Children and young people – guidance

Children and young people are potentially vulnerable study participants. Their interests must be protected, and they must not be exploited for study purposes.


  1. Study procedures or interventions that are intended to provide direct therapeutic benefit to child participants may be undertaken if:

    • the risk is justified by the anticipated benefit to the child participants
    • any ratio of anticipated benefit to risk is likely to be at least as favourable to the child participant as any available alternative.
  2. Some study procedures or interventions are not intended to be of direct benefit to child participants. However, they are likely to yield general knowledge about a children’s disorder or condition that is of vital importance for understanding or improving that disorder or condition. These procedures or interventions may be undertaken if:

    • any risk represents a minor increase over minimal risk
    • the intervention or procedure presents experiences to the child participants that are reasonably commensurate with those inherent in the participants’ actual or expected medical, psychological, social or educational situations.
  3. Study procedures that are not intended to directly benefit the child participants and are not covered by points 1. and 2. above may be undertaken only if the risk presented by the interventions to the child participants is:

    • minimal, and
    • commensurate with the importance of the knowledge to be gained.

Informed consent

Children must, if possible, provide their informed consent to participating in a study.

If a child is unable to provide informed consent, the child must provide informed assent if possible, and consent should be obtained from their parents or legal guardian.

Suitable information sheets and consent forms must be provided for studies involving children.

General considerations

Before undertaking any study that involves child participants, the investigator must ensure that:

  • children will not be involved in a study that might be carried out equally well with adults
  • a study that involves child participants must relate to the health needs of children
  • where a study involves children, it should involve the least vulnerable children
  • if a choice of age groups is possible, older children should be involved in preference to younger ones
  • the study is designed or supervised and carried out by people experienced in working with children
  • the number of children involved is limited to the number that is scientifically and clinically essential.


Families and children must not receive any financial payments or other reward for participating in a study. Only expenses resulting from participation may be reimbursed.

Retaining and using personally identifiable health data

Study data on child participants should be kept by the researcher for 10 years after that participant has reached 16 years of age.

Children have the right to withdraw their consent to the continued use or retention of personally identifiable health data once they turn 16 years of age.

Applicable laws and regulations

Section 36 of the Care of Children Act 2004 governs consent to any medical, surgical or dental procedures in relation to a child.

Right 7 of the Code of Health and Disability Services Consumers Rights 1996 applies to consent to treatment and/ or research.

For more information

For more information, refer to the NEAC Guidelines for Intervention Studies: Appendix 2.