As the Research and Research Ethics Committee, we approve and monitor all research conducted at the Hospital, ensuring that the rights, safety and well-being of participants in clinical studies are safeguarded.
General information
Documents to be submitted
The documentation must be sent at least eight days prior to the date of the meeting and the responses are issued within eight working days after the meeting.
- Protocol: Two physical copies (English and Spanish) duly legended and one copy in electronic format.
- Investigator's Manual: Two physical copies (English and Spanish) duly legended and one copy in electronic format.
- Informed Consent: Three copies (Spanish) duly legislated and one copy in electronic format.
You may consider the following information for informed consent:
- Research and Research Ethics Committee.
- President: Father Jaime Alberto López Monsalve
- E-mail: comiteinvestigaciones@hptu.org.co
- Phone: (604) 445 90 00 ext 8905
- Documentation for patients: One copy (Spanish) duly legended and one copy in electronic format.
Liability policy for potential damages, clarifying that it covers the study and the research center. Fill out the format PRESENTATION OF INSURANCE POLICY FOR PARTICIPANTS AND MINIMUM CONTENT FOR EVALUATION OF THE CIEI.
Members of the Research and Research Ethics Committee
The committee is made up of eleven members in total, in compliance with the regulations of resolution 2378 of 2008.
Chairman of the Committee
Presbyter Jaime Alberto Lopez Monsalve
Catholic Priest
Function: Ethical advisor
Vice-Chairman of the Committee
Sergio Jaramillo Velásquez
Physician specializing in laboratory medicine
Function: Vice-Chairman of the Committee
Committee Secretary
John Jairo Zuleta Tobón
Obstetrician and Gynecologist, Master's degree in clinical epidemiology.
Function: Project evaluator and secretary of the Committee.
Members
Gladys Bedoya Restrepo
Lady volunteer
Function: Community representative
Beatriz de la Trinidad Restrepo Castaño
Lady volunteer
Function: Community Representative (alternate)
Juan Manuel Toro Escobar
Internist, master's degree in epidemiology
Function: Project evaluator
Gustavo Adolfo Gutiérrez Soto
Production Engineer, Master in Administration
Function: Non-medical professional
Carlos Enrique Yepes Delgado
Specialist in Health Services Administration, Master in Public Health/PhD in Epidemiology
Function: Project evaluator
Adriana Patricia Diaz Diaz
Nurse specialist in IPS Management, specialist in Occupational Health, master in Education.
Function: Project evaluator and external institution representative.
Juan Pablo Botero Aguirre
Pharmaceutical chemist, magister in Epidemiology, specialist in Artificial Intelligence.
Function: Project evaluator
Luz Yeidy Aristizabal Henao
Nurse specialist in Vascular Critical Care, magister in Epidemiology.
Function: Project evaluator
Xiomara Carmona Montoya
Nurse specialist in Pain and Palliative Care, magister in Bioethics and Biolaw
Function: Ethical advisor
2024 Dates
January: 18
February: 1, 15, 29
March: 14
April: 4, 18
May: 2, 16, 30
June: 13, 27
July: 11, 25
August: 8, 22
September: 5, 19
October: 3, 17, 31
November: 14, 28
December: 12
Documentos a someter para estudios de industria farmacéutica
La documentación se debe enviar con mínimo ocho días de anticipación a la fecha de la reunión y las respuestas las emiten en un plazo de ocho días hábiles después de la reunión.
- Protocolo: Dos copias en físico (inglés y español) debidamente legajadas y una copia en formato electrónico.
- Manual del investigador: Dos copias en físico (inglés y español) debidamente legajadas y una copia en formato electrónico.
- Material para pacientes: Una copia (español) debidamente legajada y una copia en formato
electrónico. - Consentimiento informado: Tres copias (español) debidamente legajadas y una copia en formato electrónico.
- Póliza de responsabilidad por daños potenciales: Diligenciar formato, presentación de la
póliza de seguros para los participantes y contenido mínimo para evaluación del CIEI.
Tenga en cuenta la siguiente información para el consentimiento informado:
Comité de Investigaciones y Ética en Investigaciones.
- Presidente: Padre Jaime Alberto López Monsalve
- Correo electrónico: comiteinvestigaciones@hptu.org.co
- Teléfono: (604) 445 90 00 ext 8905
- Póliza de responsabilidad por daños potenciales, aclarando que cubre al estudio y al
centro de investigación.
La documentación debe ser enviada a la dirección calle 78B # 69-240, Hospital Pablo Tobón Uribe, piso 9, Torre B, Departamento
de Investigación; con mínimo ocho días de anticipación a la fecha de la reunión. Las respuestas
se emiten en un plazo de ocho días hábiles después de la reunión.
Documentos a someter para evaluación de protocolos de investigadores sin relación con empresa farmacéutica
2024 Rates
- Initial evaluation and supervision during the first year from the date of approval (follow-up, evaluation of amendments, review of adverse events, etc.): Eight SMMLV plus VAT, equivalent to $ 10,400,000 plus $1,976,000, for a total of $ 12,376,000 (Twelve million three hundred seventy-six thousand pesos).
- Supervision after the first year: The cost for each year or fraction of a year of follow-up from the date of approval is eight SMMLV plus VAT, equivalent to $10,400,000 plus $1,976,000, for a total of $12,376,000 (Twelve million three hundred and seventy-six thousand pesos).
- Evaluation at an extraordinary meeting requested by the sponsors: Thirteen SMMLV plus VAT, equivalent to $ 16,900,000 plus $ 3,211,000; for a total of $ 20,111,000 (Twenty million one hundred and eleven thousand pesos).
Amendments
For the submission of amendments to the protocol, investigator's manual or informed consent, the documents must be sent with change controls.
Verify that the amendment of the informed consent is made on the version previously accepted by the Committee and not on the generic template.
Tarifas 2024
- Evaluación inicial y supervisión durante el primer año a partir de la fecha de aprobación (seguimiento, evaluación de enmiendas, revisión de eventos adversos, etc.): Ocho SMMLV más IVA, equivalentes a $ 10.400.000 más $1.976.000, para un total de $ 12.376.000 (Doce millones trescientos setenta y seis mil pesos).
- Supervisión después del primer año: El costo por cada año o fracción de año de seguimiento a partir de la fecha de aprobación son ocho SMMLV más IVA, equivalentes a $ 10.400.000 más $1.976.000; para un total de $ 12.376.000 (Doce millones trescientos setenta y seis mil pesos).
- Evaluación en reunión extraordinaria solicitada por los patrocinadores: Trece SMMLV más IVA, equivalentes a $ 16.900.000 más $ 3.211.000; para un total de $ 20.111.000 (Veinte millones ciento once mil pesos).
Documents of interest
- Fees HPTU Research Committee - 2024
- HPTU Research Committee Timeline - 2024
- Amendments and extensions of studies HPTU Research Committee
- Recruitment Strategies HPTU Research Committee
- Regulatory Standards HPTU Research Committee
- Documents to be submitted for protocol evaluation for non-pharmaceutical company related investigators
- Protocol instructions for external investigators
- Participant insurance policy and minimum content for evaluation
