UK: Clinical trials

Last Updated: 21 October 2003
Article by Alexandra Johnstone

New regulations on consent in clinical trials

The Medicines for Human Use (Clinical Trials) Regulations 2003 (‘the Regulations’) will bring into force a European Directive1 on clinical trials relating to medicinal products. The Regulations have important implications for clinical trials where research into medicinal products is involved. The scope of this article does not permit a full discussion of the Regulations and any healthcare body considering entering a clinical trial is advised to seek legal advice on their effect. However, some of the key issues raised are discussed below.

Adult patients

Where a trial is to involve adult competent patients, the proposed subjects must give informed consent to involvement in the trial, although the Regulations do not define the extent of information required to constitute ‘informed consent ’.These subjects are to have an interview with the authorised health professional responsible for the conduct of the trial or an appropriately qualified member of the trial team. The interview must give the subject an opportunity to ‘understand the objectives, risks and inconveniences of the trial and the conditions under which it is to be conducted ’.2 The subject must be provided with a contact point where he may obtain further information about the trial.

Children aged under 16

Where proposed clinical trials concern children under 16 years old, the Regulations set down principles by which such trials are to be conducted. The trial has to be designed to minimise pain, discomfort, fear and any other foreseeable risk in relation to disease and the child ’s stage of development. The risk and degree of distress ‘must be specifically defined and constantly monitored ’ and account taken of the patient ’s interests over any interests of science and society.

A parent, or someone with parental responsibility, must give informed consent to the child taking part in the trial. That person must have an interview with the healthcare professional responsible for the trial for the purposes described above in relation to adult subjects. Such a person must also be given a contact point where he may obtain further information about the trial. Such a person is entitled to withdraw the child from the trial at any time by revoking informed consent.

The child subject does not have a right to consent to involvement in the trial, but must have received information, regarding the trial, its risks and benefits, according to his capacity to understand from staff with professional experience of children. Where a child indicates that he does not wish to be involved in a trial, the healthcare professional responsible for the trial will consider those wishes, taking into account the child ’s capability to form an opinion and assess the information about the trial.

A clinical trial involving child subjects must relate directly to a clinical condition from which the child suffers, or be of such a nature that it can only be carried out on children. Some direct benefit for the children involved in the clinical trial is to be obtained from the trial. This is a difficult condition to satisfy in view of the nature of clinical trials (see below).

Incapacitated adults

The Regulations also make provision for incapacitated adults to be involved in clinical trials. Such a patient ’s legal representative can give informed consent to involvement in a trial. This is a departure from existing English law. A ‘legal representative ’is defined in the Regulations.

Similar procedures apply to the legal representative as to the parent of a child involved in a clinical study. The legal representative is to be provided with a contact point to obtain further information about the trial, and must be informed of the right to withdraw the subject from the trial at any time.

An adult incompetent patient must receive information regarding the trial, its risks and benefits according to his capacity to understand. Where the subject indicates that he does not wish to participate, or wishes to be withdrawn from a trial, the healthcare professional responsible for conducting the trial must consider his wish, having regard to his capacity.

The Regulations also provide that where such patients are to be involved in a trial there must be grounds for ‘expecting that administering the medicinal product to be tested in the trial will produce a benefit to the subject outweighing the risks or produce no risk at all ’. This is likely to be a very difficult assessment to reach at the outset of the trial as the very purpose of the trial will involve testing the efficacy and risks/benefits balance of the medicinal product. The Regulations also provide that the clinical trial must be related directly to a life threatening or debilitating condition from which the subject suffers.

The Regulations set down principles relating to the conduct of trials involving adult incompetent patients in similar terms to those principles relating to child patients.


The Regulations are to be laid before Parliament in October 2003 and are planned to come into force on 1 May 2004.At the time of writing, the transitional provisions have not yet been published. RadcliffesLeBrasseur is monitoring developments closely.


1 Directive on Good Clinical Practice in Clinical Trials (2001/20/EC)
2. The Medicine for Human Use (Clinical Trials) Regulations 2003, Schedule 1,Part 3

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.


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