Under the Regulations a ‘minor’ is a person under the age of 16 years.
The regulations prescribe a hierarchy for determining who should be approached to give informed consent on behalf of a minor prior to their inclusion in the trial. The provisions for informed consent by a legal representative only apply if by reason of the emergency nature of the treatment provided as part of the trial no person with parental responsibility can be contacted prior to the proposed inclusion of the minor.
- Parent : a parent or person with parental responsibility
- Personal legal representative : a person not connected with the conduct of the trial who is suitable to act as a legal representative by virtue of their relationship with the minor, and available and willing to do so
- Professional legal representative : a person nominated by the relevant healthcare provider (eg: an acute NHS Trust) who is not connected with the conduct of the trial
The Medicines for Human Use (clinical trials) and Blood Safety and Quality Amendment Regulations 2008 made additional provision relating to trials involving minors in emergency situations. Where the treatment to be given to a minor as part of the trial needs to be administered urgently, time may not allow for the written consent of a person with parental responsibility or a legal representative to be obtained first.
The amendment allows minors to be entered into a trial prior to informed consent being obtained provided that:
- Having regard to the nature of the trial and the particular circumstances of the case, it is necessary to take action for the purpose of the trial as a matter of urgency, but, it is not reasonably practicable to do obtain informed consent prior to entering the subject and
- The action to be taken is carried out in accordance with a procedure approved by the ethics committee
Where a minor is recruited in an emergency situation without prior informed consent, steps must be taken to seek informed consent from a person with parental responsibility or a legal representative as soon as practicable after the initial emergency has passed.
Where consent is withheld, the participant must be withdrawn from the trial.
1. The parent or legal representative has had an interview with the investigator, or another member of the investigating team, in which opportunity has been given to understand the objectives, risks and inconveniences of the trial and the conditions under which it is to be conducted.
2. The parent or legal representative has been provided with a contact point where further information about the trial may be obtained
3. The parent or legal representative has been informed of the right to withdraw the minor from the trial at any time
4. The parent or legal representative has been given informed consent to the minor taking part in the trial
5. The parent or legal representative may, without the minor being subject to any resulting detriment, withdraw the minor from the trial at any time by revoking the informed consent
In the event of an emergency the above points do not apply
6. The minor has received information, according to his or her capacity of understanding, about the trial and its risks and benefits. The information must be given by staff with experience with minors.
7. The investigator must consider the explicit wish of a minor capable of forming an opinion and assessing the information provided. This applies both to the wish of a minor to refuse to take part, or to withdraw from the trial at any time.
8. No incentives or financial inducements are given either to the minor or to the parent or legal representative, except the provision of compensation for injury or loss.
9. The clinical trial relates directly to a condition from which the minor suffers or is of such a nature that it can only be carried out on minors
10. Some direct benefit for the group of participants involved in the trial is to be obtained from the trial
11. The trial is necessary to validate data obtained (a) in other clinical trials involving persons able to give informed consent, or (b) by other research methods.
12. The corresponding scientific guidelines or the European Medicines Agency (EMEA) are followed.
- Informed consent by a parent or legal representative shall represent the minor’s presumed will
- The trial has been designed to minimise pain, discomfort, fear and any other foreseeable risk in relation to the disease and the minor’s stage of development
- The risk threshold and the degree of distress have to be specially defined and constantly monitored
- The interest of the participant always prevails over those of science and society