Frequently Asked Questions (FAQ)

Ethical and scientific review of research proposals within the NSW public health system

• What is NSW Health's system of single ethical and scientific review of multi-centre research and how does it work?
Can researchers opt out of the system?
Does the system apply outside of NSW Health?
Are there any exceptions to the single review principle?
How does a HREC become a lead HREC?
Are there different types of lead HREC?
Which HRECs are lead HRECs?
Can I submit my research project to any lead HREC?
Will a lead HREC automatically accept a multi-centre research application?
Can a multi-centre research application be submitted to more than one lead HREC?
Can an application be withdrawn from one lead HREC and submitted to another?
Is there an appeal mechanism if the lead HREC does not approve the application?
What is the 60-day clock and what are the consequences if this is exceeded?
What happens to multi-centre research projects approved by a NSW Health HREC prior to implementation of the single ethical review system?
Will the single ethical review system be evaluated?
Where can I get more information/advice?

What is the role of the co-ordinating investigator?
What is the role of the local principal investigator?
What is the role of the HREC Executive Officer?
What is the role of the Research Governance Officer?
What is the role of the NSW Health Shared Scientific Assessment Committee (SSAC)?
Does the co-ordinating investigator have to reside within NSW?
Who reviews the Participant Information Sheet and Informed Consent document/s?
Who signs the CTN form and when does this happen?
Who is responsible for monitoring multi-centre research projects?
Is the local principal investigator required to submit annual reports to the lead HREC that approved the project?
Who is responsible for reviewing reports of adverse events?
Is the lead HREC responsible for scientific/technical assessment of the research project?
Where can I get more information/advice?

Do I have to use the NEAF?
Do HRECs have to accept the NEAF?
How do I access the NEAF?
How do I submit the NEAF once it's completed?
Can the NEAF be submitted electronically?
Can I track the progress of my NEAF application electronically?
What's the difference between the NSW NEAF and the NHMRC NEAF?
I've already completed the NHMRC NEAF, do I still have to complete the NSW version?
Who is required to sign the NEAF?
Who is the applicant?
How do I make changes to the NEAF once it's locked?
Where do I get the HREC Application Reference Number?
Where can I get more information/advice?

What is a site?
When is an SSA required?
Is an SSA required for private facilities?
Can a research project begin without an SSA?
Why is it necessary to complete the SSA Form in addition to the ethics application?
Why is there some duplication between the SSA Form and the NEAF?
Who is responsible for completing and submitting the SSA Form?
How do I complete the SSA Form?
Can I submit the SSA Form at the same time as I submit my ethics application?
I've received an approval letter from the lead HREC, what do I do now?
How do I know who the Research Governance Officer is for this site?
Is the SSA Form reviewed by the local HREC?
Can sites make changes to the Participant Information Sheet and Informed Consent documents?
Can the Research Governance Officer request changes to the research project?
How do I add a site once the application has been reviewed/approved?
How do I make changes to the SSA Form once it's locked?
Is there an appeal mechanism if the SSA is not approved?
Where can I get more information/advice?