Frequently Asked Questions
I have a low risk study that I want to have reviewed what do I need to do?
The HREC Chairperson must first confirm that it is appropriate for review as a low risk study. Please submit a Protocol/Protocol summary to the research office e-mail SVHS.Reserach@svha.org.au . You will be informed of the Chairperson’s decision as soon as possible.
When do the HREC Executive meetings take place?
Dates for HREC Executive meetings are not published, however they take place approximately every 2 weeks. For your submission to be reviewed at a given meeting, both the hard copy (with original wet ink signatures) and electronic copy submission must reach the Research Office, Translational Research Centre by 5 p.m. on the Thursday before the meeting.
I would like to submit a study for full HREC review how do I do this?
Read the submitting for ethics review instructions on our website making sure to read the NEAF submission checklist.
When do the Full HREC meetings take place?
The meeting and submission deadline dates are available here.
I am Head of Department and also an investigator on a study can I sign as Head of Department?
No, where an investigator for the study is also the Head of Department, certification must be sought from the person to whom the Head of Department is responsible. Investigators must not approve their own research on behalf of the department.
I am a St Vincent’s Hospital staff member and also studying for my PhD, can I be named as Principal Investigator on the NEAF/LNR?
Yes, students who are St Vincent’s Hospital staff members can be named as Principal Investigator for as long as their employment contract remains in place.
What is the difference between Co-ordinating Investigator and Principal Investigator?
The Co-ordinating Investigator is the individual who takes overall responsibility for the research project. They are responsible for ongoing communication with the HREC and passing on any outcomes from this to the Principal Investigators. For single centre research, Co-ordinating Investigator and Principal Investigator are synonymous.
Do you have a Protocol template I can use?
Yes we have developed a Protocol template and recommend it is used for investigator initiated research submitted to our office. It has helpful guidance on what information to include in relation to recruitment and consent, investigational plan, tissue collection and data confidentiality. The Protocol templates can be accessed here.
How do I remove the draft watermark from the LNR/NEAF form?
In order to remove the draft watermark from the form, you must first ‘lock’ it. Details on how to do this are available here.
Are electronic signatures accepted?
No, original wet ink signatures are required to be provided on LNR and NEAF forms.
I wish to apply for approval of a private site what do I need to do?
In order for St Vincent’s Hospital HREC approval to be able to extend to the private entities, an External Entity agreement is required (Ministry of Health policy Directive PD 2008_046). Details of the following need to be e-mailed to the Research office SVHS.Research@svha.org.au Full business name and address, ABN, contact name and details of who will facilitate signing of the agreement.
I need to prepare a Participant Information Sheet do you have a template?
St Vincent’s Hospital HREC will only accept forms that are based on the current NH&MRC template documents, with standard sections and section wording used as appropriate throughout. Templates are available here.
I am currently working on a Main Participant Information Sheet that will be submitted for review. I understand that specific wording surrounding risks to reproduction is needed for Catholic sites, do you have further guidance on what is accepted?
Guidance can be found here.
I am drafting a Participant Information Sheet what information do I put in the ‘who to contact – Reviewing HREC details’ section?
Details of reviewing HREC (St Vincent’s Hospital HREC): HREC Executive Officer, Tel: 02 8382 4960, E-mail: SVHS.Research@SVHA.org.au. Please remove names of Research Office personnel.
I am drafting an eCTN what are the approving authority details?
Name of Approving Authority: St Vincent's Hospital Sydney Limited. Approving Authority Contact Officer: Dr Pamela Blaikie. Position: Research Office Manager. Contact Phone: 02 8382 4960. Contact e-mail - SVHS.Research@SVHA.org.au.
My annual report is due but my study hasn’t yet commenced do I still need to submit an annual report?
Yes, annual reports are due on the yearly anniversary of ethics approval regardless if the study has commenced or not. Submission of an annual progress report is a condition of ongoing study approval.
I am part of a multi-site study am I required to submit an site annual report to SVH HREC?
For multi-centre studies, only the lead site is required to submit an annual report to SVH HREC i.e. individual site reports are not required to be submitted to SVH HREC.
I need to make an amendment to an approved project what do I do?
The Amendment Form is available on our website insert here . When submitting to ethics, please ensure you fully complete the summary of issues relating to the amendment section, and submit in hard copy and by e-mail SVHS.Research@SVHA.org.au to the Research Office.