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Research Ethics Committee of IDP

About Us

the committee

Research Ethics Committee of IDP (CEP-IDP/BSB): Ensuring Ethics in Research with Human Subjects.
 
The Research Ethics Committee of the Brazilian Institute of Education, Development and Research (CEP-IDP/BSB) is a multidisciplinary collegiate body of a consultative, deliberative and educational nature. Our main objective is to evaluate and monitor research and development projects involving human beings, ensuring that they are conducted ethically and responsibly.

Our Mission Its purpose is to defend the integrity of research participants, promote reflection and debate on ethical issues in research, and ensure compliance with current regulations and legislation. 

Our Activities This includes ethical analysis of research projects, monitoring the progress of the research, preparing reports, and providing training in research ethics. 

The CEP/IDP is composed of members from diverse fields of knowledge, including researchers, professors, representatives of research participants, and members of civil society. This diversity ensures a comprehensive and rigorous evaluation of research projects. 

Together, we build a future of research with ethics and responsibility! 

REGIMENT

Our activities are regulated by our Internal Regulations, approved on [date]. They comply with current research legislation, especially Resolutions No. 706/2023, No. 466/2012 and No. 510/2016, Operational Standard No. 001/2013 of the National Health Council (CNS) of the Ministry of Health (MS), and the National Research Ethics Committee (CONEP), Law No. 14.874/2024 which governs research with human beings and establishes the National System of Ethics in Research with Human Beings, and the Institution's own regulations.

INTERNAL REGULATIONS

MEETING CALENDAR

Our meetings are ordinarily held once a month and extraordinarily, whenever necessary, upon convocation by the Coordinator. Decisions will be made by seeking consensus among the members and, when necessary, by majority vote.

Meetings are held virtually and led by the coordinator, or in their absence, by the vice-coordinator. There will be no meetings during the institutional recess period, as determined by the IDP/BSB academic calendar.  

REGIMENT

Our activities are regulated by our Internal Regulations, approved on [date]. They comply with current research legislation, especially Resolutions No. 706/2023, No. 466/2012 and No. 510/2016, Operational Standard No. 001/2013 of the National Health Council (CNS) of the Ministry of Health (MS), and the National Research Ethics Committee (CONEP), Law No. 14.874/2024 which governs research with human beings and establishes the National System of Ethics in Research with Human Beings, and the Institution's own regulations. 

INTERNAL REGULATIONS

MEETING CALENDAR

Our meetings are ordinarily held once a month and extraordinarily, whenever necessary, upon convocation by the Coordinator. Decisions will be made by seeking consensus among the members and, when necessary, by majority vote.

Meetings are held virtually and led by the coordinator, or in their absence, by the vice-coordinator. There will be no meetings during the institutional recess period, as determined by the IDP/BSB academic calendar.  

Documents and Legislation 

Our activities comply with current research legislation, especially the following regulations:

To request the evaluation of a Research Project at CEP-IDP/BSB, first read CNS Resolution 466/12 and complementary resolutions (CONEP RESOLUTIONS) and follow the instructions below: 

  • 1. Research projects and supporting documents must be submitted in one (01) copy on the Brazil Platform (http://aplicacao.saude.gov.br/plataformabrasil/login.jsf) with all documents required by the CEP duly signed and digitized (scanned);
  • 2. The RESEARCH PROJECT COVER SHEET will be completed on the Brazil Platform and, after being signed by the Principal Investigator and also by the Director of the Proposing Institution, must be scanned and attached to the aforementioned platform.
  • 3. The documents required for submitting projects to CEP-IDP/BSB, and their respective templates, are available at the end of this article.
  • 4. All members of the research team listed in the CEP-IDP/BSB template document (Detailed Team) must be registered on the Plataforma Brasil in the Research Team field;
  • 5. Failure to submit all required documentation will result in the research project being rejected by the CEP-IDP/BSB.
  • 6. Any proposed modification to the original project must be submitted to the Ethics Committee (CEP) as an AMENDMENT, with the justification for the amendment. We clarify that amendments must be written clearly and concisely, identifying the part of the protocol to be modified and the justifications (see document template on the website). Furthermore, it is necessary to attach the updated version of the research project to the Plataforma Brasil, highlighting the proposed modifications.
  • 7. Proposals to extend or continue the research with the same recruited subjects, without essential changes to the objectives and methodology of the original project, must be submitted to the Ethics Committee through an EXTENSION request.
  • 8. A new research protocol must be submitted to the Ethics Committee whenever there are significant changes to the research objective and method.
  • 9. All project processing must be carried out via Plataforma Brasil. The CEP-IDP/BSB will not accept printed documents related to the research protocol, except in cases where the Committee specifically requests it.
  • 10. Detailed guidance for accessing the Brazil Platform and registering a research project (link to the document).

ObservationTo facilitate understanding of the project's progress, see the... Explanatory Flowchart.

To request the evaluation of a Research Project at CEP-IDP/BSB, first read CNS Resolution 466/12 and complementary resolutions (CONEP RESOLUTIONS) and follow the instructions below:

Attention!

  • If you receive project issues via Plataforma Brasil, open the substantiated opinion, as this document contains all the issues to be addressed (template of a Response Letter to the issues in the Substantiated Opinion).
  • Any modifications or amendments to the protocol must be submitted to the Ethics Committee in a clear and concise manner, identifying the part of the protocol to be modified and the justifications (model of a Letter of Submission of Amendment to a Project).
  • Partial and final reports must be submitted to the Ethics Committee every six (06) months after approval of the research project and at the end of the study (template for preparing partial and final research reports).

In the case of the creation of a biorepository linked to a specific research project, without future use of the samples, in addition to the documents required for project submission, the following documents must also be attached:

1. Declaration of the creation of a Biorepository without future use of the samples.

2. Internal Regulations for the Formation of the Biorepository  

3. Biorepository Infrastructure Statement  

4. Informed Consent Form for participants. 

Guidelines 

Step-by-step submission process 

With Plataforma Brasil, researchers can easily track their projects at every stage, from submission to final approval by the Ethics Committee (CEP) and, when necessary, by CONEP (National Ethics Committee). 

See the step by step:

1

The researcher submits the project via Plataforma Brasil. 

2

CONEP distributes the project to CEP-IDP/BSB. 

3

CEP-IDP/BSB receives the project. 

4

Document Evaluation:
a. Documentation approved? 
YesProject sent to reviewer designated by the Ethics Committee. 
NoProject returned to researcher for corrections. 

5

Project Evaluation:
a. The reviewer receives the project via Plataforma Brasil and a notification email. 
b. The reviewer performs an ethical and documentary analysis of the project. 
c. The reviewer submits the report via Plataforma Brasil to the coordination and administrative collaborator of the Ethics Committee. 
d. Meeting of the board: 
– Reading of the opinion. 
– Discussion with other reviewers. 
e. Reviewers prepare the collegiate body's opinion. 

6

The committee's opinion has been sent to the researcher. 

Notes:

  • The project evaluation process only begins after document approval.
  • The opinion of the panel is the final opinion, following the discussion at the meeting.
  • Research can be followed at its different stages on the Brazil Platform.
  • CONEP is responsible for distributing the projects to the committees registered on the Brazil Platform.
  • The CEP-IDP/BSB is responsible for the ethical and documentary evaluation of projects assigned to it.
  • The reviewers are responsible for the individual analysis of the projects.
  • The board is responsible for the final decision on the projects.
  • This flowchart aims to present a comprehensive overview of the project submission and evaluation process on the Plataforma Brasil platform, considering the different stages and the actors involved.

Tips:

To facilitate understanding of the project's progress, it is necessary to clearly explain: 

  1. The type of study: whether qualitative/quantitative and their respective subtypes.
  2. The objectives of the work.
  3. The procedures that will be used for data generation/collection, such as interviews, field notes, audio/video recordings, blood sample collection, ultrasound examinations, weight and height measurements, etc.
  4. The type of analysis – statistical (with specified resources), qualitative, documentary, content analysis, etc.
  5. The risks and benefits of research, especially for research participants, even if they are indirect benefits (remember that all research carries risks for participants, therefore, under no circumstances is there any risk-free research).
  6. Ethical considerations: protection of confidentiality, preservation against embarrassment, prevention of risks that may arise from research procedures, protection of vulnerable groups, etc.
  7. Regarding the research participants:
    7.1. The exclusion and inclusion criteria,
    7.2. Recruitment methods (how candidates will be contacted, selected, approached).
    7.3. Whether they belong to vulnerable groups (if so, justify the choice). 
  8. The existing infrastructure for conducting the research at the institution where it will be carried out, or at the institution where data will be collected/generated, if this procedure involves using the infrastructure of that location.
  9. In the budget, a detailed list of research costs should be provided, clearly indicating who is responsible for funding each expense: Is the project funded? If so, who is funding it? Is it self-funded?
  10. Regarding the timeline: to avoid a lag between the date of approval by the Ethics Committee and the data collection period, it is suggested to schedule the start of data collection for three months after the research protocol is submitted to the Ethics Committee.
  11. Pay attention to the researcher's information (see template in "documents" – each researcher involved, even undergraduate students, must have their Lattes curriculum attached).
  12. No Informed Consent Form:
    12.1. Use clear, simple, and objective language, appropriate to each participant profile, so that they can truly understand what the research is about.
    12.2. Include the research objectives and the procedures to which the participants will be subjected.
    12.3. If including participants under the age of 18, prepare an Informed Consent Form for their guardian to sign.
    12.4. If including children/adolescents (between 07 and 18 years old), prepare an Assent Form.
    12.5. If using secondary data (such as medical records, for example), request a waiver of the Informed Consent Form, providing justification (template in the list of documents).
  13. cover sheet
    13.1. The proposing institution will be the Brazilian Institute of Education, Development and Research – IDP/BSB. 
    13.2. Data collection instruments, such as questionnaires, interview guides, service protocols, documentary data records, etc. 

Important!

  • The documents must be in PDF format, A4 size, and editable (allow copy and paste) and can be signed (except for the Informed Consent Form and Assent Form) and submitted via Plataforma Brasil.
  • The ethical review of research projects is a meticulous process that can be time-consuming. Therefore, researchers should submit their projects well in advance so that the schedule of monthly meetings of the CEP-IDP/BSB does not negatively impact their research.
  • It is the responsibility of researchers to keep up with changes to the CEP-IDP/BSB (Ethics Committee for Research with Human Beings of Brasília), especially the schedule for closing the agenda and monthly meetings;
  • The CEP-IDP/BSB only analyzes projects that have not yet begun their data collection phase;
  • Research involving indigenous populations and cooperation with foreign organizations (special thematic areas), in addition to evaluation by the CEP-IDP/BSB, will also be evaluated by CONEP. Therefore, the researcher should take this additional timeframe into account in the research schedule. 

Explanatory flowchart 

General Questions

All projects involving human beings (directly or indirectly), including projects using secondary data, sociological, anthropological, and epidemiological research, must be submitted to the Research Ethics Committee for review. The CEP-IDP/BSB does not evaluate projects involving animals. 

The CEP-IDP/BSB does not review projects after data collection has begun. 

Yes. However, the link must be made when filling out the cover sheet. 

All research projects involving human subjects (directly or indirectly) must be submitted to the Ethics Committee (CEP) for evaluation, whether they are undergraduate, specialization, master's, doctoral, etc. projects. The CEP/CONEP system only allows graduates to be considered researchers. Therefore, if the research is being conducted by an undergraduate student completing their course, the student cannot be listed as the principal investigator. 

No. Projects involving human beings, directly or indirectly, can only begin after effective approval by the Ethics Committee. 

According to CNS Resolution 466/12, the analysis of the ethical nature of a research project cannot be dissociated from the analysis of its scientific validity. However, this does not mean that the Ethics Committee issues opinions on the methodology used in the research, but rather on the possible ethical implications or repercussions arising from the methodological choices adopted. 

Yes. Any changes involving methodology, ethical criteria, changes in the researcher or interviewer team, as well as other relevant considerations, must be communicated immediately. 

According to CNS Resolution 466/12, it is the researcher's responsibility to "keep the research data on file, under their custody, for 5 (five) years, including individual records and all other documents recommended by the Ethics Committee". 

The cover sheet is generated after the basic project information is compiled on the Plataforma Brasil platform. Its purpose is to express the researcher's and institution's commitment to complying with CNS Resolution 466/12. The cover sheet will be responsible for the legal consistency of the project, identifying the researcher, institution, and Ethics Committee, following regulations and indicating the corresponding responsibilities. 

In general terms, the Informed Consent Form (ICF) must provide the research participant with all the information necessary for them to decide whether or not to participate in the research. It is necessary to read resolution 466/12 and consult the template available on the CEP-IDP/BSB website. 

Yes, you can use another template as long as all the necessary information is included and written in a direct, simple, and clear way, without technical terms or jargon, since the goal of the informed consent form is to be understood by the research participants in particular. 

Yes. There are special situations in which the Informed Consent Form (TCLE) may be waived, and it should be replaced by a waiver of TCLE, stating the reasons why it was impossible to obtain it, and the Ethics Committee (CEP) will judge its relevance. 

When the research participant is a minor, between 07 and 18 years old, or legally incapacitated; without prejudice to the requirement of informed consent from their legal guardians. 

This allows participants involved in the research to get in touch regarding any issues related to the research process, providing easy access to the researcher and the responsible committee. 

It is recommended to use the institutional address and the postal code, considering the greater ease of access for research participants. 

In order for the Ethics Committee (CEP) to assess whether research participants are being subjected to any type of constraint at any stage of the research, modifications may be necessary to make the research instrument more ethically appropriate and less invasive of the individual's privacy. In this case, if an ethical problem arises, it will be up to the CEP to provide guidance on the necessary points. 

No, because pre-testing involves human subjects. Only after approval by the Ethics Committee (CEP) can you "pre-test," and you must submit any implemented changes to the CEP. 

It serves to evaluate the technical capacity and ethical suitability of the principal investigator and other participants in conducting the research. 

The Ethics Committee (CEP) suggests scheduling a three-month period between the submission date of the research project and the start date of data collection. This timeframe is suggested considering the number of CEP members, the frequency of meetings, and the possibility of your project encountering outstanding issues. 

Yes, to ensure proper coverage, from an ethical standpoint, for the patient, the researcher, and the institution itself. 

According to the "Questions and Answers" document prepared by CONEP, which can be found on the following page: http://conselho.saude.gov.br/web_comissoes/conep/index.html, research involving only publicly available data that does not identify research participants, or only literature reviews without the involvement of human subjects, does not require approval from the CEP/CONEP System. However, it should be noted that if there is a possibility of identifying the research subject, the research must be registered with the CEP. The researcher should also consider the possibility of requiring CEP approval from a scientific journal when submitting an article for publication. In this case, the researcher should contact the CEP beforehand to obtain further clarification. 

Any outstanding issues must be addressed within 30 days of the date of the meeting in which the project was evaluated. After this period, the protocol may be archived. The detailed report contains all the necessary information.  

Most of the time, the problem is a failure to comply with the provisions of resolution 466/12. To ensure that your project is adequate and meets all regulatory requirements, check resolution 466/12. 

No. The entire process takes place online, via Plataforma Brasil, and the researcher must follow it through the website:  www.saude.gov.br/plataformabrasil. 

Contact

The CEP-IDP/BSB is located at SGAS Quadra 607 – Módulo 49 – Via L2 Sul – Brasília – DF, CEP 70.200-670. 
Phone contact: 61 99603-8549
Email: cep@idp.edu.br

Hours of Operation 
Monday to Friday, from 9 am to 12 pm and from 14 pm to 17 pm.