Abstract

Inherent to all medical research is respect for the rights of the individual. Neonatal research is made more complex by the issue of proxy consent. Obtaining valid informed consent for entry of an infant into a research project needs to deal with this complexity. New evidence on the role and responsibilities of parents in giving consent has implications for all clinical staff that are considering embarking on and/or recruiting infants in research projects. This review explores the issues around informed consent for neonatal research and provides a framework by which consent could be improved. It is to be hoped that such improvements to the process will increase recruitment of infants to research studies while enhancing the validity of the consent process.