"clinical trial" means a trial of drugs or techniques that necessarily
involves the carrying out of medical or dental treatment on the participants
in the trial.
"medical or dental treatment" or
"treatment" means:
(a) medical treatment (including any medical or surgical
procedure, operation or examination and any prophylactic, palliative or
rehabilitative care) normally carried out by or under the supervision of a
medical practitioner, or
(b) dental treatment (including any dental
procedure, operation or examination) normally carried out by or under the
supervision of a dentist, or
(c) any other act declared by the regulations to
be treatment for the purposes of this Part,
(and, in the case of treatment in
the course of a clinical trial, is taken to include the giving of placebos to
some of the participants in the trial), but does not include:
(d) any
non-intrusive examination made for diagnostic purposes (including a visual
examination of the mouth, throat, nasal cavity, eyes or ears), or
(e)
first-aid medical or dental treatment, or
(f) the administration of a
pharmaceutical drug for the purpose, and in accordance with the dosage level,
recommended in the manufacturer's instructions (being a drug for which a
prescription is not required and which is normally self-administered), or
(g)
any other kind of treatment that is declared by the regulations not to be
treatment for the purposes of this Part.
"major treatment" means treatment (other than special treatment or treatment
in the course of a clinical trial) that is declared by the regulations to be
major treatment for the purposes of this Part.
"minor treatment" means treatment that is not special treatment, major
treatment or treatment in the course of a clinical trial.
"person responsible" has the meaning given by section 33A.
"special treatment" means:
(a) any treatment that is intended, or is
reasonably likely, to have the effect of rendering permanently infertile the
person on whom it is carried out, or
(b) any new treatment that has not yet
gained the support of a substantial number of medical practitioners or
dentists specialising in the area of practice concerned, or
(c) any other
kind of treatment declared by the regulations to be special treatment for the
purposes of this Part,
but does not include treatment in the course of a
clinical trial.
(2) For the purposes of this Part, a person is incapable of
giving consent to the carrying out of medical or dental treatment if the
person:
(a) is incapable of understanding the general nature and effect of the
proposed treatment, or
(b) is incapable of indicating whether or not he or
she consents or does not consent to the treatment being carried out.
(3) For
the purposes of this Part, a person shall be taken to object to the carrying
out of medical or dental treatment:
(a) if the person indicates (by whatever
means) that he or she does not want the treatment to be carried out, or
(b)
if the person:
(i) has previously indicated, in similar circumstances, that he
or she did not then want the treatment to be carried out, and
(ii) has not
subsequently indicated to the contrary.
