Streamlined ethical review means that an eligible multi-site research project is only required to have one ethical review by an accredited HREC.
There are two streamlined review schemes:
- Victorian State Single Ethical Review Program (SERP) for multi-site research within Victoria
- National Mutual Acceptance (NMA) for multi-site research to be conducted in publicly funded health services in Victoria and/or ACT, NSW, QLD, SA and WA.
Before embarking upon multi-site streamlined applications, researchers will need to:
- Contact the Alfred Health Office of Ethics & Research Governance to discuss the application
- Be familiar with the Streamlining Ethical Review Guide
- Attend a training session (exemptions may apply if a researcher has previously submitted a streamlined application to the Alfred Hospital Ethics Committee and/or Office of Ethics & Research Governance)
- Read the ethics and site requirements for research and follow any instructions therein
- Obtain specific instructions from the Victorian Department of Health & Human Services for:
Research involving participants unable to provide informed consent
A legal opinion is to be included in the ethics application of studies involving participants unable to provide informed consent or where there is potential for the participant to lose the ability to provide consent and the research is to be conducted in jurisdictions other than Victoria.
The legal opinion should provide confirmation that the proposed enrolment/consent processes and participant facing materials comply with the relevant legislation in each of the States and Territories involved.
This will also apply to amendment applications for approved studies in which the intention is to include sites in a jurisdiction not already included in the application.
The legal opinion is to be organised by the Co-ordinating Principal Investigator, typically through the sponsor (commercial/university/institution) of the study. If the study is investigator initiated, the Legal Counsel from an interstate hospital with experience in conducting these kinds of trials may be willing to provide the opinion.