Internal Rules

The Research Ethics Committee – Unicamp – Campinas Campus, hereinafter referred to in these Bylaws as “CEP”, “Committee” or “Research Ethics Committee”, is a Collegiate body, 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 Pro-Rector of Research at Unicamp and the Ministry of Health (MS), in compliance with CNS Resolution No. 706/2023 and Operational Standard 001/2013 and with the terms of CNS Resolution No. 466/2012 and its complementary ones.

These INTERNAL REGULATIONS incorporate, from the perspective of the individual and the collective, bioethical references, such as autonomy, non-maleficence, beneficence, justice and equity, among others, and aim to ensure the rights and duties that concern research participants, the scientific community and the State. Research projects involving human beings must comply with CNS Resolution No. 466/2012 and its complementary resolutions.

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 complete independence of action in the exercise of their functions, and must keep information confidential and secret. At the beginning of their functions, all members of the CEP, including its administrative staff, must sign the Commitment and Confidentiality Agreement regarding their administrative and/or reporting activities, in which they attest to their responsibility to maintain and safeguard the confidentiality of their work on projects and other demands of this CEP.

§ 2º It is not the CEP's responsibility 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, at any level, will constitute an infraction of breach of confidentiality, subject to the penalties provided for by law.

§ 3 In cases of requests for information on projects that are being 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for informing the final decision of the opinions issued: approved, pending, not approved, archived, suspended and withdrawn.

§ 4º The CEP/Unicamp has a secretariat with exclusive space to serve the academic community in general and research participants and is located on the 1st floor of Building I of FCM-Unicamp, located at Rua Saturnino de Brito, nº 45, CCUEC Building, Floor 2, Wing BD3, Cidade Universitária, Campinas-SP, CEP: 13083-889, and services for researchers and the general public are provided from Monday to Friday, from 08:00 am to 11:30 am and from 13:00 pm to 17:30 pm, by telephone (19) 3521-8936 / 3521-7187 and by email cep@unicamp.br.

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:

I – Draft the Internal Regulations.

II – Maintain the appropriate composition, in order to guarantee and maintain a quorum for deliberative activities at the Board meetings.

III – Choose, for the Board of Directors, members of the CEP who do not present a potential conflict of interest, by vote of the absolute majority (50% plus one) of the total number of full members.

IV – 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.

V – Review, from an ethical perspective, the research protocols generated by the academic community, in order to guarantee and protect the integrity and rights of the participants in these studies, issuing opinions within the normative deadlines stipulated in these Bylaws.

VI – Monitor the development of projects, through periodic reports from the researchers responsible.

VII – Analyze research protocols of the proposing Units and/or bodies linked to CEP/Unicamp or indicated by CONEP.

§ 1º The CEP may refuse to carry out the ethical assessment of research protocols indicated by CONEP, upon justification.

§ 2 The CEP is prohibited from charging any fees for the analysis of research protocols.

VIII – When analyzing and deciding on the ethical aspects of the research assessed, the CEP becomes jointly responsible for ensuring the protection of research participants.

IX – Maintain the confidentiality and secrecy of all data obtained in the execution of their task, in the deliberations of the Board in ordinary and extraordinary meetings, in the archiving of protocols and research activity reports for five years, after the conclusion of the study declared in the final report.

X – Receive research participants, their parents/legal guardians and/or other interested parties, in cases of complaints, reports or notifications about events that may alter the normal course of a study, deciding on its continuation, modification, suspension or other measures that it deems necessary. XI – 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.

XII – Request the opening of an investigation by the competent bodies, in accordance with Resolution 466/2012 CNS/MS, for the cases included in the previous paragraph and which require evaluation by other bodies.

XIII – Maintain regular and permanent communication with CONEP, by sending reports on its activities, within the regulatory deadlines and fulfilling the duties assigned by current legislation.

ARTICLE 3. The Ethics Committee is made up of an administrative body, a Board of Directors and a Board with 32 reporting members and 5 representatives of research participants (RPPs).

§ 1º The administrative body is made up of professionals who work exclusively in CEP/Unicamp activities, such as reception, secretarial work, forwarding and issuing documents, and are prevented from carrying out reporting and issuing opinions on projects.

§ 2º The Board is made up of participants of legal age and has a multidisciplinary nature, following the principle that the same professional category cannot occupy more than half of this composition.

§ 3º As reporting members that make up the Board, the CEP must have representative(s) of civil society and at least one student regularly enrolled in a postgraduate program, Doctorate level, at Unicamp.

§ 4º The CEP may have consultants ad-hoc, whether or not belonging to Unicamp, with the purpose of providing technical support for issuing opinions, provided that they are not members of the CEP.

ARTICLE 4. Member renewals shall be requested by means of a communication from the Ethics Committee to Unicamp bodies (Colleges, Institutes, Centers, Nuclei, etc.) or to members external to Unicamp. When requested to the respective university bodies, the term of office of new members shall begin at the first meeting of the month following their nomination, and reappointment of members shall be permitted.

§ 1º Internal members, appointed by their bodies of origin, must have their appointment confirmed by means of an institutional document sent to the CEP, by the respective Unicamp body, within 30 (thirty) days after the request by the Committee.

§ 2º The candidate for external member must send to the CEP secretariat a letter justifying and substantiating his/her interest in being part of the aforementioned Board, as well as proving research experience. The Board will decide whether or not to accept this candidacy.

§ 3 All new members joining the Committee must receive training offered by the CEP so that they become fully qualified to assess and analyze projects and issue opinions.

§ 4º The dismissal of internal members must be informed to the CEP by the respective originating body, which must indicate new member(s) in a number not less than the number of dismissed members and within 30 (thirty) days after communication of the dismissal.

§ 5º It is the responsibility of the CEP to communicate to CONEP the situations of vacancy or removal of members and to forward the replacements made, justifying them in accordance with Operational Standard CNS 001/2013 and Resolution CNS nº 706/2023.

ARTICLE 5. The Committee will be headed by a Board of Directors, formed by members of the CEP who have professional ties with Unicamp and represented by 1 (one) Coordinator and the 1st and 2nd Vice Coordinators, elected by the members of the Board through secret ballot, in a plenary meeting, with a deliberative quorum of 50% (fifty percent) of the reporting members plus 1 (one) more member, at the end of each four-year term.

§ 1º The term of office of the Coordinator and Vice Coordinator is four years, with reappointment permitted.

§ 2º The term of office of CEP members is four years, with reappointment permitted.

§ 3 The mandate of the RPPs may be “pro tempore".

ARTICLE 6. The Coordinator is responsible for:

§ 1 Chair the meetings.

§ 2 Determine the distribution of documents and research projects to the rapporteurs.

§ 3 Decide on the calling of ordinary and extraordinary meetings.

§ 4º Be responsible for preparing and sending final opinions to researchers.

§ 5 Forward requests for reconsideration to the plenary session.

§ 6 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 in the event of his/her absence.

ARTICLE 9. This CEP maintains a Board composed of reporting members, including the members of the Board of Directors. The quorum for decision-making is established considering the number of active members in the Committee, as established in these Bylaws.

ARTICLE 10. Active members are those with regular activities in the CEP, represented by the issuance of opinions, attendance at monthly regular meetings and meeting other demands, as established in these Bylaws.

ARTICLE 11°. 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 12°. 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 13. The issuance of opinions must meet the following deadlines, counted from the date of documentary validation of the respective project.

§ 1 Five days for the reviewer to refuse to report, provided that it is justified on the Plataforma Brasil.

§ 2 Until the day before the regular meeting of the current month, for the issuing of the rapporteur's opinion on the first version of the project.

§ 3 Ten days to issue the report of the study rapporteur with responses to pending issues, notifications and amendments, counted from the date of documentary validation of the respective project.

ARTICLE 14. The rapporteur who does not fulfill his/her activities within the deadlines set forth in the previous article, without presenting justifications accepted by the Board of Directors, will be automatically removed from the CEP/CONEP system, the Plataforma Brasil System and the CEP.

ARTICLE 15. The rapporteur who is absent from regular meetings for three consecutive days, without justification accepted by the Board of Directors, will be excluded from the membership, after returning the research projects under his/her responsibility.

ARTICLE 16°. 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 17. In any of the conditions provided for in Articles 13, 14 and 15, the CEP will inform the originating body of the dismissal of the absent members, requesting, or not, their respective replacement.

ARTICLE 18. The rapporteur is prohibited from engaging in activities in which private interests may compromise the public interest and his/her impartiality in the exercise of his/her functions in the CEP/CONEP system.

ARTICLE 19. The submission of projects by researchers in the Plataforma Brasil system will follow the following conditions:

§ 1º The submission of the research project, responses to pending issues, notifications and amendments may be made on any day of the month.

§ 2 The document check will be carried out within 10 days after the submission of the research project.

§ 3 The first substantiated opinion will be issued within 30 days from the date of documentary acceptance of the submitted material.

ARTICLE 20. The CEP will receive projects generated by the academic community and submitted for ethical assessment through the Plataforma Brasil System, in accordance with the current rules for inclusion and analysis of documents.

§ 1º The initial evaluation of the projects will be carried out by a rapporteur, followed by the evaluation of the Board in a plenary meeting closed to the public, maintaining secrecy and confidentiality, ending with the issuing of the opinion substantiated by one of the members of the Board of Directors, respecting the provisions of Article 23 of these Regulations. § 2º The analysis of the research protocol will culminate in the issuing 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.

§ 3º The data collection provided for in the research protocols may only begin after approval of the respective project by the CEP and CONEP, when applicable.

ARTICLE 21. The CEP will consider, in a plenary meeting, requests for reconsideration of non-approved protocols, upon justified request from the proponent(s).

ARTICLE 22. The minimum quorum for the start of meetings is 50% (fifty percent) plus one of the members present.

ARTICLE 23. The CEP may issue opinions “Ad Referendum"only in cases of analysis of pending responses and for analysis of appeals, never in the initial analyses. The initial analysis of a research protocol must always be discussed in a meeting with the other members of the CEP, and it is not acceptable for the rapporteur to propose the processing"ad referendum” in the initial protocol analyses.

ARTICLE 24. The 11 (eleven) ordinary meetings of the CEP 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 25. CEP meetings begin with reports from the members of the Board of Directors and members, followed by a vote on the summary of the previous meeting and the raising of more sensitive protocols for consideration by the Board. The members of the Board are then divided into groups to discuss the remaining protocols. Occasionally, the meetings may be preceded by a speech by advisors. .

ARTICLE 26. The CEP's decisions must be approved by a quorum 50% plus one of the number of those present at the Board meeting.

ARTICLE 27. All members shall have the right to speak and vote in the Board's deliberations.

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 28. The members of the Board of Directors may be prevented from exercising their functions while they are subject to an administrative procedure or legal proceeding incompatible with the duties of the CEP, upon presentation of copies of the respective records. Such impediment must be approved by at least 2/3 of the members of the CEP, in an extraordinary meeting called especially for this purpose.

ARTICLE 29. In face-to-face meetings, the presence of members will be recorded by signing an appropriate list at the beginning of each regular and extraordinary meeting. In the case of virtual meetings, attendance will be recorded using tools available for this purpose.

ARTICLE 30. Any changes to the infrastructure, composition of members and/or administrative staff of the CEP must be communicated to CONEP.

ARTICLE 31. The CEP, upon receiving complaints or noticing situations of ethical infractions, especially those that imply risks to research participants, must communicate the facts to the competent bodies for investigation and, if applicable, to the Public Prosecutor's Office.

ARTICLE 32. The CEP will approve, in the first two months of each year, a training plan for its members and the academic community to promote education in ethics in research involving human beings.

ARTICLE 33. In the event of a strike, the CEP will promote the fulfillment of essential activities regarding the processing of research protocols and community service, establishing effective communication on forms of contact with the Committee and CONEP.

ARTICLE 34. In cases of institutional recess, the CEP will inform the academic community and research participants and/or their representatives of the period and the forms of contact with the CEP and CONEP, in advance, through electronic dissemination.

ARTICLE 35°. 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 36. The validity period of registration and accreditation, which will be 4 (four) years, as well as that at the end of this period, renewal of accreditation must be requested from CONEP.

ARTICLE 37°. 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 38. This Regulation shall come into force after its approval in a plenary meeting and, also consecutively, by CONEP.

ARTICLE 39°. 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.