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Resource for Researchers You are here:HomeResearchResearchersResource for Researchers National Ethics Guidelines and Resources Australian Clinical Trial Handbook (2018) Australian Code for the Respon DHHS Clinical Trials and Research Information ICH Guideline for Good Clinical Practice (2016) National Statement on Ethical Conduct in Human Research (2007) Updated 2018 SPIRIT Statement Guidance For Clinical Trial Protocols SPIRIT Checklist Ethics and Governance Submission Guidelines Ethics Submission Guide (2020) ERM User Guide (2020) Insurance Information for Clinical Trials (2020) Principal Investigator Roles in Single Site Research Projects Principal Investigator Roles in Multi Site Research Projects Statistical Consulting Centre (University of Melbourne) Victorian HPPs and IPPs Summary Victorian Specific Module (VSM) Guidelines VMIA Clinical Trials Risk and Insurance Guide (2018) SVHM-Specific Guidelines Advertising Guidelines (2020) Breach Report Guidelines (2020) COVID-19 Trial Activity Guidelines (2020) Data Retention Guidelines Onsite Activity of External Sponsors Guidelines (2020) SVHM Site-Specific Guidelines (2020) Remote Monitoring Guidelines (2020) Satellite / Recruitment and Service Site Guidelines (2020) Administrative SOPs Chapter 1. Values and Principles of Ethical Conduct 1.1 - Application of Values and Principles of Ethical Conduct Chapter 2. Risk, Benefit and Consent 2.1 - Assessment of Risks and Benefits 2.2 - Obtaining and Honouring Consent 2.3 - Qualifying or Waiving Conditions Chapter 3. Ethical Considerations Specific to Research Methods 3.1 - Qualitive Methods 3.2 - Databanks 3.3 - Interventions and Therapies 3.4 - Human Tissue Samples 3.5 - Human Genetics 3.6 - Human Stem Cells Chapter 4. Ethical Considerations Specific to Participants 4.1 Ethical Consideration Specific to Participants Chapter 5. Research Governance and Ethical Review 5.1 - Low Risk Research 5.2 - Composition of the Committee 5.3 - Appointment of HREC Members 5.4 - Induction of New HREC Members 5.5 - Responsibilities of HREC Members 5.6 - Training for HREC Members 5.7 - Documentation and Record Management 5.8 - Research Misconduct 5.9 - Making and Communicating Decisions 5.10 - Expert Opinion 5.11 - Minimising Duplication of Ethical Review 5.12 - Conflicts of Interest 5.13 - Monitoring of Approved Research 5.14 - Complaints Handling 5.15 - Timelines for Ethical Review 5.16 - Reporting and Accountability 5.17 - Fees and Charges 5.18 - Collaborative Research Groups 5.19 - Training Researchers 5.20 - Management of Research Data and Primary Materials 5.21 - Authorised Prescriber Endorsement 5.22 - Ionising Radiation 5.23 - SERP 5.24 - Legal Review 5.25 - Quality Assurance 5.26 - Safety Reporting 5.27 - Standard Operating Procedures