Numerous policies, guidelines and regulations, at national and international levels, which prescribe best research governance practice to help 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 (2007 updated 2018)
- Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) Annotated with TGA comments (2018)
- The Australian Clinical Trial Handbook (2020)
Standard Operating Procedures
Go to the Standard Operating Procedures page now.
Policy & guidelines
In addition to being familiar with the national guidelines, all researchers at RMH, VIDRL and NWMH must conduct their research in accordance with the MH Research Policy and Guidelines for Research Practice.
The research policy has been developed to clearly set out the framework within which all research at RMH, VIDRL and NWMH must be undertaken.
This policy applies to all persons employed by MH and to any person undertaking research involving MH patients, staff and/or other resources.
All collaborative research projects in which MH is involved must also comply with this policy.
The research policy is one of MH's key policies.
Research integrity is a way of thinking and behaving that ensure that research undertaken is trustworthy.
Melbourne Health (MH) is committed to supporting a research culture that encourages responsible research practices based on the principles of research integrity. Responsible research practices guide researchers in the conduct of their work as well as in their engagement with the practical, ethical and intellectual challenges inherent in research.
It is a basic expectation and requirement of MH that its researchers are committed to high standards of professional conduct. Researchers have a duty to ensure that their work enhances the good name of MH and the profession to which they belong. These guidelines and the associated procedures apply to all individuals at MH engaged in research at any of it sites (Royal Melbourne Hospital, Victorian Infectious Diseases Reference Laboratory and NorthWestern Mental Health).
These guideline should be read in conjunction with the Australian Code for the Responsible Conduct of Research (2018), its subdocuments and MH Research Policy, guidelines and SOPs.
The Guidelines for Research Project Costing advise staff on the COSTING financial processes for establishing and undertaking a research project at H.
The Guidelines for Research Project Payments advise staff on the PAYMENTS financial processes for research project at MH.
The Data Management in Research Guideline replaces the Guideline for Data Management in Research 2015.
The guideline clearly set out the roles and responsibilities of Melbourne Health (MH) and persons conducting research at MH for Data management throughout the entire Data lifecycle including generation, collection, access, use, analysis, disclosure, storage, retention, disposal, sharing and re-use of Data.
These guidelines apply to all research undertaken at MH.
This guideline has been developed to clearly set out when a research agreement is required, the roles and responsibilities of Melbourne Health (MH) stakeholders in identifying the requirement for an agreement, review, execution and compliance with terms and condition of the agreement.
The Guidelines for Handling Complaints in Research clearly set out the roles and responsibilities of MH and its Human Research and Ethics Committee and the processes in place in relation to managing any complaints that may be received in relation to research undertaken at and/or by MH.
The Guidelines for Handling Conflicts of Interest in Research clearly set out the roles and responsibilities of MH, its Human Research Ethics Committee, advisors to those committees and research staff and the processes in place in relation to managing any potential or real conflicts of interest.
The Guidelines for Monitoring and Reporting of Safety for Clinical Trials Involving Therapeutic Products and Other Clinical Research clearly set out the roles and responsibilities of MH, its Human Research Ethics Committee, investigators and sponsors, and the processes in place in relation to monitoring and reporting reports of adverse events, including serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs), involving clinical trials for which RMH, or an MH HREC, is responsible.
*This document was updated on 17 September 2019 as follows:
- Clarification that follow-up information for safety reports is required to be submitted to the MH HREC in the following instance
- Follow-up report when there is a worsening of the event.
- Final report when the safety report does not contain the resolution of the event and this information has become available.
- Upgrade formatting of the document to the current guideline document
These guidelines set out the requirements for publication and authorship of research at MH.
These guidelines govern all research research outputs by MH staff and others where the research was conducted at RH.
They define the responsibilities of researchers and authors including requirement for declaring conflicts of interest, acknowledgements, listing people as authors as well as defining unacceptable authorship.
These guidelines clearly set out the responsibilities of MH staff and others using MH resources in conducting research involving the use of human issue samples in research.
They outline when and how human tissue may be used for research. These guidelines have been written in accordance with the National Statement on Ethical Conduct in Human Research (2007) and the Australian Code for the Responsible Conduct of Research (2007).
These guidelines provide for the registration of all Human Tissue Banks in use at MH.
The Data Storage and Security Guideline is a supporting document for the MH Data Management in Research Guideline.
The Guideline has been developed to clearly set out storage requirements, roles and responsibilities of Melbourne Health (MH) and persons involved in the management of storage and security for research data at MH.
These guidelines have been developed to set out the requirements for archiving, retention and disposal of research data at Melbourne Health (MH). Appropriate archiving and retention of research Data and Metadata should follow good Data management practices and support the audit trail.