National Health and Medical Research Council Regulation 2016 made under the National Health and Medical Research Council Act 1992 Compilation No. 1 Compilation date: 20 March 2024 Includes amendments: F2024L00294 Registered: 3 April 2024 About this compilation This compilation This is a compilation of the National Health and Medical Research Council Regulation 2016 that shows the text of the law as amended and in force on 20 March 2024 (the compilation date). The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law. Uncommenced amendments The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the Register for the compiled law. Application, saving and transitional provisions for provisions and amendments If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes. Editorial changes For more information about any editorial changes made in this compilation, see the endnotes. Modifications If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the Register for the compiled law. Self‑repealing provisions If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes. Contents Part 1—Preliminary 1 Name 3 Authority 5 Definitions Part 2—Regulatory recommendations and guidelines 6 Consultation about regulatory recommendations—information required in notices 7 Consultation about guidelines—information required in notice 8 Interim regulatory recommendations and guidelines—information required in notices 9 Proposal to dispense with consultation requirements—notice requirements Part 3—Application, savings and transitional provisions 10 Savings—repeal of National Health and Medical Research Council Regulations 2006 Endnotes Endnote 1—About the endnotes Endnote 2—Abbreviation key Endnote 3—Legislation history Endnote 4—Amendment history Part 1—Preliminary 1 Name This is the National Health and Medical Research Council Regulation 2016. 3 Authority This instrument is made under the National Health and Medical Research Council Act 1992. 5 Definitions In this instrument: Act means the National Health and Medical Research Council Act 1992. NHMRC website means the website established and maintained by the NHMRC. Part 2—Regulatory recommendations and guidelines 6 Consultation about regulatory recommendations—information required in notices (2) A notice under subsection 12(2) of the Act must include the following: (a) the subject matter of the proposed regulatory recommendation to which the notice relates; (b) a summary of the proposed recommendation; (c) the last day on which the Council will accept submissions relating to the proposed recommendation, which must be a day that is at least 30 days after the notice is published on the NHMRC's website. Note: A notice under subsection 12(2) of the Act must also include the information mentioned in that subsection. (3) A notice under paragraph 12(3)(a) of the Act must include the following: (a) the subject matter of the draft recommendation; (b) the last day on which the Council will accept submissions relating to the draft recommendation, which must be a day that is at least 30 days after the notice is published on the NHMRC's website. Note: A notice under paragraph 12(3)(a) of the Act must also include the information mentioned in that paragraph. (4) A notice under paragraph 12(3)(b) of the Act must include the following: (a) the subject matter of the recommendation; (b) the reasons why the Council no longer proposes to provide the recommendation to the CEO. Note: A notice under paragraph 12(3)(b) of the Act must also include the information mentioned in that paragraph. 7 Consultation about guidelines—information required in notice A notice under paragraph 13(d) of the Act must include the following: (a) the subject matter of the draft guidelines to which the notice relates; (b) the last day on which the Council or the Australian Health Ethics Committee will accept submissions relating to the draft guidelines, which must be a day that is at least 30 days after the notice is published on the NHMRC's website. Note: A notice under paragraph 13(d) of the Act must also include the information mentioned in that paragraph. 8 Interim regulatory recommendations and guidelines—information required in notices A notice under subsection 14(2), (4) or (6) of the Act must include the following: (a) the subject matter of the interim regulatory recommendation, or the interim guidelines, to which the notice relates; (b) a statement about where copies of the interim regulatory recommendation or interim guidelines can be obtained; (c) the last day on which the Council or the Australian Health Ethics Committee will accept submissions relating to the interim regulatory recommendation or interim guidelines, which must be a day that is at least 30 days after the notice is published on the NHMRC's website. Note: A notice under subsection 14(2), (4) or (6) of the Act must also include the information mentioned in subsection 14(2), (4) or (6) of the Act, as the case requires. 9 Proposal to dispense with consultation requirements—notice requirements (1) A notice under subsection 14B(2) of the Act must be published within 30 days after the day the Council, or the Australian Health Ethics Committee, decides to propose to dispense with the requirements (the consultation requirements) set out in section 12 or 13, or subsection 14A(2), of the Act. (2) A notice under subsection 14B(2) of the Act must include the following: (a) the subject matter of the proposed regulatory recommendation or the proposed guidelines in relation to which the Council or the Australian Health Ethics Committee proposes to dispense with the consultation requirements; (b) a summary of the proposed regulatory recommendation or the proposed guidelines. Note: A notice under subsection 14B(2) of the Act must also include the information mentioned in that subsection. Part 3—Application, savings and transitional provisions 10 Savings—repeal of National Health and Medical Research Council Regulations 2006 Despite the repeal of the National Health and Medical Research Council Regulations 2006 by Schedule 1 to this instrument, those Regulations as in force immediately before they were repealed continue to apply, in relation to a notice published before the commencement of this instrument, as if the repeal had not happened. Endnotes Endnote 1—About the endnotes The endnotes provide information about this compilation and the compiled law. The following endnotes are included in every compilation: Endnote 1—About the endnotes Endnote 2—Abbreviation key Endnote 3—Legislation history Endnote 4—Amendment history Abbreviation key—Endnote 2 The abbreviation key sets out abbreviations that may be used in the endnotes. Legislation history and amendment history—Endnotes 3 and 4 Amending laws are annotated in the legislation history and amendment history. The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation. The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law. Editorial changes The Legislation Act 2003 authorises First Parliamentary Counsel to make editorial and presentational changes to a compiled law in preparing a compilation of the law for registration. The changes must not change the effect of the law. Editorial changes take effect from the compilation registration date. If the compilation includes editorial changes, the endnotes include a brief outline of the changes in general terms. Full details of any changes can be obtained from the Office of Parliamentary Counsel. Misdescribed amendments A misdescribed amendment is an amendment that does not accurately describe how an amendment is to be made. If, despite the misdescription, the amendment can be given effect as intended, then the misdescribed amendment can be incorporated through an editorial change made under section 15V of the Legislation Act 2003. If a misdescribed amendment cannot be given effect as intended, the amendment is not incorporated and "(md not incorp)" is added to the amendment history. Endnote 2—Abbreviation key ad = added or inserted o = order(s) am = amended Ord = Ordinance amdt = amendment orig = original c = clause(s) par = paragraph(s)/subparagraph(s) C[x] = Compilation No. x /sub‑subparagraph(s) Ch = Chapter(s) pres = present def = definition(s) prev = previous Dict = Dictionary (prev…) = previously disallowed = disallowed by Parliament Pt = Part(s) Div = Division(s) r = regulation(s)/rule(s) ed = editorial change reloc = relocated exp = expires/expired or ceases/ceased to have renum = renumbered effect rep = repealed F = Federal Register of Legislation rs = repealed and substituted gaz = gazette s = section(s)/subsection(s) LA = Legislation Act 2003 Sch = Schedule(s) LIA = Legislative Instruments Act 2003 Sdiv = Subdivision(s) (md) = misdescribed amendment can be given SLI = Select Legislative Instrument effect SR = Statutory Rules (md not incorp) = misdescribed amendment Sub‑Ch = Sub‑Chapter(s) cannot be given effect SubPt = Subpart(s) mod = modified/modification underlining = whole or part not No. = Number(s) commenced or to be commenced Endnote 3—Legislation history Name Registration Commencement Application, saving and transitional provisions National Health and Medical Research Council Regulation 2016 6 May 2016 (F2016L00682) 7 May 2016 (s 2(1) item 1) Statute Law Amendment (Prescribed Forms) Regulations 2024. 15 Mar 2024 (F2024L00294) Sch 1 (items 36–49): 20 Mar 2024 (s 2(1) item 1) — Endnote 4—Amendment history Provision affected How affected Part 1 s 2..................... rep LA s 48D s 4..................... rep LA s 48C Part 2 s 6..................... am F2024L00294 s 7..................... am F2024L00294 s 8..................... am F2024L00294 s 9..................... am F2024L00294 Schedule 1................ rep LA s 48C