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News & Knowledge

Costa Rica: Modification to the regulatory law of biomedical research

12th October 2016

Soley Saborío & Asociados (Costa Rica)

MSI's Costa Rica law member Soley Saborío & Asociados provides further information on the new legislation which was introduced in August regarding the promotion of the personal autonomy of disabled persons.

On 30 August 2016 the Costa Rican Government introduced a new bill: “Law for the promotion of the personal autonomy of disabled persons”, Law No.9379.

The new law establishes that disabled persons shall grant their free and informed consent in order to participate in scientific research, this law also prohibits that their “guarantor” (new legal entity that substitutes the representative of a disabled person) grants the informed consent replacing the disabled person.

According to the aforementioned, it can be concluded that all informed consent granted by a disabled person shall be conferred and signed by the disabled person. It can be assumed that, as far as the disabled person has named a “guarantor”, such guarantor must also sign the informed consent as a guarantee of the participant’s willfulness.

This interpretation, made in order to protect the principle of autonomy, should be clarified by new administrative regulations, which shall be published within the following 6 months.  Nevertheless, it is important to clarify that the new Law 9379 is effective as of its publication date, August 30, 2016.