In order to avoid unnecessary pending issues that, therefore, can be eliminated before the submission of the Research Protocol, it is important to carefully read some basic information that the ZIP CODE - Bahiana disposes. These measures will reduce the time for the release of the substantiated opinion and/or approval.
The responsible researcher must, at the beginning of the submission, link all assistant researchers and team members, so that everyone can have access to information related to the project, as well as carry out edits, adjustments and corrections to it.
It must contain a description of all stages of the research, including the presentation of partial and final reports.
• It is necessary to be careful that the date of collection does not come before CEP approval, suggesting that the survey has already been carried out.
• When preparing the project, the responsible researcher must commit to starting the research only after approval by the CEP. Therefore, this statement must be inserted in the project body, below the schedule.
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In this space, the items must be detailed with their respective values and the type of budget must be identified, such as costing, which is the appropriation of research costs by the responsible researcher, such as the capital arising from investments. For example, the budget of pharmaceutical industries (aimed at profit-investment), grants from the incentive to carry out research, research development institutions (CNPQ, FIOCRUZ, FAPESP etc.) and, finally, the value that is related to other types of financial links, which must be justified in the “Other information” field, containing reasons or considerations at the researcher's discretion.
Before printing, scanning and attaching the cover sheet, care must be taken to have it checked in the following aspects:
• spaces for the signatures of the responsible researcher and the proposing institution filled in, with the responsible's stamp and/or CPF;
• Sponsor field filled in, if the research is financed by a natural or legal person and in the case of research with high budgets, not funded by the researchers.
Click here and access the information about filling out the form by requesting the signature of its cover page.
For the preparation of the research project and also the TCLE, it is extremely important that researchers read the Resolution 466/212 of the CNS/MS.
The IC is the term that guarantees the autonomy of the participants. For this reason, it is essential that the language is clear, simple and accessible to the population studied, removing the technical terms.
In order to guarantee autonomy, the researcher will have to properly define the research objectives, the direct and indirect benefits, the risks and mitigating measures of these risks, which may occur during the research. Regarding the body of the TCLE text, researchers must commit to maintaining the confidentiality of the information, questionnaires or materials collected. When applying a questionnaire, interviews or other data collection material, the researcher must ensure that the content of the questions is briefly described.
It is mandatory to provide a copy of equal content to the participant with the proper signature of the researcher, and this must be explicit in the TCLE, as well as the full address and ZIP CODE-Bahiana in case of doubt or legal situation.
• It is essential to know the research participant well: gender, race, age, education level, income, among others. These indicators must be evaluated at the time of preparing the TCLE, as the written text will be adequate based on this information.
• It is essential to establish more than one form of contact between participants and researchers.
• It is important that the space for fingerprinting be inserted.
Once the research methodology is defined, it must be informed, in a clear and detailed way, in the project body and, also, to the research participant. In case of applying a questionnaire, the content of the questions must be briefly inserted in the TCLE, so that the participant is aware of what will be asked before accepting to participate in the research, thus avoiding any kind of embarrassment. The storage time and the way in which all collected materials will be discarded must be defined.
There are risks in every research, which is why they must be described in the methodology and in the TCLE, and measures must be presented to prevent, minimize or remedy the risks, guaranteeing the research subject not to participate or stop the research due to the resulting damage.
Letter of agreement or Declaration of agreement from the participating and co-participating institutions (institutions that serve as the locus for carrying out the research), a document that must include the signature and stamp of the qualified technical responsible or the manager responsible for the institution.
If necessary, the responsible researcher and/or assistant must request the signature of the Approval Opinion issued electronically by Plataforma Brasil, with a minimum period of 48 hours, by means of a formal request sent to firstname.lastname@example.org This opinion can be accessed through Plataforma Brasil, under the title "PB_PARECER_CONSUBSTANCIADO_CEP_xxxxx.pdf", in attached documents.
The researcher who presents a pending response greater than two submission versions will have his project withdrawn, and the researcher must submit it again and wait for the normal procedures for ethical appraisal.
The deadline for the 1st opinion is 30 working days and for the 2nd opinion (pending response) is 30 days from the resubmission.