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Chapter 5: Independent Supervision of Medical and Research Procedures

This Chapter considers another area of particular sensitivity: the supervision of medical and research procedures, including sterilisation, donation of tissue or bone marrow, and abortion. The Law Commission recommended independent supervision to ensure that the best interests of the person without capacity are protected in all circumstances. The Government wishes to ensure that there are sufficient safeguards.

 

Background
Treatments requiring court approval
Treatments requiring a second doctor's certificate
Departing from the best interests criteria
Research procedures not intended to benefit the participant
Mental incapacity Research Committee

 

Background

5.1. The Law Commission thought that certain types of serious medical procedures, including sterilisation, donation of tissue or bone marrow, and abortion, should be subject to additional independent supervision to ensure that the best interests of the person without capacity are protected. In some exceptional instances there might also be situations where the person's best interests are not the only consideration.

 

5.2. The Law Commission recommended that decisions on some procedures should be either:

 

considered by the courts;

 

the subject of an independent second medical opinion;

 

the subject of consideration by the court or the second opinion procedure; or

 

(in relation to certain types of research) subject to another kind of supervisory mechanism.

 

5.3. The Law Commission recommended that where there was a valid advance statement, or a power of attorney covering the specific issue in question or the court had appointed a manager to deal with the particular decision, the special procedures might not be necessary and hence their recommendations integrate these other methods of decision making into their proposals in these areas.

 

5.4. The Government accepts the principle behind many of the recommendations made in these areas, but seeks views on how the proposals would work in practice. This chapter, however, also sets out a number of key ethical issues, on which the Government would welcome views as to whether the Law Commission's recommendations are appropriate.

 

5.5. Consideration of the procedures discussed in this chapter is most likely to arise in relation to those whose incapacity is expected to be prolonged or permanent. Where a person is likely to recover capacity, making a treatment decision that is relatively irrevocable, such as that concerning sterilisation other than in the case of necessity to treat a disease, is likely to be inappropriate.

 

Treatments requiring court approval

5.6. Respondents to the Law Commission's consultation were unanimous in agreeing that some medical decisions should always require prior judicial approval. The court could achieve this by making a one-off decision or by appointing a manager to take the decision in question. The Law Commission recommended that the court need not be involved if the person without capacity had appointed an attorney to take the decision on his or her behalf and the power of attorney specifically covered the issues subject to this special procedure (1). They recommended that the general authority to act reasonably should not be able to authorise any treatments or procedures which required the authorisation of the court or the consent of an attorney or manager.

 

5.7. The Government has some doubts about whether an attorney should be able to consent to medical procedures which would otherwise require court approval. Under the ethical codes of the medical profession, doctors will only offer treatment if they perceive it to be in a patient's best interests to receive it. There is no question of doctors being forced to offer treatment if they do not believe it to be in a patient's best interests. An attorney therefore has to form his or her own view of the patient's best interests. If that view is that the proposed treatment is in the patient's best interests, the attorney will agree with the doctor and consent. If the attorney disagrees that the treatment is in the patient's best interests, he will wish to refuse the treatment. Were this not to be permitted, the matter might then need to be considered by the court. In such a situation, it would appear that the attorney is in some sense acting as a double check in that his powers only extend to agreeing with the doctor.

 

Q35. Should an attorney be able to consent to medical procedures which would otherwise require the approval of the court?

 

Q36. Should an attorney ever be able to refuse treatment?

 

 

Sterilisation

 

5.8. The Law Commission separated sterilisations into three categories, those required:

 

to treat a disease of the reproductive organs;

 

to relieve an existing detrimental effect of menstruation; and

 

to deal with contraception.

 

5.9. The Law Commission recommended that any treatment or procedure intended or reasonably likely to render the person permanently infertile should require court authorisation unless it is to treat a disease of the reproductive organs or relieve existing detrimental effects of menstruation. They noted that none of their respondents had suggested that judicial supervision was necessary in respect of treatment of a disease of the reproductive organs. The Government notes that treatment of diseases other than those affecting the reproductive organs, such as chemotherapy for cancer, may be likely to render a person permanently infertile. This issue is therefore considered both in this section, in the context of treatments requiring court approval, and in the next section, which looks at procedures which require a second doctor's certificate.

 

5.10. The Government recognises the sensitivity of this subject, and is particularly concerned that legislation on sterilisation should be accompanied by appropriate safeguards.

 

Q37a. Should the court be asked to rule on all proposed sterilisations for contraceptive purposes?

 

Q37b. Should the court be asked to rule on all proposed sterilisations to relieve the existing detrimental effects of menstruation?

 

Q37c. Should the court be asked to rule on all treatment for diseases where the treatment will, or is reasonably likely to, render the person permanently infertile?

 

 

Donation of tissue or bone marrow

 

5.11. The Law Commission recommended that any treatment or procedure to facilitate the donation of non-regenerative tissue or bone marrow should require court authorisation. Organ donation will rarely seem in the best interests of the person without capacity, but could have long-term implications for them, for example if the person who requires the organ is a close family relative who has caring responsibilities for the person without capacity.

 

5.12. Since the publication of the Law Commission's Report, the judgement in Re Y (2) has clarified that, under existing common law, any proposal for bone marrow donation from an adult incapable of giving consent must first be aired in the courts, who will consider whether such a procedure would be lawful in the individual circumstances of the case.

 

5.13. The Government accepts the principle, and the current common law position, that the court should rule on any treatment or procedure to facilitate donation of non-regenerative tissue or bone marrow from an adult incapable of giving consent. Again, however, the Government is concerned to ensure that adequate safeguards are in place. Accordingly it seeks the views of respondents on whether there should be procedural safeguards for the donation of any other organs or tissue. This may include regenerative tissue, other than bone marrow, such as blood. We note that for blood, current guidance issued by the National Blood Service stresses that collection teams should screen out any adult who they consider is incapable of understanding the information with which they are provided. Conversely, views are also sought on whether any non-regenerative tissues or bone marrow should be excluded from the general rule.

 

Q38. Should the donation of any organs be excluded from this general rule?

 

Q39a. Should it ever be necessary to consider an incapacitated person as a donor of regenerative tissue?

 

Q39b. If so, should there be procedural safeguards similar to those which exist for non-regenerative tissue or bone marrow?

 

 

Power to prescribe further treatments

 

5.14. The Law Commission suggested that the Secretary of State for Health should have the power to prescribe further treatments which required court authorisation to ensure that any changes in medical science would not require the amendment of primary legislation.

 

5.15. The Government agrees with this recommendation.

 

Treatments requiring a second doctor's certificate

5.16. The Law Commission thought that a second opinion procedure would sometimes be more appropriate than court proceedings. This would be consistent with the treatments for mental disorder specified in section 58 of the Mental Health Act 1983. The types of decisions the Law Commission recommended for inclusion in this category relate to a medical complaint from which the person without capacity is already suffering. The doctor giving the second opinion would be required to certify whether the person had the capacity to understand the implications of the treatment and consequently make a decision about whether to consent to or refuse it; and whether the treatment or procedure proposed was indeed in the patient's best interests.

5.17. The Law Commission thought that this procedure would be unnecessary where a donee of a power of attorney or a court appointed manager could make the decision. They recommended that the general authority to act reasonably should not be able to authorise treatments specified as requiring a certificate from an independent doctor appointed for that purpose by the Secretary of State. This should not prevent action being taken to prevent the death of the patient or serious deterioration in his or her condition while the certification or consent is being sought.

 

Sterilisation

5.18. The Law Commission recommended that any treatment or procedure likely to render the person concerned permanently infertile should require a certificate from an independent medical practitioner where it is for relieving the existing detrimental effects of menstruation. The Government wishes to ensure that sufficient safeguards are provided, and question 37, above, has sought views on whether the court should take responsibility for such decisions.

 

Abortion

5.19. The Law Commission recommended that the second opinion procedure should also apply where abortion was being considered. The current law already requires two doctors to certify in good faith that the statutory grounds for abortion are met.

5.20. The Government considers that the existing legislation provides an acceptable framework for decision-making in this area. Consideration will be given as to whether practice can be improved within the current statutory framework.

 

Treatments for Mental Disorder

5.21. The Law Commission also recommended that such a procedure should apply when it is proposed to administer medical treatment for mental disorder described in section 58(1) of the Mental Health Act 1983 where the person does not have capacity to consent to that treatment. The Law Commission preferred this option to suggesting that patients should always be detained and treated under the Mental Health Act as this might increase the number of people compulsorily detained. Certain forms of treatment may be given under the Mental Health Act without the consent of the patient, but the doctor is still required by the Mental Health Act Code of Practice to try to obtain consent. The Law Commission regarded a written advance refusal of treatment to be as valid as an oral refusal given at the time the treatment is proposed. Only if the statutory criteria are met could the person be lawfully detained and treated under the Mental Health Act 1983. The Government supports this recommendation.

Q40. Do the proposals for a second medical opinion provide a sufficient safeguard in relation to:

i. sterilisation to relieve the existing detrimental effects of menstruation;

ii. abortion; or

iii. medical treatment for mental disorder?

5.22. The Law Commission also proposed that the Secretary of State for Health should be able to add to the list of procedures to be included in the second opinion category.

Q41. The Government would welcome views on other procedures which should be added to the list proposed by the Law Commission.

 

Departing from the best interests criteria

5.23. The Law Commission also recommended that there are certain exceptional situations where a departure from the best interests criteria can be justified.

 

 

Withdrawing artificial nutrition and hydration

 

5.24. The majority of respondents to the Law Commission proposals believed that any decision to withdraw artificial feeding from a patient in a persistent vegetative state should require the prior approval of the court. The Law Commission thought that the main difficulties here lay in withdrawing treatment rather than commencing it, as the best interests criteria would clearly apply in deciding whether a particular course of action, such as an operation to allow direct feeding, would be appropriate (3). The question to be determined for PVS patients already being provided with artificial hydration and nutrition is, if the patient has any interests at all, whether such treatment is in their best interests. The Law Commission thus recommended that discontinuing the artificial nutrition and hydration of a patient who is 'unconscious, has no activity in the cerebral cortex and no prospect of recovery should be lawful if certain statutory requirements are met' (4).

 

5.25. The Government notes the 1996 report of the Royal College of Physicians on the persistent vegetative state (5) which found that there was no evidence that electroencephalography, which measures activity in the cerebral cortex, provided evidence which could improve upon the clinical diagnosis of permanent vegetative state. Such patients may show low levels of activity in the cerebral cortex. The Government therefore seeks views on the following definition:

 

"patients who have no prospect of recovery who are either unconscious or in a permanent vegetative state".

 

Q42. Should the discontinuation of artificial nutrition and hydration be lawful for defined patients if certain statutory criteria are met?

 

Q43. Is "patients who have no prospect of recovery who are either unconscious or in a permanent vegetative state" a suitable definition?

 

 

5.26. The Law Commission suggested that advance refusal of artificial nutrition or hydration could validly be made. The Law Commission also recommended that such a decision could also be taken by a person acting under a power of attorney. A patient could not, however, refuse by advance directive direct oral nutrition or hydration as this would fall within the definition of basic care. The Government agrees that direct oral nutrition and hydration should always be offered, but is concerned to avoid the possibility of force feeding.

 

5.27. The Law Commission thought that there might come a time when a sufficient bank of case law had been established to allow such decisions to be made under the second opinion procedure rather than by the court. Any such change would only be effected after consultation and following an affirmative resolution of each House of Parliament. Any case of dispute could still be referred to the courts if necessary.

 

5.28. The Government would welcome views on whether these recommendations, and in particular the recommendation that a power of attorney should be able to confer the right to direct the withdrawal of artificial nutrition or hydration, offer sufficient safeguards for the patient. An alternative would be for all such cases to be decided by the courts. While such a proposal would have clear resource implications, the Government would welcome views on whether such a step is necessary. The Government agrees that an affirmative resolution of both Houses of Parliament should precede any move to allow decisions to withdraw artificial nutrition and hydration to be made under the second opinion procedure rather than by the court, but would welcome views as to whether it is likely that any move in this direction would be appropriate, and whether any additional safeguards would need to be provided.

 

Q44a. Should the court retain the exclusive right to make decisions on the withdrawal of artificial nutrition or hydration; or

 

Q44b. Should a person acting under a power of attorney be able to make such decisions? or

 

Q44c. Could these decisions appropriately be made by the second opinion procedure?

 

Q45. If either of the alternatives to the court retaining exclusive rights is considered appropriate, are any additional safeguards necessary in order to protect the patient?

 

5.29. The Law Commission recommended that, although the patient in PVS might not technically have any best interests, the factors included in the best interests checklist might nevertheless be valid e.g. the wishes and feelings of the patient and those near to him or her.

 

5.30. The Government notes the alternative view that such patients do have best interests. This view makes it even more important that each of the best interests criteria must be considered in every case.

 

Q46. In considering the continuance or withdrawal from PVS patients of artificial nutrition and hydration, should regard be given to the best interests guidance?

 

 

Procedures to benefit others

 

5.31. The second area in which the Law Commission thought there might be a case for departing from the best interests criteria is to facilitate procedures for the benefit of others.

 

5.32. The Law Commission recommended that the Secretary of State for Health might make an order providing for the carrying out of a procedure in relation to a person without capacity to consent, if the procedure, although not carried out for the benefit of that person, will not cause him or her significant harm and will be of significant benefit to others. The Law Commission were not wholly convinced that the case for this change had been proved, particularly as they had not specifically asked for comments on this issue, but they thought that it might become necessary in the future. Any such order should not be made before there had been thorough consultation and the patient should be able to object, for example through an advance refusal or an attorney. Any order made by the Secretary of State would need to specify whether court authorisation or an independent second opinion procedure should apply.

 

5.33. This recommendation would cover procedures such as genetic screening, which involves taking a sample of blood or other bodily fluids from the patient in order to investigate the genetic make up of that person. This might have significant benefit for other members of the patient's family e.g. to see if a debilitating condition is likely to be inherited, to assist in determining treatment options and enabling that person to make decisions about their future care and reproductive choices. A further procedure is elective ventilation, where an unconscious patient whose death is regarded as inevitable, is ventilated mechanically to enable the retrieval and transplantation of donor organs to take place after death. This benefits the recipients of any organs received. However, there are also potential problems for the patient, their relatives and the wider public. The procedure by which the patient is ventilated may result in the patient entering the persistent vegetative state, which is not in their interests nor in those of relatives. Further, any publicity surrounding this area, which many people find an uncomfortable subject, may impact adversely on organ donation rates. Both of these procedures are currently unlawful.

 

5.34. This is potentially a wide-ranging recommendation, and, given that the Law Commission did not specifically consult on this issue, the Government would particularly welcome views on the following:

 

Q47. Are there any circumstances in which it is ethical and reasonable to apply to patients unable to give consent medical procedures of benefit to others?

 

Research procedures not intended to benefit the participant

5.35. Although it may be in a patient's best interests to participate in research which may benefit him or her, this cannot be said to be the case where the research is non-therapeutic i.e. the patient will not benefit directly. If a patient does not have the capacity to consent, any researcher who touches or restrains that person in the course of research will be committing an assault. The research may, however, be of benefit in understanding better the condition from which the patient suffers and may assist future sufferers. The consensus on consultation was that such research could be justifiable where it was concerned with the condition from which the person without capacity suffered and the procedures involved minimal risk and invasiveness. The Law Commission thus recommended that research could be carried out as long as it was into the condition from which the patient suffered and certain statutory procedures were followed.

 

5.36. The Law Commission recommended that the research involved need not be purely medical but that it would need to satisfy the following:

 

that it is desirable to provide knowledge of the causes or treatment of, or of the care of people affected by, the incapacitating condition with which any participant is or may be affected;

 

that the object of the research cannot be effectively achieved without the participation of persons who are or may be without the capacity to consent; and

 

that the research will not expose a participant to more than negligible risk, will not be unduly invasive or restrictive of a participant and will not unduly interfere with a participant's freedom of action or privacy.

 

 

Council of Europe Convention on Human Rights and Biomedicine

 

5.37. The Council of Europe Convention on Human Rights and Biomedicine recognised that non-therapeutic research on a person not able to consent could be ethical if strict safeguards were provided. Such research must fulfil the general safeguards for any form of research on a person not able to consent, which are that:

 

there is no alternative of comparable effectiveness to research on humans;

 

the risks which may be incurred by that person are not disproportionate to the potential benefits of that research;

 

the research project has been approved by a competent body after independent examination of its scientific merit, including assessment of the importance of the aim of the research, and multidisciplinary review of its ethical acceptability (in England and Wales this role would be fulfilled by either the Multi-Centre Research Ethics Committees; the Local Research Ethics Committees; the Gene Therapy Advisory Committee (GTAC); or the United Kingdom Xenotransplantation Interim Regulatory Authority (UKXIRA));

 

research of comparable effectiveness cannot be carried out on individuals capable of giving consent;

 

authorisation has been given in the manner provided for by law after relevant information has been given; and

 

the person concerned does not object.

 

5.38. As well as these general conditions, non-therapeutic research must also meet the following additional conditions:

 

the research has the aim of contributing, through significant improvement in the scientific understanding of the individual's condition, disease or disorder, to the ultimate attainment of results conferring benefit on the person concerned or on other persons in the same age category or afflicted with the same disease or disorder or having the same condition; and

 

the research entails only minimal risk and minimal burden for the individual concerned. (6 )

 

5.39. The Government recognises the high level of feeling about the ethical implications of the Law Commission's recommendations, and the work of the Council of Europe in this area, and therefore seeks views on whether such research should be acceptable, and, if so, on what safeguards could be employed to ensure no abuse of such a scheme.

 

Q48. Should research procedures not intended to benefit the patient be allowed?

 

Q49. Are the safeguards proposed by the Council of Europe adequate to ensure that any scheme would not be open to abuse?

 

Q50. What, if any, additional safeguards would be required?

 

Mental incapacity Research Committee

5.40. The Law Commission recommended the establishment of a statutory Mental incapacity Research Committee which would authorise particular research projects (although further authorisation would be required regarding the participation of particular individuals).

 

5.41. If safeguards with which research projects must comply are provided by law, the Government is not convinced that an additional committee is required to supplement the established system of Local Research Ethics Committees and the newly developed system of Multi-Centre Research Ethics Committees.

 

5.42. The Law Commission recommended that, once the research was authorised by the Committee, there was a need for a separate individualised and independent check to confirm whether any particular proposed participant should indeed be brought into the project. In each case the researcher would have to ascertain whether the proposed participant had the capacity to consent. If they did not, then an independent check would be required. This could be by means of obtaining the consent of an attorney or court-appointed manager specifically authorised to make a decision on this matter; a certificate from a doctor not involved in the research that participation was appropriate; or the approval of the court (this would be most likely to occur where there was some disagreement, for example between a family member and an attorney); or, in rare cases the research was authorised as not involving direct contact between researcher and participant - such as covert observation of a patient.

 

5.43. An advance refusal would prohibit the patient's participation, as would any indication that he or she objects. Regard would be given to the best interests guidance in consideration of the particular circumstances of the case.

 

5.44. If a decision is taken to legislate in this area, the Government would accept the recommendation that a patient's objection should prohibit participation, which would provide an extra safeguard to help ensure that research is only carried out in appropriate cases.

 

Q51. What benefits would a Mental incapacity Research Committee provide over and above that provided by Local and Multi-Centre Research Ethics Committees?

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1 Consideration of the Law Commission's recommendations relating to powers of attorney is given in Chapter 6. See in particular the requirement for an attorney to act in a person's best interests in paragraph 6.17.Independent Supervision

 

2 Re Y [1997] 2 WLR 556.Independent SupervisionIndependent Supervision  

 

3 The House of Lords Select Committee on Medical Ethics offered a different view. Pointing out that in many cases it would not be possible to give full consideration to the best interests criteria when commencing treatment (for example in an emergency), the Select Committee concluded "for most practical purposes we do not discern any significant ethical difference between those decisions which involve discontinuing a treatment already begun and those which involve not starting a treatment" - HL Report 21-I, para. 251.

 

4 Law Com 231, para. 6.20.

 

5 Review of a Working group convened by the Royal College of Physicians and endorsed by the Conference of Medical Royal Colleges and their Faculties of the United Kingdom: The Permanent Vegetative State Journal of the Royal College of Physicians of London (1996) 30 (2) 119-121.

 

6 Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, Articles 16 and 17.