CEP

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.

• 2. It is not within the purview of the Ethics Committee to issue information about the content of projects under consideration or for which an opinion has already been issued. Therefore, any breach of this commitment by any of its members, at any level, will constitute a breach of confidentiality, subject to the penalties provided by law.
• 3. In cases where information is requested regarding projects that have been processed or are currently being processed, the Ethics Committee (CEP) will only be responsible for providing the final decision of the opinions issued: approved, pending, not approved, archived, suspended, and withdrawn.

§ 4 The CEP/Unicamp has a secretariat with an exclusive space for serving the academic community in general and research participants and is located on the 2nd Floor, Wing BD3 of the CCUEC Building, situated at Rua Saturnino de Brito, nº 45, CEP: 13083-889, Cidade Universitária, Campinas-SP, with service to researchers and the general public 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.

• 1. The Ethics Committee may refuse to conduct ethical reviews of research protocols submitted by CONEP, with justification.

§2. The Ethics Committee 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 – To 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 deemed necessary.

XI – To request the establishment of an Internal Technical Committee (ITC) for cases of ethical irregularities in research projects that have received an opinion issued by this Ethics Committee.

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 composed of an administrative body, a Board of Directors and a Collegiate Body with at least 20 (twenty) reporting members and at least 1 (one) representative of research participants (RPP).

• 1. The administrative staff consists of professionals who work exclusively on the activities of CEP/Unicamp, such as reception, secretarial work, forwarding and dispatching documents, and are prohibited from carrying out reports and issuing opinions on projects.
• 2. The Board is composed of participants of legal age and has a multidisciplinary character, adhering to the principle that the same professional category may not occupy more than half of its composition.
• 3. As reporting members that make up the Board, the CEP must include representative(s) from civil society and at least one student regularly enrolled in a doctoral-level postgraduate program 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.

• 1. Internal members, designated by their originating bodies, 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.
• 2. Candidates for external membership must submit a letter to the CEP secretariat justifying and explaining their interest in joining the aforementioned Committee, as well as demonstrating research experience. The Committee will decide whether or not to accept the application.
• 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.
• 4. The dismissal of internal members must be reported to the Ethics Committee 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 the dismissal notification.
• 5. When there is a change in the composition of the Ethics Committee, at least one-third of the members from the previous composition must be maintained.
• 6. It is the responsibility of the Ethics Committee (CEP) to inform CONEP of situations of vacancy or absence of members and to forward the replacements made, justifying them in accordance with CNS Operational Standard 001/2013 and CNS Resolution No. 706/2023.

§ 7. Members of the Ethics Committee may not be remunerated for the performance of their duties; however, they may receive reimbursement for expenses incurred for transportation, lodging, and meals, provided that they are excused from other obligations by their institution of origin during their working hours at the Ethics Committee, 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 an effective professional link 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.

• 1. The term of office for the Coordinator and Vice Coordinator is four years, with the possibility of reappointment.
• 2. The term of office for CEP members is four years, with reappointment permitted.

§ 3 The term of office for RPPs is 3 (three) years, starting from the date of their appointment.

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.

§ 4. To be responsible for preparing the final reports.

§ 5 Forward requests for reconsideration to the plenary session.

§ 6 Represent the Committee in all instances, inside and outside Unicamp.

§ 7. To train the new reporting members.

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 comply with the following deadlines, counted from the date of document 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 deadline for document verification is 10 (ten) business days, as provided for in art. 14 of Law No. 14.874/2024.

§ 3 The deadline for analysis and issuance of the initial opinion on research protocols is 30 (thirty) working days, counted from the full acceptance of the protocol documentation, in accordance with art. 14 of Law No. 14.874/2024.

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.

§ 1 The initial evaluation of the projects will be carried out by a rapporteur, followed by an evaluation by the Board in a plenary meeting closed to the public, maintaining secrecy and confidentiality, finalized with the issuance of a substantiated opinion by one of the members of the Board of Directors, respecting the provisions of Article 23 of these Rules of Procedure.

§ 2 The analysis of the research protocol will culminate in the issuance of a substantiated opinion classifying it as:

• • Research approval;
  • Research not being approved; or
  • Suspension, when approved research, already underway, needs to be interrupted for safety reasons.

§ 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. If there is a complaint of ethical deviation by any member of the Research Ethics Committee (CEP), within the scope of their functions in this committee, the board of directors will inform the reported member of the content of the complaint and the need for his/her removal from his/her activities as a member of the CEP, until the end of the investigation and vote by the collegiate, which must occur within a period of up to 60 days, counting from the date of receipt of the complaint.

ARTICLE 25. To investigate the complaint, an Internal Technical Committee (ITC) will be formed, consisting of 3 or 5 members and 1 secretary from the Ethics Committee appointed by the board of directors. These members will be chosen following the premise that they have no conflict of interest, as determined by the relevant institutional regulations.

ARTICLE 26. A report detailing the facts and the investigation will be prepared for presentation to the board for discussion. The report will be forwarded to the accused, who will have the right to present his or her defense at a subsequent regular meeting of the CEP.

ARTICLE 27. If the complaint is proven and the report is approved by the board, the member will be permanently removed from the Committee. Otherwise, the member may return to their duties.

ARTICLE 28. The final report approved by the collegiate body will be forwarded by the Board of Directors to the accused and to the higher authorities of the institution for their information.

ARTICLE 29. 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 30. CEP meetings will begin with reports from the Board of Directors and members, followed by deliberation on the minutes of the previous meeting. Then, the protocols selected for consideration by the Board will be presented. Occasionally, members may participate. before the start of the work.

Sole paragraph – The “ad hoc” member is not part of the Ethics Committee's membership and does not belong to the collegiate body; therefore, they should not participate in meetings or have access to the entire protocol for which they were invited to issue their opinion. To make their considerations, the “ad hoc” member must be in the room with the other members and receive from the Ethics Committee only the information strictly necessary for the execution of their task.

ARTICLE 31. After the initial stage, the members will be distributed into thematic chambers (groups) for the analysis of the remaining protocols, coordinated by the coordinators or by a member designated by them. The work will be conducted in groups, with private and confidential discussion. In cases where there is no consensus in a particular chamber, the protocol will return for joint analysis by the Board.

ARTICLE 32. Virtual meetings will preferably be held using the Google Meet, Zoom, Microsoft Teams, or Skype platforms, in that order of priority. Member attendance will be recorded by typing their full name into the form. chat from the platform used and, where applicable, by an automatically generated attendance list.

ARTICLE 33. The main room and thematic chambers will be administered by the administrative secretaries of the CEP, who will control access and guarantee the privacy, secrecy, and confidentiality of the discussions and coordinations. Coordinators or a member designated by them may also participate. Coordinators and secretaries may move between all virtual rooms whenever necessary.

ARTICLE 34. Meetings will have an average duration of four hours. After the conclusion of ordinary meetings, a summary will be prepared from the transcript of the recording, and the minutes will be printed, bound, and filed in the CEP Secretariat.

ARTICLE 35. Technical issues, such as network outages, connection instability, or operational difficulties, will be resolved through immediate telephone contact with the CEP Secretariat.

ARTICLE 36. The CEP's decisions must be approved by a quorum 50% plus one of the number of those present at the Board meeting.

ARTICLE 37. All members shall have the right to speak and vote in the Board's deliberations.

Sole paragraph – The Coordinator shall exercise the right to speak, vote, and may cast the deciding vote in situations of equal voting, thus expressing the decisive vote.

ARTICLE 38. 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 39. 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 40. Any changes to the infrastructure, composition of members and/or administrative staff of the CEP must be communicated to CONEP.

ARTICLE 41. 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 42. 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 43. 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 44. In cases of institutional recess, the Ethics Committee (CEP) will inform the academic community and research participants and/or their representatives of the recess period and the ways to contact the CEP and CONEP, in advance, through electronic dissemination.

ARTICLE 45°. 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 46. The validity period of the registration and accreditation shall be 4 (four) years, and at the end of this period, the renewal of the accreditation must be requested from CONEP.

ARTICLE 47°. 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 48. This Regulation shall come into force after its approval in a plenary meeting and, also consecutively, by CONEP.

ARTICLE 49°. 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.

Zeferino Vaz University City, January 05, 2026.