After the detailed form and relevant documents (“research protocol”) are submitted, the Secretariat of the CEPH/FGV will check the documents within 10 days. After confirmation of receipt of all the necessary documents, the members of the CEPH/FGV will issue an opinion on the ethical aspects of the study, within 30 days.

The members can at any time request additional information and/or the presence of the researcher at meetings to clarify details of the study.

The analysis of the research protocol will culminate in its classification into one of the following categories:

I – Approved: when the protocol is found to be fully adequate for execution.

II – Pending: when the decision is that correction is needed, in which case alterations or complementations of the research protocol will be requested. No matter how simple the requirement, the protocol will continue to be “pending” until all matters are totally satisfied.

III – Not approved: when the decision considers that the ethical obstacles of the protocol are so serious that they cannot be overcome by following the process for those classified as “pending”.

IV – Shelved: when the researcher fails to meet the deadline to send responses to the pending matters indicated or fails to appeal.

V – Suspended: when an approved study, already in progress, must be interrupted for reason of security, especially regarding the participants in the study.

VI – Withdrawn: when the CEPH/FGV accepts the justified solicitation of the researcher in charge to withdraw the protocol before its ethical evaluation, in which case the protocol will be considered closed.

The research activities can only be commenced after the status of “approved” is granted by the CEPH/FGV, unless determination otherwise by the CEPH/FGV. If the opinion is for classification as pending, the researcher will have 30 days, counted from its issuance, to resolve the pending matters. After this period, the CEPH/FGV will have 30 days to issue the final opinion, approving or rejecting the protocol. Any pending matters that are merely documental in nature will be previously considered by the technical-administrative staff and/or the Coordination of the CEPH/FGV, and communicated directly to the researcher.

If the researcher disagrees with the decision made by the CEPH/FGV, he/she may request, one time only, reconsideration of the decision by the body itself, by presenting the reasons for believing the proposed research procedures obey the requirements of the Internal Rules, within 30 days counted from issuance of the finding by the CEPH/FGV.

The researcher can present amendments (proposals to modify the original project, submitted along with the corresponding justification) to the CEPH/FGV, clearly and succinctly, identifying the part of the protocol to be modified and the justifications. The amendment will be analyzed by the instances for its final approval.

Even if the study does not involve relevant ethical questions, the researcher can submit the project to the CEPH/FGV to obtain advice from the members or if approval by the CEPH/FGV is a requirement of an external research finance institution. The research must indicate this at the end of the detailed submission form.