CEP-CHS

According to the CEP-CHS/Unicamp calendar, presentations of research protocols generally take place by the tenth of each month. Thus, the research protocol is considered at the regular meeting at the end of the month. Therefore, the consubstantiated opinion will probably be released by the tenth of next month (see CEP-CHS/Unicamp meeting calendar).

While the research protocol is In Ethical Consideration, the research team will not be able to make any changes to the research protocol. However, if you have identified any error, or absence of any document in the research protocol. While waiting for the release of the consubstantiated opinion, the research team can try to provide the documents that may be necessary to compose the research protocol, such as the Term of Consent signed from the place where the data will be generated.

Mandatorily, during the ethical assessment, the research team must:

1. Access the Plataforma Brasil to verify the status of the research protocol.
   Although Plataforma Brasil eventually sends an email to the research teams informing that “the research protocol was accepted for CEP analysis. Meaning that the CEP completed the document validation”, it is necessary to access the Plataforma Brasil to verify the status of the Research Protocol:

• In Reception and Document Validation: the research protocol has not yet been accepted for ethical review;
• Document pending: the CEP issued pending documents that need to be adequate for the research protocol to be appreciated. When completing the requested adjustments, in Step 06 click on Send project to CEP;
• In Ethics Appreciation: means that the research protocol had the documents accepted for ethical appreciation. However, this does not mean that your research protocol is approved and that the generation of data with human beings can begin. Since it is necessary to wait for the issuance of the Consolidated Opinion.

2. With the research protocol in Ethical Appreciation, after the date of the Ordinary Meeting, until the tenth of the following month, Access the Brazil Platform to verify the Embodied Opinion:

To locate the embodied opinion:

1. Access the Brazil Platform;
2. On the main screen, in the Research Projects List section, under Action, next to the magnifying glass icon, click the opinion icon (a white sheet with the capital P). Click Last Opinion. Thus, the latest opinion issued by CEP-CHS/Unicamp will be downloaded.
3. The status of the opinion can be:

• Okay: this means that the research can be started, since there are no ethical obstaclesc. However, even so, before starting to generate data, it is necessary to read the consubstantiated opinion, especially the Recommendations section (if any), the Conclusions or Pending Issues and List of Inadequacies and the Final Considerations at the CEP's discretion;
• Pending: the generation of data with human beings and/or identifiable data still can't be inisociety🇧🇷 Read the consubstantiated opinion, especially the Recommendations section (if any), the Conclusions or Pending Sections and the List of Inadequacies and the Final Considerations at the CEP's discretion.

Thus, it will be necessary to make adjustments to the research protocol and/or clarify situations asked by CEP-CHS/Unicamp, in addition to preparing a Response Letter to Pending Issues (below we will present how to proceed to respond to pending issues.

• Not approved: the protocol presents ethical obstacles that undermine the rights of research participants.

4. For research protocols with pending status, you must:
   
   4.1. Identify pending issues presented by CEP-CHS/Unicamp;
   4.2. In the Stages of the Brazil Platform, make adjustments to the sections that are necessary, including updating the schedule (when necessary), considering that the assessment of the Response to Pending Issues will take place within ten working days, about;
   4.3. Between Steps 05 and 06 of Plataforma Brasil, exclude files that need adjustments, as indicated in the Consolidated Opinion, such as: TCLE, project file. Attach the updated versions, with the changes highlighted in yellow;
   4.4 Between Steps 05 and 06, section Declaration of Researchers, append a Response Letter to Pending Issues.

Despite the name of the document being Carta Reply, it must be attached to the Plataforma Brasil, and not sent to the CEP's physical facilities by any other means. Since the ethical assessment is carried out exclusively via Plataforma Brasil.

To do so, copy all pending issues presented in the consolidated opinion and paste them in a text file. Responding punctually to each of them, for example:

4.5. In Step 06, click Send Project to the CEP and wait for the New Consolidated Opinion to be issued in approximately ten working days.

5. When the research protocol is approved by CEP-CHS/Unicamp, in the main area of ​​Plataforma Brasil the status (Situation) will be Approved. However, it is still necessary to view the Embodied Opinion with possible recommendations from CEP-CHS/Unicamp, in addition to general and specific guidelines.

6. While the survey is being carried out, some functionalities remain available on the Plataforma Brasil, such as:

• Send Notification: 
• Submit Amendment: 

6.1. Sending Notification on the Brazil Platform:

6.1.1. Sending a Letter of Authorization (Term of Consent) from the Institution where the research will be carried out or where data and identifiable information will be used. As a rule, the Letter of Authorization must be sent before the start of field research;

6.1.2 Sending Partial report from the search (https://1drv.ms/w/s!AtkUNJcnB_YUkJdTUtiUkiAreV47qg?e=w06azt), informing some intercurrence with research participants. Sending this report is only mandatory in case of intercurrences. Since the shipment must be made promptly.

6.1.3 Sending a Project Cancellation or Suspension Report. There is no Report template. Then, you can send a report of free choice by the research team and/or fill in the Justification field;

6.1.4 Mandatory for all research protocols approved by CEP-CHS/Uniamp, submission of Final report from the search (https://1drv.ms/w/s!AtkUNJcnB_YUkJdTUtiUkiAreV47qg?e=w06azt🇧🇷 The report is succinct, informing how the data was generated, main findings, links to publications, informing change of title.

In order for the Notification to be sent to CEP-CHS/Unicamp, click on Send Notification.

6.2 Submission of Amendment on the Brazil Platform:

When there is a proposal for some change in the research protocol, an Amendment must be sent, via Amendment, to the research protocol approved by CEP-CHS/Unicamp. When sending the Amendment, it will be necessary to wait for approval by CEP-CHS/Unicamp to put them into practice.

However, if there are substantial changes to the approved research protocol, or if the objective of the research changes, an Amendment should not be proposed, but proceed with a New Submission of the research protocol for ethical consideration.

Furthermore, the Amendment's ethical consideration schedule is the same as for a new research protocol. Therefore, it is necessary to update the schedule in Stage 05 of the Plataforma Brasil and between Stages 05 and 06 of the Plataforma Brasil, delete the project file and attach the version with the schedule and the updates in the methodology.

6.2.1. Access the Brazil Platform;

6.2.2. In Action, click on the magnifying glass icon of the research protocol approved by CEP-CHS/Unicamp (8142);

6.2.3. In Actions, click on the Amendment (+) icon;

6.2.4. In Step 01 of Plataforma Brasil, whether the Amendment is exclusive to CEP-CHS/Unicamp or whether it should also be appreciated by CEPs from co-participating institutions. In the second case, the assessment time for both CEPs must be foreseen in the schedule;

6.2.5. In the Stages of the Brazil Platform, update all the necessary information (research team, methodology, schedule, etc.). Changes made to the Stages of the Brazil Platform must be highlighted IN ALL CAPS;

6.2.6. Between Steps 05 and 06, delete the files that need to be updated and attach them again (TCLE, project file, etc.), with the changes highlighted in yellow;

6.2.7 In Step 06 list the proposed changes, in addition to justifying them;

6.2.8 Click Send Project to CEP.