The safety and well-being of trial participants, other patients, visitors, researchers and other clinical and support staff is paramount. As developments surrounding the COVID-19 pandemic evolve, investigators and coordinators are asked to note the current arrangements for new and existing research studies at Melbourne Health.
Important information: COVID-19 impact on research operations at Melbourne Health
Advice for Clinical Trials and Other Clinical Research Studies
Melbourne Health (MH) has reviewed and provides updated advice in relation to clinical trials and other clinical research activity effective 13 May 2020.
Management of individual studies is at the discretion of, and should be coordinated by, the respective principal investigators (PIs) in consultation with their research teams and heads of department/clinical service and in accordance with current MH advice.
For current advice refer to MH COVID-19 Advice for Clinical Trials and other Clinical Research studies (13 May 2020).
Immunisation of study participants with SAR-CoV-2 vaccine
Guidance has been developed relating to the administration of the SAR-COV-2 vaccine to study participants.
For current advice please download and refer to the MH HREC Office for Research – Advice re COVID vaccines.
Impact on the Office for Research
The Office for Research remains open for business and will continue to receive and assess ethics and governance applications. However, there may delays in responding to your enquiries. In line with social distancing and safety advice and to ensure staff availability for continuity of service, some of the team will work from home each week (with staff available via email during office hours).
We are prioritising ethics and governance review, including management of funding and grants, and collaborative research arrangements for:
- COVID-19 related research studies. Submit completed COVID-19 applications via ERM and by email to HRECSubmissionsFolder@mh.org.au. To avoid delay you must include the following in the subject line: COVID-19 New Study application Project number 2020.XXX
- Matters impacting safety and wellbeing of participants in all ongoing clinical research. For example, amendments to ongoing studies in response to significant safety issues requiring urgent safety measures, to facilitate home visits, telehealth, etc.
The prioritisation of these activities means that there will be delays in the review and approval of other research activities.
Researchers can contact the office for research on (03) 9342 8530 or by email to: email@example.com.
If the query/correspondence is related to a particular study, include the MH project number in the information provided and subject line.
For meetings, we are more than happy to meet via Zoom or other online meeting platform.
Covid-19 Update from the Coordinating Office for Clinical Research (DHHS)
COVID-19 Guidance for Clinical Trials and Research Projects
COVID-19 guidance has been developed nationally, relating to clinical trials and related projects. Please refer to the National Mutual Acceptance (NMA) page of the Clinical Trials and Research website for information.
This page includes:
- National guidance from the Australian Clinical Trial Project Reference Group (CTPRG)
- Combined industry guidance from the Research & Development Taskforce (RDTF)
Documents will be updated as the COVID-19 situation progresses, so please refer to the website each time you require information.
Consent for COVID-19 Research Projects
There is a template Participant Information and Consent Form (PICF) available for Coronavirus or related research that involves collection of health information and/or samples.
Please note that the template PICF wording relates to Victorian legislation.
If you are using the PICF template for a National Mutual Acceptance (NMA) project, please insert specific references for health information and samples in line with relevant state/territory legislation.
Research Projects in Victoria
If you have questions or concerns about ongoing research projects, please refer to the reviewing organisation's website in the first instance. Should you need to contact the research office directly, their details are available on the websites.
Victorian Research Managers have released a COVID-19 statement, which is on the Clinical Trials and Research website.
The National Health and Medical Research Council (NHMRC) has published a statement on COVID-19 impact, including information for recipients of NHMRC research grants.
The statement is available on the NHMRC website.
Contacting the Coordinating Office for Clinical Research (DHHS)
The Coordinating Office for Clinical Trial Research remains available to assist you with ethics and governance enquiries, and ERM guidance.
Researcher enquiries: 03 9096 7394
Research office information: 03 9096 7398
Hours: 9am-5pm, Monday-Friday
We thank you for your patience and understanding during this time, while there may be restrictions to usual work environments.