The Office for Research provides important resources to assist investigators and research personnel with conducting research.
Protocol development
- Melbourne Health protocol template
- SPIRIT 2013 Statement: This provides recommendations for a minimum set of scientific, ethical, and administrative elements that should be addressed in a clinical trial protocol.
- Consort Statement: Provides standards for reporting trials that should be considered in development of trial protocols.
- MH statistical review process and MH statistical review proforma
- Peer review process and Peer Review Proforma
Consumer Engagement
Reasons for involvement of consumers in research include:
- It makes for better research
- There is a strong moral case based on social justice for doing so
- It is increasingly being demanded by funding bodies
- it is a requirement of the National Clinical Trials Governance Framework
- RMH Consumer, Carer & Community Participation
- VCCC Consumer engagement toolkit
- Australian Clinical Trials Alliance Consumer Involvement & Engagement Toolkit
- NHMRC Statement on consumer and community involvement in health and medical research
Statistical support
Statistical input:
- should be appropriate to the study.
- be sought during the design stage of the project and prior to the submission of the project.
- will assist with development of the research question(s), selection of study design, sample size calculation and statistical analysis plan.
Researchers are free to choose their own statistical reviewers.
Researchers should allow on average 1-2 weeks for obtaining a statistical review. Please confirm timeframes with the reviewer early in the process.
For MH researchers - the MH Office for Research has made arrangements for the University of Melbourne - Methods and Implementation Support for Clinical and Health (MISCH) research platform to provide statistical support.
MISCH can provide collaborative Biostatistics and Health Economics research support, research and grant development, analysis and publication. For more information or to contact MISCH visit the website.
Literature Review support
Comprehensive / systematic literature review support can be provided by:
Training
- Details of training requirements and sessions, including Good Clinical Practice training at Melbourne Health are listed on the Research Education and Training page.
Search MEDLINE
Australian Regulatory Authorities
- Therapeutic Goods Administration
- Note for guidance on good clinical practice
- National Health and Medical Research Council
- Medicines Australia
NHMRC Australian Health Ethics Committee (AHEC) Information for Human Research Ethics Committees
- National Statement on Ethical Conduct in Human Research (2007)
- Australian Code for the Responsible Conduct of Research
- Safety monitoring and reporting in clinical trials involving therapeutic goods (2016)
Risk-based Management and Monitoring of Clinical Trials involving Therapeutic Goods (2018) https://www.nhmrc.gov.au/about-us/publications/safety-monitoring-and-reporting-clinical-trials-involving-therapeutic-goods
Reporting of Serious Breached of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods (2018) https://www.nhmrc.gov.au/about-us/publications/safety-monitoring-and-reporting-clinical-trials-involving-therapeutic-goods
Data Safety Monitoring Boards (DSMBs) (2018) https://www.nhmrc.gov.au/about-us/publications/safety-monitoring-and-reporting-clinical-trials-involving-therapeutic-goods
Australian code for the care and use of animals for scientific purposes (the Code, 2013) https://www.nhmrc.gov.au/about-us/publications/australian-code-care-and-use-animals-scientific-purposes
Best practice methodology in the use of animals for scientific purposes (2017) https://www.nhmrc.gov.au/about-us/publications/best-practice-methodology-use-animals-scientific-purposes
- Human Ethical Issues
- Ethical Aspects of Human Genetic Testing
- Ethical Considerations in Quality Assurance and Evaluation Activities
Victorian Managed Insurance Authority
Other Human Ethics Resources
- Monash Bioethics Review
- World Medical Association, Declaration of Helsinki (1996)
- Canadian Institutes of Health: Responsible Conduct of Research