Ramsay Human Research Ethics Committees (RHC HRECs) review Ethics applications from researchers who are accredited practitioners at Ramsay facilities and Ramsay Health Care staff members. Under the Terms of Reference, the HRECs can review proposed research projects if:

1. it is to be conducted in a Ramsay Hospital by Accredited practitioners or staff, or
2. it will be conducted in co-located Practitioners rooms and is Low or Negligible Risk Research.

All applications for research need to be submitted via REGGS, please see our REGGS page for helpful resources.

Once you have created your REGGS Project Registration Form your HREA application will be available in REGGS for you to complete. A Checklist of required supporting documentation can be downloaded here.

Ramsay Health Care operates two Human Research Ethics Committees constituted and operating in accordance with the requirements of The National Statement on Ethical Conduct in Human Research, 2023 (and its successors). Our Committees have wide representation, encompassing medical practitioners, allied health professionals, experienced researchers, lawyers, clergy and community representatives.

• The Ramsay Health Care WA|SA Human Research Ethics Committee;
• The Ramsay Health Care Human Research Ethics Committee A.

For further information and queries please email the HREC Executive at RamsayHREC.WA-SA@ramsayhealth.com.au or HREC.RHC@ramsayhealth.com.au; or phone (02) 9433 3854.

The Terms of Reference for the RHC HRECs may be downloaded here (hyperlink).

RHC HREC A

Chair: Dr David Carter

Meetings This Committee holds meetings on a monthly basis.

Any applications submitted after the latest submission deadline will not be considered until the next meeting.

Please note meeting dates are subject to change at the discretion of the Chair. Refer to published dates via webpage for the current meeting schedule.

Contact Us:

For further information and queries, please email our Executive Officer at HREC.RHC@ramsayhealth.com.au or phone (02) 9433 3854.

WA/SA

Chair: A/Prof. Beverly Ewens and A/Prof. Rosemary Saunders

Meetings

This Committee holds meetings on a bi-monthly basis.

Any applications submitted after the latest submission deadline will not be considered until the next meeting.

Please note meeting dates are subject to change at the discretion of the Chair. Refer to published dates via webpage for the current meeting schedule.

Contact Us:

For further information and queries, please email our Executive Officer at RamsayHREC.WA-SA@ramsayhealth.com.au or phone (02) 9433 3854.

All Ramsay HRECs charge the following fees for different types of Ethical Review application:

Effective 1 March 2023.

Notes:

1. Initial application review fees are charged upon submission and non-refundable.
2. Annual Ethics Administration fee is charged annually in advance upon approval and thereafter on the anniversary of the Approval Date until the trial is completed.
3. Fees may be waived at the discretion of the National Research Unit.
4. All fees are payable to the Ramsay Hospital Research Foundation (ABN 11 607 036 948).

Ramsay HRECs will consider applications by a Ramsay Accredited Practitioners of a Facility for endorsement for the purpose of becoming an authorised prescriber of an unapproved therapeutic good under the Therapeutic Goods Act 1989 (Cth) at that Facility.

Applications for Authorised Prescriber Scheme endorsement by the Ramsay Health Care HRECs must be made via REGGS. Practitioners are referred to the Therapeutic Goods Administration Guidance for further information on the Authorised Prescriber Scheme.

To download instructions and a checklist of required documentation see our Helpful Resources at the bottom of this page. Please contact the HREC Executive for further information.

Quality Audit (QA) and Quality Improvement studies are activities where the primary purpose is to monitor, evaluate or improve the quality of health care delivered by a health care provider. Such studies are an essential and integral part of health care delivery. The ethical principles of integrity, respect for persons, beneficence and justice apply to all QA activities just as they do in research studies.

It can be difficult to clearly identify whether a proposed study is QA or research. Additionally, some QA activities raise ethical issues which may require review by the full Ethics Committee. For further information about Quality Audit and Improvement activities, please see the NHMRC guidance

QA activities are generally exempt from review by the HREC.

To undertake QA and QI activities at a Ramsay Hospital, please download and complete the RHC Quality Audit Template from the Helpful Resources at the bottom of this page and submit this by email to the RHC WA|SA HREC or RHC HREC A for review.

Please note that you may also require approval from your local Quality Team once you have received confirmation from the HREC that this is a Quality project.

A case report is a comprehensive record of a patient's symptoms, diagnosis, treatment, and post-treatment follow-up. Case reports focus on unique or uncommon occurrences and are considered fundamental in advancing medical knowledge by introducing new ideas and perspectives.

Case reports require consent from the Patient involved prior to publication. When Publishing Case Reports, some Journals may require a letter of exemption from an Ethics Committee. In order to receive an exemption, please submit this by email to the RHC WA|SA HREC or RHC HREC A for review.

You can download a Sample Case Report Form Template from our Helpful Resources section at the bottom of this page.

The National Statement describes low risk research (including some types of clinical trials), as research in which the only foreseeable risk is no greater than discomfort. Where the risk, even if unlikely, is more serious than discomfort, the research is not considered to be low risk. Examples of Lower risk research include:

• Observational studies
• Survey-based studies
• Retrospective reviews
• Data-only research proposals where the project seeks to access data from existing databanks, biobanks, registries etc.

If you are unsure whether or not your study qualifies for LNR ethical review, please contact the Ethics Secretary of your relevant committee.

Please note that a Waiver of consent for research using personal information in medical research or personal health information is considered to be higher risk and requires full HREC review as per The National Statement.

We have helpful resources available at the bottom of this page to download including:

• Protocol Templates
• Participant Information and Consent Form
• A Checklist of required documents to support your application
• Guides for Completing the Ethics Application

Higher risk research describes research in which the risk for participants or others is greater than discomfort and carries risk of harm. Higher risk research requires full ethics review by an HREC.

Higher risk studies can include any Human research, procedures, or activities where a person, organisation, vulnerable population, broader community, or the research team are exposed to physical, psychological, social, economic, legal, or travel harms. These can include:

• Human research procedures or activities where a person may experience distress or devaluation of personal worth.
• Research involving or about Aboriginal or Torres Strait Islander People or their communities.
• Any research activity involving the following:
  • People highly dependent on medical care who may be unable to give consent (National Statement 5.1.6)
  • People with cognitive impairment, an intellectual disability, or a mental illness (National Statement 5.1.6)
  • Research involving active concealment or planned deception.
• Waiver of consent for research using personal information in medical research or personal health information (National Statement 2.3.9-12)
• Prospective collection of humans biospecimens for research (National Statement 3.2.1)
• Genomic research (National Statement 3.3) excluding projects using secondary data which is non-identifiable (anonymous).
• Clinical Trials Involving Investigational Medical Products, Devices, Surgery, Surgical Procedures, or Ionising Radiation use.
• Clinical Interventions

Clinical Trials are a form of higher risk research and are defined as any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Clinical trials include but are not limited to:

• Surgical and medical treatments and procedures
• Experimental drugs and diagnostics
• Biological products
• Medical devices
• Health-related service changes
• Health-related preventative strategies
• Health-related educational interventions

We have helpful resources available at the bottom of this page to download including:

• Protocol Templates
• Participant Information and Consent Form
• RHC Waiver of Consent Form
• A Checklist of required documents to support your application
• Guides for Completing the Ethics Application

The establishment of databases (registries) for clinical and research purposes is the basis of good clinical care and a valuable tool for the investigation of research questions that can lead to improved patient outcomes.

Ramsay recommends the establishment of an Human Research Ethics Committee (HREC) approved Research Database or Registry whenever practitioners would like to utilise patient medical records for research purposes on a regular basis.

Where these databases will also seek to access medical records from Ramsay Facilities, authorisation from the Research Governance Office for the site(s) where the data will be collected will also be required before the activity commences. A Data Transfer Agreement will also be necessary in these instances.

More information about Databases can be found within National Statement on Ethical Conduct in Human Research (see Chapter 3.2) and the Guidelines approved under Section 95A of the Privacy Act.

Helpful resources are also available at the bottom of this page including:

• Database protocol template
• Database PICF template
• Data Management Plan template

Any proposed amendment to your approved Research must be submitted to your Ramsay HREC for approval prior to implementation.

Examples of amendments that would require approval include changes to the:

• procedures outlined in the approved project description or trial protocol.
• recruitment materials or participant information statement and consent form.
• inclusion and/ or exclusion criteria.
• participant groups (addition or removal) , study sites, recruitment locations.
• consent processes.
• recruitment processes including updated advertisements, emails etc
• personnel listed in the ethics application form or Sponsors.

Amendment Forms may be submitted by any team member with the exception of Changes to the Principal Investigator, which must be submitted by the outgoing Principal Investigator.

When submitting amendments, please complete the Notification of an Amendment to a Research Study Form in REGGS and include both clean and tracked copies of all amended documents.

Instructions on how to submit amendments, reports and safety notifications are available from our “REGGS Helpful Resources” page. 

For more information, or if you have any questions, please email the HREC Executive at RamsayHREC.WA-SA@ramsayhealth.com.au or HREC.RHC@ramsayhealth.com.au; or phone (02) 9433 3854

In accordance with NHMRC Guidelines, all Ramsay HRECs require an annual progress report of all approved studies. At the time of study approval, you will be notified of the submission deadline for your next annual report and you will receive a reminder from REGGS.

Instructions on how to submit amendments, reports and safety notifications are available from our “REGGS Helpful Resources” page. 

For more information, or if you have any questions, please email the HREC Executive at RamsayHREC.WA-SA@ramsayhealth.com.au or HREC.RHC@ramsayhealth.com.au; or phone (02) 9433 3854

As per the Ramsay Health Care Safety Event Reporting requirements, all

• Serious Adverse Event (SAE)/Serious Adverse Reaction (SAR)
• Significant Safety Issue (SSI)
• Suspected Unexpected Serious Adverse Reactions (SUSAR)/Unexpected Serious Adverse Device Effects (USADE)
• Urgent Safety Measures (USM)

should be reported to the approving Ramsay HREC via a Reporting Safety Events Form in REGSS. Please ensure that you attach all relevant correspondence with your form submission.

Instructions on how to submit a Safety Report are available from our ““REGGS Helpful resources” section.

For more information, or to obtain a copy of the Ramsay Health Care Safety Event Reporting Requirements, please contact the HREC Executive at RamsayHREC.WA-SA@ramsayhealth.com.au or HREC.RHC@ramsayhealth.com.au; or phone (02) 9433 3854

All breaches of protocol should be reported to the approving Ramsay HREC via REGGS as per the Ramsay Health Care Safety Event Reporting Requirements:

• Protocol deviation is any breach, divergence, or departure from the requirements of Good Clinical Practice or the clinical trial protocol
• Serious breach a breach of Good Clinical Practice or the protocol that is likely to affect to a significant degree:  
  1. The safety or rights of a trial participant, or 
  2. The reliability and robustness of the data generated in the clinical trial. 
• Suspected breach: a report that is judged by the reporter as a possible serious breach but has yet to be formally confirmed as a serious breach by the sponsor.
• Data Breach: any actual or suspected unauthorised access or use, misuse, damage, or destruction of data by any person. It can be any incident in which data is compromised, disclosed, copied, communicated, accessed, removed, destroyed, stolen, lost, or used by unauthorised individuals, whether by accident or intentional.  

Instructions on how to submit Serious Breach are available from our “REGGS Helpful resources” section.

For more information, or to obtain a copy of the Ramsay Health Care Safety Event Reporting Requirements, please contact the HREC Executive at RamsayHREC.WA-SA@ramsayhealth.com.au or HREC.RHC@ramsayhealth.com.au; or phone (02) 9433 3854

Study Participants

If you are a study participant and have any complaints or reservations about any ethical aspect of your participation in a research project, please contact the Executive Officer of the relevant reviewing committee at:

RamsayHREC.WA-SA@ramsayhealth.com.au or

HREC.RHC@ramsayhealth.com.au;

Alternatively, you may phone (02) 9433 3854 for a confidential discussion.

Researchers

If you are a researcher and have any concerns or complaints regarding the management, review, and/or determination of Ethical Review, please contact the National Research Unit at ResearchGovernance@ramsayhealth.com.au or call (02) 9433 3854.

Any complaints will be investigated by an independent party, treated in confidence and you will be informed of the outcome.