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HREC D 

Instructions for submission of application for review by HREC-D

All documents are to be submitted electronically to research.ethics@svhm.org.au by the closing date. NB – if you are submitting via SERP you will only need to upload your documents once via the online ethics form website.

 

Please use the relevant HREC application forms provided on our website.

 

HREC applications must be presented to the HREC according to:

 

Incomplete applications cannot be accepted, and will be returned to the research team.  

 

The Principal Researcher must sign all correspondence from the research team to the HREC, and all correspondence from the HREC Secretariat will be forwarded to the Principal Researcher and the person nominated as the Contact Person at Q 1.

 

If a protocol involves support that the HREC would usually anticipate to be provided at St Vincent’s Hospital (Melbourne), but this is not the case, then please provide an explanation in a covering letter, (e.g. pathology will be done off campus by a central laboratory).  

 

The application must be submitted by 4.30pm of the final application closing date according to the meeting timetable.

 

The application can be submitted in person or couriered to the Research Governance Unit Level 5 Mary Aikenhead Building 27 Victoria Pde Fitzroy. To post the application please send to Research Governance Unit St Vincent's PO Box 2900 Fitzroy Vic 3065

Documentation and number of copies:

Documentation HREC-D*
Application cover sheet – HREC-D (replaces cover letter) 1

Original signed version of the NEAF and / or Modules 1/2/3/4 of the CAF (single-sided clipped not stapled)

(copies can be double-sided)

1 original and 4 copies
Additional documents to go with NEAF (see list below) 1 original and 4 copies
Participant Information and Consent Form 1 original and 4 copies
Protocol (if separate document ie Clinical Protocol or investigator initiated protocol)
3
Investigator's brochure 3
Product Information 3
Budget
1
Questionnaires/ Surveys / Psychological Scales or inventories / documentation to patients 1 original and 4 copies
Form of Indemnity (Medicines Australia 'Standard' form if St Vincent's is a site) At least 2
Form of Indemnity (Medicines Australia 'HREC review only' form if St Vincent's and Mercy Private is a site) At least 2
Certificate of Currency of Insurance 2
Research Agreement At least 2
CTN/CTX form 1 original
Privacy Declaration Form for external researchers 1 original per person
St Vincent's Department support forms only required from Departments that are supporting or providing services to the project and who do not have a researcher on the research team. 1 original per department
Letter from St Vincent's and Mercy Private Hospital Research Committee (if SVMPH is a site) 1 copy of letter

 * Complete submission must also be emailed to research.ethics@svhm.org.au before the closing date.

Collation of applications

The Research Governance Unit will be unable to accept applications that have not been collated correctly and stapled together.

STEP 1: Collate the original set of documents

Provide 1 complete set of original documents that are relevant to the study and collate in the following order. Do not staple this set together – clip only:

  • Cover Sheet
  • Module 1 or NEAF
  • Participant Information and Consent Forms, each individually stapled if more than 1 consent form.
  • Module 2
  • Module 3
  • Module 4
  • Questionnaires, Diaries, Flyers etc.

This set must include original signature pages for modules 1, 2 & 4, be single sided only and have a cover sheet attached to the front.

 

STEP 2: Collate each copy then STAPLE together in the following order:

  • Module 1 or NEAF
  • Participant Information and Consent Forms, each individually stapled if more than 1 consent form.
  • Module 2
  • Module 3
  • Module 4
  • Questionnaires, Diaries, Flyers etc.

Copies should be double sided.

 

STEP 3: Collate legal / research governance documentation

Please provide the following original documents:

  • Indemnity Form (at least 2 copies of each indemnity form)
  • Insurance Certificate (1 or provide policy number if the insurance policy is approved by VMIA)
  • Research Agreement (at least 2 copies)
  • 1 original CTN/CTX form
  • 1 original privacy declaration form per person
  • 1 budget

 

STEP 4: Collate other documentation

  • Commercially sponsored Protocols (3 copies)
  • Commercially Sponsored Investigator Brochures (3 copies)

 

Notes related to documentation

NEAF (National Ethics Application Form)

If you are submitting NEAF you must also submit the following documentation:

Victorian Specific Module

 

CAF (Common Application Form) 

If the application form is the CAF, all applicants should submit Module 1 of the CAF. Submit Module 2 if your study involves drugs and devices. The CAF can be downloaded from DoH website.

 

NB: Device studies using TGA registered devices for the indication for which they are registered and which are already part of standard practice at St Vincent's Hospital (Melbourne) may go to either HREC-D  (preferred).

 

Applicants must provide information on all drugs to be used in a clinical trial, including drugs that are registered with the TGA for the indication they are being used for in the trial.

 

Applicants should also provide Product Information for these drugs.  

 

Submit Module 3 if your study involves human tissue

 

Submit Module 4 if your study involves the use of radiation

 

Please also refer to the Research involving radiation section of this website  

 

If a member of the research team is not employed by St Vincent's Hospital (Melbourne), please complete and submit one Privacy Declaration Form per person.

  

If your study involves the STV Interpreting Services Department            

Refer to the 'Research Policy and Guidelines' for Interpreting Service            

The Chief Interpreter should complete Q 1.40 in Module 1 of the CAF.            

If you are using the NEAF then submit Q 1.40 in Module 1 of the CAF with your application.    

 

For research involving drugs under the Special Access Scheme (including thalidomide)

Please refer to the Special Access Scheme section of our website.

                 

Research Agreement

Please refer to the Research Agreement section of our website 

 

Indemnity and evidence of insurance

Please refer to the Indemnification and evidence of insurance section of our website

 

Contact

If you have any queries regarding HREC-D submissions please contact:

Senior Administrative Officer and Secretary to HREC-D Committee
Ph: (03) 9288 3930

OR
 
Research Governance Unit - General enquires
Ph. (03) 9288 2394

41 Victoria Parade, Fitzroy VIC 3065, Australia. Phone: (03) 9288 2211