Research

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

This type of review is suited to proposals to conduct quality assurance activities or research that poses low or negligible risk when the Austin Health CRRC is reviewing a project on behalf of multiple sites.

This type of application relates to National Mutual Acceptance. It is required when the Austin Health CRRC  is reviewing a project on behalf of multiple sites. 

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/CPI, preferred meeting, date and CAS booking number. The Office for Research will confirm your submission booking via email.  

Every research project at the Austin must undergo both an Ethics Review and a Site Specific Review (Governance). For Multi-Site Applications we recommend NOT submitting your Governance package until Ethics Approval has been granted.

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

Where Austin Health is the reviewing HREC/CRRC for multiple sites, approval will be notified by one Ethics Approval Letter for all sites. A Project Authorisation letter can be issued only once all the site specific documents have been submitted and reviewed. A research project may not commence at Austin Health until a Project Authorisation letter has been received.

Submitting your Multi-site Ethics Package

  1. At least two weeks before your LNRR application is ready for submission, please call the Central Allocation System (CAS) on (61 3) 9096 7395 to have your application allocated to your reviewing HREC. 
  2. You must contact the Office for Research as soon as possible to book a submission slot at your preferred meeting as numbers are limited by calling (03) 9496 4099 or (03) 9496 3613 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)
  3. Log in to the online ethics form website
  4. Complete the HREA. (Tips for e-submission can be found here)
  5. Upload all supporting documentation (Note: scanning may be required)
  6. Email an electronic copy of your submission to ethics@austin.org.au.

Submitting your Governance Package

  1. Log in to the online ethics form website
  2. Complete the SSA as appropriate
  3. Upload all supporting documentation (Note: scanning may be required)
  4. Email an electronic copy of your entire submission to RGO -  ETHICS02@austin.org.au 

Signatures

  • Signatures should be submitted with the project submission.
  • Digital signatures can be inserted into documents such as the NEAF 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.

“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.

Forms: Multi-Site Submission

Ethics Package:

               ·         New Application Payment Form

·         Ethics checklist

 

·         Cover letter

 

·        HREA  (Human Research Ethics Form - signed by All PIs & Head of Department) - Please ensure to populate the HREC Reference Number

 

·         VSM (Victorian Specific Module)

 

·        Protocol

 

·         Master PICF 

 

·         Master PICF Complaints Section contact detail guidelines

If Applicable:

·         Master Patient card/Diary/ Questionnaire/Survey/Flyer

 

·         For information regarding Likert scales, see:  http://www.cdc.gov/dhdsp/pubs/docs/cb_february_14_2012.pdf

 

 

NOTE: No Victorian Specific Module (VSM) is required LNRR applications if LNR Vic Form is used.

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/)

 

·         Site Budget - Grant Approval or funding agreement

 

 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 

 

·         Research Agreement

 

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

 

·         Austin Health Site Specific Patient Card/Diary/Questionnaire/Survey

 

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