Ethics Committeein Research

CEI is an independent organization, among its functions it will review in a timely manner the ethical and methodological principles and compliance with:

Resolution 8430 of 1993
Resolution 2378 of 2008
Mandatory INVIMA compliance guides
CEI's own standards
Helsinki Declaration
International Guidelines for Good Clinical Practice

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Our Objective

Evaluate the risks and benefits of clinical research, promoting ethics and integrity inherent to the human being in accordance with constitutional and legal principles and values, safeguarding the rights of participants during a Clinical Trial.

The Research Ethics Committee evaluates the following clinical trials:

Phase I
Phase IIA
Phase IIB
Phase IIIA
Phase IIIB
Phase IV (with intervention)
Observational studies
Biobank

University undergraduate and postgraduate research projects (Inter-institutional Agreement)
Research carried out by the IPS Clínica de la Costa SAS, in special agreement with the Simón Bolívar University.

What kind of research do we evaluate?

Principles and Ethical Framework

The Ethical Principles are accepted to carry out research with subjects, whether established by national and international guidelines of: Good Clinical Practices (GCP).

The Ethical Framework must be based on the principles contemplated:

Nuremberg Code of Ethics (1946)
Declaration of Helsinki (1964)
Belmont Report (1976-79)
International Ethical Guidelines for Biomedical Research Involving Human Beings (CIOMS 2017)
World Health Organization (WHO)