Last April Costa Rican Congress passed a new law for biomedical research. Law No. 9234 is titled Ley Reguladora de la Investigación Biomédica, or “Law for the Regulation of Biomedical Research” and comes as the expected solution to the chaos in which biomedical research was left after all clinical investigation on humans was suspended by the Constitutional Court in 2010.
At that time the Constitutional Court, in decision 2010-001668, declared that all clinical investigation on humans should be suspended until laws were enacted to properly regulate the activity. The Court considered the human life and health were at risk with the activity, and such risk could not be regulated through executive decrees, as was the case at that time, but required a law passed by Congress. More than four years later Congress has finally pass the required law.
Law 9234 includes provisions that aim to respect the rights of participants, including, among others, their health, security, informed consent, use of biologic samples, withdrawal as participant, privacy, data use and information.
The law creates the Consejo Nacional de Investigación en Salud (CONIS) or “National Council for Health Investigation”. This council will have technical, scientific and ethical duties, and will be independent but linked to the Ministry of Health. CONIS will act as the regulatory body in charge of authorizing, keeping control and supervising investigations. It could even suspend or terminate investigations. Conis will also authorize the operation of the Comités Eticos Científicos (CEC) or “Ethical Scientific Committees”, required to carry out any biomedical research.
The law also defines and regulates the relationship between researchers, CEC’s, sponsors, organizations contracted for the administration of the research, organizations contracted for the research and participants. It also contains sanctions for undue research, which in the gravest cases go to up to 10 years in prison.
Law 9234 entered into effect on April 25th 2014.