| Research Policy and Guidelines |
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Research Policy
The research policy has been developed to clearly set out the framework within which all research at Melbourne Health must be undertaken. This policy applies to all persons employed by Melbourne Health and to any person undertaking research involving Melbourne Health patients, staff and/or other resources. All collaborative research projects in which Melbourne Health is involved must also comply with this policy. The research policy is one of Melbourne Health's key policies and is available on the Melbourne Health intranet.
Below are Research guidelines for the following:
Guidelines for Clinical Trial Costing at Melbourne Health
These guidelines have been developed to advise staff on the COSTING financial processes for establishing and undertaking a clinical trial at Melbourne Health.
Guidelines for Clinical Trial Payments at Melbourne Health
These guidelines have been developed to advise staff on the PAYMENTS financial processes for clinical trials at Melbourne Health.
Communicating with the HREC, Sponsors and Melbourne Health's Insurer
The guidelines for Communicating with the HREC, Trial Sponsors and Melbourne Health’s Insurer clearly set out the roles and responsibilities of Principal Investigators and other researchers at Melbourne Health in relation to communicating with Melbourne Health’s (MH’s) HRECs, clinical trial sponsors and MH’s Insurers, VMIA (Victorian Managed Insurance Authority).
Guidelines for Data Management in Research
These guidelines govern the collection, use, storage, disclosure and destruction of information (data) in human research. They also govern the creation and use of databanks in research. Further they govern the use of information that has previously been collected and stored in a database for a primary purpose other than research that researchers wish to access, or may wish to access in the future, for research purposes. These guidelines also apply to quality assurance activities
Guidelines for Handling Complaints in Research
These have been developed to clearly set out the roles and responsibilities of Melbourne Health and its Research and Ethics Committees and the processes in place in relation to managing any complaints that may be received in relation to research undertaken at and/or by Melbourne Health.
Guidelines for Handling Conflicts of Interest in Research
The guidelines clearly set out the roles and responsibilities of Melbourne Health, its Human Research Ethics Committees, advisors to those committees and research staff and the processes in place in relation to managing any potential or real conflicts of interest.
Guidelines for Monitoring and Safety for Clinical Trials Involving Therapeutic Products and Other Clinical Research
These Guidelines for Monitoring and Reporting of Safety for Clinical Trials Involving Therapeutic Products and Other Clinical Research have been developed to clearly set out the roles and responsibilities of Melbourne Health (MH), its Human Research Ethics Committees, 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 MH, or a MH HREC, is responsible.
Guidelines for Research Practice
It is a basic expectation and requirement of Melbourne Health (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.
These guidelines contain specific procedures for responding to allegations of research/research misconduct. As required in the Australian Code for the Responsible Conduct of Research, where a complaint about research or researchers may raise the possibility of misconduct, these procedures should be followed. These guidelines should be read in conjunction with the Australian Code for the Responsible Conduct of Research (2007).
Guidelines for Research Publications and Authorship
These guidelines have been developed to set out the requirements for publication and authorship of research at Melbourne Health. These guidelines govern all research articles submitted to journals for publication by Melbourne Health staff and others where the research was conducted at Melbourne Health. They define the responsibilities of researchers and authors. They provide for the registration of research publications and declaration of authorship with the Research Directorate. They define the requirements for listing people as authors as well as defining unacceptable authorship.
Guidelines for the Use of Human Tissue Samples
These guidelines have been developed to clearly set out the responsibilities of Melbourne Health staff and others using Melbourne Health 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 Melbourne Health.
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