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Key messages

 
  1. Consent is only valid if it is given voluntarily by an autonomous person who has been fully informed.

  2.  Obtaining consent (and assent) is a process that involves providing information, evaluating understanding, documenting, frequent re-checking and where necessary, re-consenting.   

  3. Subjects who do not have full mental capacity should have a representative throughout the course of their participation in research until they regain or attain full capacity.
  4.  There is no one-size-fit-all approach when it comes to obtaining consent and/or assent – whether they should be obtained, and how they can be obtained. The approach must be sensitive to the needs and circumstances of research subjects in order to protect their rights, safety and welfare.