Federal Register of Legislation - Australian Government

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Regulations as made
These regulations repeal the Australian Institute of Health and Welfare Ethics Committee Regulations 1989 which are due to sunset on 1 April 2018 and replace it with new regulations to implement minor changes in order to be consistent with the current guidance provided by the National Health and Medical Research Council (NHMRC) on the preferred composition of Human Research Ethics Committees.
Administered by: Health
Made 15 Mar 2018
Registered 20 Mar 2018
Tabled HR 26 Mar 2018
Tabled Senate 22 Mar 2018
Table of contents.

Commonwealth Coat of Arms of Australia

 

Australian Institute of Health and Welfare (Ethics Committee) Regulations 2018

I, General the Honourable Sir Peter Cosgrove AK MC (Ret’d), Governor‑General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulations.

Dated 15 March 2018

Peter Cosgrove

Governor‑General

By His Excellency’s Command

Greg Hunt

Minister for Health

 

 

 

 

  

  

  


Contents

1............ Name............................................................................................................................. 1

2............ Commencement............................................................................................................. 1

3............ Authority....................................................................................................................... 1

4............ Schedules...................................................................................................................... 1

5............ Definitions..................................................................................................................... 1

6............ Functions of Ethics Committee...................................................................................... 2

7............ Composition of Ethics Committee................................................................................. 3

Schedule 1—Repeals                                                                                                                                       4

Australian Institute of Health and Welfare Ethics Committee Regulations 1989                    4

 


1  Name

                   This instrument is the Australian Institute of Health and Welfare (Ethics Committee) Regulations 2018.

2  Commencement

             (1)  Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1.  The whole of this instrument

The day after this instrument is registered.

21 March 2018

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

             (2)  Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

                   This instrument is made under the Australian Institute of Health and Welfare Act 1987.

4  Schedules

                   Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

5  Definitions

Note:          A number of expressions used in this instrument are defined in the Act, including the following:

(a)    Director;

(b)    health‑related information and statistics;

(c)    Institute;

(d)    production;

(e)    welfare‑related information and statistics.

                   In this instrument:

Act means the Australian Institute of Health and Welfare Act 1987.

identifiable data has the meaning given by subsection 6(5).

Institute activities has the meaning given by subsection 6(3).

Institute‑assisted activities has the meaning given by subsection 6(4).

6  Functions of Ethics Committee

Functions

             (1)  For the purposes of subsection 16(2) of the Act, the Ethics Committee has the following functions:

                     (a)  to consider ethical matters relating to Institute activities or Institute‑assisted activities, including:

                              (i)  advising the Institute on such matters; or

                             (ii)  imposing conditions, on ethical grounds, on the Institute engaging in Institute activities;

                     (b)  to advise any body or person on ethical matters relating to the collection and production of:

                              (i)  health‑related information and statistics; or

                             (ii)  welfare‑related information and statistics;

                     (c)  the function of the Ethics Committee under paragraph 29(2)(c) of the Act;

                     (d)  the functions of a Human Research Ethics Committee under guidelines in force from time to time under section 95 or 95A of the Privacy Act 1988;

                     (e)  to provide written annual reports of the Ethics Committee’s operations to the Institute;

                      (f)  any other functions of the Ethics Committee under the Act or any other law.

             (2)  The Ethics Committee, in performing the functions mentioned in paragraphs (1)(a), (b) and (c):

                     (a)  must have regard to any relevant ethical principles and standards formulated or adopted by the National Health and Medical Research Council; and

                     (b)  may have regard to any other matters that the Ethics Committee considers relevant.

Definitions

             (3)  Institute activities are activities engaged in, or proposed to be engaged in, by the Institute, including:

                     (a)  releasing data, including identifiable data; or

                     (b)  associating, or assisting, with Institute‑assisted activities.

             (4)  Institute‑assisted activities are activities engaged in, or proposed to be engaged in, by bodies or persons (other than the Institute) in association with, or with the assistance of, the Institute.

             (5)  Identifiable data is data from which a person (within the meaning of section 29 of the Act) can be identified.

7  Composition of Ethics Committee

                   For the purposes of subsection 16(2) of the Act, the Ethics Committee consists of the following members:

                     (a)  a Chair of the Ethics Committee;

                     (b)  a Deputy Chair of the Ethics Committee;

                     (c)  the Director or a person nominated by the Director;

                     (d)  at least one person with knowledge of, and current experience in, the professional care, counselling or treatment of people;

                     (e)  at least one person with knowledge of, and current experience in, areas of research that are regularly considered by the Ethics Committee;

                      (f)  a person nominated by the persons responsible in the States and Territories for registering births, deaths and marriages;

                     (g)  at least one person who performs a pastoral care role in a community;

                     (h)  at least one lawyer;

                      (i)  at least 2 persons (including at least one man and at least one woman) who:

                              (i)  are able to represent general community attitudes; and

                             (ii)  are not affiliated with the Institute; and

                            (iii)  are not currently involved in medical, scientific or legal work.

Example 1: For paragraph (d), a medical practitioner, clinical psychologist, social worker or nurse.

Example 2: For paragraph (g), an Aboriginal elder or a minister of religion.

Note:          The members of the Ethics Committee are appointed by the Institute under subsection 16(1) of the Act.