Consent in Clinical Trials
Response from the Joint Ethico-Medical Committee of The Catholic Union Of Great Britain and The Guild Of Catholic Doctors
To the Medical Control Agency on Consultation Letter: MLX 287.European Union Directive 2001/20/EC on Good Clinical Practice in Clinical Trials – Consultation on the UK’s proposed implementing regulations, specifically to the draft guidance on consent by a legal representative on behalf of a person not able to consent.
The Joint Ethico-Medical Committee is composed of members drawn from the two parent bodies. The Catholic Union is an organisation of the Catholic laity which is not affiliated to the hierarchy but which represents the Catholic viewpoint, where relevant, in Parliamentary and legislative matters. The Guild of Catholic Doctors represents Catholic Medical Practitioners in the United Kingdom.
In preparing our response we have taken note of the original European Directive and would draw attention specifically to the following sections thereof:
(Preamble) (3) Persons who are incapable of giving legal consent to clinical trials should be given special protection. It is incumbent upon the Member States to lay down rules to this effect. Such persons may not be included in clinical trials if the same results can be obtained using persons capable of giving consent. Normally these persons should be included in clinical trials only when there are grounds for expecting that the administering of the medicinal product would be of direct benefit to the patient, thereby outweighing the risks. Criteria for the protection of children in clinical trials therefore need to be laid down.
(4) In the case of other persons incapable of giving their consent, such as persons with dementia, psychiatric patients, etc., inclusion in clinical trials in such cases should be on an even more restrictive basis. Medicinal products for trial may be administered to all such individuals only when there are grounds for assuming that the direct benefit to the patient outweighs the risks. Moreover in such cases the written consent of the patient’s legal representative, given in cooperation with the treating doctor, is necessary before participation in any such clinical trial.
(5) The notion of legal representative refers back to existing national law and consequently may include natural or legal persons, an authority and/or a body provided for by national law.
Article 4 (i) and Article 5 (h) 'The interests of the patient always prevail over those of science and society.'
Article 5 (a) '...consent must represent the subject’s presumed will and may be revoked at any time, without detriment to the subject.'
The UK proposals as laid out in the draft guidance, for the implementation of EU Directive 2001/20/EC do not seem adequately to recognise the difference between therapeutic and non-therapeutic research. It is clear, however, from the directive itself (Preamble at 3 & 4, above) that only therapeutic research (i.e.: that which has a potential benefit for the subject) is permissible in those who cannot give consent. We consider that non-therapeutic research can never be permitted without the consent of the subject. Our comments, therefore, like the document, deal only with such research as is therapeutic.
In the case of children below the age of consent (i.e. non ‘Gillick’ competent) the legal representative in the UK is the parent, or rarely a court. Ethically, consent can only be given for treatment which is in the best interests of the child. On the other hand it is now usual for a child below the age of consent to be asked, whenever possible, to give their assent to what is proposed.
The original EU document makes it clear that the use of the term ‘legal representative’ refers to existing national law (5 above) and does not intend to provide for other ad hoc arrangements. However, your Consultation letter (MLX 287), at 5.2.1 paragraph 4 and 5.2.2, seems to understand the European document as requiring the introduction of the notion of ‘legal representative’ into UK law, where none at present exists.
In the draft Statutory Instrument ‘Medicines’, at schedule 1, Part 1, 2 (a) (ii) (a) or (b), we do not consider it appropriate, nor indeed legal, to enrol the services of an “ad hoc” legal representative, without any legal status, to give consent if a parent is not available, or - in the case of an adult - no relative is available to indicate assent. It must be noted that relatives may neither be sufficiently informed of the patient’s wishes nor genuinely disinterested in the outcome, and some may feel that such responsibility imposes an unfair burden upon them. In case of clinical necessity or emergency, where a new (and experimental) form of treatment is thought likely to provide the best, or at least a very substantial, prospect of cure it may be given on the basis of ‘necessity’ to preserve the patient’s medical best interests. If the case is not urgent no experimental procedure should be allowed in the absence of valid (prior) consent from the subject.
In UK law there is at present no legal provision for a ‘representative’ and it is not appropriate to seek to introduce them by departmental ruling. We would emphasise that the interests of the incompetent are no less than those of the competent in these matters and that any decision should therefore be even more carefully made than when they are able to decide for themselves.
However, should a change in the law come to permit a ‘legal representative’, then the rights of the subject must be carefully protected. The safeguards in Schedule 1, Part 1, at 2 (a) (ii) (a) and 2 (b) (iii) (a) where the treating doctor is given authority to consent on the patient’s behalf, or at 2 (a) (ii) (b) or 2 (b) (iii) (b) where the health care provider can nominate anyone to take such a decision, are totally inadequate. The EU document itself requires written consent from both the treating doctor and the ‘legal representative’.
Neither of these groups of persons, proposed as legal representatives in the consultation, is sufficiently independent (nor has sufficient knowledge of the patient) to make a genuinely independent decision. (See the directive at Article 5, (a) above). The treating doctor would, in all probability, be a colleague of the researcher and would almost automatically consent if an ethics committee had given approval. (Ethics committees are limited to indicating that they have found no ethical problem with proposed research in general but cannot support or commend a particular project nor comment on the ethics of a particular case). At (b) there is no indication of what criteria are to be applied to the selection of a ‘legal representative’ or with which qualities they should be endowed.
If such legal representatives were to be formally recognised it would seem to us necessary, in order to obtain genuinely independent ‘consent’, to look outside the medical sphere altogether, perhaps to a chaplain of the appropriate creed or to an independent lawyer.
At Schedule 1, Part 3, 1 and Part 4, 1, “An opportunity to understand” is an inadequate safeguard for the patient who, if he/she is having difficulties, needs to have carefully directed assistance to understanding insofar as they may be able.
At Schedule 1, Part 4, 6, and Part 5, 6, we think the meaning is ‘capacity for understanding’ rather that ‘capacity of understanding’.
At Schedule 1, Part 5, 7, for the investigator merely to ‘consider’ the explicit wish of the subject is totally inadequate and pays insufficient attention to the subject’s human rights. Such a wish, however expressed, must be binding on the investigator and the wording should therefore be ‘followed’ or at the very least ‘respected’ ‘by the investigator’.
In conclusion we note that one of the Department of Health’s 12 key points on consent states "No-one can give consent on behalf of an incompetent adult." We are therefore very concerned that the government is using the vehicle of a statutory instrument in order to introduce the practice of a legal representative granting consent on behalf of incompetent adults. If proper consent cannot be obtained in a situation where it is required, that should be a bar to such research and certainly, in the case of non-therapeutic research – an absolute bar. In the case of children, parental consent (or, if not available, consent from an appropriate court), together with assent from the subject, should be required for research on children – and since this must presuppose the subject’s own best interests this would exclude non-therapeutic research.
We believe our comments are in keeping with the intention of the original EU document and also with the European Convention on Human Rights.
Dr Michael Jarmulowicz FRCPath., MB,BS., BSc - Chairman JEMC
11th May 2003