Research Ethics Committee Pecege
CEP – Pecege

email: cep@pecege.com
cep.pecege.com

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  3. Schedules and deadlines

3. Schedules and deadlines

To perform its work, CEP-PECEGE needs a deadline ranging from the reception date of documents submitted by the researcher, to the issuance and submission of the consolidated report, containing its decision, to the researcher.

This deadline is defined by Conep (Operating Standard CNS nº 001/2013) and was incorporated into the CEP-PECEGE Regulation. If the researcher wants more information about the deadlines adopted by CEP-PECEGE, it is important to refer to the CEP-PECEGE Regulation

Projects should be sent to the Research Ethics Committee through Plataforma Brasil with, at least, 40 days in advance to be analyzed at the meeting.

In any situation (initial protocol or response to pending requests), research protocols will only be analyzed if all mandatory documents are correct and available in Plataforma Brasil (see the menu “Instructions for submission”, on this website, to have access to the list of documents that are necessary).

Reports are released, at the latest, in 5 days after the date of the meeting.

Annual calendar of ordinary meetings of CEP-PECEGE

Obs. : Dates and schedules presented above may be modified, according to CEP’s Collegiate, to meet the demand of research to be analyzed.
Extraordinary meetings may be requested by CEP’s Coordination.

 

3.1. Deadline for submitting research protocols - First submission

Initial protocols should be sent to CEP-PECEGE, at least, 40 days prior to the subsequent meeting. That is, considering the deadlines and schedule of the research, the researcher should choose, in the annual calendar of meetings of CEP-PECEGE, the date of a meeting that best meets their needs.

Thus, all necessary documents, plus the research project, should be referred to CEP-PECEGE 40 (forty) days prior to the date of the chosen meeting.

All referrals will be performed via Plataforma Brasil.

To know the step by step of the first submission, refer to the manuals available in the item “Documents and Orientations”.

Consolidated reports are released, at the latest, in 5 days after the date of the meeting.

Annual calendar of ordinary meetings of CEP-PECEGE

Obs.: Dates and schedules presented above may be modified, according to CEP’s Collegiate, to meet the demand of research to be analyzed.
Extraordinary meetings may be requested by CEP’s Coordination.

3.2. Deadline for submitting answers to pending requests

Whenever the researcher receives a consolidated report from CEP-PECEGE, they should pay attention to the last page of the report, in which the section “Report Status” is included.

If the researcher has received a report with a “PENDING” status, this means that the beginning of the research has not yet been authorized and that they should respond to the pending requests listed in the report.

This response should be elaborated and forwarded in a specific document, the Response Letter, following the model available, in up to 30 (thirty) days, starting from the date of signature of the consolidated report.

 

After receiving the Response Letter, CEP-PECEGE will issue a new report in up to 40 days, starting from the date of the researcher’s response recorded in Plataforma Brasil.

If the researcher doesn’t comply with the pending requests in up to 30 (thirty) days, the protocol will be considered “ARCHIVED” and it won’t be possible to perform the research

In this case, since the report presented a status of ‘PENDING’, the researcher should update the schedule of his research and, when appropriate, justify the feasibility of performing the research even with a narrow deadline.

It is important to note that, according to the sole paragraph of article 2 of the CEP-PECEGE Regulation, conducting research with human beings, without due approval of CEP-PECEGE, will be considered a “serious disciplinary infringement”, provided for exceptions.

All referrals will be performed via Plataforma Brasil.

To know the step by step of the submission of the response to pending requests, refer to the Item “Documents and Orientations” to Visualize Pending Project Report.

Reports are released, at the latest, in 5 days after the date of the meeting.

3.3. Deadline for submitting partial and final reports

According to current ethical guidelines, the researcher should submit reports during the development of the research to CEP.
There are two reports: a partial report and a final report.

The partial report is a simple report, in which the researcher informs CEP about the progress of the research work.
The partial submission deadline is dependent on the research schedule.

The recommendation is for the researcher to forward to CEP-PECEGE the partial report when the research development reaches the intermediate stage of the schedule, between the estimate of beginning and ending, and some results have already been produced. Therefore, there is no predetermined deadline for submission and it should be established at the discretion of the researcher themself.

The partial report should be sent to CEP via Plataforma Brasil, following the instructions available in the menu “Instructions for submission”.

The final report is the report of the end of the research, in which the researcher communicates  CEP of the results of the research and formalizes its end.
The deadline for submitting the final report is 30 days after the presentation of the final paper.

Submission of the final report is mandatory and should be sent via Plataforma Brasil, following the instructions available in the menu “Instructions for submission”.

3.4. Deadline for submitting appeals to CEP

Whenever the researcher receives a consolidated report from CEP-PECEGE, they should pay attention to the last page of the report, in which the section “Report Status” is included.

If the researcher has received a report with the “UNAPPROVED” status, the researcher will immediately be prevented from continuing their research and should interrupt any process regarding the study subjects.

A report with the status of “Unapproved” is issued when the collegiate of CEP thinks that the research design has a serious ethical impediment and that work should not be performed.

On rare occasions, if any information or new fact may change the decision of CEP, the researcher may forward an appeal request to CEP-PECEGE, presenting these facts or information, and requesting the reopening of the research protocol analysis process.

After receiving a report with the status of “Unapproved”, the researcher may draw up and forward a document (there is no predefined model), exposing their reasons for the request for reconsideration, within a maximum of 30 (thirty) days, counted from the date of signature of the consolidated report.

In this case, it is necessary to update the research schedule and, when applicable, justify the feasibility of conducting the research even with a narrow deadline.

It is important to note that, according to the sole paragraph of article 2 of the CEP-PECEGE Regulation, conducting research with human beings, without due approval of CEP-PECEGE, will be considered a “serious disciplinary infringement”.

All referrals will be performed via Plataforma Brasil.

Reports are released, at the latest, in 5 days after the date of the meeting.