Research guidelines and legislation
All human research must be done within legislative framework and guidelines.
Related or governing legislation, policy and agreements
National Health and Medical Research Council (NHMRC)
- Australian Code for the Responsible Conduct of Research, (2007) (Updated 2018)
- Ethical Conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders (2018)
- Framework for Monitoring: Guidance for the national approach to single ethics review for multi-centre research, 2012.
- Guide to Managing and Investigating Potential Breaches of the Australian Code for the Responsible Conduct of Research (2018)
- Guidelines to Promote the Wellbeing of Animals Used for Scientific Purposes, 2008
- Keeping research on track II
- National Certification Handbook, 2012
- National Statement on Ethical Conduct in Human Research, (2007) (Updated 2018), as amended from time to time
- Values and Ethics - Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research
Queensland Health
- Research management policy (PDF 235 kB)
- Research involving patients who are unable to give consent Policy Statement (April 2018) (PDF 446 kB)
- Standard Operating Procedures for Queensland Health Research Governance Officers
(PDF 737 kB) - Standard Operating Procedures for Queensland Health Human Research Ethics Committee (HREC) Administrators (PDF 1111 kB)
AIATSIS
Australian Radiation Protection and Nuclear Safety Agency (ARPANSA)
- Code for Radiation Protection in Planned Exposure Situations (2020)
- Code of Practice Exposure of Humans to Ionizing Radiation for Research Purposes 2005 (Cth)
- Guide for Radiation Protection in Existing Exposure Situations (2017)
- Fundamentals for Protection Against Ionising Radiation (2014)
- Radiofrequency Electromagnetic Energy and Health: Research Needs
International Society for Pharmacoepidemiology (ispe)
Queensland Government
- Health Sector (Clinical Records) Retention and Disposal Schedule
- Health Sector (Corporate Records) Retention and Disposal Schedule
Department of Health and Aged Care
- National Standard Operating Procedures for Clinical Trials
- National Principles for Teletrials in Australia
Therapeutic Goods Administration (TGA)
- Note for Guidance on Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, 2000
- Therapeutic Goods Administration ICH Guideline for Good Clinical Practice
Queensland Government Legislation
- Research Involving Human Embryos and Prohibition of Human Cloning for Reproduction Regulation 2015 (Qld)
- Transplantation and Anatomy Act 1979 (Qld)
- Powers of Attorney Act 1998 (Qld)
- Public Health Act 2005 (Qld)
- Research Involving Human Embryos and Prohibition of Human Cloning for Reproduction Act 2003 (Qld)
- Hospital and Health Boards Act 2011 (Qld)
- Information Privacy Act 2009 (Qld)
- Coroners Act 2003 (Qld)
- Guardianship and Administration Act 2000 (Qld)
Australian Government Legislation
- Privacy Act 1988 (Cth)
- Prohibition of Human Cloning for Reproduction Act 2002 (Cth)
- Research Involving Human Embryos Act 2002 (Cth)
- Gene Technology Act 2000 (Cth)
- Gene Technology Regulations 2001 (Cth)
- Therapeutic Goods Act 1989 (Cth)
- Therapeutic Goods Regulations 1990 (Cth)
- Defence Trade Controls Act 2012 (Cth)
Supporting documents
Clinical Oncology Society of Australia (COSA)
Medicines Australia
Medical Technology Association of Australia (MTAA)
- Medical Technology Association of Australia, Clinical Investigation Research Agreements
- Clinical investigation research agreement (CIRA)
- Standard indemnity form for a clinical investigation
- Compensation guidelines
National Health and Medical Research Council (NHMRC)
- NHMRC ethical issues and resources
- Standardised participant information and consent forms
- Standard Operating Procedures for Queensland Health HREC Administrators
- Standard Operating Procedures for Queensland Health RGOs
Therapeutic Goods Administration (TGA)
- Therapeutic Good Administration: