The general functions of the Research Bioethics Committee of the Metropolitan University of Education, Science and Technology (UMECIT) are derived from ethical principles, as well as ensuring the proper actions of researchers, based on respect for the aspects implicit bioethics in investigative praxis. Additionally, it seeks to guarantee the development of research and its protocols adjusted to the contributions of bioethics, in order to protect the interests of the participants that are part of it, encourage the dissemination and dissemination of bioethics in all fields of knowledge, promote and promote permanent actions, crystallized in training and support activities, on issues related to ethics in various disciplines, plagiarism and ethics in research.
The Research Bioethics Committee of the Metropolitan University of Education, Science and Technology (UMECIT) has the main functions of approving, deferring, auditing, suspending and canceling all biomedical research that involves the participation of human beings, guaranteeing that all research in which they participate, is carried out within the framework of respect for their dignity, integrity and identity.
The Research Bioethics Committee of the Metropolitan University of Education, Science and Technology (UMECIT) has advisory, educational and regulatory tasks, which are detailed:
1. Advisory Tasks:
1.1. Evaluate the ethical and scientific aspects of the research protocols carried out at the Institution, as long as they are requested through the Research and Postgraduate Department, specifically through the Research Committee.
1.2. Ensure that the rights, physical and moral integrity and confidentiality of the people participating in clinical research activities are always protected and respected based on human rights and individual guarantees.
1.3. Evaluate that within the clinical research projects the people participating in the research activities are not exposed to unnecessary treatments according to the objectives of the study.
1.4. Evaluate the competence of the research team and monitor the use of adequate instruments and trained personnel to carry out each of the techniques proposed in the studies.
1.5. Verify that the informed consent document complies with the requirements established in the Good Clinical Practices (GCP) established in the International Conference on Harmonization (ICH) and in the current national laws on the matter.
1.6. Request the principal investigator and/or study proponent, the modifications related to the consent process and the informed consent document.
1.7. Verify that the damages caused to the subjects involved in a clinical study are equitably compensated, in the cases that so require.
2. Educational Tasks:
2.1. Maintain the academic level and promote permanent training activities for the commissioners of the Committee, in relation to ethics and the science of biomedical research and project their knowledge.
2.2. Support any institution, public or private, national or international, interested in the dissemination of bioethics in research and medical ethics.
23. Promote teaching.
3. Regulatory Tasks:
3.1. Approve, postpone, reject or suspend clinical research protocols submitted for evaluation.
3.2. Evaluate that the informed consent process (how, where, who, to whom, time, opportunity) and that the informed consent document meets the requirements according to the International Conference on Harmonization (ICH), Federal Administration US Food and Drug Administration (FDA), European Medicines Agency (EMEA).
3.3. Evaluate changes, deviations, violations of the protocol and the general conduct of the investigation.
3.4. Collaborate with other national and international institutions in the elaboration of norms and regulations related to the establishment of other Bioethics Committees at the national level.
3.5. Suspend, for reasons of proven urgency, or cancel at any time, the approval or performance of a research project, when it is verified that there is a danger to the health or well-being of the participating subjects.
3.6. Check the suitability and capacity of the principal investigator.
3.7. Establish a database with the information pertinent to the clinical studies submitted for consideration.
3.8. Keep detailed minutes of all your meetings and keep a file of each protocol submitted to your consideration.
3.9. Maintain an active file of the studies submitted for its consideration, in order to carry out a longitudinal evaluation of the development of the investigations until their completion and results.
3.10. Ensure strict compliance with the Good Clinical Practice (GCP) standards during investigations.
3.11. Follow up and monitor the execution of research projects, requesting periodic reports from the researcher and knowing the report on completion of the investigations.
3.12. Know and evaluate all adverse events and the most relevant situations that occur during the development of a clinical study.
3.13. Know the complaints of patients or individuals about anomalous situations related to a clinical study.
3.14. Safeguard the files of the projects submitted for evaluation, as well as all the documentation that supports their activities, for at least four (4) years after the completion of a study.
3.15. Maintain strict confidentiality within the framework of the provisions regarding professional secrecy, regarding meetings, documents, requests, research projects and matters related to the Bioethics Committee of the Metropolitan University of Education, Science and Technology (UMECIT).
3.16. Conduct regular and "for cause" audits of the Principal Investigator.
3.17. Request the opinion of an external consultant or specialist on the issues of the protocols under evaluation, if the case requires it.
3.18. Invite the researcher or his collaborators to respond to concerns or make clarifications related to the protocol submitted for evaluation by the Committee.
