Children and young people should routinely be offered the opportunity to participate in and to benefit from medical research, according to updated guidance from the Royal College of Paediatrics and Child Health.

Guidance on clinical research involving infants, children and young people provides updated practical guidance on ethical issues in relation to research involving children, aimed at research councils. It reflects many of the changes that have taken place with regards to EU regulations over the last 14 years.

Key principles include:

  • Risk: Research should ideally carry no greater than minimal or low risk. However, research that involves greater than minimal risk may be acceptable if the interventions involve diagnostic procedures or treatments that are important for the individual child
  • Assent or Consent: In most instances, the child's assent or consent should be underpinned by parent consent. However, in the context of research, dissent should be respected, even if parent consent continues.
  • Sedation: Researchers must justify the use of sedation, and provide evidence that appropriate monitoring will be in place during the procedure, and that they possess the necessary competencies and skills to carry out the procedures, and to deal immediately with any adverse effects.
  • Rewards: The nature of any token of thanks should be in proportion with the age of the child, approved by the research ethics committee, and made clear in the parent/patient information sheets.

Professor Neena Modi, lead author of the guidance, said:

"Children require protection, but this should not preclude the claim of other rights, including the right to the highest standard of healthcare, to be informed, express their views, and influence decisions made about them.

"The more robust research we can conduct, the greater the likelihood of developing new treatments and procedures that will greatly improve healthcare for children and young people.

"Of course research ethics and research regulations are not static and evolve over time. These updated guidelines reflect current regulations and should help researchers make the right decisions about child health research in the best interest of the child."

The guidance also emphasises the importance of involving children, young people and parents in all aspects of medical research - from prioritisation to development and dissemination.