Links 

Contents

(click on the links below to jump to that section on this page)

Research conduct 

Human research 

Clinical audit/quality assurance

Animal research

Research funding

Research-related organisations

Journals

Professional development/training

Research conduct:

• Australian Code for the Responsible Conduct of Research  

Human research – ethical guidelines:

• National Statement on Ethical Conduct in Human Research  (NHMRC 2007) 
• Human Research Ethics Handbook (NHMRC 2001)
• Values and Ethics - Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research    
• Guidelines for Ethical Review of Research Proposals for Human Somatic Cell Gene Therapy and Related Therapies (1999)

Human research – clinical trials:

• TGA Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95)  
• TGA Note for guidance on clinical safety data management: definitions and standards for expedited reporting (CPMP/ICH/377/95)
• VMIA Guidelines for Clinical Trials for Victorian public hospitals  

Human research – Australian Regulatory Authorities:

• Therapeutic Goods Administration 
• National Health and Medical Research Council   
• Medicines Australia

Human research – International Regulatory Authorities:

• Food and Drug Administration (USA)
• European Medicines Agency (EU) 
• Medicines and Healthcare products Regulatory Agency (MHRA) (UK) 
• Swedish Medicines Agency 

Human research – first time in humans protocol:

• Download the Guidelines and documentation from the VMIA website

Human research – insurance:

• Victorian Managed Insurance Authority
• VMIA Clinical Trials website   

Human research – clinical trial registries

• ICMJE requirements (see section III.J. Obligation to Register Clinical Trials)
• World Health Organisation International Clinical Trial Registry Platform
• Australia and New Zealand Clinical Trial Registry (ANZCTR)
• ClinicalTrials.gov 
• Chinese Clinical Trial Registry (CHiCTR) 
• Clinical Trials Registry - India (CTRI)
• Nederlands Trial Register 
• UMIN Clinical Trials Registry

Clinical audit/quality assurance:

• When does Quality Assurance in Health Care Require Independent Ethical Review? (NHMRC 2003)  

Animal research – regulations:

• Australian Code of Practice for the care and use of animals for scientific purposes (NHMRC 7th edition 2004)
• Guidelines for the generation, breeding, care and use of genetically modified and cloned animals for scientific purposes (NHMRC 2007) 
• Code of Practice for the Housing and Care of Laboratory Mice, Rats, Guinea Pigs and Rabbits (DPI 2004)
• All other Victorian Codes of Practice for Animal Welfare

Research funding:

• Please refer to the Research Funding section of this website
• Subscribe to the University of Melbourne Research Funding Bulletin

Research-related organisations:

• Association of Clinical Research Professionals 
• BioMelbourne Network – subscribe to the BioMelbourne Briefing
• Nucleus Network
• Research Australia

Journals:

• Caroline Chisholm Centre for Health Ethics Bulletin (available in the Carl de Gruchy Library)
  Cambridge Quarterly of Healthcare Ethics: CQ;
• The International Journal for Healthcare Ethics Committees (also available in the Carl de Gruchy Library)
• Journal of Bioethical Inquiry (available in the Carl de Gruchy Library)
• The Journal of Law, Medicine and Ethics: A Journal of the American Society of Law, Medicine and Ethics (also available in the Carl de Gruchy Library)  
• Journal of Medical Ethics (also available in the Carl de Gruchy Library) Monash Bioethics Review (available in the Carl de Gruchy Library)

Professional development/training:

• The University of Melbourne School of Enterprise – specialist courses in conduct of clinical research
• Nucleus Network – specialist courses in conduct of clinical research