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Greater than Low Risk Application Form - HREA
According to the National Statement on Ethical Conduct in Human Research 2023, Chapter 2.1,
"Risk in research exists on a continuum with the risk profile of an individual research project falling somewhere along this continuum. In order to determine the proportionate level of review and oversight for each project, the use of risk categories is useful".
Additionally greater than low risk is "Research in which the risk for participants or others is greater than discomfort is not low risk research. Research in this category is considered higher risk research and carries risk of harm. Higher risk research requires review by an HREC"
DECISION AID
SUBMISSION CLOSING DATES
REGISTER YOUR APPLICATION
HINTS FOR ETH SUBMISSION
HINTS FOR PROTOCOL
TEMPLATES
ETHICS SUBMISSION REQUIREMENTS FOR CLINICAL TRIALS
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.
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’.
- 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.
If your application is a ‘Greater than low risk’ application please see submission closing dates: Please click here for submission closing dates.
https://regis.health.nsw.gov.au/
- 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.
- Please see our Specialist Ethics Approvals page for details on specialised ethics applications and their requirements.
OHMR REGIS Videos
Please click here for helpful how to information and video content from eHealth NSW REGIS and the Office for Health and Medical Research's Ethics and Governance Unit.
These videos will support those submitting applications through REGIS.
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 templates 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.
Ethics submission requirements for Clinical Trials
To be reviewed by the SWSLHD Human Research Ethics Committee (in addition to the above requirements).
- Please ensure the HREC Indemnity is uploaded with the ETH application in REGIS or provide 3 x hardcopies to the Research Directorate depending on the sponsor requirements. Hardcopies can be mailed or delivered to: Level 2, Clinical School, Liverpool Hospital.
NOTE: Must be signed by the Sponsor.
Correct Institution Details for CTRAs:
South Western Sydney Local Health District
Administration Building, Eastern Campus, Liverpool Hospital
Locked Bag 7279, Liverpool BC 1871, ABN: 46 738 965 845
- Radiation Safety Officer Report (if applicable to the study)
For NSW/ QLD only – a letter from the PI stating that radiation exposure is part of routine care.
OR
If radiation exposure is additional to that received an independent assessment report by a Medical Physicist. For VIC – complete section 4 of the Victorian Specific Module for each site.
- If the study involves site/s in Victoria, please provide the Victorian Specific Module.
NOTE: All sections completed and section 4 must be completed for each site.
Early Phase Clinical Trial Requirements
As of April 2018, The Office for Health and Medical Research - NSW Health mandated that Early Phase Clinical Trials (EPCTs) must be submitted and reviewed to Sydney Children’s Health Network (SCHN) for paediatric studies or Bellberry Limited for adult studies.
The South Western Sydney Local Health District Human Research Ethics Committee is not able to provide ethics approval for EPCTs. Please click here to view the document.
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