Introduction

Children and young people need safe and effective medicines that reflect their changing physiological emotional and psychological status. Ethical and legal tensions arise in the testing of medicines, especially those that are connected with sexual health and sensitive questions of behaviour and lifestyle. Young people's freedom to explore their developing sexuality and independence has to be set against the need to protect them from abuse and exploitation, and the associated risks of pregnancy and sexually transmitted diseases.

Safe and effective contraception for young people under 16 years of age is considered an important part of the overall campaign to reduce teenage pregnancies. However, these agents are not well tolerated in this age group, and there has been limited research to address this. Despite recent welcomed clinical trials of investigational medicinal products (CTIMP) applications to research ethics committees (RECs) in the UK, concern has been raised about the ethical and legal situation surrounding the proposed inclusion into such studies of those as young as 12 years of age.

Research protocols for CTIMPs must conform to regulatory and legal frameworks and be reviewed and approved by RECs before proceeding.1 ,2 Little formal guidance exists as to how RECs might address proposals to conduct safety and efficacy trials of contraceptive agents in young people under the age of 16.

The purpose of this paper is to consider the ethical and legal issues posed by such proposals and suggest how guidance might be framed.