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Resource for Researchers You are here:HomeResearchResearchersResource for Researchers National Statement on Ethical Conduct in Human Research (2007) Updated 2018 Australian Code for the Responsible Conduct of Research (2018) Victorian Managed Insurance Authority (VMIA) Guidelines for Clinical Trials for Victorian Public Hospitals (2012) Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) Annotated with TGA comments (2000) Access to unapproved therapeutic goods – Clinical Trials in Australia (2004) The Australian Clinical Trial Handbook – A simple practical guide to the conduct of clinical trials to international standards of Good Clinical Practice (GCP) in the Australian Context (2006) Coordinating Centre for Human Research Ethics Statistical Consulting Centre - Provides assistance to researchers with statistical work that instigates and supports academic research Site specific requirements for participant information and consent forms at St Vincent's 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