Guardianship Amendment Act 1998 (NSW)
New South Wales
Guardianship Amendment Act 1998
No 7
Contents
Page
1 Name of Act 2 2 Commencement 2
3 Amendment of Guardianship Act 1987 NO 257 2 3 Schedule 1 Amendments
New South Wales
Guardianship Amendment Act 1998
No 7
Act No 7, 1998
An Act to amend the Guardianship Act 1987 in relation to the participation in clinical trials of persons who lack the capacity to consent to their own medical and dental treatment; and for other purposes. [Assented to 12 May 1998]
| Section 1 | Guardianship Amendment Act 1998 No 7 |
The Legislature of New South Wales enacts:
1 Name of Act
This Act is the Guardianship Amendment Act 1998.
2 Commencement
This Act commences on a day or days to be appointed by proclamation.
3 Amendment of Guardianship Act 1987 No 257
The Guardianship Act 1987 is amended as set out in Schedule 1 .
Guardianship Amendment Act 1998 No 7
Amendments Schedule 1 Schedule 1 Amendments
(Section 3)
Section 6M Tribunal may declare appointment has effect
Omit “in need of guardianship” from section 6M (2) (a).
Insert instead “in need of a guardian”.
Section 32 Objects
Omit “only” from section 32 (b).
Section 33 Definitions
Insert in alphabetical order in section 33 (1):
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.
Section 33 ( 1 ) , definition of “major treatment” Insert “or treatment in the course of a clinical trial” after “special treatment”.
Section 33 ( 1 ) , definition of “medical or dental treatment”
clinical trial, is taken to include the giving of placebos to some of the Insert instead “(and, in the case of treatment in the course of a Omit “but does not include”. participants in the trial), but does not include”. Section 33 ( 1 ) , definition of “minor treatment” Omit “neither special treatment nor major treatment”. the course of a clinical trial”.
Guardianship Amendment Act 1998 No 7
| Schedule 1 | Amendments |
Section 33 ( 1 ) , definition of “special treatment”
Omit paragraph (c). Insert instead:
(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.
Section 35 Offences
Insert “or treatment in the course of a clinical trial” after “special treatment” in the penalty provision to section 35 (1) .
Part 5, Division 4A
Insert after section 45A:
Division 4A Clinical trials 45AA Tribunal may approve clinical trials
(1)
The Tribunal may approve, in accordance with this section, a clinical trial as a trial in which patients to whom this Part applies may participate.
(2) The Tribunal may give an approval under this section
only if it is satisfied that:
(a)
the drugs or techniques being tested in the clinical trial are intended to cure or alleviate a particular condition from which the patients suffer, and
(b)
the trial will not involve any known substantial risk to the patients (or, if there are existing treatments for the condition concerned, will not involve material risks greater than the risks associated with those treatments), and
Guardianship Amendment Act 1998 No 7
Amendments Schedule 1 the development of the drugs or techniques has reached a stage at which safety and ethical considerations make it appropriate that the drugs or techniques be available to patients who suffer from that condition even if those patients are not able to consent to taking part in the trial, and
having regard to the potential benefits (as well as the potential risks) of participation in the trial, it is in the best interests of patients who suffer from that condition that they take part in the trial, and
committee and complies with any relevant the trial has been approved by a relevant ethics guidelines issued by the National Health and Medical Research Council. The fact that a clinical trial will or may involve the giving of placebos to some of the participants in the trial does not prevent the Tribunal from being satisfied that it is in the best interests of patients that they take part in the trial.
The Tribunal’s approval of a clinical trial under this section does not operate as a consent to the participation in the trial of any particular patient to whom this Part applies. The appropriate consent must be obtained under Division 3 or 4 before any medical or dental treatment in the course of the trial is carried out on the patient.
ethics committee means: In this section:
(a) for so long as there is any relevant Institutional Ethics Committee registered by the Australian Health Ethics Committee established under the National Health and Medical Research Council Act 1992 of the Commonwealth-an Institutional Ethics Committee so registered, or (b) in the absence of such a committee, an ethics committee established by: (i) an area health service or a public hospital, or
Guardianship Amendment Act 1998 No 7
| Schedule 1 | Amendments |
(ii) a university, being an ethics committee concerned, wholly or partly, with medical research, or
(iii) the National Health and Medical Research Council.
45AB Consent for participation in clinical trials in individual
cases
(1) If the Tribunal is satisfied as to the matters specified in section 45AA (2) in relation to a clinical trial, it may, by order, determine:
(a) that the function of giving or withholding consent for the carrying out of medical or dental treatment on patients in the course of the trial is to be exercised by the persons responsible for the patients (in which case Division 3 applies), or (b) that the Tribunal is to exercise that function itself (in which case Division 4 applies). (2) Before making a determination referred to in subsection (1) (a), the Tribunal must be satisfied that the form for granting consent and the information available about the trial provide sufficient information to enable the persons responsible to decide whether or not it is appropriate that the patients should take part in the trial.
Section 51A Fewer than 3 Tribunal members may deal with certain matters
Omit “or special treatment” from section 51A (1) (a). clinical trial”.
| Omit “and special treatment”. | ||
| Section 51A (3) | ||
| Insert instead “, special treatment and clinical trial”. | ||
| Guardianship Amendment Act 1998 No 7 | ||
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|
Insert after section 76A (2):
(2A)
Despite subsection (2), if the Tribunal, during the period of 12 months covered by the report, approved a clinical trial (within the meaning of Part 5) under section 45AA, the report must include details of the trial (or proposed trial).
[Minister’s second reading speech made in-
Legislative Assembly on 8 April 1998 Legislative Council on 29 April 1998]
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