Research involving ionising radiation
Researchers proposing to expose research participants to ionising radiation should provide information that allows consent to be properly considered by research participants.
https://www.thermh.org.au/research/office-for-research/ethics/research-involving-ionising-radiationConsent process for research involving people without decision-making capacity
The Medical Treatment Planning and Decisions Act 2016 (Vic) provides a framework for making decisions about medical treatment when people do not have the capacity to make their own decisions.
https://www.thermh.org.au/research/office-for-research/ethics/consent-process-for-research-involving-people-without-decision-making-capacityThe RMH's research integrity advisers are a key resource for advice and support with regard to research integrity and misconduct, as well as our processes and procedures relating to research integrity.
https://www.thermh.org.au/research/about-research/conducting-research-at-the-rmh/research-integrity/research-integrity-advisorsREDCap for data collection in research
Research data and metadata must be collected, stored, retained, used and disposed of in a way that protects the rights, safety, and wellbeing of the research participants and wider community. REDCap can help meet these data requirements.
https://www.thermh.org.au/research/about-research/conducting-research-at-the-rmh/redcap-for-data-collection-in-researchResearch integrity is a way of thinking and behaving that ensures that research undertaken is trustworthy.
https://www.thermh.org.au/research/about-research/conducting-research-at-the-rmh/research-integrityResearch integrity is a way of thinking and behaving that ensure that research undertaken is trustworthy.
https://www.thermh.org.au/research/resources-to-support-clinical-research-at-the-rmh/online-research-integrity-education-and-resourcesREDCap (Research Electronic Data Capture) is a secure web application for building and managing online surveys and databases
https://www.thermh.org.au/research/resources-to-support-clinical-research-at-the-rmh/redcap-supportInternal audit of research is an important means by which the Royal Melbourne Hospital ensures research auspices is conducted in accordance with good clinical practice (GCP) and approved ethical guidelines
https://www.thermh.org.au/research/office-for-research/post-approval-project-management/auditing-research-projectsSerious Breach is a breach of Good Clinical Practice or the protocol that is likely to affect to a significant degree the safety or rights of a research participant or the reliability and robustness of the data generated in the research project.
https://www.thermh.org.au/research/office-for-research/post-approval-project-management/serious-breachesSafety and adverse event reports
Maintaining and reporting of adverse events and safety information in research will ensure that RMH complies with the NHMRC's National Statement.
https://www.thermh.org.au/research/office-for-research/post-approval-project-management/safety-and-adverse-event-reportsThe Royal Melbourne Hospital is required to monitor all approved research until the completion of the project.
https://www.thermh.org.au/research/office-for-research/post-approval-project-management/post-approval-monitoringReporting to the Research Office is a condition of ongoing ethics approval.
https://www.thermh.org.au/research/office-for-research/post-approval-project-management/progress-and-final-reportsFrom time to time, amendments to research projects are required often due to protocol changes, updated investigator brochures, personnel changes on the study, site additions, and more. Researchers and sponsors must notify the HREC of such changes.
https://www.thermh.org.au/research/office-for-research/post-approval-project-management/amendmentsStudy to understand risk of Alzheimer’s disease in middle-aged adults Research study
An Australian-first online study of psychological, lifestyle and genetic factors that increase risk of Alzheimer’s disease.
https://www.thermh.org.au/research/clinical-trials-research-studies/study-to-understand-risk-of-alzheimers-disease-in-middle-aged-adultsThe Department of Anaesthesia and Pain Management has a proud history of conducting quality research.
https://www.thermh.org.au/services/anaesthesia-pain-management/anaesthesia-researchCombination treatment for locally advanced or metastatic ER-positive breast cancer Research study
A phase II, multicentre, randomised study to compare the efficacy of venetoclax plus fulvestrant as a combination treatment for locally advanced or metastatic ER-positive breast cancer.
https://www.thermh.org.au/research/clinical-trials-research-studies/combination-treatment-for-locally-advanced-or-metastatic-er-positive-breast-cancerDeferiprone as a treatment for Alzheimer’s disease Research study
A clinical trial to investigate whether deferiprone delays dementia progression in the early stages of dementia.
https://www.thermh.org.au/research/clinical-trials-research-studies/deferiprone-as-a-treatment-for-alzheimers-diseaseAntipsychotic dose reduction to improve recovery and function in young people with psychosis Research study
The REDUCE study is testing whether reducing the dosage of antipsychotic medication of people recovering from their first episode of psychosis can lead to them having better recovery outcomes.
https://www.thermh.org.au/research/clinical-trials-research-studies/antipsychotic-dose-reduction-to-improve-recovery-and-function-in-young-people-with-psychosisPerampanel to control and prevent seizures in patients with brain tumours Research study
A randomised controlled trial assessing the safety and effectiveness of perampanel, an anti-epileptic drug, in people with brain tumours.
https://www.thermh.org.au/research/clinical-trials-research-studies/perampanel-to-control-and-prevent-seizures-in-patients-with-brain-tumoursEtrolizumab for people with ulcerative colitis who have never used TNF inhibitors Research study
This study aimed to evaluate etrolizumab as a treatment for patients with moderate to severe ulcerative colitis who are naive to TNF inhibitors.
https://www.thermh.org.au/research/clinical-trials-research-studies/etrolizumab-for-people-with-ulcerative-colitis-who-have-never-used-tnf-inhibitors