The Human Research Ethics & Governance office is committed to providing support to all stakeholders in the research process and to facilitating the conduct of well-designed, scientifically sound and ethically appropriate human research in the public interest.
ETHICS AND GOVERNANCE
The Peter Mac Ethics Committee is constituted and operates in accordance with the National statement ethical conduct in human research and relevant state and national legislation, regulations and guidelines. It is certified by the National Health and Medical Research Council to review human research in the area of oncology.
The separation of responsibility for the governance of research from ethical review of that research is a key concept underpinning the introduction of multisite ethical review models.
Human research projects may be reviewed and approved by the Peter Mac Ethics Committee for multiple participating sites under the National Mutual Acceptance Scheme.
Governance review and authorisation of research projects is carried out by the Human Research Ethics & Governance office.
ALERT: COVID-19 ADVICE FOR RESEARCHERS
COVID-19 will have a significant impact on research at the Peter MacCallum Cancer Centre (Peter Mac). A number of measures have been introduced to manage research capacity and manage the safety of research participants and research staff.
Peter Mac Executive has introduced measures to manage the safety of clinical research staff and participants during the COVID-19 pandemic, and to manage pressure on clinical services. See Peter Mac Executive below.
Peter Mac Human Research Ethics Committee (HREC) has provided approval of measures manage the safety of clinical research staff and participants. See Peter Mac HREC below.
Peter Mac Research Governance Office (RGO) has provided advice on approval of measures to manage the safety of clinical research staff and participants. See Peter Mac RGO below.
Peter Mac HREC and RGO have provided advice regarding expedited review of COVID-19 related research. See Expedited Review of COVID-19 Research below.
Management of research in response to COVID-19
After careful consideration, the Research Executive Team, in consultation and with the full support of our Chief Executive Shelley Dolan, introduced measures to appropriately manage clinical research staff and participants during the COVID-19 pandemic and to manage the pressure on our clinical services.
The detailed attached advice was effective from 30 March 2020.
Phased Increase in Clinical Research Activity
With the State and Federal governments’ restrictions significantly slowing the rate of new COVID-19 infections, and in consultation with our Infection Prevention Department, Research Executive and Chief Executive, we are now planning a strategic and staged escalation of clinical research activity.
Increased clinical research activities will proceed in a phased manner until full reactivation of all research activities at Peter Mac is eventually established. The timing of the phase roll-outs will be guided by consultations with Peter Mac’s Infection Prevention and Chief Executive Shelley Dolan. Further increases in research activities will be guided with consideration of advice from State and Federal governments.
Important to our escalation strategy is the ability to rapidly phase roll-backs of individual trials if necessary and advised.
The
attached advice
is effective from 1 May 2020.
The Peter Mac HREC provide the attached advice to researchers and clinicians conducting human research under a Peter Mac HREC ethical approval.
All research projects must consider what measures they can introduce to reduce participant and staff exposure to COVID-19 and to reduce impact on hospital resources. In many case this will result in the projects being put on hold.
The safety of research participants and staff is our priority.
The Peter Mac RGO provides the attached advice to researchers and clinicians conducting human research at the Peter MacCallum Cancer Centre.
All research projects must consider what measures they can introduce to reduce participant and staff exposure to COVID-19 and to reduce impact on hospital resources. In many case this will result in the projects being put on hold.
The safety of research participants and staff is our priority.
The Peter Mac HREC and Research Governance Office will expedite the review of COVID-19 related research.
Submissions to the HREC can be made at any time and will be reviewed online by the HREC. For submission instructions see New Ethics Application. Please email ethics@petermac.org when a submission is made to assist in expediting review.
Submissions to the RGO can be submitted at any time and will be promptly reviewed. For submission instructions see New Governance Application. Please email ethics@petermac.org when a submission is made to assist in expediting review.
NOTE: The Victorian Department of Health and Human Services has developed a template Participant Information and Consent Form (PICF) available for Coronavirus or related research that involves collection of health information and/or samples.
Contact
Email: ethics@petermac.org