
public health policies.
Art. 16 - The members are responsible for:
I - study and report within the established deadlines the matters assigned to them;
II - attend the meetings, reporting research projects, casting votes and expressing oneself regarding the
matters under discussion;
III - request voting on matters on an urgent basis;
IV - present proposals on issues related to CONEP;
V - perform the duties assigned to them;
VI - maintain the confidentiality of information related to the processes analyzed.
Section IV
Operation
Art. 17 - CONEP will ordinarily meet 11 times a year, monthly, from February to December, and
extraordinarily when summoned by the CNS Plenary, at the request of its Coordinator or as a result of
request of half plus one of its members.
Art. 18 - The meetings will be held with the minimum presence of more than half of its members.
Art. 19 - The meetings will be open to the public, admitting the presence of observers, except when analyzing
(reporting, debates and voting) of research projects sent to CONEP and the analysis of complaints or
confidential situations.
Paragraph One - Observers will not be allowed to participate in discussions or ask questions during the
meeting.
Second Paragraph - CONEP shall determine, on occasions that justify secrecy, that the meeting be closed to the
public.
Art. 20 - CONEP's deliberations will be taken in meetings, by vote of more than half of the members
gifts.
Art. 21 - The deliberations will be recorded in opinions signed by the Coordinator.
Art. 22 - The agenda will be prepared including the materials defined in the previous meeting and with the research protocols
presented for consideration, in chronological order of arrival.
Art. 23 - Copies of the research projects to be considered will be distributed to a rapporteur and, when judged
necessary, to a co-rapporteur. The rapporteur's written report and the co-rapporteur's observations will be presented for
appreciation of the collegiate at the next meeting.
Art. 24 - The discussion will be initiated by the report and opinion of the rapporteur, followed by the observations of the co-rapporteur. After
of them other members may voluntarily present their point of view.
Sole Paragraph - The rapporteur who cannot be present at the meeting must send his report in writing, to be
read at the meeting by the executive secretary.
Art. 25 - The assessment of each matter will result in one of the following resolutions:
I - fully approved;
II - approved pending; when the Commission considers the protocol acceptable, but identifies
certain problems with the protocol, the consent form or both, and recommend a review
or request a modification or relevant information, which must be met in 60 (sixty) days by
researchers, for final assessment by CONEP.
III - withdrawn; when, after the deadline, the protocol remains pending; and
IV - not approved.
Sole Paragraph - This resolution will be transmitted to the CEP in the form of an Opinion, signed by the Coordinator.
Art. 26 - After the discussion, there being no position defended by the absolute majority of those present, the project
fall into one of the following situations:
I - "Need information complementation";
II - "Sufficient information, with controversial opinions". In this case, a CONEP subcommittee will be appointed to
continue discussions and re-present the protocol to the plenary.
Sole Paragraph - Whenever deemed necessary, an ad hoc consultant may be requested for consideration.
Art. 27 - The rapporteurs may request the necessary measures to clarify the matter proposed for analysis.
Sole Paragraph - After entering the agenda, the matter must be voted on within a maximum period of up to two
meetings.
Art. 28 - The member who does not consider himself sufficiently informed about the matter under examination, may request views from the
office, propose steps or postpone the discussion or vote, and must offer an opinion until the meeting
Following.
Art. 29 - CONEP's deliberations should not participate in the assessment of research projects,
Collegiate members directly involved in them.
CHAPTER III
- FINAL DISPOSITIONS -
Art. 30 - The omitted cases and doubts arising from the application of these Internal Regulations will be resolved by the
CONEP meeting with the presence of at least 2/3 of its members, and as a resource by the National Council
of health.
Art. 31 - The present Internal Regulation may be altered through the proposal of 2/3 of the members of CONEP and
homologation by CNS.
Art. 32 - The present Regulation will come into force after approval by the vote of 2/3 of the members of CONEP and
homologation by CNS.
Art. 33 - The work of members, coordinator, assistant coordinators, consultants and "ad hoc" members, will not be
paid, being considered of relevant public interest.
National Health Council - "Effecting Social Control".
Esplanada dos Ministérios, Block “G” - Annex Building, Wing “B” - 1st floor - Room 103B - 70058-900 - Brasília, DF
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