This Regulation, approved at a plenary meeting of the Research Ethics Committee (CEP), governs the criteria for composition, election of board, competence and procedures of CEP/Unicamp – Campus Campinas.
CHAPTER I – PURPOSE AND RESPONSIBILITIES
The Research Ethics Committee – Unicamp – Campus Campinas, hereinafter referred to in these Regulations as “CEP” or “Committee”, is a collegiate body, constituted under the terms of Resolution 196, of the National Health Council (CNS), issued on 10/ 10/1996, and its supplementaries. It was established through Ordinance No. 20 of the Faculty of Medical Sciences (FCM)-Unicamp, in 1997 and currently, due to its institutional nature, it is linked to the Dean of Research at Unicamp and the Ministry of Health (MS), in accordance with current legislation and the terms of Resolution 466/2012, issued by the CNS,/MS.
ARTICLE 1. The purpose of the CEP is to analyze, regulate and enforce the ethical aspects of research involving human beings, arising from Unicamp's major areas of knowledge. Additionally, the CEP can assume the same functions in relation to projects external to the University, as long as they are indicated by the National Research Ethics Commission - CONEP.
- 1º The CEP and its members have total independence of action in the exercise of their functions, and must keep information confidential and confidential. At the beginning of their duties, all CEP members, including their administrative employees, must sign the Commitment and Confidentiality Agreement relating to their administrative and/or reporting activities, in which they attest to their responsibility to maintain and ensure the confidentiality of their work. work on projects and other demands of this CEP.
- 2º It is not the responsibility of the CEP to issue information on the content of projects in progress or with an opinion already issued, so that the breach of this commitment by any of its members, in any instance, will constitute an infraction of breach of confidentiality, subject to the penalties provided for by law.
- 3º In cases of requesting information on projects processed or in progress, the CEP will only be responsible for informing the final decision of the opinions issued: approved, pending, not approved, archived, suspended and withdrawn.
- 4th The CEP is located on the 1st floor of Building I of FCM-Unicamp, located at Rua: Tessália Vieira de Camargo, 126; cep 13083-887 Campinas – SP, serving researchers and the general public from Monday to Friday, from 08:00 am to 11:30 am and from 13:00 pm to 17:00 pm, via telephone (19 ) 3521-8936 / 3521-7187 and email email@example.com.
ARTICLE 2. The CEP will be responsible for all the attributions conferred by Resolution 466/2012 CNS/MS and other legislation in force, with emphasis on the following attributions:
- 1st Play a deliberative, consultative and educational role, with primary responsibility for decisions on the ethics of research to be carried out and in which human beings participate.
- 2nd Review, from ethical aspects, the research protocols generated by the academic community, in order to guarantee and protect the integrity and rights of participants in these researches.
- 3º Monitor the development of projects, through periodic reports from the responsible researchers.
- 4º When analyzing and deciding on the ethical aspects of the research evaluated, the CEP becomes co-responsible for guaranteeing the protection of research participants.
- 5º Maintain the confidential custody of all data obtained in the execution of its task and the archiving of protocols and reports of research activities for five years, after the end of the study declared in the final report.
- 6º Receive research participants, their parents/legal guardians and/or other interested parties, in cases of complaints, denunciations or notifications about events that may alter the normal course of a study, deciding on its continuation, modification, suspension or other measures that consider necessary.
- 7th Request the establishment of an Internal Technical Committee (CTI) for cases of irregularities of an ethical nature in research projects e that had an opinion issued by this CEP.
- 8th Request the initiation of an inquiry to the competent bodies, in accordance with Resolution 466/2012 CNS/MS, for cases included in the previous paragraph and which require evaluation by other bodies.
§ 9 Maintain regular and permanent communication with CONEP and fulfill the duties designated by legislation.
CHAPTER II – COMPOSITION
ARTICLE 3. The Committee is made up of an administrative body, a Board of Directors and by a collegiate with 42 reporting members.
- 1st The administrative body is made up of professionals who work in the reception, secretariat, forwarding and dispatch of documents, being prevented from carrying out reports and issuing project opinions.
- 2nd The collegiate is made up of participants of legal age, and has a multidisciplinary character, complying with athe principle that the same professional category cannot occupy more than half of this composition.
- 3º As reporting members that make up the collegiate, the CEP must have a representative(s) from civil society and at least one student regularly enrolled in a postgraduate/doctoral level program at Unicamp.
- 4º The CEP may count on consultants and following the best practices, whether or not they belong to Unicamp, with the purpose of providing technical support for issuing opinions.
ARTICLE 4. The term of office of the members of the collegiate is three years, with the exception of representatives of civil society who may be “pro-tempore”. Renewal of members will be requested through communication from the Committee to Unicamp bodies (Faculties, Institutes, Centers, Centers, etc.) or request to the Committee for candidates for members external to Unicamp. When requested, the bodies The term of office of new members will begin at the first meeting of the month following the appointment, with reappointment of members being permitted.
- 1º The internal members, appointed by their bodies of origin, must have their appointment confirmed through a letter sent to the CEP, by the respective body of the State University of Campinas, within 30 (thirty) days after the request by the Committee.
- 2 Candidates for external members must send a letter to the CEP secretariat justifying their interest in joining the aforementioned panel, as well as proving experience in research. The Board will decide whether or not to accept the application.
- 3rd All new members joining the Committee must receive the training offered by the CEP so that they become fully qualified to evaluate projects and issue opinions.
- 4º The dismissal of internal members must be informed to the CEP by the respective body of origin, which must appoint new member(s) in a number no less than the number of terminated members, and within 30 (thirty) days after communication of the dismissal .
- 5º It is up to the CEP to communicate to CONEP the situations of vacancy or removal of members and forward the replacements made, justifying them in accordance with the Operational Standard CNS 001/2013.
- 6º Members of the CEP cannot be remunerated for carrying out their duties, but may, however, receive reimbursement for expenses incurred with transportation, accommodation and food, and it is essential that they are exempted by the institution from other obligations during the hours of their work at the CEP, given the public relevance of the function.
ARTICLE 5. The Committee will be directed by a Board of Directors formed by members of the CEP who have a professional relationship with Unicamp and represented by a Coordinator, the 1st and 2nd Vice-coordinators and a Secretary, elected from among the members of the collegiate through a secret vote, in plenary meeting at the end of each three-year term.
§ 1 The term of office of these members is three years.
CHAPTER III - ATTRIBUTIONS OF THE BOARD OF DIRECTORS
ARTICLE 6. The Coordinator is responsible for:
- 1st Chair the meetings.
- 2nd Determine the distribution of documents and research projects to rapporteurs.
- 3rd Decide on the convening of ordinary and extraordinary meetings.
- 4th Be responsible for preparing and sending final opinions to researchers.
- 5th Forward requests for reconsideration to the plenary.
- 6th Represent the Committee in all instances, inside and outside Unicamp.
ARTICLE 7. The 1st Vice-coordinator is responsible for replacing the coordinator, in their impediments.
ARTICLE 8. The 2nd Vice-coordinator is responsible for replacing the 1st Vice-coordinator if he/she is unable to do so.
ARTICLE 9. The Secretary is responsible for:
- 1st Call meetings, at the request of the Coordinator.
- 2º Be responsible for preparing minutes and summaries.
§ 3º Be responsible for processing incoming and outgoing correspondence.
CHAPTER IV - ATTRIBUTIONS OF REPORTING MEMBERS
This CEP maintains a collegiate body made up of reporting members, including the members of the Board of Directors. O quorum for decision making is established considering the number of active members on the Committee.
Active members are those with regular activities in the CEP, represented by issuing opinions, attending regular monthly meetings and meeting other demands.
ARTICLE 10°. It will be up to the rapporteur to assess and analyze the research projects allocated to him through the Plataforma Brasil System, respecting the principles of confidentiality and impartiality, issuing his opinion within the deadlines set out in these Regulations.
ARTICLE 11°. Opinions will be issued through analysis of documentation relevant to the project, as well as its amendments, notifications, reports and other complements.
Sole paragraph – The rapporteur will be prevented from issuing opinions or participating in the decision-making process in cases of research protocols in which he is directly or indirectly involved or under any other condition that characterizes a conflict of interest.
ARTICLE 12°. The issuance of opinions must meet the following deadlines, counting from the date of documentary validation of the respective project:
- 1st Five days for justified refusal to report.
- 2nd Until the day before the ordinary meeting of the current month, for the reporting of the first version of projects.
- 3rd Ten days for reporting responses to pending issues, notifications and amendments, counting from the date of documentary validation of the respective project.
ARTICLE 13°. The rapporteur who does not carry out his activities within the deadlines set out in the previous article, without presenting justifications accepted by the Board of Directors, will be automatically disconnected from the CEP/CONEP system of the Plataforma Brasil System and the CEP.
ARTICLE 14°. The rapporteur who presents three consecutive absences from ordinary meetings, without justification accepted by the Board of Directors, will be excluded from the membership, after the return of the research projects under his responsibility.
ARTICLE 15°. The rapporteur who presents four absences from ordinary meetings, during the current year and regardless of the justification, will be excluded from the list of reporting members, after returning the research projects under his responsibility.
ARTICLE 16. In any of the conditions provided for in Articles 13, 14 and 15, the Committee will inform the original Body of the dismissal of the missing members, requesting, or not, their respective replacement.
ARTICLE 17°. The rapporteur is prohibited from carrying out activities in which private interests could compromise the public interest and his impartiality in the exercise of his functions in the CEP/CONEP system.
CHAPTER V – PROCESSING OF PROJECTS
ARTICLE 18°. The submission of projects by researchers to the Plataforma Brasil System will follow the following conditions:
- 1st Submission of the research project, responses to pending issues, notifications and amendments may be carried out on any day of the month.
- 2º Documentary checking will be carried out within 10 days after submission of the research project.
- 3rd The first substantiated opinion will be issued within 30 days from the date of documentary acceptance of the submitted material.
ARTICLE 19. The CEP will receive projects generated by the academic community and submitted for ethical assessment through the Plataforma Brasil System in accordance with the rules for inclusion and analysis of current documents.
- 1º The initial evaluation of the projects will be carried out by a rapporteur, followed by the evaluation of the collegiate body in a plenary meeting closed to the public, and concluded with the issuance of a substantiated opinion by one of the members of the CEP Board of Directors, respecting the provisions of Article 23 of this Regulation.
- 2º The analysis of the research protocol will culminate in the issuance of the opinion substantiated with its classification as:
- Approved: when the protocol is suitable for execution.
- Pending: when there is a need for correction, clarifications and/or changes to the research protocol are requested. As long as the requirement made is not met satisfactorily, the protocol will continue to be “pending”. The researcher will have a period of thirty (30) days to meet the requirement, counting from the issuance of the opinion in the Plataforma Brasil System.
- Not approved: when the ethical obstacles to the protocol are considered to be of such gravity that they cannot be overcome by simply reviewing the protocol. In decisions not to approve, an appeal may be made to the CEP itself and/or Conep within 30 days, whenever any new fact is presented to justify the need for a reanalysis.
- Retired: when the CEP/Conep System accepts the request of the responsible researcher, with justification, to withdraw the protocol, before its ethical assessment. In this case, the protocol is considered closed.
- Suspended: when approved research, already in progress, must be interrupted for safety reasons, especially regarding the research participant, or another justifiable reason.
- Filed: when the researcher fails to meet the 30 deadline to send responses to pending issues or to appeal the decision of the CEP/CONEP system.
- 3rd Data collection provided for in the research protocols can only begin after approval of the respective project by CEP and CONEP, when applicable.
ARTICLE 20°. The Committee will consider requests for reconsideration on unapproved protocols in a plenary meeting, upon justified request from the proponent(s).
ARTICLE 21. The minimum quorum for meetings to begin is 50% (fifty percent) of the members plus one of those present.
CHAPTER VI – GENERAL PROVISIONS
ARTICLE 22°. The 11 (eleven) ordinary CEP meetings scheduled for the year will be held once a month, from February to December, with extraordinary meetings being called when necessary in virtual, hybrid or in-person mode.
Sole paragraph – Extraordinary meetings may be called by the Coordinator or at the request of at least 50% plus one of the Committee members, respecting a minimum period of three days from the call for due communication.
ARTICLE 23. Committee meetings begin with reports from the Coordination and members, followed by a vote on the summary of the previous meeting, and the survey of more delicate protocols for consideration in the plenary. Then, the members of the collegiate are divided into groups to discuss the other protocols. Occasionally, meetings may be preceded by advisors speaking ad-hoc.
ARTICLE 24. The Committee's deliberations must be approved by a quorum of 50% plus one of the number of those present at the collegiate meeting.
ARTICLE 25°. For the collegiate's deliberations, all members will have the right to voice and vote.
Sole Paragraph – The Coordinator will have the right to voice and address questions, but will not have the right to vote, except in situations of equal voting, when he will express the decisive vote.
ARTICLE 26°. The members of the Board of Directors may be prevented from carrying out their functions, while responding to an administrative procedure or legal process incompatible with the Committee's duties, in view of copies of the respective records. Said impediment must be approved by at least 2/3 of the Committee members, in an extraordinary meeting called especially for this purpose.
ARTICLE 27°. In face-to-face meetings, the presence of members will be recorded by signing the appropriate list at the beginning of each ordinary and extraordinary meeting. In the case of virtual meetings, attendance will be recorded using tools available for this purpose.
ARTICLE 28°. In the event of a strike, the CEP will promote essential activities regarding the processing of research protocols and service to the community, establishing effective communication on forms of contact with the Committee and CONEP;
ARTICLE 29. In cases of institutional recess, the CEP will inform the academic community and research participants and/or their representatives about the period of this period and the means of contacting the CEP and CONEP, in advance, through electronic dissemination.
ARTICLE 30°. The Unicamp academic community will be guided on the procedures and ethical precepts in research involving human beings through the “CEP das Unites” program.
ARTICLE 31°. These Regulations may only be changed by decision in a plenary meeting, and each proposed change must be approved by at least 2/3 of the members present.
ARTICLE 32°. This Regulation will come into force immediately after its approval in a plenary meeting.
ARTICLE 33°. Cases omitted from these Regulations will be decided by the Board of Directors or in a plenary meeting of the Committee, until the necessary amendments are approved.
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