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 (2007)
- Australian Code for the Responsible Conduct of Research (2007)
- Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) Annotated with TGA comments (2000)
- Access to unapproved therapeutic goods – Clinical Trials in Australia (2004)
- The Australian Clinical Trial Handbook – A simple practical guide to the conduct of clinical trials to international standards of Good Clinical Practice (GCP) in the Australian Context (2006)
RMH policy & guidelines
In addition to being familiar with the national guidelines, all researchers at RMH must conduct their research in accordance with the RMH 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 must be undertaken.
This policy applies to all persons employed by RMH and to any person undertaking research involving RMH patients, staff and/or other resources.
All collaborative research projects in which RMH is involved must also comply with this policy.
The research policy is one of RMH's key policies.
It is a basic expectation and requirement of RMH 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 RMH and the profession to which they belong. These guidelines and the associated procedures apply to all individuals at RMH 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).
The Guidelines for Research Project Costing advise staff on the COSTING financial processes for establishing and undertaking a research project at RMH.
The Guidelines for Research Project Payments advise staff on the PAYMENTS financial processes for research project at RMH.
The Guidelines for Communicating with the Human Research Ethics Committee (HREC), Trial Sponsors and Insurers clearly set out the roles and responsibilities of Principal Investigators and other researchers in relation to communicating with RMH's HRECs, clinical trial sponsors and insurers, Victorian Managed Insurance Authority (VMIA).
The Guidelines for Data Management in Research govern the collection, use, storage, disclosure and destruction of information (data) in human research.
They also govern the:
- creation and use of databases in research
- 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.
The Guidelines for Handling Complaints in Research clearly set out the roles and responsibilities of RMH 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 RMH.
The Guidelines for Handling Conflicts of Interest in Research clearly set out the roles and responsibilities of RMH, 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 RMH, 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 RMH HREC, is responsible.
These guidelines set out the requirements for publication and authorship of research at RMH.
These guidelines govern all research articles submitted to journals for publication by RMH staff and others where the research was conducted at RMH. They define the responsibilities of researchers and authors.
They provide for the registration of research publications and declaration of authorship with the Office for Research. They define the requirements for listing people as authors as well as defining unacceptable authorship.
These guidelines clearly set out the responsibilities of RMH staff and others using RMH 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 RMH.