Capacity to give informed consent to participate in medical research

Abstract

According to the existing regulation, the consent to participate in medical research can be given only by a person who has the capacity to provide it. As this capacity is not explained in further detail, the author of this paper is interested in determining what it includes and which persons generally have this capacity. The answer to these questions is pursued through a comparative analysis of the legal solutions contained in international regulations as well as in some national regulations on medical research involving human subjects. In the first part of this paper, the author compares the capacity to give informed consent and the contractual capacity. On the basis of this comparative analysis, the author concludes that there are certain differences between the two as the capacity to give informed consent is generally equaled with the capacity to exercise reasonable judgment. In the second part of this paper, the author asserts that the reasons of legal certainty have imposed the need to associate the capacity to give informed consent with a certain age, which has been accepted in national legislations (by prescribing either the age of maturity or a younger age). In the final part of this paper, the author concludes that linking this capacity to a certain age leads to the following circumstances: the persons under the prescribed age are considered incapable of giving informed consent even though they are capable of exercising reasonable judgment; the persons above the prescribed age are assumed to be capable of giving consent, unless they are physically or mentally incapacitated, which is determined which is determined in the process of obtaining an informed consent for medical research when the researcher accesses the person's capacity to exercise reasonable judgment.

Keywords

• medical law
• medical research
• capacity to give informed consent
• contractual capacity
• legal age