Procedure for review, approval, modification, or ethics disapproval of a research protocol:
- Applications for ethical review of a research protocol will be processed in order of entry.
- The Ethics Committee will meet to appoint internal reviewers and, if necessary, external reviewers.
- The Secretary will send each reviewer a printed copy of the protocol, a format for ethical review (Appendix 2) and an application letter, including a code assigned to identify the application for ethical review of the protocol.
- Reviewers have a period of 15 calendar days to evaluate the protocol and within this period they must complete the respective format, considering international standards for this purpose.
II) Approval, modification or disapproval
- Reviewers must participate in a meeting convened by the secretary of IEC to decide by consensus, or otherwise, by majority vote, approval, modification or disapproval of the research protocol, noting this process in the book of records and filing the forms completed by each reviewer.
- Protocol Reviewers will participate in the meeting convened by IEC to:
- In case of approval of the protocol: sign each page of the protocol being approved by the reviewers and the Chairman of the IEC, draft a letter to communicate the decision of the committee, using the format described in Annex 2.Informed consent must be signed and sealed by the Chairman. These are the official documents that all participants recruited for the study must sign. If any modification is needed for the informed consent, it must be approved by the IEC and the modified version must be signed and sealed again.
- In case of modification of the protocol: draft a letter to communicate the changes required to adopt the protocol, using the format described in Annex 2, which should describe the changes requested. If necessary, request a meeting between IECPrincipal Researcher of the Project for clarification. Once the modified protocol is submitted, the Chairman of shall ensure that the protocol has the requested changes, and the remaining contents of the protocol is the same submitted for initial review. The President has the authority to proceed with the approval or reconvene if the reviewers had further points for discussion. To meet this requirement, we proceed according to the above.
- In case of disapproval: The Ethics Committee shall prepare and submit a letter to the Principal Researcher to communicate the reasons for not approving the protocol using the format described in the Instruments menu.