{"id":166,"date":"2026-02-12T00:26:02","date_gmt":"2026-02-12T00:26:02","guid":{"rendered":"https:\/\/pr0100.com\/smiot\/?page_id=166"},"modified":"2026-02-13T00:11:32","modified_gmt":"2026-02-13T00:11:32","slug":"comite-de-etica","status":"publish","type":"page","link":"https:\/\/smiot.org\/en\/comite-de-etica\/","title":{"rendered":"Research Ethics Committee"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"166\" class=\"elementor elementor-166\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2c421a0 e-flex e-con-boxed wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no e-con e-parent\" data-id=\"2c421a0\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-629c81e elementor-widget elementor-widget-heading\" data-id=\"629c81e\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Research Ethics Committee<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-af72ae6 elementor-widget elementor-widget-heading\" data-id=\"af72ae6\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">(CEI-SMIOT)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-722a066 e-flex e-con-boxed wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no e-con e-parent\" data-id=\"722a066\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-1be240b e-con-full e-flex wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no e-con e-child\" data-id=\"1be240b\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9a2aebc elementor-widget elementor-widget-heading\" data-id=\"9a2aebc\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Objective of the Research Ethics Committee (SMIOT-REC)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c4a30fc elementor-widget elementor-widget-text-editor\" data-id=\"c4a30fc\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">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.<\/span><\/p><h4><span style=\"font-weight: 400;\">To achieve this, the CEI-SMIOT<\/span><\/h4>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-5866e93 e-flex e-con-boxed wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no e-con e-parent\" data-id=\"5866e93\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-59d84ba e-con-full e-flex wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no e-con e-child\" data-id=\"59d84ba\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7e4fab7 elementor-widget elementor-widget-text-editor\" data-id=\"7e4fab7\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Reviews research protocols from ethical, methodological, and regulatory perspectives.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-105d8a4 e-con-full e-flex wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no e-con e-child\" data-id=\"105d8a4\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-98bb590 elementor-widget elementor-widget-text-editor\" data-id=\"98bb590\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">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.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-ecd6459 e-con-full e-flex wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no e-con e-child\" data-id=\"ecd6459\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0691d62 elementor-widget elementor-widget-text-editor\" data-id=\"0691d62\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Promotes a culture of responsible research founded on respect for individuals, confidentiality of information, and transparency in the generation of scientific knowledge.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-34cbf6f valores e-flex e-con-boxed wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no e-con e-parent\" data-id=\"34cbf6f\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-8c136a2 e-con-full e-flex wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no e-con e-child\" data-id=\"8c136a2\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-dfe55fa elementor-widget elementor-widget-heading\" data-id=\"dfe55fa\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Operations and Procedures Manual of the CEI-SMIOT <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-159b6f9 elementor-widget elementor-widget-text-editor\" data-id=\"159b6f9\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\tThe 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:\n<ul>\n \t<li><strong>Committee Scope<\/strong>\n<ul>\n \t<li>Types of studies reviewed, including clinical, observational, retrospective, database research, biobank studies, survey-based research, technological innovation, and related projects.<\/li>\n \t<li>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.<\/li>\n<\/ul>\n<\/li>\n \t<li><strong>Research Project Submission Process<\/strong>\n<ul>\n \t<li>Basic requirements for protocol submission, including application forms, protocol versions, cover letters, study timelines, budgets (when applicable), informed consent documents, and data collection instruments.<\/li>\n \t<li>Criteria used to classify studies according to risk level (minimal risk, greater-than-minimal risk, or other applicable categories).<\/li>\n \t<li>Additional documentation required for studies involving vulnerable populations, biological specimens, sensitive data, or experimental interventions.<\/li>\n<\/ul>\n<\/li>\n \t<li><strong>Review and Decision-Making Process<\/strong>\n<ul>\n \t<li>Assignment of reviewers within the Committee<\/li>\n \t<li>Estimated review timelines.<\/li>\n \t<li>Types of Committee decisions, including Approved, Conditionally Approved, Not Approved, or Outside the Committee's Scope.<\/li>\n \t<li>Procedures for responding to Committee comments, submitting revisions, and resubmitting protocols.<\/li>\n \t<li>Study monitoring and continuing review.<\/li>\n \t<li>Requirements for progress reports and final study reports.<\/li>\n \t<li>Procedures for reporting adverse events, protocol deviations, and substantial protocol amendments.<\/li>\n \t<li>Ethical criteria for the suspension or termination of research studies.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-75a2015 elementor-widget elementor-widget-button\" data-id=\"75a2015\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/drive.google.com\/file\/d\/1ffIPKOiwZW0r1aO24u8ELI5AyV1KCMXB\/view?usp=sharing\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-file-download\" viewbox=\"0 0 384 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M224 136V0H24C10.7 0 0 10.7 0 24v464c0 13.3 10.7 24 24 24h336c13.3 0 24-10.7 24-24V160H248c-13.2 0-24-10.8-24-24zm76.45 211.36l-96.42 95.7c-6.65 6.61-17.39 6.61-24.04 0l-96.42-95.7C73.42 337.29 80.54 320 94.82 320H160v-80c0-8.84 7.16-16 16-16h32c8.84 0 16 7.16 16 16v80h65.18c14.28 0 21.4 17.29 11.27 27.36zM377 105L279.1 7c-4.5-4.5-10.6-7-17-7H256v128h128v-6.1c0-6.3-2.5-12.4-7-16.9z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Download Operations Manual<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-272f4e3 e-flex e-con-boxed wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no e-con e-parent\" data-id=\"272f4e3\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-9c8ad6e e-con-full e-flex wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no e-con e-child\" data-id=\"9c8ad6e\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-d47c3b8 e-con-full e-flex wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no e-con e-child\" data-id=\"d47c3b8\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2b3d568 elementor-widget elementor-widget-heading\" data-id=\"2b3d568\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Rules of Procedure of the CEI-SMIOT<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5013547 elementor-widget elementor-widget-text-editor\" data-id=\"5013547\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>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:<\/p><ul><li><strong>Committee Membership and Requirements<\/strong><ul><li>Qualifications and professional backgrounds of Committee members, including orthopedic surgeons, methodologists, bioethicists, legal experts, and community representatives.<\/li><li>Appointment procedures for the Chair, Secretary, and other Committee officers.<\/li><li>Terms of service, member replacement, and renewal procedures.<\/li><\/ul><\/li><li><strong>Meetings and Quorum<\/strong><br \/><ul><li>Frequency of regular meetings and provisions for extraordinary meetings.<\/li><li>Requirements for establishing a valid quorum for deliberation and voting.<\/li><li>Voting procedures and decision-making processes.<\/li><\/ul><\/li><li><strong>Confidentiality and Conflict of Interest<\/strong><ul><li>Confidentiality obligations for all Committee members regarding research information.<\/li><li>Disclosure and management of conflicts of interest, particularly when a Committee member is also involved as an investigator in a submitted study.<\/li><li>Measures to address violations of these responsibilities.<\/li><\/ul><\/li><li><strong>Guiding Ethical Principles<\/strong><ul><li>Commitment to respect for human dignity, justice, beneficence, non-maleficence, and respect for autonomy.<\/li><li>Compliance with current national regulations and internationally accepted ethical standards.<\/li><li>Coordination with Other Ethics Committees<\/li><li>Collaboration with institutional ethics committees at hospitals or universities involved in multicenter studies.<\/li><li>Recognition and validity of ethical opinions issued by the CEI-SMIOT<\/li><\/ul><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4575fd1 elementor-widget elementor-widget-button\" data-id=\"4575fd1\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/drive.google.com\/file\/d\/1tX91n9Lr-kRTL8WLJnIOyabtJTwHUKUN\/view?usp=sharing\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-file-download\" viewbox=\"0 0 384 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M224 136V0H24C10.7 0 0 10.7 0 24v464c0 13.3 10.7 24 24 24h336c13.3 0 24-10.7 24-24V160H248c-13.2 0-24-10.8-24-24zm76.45 211.36l-96.42 95.7c-6.65 6.61-17.39 6.61-24.04 0l-96.42-95.7C73.42 337.29 80.54 320 94.82 320H160v-80c0-8.84 7.16-16 16-16h32c8.84 0 16 7.16 16 16v80h65.18c14.28 0 21.4 17.29 11.27 27.36zM377 105L279.1 7c-4.5-4.5-10.6-7-17-7H256v128h128v-6.1c0-6.3-2.5-12.4-7-16.9z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Download Bylaws<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-067b65d valores e-flex e-con-boxed wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no e-con e-parent\" data-id=\"067b65d\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-63b01d9 e-con-full e-flex wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no e-con e-child\" data-id=\"63b01d9\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ef165d1 elementor-widget elementor-widget-heading\" data-id=\"ef165d1\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\"> How to Submit a Research Project for Ethical Review by the CEI-SMIOT?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-45963c3 elementor-widget elementor-widget-text-editor\" data-id=\"45963c3\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">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:<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1213053 e-con-full e-flex wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no e-con e-child\" data-id=\"1213053\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-1d8cf9c e-con-full e-flex wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no e-con e-child\" data-id=\"1d8cf9c\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-cfda758 listado-bullet elementor-widget elementor-widget-text-editor\" data-id=\"cfda758\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Prepare all required study documentation in accordance with the SMIOT Operations and Procedures Manual, including:\n- Complete research protocol \n- Informed consent forms \n- Required application forms \n- Research instruments and questionnaires \n- Letters of authorization \n- Any additional supporting documentation, as applicable<\/span><\/p><p><span style=\"font-weight: 400;\">Ensure Your Protocol Includes the Following<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">A sound scientific and ethical justification for the study.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">A comprehensive risk\u2013benefit assessment.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Data confidentiality and privacy protection strategies.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">A plan for the management of adverse events and predefined study suspension criteria.<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">Submit your complete application by email to SMIOT for registration and referral to the Research Ethics Committee (SMIOT-REC): <\/span><a href=\"mailto:proyectos@smiot.org\"><span style=\"font-weight: 400;\">proyectos@smiot.org<\/span><\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-39025e2 e-con-full e-flex wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no e-con e-child\" data-id=\"39025e2\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-cc543d8 e-con-full e-flex wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no e-con e-child\" data-id=\"cc543d8\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5e837e0 listado-bullet elementor-widget elementor-widget-text-editor\" data-id=\"5e837e0\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><strong>Once your submission has been received, SMIOT will provide you with:<\/strong><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Your project registration number or reference ID.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Confirmation of whether your documentation is complete or requires preliminary revisions.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Information regarding the next steps in the ethical review process.<\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Comit\u00e9 de \u00c9tica en Investigaci\u00f3n (CEI-SMIOT) Objetivo del Comit\u00e9 de \u00c9tica en Investigaci\u00f3n (CEI-SMIOT) El Comit\u00e9 de \u00c9tica en Investigaci\u00f3n de la Sociedad Mexicana de Investigaci\u00f3n en Ortopedia y Traumatolog\u00eda (SMIOT) tiene como objetivo principal proteger los derechos, la seguridad, la dignidad y el bienestar de las personas que participan en proyectos de investigaci\u00f3n relacionados con la ortopedia y las ciencias musculoesquel\u00e9ticas. Para ello, el CEI-SMIOT: Eval\u00faa los protocolos de investigaci\u00f3n desde una perspectiva \u00e9tica, metodol\u00f3gica y regulatoria. Verifica que los estudios se apeguen al Reglamento de la Ley General de Salud en Materia de Investigaci\u00f3n para la Salud, as\u00ed como a declaraciones y gu\u00edas internacionales (Helsinki, CIOMS, ICH-GCP, entre otras). Promueve una cultura de investigaci\u00f3n responsable, basada en el respeto a las personas, la confidencialidad de la informaci\u00f3n y la transparencia en la generaci\u00f3n de conocimiento. Manual de Operaciones y Procedimientos del CEI-SMIOT El Manual de Operaciones y Procedimientos para la Revisi\u00f3n y Dictaminaci\u00f3n de Proyectos de Investigaci\u00f3n de la SMIOT es un documento pr\u00e1ctico que explica, paso a paso, c\u00f3mo funciona el Comit\u00e9. En t\u00e9rminos generales, en este manual las y los miembros, as\u00ed como las personas que someten proyectos, pueden encontrar: Alcance del Comit\u00e9: Tipos de estudios que revisa (cl\u00ednicos, observacionales, retrospectivos, uso de bases de datos, biobancos, estudios con encuestas, innovaci\u00f3n tecnol\u00f3gica, etc.). \u00c1reas y contextos en los que el CEI-SMIOT puede emitir dictamen (multic\u00e9ntricos, privados, colaboraciones con hospitales, universidades, industria, etc.). Proceso de sometimiento de proyectos: Requisitos b\u00e1sicos para enviar un protocolo (formato de solicitud, versi\u00f3n del protocolo, carta de presentaci\u00f3n, cronograma, presupuesto cuando aplique, hoja(s) de consentimiento informado, instrumentos de recolecci\u00f3n de datos, etc.). Criterios para determinar si un estudio es con riesgo m\u00ednimo, mayor que m\u00ednimo u otra categor\u00eda aplicable. Documentaci\u00f3n adicional cuando se incluyen poblaciones vulnerables, muestras biol\u00f3gicas, datos sensibles o intervenciones experimentales. Flujo de revisi\u00f3n y dictaminaci\u00f3n: C\u00f3mo se asignan ponentes o revisores dentro del Comit\u00e9. Tiempos estimados de revisi\u00f3n. Tipos de dictamen (aprobado, condicionado, no aprobado, no competencia del Comit\u00e9, etc.). Manejo de aclaraciones, respuestas a observaciones y re-sometimientos. Seguimiento y monitoreo. Lineamientos para informes de avance y cierre de estudio. Procedimientos para notificaci\u00f3n de eventos adversos, desviaciones al protocolo y modificaciones sustanciales. Criterios para suspensi\u00f3n o cancelaci\u00f3n de un estudio desde la perspectiva \u00e9tica. Descargar Manual Reglamento de Funcionamiento del CEI-SMIOT El Reglamento de Funcionamiento del Comit\u00e9 de \u00c9tica en Investigaci\u00f3n de la SMIOT establece el marco de funcionamiento interno del Comit\u00e9, es decir, c\u00f3mo se organiza, qui\u00e9n lo integra, c\u00f3mo sesiona y qu\u00e9 normas rigen su actuaci\u00f3n. Usualmente incluye aspectos como: Integraci\u00f3n y requisitos de los miembros del Comit\u00e9: Perfil de las y los integrantes (ortopedistas, metod\u00f3logos, bioeticistas, abogados, representantes de la comunidad, etc.). Nombramiento de la Presidencia, Secretar\u00eda y dem\u00e1s cargos. Duraci\u00f3n de los periodos, relevo y renovaci\u00f3n de miembros. Sesiones y qu\u00f3rum: Frecuencia de las sesiones ordinarias y posibilidad de sesiones extraordinarias. Reglas para establecer qu\u00f3rum v\u00e1lido de deliberaci\u00f3n y votaci\u00f3n. Mecanismos de votaci\u00f3n y adopci\u00f3n de acuerdos. Confidencialidad y conflicto de inter\u00e9s: Obligaciones de todas las personas integrantes en cuanto a confidencialidad de la informaci\u00f3n de los proyectos. Declaraci\u00f3n y manejo de conflictos de inter\u00e9s (por ejemplo, cuando una persona del Comit\u00e9 es tambi\u00e9n investigadora en el proyecto sometido). Medidas en caso de incumplimiento de estas obligaciones. Principios de actuaci\u00f3n: Enfoque en el respeto a la dignidad humana, justicia, beneficencia, no maleficencia y autonom\u00eda. Alineaci\u00f3n con la normativa nacional e internacional vigente. Relaci\u00f3n con otras instancias: Coordinaci\u00f3n con comit\u00e9s locales de hospitales o universidades cuando el proyecto es multic\u00e9ntrico. Reconocimiento y validez de los dict\u00e1menes emitidos por el CEI-SMIOT. Descargar Reglamento \u00bfC\u00f3mo someter un proyecto a evaluaci\u00f3n \u00e9tica por el CEI-SMIOT? Si deseas que tu protocolo sea revisado por el Comit\u00e9 de \u00c9tica en Investigaci\u00f3n de la SMIOT, el procedimiento general es el siguiente: Preparar la documentaci\u00f3n del estudio, de acuerdo con lo se\u00f1alado en el Manual de Operaciones y Procedimientos (protocolo completo, consentimientos informados, formatos, instrumentos, cartas de autorizaci\u00f3n, etc.). Asegurarte de que el protocolo incluya: Justificaci\u00f3n cient\u00edfica y \u00e9tica. Evaluaci\u00f3n de riesgos y beneficios. Estrategias de confidencialidad y manejo de datos. Plan de manejo de eventos adversos y criterios de suspensi\u00f3n. Enviar el proyecto por correo electr\u00f3nico a la SMIOT para su registro y canalizaci\u00f3n al CEI: proyectos@smiot.org En la respuesta de SMIOT se te indicar\u00e1: N\u00famero o clave de registro del proyecto. Si la documentaci\u00f3n est\u00e1 completa o se requieren ajustes iniciales. Los pasos siguientes en el proceso de revisi\u00f3n.<\/p>","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-166","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/smiot.org\/en\/wp-json\/wp\/v2\/pages\/166","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/smiot.org\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/smiot.org\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/smiot.org\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/smiot.org\/en\/wp-json\/wp\/v2\/comments?post=166"}],"version-history":[{"count":19,"href":"https:\/\/smiot.org\/en\/wp-json\/wp\/v2\/pages\/166\/revisions"}],"predecessor-version":[{"id":212,"href":"https:\/\/smiot.org\/en\/wp-json\/wp\/v2\/pages\/166\/revisions\/212"}],"wp:attachment":[{"href":"https:\/\/smiot.org\/en\/wp-json\/wp\/v2\/media?parent=166"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}