REC (Comité de Ética de la Investigación) is the acronym for Research Ethics Committee. REC is operated through the National Bioethics Commission. It is an autonomous and interdisciplinary group of doctors from different specializations, nurses, social workers, sociologists, anthropologists, psychologists, philosophers, and lawyers. All these members are supposed to have bioethics training and are community representatives affected by the health condition under study or other health service users. All members should possess a professional license, experience related to the research area, and authorized training.
REC must consist of at least three scientists. REC members must have expertise in the subjects investigated at the institution.
REC works to maintain and protect the dignity and rights of human volunteers for clinical trials. REC also keeps a record of reviewing the informed consent and protecting the volunteers.
REC ensures independent, timely, and competent review of all the ethical aspects of a clinical trial protocol. REC verifies that the process is confidential and private. It also ensures that the trial is safe by evaluating possible risks and expected benefits to the volunteers.
The applicant or the manufacturer must obtain a favorable response from the REC, biosafety committee, and the health institution where the study is being conducted. The REC provides the decision for the research protocol and informed consent form to the applicant before the submission of a request for protocol authorization to COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios).
REC approves and assesses the research protocol at the initial level of the project and throughout the project duration. REC’s decision is submitted to COFEPRIS as part of the application to obtain protocol authorization.
The agenda of REC and corresponding documents for each session must be delivered at least seven days prior to the meeting. It is then recommended that the REC’s decision be sent within a period not exceeding five working days after the committee has met, or if applicable, not to exceed thirty calendar days from the review request date. The approval of a new application is valid for one year. REC should establish procedures for monitoring approved studies from the point at which the decision was made until the completion of the investigation and reporting of results. To know more about COFEPRIS and to get end-to-end Regulatory services in Mexico, reach out to Freyr experts at https://www.freyrsolutions.com.mx/