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Guidance

NSW Health Research Applications

All applications for ethical and scientific review and site authorisation of research taking place within the NSW public health system must be submitted through this Online Forms Website.



This on-line system allows researchers to fill in application forms electronically, however applications must be submitted in hard copy (with signatures and supporting documents) to:
  • the HREC Executive Officer, for HREC review;
  • the Research Governance Officer, for site authorisation.

When can I start my research project?

Which form(s) should I complete?

National Ethics Application Form (NEAF)

Application Form for Ethical and Scientific Review of Low and Negligible Risk Research (LNR Application Form)

Site Specific Assessment (SSA) Form

Site Specific Assessment Form for Low and Negligible Risk Research (LNR SSA)

Access Request Form

Who to contact for assistance

















When can I start my research project?

You can only commence human research at a NSW Public Health Organisation once you have received written notification of authorisation from the Public Health Organisation's Chief Executive or their delegate. This will only be provided once:

  • the research project has been reviewed and approved by a HREC that is constituted and operates in accordance with the National Statement on Ethical Conduct in Human Research (2007);
  • the research project has been reviewed by the Public Health Organisation through a process of site specific assessment or access request review.

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Which form(s) should I complete?

Research involving more than low risk1 Low and negligible risk research2
Research projects being conducted at sites under the control of a NSW Public Health Organisation National Ethics Application Form (NEAF)



and



Site Specific Assessment (SSA) Form3

Application Form for Ethical and Scientific Review of Low and Negligible Risk Research (LNR Application Form)


and



Site Specific Assessment Form for Low and Negligible Risk Research (LNR SSA)3

Research projects that only involve access to participants, their tissue or data through a NSW Public Health Organisation National Ethics Application Form (NEAF)



and



Access Request Form4

Application Form for Ethical and Scientific Review of Low and Negligible Risk Research (LNR Application Form)



and



Access Request Form4









1 Research in which the risk to participants is more serious than discomfort, as described in the National Statement on Ethical Conduct in Human Research (2007).







2 Research in which the risk to participants is no more than discomfort or inconvenience, as described in the National Statement on Ethical Conduct in Human Research (2007).







3 An SSA Form is required for each site at which the research will be conducted; a site is facility, location or service where the research is being conducted.







4 Only one Access Request Form is required for each Public Health Organisation for each project; it is not necessary to complete a form for each individual facility, location or service within the Public Health Organisation.

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National Ethics Application Form (NEAF)

Purpose of the NEAF

The purpose of the NEAF is to enable applicants to provide sufficient detail about the research project to allow a Human Research Ethics Committee (HREC) to make an informed decision about the ethical and scientific acceptability of the proposal.

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When the NEAF should be used

The NEAF should be used for all applications for ethical and scientific review relating to research in which the risk to participants is more serious than discomfort, as described in the National Statement on Ethical Conduct in Human Research (2007).

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Creating a NEAF

  1. On the 'MY PROJECTS' page, click on the 'Create New Project' button.
  2. You will be prompted to nominate which state you are submitting your application in; select 'New South Wales'.
  3. You will be prompted to nominate the type of form you wish to create; select 'NEAF'.

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Completing the NEAF

The NEAF must be completed by the Co-ordinating Investigator responsible for the conduct of the research project within the NSW public health system.







You must complete all questions on the form. Detailed question-specific guidance can be accessed by clicking on the guidance icon View Guidance at the relevant questio







If you are still unsure about what is required, you should seek clarification from the Executive Officer of the HREC that you are submitting the form to. Contact details for HREC Executive Officers are maintained on the NSW Department of Health website at: http://www.health.nsw.gov.au/ethics/Pages/contacts-hrecs.aspx

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Submitting the NEAF

  1. When your NEAF is complete, ensure that the form is open and click on the navigate icon Navigate.
  2. This will take you to the 'Navigate' screen; once there, click on the 'Submission' tab.
  3. This will take you to the 'Submission' screen; once there, click on the 'Generate submission code' button.
  4. Once you have generated a submission code, download and print a copy of the form for review and submission by clicking on 'Generate PDF'.
  5. Once you have printed the form and acquired the necessary signatures, forward the required number of hard copies to the Executive Officer of the HREC that you are submitting the form to, along with a covering letter and documentation for review by the HREC, for example:
    • Protocol;
    • Curriculum vitae of the Co-ordinating Investigator and Principal Investigator(s);
    • Signed declaration and undertaking by the Data Custodian and Co-ordinating Investigator (if seeking access to a NSW Health owned or managed statewide data collection);
    • Participant Information Sheet and Consent Form;
    • Questionnaires/surveys;
    • Data collection forms;
    • Recruitment materials (e.g. advertisements, letter to potential participants or others such as doctors);
    • Radiation safety report (for research involving ionising radiation);
    • For clinical trials:
      • Investigator's brochure or product information;
      • Clinical Trial Notification Scheme Form or Clinical Trial Exemption Scheme Form.
Please note
  • Co-ordinating Investigators are advised to discuss their project with the Executive Officer of the HREC that they are submitting the form to before generating a submission code and submitting the NEAF; the Executive Officer will also clarify the number of hard copies required for submission.
  • Generating a submission code does not submit the application to the HREC Executive Officer; it saves the form and generates a submission code which then appears on each page of the form.
  • A copy of the form printed before you have generated a submission code cannot be processed.

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What happens next?

The HREC Executive Officer will assess whether the application is valid (complete) and ready for HREC review.







If the application is valid, the HREC Executive Officer will inform the Co-ordinating Investigator in writing of the date of the meeting at which the application will be considered.

If the application is invalid, the HREC Executive Officer will inform the Co-ordinating Investigator in writing of the reasons why the application is invalid, and/or may request additional information.







Following review by the HREC, the HREC Executive Officer will notify the Co-ordinating Investigator of the outcome of the HREC review. This will be in writing and, where possible, will be no later than 10 working days from the date of the meeting at which the application was reviewed.

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Application Form for Ethical and Scientific Review of Low and Negligible Risk Research (LNR Application Form)

Purpose of the LNR Application Form

The purpose of the LNR Application Form is to enable applicants to provide sufficient detail about the research project to allow a Human Research Ethics Committee (HREC) to make an informed decision about the ethical and scientific acceptability of the proposal.

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When the LNR Application Form should be used

The LNR Application Form should be used for all applications for expedited ethical and scientific review by a NSW Health HREC relating to research in which the risk to participants is no more than discomfort or inconvenience, as described in the National Statement on Ethical Conduct in Human Research (2007)







If you believe that your research project involves only low or negligible risk and may be eligible for expedited ethical and scientific review, you must discuss the project with the Executive Officer of the HREC that you are submitting the form to, before completing this form.







If the HREC Executive Officer advises you that the project is not eligible for expedited review, you must complete an application for full HREC review using the National Ethics Application Form (NEAF).







The HREC may request a full review using NEAF following assessment of your application for expedited review if it considers the risk to participants to be greater than low risk.

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Creating an LNR Application Form

  1. On the 'MY PROJECTS' page, click on the 'Create New Project' button.
  2. You will be prompted to nominate which state you are submitting your application in; select 'New South Wales'.
  3. You will be prompted to nominate the type of form you wish to create; select 'LNR'.

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Completing the LNR Application Form

The LNR Application Form must be completed by the Co-ordinating Investigator responsible for the conduct of the research project within the NSW public health system



You must complete all questions on the form. Detailed question-specific guidance can be accessed by clicking on the guidance icon View Guidance at the relevant question.







If you are still unsure about what is required, you should seek clarification from the Executive Officer of the HREC that you are submitting the form to. Contact details for HREC Executive Officers are maintained on the NSW Department of Health website at: http://www.health.nsw.gov.au/ethics/Pages/contacts-hrecs.aspx

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Submitting the LNR Application Form

  1. When your LNR Application Form is complete, ensure that the form is open and click on the navigate icon Navigate.
  2. This will take you to the 'Navigate' screen; once there, click on the 'Submission' tab.
  3. This will take you to the 'Submission' screen; once there, click on the 'Generate submission code' button.
  4. Once you have generated a submission code, download and print a copy of the form for review and submission by clicking on 'Generate PDF'.
  5. Once you have printed the form and acquired the necessary signatures, forward the required number of hard copies to the Executive Officer of the HREC that you are submitting the form to, along with a covering letter and documentation for review by the HREC, for example:
    • Protocol;
    • Curriculum vitae of the Co-ordinating Investigator and Principal Investigator(s);
    • Signed declaration and undertaking by the Data Custodian and Co-ordinating Investigator (if seeking access to a NSW Health owned or managed statewide data collection);
    • Participant Information Sheet and Consent Form;
    • Questionnaires/surveys;
    • Data collection forms;
    • Recruitment materials (e.g. advertisements, letter to potential participants or others such as doctors).
Please note
  • Co-ordinating Investigators are advised to discuss their project with the Executive Officer of the HREC that they are submitting the form to before generating a submission code and submitting the LNR Application Form; the Executive Officer will also clarify the number of hard copies required for submission.
  • Generating a submission code does not submit the application to the HREC Executive Officer; it saves the form and generates a submission code which then appears on each page of the form.
  • A copy of the form printed before you have generated a submission code cannot be processed.

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What happens next?

The HREC Executive Officer will assess whether the application is valid (complete) and ready for expedited HREC review.







If the application is valid, the HREC Executive Officer will inform the Co-ordinating Investigator of the timeframe in which the application will be reviewed.







If the application is invalid, the HREC Executive Officer will inform the Co-ordinating Investigator in writing of the reasons why the application is invalid, and/or may request additional information.







Following review, the HREC Executive Officer will notify the Co-ordinating Investigator in writing of the outcome.







The HREC may request a full review using NEAF following assessment of your application for expedited review if it considers the risk to participants to be greater than low risk.

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Site Specific Assessment (SSA) Form

Purpose of the SSA Form

The purpose of the SSA Form is to enable applicants to provide sufficient detail about the research project to enable the Chief Executive or their delegate to make an informed decision about the acceptability of the proposal to a NSW Public Health Organisation.

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When the SSA Form should be used

The SSA Form should be used for site specific assessment of research projects involving more than low risk to participants, and where the research proposal has been submitted for ethical and scientific review using the National Ethics Application Form (NEAF).







Examples of research projects that require completion of this form include projects that involve one or more of the following activities at site under the control of a NSW Public Health Organisation.

  • enrolling participants into research (e.g. obtaining informed consent, screening);
  • carrying out protocol-specific research procedures with or on participants
  • managing and analysing data, tissue, and responses from surveys and questionnaires collected for or from research.
This form must be completed for each site (i.e. each facility, location or service) under the control of a NSW Public Health Organisation at which the research project is being conducted.

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Creating an SSA Form

The Co-ordinating Investigator must create an SSA Form for each site at which the research project is being conducted. To create an SSA form:

  1. Ensure that your NEAF is open and click on the 'SSA' tab.
  2. This will take you to the 'SSA' screen; once there, enter the number of forms you wish to create in the box and click on 'Create a new SSA Form'.
  3. Select the form you wish to open; you will be prompted to nominate which state the site is located in; select 'New South Wales'.
  4. You will be prompted to nominate the type of form you wish to create; select 'SSA'.
  5. Transfer one form to each Principal Investigator involved in the research project. For detailed guidance on how to transfer the form, select 'How to' from the 'Help' menu (to see an on-line demonstration); or select 'User manual' from the 'Help' menu (to download the user manual).
  6. Do not generate a submission code for the SSA Form before sending it to the Principal Investigator.

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Completing the SSA Form

The SSA Form must be completed by the Principal Investigator responsible for the research project at the site.







You must complete all questions on the form. Detailed question-specific guidance can be accessed by clicking on the guidance icon View Guidance at the relevant question.







If you are still unsure about what is required, you should seek clarification from the Research Governance Officer responsible for the site. Contact details for Research Governance Officers and information on the facilities, locations or services covered by them are maintained on the NSW Department of Health website at: http://www.health.nsw.gov.au/ethics/Pages/rgo-contact-details.aspx

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Submitting the SSA Form

  1. When your SSA Form is complete, ensure that the form is open and click on the navigate icon Navigate.
  2. This will take you to the 'Navigate' screen; once there, click on the 'Submission' tab.
  3. This will take you to the 'Submission' screen; once there, click on the 'Generate submission code' button.
  4. Once you have generated a submission code, download and print a copy of the form for review and submission by clicking on 'Generate PDF'.
  5. Once the form has been finalised and printed, forward the required number of copies of the completed form in hard copy to the Research Governance Officer responsible for the site, along with a covering letter, a copy of the HREC approval letter and documentation for review by the Research Governance Officer, for example:
    • Protocol;
    • Curriculum vitae of the Principal Investigator for the site;
    • Participant Information Sheet and Consent Form to be used at the site;
    • Questionnaires/surveys to be used at the site;
    • Data collection forms to be used at the site;
    • Recruitment materials (e.g. advertisements, letter to potential participants or others such as doctors) to be used at the site;
    • Radiation safety report (for research involving ionising radiation); and
    • For clinical trials:
      • Investigator's brochure or product information;
      • Clinical Trial Notification Scheme Form or Clinical Trial Exemption Scheme Form;
      • Clinical Trial Research Agreement;
      • Documentation on indemnity and insurance.
Please note
  • Principal Investigators are advised to discuss their project with the Research Governance Officer that they are submitting the form to, before generating a submission code and submitting the SSA Form; the Research Governance Officer will also clarify the number of hard copies required for submission.
  • Generating a submission code does not submit the application to the Research Governance Officer; it saves the form and generates a submission code which then appears on each page of the form.
  • A copy of the form printed before you have generated a submission code cannot be processed.
  • Applications for site specific assessment can be submitted to the Research Governance Officer whilst the ethical review is in progress.

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What happens next?

The Research Governance Officer will assess whether the application is valid (complete) and ready for review.







If the application is valid, the Research Governance Officer will inform the Principal Investigator of the timeframe in which the application will be reviewed.







If the application is invalid, the Research Governance Officer will inform the Principal Investigator in writing of the reasons why the application is invalid, and/or may request additional information.







When review of the SSA Form is completed, the Research Governance Officer will make a recommendation to the Chief Executive or their delegate as to whether the project should be authorised, not authorised or requires Chief Executive/delegate consideration.







Following consideration by the Chief Executive or their delegate, the Research Governance Officer will notify the Principal Investigator whether or not the project is authorised for commencement at the site.

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Site Specific Assessment Form for Low and Negligible Risk Research (LNR SSA)

Purpose of the LNR SSA Form

The purpose of the LNR SSA Form is to enable applicants to provide sufficient detail about the research project to enable the Research Governance Officer or other authorised person to make an informed decision about the acceptability of the proposal to a NSW Public Health Organisation.

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When the LNR SSA Form should be used

This form should be used for site specific assessment of research projects involving only low or negligible risk to participants, and where the research proposal has been submitted for expedited review by a NSW Health HREC using the Application Form for Ethical and Scientific Review of Low and Negligible Risk Research (LNR Application Form).







Examples of research projects that require completion of this form include projects that involve one or more of the following activities at a site under the control of a NSW Public Health Organisation:

  • enrolling participants into research (e.g. obtaining informed consent, screening);
  • carrying out protocol-specific research procedures on participants;
  • managing and analysing data, tissue, and responses from surveys and questionnaires collected for or from research.
This form must be completed for each site (i.e. each facility, location or service) under the control of a NSW Public Health Organisation at which the research project is being conducted.

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Creating an LNR SSA Form

The Co-ordinating Investigator must create an LNR SSA Form for each site at which the research project is being conducted. To create an LNR SSA form:

  1. Ensure that your LNR Application Form is open and click on the 'SSA' tab.
  2. This will take you to the 'SSA' screen; once there, enter the number of forms you wish to create in the box and click on 'Create a new SSA Form'.
  3. Select the form you wish to open; you will be prompted to nominate which state the site is located in; select 'New South Wales'.
  4. You will be prompted to nominate the type of form you wish to create; select 'SSA'.
  5. Transfer one form to each Principal Investigator involved in the research project. For detailed guidance on how to transfer the form, select 'How to' from the 'Help' menu (to see an on-line demonstration); or select 'User manual' from the 'Help' menu (to download the user manual).
  6. Do not generate a submission code for the LNR SSA Form before sending it to the Principal Investigator.

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Completing the LNR SSA Form

The LNR SSA Form must be completed by the Principal Investigator responsible for the research project at the site

You must complete all questions on the form. Detailed question-specific guidance can be accessed by clicking on the guidance icon View Guidance at the relevant question.







If you are still unsure about what is required, you should seek clarification from the Research Governance Officer responsible for the site. Contact details for Research Governance Officers and information on the facilities, locations or services covered by them are maintained on the NSW Department of Health website at: http://www.health.nsw.gov.au/ethics/Pages/rgo-contact-details.aspx

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Submitting the LNR SSA Form

  1. When your LNR SSA Form is complete, ensure that the form is open and click on the navigate icon Navigate.
  2. This will take you to the 'Navigate' screen; once there, click on the 'Submission' tab.
  3. This will take you to the 'Submission' screen; once there, click on the 'Generate submission code' button.
  4. Once you have generated a submission code, download and print a copy of the form for review and submission by clicking on 'Generate PDF'.
  5. Once the form has been finalised and printed, forward the required number of copies of the completed form in hard copy to the Research Governance Officer responsible for the site, along with a covering letter, a copy of the Application Form for Ethical and Scientific Review of Low and Negligible Risk Research, a copy of the HREC letter of approval and documentation for review by the Research Governance Officer, for example:
    • Protocol;
    • Curriculum vitae of the Principal Investigator for the site;
    • Participant Information Sheet and Consent Form to be used at the site;
    • Questionnaires/surveys to be used at the site;
    • Data collection forms to be used at the site;
    • Recruitment materials (e.g. advertisements, letter to potential participants or others such as doctors) to be used at the site.
Please note
  • Principal Investigators are advised to discuss their project with the Research Governance Officer that they are submitting the form to, before generating a submission code and submitting the LNR SSA Form; the Research Governance Officer will also clarify the number of hard copies required for submission.
  • Generating a submission code does not submit the application to the Research Governance Officer; it saves the form and generates a submission code which then appears on each page of the form.
  • A copy of the form printed before you have generated a submission code cannot be processed.
  • Applications for site specific assessment can be submitted to the Research Governance Officer whilst the ethical review is in progress.

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What happens next?

  • The Research Governance Officer will assess whether the application is valid (complete) and ready for review.
  • If the application is valid, the Research Governance Officer will inform the Principal Investigator of the timeframe in which the application will be reviewed.
  • If the application is invalid, the Research Governance Officer will inform the Principal Investigator in writing of the reasons why the application is invalid, and/or may request additional information.
  • When review of the LNR SSA Form is completed, the Research Governance Officer will inform the Principal Investigator.
  • Signing of the declaration 'Declaration by the Research Governance Officer (or other authorised person)' indicates that authorisation to commence the project at the site has been granted.

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Access Request Form

Purpose of the Access Request Form

The purpose of the Access Request Form is to enable applicants to provide sufficient detail about the research project to enable the Research Governance Officer or other authorised person to make an informed decision about whether or not the Public Health Organisation supports the research project.

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When the Access Request Form should be used

The Access Request Form should be used if the research project only requires access to participants, their tissue or data through a NSW Public Health Organisation and does not involve conducting research at any facilities, locations or services under the control of that Public Health Organisation.







Examples of research projects that require completion of this form include projects that only involve one or more of the following activities at a NSW Public Health Organisation:

  • Participant recruitment (but not enrolment) through posters, leaflets or handouts, and letter of invitation;
  • Distribution of surveys and questionnaires;
  • Access to data, images or tissue held at the facility, location or service but not processing or analysis.
This form should be completed for each Public Health Organisation supporting the research project. Only one form is required for each Public Health Organisation; it is not necessary to complete a form for each individual facility, location or service within the Public Health Organisation.

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Creating an Access Request Form

  1. Ensure that your NEAF or LNR Application Form is open and click on the 'SSA' tab.
  2. This will take you to the 'SSA' screen; once there, enter the number of forms you wish to create in the box and click on 'Create a new SSA Form'.
  3. Select the form you wish to open; you will be prompted to nominate which state the site is located in; select 'New South Wales'.
  4. You will be prompted to nominate the type of form you wish to create; select 'Access Request'.

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Completing the Access Request Form

The Access Request Form must be completed by the Co-ordinating Investigator responsible for the research project requesting support from a Public Health Organisation in the form of access to participants, tissue or data.







You must complete all questions on the form. Detailed question-specific guidance can be accessed by clicking on the guidance icon View Guidance at the relevant question.







If you are still unsure about what is required, you should seek clarification from the Research Governance Officer responsible for the Public Health Organisation. Contact details for Research Governance Officers and information on the facilities, locations or services covered by them are maintained on the NSW Department of Health website at: http://www.health.nsw.gov.au/ethics/Pages/rgo-contact-details.aspx

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Submitting the Access Request Form

  1. When your Access Request Form is complete, ensure that the form is open and click on the navigate icon Navigate.
  2. This will take you to the 'Navigate' screen; once there, click on the 'Submission' tab.
  3. This will take you to the 'Submission' screen; once there, click on the 'Generate submission code' button.
  4. Once you have generated a submission code, download and print a copy of the form for review and submission by clicking on 'Generate PDF'.
  5. Forward the completed application form to the Research Governance Officer responsible for the Public Health Organisation, along with a copy of the HREC letter of approval and a copy of the Application Form for Ethical and Scientific Review of Low and Negligible Risk Research (where relevant); and all documents to be distributed through the facilities, locations or services within the Public Health Organisation; and written confirmation of support from staff of the facilities, locations or services through which you are seeking access to participants, tissue or data, for example:
    • individuals who agreed to put up posters;
    • staff who agreed to hand out leaflets or handouts;
    • doctors who agreed to hand out letters of invitation to potential participants, or notify them of your research project;
    • head of department/manager who agreed to distribute questionnaires or surveys to staff by e-mail;
    • head of department or data custodian who agreed to provide access to medical records, data or tissue held in collections or databases under their management, in line with ethical conditions imposed by the approving HREC.
Please note
  • Generating a submission code does not submit the application to the Research Governance Officer; it saves the form and generates a submission code which then appears on each page of the form.

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What happens next?

  • The Research Governance Officer will assess whether the application is valid (complete) and ready for review.
  • If the application is invalid, the Research Governance Officer will inform the Co-ordinating Investigator in writing of the reasons why the application is invalid, and/or may request additional information.
  • If the application is valid, the Research Governance Officer or other authorised person will review the Access Request Form and inform the Co-ordinating Investigator of the outcome of this review.
  • Signing of the declaration 'Declaration by the Research Governance Officer (or other authorised person)' indicates that authorisation to commence the project at the site has been granted.

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Who to contact for assistance

For technical issues

This includes issues relating to managing your Online Forms account (e.g. changing details, password issues etc.) and assistance with managing forms (e.g. importing, creating, navigating, transferring, printing, duplicating, generating submission codes etc.):

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Ethical and scientific review

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Site authorisation

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Further guidance is also available from the 'Help' page of this on-line system; select 'How to' from the 'Help' menu (for on-line demonstrations; or select 'User manual' to download a user manual.

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