Australian Institute of Health and Welfare Ethics Committee Regulations 1989
Statutory Rules 1989 No. 118 as amended
made under the
Australian Institute of Health and Welfare Act 1987
This compilation was prepared on 5 April 2002
taking into account amendments up to SR 2002 No. 62
Prepared by the Office of Legislative Drafting,
Attorney-General’s Department, Canberra
Contents
1 Name of Regulations [see Note 1]
2 Definition
3 Functions
4 Composition
Notes
1 Name of Regulations [see Note 1]
These Regulations are the Australian Institute of Health and Welfare Ethics Committee Regulations 1989.
2 Definition
In these Regulations:
identifiable data means data from which an individual can be identified.
3 Functions
The functions of the Ethics Committee are:
(a) to form an opinion, on ethical grounds, about the acceptability of, and to impose any conditions that it considers appropriate on:
(i) activities that are being, or are proposed to be, engaged in by the Institute in the performance of its functions; and
(ii) activities that are being, or are proposed to be, engaged in by other bodies or persons in association with, or with the assistance of, the Institute in the performance of its functions; and
(iii) the release, or proposed release, of identifiable data by the Institute for research purposes;
having regard to any relevant ethical principles and standards formulated or adopted by the National Health and Medical Research Council and to any other matters that the Ethics Committee considers relevant;
(b) where appropriate, to revise an opinion so formed or to form another opinion;
(c) to inform the Institute from time to time of the opinions so formed or as revised and its reasons for forming or revising those opinions; and
(d) to provide a written annual report of the Ethics Committee’s operations to the Institute.
4 Composition
The Ethics Committee is to consist of the following members:
(a) a chairperson;
(b) the Director of the Institute or a nominee of the Director;
(c) a person with knowledge of, and current experience in, the professional care, counselling or treatment of people;
(d) a person with knowledge of, and current experience in, the areas of research that are regularly considered by the Ethics Committee;
(e) a nominee of the person in each State and Territory who is responsible for registering births, deaths and marriages in that State or Territory;
(f) a minister of religion or a person who performs a similar role in a community;
(g) a lawyer;
(h) at least 1 person of each gender who is able to represent general community attitudes, is not affiliated with the Institute and is not currently involved in medical, scientific or legal work.
Examples for paragraph (c)
A medical practitioner, a clinical psychologist, a social worker or a nurse.
Example for paragraph (f)
An Aboriginal elder.
Notes to the Australian Institute of Health and Welfare Ethics Committee Regulations 1989
Note 1
The Australian Institute of Health and Welfare Ethics Committee Regulations 1989 (in force under the Australian Institute of Health and Welfare Act 1987) as shown in this compilation comprise Statutory Rules 1989 No. 118 amended as indicated in the Tables below.
Table of Statutory Rules
Year and
number | Date of notification
in Gazette | Date of
commencement | Application, saving or
transitional provisions |
1989 No. 118 | 21 June 1989 | 21 June 1989 | |
2002 No. 62 | 5 Apr 2002 | 5 Apr 2002 | — |
Table of Amendments
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted |
Provision affected | How affected |
Rr. 1, 2............... | rs. 2002 No. 62 |
R. 3................. | am. 2002 No. 62 |
R. 4................. | rs. 2002 No. 62 |
Overview
The Australian Institute of Health and Welfare Ethics Committee Regulations 1989 were enacted under the Australian Institute of Health and Welfare Act 1987, with the aim of establishing an ethics committee to ensure that the activities of the Australian Institute of Health and Welfare (AIHW) and its associated entities are conducted in accordance with relevant ethical principles and standards. The primary objective of these regulations is to provide a framework for the formation of opinions on ethical matters related to the AIHW’s functions and the release of identifiable data for research purposes. The Ethics Committee is tasked with reviewing activities and providing advice to the AIHW, ensuring that ethical considerations are integral to decision-making processes. This legislation is designed to uphold the integrity of research and data handling practices within the health and welfare sectors, thereby protecting the rights and interests of individuals whose data may be involved.
Scope and Application
The Australian Institute of Health and Welfare Ethics Committee Regulations 1989, made under the Australian Institute of Health and Welfare Act 1987, provide a framework for the establishment and operation of the Ethics Committee within the Australian Institute of Health and Welfare. The Regulations outline the composition and functions of the Ethics Committee, which is responsible for forming opinions on ethical matters related to activities undertaken by the Institute, including those conducted in association with other bodies or persons. This includes assessing activities and the release of identifiable data for research purposes, ensuring compliance with ethical principles and standards set by the National Health and Medical Research Council. The Ethics Committee is required to inform the Institute of its opinions and to provide an annual written report on its operations. The Committee’s membership includes a diverse range of individuals, such as a chairperson, a Director or nominee of the Institute, and representatives with expertise in professional care, research, community roles, legal matters, and general community attitudes. The Regulations apply within the Commonwealth jurisdiction, ensuring that ethical considerations are consistently addressed in the activities of the Institute and its associated entities.
Key Provisions
The Australian Institute of Health and Welfare Ethics Committee Regulations 1989 (the "Regulations") establish the framework for the operation of the Ethics Committee under the Australian Institute of Health and Welfare Act 1987. These Regulations define the functions and composition of the Ethics Committee, providing specific guidance on its role in ensuring ethical standards within the Institute's activities. The Regulations identify the key functions of the Ethics Committee, including forming opinions on the ethical acceptability of activities undertaken by the Institute or associated bodies (Regulation 3(a)), revising these opinions as necessary (Regulation 3(b)), and providing written annual reports to the Institute (Regulation 3(d)).
Under Regulation 4, the Ethics Committee is composed of various members, each bringing specific expertise to ensure a balanced and comprehensive approach to ethical considerations. The Committee includes a chairperson, the Director of the Institute or their nominee (Regulation 4(b)), a person with experience in professional care or treatment (Regulation 4(c)), and a person knowledgeable in research areas regularly considered by the Committee (Regulation 4(d)). Additionally, the Committee comprises a nominee of the person responsible for registering births, deaths, and marriages in each State or Territory (Regulation 4(e)), a minister of religion or a similar community role representative (Regulation 4(f)), a lawyer (Regulation 4(g)), and at least one person from each gender who represents general community attitudes and is unaffiliated with the Institute (Regulation 4(h)).
The Regulations impose obligations on the Ethics Committee to adhere to the outlined functions and composition requirements. Specifically, the Committee must form and revise opinions on ethical matters, inform the Institute of these opinions, and provide annual written reports (Regulation 3). Failure to comply with these obligations may lead to scrutiny and potential repercussions, as the Committee's role is critical in upholding ethical standards within the Institute's operations.
There are no explicit offences, penalties, or civil/criminal consequences detailed within the Regulations themselves for non-compliance. However, the ethical oversight provided by the Committee is crucial to the Institute's compliance with broader ethical standards and legal requirements. Any significant breach of ethical standards or failure to comply with the Committee's functions could lead to broader legal or reputational consequences for the Institute, potentially impacting its operations and funding.