Historically, it could take a researcher many, many months to undertake the approvals process, mostly because of a lack of standardisation of forms and processes across health services.
A working group has been meeting regularly to address this issue across the Monash Partners organisations. Applications are still subject to the same rigorous approval criteria, however, streamlining has reduced complexity and improved timeframes.
Cross Partnership Research Ethics and Governance Working Group
Below are the members of the Monash Partners Research Ethics and Governance Working Group, chaired by Professor Paul Myles.
Professor Paul Myles is chair of the Academic Board of Anaesthesia and Perioperative Medicine, and director of Anaesthesia and Perioperative Medicine at The Alfred. He holds a Master degree in Public Health (MPH), a doctorate (MD) degree in cardiothoracic anaesthesia, a Doctor of Science (DSc), and is an Australian National Health and Medical Research Council (NHRMC) Practitioner Fellow.
- Professor Paul Myles
- Mr Simon Barrett
- Dr Andrew Carey
- Ms Lee-Anne Clavarino
- Ms Deborah Dell
- Associate Professor Rose French
- Ms Angela Henjak
- Dr Souheir Houssami
- Professor Alison Hutchinson
- Ms Janet Russell
- Ms Anne Spence
- Professor David Taylor
- Professor Nik Zeps
“We have a talented and committed team in this working group and when we achieve our goal of standardising processes across the Monash Partners catchment area, huge improvements can be made.”Professor Paul Myles, Lead, Research Ethics and Governance Working Group.
Over the last 12 months the Monash Partners Research Ethics and Governance Working Group has achieved the following:
- A requirement for all researchers to be trained in Good Clinical Research Practice (GCP)
- Standard national ethics forms (HREA, not institution-specific Ethics and Governance forms), enabling researchers to use the same documents to seek Ethics approval and Governance authorisation for multi-site projects
- Standardisation of other governance forms and approval across each of the MP sites
- Site Specific Authorisation addendum (local governance)
- Standardised Clinical Trials Agreement (CTA) and Research Collaboration Agreement (RCA)
- Acceptance of electronic sign offs for agreements to shorten start-up time
- A co-enrolment policy has been provided to MP sites
- A list of MP clinician-researchers who are willing to contribute to a DSMC or “drug trial safety officer” role for investigator-initiated trials
- Progress has been made to jointly evaluate a single electronic Ethics and Governance system platform for Monash Partners
- Currently evaluating various models for Mutual Acceptance of ethics approval across MP sites.
You will find relevant Forms and Resources, here.