Research and Ethics Office

Low Risk HREA

ETHICS SUBMISSION REQUIREMENTS FOR STUDIES TO BE REVIEWED BY THE SWSLHD HUMAN RESEARCH ETHICS COMMITTEE
- DECISION AID
- REGISTER YOUR APPLICATION
- HINTS FOR ETH SUBMISSION
- HINTS FOR PROTOCOL
- TEMPLATES

SWSLHD Ethics Requirements

You can make an appointment to discuss your application by phoning the Research Directorate on 02 8738 8304 or email SWSLHD-Ethics@health.nsw.gov.au

Ethics submission requirements for studies to be reviewed by the SWSLHD Human Research Ethics Committee

Have you completed a decision aid?

Before submitting a new application to the Research and Ethics Office, and if you are not sure what level of risk your project is i.e. whether you should complete a Low Risk HREA or a Greater than Low Risk HREA. We initially recommend that you complete a Decision Aid. The Decision Aid will determine the level of risk the project is and which application you should complete.

NOTE: The National Statement (document that governs the Ethical principles in Australia and is used by the Ethics Committee in reviewing applications) has been updated in 2018. Further information in relation to the update can be found at https://nhmrc.gov.au/research-policy/ethics/national-statement-ethical-conduct-human-research.

Please note a Site Specific Application (STE application in REGIS), is required for all sites involved in the research in SWSLHD when you apply for either a ‘low risk ethics application’ or ‘greater than low risk ethics application’.

Decision Aid

  • Complete the Decision Aid form 
  • Email the Decision Aid to SWSLHD-Ethics@health.nsw.gov.au with subject line: Decision Aid Review.
  • The Research Directorate will email you back with a decision regarding what risk review pathway you should complete in REGIS.

Register your application in REGIS:

https://regis.health.nsw.gov.au/

Hints for ETH submission in REGIS

  • The Coordinating Principal Investigator (CPI) will be able to give application access to team members to draft the HREA and SSA forms.
    NOTE: The CPI and Principal Investigator (PI) must submit the final applications in replacement of physical signatures in REGIS.
  • The PI must submit the SSA on behalf of the Research Team in REGIS.
  • All NSW/ACT sites where the research will be conducted are required to be listed in the Project Registration. If the sites are not selected at the time of registration, the SSA will not generate and the sites will no be added until ethics approval, via an amendment submission.
  • HREA Hints: Q1.9.10 MUST be the CPI and Q1.9.11 MUST have YES selected.
  • Please ensure a Protocol based on the SWSLHD template:Protocol Template is uploaded with the ETH application in REGIS.
    NOTE: Applications will not be considered without a Protocol. 

Hints for protocol:

Please use the National Statement on Ethical Conduct in Human Research (2007) - Updated 2018 for ethical guidance when writing the protocol.

Please ensure the following sections are described in the protocol:

  • Background, Aims, Plan of investigation
  • Descriptive study design
  • Data Sources and Population
  • Recruitment and Screening
  • Inclusion/Exclusion Criteria
  • Sample Size
  • Data analysis
  • Consent Process/Justification for a waiver of consent
  • Study procedures
  • Ethical considerations: risks, benefits, confidentiality and privacy, data storage, safety.
  • Research Outcomes
  • Please upload all other relevant study documents with the ETH application in REGIS. e.g. MASTER Participant Information Sheet, MASTER Consent Form, Investigator Brochure, Questionnaire, Data Collection Form, Flyer, Brochure, Telephone Script, Patient ID Card, Email Invitation Template, etc.
    NOTE: All master documents must have a version number and date in the footer on each page. E.g. “Protocol, Version 1.0, 11.10.2019.
  • We recommend that you use our as this will reduce the chance of missing any important information that is required for Ethics Approval. Please click here to download the PIS and CF Templates.
     

 

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Last Updated: 13 February, 2020
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