The Ministry of Health and Social Protection published for public consultation a draft resolution proposing to update the requirements, procedures, and administrative conditions applicable to health research involving human subjects in Colombia, partially repealing Resolution 8430 of 1993. The initiative aims to harmonize the national regulatory framework with international ethical and scientific standards, including Good Clinical Practice (GCP / ICH-GCP) guidelines, in order to strengthen the protection of the rights, safety, and well-being of research participants.
The draft proposes to establish more specific requirements for investigators, sponsors, Contract Research Organizations (CROs), and Research Ethics Committees (RECs), defining their responsibilities in the evaluation, approval, and oversight of studies. It also proposes to regulate the content, process, documentation, and updating of informed consent, ensuring that participation is free, voluntary, and fully informed.
Additionally, the draft includes specific provisions for the protection of vulnerable populations, including children, adolescents, pregnant women, and persons with disabilities, as well as guidelines on risk management, personal data confidentiality, and insurance coverage for potential research-related harm.
Through this initiative, the Government seeks to strengthen the regulatory framework for health research and enhance the protection of research participants, in line with international standards.
