- read the CNS Resolution No. 510 of 2016 which provides for the ethical assessment of research protocols involving human beings and/or identifiable data, whose methodologies are typical of Human and Social Sciences, paying attention to the Rights of Research Participants.
- Rethink and rewrite some parts of the Research Project considering ethical appreciation, not scientific merit. That is, some information on the methodology needed to be incremented, such as: how the recruitment and selection of research participants will take place, how to obtain the contact to get in touch, approximate number of meetings, estimated duration of meetings, where data generation will take place, whether in person and/or remotely, etc.
- Considering that Consent is one of the Research Participant's rights, prepare a document in which it is presented how the free and informed consent of research participants will occur, as well as how the consent will be registered.
We present a script for the Free and Informed Consent Form (TCLE), with explanatory comments for each mandatory section in the Consent in the light of Resolution CNS Nº. 510 of 2016. CEP-CHS/Unicamp will appreciate the consent model that the research team proposes to use. Therefore, this document should only be presented to research participants after approval by CEP-CHS/Unicamp. That is, for the time being, present a document without signatures for CEP-CHS/Unicamp to appreciate.
In addition, it is suggested to read Section II of CNS Resolution No. 510 of 2016, which provides for the Registration of Consent.
- If you need to enter an institution to carry out the research and/or there is a need to obtain data from the institution, a Letter of Authorization from the Institution is required. It is suggested to use the Term of Consent, which needs to be signed when presenting it to CEP-CHS/Unicamp.
- Access to Platform Brazil.
If you have not yet registered on this Platform, click on Register, fill in your personal data and attach:
– Copy of identification document;
– An identification photo (can be self portrait);
- Resume.
The three files must be named without special characters (accent, space, cedilla, etc.), such as: identification, photo, curriculum.
Furthermore, in the Add Institution section -> type Unicamp (or the institution you are affiliated with) and click on the magnifying glass icon -> type the name of the unit from Unicamp that you have the institutional bond -> Click until it is highlighted with a rectangle -> Click on Add -> Click on Save.
At the end of the registration, an e-mail will be sent with your access password to the Brazil Platform;
- On the main page of Plataforma Brasil, click on New Submission;
- In Step 01 of Plataforma Brasil, Research Team section, include the name of the advisor and/or the research team, as well as the name of the advisees, if any. In the Proponent Institution section, select the Unicamp unit with which you have an institutional link. It is important to indicate as Proponent Institution the unit in which you have a link with Unicamp.
- In Stage 03 of Plataforma Brasil, Design section, it is possible to write: “See methodology”;
- In Step 04 of Plataforma Brasil, copy the information from the project script (summary, methodology, etc.), thinking mainly about research participants: recruitment, selection, how they will be approached, where contacts will be obtained, how data is generated with research participants, how many meetings, etc.;
- In Step 04 of Plataforma Brasil, section Primary Outcome, inform the Expected Results of the survey. When relevant, it is possible to inform “Not Applicable”;
- In Step 04 of Plataforma Brasil, Inclusion Criteria section, characterize the population to be researched (potential research participants);
- In Step 05 of Plataforma Brasil, even if the funding is your own, indicate in the budget which costs you will likely have with the research;
- In Step 05 of Plataforma Brasil, Participating Institution: if the field is filled in, the CEP of the indicated institution will also appreciate the research. Therefore, verify if the place where the research will be carried out has an Ethics Committee;
- Between Steps 05 and 06 of Plataforma Brasil, print the Face Sheet, fill in the CNPJ, position, etc.), date, sign, and forward it to the Unicamp unit's Board of Directors' e-mail that you have the institutional link to sign. Subsequently, attach it to the Brazil Platform;
- Between Steps 05 and 06 of Plataforma Brasil, section Declaration of Researchers, include a copy of proof of link with Unicamp. If you are a student: a copy of the updated Certificate of Enrollment. If you are a teacher, researcher or PAEPE career professional: copy of the functional or other document.
- Between Steps 05 and 06 of Plataforma Brasil, section Declaration of the Institution, include, if necessary, the Term of Consent of the Institution where the research data will be generated, according to the model indicated in item 04 of this step-by-step;
- Between Steps 05 and 06 of Plataforma Brasil, Free and Informed Consent Form (TCLE) section, attach the Consent form to be performed with research participants. It is suggested to use the script of item 03 of this step by step;
- Between Steps 05 and 06 of Plataforma Brasil, section Detailed Project/Researcher's Brochure, include the project file, according to the script in item 02 of this step-by-step;
- Before proceeding to Stage 06 of Plataforma Brasil, it is suggested to check this checklist on the presentation of research protocols to be presented for ethical appreciation, thus reducing pending issues: https://1drv.ms/w/s!AtkUNJcnB_YUmK5zxeYp_fl1Bq7N3g?e=DBN6ek;
- In Step 06 of Plataforma Brasil, click Send Project to CEP. Therefore, on the home page of Plataforma Brasil, the status of your research protocol should be In Reception and Document Validation. Otherwise, if the Status is in Editing, it means that the protocol has not yet been sent to CEP-CHS/Unicamp.