Research

Single Site Low & Negligible Risk Research (LNRR) - New Applications

“Low risk research” is defined as research in which the only foreseeable risk is one of discomfort. “Negligible risk research” is defined as research in which the only foreseeable risk is no more than inconvenience.

Single Site Submissions

This type of review is suited to proposals to conduct quality assurance activities or research that poses low or negligible risk.

“Low risk research” is defined as research in which the only foreseeable risk is one of discomfort. “Negligible risk research” is defined as research in which the only foreseeable risk is no more than inconvenience. 

For guidance regarding the level of review required for a research project, please see the checklist and LNRR guideline.

Please note: If your study requests a waiver of consent (as per Chapter 2.3 of the National Statement) then the study cannot be LNRR. If this is the case, please see 'Single Site Submission' for submission requirements.

Every research project at the Austin must undergo both an Ethics Review and a Site Specific Review (Governance). You are encouraged to submit BOTH your ethics and governance packages at the same time to ensure your project is reviewed in a timely fashion. 

You must email the Office for Research as soon as possible to book a submission slot at your preferred meeting as numbers are limited. Your booking email should contain the following information: Protocol number and title, PI, preferred meeting date. The Office for Research will confirm your submission booking via email.  

Please see the list below of required documents and refer to the instructions for submitting your Ethics Package and Governance Package.

For single site applications approval will be notified by an Ethics Approval letter and  Site Specific Authorisation letter.  Project Authorisation can be issued only once ethical approval is obtained AND all the site specific documents have been submitted and reviewed. A research project may not commence at Austin Health until an Ethics Approval letter and Project Authorisation letter has been received.

Submitting your Single Site Ethics and Governance Package

1. Book your submission slot with the Office for Research as soon as possible by calling (03) 9496 4090 or emailing the title of your study and the Principal Investigator's name to ethics@austin.org.au (please note, there are limited submission slots so book early)

2. Log in to the online ethics form website

3. Complete the HREA and SSA as appropriate. (Tips for e-submission can be found here)

4. Upload all supporting documentation (Note: scanning may be required)

5. Email an electronic copy of your submission to ethics@austin.org.au.

(Please Note: Governance package will NOT be required to be submitted to Austin Health if Austin Health is not a participating site)

Signatures

  • Signatures should be submitted with the project submission.
  • Digital signatures can be inserted into documents such as the HREA and SSA and saved as a PDF.
  • Wet ink signed pages should be individually scanned and saved as a PDF.

For immediate confirmation that your email has reached us, set up an automated 'Delivery Receipt Notification' before you send your email.

Forms: Single Site Submission

Ethics Package:

·     New Application Payment Form

·     Cover letter

·     HREA (Human Research Ethics Application; signed by PIs & Head of Department)

·     Protocol

If Applicable:

·         Austin Health (AH) Site Specific PICF must include:

(a)  the AH logo and barcode and place for a patient label sticker (HIS will only accept a PICF on the standard AH template. No deviations to this template will be accepted.)  

(b) complaints section contact details guidelines

·     For the Person Responsible Oral Information and Consent template, please see SOP 006 

·       Austin Health (AH) Site Specific PICF must include:

Governance Package:

·     Cover Letter and Checklist

·     Fully signed (All Investigators & Head of Department) SSA (Site Specific Assessment Form; final version with submission code - no DRAFT watermark)

·     Austin Health Investigator Curriculum Vitae

·     GCP Certificate (http://www.austin.org.au/research/training-for-researchers/)

If Applicable:

·     Research Agreement

·     Insurance

·     Site Budget - Grant approval or funding arrangement

·     Austin Health Departmental Sign offs (Pharmacy,PathologyRadiologyNuclear Medicine/PET Centre, Therapeutic Devices & Health Information Services)

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