Research Ethics Committee

(CEI-SMIOT)

Objective of the Research Ethics Committee (SMIOT-REC)

The Research Ethics Committee of the Mexican Society for Research in Orthopedics and Traumatology (SMIOT) is committed to protecting the rights, safety, dignity, and well-being of individuals participating in research projects related to orthopedics and musculoskeletal sciences.

To achieve this, the CEI-SMIOT

Reviews research protocols from ethical, methodological, and regulatory perspectives.

Verifies that studies comply with the Regulations of the Mexican General Health Law on Health Research, as well as internationally recognized guidelines and declarations, including the Declaration of Helsinki, CIOMS, and ICH-GCP.

Promotes a culture of responsible research founded on respect for individuals, confidentiality of information, and transparency in the generation of scientific knowledge.

Operations and Procedures Manual of the CEI-SMIOT

The SMIOT Operations and Procedures Manual for the Ethical Review of Research Projects is a practical guide that explains, step by step, how the Committee operates. It provides Committee members and investigators with comprehensive guidance on the ethical review process, including:

Committee Scope
- Types of studies reviewed, including clinical, observational, retrospective, database research, biobank studies, survey-based research, technological innovation, and related projects.
- Research settings and contexts in which the CEI-SMIOT may issue ethical opinions, including multicenter studies, private institutions, collaborations with hospitals, universities, and industry partners.
Research Project Submission Process
- Basic requirements for protocol submission, including application forms, protocol versions, cover letters, study timelines, budgets (when applicable), informed consent documents, and data collection instruments.
- Criteria used to classify studies according to risk level (minimal risk, greater-than-minimal risk, or other applicable categories).
- Additional documentation required for studies involving vulnerable populations, biological specimens, sensitive data, or experimental interventions.
Review and Decision-Making Process
- Assignment of reviewers within the Committee
- Estimated review timelines.
- Types of Committee decisions, including Approved, Conditionally Approved, Not Approved, or Outside the Committee's Scope.
- Procedures for responding to Committee comments, submitting revisions, and resubmitting protocols.
- Study monitoring and continuing review.
- Requirements for progress reports and final study reports.
- Procedures for reporting adverse events, protocol deviations, and substantial protocol amendments.
- Ethical criteria for the suspension or termination of research studies.

Rules of Procedure of the CEI-SMIOT

The Bylaws of the SMIOT Research Ethics Committee establish the Committee's internal governance, organizational structure, operational procedures, and the standards that guide its activities. The document generally includes the following:

Committee Membership and Requirements
- Qualifications and professional backgrounds of Committee members, including orthopedic surgeons, methodologists, bioethicists, legal experts, and community representatives.
- Appointment procedures for the Chair, Secretary, and other Committee officers.
- Terms of service, member replacement, and renewal procedures.
Meetings and Quorum
- Frequency of regular meetings and provisions for extraordinary meetings.
- Requirements for establishing a valid quorum for deliberation and voting.
- Voting procedures and decision-making processes.
Confidentiality and Conflict of Interest
- Confidentiality obligations for all Committee members regarding research information.
- Disclosure and management of conflicts of interest, particularly when a Committee member is also involved as an investigator in a submitted study.
- Measures to address violations of these responsibilities.
Guiding Ethical Principles
- Commitment to respect for human dignity, justice, beneficence, non-maleficence, and respect for autonomy.
- Compliance with current national regulations and internationally accepted ethical standards.
- Coordination with Other Ethics Committees
- Collaboration with institutional ethics committees at hospitals or universities involved in multicenter studies.
- Recognition and validity of ethical opinions issued by the CEI-SMIOT

How to Submit a Research Project for Ethical Review by the CEI-SMIOT?

If you would like your research protocol to be reviewed by the SMIOT Research Ethics Committee (SMIOT-REC), please follow the general procedure outlined below:

Prepare all required study documentation in accordance with the SMIOT Operations and Procedures Manual, including: - Complete research protocol - Informed consent forms - Required application forms - Research instruments and questionnaires - Letters of authorization - Any additional supporting documentation, as applicable

Ensure Your Protocol Includes the Following

A sound scientific and ethical justification for the study.
A comprehensive risk–benefit assessment.
Data confidentiality and privacy protection strategies.
A plan for the management of adverse events and predefined study suspension criteria.

Submit your complete application by email to SMIOT for registration and referral to the Research Ethics Committee (SMIOT-REC): proyectos@smiot.org

Once your submission has been received, SMIOT will provide you with:

Your project registration number or reference ID.
Confirmation of whether your documentation is complete or requires preliminary revisions.
Information regarding the next steps in the ethical review process.