Mayo Clinic Proceedings has published a guidance document on obtaining informed consent from paediatric population to participate in a biorepository. Practices have become more complex, the task of developing appropriate informed consent practices has become more challenging. Written on behalf of the Consent, Education, Regulation, and Consultation Workgroup of the eMERGE Network, this document addresses the unique issues that arise for biorepositories that aim to collect samples from paediatric participants as a guidance for investigators and institutional review board (IRB) members in the United States regulatory context. The evolving roles of parents and children in making decisions related to research participation as children mature and the role of the IRB are the two main issues that are addressed in this article around which the recommendations are made. The document also presents guidance on a variety of paediatric-specific consent issues that arise frequently in the development of biorepositories.

More information: eMERGE Network, Article, OrphaNews