Ethical Review of Research
In Australia, Human Research Ethics Committees (HRECs) review research proposals. To conduct research at an Adventist Healthcare facility, you can submit your research proposal to our AHCL HREC. Should you have already obtained ethical approval through an Australian HREC, you can skip this step and move on to the application for Research Governance review.
AHCL HREC meeting dates
The full-board HREC reviews 'greater than low risk' projects and Waivers of Consent, as well as endorses Authorised Prescriber applications. It meets seven times per year.
2024 Meeting Dates:
| Meeting Date | Submission Closing Date |
|
February 7 |
January 10 |
The AHCL HREC sub-committee meets at the call of the chairperson and reviews 'low-negligible risk' projects, case studies, project amendments, progress reports and exemptions from ethical review.
All submissions to the AHCL HREC need to be emailed to research@sah.org.au by the submission closing date for full-board meetings, and are accepted at any time for sub-committee review.
How to apply for ethical review of a lower or higher risk study
How to apply to be exempt from ethical review
Download Protocol Outline - Exemption from Ethical Review
Retrospective studies and applying for a 'Waiver of Consent'
Resources, forms & templates
AHCL Resources & Templates
- AHCL Research Policy
- Participant Information & Consent Form PICF Template
- Amendment Application Form
- Annual Progress / Final Report
- AHCL Protocol Template – Observational or Experimental Design (not sponsored clinical trial)
- AHCL Protocol Template – Sponsored Clinical Trial Design
Safety Reporting
- Serious Breach Report Form (Sponsor)
- Suspected Breach Report Form (Institution-Individual)
- Significant Safety Issue Report Form
NHMRC Guidelines & Guides
Australian Code for the Responsible Conduct of Research, 2018
The 2018 Code is a principles-based document that articulates the broad principles and responsibilities that underpin the conduct of Australian research. Adherence to the 2018 Code is a requirement for conducting research at and with AHCL. The co-authors have released a number of downloadable guides that we highly recommend you read via the link below.
- NHMRC National Statement on ethical conduct in human research
- Australian Code for the Responsible Conduct of Research - Guidance documents
External Resources
- Australian Privacy Principle 6 — use or disclosure of personal information
- Health Privacy Principles
- Guidelines under Section 95A of the Privacy Act 1988 (Waiver of Consent)
- Privacy Act 1988
Fees for research review
Fees are payable upon receipt of an Application for Ethical Review, an amendment to an approved research project and/or a Site Specific Assessment Form. Fees are non-refundable, even if a submission is unsuccessful or is withdrawn prior to consideration or determination.
ACHL Research Ethics & Governance Fee Schedule
|
Research type |
Ethics fees |
Governance fees |
Amendment fees |
| Investigator initiated1 | Nil | Nil | Nil |
|
Cooperative / collaborative group2 without commercial sponsorship |
Low/negligible risk:3 Greater than low risk:4 |
$500.00 |
Standard: $150.00 Complex: $450.00 |
|
Commercially sponsored5 (includes pharmaceutical and collaborative / cooperative group) |
$3,000.00 |
$3,600.00 |
Standard: $500.00 Complex: $1,700.00 |
AHCL ethics and governance fees are charged per submission of documents to the Research Office for review. For a definition of amendment types, please refer to Section 3 of the AHCL RESEARCH ETHICS AND GOVERNANCE FEES policy available to download below.
1. Investigator initiated research has the following characteristics:
- The principal investigator is accredited or employed by Adventist HealthCare Limited (AHCL)
- The principal investigator is the primary author or custodian of the study protocol
- If the principal investigator is affiliated with ANU then there must be a co-investigator on the project accredited or employed by AHCL
2. Cooperative/Collaborative group without commercial sponsorship has the following characteristics:
- The co-operative group must be the primary author and custodian of the research protocol
- The sponsor is a research institute, university or collaborative group
- The research addresses clinical questions and not industry or commercial interests
- The cooperative group must declare the nature of any sponsorship from a pharmaceutical entity or other entity that may directly benefit commercially from the research outcomes
- The research project must have a PI accredited or employed by AHCL
3. Low/negligible risk research projects fall within the definition contained within the National Statement:
- Negligible risk projects: no foreseeable risk of harm or discomfort and no more than inconvenience to participants
- Low risk: where the foreseeable risk is one of discomfort
4. Greater than no risk research projects fall within the definition contained within the National Statement:
- Where the risk even if unlikely is more serious than discomfort, the research is not low risk.
5. Commercially sponsored research has the following characteristics:
- The research is initiated by a pharmaceutical/device company or a cooperative collaborative group with commercial funding
- The research is conducted to investigator a medication/device for commercial exploitation by its manufacturer/sponsor
- The study protocol has been developed and is the responsibility of a pharmaceutical/device company of other commercial entity