Research and Research Ethics Committee

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.

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.

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).
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

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
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