La investigación que incluye a seres humanos como participantes debe ser, en principio, revisada por un Comité de Ética de la Investigación (Research Ethics Committee, REC) capacitado, también llamado Junta de Revisión Institucional (Institutional Review Board, IRB). La revisión ética de protocolos de investigación realizada antes del comienzo de los estudios de investigación se ha convertido en un requisito fundamental de la investigación aceptable en todos los países, a excepción de unos pocos.
En el caso de la "investigación internacional cooperativa en salud" que incluye investigadores y financiamiento de países de ingresos elevados a fin de realizar investigaciones para la salud en países de ingresos bajos y medianos, esto es especialmente importante, y la revisión ética a menudo es compleja. Además, la investigación se vuelve cada vez más internacional y se lleva a cabo en más de un país al mismo tiempo.
Los REC o IRB aptos y, en los casos en que corresponda, los comités de ética nacionales, las pautas de ética de elevada eficacia que adaptan las pautas internacionales a las condiciones locales y la gestión eficaz o los "procedimientos operativos estándar" para los REC y las IRB facilitarán la realización de la investigación ética y reducirán los riesgos, además de aumentar los beneficios de la investigación para la salud, en especial, en los países de ingresos bajos y medianos.
Esta sección de HRWeb brinda información de contacto fundamental para las revisiones éticas de la investigación en salud en los países. La información es proporcionada en parte por COHRED, pero mayormente por los Comités de Ética de la Investigación en sí mismos, conforme a un acuerdo con HRWeb.
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 SOP 1SOP 1 - (doc, 91 Kb) |
| Brochure d'information aux chercheurs Document montrant les procedures de soumission de protocoles au CNERS - (pdf, 2960.7 Kb) |
| Calendar of RNEC Mtngs 2011 Calendar of RNEC Mtngs 2011 - (docx, 39.92 Kb) |
| CIRE depliant-Flyer Une Vision et un outil au service du développement durable de la Région des pays des Grands Lacs Africains. - (pdf, 73.06 Kb) |
| Consent Template Consent Template - (doc, 30 Kb) |
| Constituting an IRB Guideline Constituting an IRB Guideline - (doc, 122 Kb) |
| FHS IRB review cycle deadlines (2014) (docx, 12.85 Kb) |
| Form No 3. Application form for Ethics Approval (doc, 143 Kb) |
| Form No 3. Application form for Ethics Approval (doc, 143 Kb) |
| Form No 4. Checklist for Application (doc, 54 Kb) |
| Form No. 5-Letter of Clearance from Biostatistician (doc, 29.5 Kb) |
| Form No. 6- Application for Protocol Amendment Form (doc, 69 Kb) |
| Form No. 7- Serious Adverse Events Reporting Form (doc, 33 Kb) |
| Form No. 8-Project Update and Closure Form (doc, 40 Kb) |
| Forn No 9. Ethical review Fee Schedule (doc, 30.5 Kb) |
| General outline General outline for a study protocol: - (docx, 12.96 Kb) |
| Guías Operativas - CEISH -Hospital San José - FUCS Bogotá, 2009 - (pdf, 497.86 Kb) |
| Guideline for submission of a proposal, 2013 version Details guidelines for submission of a proposal to the REC Lesotho. Developed in 2011 and updated in 2013. - (doc, 177.5 Kb) |
| Guidelines Guidelines for submission of a research proposal are described. - (doc, 177.5 Kb) |
| Guidelines Steps for submission of a health research proposal are described. - (doc, 177.5 Kb) |
| Guidelines Steps for submission of a health research proposal are described. - (doc, 177.5 Kb) |
| Guidelines The steps for submission of a health research proposal are described. Published in 2011 and updated in 2013. - (pdf, 737.99 Kb) |
| Guidelines for Protocol Submission Guidelines for Protocol Submission - (docx, 20.35 Kb) |
| Guidelines for submission Describe the guidelines for submission of a health research proposal to the National Health Research Ethics committee. - (doc, 177.5 Kb) |
| Guidelines for submission of a proposal Describe the requirements for submission of a health research proposal to the National Health Research Ethics Committee. - (doc, 177.5 Kb) |
| Guidelines for submission of a research proposal Describe the guidelines for submission of a health research proposal to the Research Ethics Committee Lesotho. Developed in 2011 and updated in 2013. - (doc, 177.5 Kb) |
| Guidelines for Submission to School of medicine Research Ethics Committee Submission Guidelines - (doc, 60 Kb) |
| Information on Ethical Clearance for the Conduct of Research in the Ghana Health Service (pdf, 123.98 Kb) |
| Informed Consent template Informed Consent template - (doc, 28.5 Kb) |
| INSTITUTIONAL RESEARCH AND ETHICS COMMITTEE (IREC) REVIEW CONTINUING REVIEW IREC REVIEW CONTINUING REVIEW - (doc, 154.5 Kb) |
| List of REC Members List of REC Members - (doc, 66.5 Kb) |
| National Health Research Policy Background, guidelines, vision and challenges of health research in Lesotho are described. Published in 2008. - (pdf, 310.92 Kb) |
| National Health Research Policy Current status, challenges, vision of health research in Lesotho are described. - (doc, 315.5 Kb) |
| National Health Research Policy Describe the policy guidelines, challenges and vision for health research in Lesotho; published in 2008. - (doc, 315.5 Kb) |
| National Health Research Policy Describe the policy guidelines, challenges and vision of health research in Lesotho. - (doc, 315.5 Kb) |
| National Health Research Policy Published in 2008. Describes about the background, vision, challenges and guidelines for health research in Lesotho. - (pdf, 310.92 Kb) |
| National Health Research Policy The document is about the National Policy on Health Research in Lesotho. It describes the current situation, policy guidelines and vision on health research. Developed in 2008. - (doc, 315.5 Kb) |
| National Health Research Policy, Lesotho Background, vision and guiding policy for Health Research in Lesotho, developed in 2007 and updated in 2008. - (pdf, 310.92 Kb) |
| National Health Research Policy, Lesotho Describe current situation , challenges and vision of health research in Lesotho. Developed in 2008. - (doc, 315.5 Kb) |
| NHRP Hea.lth Research Policy developed in 2008 - (doc, 315.5 Kb) |
| Procedures for applying for review (doc, 27 Kb) |
| Procedures for subm (doc, 36 Kb) |
| Reglement Interieur Règlement Interieur adopté le 13 Janvier 2011 - (doc, 0 Kb) |
| Reglement Interieur AMENDE 2011 (doc, 0 Kb) |
| REQUIREMENTS FOR SUBMISSION OF NEW PROTOCOLS FOR REVIEW (pdf, 46.77 Kb) |
| REQUISITOS DE SOLICITUD PARA LA EVALUACIÓN BIOÉTICA DE LOS PROTOCOLOS DE INVESTIGACIÓN BIOMÉDICA. Requisitos minimos de presentacion de un protocolo - (doc, 28 Kb) |
| Research Ethics Application form/ Kenyatta National Hospital/University of Nairobi Research Ethics Application form - (pdf, 57.57 Kb) |
| Research Ethics Clearance System Process of reviewing and approving a research proposal is described. - (doc, 121 Kb) |
| Reviewing Final Report SOP Reviewing Final Report SOP - (doc, 77 Kb) |
| Revised TASO Research Requirements Revised TASO Research Requirements - (pdf, 31.85 Kb) |
| SOMREC SOP 10 SOMREC SOP 10 - (doc, 83.5 Kb) |
| SOMREC SOP 11 SOMREC SOP 11 - (doc, 124 Kb) |
| SOMREC SOP 12 SOMREC SOP 12 - (doc, 106.5 Kb) |
| SOMREC SOP 13 SOMREC SOP 13 - (doc, 58 Kb) |
| SOMREC SOP 14 SOMREC SOP 14 - (doc, 83.5 Kb) |
| SOMREC SOP 2 SOMREC SOP 2 - (doc, 82.5 Kb) |
| SOMREC SOP 3 SOMREC SOP 3 - (doc, 78.5 Kb) |
| SOMREC SOP 4 SOMREC SOP 4 - (doc, 93 Kb) |
| SOMREC SOP 5 SOMREC SOP 5 - (doc, 127 Kb) |
| SOMREC SOP 5 SOMREC SOP 6 - (doc, 105 Kb) |
| SOMREC SOP 7 SOMREC SOP 7 - (doc, 124 Kb) |
| SOMREC SOP 8 SOMREC SOP 8 - (doc, 95 Kb) |
| SOMREC SOP 9 SOMREC SOP 9 - (doc, 100 Kb) |
| SOP No. 8: SUBMITING AN APPLICATION FOR ETHICS CLEARANCE (doc, 36 Kb) |
| SOP No. 8: SUBMITING AN APPLICATION FOR ETHICS CLEARANCE (doc, 36 Kb) |
| SOP's SOP's from RNEC - (doc, 0 Kb) |
| Standard Operating Procedures Describe the routine administrative and review process of the Research Ethics Committee. - (doc, 1124 Kb) |
| Standard Operating Procedures Routine operating system of the Health Research Ethics Committee. Developed in 2011 and modified in 2013. - (doc, 1124 Kb) |
| Standard Operating Procedures The routine procedures of the National Health Research Ethics Committee are described. - (doc, 1124 Kb) |
| Standard Operating Procedures The routine procedures of the Research Ethics Committee Lesotho. Developed in 2011 and updated in 2013. - (doc, 1124 Kb) |
| Testing Document for RHInnO Protocol - (docx, 9.79 Kb) |
| UFS Research Ethics Application Form UFS Research Ethics Application Form - (doc, 647 Kb) |
| UFS Undergraduate Ethics Approval Application Form UFS Undergraduate Ethics Approval Application Form - (doc, 512.5 Kb) |
| ZIREC SOPs and Mission Statement ZIREC SOPs and Mission Statement - (doc, 36.5 Kb) |
| Brochure de l'investigateur Document qui décrit la composition du dossier, les étapes de dépot, et les engagements du soumissionnaire - (pdf, 1083.78 Kb) |
| CERB Document - (pdf, 48.3 Kb) |
| First African Conference for Administrators of Research Ethics Committees (AAREC) Report Efforts to strengthen the capacity of research ethics committees in Africa have, to date, targeted research ethics committee (RECs) chairs and members, without a focus on the research ethics committee administrators (RECAs), who manage the RECs and are responsible for facilitating the review process, supporting capacity strengthening, and developing norms and standards for best practice in ethics review. To bridge this gap, the first African conference for Administrators of Research Ethics Committees (AAREC) was organized by MARC. - (pdf, 2020.8 Kb) |
| Mana Tangata (pdf, 78.65 Kb) |
| Mana Tangata Investigacion en poblaciones vulnerables - (pdf, 78.65 Kb) |
| Testing for RHInno Publication - (docx, 9.79 Kb) |
| Testing for RHInno Publication - (pdf, 80.71 Kb) |
| Health Canada's CHVI Regulatory Capacity Building Newsletter Health Canada HIV Vaccine Initiative Regulatory Capacity building network Newsletter - (pdf, 143.64 Kb) |
| Mapping African ethical Review committee activity onto capacity needs: the MARC initiative and HRWeb's interactive database of RECs in Africa Mapping African ethical Review committee activity onto capacityneeds - (pdf, 359.7 Kb) |
| MARC Canada Meeting Report MARC Canada Meeting Report - (pdf, 405.67 Kb) |
| The South African Journal of Bioethics and Law The South African Journal of Bioethics and Law (SAJBL) (2012 Vol. 5 No. 2) has been published. |
| Health Canada's CHVI Regulatory Capacity Building Newsletter Health Canada HIV Vaccine Initiative Regulatory Capacity building network Newsletter - (pdf, 143.64 Kb) |
| Mapping African ethical Review committee activity onto capacity needs: the MARC initiative and HRWeb's interactive database of RECs in Africa Mapping African ethical Review committee activity onto capacityneeds - (pdf, 359.7 Kb) |
| MARC Canada Meeting Report MARC Canada Meeting Report - (pdf, 405.67 Kb) |
| The South African Journal of Bioethics and Law The South African Journal of Bioethics and Law (SAJBL) (2012 Vol. 5 No. 2) has been published. |
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