Defining the Role of Mature Minors in the Medical Research Consent Process

Abstract

In recent years, there has been an increase in the number of minors included in a broad range of medical research studies. To date, however, little attention appears to have been paid to how the role of minors in the consent process leading to participation in these studies should be defined. This thesis reviews the legal and ethical instruments and principles that define the role of mature minors in the medical research consent process in Canada at present. The thesis goes on to recommend a framework that should be added to the Tri-Council Policy Statement whereby all minors undergo a capacity assessment using a validated instrument. According to this framework, the consent of those who are found to have decision-making capacity (i.e. are mature minors), unless precluded by law, shall be necessary and sufficient. There are few instances where the law prevents mature minors from consenting to their own participation.