Research involving a child and vulnerable adults

Children are only involved in medical research if for some reason it is not possible to carry out the study on adults. The ethics committee will want to be sure that the study is beneficial to the child and will involve only minimal risk or discomfort.


16-18 year olds

If a young person between the age of 16-18 is thought to have a clear understanding of what the research involves they will be allowed to give their own consent.


Children under 16

The ideal situation for any child under 16 would be that the child and the parent/s are in agreement about giving consent. By law it is possible that a child younger than 16 can give their own consent in the following circumstances:

  1. The child has been counselled and does not want to involve a parent.
  2. The child is mature enough to understand what the research is about and any risks or benefits involved.

These circumstances would be very unusual.


Parental consent

Where a child is too young or incapable of understanding what is involved in the research a parent will be given the power to consent. One parent can give consent, but it is advisable that both parents agree if possible.



When a parent or guardian of a child under 16 is giving consent on the child's behalf, it is very important that the child wherever possible assents to the research. Assent means that child agrees with the parent's decision to give consent.


Giving assent for research involving an adult

Some adult patients are not capable of giving their own consent for research. This could be due to

  1. Severe mental illness
  2. Learning difficulties
  3. Because of unconsciousness or semi-consciousness

Sometimes important research needs to be carried out in emergency situations when a patient may be too ill to give their consent to take part. This means that some other way of gaining consent needs to be used. At the moment consent will often be given by a doctor who has no involvement in the study and can act in the best interest of the patient. Even though relatives are not currently able to give consent on behalf of the patient it is usually the case that the medical staff will seek the agreement of close relatives (assent) before going ahead with the research.

Once a patient recovers enough they will be asked for their consent to continue in the study.

In the case of a patient with learning difficulties of severe mental illness doctors should seek independent advice about whether the person is capable of giving their own consent.

Future health policy is likely to give more rights to the person closest to an incapacitated patient to give consent on their behalf.


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