{"id":"F2016L00682","name":"National Health and Medical Research Council Regulation 2016","slug":"national-health-and-medical-research-council-regulation-2016","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":129247,"registerId":"commonwealth-F2016L00682-current","compilationNumber":null,"startDate":"2026-04-03","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"Part 1","sectionType":"part","heading":"Preliminary","content":"## Part 1—Preliminary","sortOrder":0},{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\n  This is the National Health and Medical Research Council Regulation 2016.","sortOrder":1},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\n  This instrument is made under the National Health and Medical Research Council Act 1992.","sortOrder":2},{"sectionNumber":"5","sectionType":"section","heading":"Definitions","content":"#### 5 Definitions\n\n  In this instrument:\n\n> Act means the National Health and Medical Research Council Act 1992.\n\n> NHMRC website means the website established and maintained by the NHMRC.","sortOrder":3},{"sectionNumber":"Part 2","sectionType":"part","heading":"Regulatory recommendations and guidelines","content":"## Part 2—Regulatory recommendations and guidelines","sortOrder":4},{"sectionNumber":"6","sectionType":"section","heading":"Consultation about regulatory recommendations—information required in notices","content":"#### 6 Consultation about regulatory recommendations—information required in notices\n\n  (2) A notice under subsection 12(2) of the Act must include the following:\n    (a) the subject matter of the proposed regulatory recommendation to which the notice relates;\n    (b) a summary of the proposed recommendation;\n    (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.\n\n> Note: A notice under subsection 12(2) of the Act must also include the information mentioned in that subsection.\n\n  (3) A notice under paragraph 12(3)(a) of the Act must include the following:\n    (a) the subject matter of the draft recommendation;\n    (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.\n\n> Note: A notice under paragraph 12(3)(a) of the Act must also include the information mentioned in that paragraph.\n\n  (4) A notice under paragraph 12(3)(b) of the Act must include the following:\n    (a) the subject matter of the recommendation;\n    (b) the reasons why the Council no longer proposes to provide the recommendation to the CEO.\n\n> Note: A notice under paragraph 12(3)(b) of the Act must also include the information mentioned in that paragraph.","sortOrder":5},{"sectionNumber":"7","sectionType":"section","heading":"Consultation about guidelines—information required in notice","content":"#### 7 Consultation about guidelines—information required in notice\n\n  A notice under paragraph 13(d) of the Act must include the following:\n    (a) the subject matter of the draft guidelines to which the notice relates;\n    (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.\n\n> Note: A notice under paragraph 13(d) of the Act must also include the information mentioned in that paragraph.","sortOrder":6},{"sectionNumber":"8","sectionType":"section","heading":"Interim regulatory recommendations and guidelines—information required in notices","content":"#### 8 Interim regulatory recommendations and guidelines—information required in notices\n\n  A notice under subsection 14(2), (4) or (6) of the Act must include the following:\n    (a) the subject matter of the interim regulatory recommendation, or the interim guidelines, to which the notice relates;\n    (b) a statement about where copies of the interim regulatory recommendation or interim guidelines can be obtained;\n    (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.\n\n> 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.","sortOrder":7},{"sectionNumber":"9","sectionType":"section","heading":"Proposal to dispense with consultation requirements—notice requirements","content":"#### 9 Proposal to dispense with consultation requirements—notice requirements\n\n  (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.\n  (2) A notice under subsection 14B(2) of the Act must include the following:\n    (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;\n    (b) a summary of the proposed regulatory recommendation or the proposed guidelines.\n\n> Note: A notice under subsection 14B(2) of the Act must also include the information mentioned in that subsection.","sortOrder":8},{"sectionNumber":"Part 3","sectionType":"part","heading":"Application, savings and transitional provisions","content":"## Part 3—Application, savings and transitional provisions","sortOrder":9},{"sectionNumber":"10","sectionType":"section","heading":"Savings—repeal of National Health and Medical Research Council Regulations 2006","content":"#### 10 Savings—repeal of National Health and Medical Research Council Regulations 2006\n\n  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.","sortOrder":10}],"analysis":{"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"},"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":true,"description":"This instrument replaces the National Health and Medical Research Council Regulations 2006 and prescribes updated procedural requirements for consultation notices — specifying required notice elements, minimum 30‑day submission periods and publication on the NHMRC website — while saving the 2006 Regulations for notices published before commencement (reg 10). The change is procedural and limited to notice content, timing and transitional treatment; it relies on the Act for substantive authority."},"complexity_factors":["Multiple cross-references to the National Health and Medical Research Council Act 1992 (e.g. subsections 12(2), 12(3)(a), 12(3)(b), 13(d), 14(2),(4),(6), 14A(2), 14B(2)) which require reading this regulation alongside the Act","Different notice-types with slightly different mandatory contents (consultation notices, draft recommendation notices, interim recommendations/guidelines notices, proposals to dispense with consultation) (regs 6–9)","Minimum timing rules for submissions (a last day at least 30 days after NHMRC website publication) across several notice types (regs 6(2)(c), 6(3)(b), 7, 8(c))","Specific publication/timing obligation for a proposal to dispense with consultation (must publish within 30 days of the decision) (reg 9(1))","Requirement to state where copies can be obtained for interim instruments (reg 8(b)) adds an operational step for administrators","Transitional/savings clause preserving the 2006 Regulations for notices published before commencement, creating a dual-regime window (reg 10)"],"plain_english_summary":"This Regulation sets what the NHMRC Council or the Australian Health Ethics Committee must publish when consulting on regulatory recommendations or draft guidelines: the subject, a short summary, where to obtain the documents, and a final day for submissions (which must be at least 30 days after publication on the NHMRC website). It also fixes notice timing for proposals to dispense with consultation and preserves prior 2006 Regulations for notices published before this instrument commenced."},"kimi_summary":{"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"The regulation maintains its original narrow, procedural scope. It was enacted to support the NHMRC Act 1992 by specifying consultation notice requirements, and it continues to serve exactly that purpose without expansion into substantive policy areas. The 2016 version replaced the 2006 regulations but did not broaden the scope — it modernised the framework (adding website publication requirements) while keeping the same limited focus on administrative consultation procedures."},"complexity_factors":["Very short instrument — only 10 sections across 3 Parts","Minimal defined terms — only 2 definitions ('Act' and 'NHMRC website')","Simple structure — follows chronological consultation process without nested conditions","No exceptions to exceptions — straightforward mandatory requirements for notice content","Limited cross-referencing — only references to specific subsections of the parent Act (1992) without complex interdependencies","Procedural focus — purely administrative requirements rather than substantive regulatory prohibitions or permissions"],"plain_english_summary":"This regulation prescribes how the NHMRC must consult the public when developing health guidelines, recommendations and interim or expedited advice. It requires clear website notices, at least 30 days for submissions, and explanations of proposed changes — ensuring researchers, health professionals, committees and the public can participate.\n\nIt also preserves a savings rule so notices published under the earlier 2006 regime remain governed by the old rules."}},"importantCases":[],"_links":{"self":"/api/acts/national-health-and-medical-research-council-regulation-2016","history":"/api/acts/national-health-and-medical-research-council-regulation-2016/history","analysis":"/api/acts/national-health-and-medical-research-council-regulation-2016/analysis","conflicts":"/api/acts/national-health-and-medical-research-council-regulation-2016/conflicts","importantCases":"/api/acts/national-health-and-medical-research-council-regulation-2016/important-cases","documents":"/api/acts/national-health-and-medical-research-council-regulation-2016/documents"}}