Regulating doctors, ensuring good medical practice

Consent to research: Emergency research

  1. 19. Circumstances may arise where involvement in research has the potential to benefit a child or young person who lacks capacity, but an urgent decision about the child’s involvement needs to be made before it is possible to get consent from a parent. This may arise because a parent cannot reasonably be contacted, or they do not have capacity to consent because of their own condition or distress. In such cases you can involve a child or young person in research if you have the approval of a research ethics committee for such recruitment. You must seek the consent of a parent as soon as possible to continue involving them in the project.
  2. 20. There are specific legal requirements that relate to involving children or young people under 16 in emergency clinical trials of investigational medicinal products. Annex B contains further guidance on the legal requirements in these circumstances.

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