The human tissue bill and the mental capacity bill

Many authorities have expressed reservations about some provisions in the human tissue bill, which parliament will debate again at the end of June. Although these general concerns remain relevant, we must draw attention to another issue that has been largely glossed over—namely, the use of tissue and genetic information obtained from people with mental incapacity. The human tissue bill is one of several pieces of legislation which in their current form are likely to make research involving adult patients with critical illness, learning disability, or mental illness, either difficult or impossible.

One of the central themes of the human tissue bill is that “appropriate consent” or “qualifying consent” must be obtained before tissue from a living person may be used, stored, or genetically analysed. Failure to do so constitutes a criminal offence. Where the tissue comes from a living adult, the person himself or herself must give the consent.¹ This indicates it may become a criminal offence to use, store, or genetically analyse human tissue taken from adults who lack capacity to make a decision themselves. Responding to these concerns, the government stated that an additional piece of proposed legislation, the mental capacity bill, would make it possible for a third party to authorise legally such interventions. However, the initial draft of the mental capacity bill concealed a raft of as yet unresolved legal ambiguities.

The original expectation was that the mental capacity bill would set out a framework for proxy consent when tissue was obtained from incompetent people. However, the primary clauses of the draft mental capacity bill were not broad enough to encompass the range of activities otherwise made criminal by the human tissue bill. Clauses 4 and 6 of the mental capacity bill authorised a person to undertake an action when providing “a form of care” for an incapacitated person, provided that such action is in the incapacitated person's best interests. The statutory definition proposed by the government for the best interests test was broad. However, much medical research, education, and DNA analysis cannot be said to be a form of care in the best interests of an incompetent person, and criminal liability will follow unless one or other of the bills is modified.

A critical report from the joint scrutiny committee on the mental capacity bill finally prompted the government to acknowledge that the draft bill failed to provide for properly regulated research involving people who lack capacity, and that without such research the development of novel treatments might be impossible.² While its response secured a basis for therapeutic research, the government balked at non-therapeutic research stating that it would explore whether research “should be able to benefit the cohort....”³

New regulations for clinical trials provide little promise.⁴ These regulations seem to ignore the concept of equipoise in clinical research. Where no likely benefit can occur to the incompetent person a clinical trial of a medicinal product may be undertaken only if there is no risk at all. Therefore a generally workable form of the mental capacity bill or human tissue bill is essential if we are to legitimise much of the research that is undertaken in incompetent adults.

The revised mental capacity bill published last week indicates some positive developments. It permits research that will contribute to knowledge of the causes, treatment, or care of people with the same or similar condition.⁵ This is subject to a list of safeguards both procedural and rule based, requiring review by an ethics committee; consultation with a person close to the incompetent person; that there be no objection from the person and no alternative means of carrying out the research with competent adults; and that the research should not involve anything that restricts the person's movements or invades their privacy in a significant way. Guidance on how to judge this last standard would be beneficial but is unavailable. It is nevertheless a welcome development, congruent with established best practice.^6-7 It departs from previously suggested phrasing that the research should be of “direct benefit to persons with that particular condition,” which would have precluded much observational or epidemiological research. One residual point is that the new bill restricts research to that which examines the causes or treatment of “a condition attributable to the impairment [or disturbance] of the mind or brain.” This may preclude research in intensive care units where the subject is incompetent not due to neurological disease, but instead due to sedative therapy which is essential to their care. One solution would be to recognise that essential therapy is part of the overall burden of disease, and permit research into the underlying illness when such therapy compromises competence. It is also important that the mental capacity bill is interpreted to recognise explicitly that it is ethical to proceed when clinical equipoise exists. Clear and enabling guidance notes, or appropriate amendments, are therefore necessary.

Some ground has also been achieved in the human tissue bill since an earlier draft of this editorial was shared with Department of Health officials. New amendments have just been announced that allow the secretary of state to specify conditions under which consent can be presumed for research involving tissue from an incompetent person.⁸ These conditions have not been itemised. It is to be hoped they will interact simply and clearly with the conditions in the revised mental capacity bill. The secretary will also be given power to set conditions allowing analysis of an incompetent person's DNA. This should alleviate the problem in earlier versions of the human tissue bill which, ignoring the Human Genetics Commission's 2002 recommendation,⁹ did not allow DNA to be analysed for the benefit of a family member (for example, to predict the risk of breast cancer). These improvements to the human tissue bill will not be realised until regulations are drafted and approved by parliament. It will be important to ensure they are prepared swiftly and that the details are sound.

The consequences of inadequate legislation in these areas are not trivial. Clear and strictly conditioned policies for non-therapeutic research and the practice of clinical genetics are essential if we are to improve care and outcome in these settings. Carefully drafted legislation, underpinned by sensible guidance, could facilitate research while addressing legitimate public concerns.