{"id":"F2018L00317","name":"Australian Institute of Health and Welfare (Ethics Committee) Regulations 2018","slug":"australian-institute-of-health-and-welfare-ethics-committee-regulations-2018","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":439541,"registerId":"F2018L00317-fast-fetch-1775955527760","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Australian Institute of Health and Welfare (Ethics Committee) Regulations 2018","content":"---\nmeta-content-style-type: text/css\nmeta-content-type: application/xhtml+xml; charset=utf-8\n---\n\n?xml version=\"1.0\" encoding=\"utf-8\" standalone=\"no\"?>\n\n![Commonwealth Coat of Arms of Australia](image.001.jpeg)\n\n \n\nAustralian Institute of Health and Welfare (Ethics Committee) Regulations 2018\n\nI, 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.\n\nDated 15 March 2018\n\nPeter Cosgrove\n\nGovernor‑General\n\nBy His Excellency’s Command\n\nGreg Hunt\n\nMinister for Health\n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\nContents\n\n1 Name\n\n2 Commencement\n\n3 Authority\n\n4 Schedules\n\n5 Definitions\n\n6 Functions of Ethics Committee\n\n7 Composition of Ethics Committee\n\nSchedule 1—Repeals\n\nAustralian Institute of Health and Welfare Ethics Committee Regulations 1989\n\n \n\n1  Name\n\n  This instrument is the Australian Institute of Health and Welfare (Ethics Committee) Regulations 2018.\n\n2  Commencement\n\n (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.\n\n \n\n- Commencement information\n- Column 1 Column 2 Column 3\n- Provisions Commencement Date/Details\n- 1. The whole of this instrument The day after this instrument is registered. 21 March 2018\n\n\nNote: This table relates only to the provisions of this instrument as originally made.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.\n\n (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.\n\n3  Authority\n\n  This instrument is made under the Australian Institute of Health and Welfare Act 1987.\n\n4  Schedules\n\n  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.\n\n5  Definitions\n\nNote: A number of expressions used in this instrument are defined in the Act, including the following:\n\n(a) Director;\n\n(b) health‑related information and statistics;\n\n(c) Institute;\n\n(d) production;\n\n(e) welfare‑related information and statistics.\n\n  In this instrument:\n\nAct means the Australian Institute of Health and Welfare Act 1987.\n\nidentifiable data has the meaning given by subsection 6(5).\n\nInstitute activities has the meaning given by subsection 6(3).\n\nInstitute‑assisted activities has the meaning given by subsection 6(4).\n\n6  Functions of Ethics Committee\n\nFunctions\n\n (1) For the purposes of subsection 16(2) of the Act, the Ethics Committee has the following functions:\n\n (a) to consider ethical matters relating to Institute activities or Institute‑assisted activities, including:\n\n (i) advising the Institute on such matters; or\n\n (ii) imposing conditions, on ethical grounds, on the Institute engaging in Institute activities;\n\n (b) to advise any body or person on ethical matters relating to the collection and production of:\n\n (i) health‑related information and statistics; or\n\n (ii) welfare‑related information and statistics;\n\n (c) the function of the Ethics Committee under paragraph 29(2)(c) of the Act;\n\n (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;\n\n (e) to provide written annual reports of the Ethics Committee’s operations to the Institute;\n\n (f) any other functions of the Ethics Committee under the Act or any other law.\n\n (2) The Ethics Committee, in performing the functions mentioned in paragraphs (1)(a), (b) and (c):\n\n (a) must have regard to any relevant ethical principles and standards formulated or adopted by the National Health and Medical Research Council; and\n\n (b) may have regard to any other matters that the Ethics Committee considers relevant.\n\nDefinitions\n\n (3) Institute activities are activities engaged in, or proposed to be engaged in, by the Institute, including:\n\n (a) releasing data, including identifiable data; or\n\n (b) associating, or assisting, with Institute‑assisted activities.\n\n (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.\n\n (5) Identifiable data is data from which a person (within the meaning of section 29 of the Act) can be identified.\n\n7  Composition of Ethics Committee\n\n  For the purposes of subsection 16(2) of the Act, the Ethics Committee consists of the following members:\n\n (a) a Chair of the Ethics Committee;\n\n (b) a Deputy Chair of the Ethics Committee;\n\n (c) the Director or a person nominated by the Director;\n\n (d) at least one person with knowledge of, and current experience in, the professional care, counselling or treatment of people;\n\n (e) at least one person with knowledge of, and current experience in, areas of research that are regularly considered by the Ethics Committee;\n\n (f) a person nominated by the persons responsible in the States and Territories for registering births, deaths and marriages;\n\n (g) at least one person who performs a pastoral care role in a community;\n\n (h) at least one lawyer;\n\n (i) at least 2 persons (including at least one man and at least one woman) who:\n\n (i) are able to represent general community attitudes; and\n\n (ii) are not affiliated with the Institute; and\n\n (iii) are not currently involved in medical, scientific or legal work.\n\nExample 1: For paragraph (d), a medical practitioner, clinical psychologist, social worker or nurse.\n\nExample 2: For paragraph (g), an Aboriginal elder or a minister of religion.\n\nNote: The members of the Ethics Committee are appointed by the Institute under subsection 16(1) of the Act.\n\nSchedule 1—Repeals\n\n \n\nAustralian Institute of Health and Welfare Ethics Committee Regulations 1989\n\n1  The whole of the instrument\n\nRepeal the instrument.\n\n \n","sortOrder":0}],"analysis":{"flash_summary_failed":{"failed":true,"reason":"Unauthenticated. Configure AI_GATEWAY_API_KEY or use a provider module. Learn more: https://ai-sdk.dev/unauthenticated-ai-gateway","source":"analysis-cron"},"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":true,"description":"This regulation replaces the Australian Institute of Health and Welfare Ethics Committee Regulations 1989. It restates the Committee’s statutory functions and membership while explicitly incorporating NHMRC ethical principles and Privacy Act human‑research guidelines, formalising reporting, and clarifying definitions for Institute activities and identifiable data. The instrument therefore updates and clarifies the Committee’s operational scope under the Act rather than creating wholly new statutory powers."},"complexity_factors":["Cross‑references to the parent Act for authority and appointments (s3; note to s7 referencing s16(1) of the Act)","References to external guidance and other statutes (NHMRC principles — s6(2)(a); Privacy Act ss95/95A — s6(1)(d))","Defined technical terms that shape scope (definitions of Institute activities, Institute‑assisted activities, identifiable data — s5 and s6(3)‑(5))","Detailed membership composition requirements with multiple role‑based criteria (s7)","Repeal of the prior 1989 instrument (Schedule 1), which requires comparison to legacy regime for full effect","Discretionary language allowing the Committee to consider other matters (s6(2)(b)) and to impose ethical conditions (s6(1)(a)(ii))","Reporting obligation (annual written reports — s6(1)(e)) which creates an ongoing administrative/process cost"],"plain_english_summary":"This instrument repeals the 1989 regulations and sets out the Ethics Committee’s functions, membership and procedures under the Australian Institute of Health and Welfare Act 1987. It requires the Committee to advise on, and where necessary impose ethical conditions for, Institute and Institute‑assisted activities (including the release of identifiable health or welfare data), to have regard to NHMRC ethical principles and Privacy Act human‑research guidelines, and to deliver an annual written report. The Institute appoints and administers the Committee and therefore carries operational responsibility and must comply with any conditions the Committee imposes."},"kimi_summary":{"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"This is a straightforward remake of the 1989 regulations with modernised language and structure. The scope remains limited to establishing the Ethics Committee's functions and composition under the AIHW Act. There is no evidence of scope creep; it performs the same regulatory function as its predecessor."},"complexity_factors":["Very short instrument (only 7 substantive sections plus commencement/repeal provisions)","Minimal defined terms (only 3 specific definitions in section 5, plus references to Act definitions)","No nested exceptions or complex conditional logic","Simple structure: definitions, functions, composition, repeal","Cross-references limited to the parent Act (Australian Institute of Health and Welfare Act 1987) and standard references to Privacy Act guidelines","Straightforward membership list with plain language requirements (e.g., 'at least one person with knowledge of...')","Single Schedule containing only a repeal of the previous 1989 regulations"],"plain_english_summary":"This legislation creates an independent Ethics Committee to review and advise on ethical issues in how the Australian Institute of Health and Welfare collects, uses and shares sensitive health and welfare data, including oversight of research and institute-assisted activities.\n\nIt affects AIHW staff, researchers and partner organisations, and indirectly people whose data is held — updating 1989 rules to strengthen privacy protections and ensure diverse community oversight."}},"importantCases":[],"_links":{"self":"/api/acts/australian-institute-of-health-and-welfare-ethics-committee-regulations-2018","history":"/api/acts/australian-institute-of-health-and-welfare-ethics-committee-regulations-2018/history","analysis":"/api/acts/australian-institute-of-health-and-welfare-ethics-committee-regulations-2018/analysis","conflicts":"/api/acts/australian-institute-of-health-and-welfare-ethics-committee-regulations-2018/conflicts","importantCases":"/api/acts/australian-institute-of-health-and-welfare-ethics-committee-regulations-2018/important-cases","documents":"/api/acts/australian-institute-of-health-and-welfare-ethics-committee-regulations-2018/documents"}}