Research

New Projects

Submission Pathway Checklist

To assist with deciphering which risk category your research project comes under, please utilse the REx Submission Pathway Checklist found here.

Single Site Submission

This type of application is for when the Austin Health HREC is reviewing a project on behalf of Austin Health only.

Every research project at the Austin must undergo both an Ethics Review and a Site Specific Review (Governance). You are encouraged you to submit 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 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 Package
  1. Book your submission slot with the Office for Research as soon as possible by calling (03) 9496 4090 or emailing by 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 NEAF as appropriate. (Tips for e-submission can be found here)
  4. Upload all supporting documentation (Note: scanning may be required)
  5. Submit the original application along with associated documentation to: 
    Office for Research
    Level 8 Harold Stokes Building
    Austin Health
    145 Studley Road
    PO Box 5555 Heidelberg
    Victoria Australia 3084
  6. Email an electronic copy of your submission to ethics@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.

FORMS: Single Site Submission

Ethics Package

Governance Package

New Application Payment Form

Cover letter

Fully signed (All PIs & Head of Department) NEAF (National Ethics Application Form; final version with submission code - no DRAFT watermark)

Waiver of Consent Request Form - ONLY If a Waiver of Consent is being requested.

VSM (Victorian Specific Module)

Protocol

If Applicable:

Austin Health (AH) Site Specific PICF must include:

 (a)  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) AH complaints section contact details

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

 Patient card/Diary/Questionnaire/Survey/Flyer

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

Investigator Brochure

Medical Physicist Report (If projects involves radiation)

CTN/CTX (If applicable)

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:

Signed Medicine Australia Standard Indemnities (If applicable)

Research Agreement

Insurance

Site Budget

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

If you are unable to open any of these links in Internet Explorer, please try an alternative browser eg: FireFox or Google Chrome

Multi-Site Reviewing Submission

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

At least two weeks before your HREC application is ready for submission, please call the Central Allocation System (CAS) on (61 3) 9096 7395, Monday to Friday 10am to 5pm EST. CAS will allocate your application to your reviewing HREC. You must also 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, Drug or non-drug study, 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). You are encouraged you to submit your ethics and governance packages at the same time to ensure your project is reviewed in a timely fashion.

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 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 HREC 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 by 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 NEAF as appropriate. (Tips for e-submission can be found here)
  5. Upload all supporting documentation (Note: scanning may be required)
  6. Submit the original application along with associated documentation to: 
    Office for Research
    Level 8 Harold Stokes Building
    Austin Health
    145 Studley Road
    PO Box 5555 Heidelberg
    Victoria Australia 3084
  7. 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. Submit the original application along with associated documentation to: 
    Office for Research
    Level 8 Harold Stokes Building
    Austin Health
    145 Studley Road
    PO Box 5555 Heidelberg
    Victoria Australia 3084
  5. 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.

FORMS: Multi-site Reviewing Submission

Ethics Package

Governance Package

New Application Payment Form

Ethics checklist

HREC applications cover letter

Fully signed (All PIs & Head of Department) NEAF (National Ethics Application Form) - Please ensure to populate the HREC Refence Number

Waiver of Consent Request Form - ONLY If a Waiver of Consent is being requested.

VSM (Victorian Specific Module)

Protocol

Master PICF 

Master PICF Complaints Section contact details

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

Investigator Brochure

NSW Privacy Form

Medical Physicist Report for each site (If projects involves radiation)

HREC review only Indemnity (If commercially sponsored)

CTN/CTX for each site

Research governance checklist and cover letter

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/)

Signed Medicine Australia Standard Indemnities

Research Agreement

Insurance (if applicable)

Site Budget

Departmental Sign offs (PharmacyPathology,RadiologyNuclear Medicine/PET Centre,Therapeutic Devices Health Information Services)

Austin Health (AH) Site Specific PICF must include:

 (a)  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) AH complaints section contact details

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

Austin Health Site Specific Patient Card, etc. (If applicable)

If you are unable to open any of these links in Internet Explorer, please try an alternative browser eg: FireFox or Google Chrome

 

Multi Site Accepting Submission

This type of application relates to Interstate Mutual Acceptance. It is required when the Austin is a participating site of a multicentre study, where ethical approval has been granted by an external lead HREC. The submission of a site specific governance package is required.  

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

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 Governance Package
  1. Log in to the online ethics form website
  2. Complete the SSA as appropriate. (Tips for e-submission can be found here)
  3. Upload all supporting documentation (Note: scanning may be required)
  4. Submit the original application along with associated documentation to: 
    Office for Research
    Level 8 Harold Stokes Building
    Austin Health
    145 Studley Road
    PO Box 5555 Heidelberg
    Victoria Australia 3084
  5. Email an electronic copy of your 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.

FORMS: Multi Site Accepting Submission

Governance Package

New Application Payment Form

Research governance checklist and cover letter

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/)

Signed Medicine Australia Standard Indemnities

Research Agreement

Insurance (if applicable)

Site Budget

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

Austin Health (AH) Site Specific PICF must include:

 (a)  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) AH complaints section contact details

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

Austin Health Site Specific Patient Card, etc. (If applicable)

CTN/CTX  (If applicable)

Complete a material transfer agreement if applicable. This agreement should be used when external parties want to be provided with materials such as tissue samples obtained by Austin Health, and Austin Health's only role is to provide this material and is not involved as a collaborator in the research project.

LEAD HREC APPROVAL Letter

LEAD HREC APPROVED NEAF (National Ethics Application Form)

LEAD HREC APPROVED VSM (Victorian Specific Module}

LEAD HREC APPROVED Protocol

LEAD HREC APPROVED Master PICF

LEAD HREC APPROVED Master Patient card/Diary/Questionnaire/Survey etc

LEAD HREC APPROVED Investigator Brochure

LEAD HREC APPROVED  Austin  Medical Physicist Report

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Low & Negligible Risk Research (LNRR) - Single Site Submission

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.

Please see the list below of required documents and refer to the instructions for submitting your Ethics 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 LNRR 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 by 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)

Please detail if you are requesting the HREC to waive consent or not.

2. Log in to the online ethics form website.

3. Complete the LNR NEAF and LNR SSA as appropriate. Ensure you generate a submission code for each form. No draft watermarks will be accepted. (Tips for e-submission can be found here)

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

5. If applicable submit 2 wet ink signed copies of the original Research Agreement with an explanatory cover letter to: 
Office for Research
Level 8 Harold Stokes Building
Austin Health
145 Studley Road
PO Box 5555 Heidelberg
Victoria Australia 3084

6. Email an electronic copy of your submission to ethics@austin.org.au. Please title the email ' New LNRR application - PI [xxxx]'

The original signed submission forms do NOT need to be submitted to the Office for Research however, you will be required to keep the original wet ink signed documents in your study file for auditing purposes.

Signatures

  • Signatures should be submitted with the project submission.
  • Digital signatures can be inserted into documents such as the LNR NEAF/Vic and LNR SSA and saved as a PDF.
  • Wet ink signed pages should be separately 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: LNRR Single Site Submission

LNR Ethics and Governance Package

New Application Payment Form

Cover letter

LNR VIC (Low and Negligle Risk Form; signed by all Investigators)

Fully signed (by 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/)

Protocol

Site budget 

 

Austin Health Investigator Curriculum Vitae

CV's (for Austin Health & Non-Austin Health employees)

If Applicable:

Austin Health (AH) Site Specific PICF must include:

 (a)  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) AH complaints section contact details

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

Patient Card/Diary/Questionnaire/Survey/Flyer

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

Research Agreement

Departmental Sign off (for example, Health Information Services)

Grant approval or funding arrangement

If you are unable to open any of these links in Internet Explorer, please try an alternative browser eg: FireFox or Google Chrome

Low & Negligible Risk Research (LNRR) - Multi Site Reviewing Submission

There are new changes to the single ethical review for multi-centre health and medical research projects in addition to multi-centre clinical trials for Victoria only. This review process now includes low and negligible risk projects. The frameworks are similar and there is a new website with helpful information.

The health and medical research website has links to application forms, guidance, reporting forms and more at: www.health.vic.gov.au/healthandmedicalresearch 

Please take the time to visit and add it to your favourites/bookmarks. The standard operating procedures are recommended reading with important information for those who have not used the streamlined system in Victoria.

 In Victoria single ethics review for all project applications will be conducted by seven reviewing ethics committees, including Austin Health's HREC. See details at: www.health.vic.gov.au/healthandmedicalresearch/ethicalreview

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.

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

Where Austin Health is the reviewing HREC for multiple sites, approval will be notified by one Ethics Approval Letter for all sites. A site specific 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 LNRR 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 by 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)

Please detail if you are requesting the HREC to waive consent or if you will obtain participant consent.

3. Log in to the online ethics form website

4. Complete the LNR VIC as appropriate. (Tips for e-submission can be found here)

5. Upload all supporting documentation (Note: (i) scanning may be required (ii) include signatures)

6. Email a copy of your entire application including signatures to ethics@austin.org.au

The original signed submission forms do NOT need to be submitted to the Office for Research however, you will be required to keep the original wet ink signed documents in your study file for auditing purposes.

Submitting your LNRR Governance Package

1. Log in to the online ethics form website

2. Complete the LNR SSA as appropriate

3. Upload all supporting documentation (Note: (i) scanning may be required (ii) include signatures)

4. Email a copy of your entire application including signatures to RGO - ETHICS02@austin.org.au

5. If applicable submit 2 copies of the Original wet ink signed Research Agreement and accompanying documents with an explanatory cover letter including the study reference number to: 

Office for Research

Level 8 Harold Stokes Building

Austin Health

145 Studley Road

PO Box 5555 Heidelberg

Victoria Australia 3084

The original signed submission forms do NOT need to be submitted to the Office for Research however, you will be required to keep the original wet ink signed documents in your study file for auditing purposes. 

Signatures

  • Signatures should be submitted with the project submission.
  • Digital signatures can be inserted into documents such as the LNR VIC and LNR 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: LNRR Multi Site Reviewing Submission

Ethics Package

Governance Package

New Application Payment Form

Cover letter

LNR VIC for projects within Victoria ONLY (Low and Negligle Risk Form; signed by all Investigators)

NEAF for projects within Victoria AND interstate (National Ethics Application Form; final version with submission code - no DRAFT watermark)

Protocol

CV's (for Austin Health & Non-Austin Health employees)

If Applicable:

Master PICF (see Department of Health standard templates)

Master PICF Complaints Section contact details

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 for LNRR applications

Research governance cover letter and Checklist

Fully signed (by 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

If Applicable:

Austin Health (AH) Site Specific PICF must include:

(a) 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) AH complaints section contact details

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

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

Grant approval or funding arrangement

Research Agreement

Departmental Sign off (for example, Health Information Services)

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Audit or Quality Improvement Submission

An audit is defined as an activity instigated by an Austin Health principal investigator (audit activity applications for external investigators will not be accepted) involving a research hypothesis which includes the analysis of data from previous collected patient information with an intention to publish or otherwise present the data beyond the staff of the hospital.

Audits are generally retrospective reviews however prospective audits can be conducted in certain circumstances.

An audit DOES NOT involve the collection of new raw data (other than information that would ordinarily be collected as part of patient management) from a patient either in person, through a survey/questionnaire nor can it be instigated by an external person.

Process of review

The Office for Research will review each application and ensure that it is indeed an audit.  If this confirmation takes place and all other relevant information has been provided then the project will be granted ethics approval, investigators will be notified of the outcome via email.  

Projects approved under this process will have approval for a one-year period with the opportunity of request an extension of ethical approval.  

The costs associated with administering this process will be covered by the institution to encourage and support audits at Austin Health.

Projects approved under this process will still be required to fulfil monitoring requirements.  At a minimum the HREC will require submission of a final report at the completion of the audit.  If the audit has been approved to continue for longer than 12 months then an annual report and a final report is required. 

HREC review of audits under this process will only take place if the audit has not yet been conducted (ie prospective approval).  The HREC will not grant approval for a project that has already been conducted (ie retrospective approval). 

 Submitting your Audit Application

1. Prepare a hard copy of your audit application with original signatures of all investigators & head of department (this original signed document should be retained by the Principal Investigator in their study file for the required storage period) and if applicable a Research Agreement.

2. Email a scanned electronic copy ONLY of your audit application to ethics@austin.org.au - Please tilte the email 'Audit Application - [insert project title]'

Please note, Audit Applications are reviewed out of session. Therefore, they are not required to be booked into a meeting.

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

FORMS: Audit or Quality Improvement Submission

Audit Package

Audit or Quality Improvement Application Form

If Applicable:

Research Agreement

Protocol

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Clinical database registration and access

Registering a Clinical Database 

Clinical Databases are collections of clinical data which have been created for clinical or administrative use. There are many such databases across the hospital; many of which have been created or modified to allow research as a secondary purpose. 

Heads of Department are now responsible for ensuring each clinical database within their department has a Data Custodian. The role of the custodian is to register the database with the Office for Research (OFR), and ensure that data are stored securely, used responsibly and that the privacy of participants is safeguarded. The custodian must also alert the OFR of any changes to the Clinical Database, such as a change in data collected, change in storage or security or change in database custodian.

If you currently have an active clinical audit approved and you wish to continue your audit, please ensure you contact the OFR and submit a DRF/DAF to register the database.

Accessing Clinical Data

Clinical data is available from either a previously registered clinical database, or a patients medical record. Although the National Statement and the Health Records Act (Vic) 2001 enables clinical data that has already been collected as part of routine clinical care to be accessed for secondary purposes such as evaluation without the need for ethical review, this type of activity still requires review and approval by the OFR prior to accessing and using the data. 

To support applications to access clinical data, the OFR have developed the Data Access Form. This review pathway may be used in place of an LNR, when:

  • The clinical data to be accessed is from an existing source (registered clinical database or medical record);
  • The proposed investigators have existing rightful clinical access (i.e. as a treating clinician or head of department); 
  • The proposed access is directly related to a training, evaluation or quality improvement activity; and Privacy, confidentiality and data security is maintained at all times. 

This review process does not grant applicants with ethical approval. 

It should also be noted that identifiable and re-identifiable health information cannot be transferred outside of the AH IT environment without written consent from participants. There are no exceptions to this in line with the Health Records Act (Vic) 2001 and the Privacy Act (1998).

Please note that if you require any modifications to be made to your approved Database Access Form (DAF), that we require you to submit a new DAF for review and approval, rather than a modification / amendment to your current application. 

FORMS: Clinical database registration and access

Clinical Database Registration Form

Database Registration Form (DRF)

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 Database access form

Database Access Form (DAF) 

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Waiver of Consent

A waiver of consent occurs where specific consent is not obtained for use of participant data or samples.

A true waiver of consent is NOT considered applicable in the following cases:

- Opt-out approach i.e. Participants are automatically enrolled in a research project but are given the opportunity withdraw via an opt out information sheet.

- Implied consent i.e. Participant consent is inferred by completion of the research project (e.g. survey/questionnaire).

- Audit of patient medical records i.e. For the purposes of quality and/or process improvement.

Process of review

Waiver of consent is considered high risk and must be reviewed by the Human Research Ethics Committee (HREC).  

In accordance with the requirements of the NHMRC National Statement on Ethical Conduct in Human Research 2007 (National Statement), sections 2.3.6 – 2.3.8, the Austin Human Research Ethics Committee (HREC) consider waiving the requirement for consent for the collection, use and/or disclosure of personal information in medical research or personal health information provided all criteria are addressed.

 

Waiver of consent will not be considered as Low Negligible Risk Research (LNRR) and must be submitted as a full application. Please see Single Site Submission (if Austin only) or Multi Site Reviewing Submission (if Multi Site) for the forms required for submission. 

When requesting a waiver of consent for a new study please complete the Waiver of Consent Request Form. This form MUST  be accompanied and completed in full to ensure your submissions is reviewed.

Research Agreements (including CTRAs, RCAs, MTAs & MOUs)

Any research involving collaboration between Austin Health and an external entity requires an agreement of some description. The nature of the research project will determine which type of agreement is required. All agreements should be accompanied by a completed Cover Sheet, Database Form and signed Contract Checklist*

* This document should be signed by Austin line manager and Austin Finance Resource Manager in section 1 as well as the Austin Responsible Executive Director in section 6

 

 

 

Agreement Type

When should this agreement be used

Requirements

Austin Audit Memorandum of Understanding

Audit Activities not involving money

1 x signed & executed e-copy

MACH Simple Research Collaboration Agreement

Investigator Initiated research collaborations between two or more MACH members not involving money

Please find MACH partner list here:

http://mach.melbourne/about/our-partners/

2 x wet inked signed hard copy

Austin Simple Research Collaboration Agreement

Non-sponsored Low Negligible Risk Research projects not involving money

2 x wet inked signed hard copy

Austin Research Collaboration Agreement

Non-sponsored Low Negligible Risk Research projects involving money where Austin is the lead collaborator

2 x wet inked signed hard copy

Austin Research Collaboration Agreement

Non-sponsored Low Negligible Risk Research projects involving money where Austin is not the lead collaborator

2 x wet inked signed hard copy

Victorian Managed Insurance Authority (VMIA) Investigator Initiated Clinical Trial Research Agreement

Investigator Initiated studies that require full review by the Austin Human Research Ethics Committee

2 x wet inked signed hard copy

Austin Material Transfer Agreement

Investigator Initiated studies that involve transfer of data/samples for analysis at another location other than Austin Health

2 x wet inked signed hard copy

Medicines Australia Clinical Trial Research Agreement

Sponsored studies that require full review by the Austin Human Research Ethics Committee

3 x wet inked signed hard copy

National Health and Medical Research Council Multi-Institutional Agreement

National Health and Medical Research Council funded studies involving multiple institutions

1 x signed & executed e-copy

 

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* This document should be signed by Austin line manager and Austin Finance Resource Manager in section 1 as well as the Austin Responsible Executive Director in section 6

 

Please follow attached flowchart to determine what agreement/s may be required as part of your research project submission. Please note this is as 3 step process. You MUST follow each step in the process.

New Project Submissions - Cut off and meeting dates 2016 & 2017

 New Application Cut Off 

cut off time: 9am

 Human Research Ethics Committee (HREC)  Meeting

 Clinical Research Review Committee (CRRC) Meeting

(for LNRR applications ONLY) 

05 Apr 2017 20 Apr 2017 26 Apr 2017
03 May 2017 18 May 2017 24 May 2017
31 May 2017 15 Jun 2017 21 Jun 2017
05 Jul 2017 20 Jul 2017 26 Jul 2017
02 Aug 2017 17 Aug 2017 23 Aug 2017
30 Aug 2017 14 Sep 2017 20 Sep 2017
27 Sep 2017 12 Oct 2017 18 Oct 2017
25 Oct 2017 09 Nov 2017 15 Nov 2017
22 Nov 2017 07 Dec 2017 13 Dec 2017

 Book early as submission spots are limited.

When the application is complete please email the fully signed/final documents to ethics@austin.org.au 

Please note, Audit Applications are reviewed out of session. Therefore, they are not required to be booked into a meeting.

Can I use the HREA form instead of the NEAF?

The NHMRC is developing a new form called the HREA (Human Research Ethics Application), which will eventually replace the National Ethics Application Form. (However, the HREA is not currently compatible with multi-site applications involving study sites in Victoria.

 

As such, all multi-site and single site studies must be submitted using the NEAF through Online Forms. The HREA will not be accepted at this time.