El Comité de Ética de Investigación en Seres Humanos de la Universidad San Francisco de Quito USFQ “CEISH-USFQ” es un órgano responsable de realizar la evaluación ética de investigaciones con seres humanos.
El CEISH-USFQ cuenta con la aprobación de:
- Ministerio de Salud Pública del Ecuador, emitida mediante Oficio Nro.MSP-VGVS-2020-0274-O de 25 de mayo de 2020.
- Office for Human Research Protections (OHRP) of United States Department of Health & Human Services. IORG0003353,IRB# 00003994
Evaluation
All research involving human subjects, their biological samples, or their information to be conducted at the Universidad San Francisco de Quito USFQ must undergo an evaluation and approval process by the CEISH-USFQ.
The requirements and relevant formats for submitting new research, amendments, renewals, and follow-up reports are available on the following pages:
Schedule
The regular sessions of the CEISH-USFQ will be held on a monthly basis on Mondays or Fridays at office G-206 of the Cumbayá campus of the Universidad San Francisco de Quito or in a hybrid format.
The agenda for each session will be scheduled with the requests processed by the CEISH-USFQ five (5) business days before the session.
Training
The Committee for Ethics in Research Involving Human Subjects at Universidad San Francisco de Quito USFQ, known as "CEISH-USFQ," offers researchers access to the free platform Training and Resources in Research Ethics Evaluation "TRREE" (https://elearning.trree.org/) for their ongoing training in research ethics.
We remind researchers that, to request the evaluation of a research project, they must have training in research ethics. If they lack such training, they must complete the following courses:
- Introduction to Research Ethics
- Informed Consent
- Good Clinical Practice. Only for clinical trial investigators.
Frequently Asked Questions
The Committee also provides advice on research ethics-related issues.
According to the Research Manual published by the Research Dean's Office of USFQ, obtaining approval from CEISH-USFQ is mandatory before conducting any research involving human subjects.
- Review the requirements to be submitted according to the type of research.
- For external researchers to USFQ:
- Request via email the CEISH-USFQ's advice on evaluation service costs.
- Make the payment of evaluation fees and submit a copy of the receipt along with other requirements.
- Prepare the documentation to be submitted using the current formats of CEISH-USFQ.
- Request ethical approval of the research via CEISH-USFQ's email. All requirements must be attached to the application for the review process to commence.
No. The "Substitutive Regulation of the Regulation for the Approval and Monitoring of Research Ethics Committees on Human Subjects (CEISH) and Assistance Ethics Committees for Health (CEAS)" issued by Ministerial Agreement No. 00005 of 2022, states:
“Article 47.- The CEISH will not evaluate research protocols whose execution is ongoing or has already been completed as of the date of submission of the documentation”.
The level of risk to participants is determined by the Committee during the evaluation process.
In applications for approval of new research with stored biological samples, the informed consent form applied to obtain the research subject's approval for storage and use of biological samples in future research must be attached.
According to the "Substitutive Regulation of the Regulation for the Approval and Monitoring of Research Ethics Committees on Human Subjects (CEISH) and Assistance Ethics Committees for Health (CEAS)", CEISH-USFQ will issue a resolution letter within:
- Sixty (60) business days from the receipt of complete documentation for research of Greater than Minimal Risk.
- Forty-five (45) business days from the receipt of complete documentation for research of Minimal Risk.
- Fifteen (15) business days from the receipt of complete documentation for research Without Risk.
These times may be extended according to the response time of the principal investigator.
CEISH-USFQ evaluates research projects under the following modalities:
- Full. Evaluation by members covering the basic profiles required by current legislation and deliberation in a Committee session. This evaluation modality is established for research of Greater than Minimal Risk.
- Expedited. Evaluation by one (1) or two (2) members. This evaluation modality is established for research of Minimal Risk and minor amendments.
- Exemption from evaluation. Evaluation by one (1) member. This evaluation modality is established for research Without Risk.
The principal investigator, in response to observations from CEISH-USFQ, may:
- Accept the observation and provide the requested or modified document.
- Not accept the observation but justify appropriately.
All observations determined by CEISH-USFQ must receive a response for the Committee to continue the evaluation process.
Research proposed by researchers external to the Universidad San Francisco de Quito USFQ are subject to evaluation service fees. This applies to:
- New research projects
- Approval renewals
- Research amendments. Starting from the fourth (4th) annual amendment.
Mixed research projects proposed by external researchers in collaboration with researchers from USFQ are not subject to evaluation service fees, as long as the research is registered on the HUBI platform or the platform established by USFQ for this purpose.
Billing Policy
In accordance with the Internal Regulations of the Research Ethics Committee on Human Subjects of Universidad San Francisco de Quito USFQ "CEISH-USFQ," research proposals submitted by external researchers to Universidad San Francisco de Quito USFQ are subject to payment of evaluation fees.
To inquire about the applicable fees, please visit the following link: https://btnpagos.usfq.edu.ec/pagos/eventos.aspx?adm=810110381
Objetivo
Contribuir a salvaguardar los derechos, la dignidad, la seguridad y el bienestar de los seres humanos participantes de investigaciones.
Funciones
- Evaluar los aspectos éticos, metodológicos y jurídicos de investigaciones con seres humanos.
- Evaluar las enmiendas o modificaciones a los documentos relacionados con la investigación inicialmente aprobada.
- Realizar el seguimiento de las investigaciones aprobadas desde su inicio hasta la recepción del informe final.
- Velar por el cumplimiento y aplicación de principios éticos en la investigación con seres humanos.
Misión
Sensibilizar a toda la USFQ sobre la importancia de proteger los derechos, dignidad, seguridad y bienestar de los seres humanos participantes de una investigación.
Integración
El CEISH-USFQ está integrado por un grupo multidisciplinario:
- Profesional de la Salud
- Profesional con experiencia en metodología de la investigación
- Profesional con conocimientos en bioética
- Profesional Jurídico
- Representante de la Sociedad Civil
