Ethics applications are prepared and submitted through our Research, Ethics and Governance portal (REGGS)
See our REGGS page for details and Helpful Resources.
In order to complete a Human Research Ethics Application (HREA) in REGGS, you must first complete the Project Registration form. For more information on how to submit applications in REGGS, please see our REGGS How-To guides or view one of our training webinars.
You must complete your HREA in REGGS in order to apply to a Ramsay HREC. Applications completed on the NHMRC HREA page will not be transferred to our HRECs and will not be accepted by Ramsay HRECs.
Ethical approval is granted when the Committee is satisfied that the conduct of the proposed research is ethical and lawful.
Supporting Documents
The following information will also be required to be submitted in conjunction with your application:
- All research studies, including Low and Negligible Risk (LNR) studies, require a protocol. It is also advisable that all clinical audits should have a formal written project plan.
- A copy of your study protocol or project summary is required to be uploaded when completing your “Project Registration” form.
- If a researcher is a student, we require confirmation from the educational institution in question that students are both adequately experienced and qualified or will be supervised.
| Document Type |
De-Identified data |
Low risk |
Greater than low risk |
Clinical Trials |
| Human Research Ethics Application (HREA) |
X |
X |
X |
X |
| Research Protocol/Project Description |
X |
X |
X |
X |
| Participant Information and Consent Forms |
X |
X |
X |
X |
|
Note this may also include Telephone script if Consent over phone or E-Consent (including all information available on electronic devices – screenshots or other)
Not required if Waiver of Consent sought; Withdrawal Form if Opt-out Consent sought
|
|
Data Collection Tools
(eg data forms, questionnaires, surveys, interview questions, psychological scales or inventories; PREMS, PROMS etc ) |
|
X |
X |
X |
| Study advertisements and other recruitment materials (eg fliers, Letter of Invitation/ Letter to GP) |
|
X |
X |
X |
| Data Management Plan (may complete separate plan or incorporate into protocol) |
|
|
X |
X |
| Radiation Frequency Declaration Form or Radiation Safety Report (as applicable) |
|
|
X |
X |
| Investigator Brochure (IB) or Product/Procedure Information
Or
ARTG Certificate for study drugs and/or devices |
|
|
X |
X |
| HREC Only Indemnity (commercially sponsored clinical trials) |
|
|
|
X |
| Abbreviated CV for each researcher |
|
X |
X |
X |
GCP certificate
|
|
|
|
X |
Approval letter from Lead HRECs (if applicable)
|
|
X |
X |
X |
Evidence of Peer or Scientific review and support for Research
|
|
|
X |
X |
Refer to our Helpful Resources section to download templates and user guides.