Application Process for Human Research

Submitting a research proposal

Submitting a research proposal

A. Engaging in research involving humans, their tissues or their medical data?

General

  1. Read the Guidelines, National Statement
  2. Talk to your supervisor, colleagues.
  3. Clearly define the question you would like answered by the research and set the study parameters.
 

Links

B. Is the project suitable for assessment as a Quality Assurance, Quality Assessment or Audit

Ethics

  1. Read and complete the QA/Audit checklist which will guide you through the process and help you make a correct assessment. The SPIRIT checklist will also help.
  2. If your responses indicate a QA/Audit application, complete the form getting the indicated signature/s, then submit to the Research Office for final approval by the HREC.
  3. Remember to include the fund transfer application covering submission cost, if any.  
  4. If a QA/Audit is not indicated then you will need to start an online application for a full ethics (NEAF) or low & negligible risk (LNR) proposal.
 

Governance

  • No Research Governance Office involvement.

C. Initiate your online application at Australian Online Forms for Research

General
  1. The starting point for all in-depth studies requiring ethics approval.
  2. This application begins both ethics and governance applications from the information you provide.
  3. SAVE your document each time you visit. DO NOT SUBMIT your proposal until you have finalised your application.
  4. Submitting your online proposal generates a code for your application; it does not advise the ethics or governance staff.
  

Notes

  • Go to the Australian Online Forms for Research site, either login or create a new account. The site provides help resources for new users.
  • If your proposed study is not clearly defined you will be asked for a lot of information that may not be relevant to your final study - therefore to save yourself and the review committees time, clearly define your project before prior to starting your online application.
  • Making online changes to your application after you have submitted your proposal will lead to new proposals (with new ID numbers) being created. You can modify your study once it has been submitted to the WSLHD Research Office.

D. Completed your Australian Online Form application? Yes: now submit to WSLDH Research Office 

General

  1. Complete your study application at Australian Online Forms. DO NOT press the submit button until you have finalised your proposal.
  2. Once you press submit, appropriate NEAF, LNR, SSA, LNR SSA and Access Request Review submissions are produced (with a unique study identifier) which the Chief Investigator then forwards with all the other requirements to the Research Office and the appropriate Research Governance Office (RGO).
  3. RGO approval requires prior HREC approval. However the overall approval timeframe can be reduced if both applications are submitted simultaneously. Applications may be submitted separately.
  4. Research projects must not commence at a PHO site until the Principal Investigator has received written notification of authorisation from the RGO of the Chief Executive/designee approval.
 

Glossary

  • NEAF: National Ethics Application Form (or full ethics submission)
  • LNR: Low and Negligible Risk
  • SSA: Site Specific Approval
  • Access Request Review: A research project that requires support from a PHO, eg. participant recruitment with no consent, or distribution of surveys and questionnaires, or access to data.
  • PHO: Public Health Organisation, eg. WSLHD, Westmead Hospital, Community Health Centres
  • HTEC: Human Research Ethics Committee
  • RGO: Research Governance Officer or Research Governance office (as per context)
  • PICF: Participant Information and Consent Forms

E. Projects requiring full ethics submission

Ethics

Step 1: The following links will take you to the documents required to complete your Full Ethics Submission:

Step 2: Pay submission fee (if applicable):

Step 3: Submit hard copy of the NEAF submission (original plus 24 copies) to the Research Office for review.

  

Governance

 Step 1: The Principal Investigator at the site compiles the Site Specific Assessment or Access Request submission by referring to the following guides and checklists:

 Step 2: Pay submission fee (if applicable):

Step 3: Submit the hard copy of the Site Specific Assessment (SSA) submission to the Research Office for review. 

F. Low and Negligible Risk submission: requires online LNR and LNR SSA

Ethics

NSW Health HRECs now provide an expedited review process for certain research projects that are considered to be low or negligible risk (LNR) to participants. Guidelines are available to assist researchers with their LNR submissions. If this does not answer all of your questions please check the guidelines for a full ethics submission or contact the Research Office.

Step 1: The following links will take you to the documents required to complete your LNR Submission:

Step 2: Submit the hard copy (original plus seven copies) of your application to the Research Office.

  

Governance

Step 1: The Principal Investigator at the site compiles the Site Specific Assessment or Access Request submission by referring to the following guides and checklists:

Step 2: Submit the original signed hard copy of the LNR Site Specific Assessment (LNR SSA) submission to the Research Office for review.

 

G. Access Request Review

General

A research project that requires support from an entity within WSLHD (eg. participant recruitment with no consent, distribution of surveys and questionnaires, access to data) can submit an access request form for authorisation for the activity.

  

Governance

These submissions may also be part of the ethics review process (Part E and Part F) when submitted to the WSLHD HREC, or separately when the ethics review is through another lead HREC.

Step 1: The Principal Investigator at the site compiles the Access Request Review submission by referring to the following guides and checklists:

Step 2: The application is submitted in hard copy to the Research Office.

Step 3: Applications will be assessed and the review will be emailed to the Principal Investigator and the contact person, detailing the review with the study Access Request Reference Number.

H. Final acceptance

Ethics

  • WSLHD HREC Project Reviews: a letter will be sent to the Principal Investigator and the WSLHD Research Governance Office stating that ethical approval for the project has been granted.
  • Non-WSLHD HREC Project Reviews: the Principal Investigator is required to send a copy of the letter of acceptance from the reviewing HREC to the WSLHD Research Governance Office with their application to run the project at WSLHD facilities.
  • For Multicentre Project Reviews: After the lead Principle Investigator has been informed of the HREC approval, site Principle Investigators are required to notify the appropriate site/facility Research Governance Office of the approval. Research Governance application/s may be required if those were not previously submitted.
  

Governance

  • Once all queries and documents have been received and reviewed, the study will be taken to the Chief Executive (or delegate) for approval or otherwise.
  • Research projects must not commence at any Public Health Organisation site until the Principal Investigator has received written notification of authorisation from the RGO of the Chief Executive/designee approval.