El derecho a la protección de datos personales en la investigación biomédica en Colombia: Una mirada desde el soft law y el hard law

Biomedical research requires for its development the use of biological samples and data that belong to people or communities. This involves ethical and legal problems related to the protection of the dignity and rights of the subjects, which have motivated the development of international regulations. Colombia has a Statutory Law regarding the right to the protection of personal data and lacks recent regulation on health research, generating legal uncertainty for researchers, and a lack of specific guarantees for subjects of rights. A critical review of the main research ethics documents (soft law), as well as national regulations, is presented, identifying principles, rights and responsibilities related to this issue, as elements for future regulations.