Adults with incapacity: code of practice for medical practitioners

4. AUTHORITY FOR RESEARCH

Key points in Part 4

Research on adults incapable of consenting is authorised under the Act provided that

It will further knowledge;

It is of benefit to the adult or others in a similar condition;

It entails little or no risk or discomfort;

the adult is not objecting;

consent has been obtained from a person with relevant powers; and

the research has been approved by The Ethics Committee.

Authority for research

4.1 Section 51 sets out the circumstances and conditions which must apply when research involving adults with incapacity is undertaken. Subsection (1) of that section specifies that the term 'research' embraces surgical, medical, nursing, dental or psychological research. Subsection (2) provides that the purpose of involving adults with incapacity in research is to gain knowledge of the causes, diagnosis, treatment and care of the adult's incapacity or the effect of any treatment or care given to the adult while he or she is incapable.

4.2 One of the overriding conditions attached to involving adults with incapacity in research is that similar research cannot be done by involving adults who can consent. This condition is paramount. It is not sufficient to say there are no capable volunteers.

4.3 The other conditions which must be fulfilled are in section 51(3) (a) to (f):

(a) The research must be of direct benefit to the adult involved. (There are circumstances in which this qualification can be waived. These are discussed below.)

(b) The research must not be carried out if the adult indicates unwillingness.

(c) Ethical approval for the research must be obtained from The Ethics Committee. The Ethics Committee, specifically established by regulations made by Scottish Ministers, The Adults with Incapacity (Ethics Committee) (Scotland) Regulations 2002, available at: http://www.opsi.gov.uk/legislation/scotland/ssi2002/20020190.htm

has the discretion to attach conditions other than those listed, when granting ethical approval. Local Research Ethics Committees have no power to grant approval for research on adults with incapacity, or to consent to it.

(d) The research involves no foreseeable risk or only minimal risk to the adult and should impose no or only minimal discomfort. These conditions should be seen in the context of the adult's standard treatment, if that is appropriate.

(e) Before any research involving the adult is undertaken consent must be obtained from a guardian or welfare attorney of the adult who has powers to consent in relation to participation in research. If none has been appointed, the consent of the adult's nearest relative is required. These conditions, which are in no particular order, must all be fulfilled before an adult who cannot consent can be involved in research.

"Emergency" Research

4.4 (An amendment to section 51 permitting adults who lack the capacity to consent to be involved in "emergency" research, in the context of a clinical trial, provided the consent of the legal representative ² is obtained was implemented by The Medicines for Human Use (Clinical Trials) Regulations 2004, available at: http://www.opsi.gov.uk/si/si2004/20041031.htm

Subject to the trial having been approved by an ethics committee such "emergency" research can proceed without ethics committee approval and without the consent of any guardian or welfare attorney, or the adult's nearest relative, if :-

(i) it has not been practicable to contact any such person before the decision to enter the adult as a subject of the clinical trial is made, and

(ii) consent has been obtained from a person, other than a person connected with the conduct of the trial, who is:-

(a) the practitioner responsible for the medical treatment provided to the adult, or

(b) a person nominated by the relevant health care provider.

Where no direct benefit to the adult exists

4.5 The first of the conditions set out above is that the research must be of real and direct benefit to the adult involved. However, subsection 51(4) of the Act provides exceptionally for the possibility that research may be carried out even where it is not likely to produce real and direct benefit to the adult. This is where the research is likely to improve the scientific understanding of the adult's condition and in the long term contribute to the attainment of real and direct benefit to persons suffering from the same form of incapacity.

Were such research to cease altogether, there could be serious consequences for future prevention and treatment of serious conditions ( e.g. into the treatment of stroke, serious head injuries, and Alzheimer's disease). It is still necessary in these circumstances to comply with subsections (1), (2), and (3) (b)-(f) of section 51 of the Act.

The Ethics Committee

4.6 Section 51 enables the Scottish Ministers to make regulations to establish The Ethics Committee and prescribe those matters which that Committee must take into account when approving research. This is not an exclusive list and The Ethics Committee may examine such other matters as are relevant and appropriate to the applications for ethical appraisal submitted to them.