National and international policies, guidelines and regulations prescribe best practice to ensure research is conducted to the highest governance and ethical standards possible.
State and federal guidelines
The principal documents which govern human research in Australia are listed below:
- National Statement on Ethical Conduct in Human Research, 2018
- Australian Code for the Responsible Conduct of Research, 2018
- Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) Annotated with TGA comments (2018)
- The Australian Clinical Trial Handbook (2020)
Policy and guidelines
In addition to being familiar with the national guidelines, all researchers working at the RMH need to comply with the RMH Research Policy and Guidelines for Research Practice. The Research Policy and our guidelines are available to the RMH staff on the policy repository via the intranet.
The RMH guidelines
- Archiving, retention and disposal of data
- Data management in research
- Data storage and security
- Financial costing and payments
- Intellectual property
- Handling complaints
- Handling conflicts of interest
- Monitoring and reporting of safety
- Publications and authorship
- Publication of case study reports
- Research integrity
- Use of human tissue
Compliance with our Standards provides public assurance that the rights, safety and well being of research participants are protected and that clinical trial data are credible.
Standard operating procedures
The RMH Office for Research has implemented Standard Operating Procedures (SOPs) to achieve at least minimum good clinical practice standards in clinical trials and other clinical research.
These SOPs are intended to provide the necessary tools to ensure that all research at the RMH is conducted in accordance with organisational requirements, ICH/GCP guidelines and applicable legislation and regulations.