Key points are not available for this paper at this time.
established best practice. 67] 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. 8These 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.
Barnish et al. (Thu,) studied this question.