Human Research Ethics Review

    Research > NSLHD Research Office > Human Research Ethics Review

    ​​​How To Submit For Human Ethics Review​​​​​​​​​​​​​​​​​​

    All new ethics applications to NSLHD HREC must be completed using REGIS. The Research Office is available to assist with queries regarding information required for your application however any technical queries regarding the REGIS website should be directed to the REGIS Help Desk on 1300 073 447.

    A hard copy submission to the Research Office is no longer required.

    Please contact the Research Office one week before the submission deadline, to adivse of your intention to submit a new application to the HREC. This is so the Research Office can assist you in ensuring you have all the information/documentation required which should prevent any unnecessary delays in processing. Additionally this will enable the Research Office to expect your application in REGIS.
    Submission Checklists are available to assist in submitting for HREC review.

    Applications not completed according to the requirements set out in the submission checklist will not be accepted.

    It is strongly advised that the templates found on the Standard Forms page of this site are used for your study documents.

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    Multi-centre interstate research (National Mutual Acceptance)

    Under the National Mutual Acceptance (NMA) agreement (formerly the Interstate Mutual Acceptance Initiative), multi-centre clinical research conducted across public health sites in NSW, VIC, SA, QLD and WA are eligible for single ethical review.   

    More information regarding NMA can be found here.

     

    Project submissions for review by the Full HREC

    The Human Research Ethics Committee (HREC) meets monthly. Meeting dates can be found on the Committee Meeting Dates page. The HREC reviews ethics applications for single site and multi-centre studies.

    Low Risk Submissions for review by the HREC Executive

    The HREC Executive meets fortnightly. Meeting dates can be found on the Committee Meeting Dates page. New projects which are considered to be low or neglible risk are eligible for expedited review by the HREC Executive. The HREC Executive also reviews amendments to approved projects.

    ​National Statement Low Risk Definition:

    The National Statement defines low risk research as follows; "Research is 'low risk' where the only foreseeable risk is  one of discomfort. Where the risk, even if unlikely, is  more serious than discomfort, the research is not low risk." (Chapter 2.1)  

       Examples of low/negligible risk research include (but are not limited to):                                                                                          

    • Use of previously stored human tissue (consent for storage of that tissue for research will also need to be considered)
    • Anonymous questionnaires/surveys in non-sensitive populations
    • Medical record review/retrospective review where all data extracted are coded or de-identified.

    Examples of research which are not LNR include (but are not limited to):                                                                                                   

    • Collection of a blood specimen (although in some instances, an additional specimen may be added at the time of routine collection)
    • Research in sensitive/vulnerable populations
    • Research that  changes a participant's standard management, for example changes to an intervention or addition of non-routine investigations.

     

    IMPORTANT: HREC approval (Ethics) and Site Authorisation (Governance) are required prior to commencement of research at any site. Requirements for site authorisation at interstate and private sites may vary. Researchers are advised to contact each site prior to commencing any research-related activities.

    ​​Please click here for information on submission to research governance for a NSLHD site.

     

    ​Helpful Links and Information
    ​HREC only indemnity form Institution Details​ 
    ​Submission deadlines
    ​Fees and Payment​s​​
    ​Amendments
    ​Milestone Reports (formerly known as Annual or Final Reports)
    ​Change Personnel
    ​Safety Reporting
    ​Ethical Review for External Entities
    ​Guidance for case reports and quality improvement
    ​Australian New Zealand Clinical Trial Registry (ANZCTR) - All Clinical Trials must be registered in a publically accessible registry prior to commencment. It is not compulsory that the Australian New Zealand Clinical Trial Registry be used, however, use of this registry is strongly suggested.
                                            
    New projects which are considered to be low or negligible risk (LNR) are eligible for expedited review by the HREC Executive.  

     

    The Research Office advises that researchers discuss their project with a member of Research Office staff PRIOR TO SUBMISSION to determine whether it is LNR or requires review by the full HREC.                                                                                                           

    Your submission must be prepared using the HREA form (online), the submission checklist and the standard document templates on this website.                                                                                                          

    Applications not completed according to the requirements set out in the submission checklist will be rejected.                                                                                                          

    National Statement Low Risk Definition:

    The National Statement defines low risk research as follows, "Research is 'low risk' where the only foreseeable risk is  one of discomfort. Where the risk, even if unlikely, is  more serious than discomfort, the research is not low risk." (Chapter 2.1)                                                                                                          

     Examples of low/negligible risk research include (but are not limited to):                                                                                                           

    • Used of previously stored human tissue (consent for storage of that tissue for research will also need to be considered)
    • Anonymous questionnaires/surveys in non-sensitive populations
    • Medical record review/retrospective review where all data extracted are coded or de-identified.

    Examples of research which are not LNR include (but are not limited to):                                                                                                          

    • Collection of a blood specimen (although in some instances, an additional specimen may be added at the time of routine collection)
    • Research in sensitive/vulnerable populations
    • Research that  changes a participant's standard management, for example changes to an intervention or addition of non-routine investigations.

    LNR SSA                                                                                                       

    At NSLHD the Site Specific Authorisation (SSA) assessment for low risk projects is submitted concurrently with the LNR submission to the HREC Executive. Please consult the LNR SSA Checklist​  to ensure that all documents are completed correctly. For more information, please refer to the Governance information on this website.                                                                                                          

    Guidance regarding appropriate sign-off from Health Information Services for studies using/accessing medical records can be found here.                                                                                                           

    If your study involves access to medical records, Health Information Services requires you to follow their standard practices and instructions for record retrieval. Note: this can only be done once you have both HREC and SSA approval/authorisation for your study. Please see their instructions, here. ​ ​                                                                                                        


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