Ethics processes

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The Women's Research Committee functions as an advisory committee to the Human Research Ethics Committee.

All research projects involving humans must receive approval by the Research Committee before they progress to the Human Research Ethics Committee, for its consideration and approval. 

All applications to the Royal Women's Hospital Research Committee and the Royal Women's Hospital Human Research Ethics Committee must be submitted via the Ethical Review Manager (ERM) platform.

About the Royal Women's Hospital Human Research Ethics Committee

The Human Research Ethics Committee (HREC) operates in accordance with:

All applications to the Women's Research Committee and the Women's Human Research Ethics Committee must be submitted via the Ethical Review Manager (ERM) platform.

Note: 

The Women’s HREC is not an NHMRC certified HREC for multi-site human research under the National Mutual Acceptance (NMA) Scheme.

There are 7 NHMRC certified HRECs in Victoria. These HRECs are based at Melbourne Health, Peter MacCallum Cancer Centre, The Royal Children’s Hospital, Alfred Health, St Vincent’s Hospital, Austin Health & Monash Health

More details of the NMA Scheme are available at: Clinical Trials and Research.

Steps to submit a Women's single site ethics application for review

 

Step 1: Create a project in ERM

All applications to the Human Research Ethics Committee must be submitted via the Ethical Review Manager platform.

Useful advice on how to create, submit and manage your ethics and research governance applications in ERM can be found at: Clinical trials and research: EMR

Form:

Create and complete the following form and sub-forms:

  • Human research and ethics application (HREA)

Once this form is initiated, the project will be assigned a 5 or 6-digit ERM (ethical review manager) identifier.

Subform:

  • Victorian Specific Module (VSM)
Step 2: EPIC Electronic Medical Record

All new projects proposed for the Women’s site must complete the REDCap survey for the project study in EPIC-EMR: EPIC Pre-Submission Survey via REDCap

You will require your 5 or 6-digit ERM number to complete the survey. This number is generated by the ERM submission system - for example:

  • HREC/XXXXX/RWHV
  • SSA/XXXXX/RWHV
  • LARF/XXXXX/RWHV

As part of your ethics submission in ERM, you are required to include the email you received from the EMR EPIC Research Team as confirmation that the REDCap survey has been completed for your project.

Clinical Informatics Assessment

All new projects must submit a clinical informatics assessment to assess the feasibility of obtaining data from EPIC-EMR.

As part of your ethics submission, you are required to include an acknowledgment email from the Clinical Informatics Analyst Research (email: Haustine.Panganiban@thewomens.org.au). 

Step 3: Scientific peer review

All projects must undergo Scientific Peer Review, prior to submission to the Women's Research Committee. 

Scientific Peer Review can be undertaken by either the relevant Departmental Research Advisory Group (DRAG) or a member of the Scientific Review Panel. 

It is the responsibility of the researchers to submit their project to either the DRAG or a member of the Scientific Review Panel (who should not be a named investigator on the project) for review.

Adequate time should be allowed for peer review so that the project is submitted well before the normal Application Closing Date to the Research Committee.

Next steps following Scientific Peer Review

Researchers should update their application following Scientific Peer Review, prior to submitting it in the Ethical Review Manager (ERM) platform, for progression to the Research Committee.

Documentation required:

  • project submission
  • peer review proforma – completed by the reviewer
  • clinical informatics assessment – completed by Research Informatics Analyst (email Haustine Panganiban).

For information on additional documents you may need to include, Refer to Step 6 below.

Step 4: Research Committee Review (via ERM)

All applications to the Research Committee must be submitted via the Ethical Review Manager (ERM) platform.

Applications must include:

  • Cover letter with background, aims, hypothesis
  • The Study Protocol
  • REDCap confirmation of completion email (Subject: Epic EMR Study Registration Survey, Study: RWHXXXXX)
  • Clinical informatics assessment
  • Scientific Peer Review Proforma  
  • The Participant Information and Consent Form (PICF)
  • The Human Research Ethics Application (HREA) signed by the Principal Investigator (PI), Associate Investigators (AIs) and relevant Head of Department (HoD)
  • A completed Victorian Specific Module (VSM) signed by Principal Investigator (PI)
  • All investigators must provide:

Guidance: How to upload documents in ERM (PDF) 

The Women’s Research Office

The Research Office will:

  • assign the project for review
  • facilitate Committee queries via ERM.
Responding to Committee queries

The Principal Investigator will be advised of the outcome of the Committee's review and any further queries or requirements. 

To respond:

  • Please provide a response to each point raised by the Committee in a letter to the Research Committee via email  Research.Ethics@thewomens.org.au
  • If document revision is required, please upload any revised project documents in tracked and clean format (including versions and dates) to ERM.
  • A delay in your response will delay progression to the Human Research Ethics Committee (HREC).
Step 5: Human Research Ethics Committee Review (via ERM)

The project progresses to the Human Research Ethics Committee, on the recommendation of the Research Committee, once the Reseach Committee's queries have been addressed and uploaded in ERM.

The Research Office will be in contact if any actions are required.

Responding to Human Research Ethics Committee queries 

The Principal Investigator will be advised of the outcome of the Committee's review, and any further queries or requirements. 

To respond:

Please provide a response to each point raised by the HREC Committee in a letter to the Committee, sent via email to: Research.Ethics@thewomens.org.au

If document revision is required, please upload any revised project documents in tracked and clean format (including versions and dates) to ERM.

A delay in your response will delay ethics approval.

Step 6: Additional documents
1. Guidance on ethics applications and ethics checklist

Additional information can be found on the Victorian Government Clinical Trials and Research website:

Clinical Trials and Research: GUIDANCE 

Clinical Trials and Research: DOWNLOADS

2. Patient Information and Consent Forms (PICF)

Complete a Patient Information and Consent Form (PICF) if the study involves participants from who you are obtaining consent. Different templates are available on the Department of Health website.

Use the template(s) that are appropriate for the type of research you are conducting.

Clinical Trials and Research: DOWNLOADS

Contact details for the Patient Infomation and Consent Form

Include the following details in the PICF when the Women's Human Research Ethics Committee is reviewing:

Example below:

Further information and who to contact

The person you may need to contact will depend on the nature of your query. If you require further information concerning this project or if you have any medical problems which may be related to your involvement in the project (for example, any side effects), you can contact the principal study doctor on 8345 2000 or any of the following people:

Clinical contact person

Name:

 

Position:

 

Telephone:

 

Email:

 

For matters relating to research being conducted at the Women’s, the details of the local site complaints person are:

Complaints contact person

Name:

Consumer Liaison

Position

The Women’s Consumer Liaison Team

Telephone

8345 2290

Email

Consumer.liaison@thewomens.org.au

If you have any complaints about any aspect of the project, the way it is being conducted or any questions about being a research participant, then you may contact:

Local Human Research Ethics Committee - Office contact (Research Governance Officer)

Name:

Research Office

Position:

Women’s Research Governance Officer

Telephone:

8345 3716

Email:

Research.office@thewomens.org.au

Participation is voluntary. If you do not wish to take part you don’t have to. If you decide to take part and later change your mind, you are able to withdraw at any stage.

3. Other participant-facing documents

Depending on the study, the other documents for submission in ERM may include:

  • letters of invitation
  • transcripts for telephone contact
  • wallet cards
  • participant diaries
  • questionnaires/self-assessment tools
  • advertising materials
  • radio scripts
  • social media text/scripts.
4. Document control

The purpose of using document control is to achieve a consistent approach for maintaining the history of trial documents using the footer content.

Before submission, please check the names of the files. They must be labelled to reflect the document and the study title (including version numbers and dates).

  • The document file name/title is to remain the same throughout the study. The only changes to the document file name should be to the version number and date. To change the title of an approved document an amendment must be submitted to the Human Research Ethics Committee (HREC).
  • Do not delete any previous versions of documents. These must remain as a reference for document control and auditing purposes.
  • Site-specific versions of documents should always be created from the approved Master, and not copied from the last site-specific version to avoid missing major updates to the Master.
  • Please ensure all submitted documents include page numbering (preferably in the format page x of y or x/y) and the following identifiers, as outlined below. There may be variations in the order of wording; however, the minimum requirements are a title, version and date. Examples include:

Protocol: a file name for a Protocol should include:

  • protocol number - (ABC)
  • version number - (V2.0)
  • version date - (17Nov2023)
  • preferred file name:
    • ABC_Protocol_V2.0 _ 17Nov2023

Patient Information and Consent Forms (PICFs): File names for PICFs should include:

  • protocol number - (ABC)
  • type of PICF - (e.g. Master Main, the Women's site-specific)
  • version number – (V1.0)
  • version date – (17Nov2023)
  • preferred file name:
    • multi-Centre: ABC_Master Main PICF V1.0_17Nov2023
    • single Centre: ABC_RWH_Main PICF V1.0_17Nov2023

If you have queries, contact the Research Office: Research.Ethics@thewomens.org.au

5. The Women’s Privacy Brochure

A copy of the Women's Privacy Brochure must be provided to all research participants following their consent to participate in research.

The Women's Privacy Brochure is available at: Your Privacy. Hard copies are also available at the Women's Welcome Centre. 

More information

Meeting dates and deadlines - Research Committee and Human Research Ethics Committee
The Women's Research Committee

Application closing dates

  • Wednesday 3 January 2024
  • Wednesday 6 March 2024
  • Wednesday 1 May 2024
  • Wednesday 3 July 2024
  • Wednesday 4 September 2024
  • Wednesday 30 October 2024

Submissions will be accepted up to 5pm on the closing day. Applications received after this time will be deferred until the next meeting of the Research Committee.

Meeting dates

All meetings will be held at 2pm.

  • Tuesday 16 January 2024
  • Tuesday 19 March 2024
  • Tuesday 21 May 2024
  • Tuesday 16 July 2024
  • Tuesday 17 September 2024
  • Tuesday 12 November 2024
The Women's Human Research Ethics Committee

Meeting dates

All meetings will be held at 4:30pm.

  • Wednesday 21 February 2024
  • Wednesday 17 April 2024
  • Wednesday 19 June 2024
  • Wednesday 21 August 2024
  • Wednesday 16 October 2024
  • Wednesday 11 December 2024
Submitting for Quality Assurance

All Quality Assurance applications must be submitted via the Ethical Review Manager (ERM) platform. 

Paper copies will not be accepted.

1. QA (Quality Assurance) VIC Form

The Women’s endorses quality assurance activity that complies with the:

1.1 Complete the Quality Assurance (QA VIC Form) for submission of these research applications in ERM:

  • Negligible risk
  • Clinical Audit
  • Quality Assurance
  • Evaluation Activities

1.2 Upload the following documents:

Research proposal/description of the project including:

  • Project title
  • Investigators
  • QA questions
  • The aims
  • methodology
  • sample size/number of records
  • data collection
  • questionnaires
  • outcomes
  • the Curriculum vitaes (CV) of all investigators.

The QA form should be signed by the Principal Investigator (PI) and relevant Head of Department (HoD).

2.  QA and EPIC Electronic Medical Record (EMR)

All new projects that will run at the Women’s site must complete the REDCap survey for the project study build in EPIC-EMR: EPIC Pre-Submission Survey via REDCap

You will require your 5 or 6-digit ERM number to complete the survey. This number is generated by the ERM submission system - for example:

  • HREC/XXXXX/RWHV
  • SSA/XXXXX/RWHV
  • LARF/XXXXX/RWHV
  • QA/XXXXX/RWHV

As part of your ethics submission in ERM you are required to include the email you received from the EMR EPIC Research Team as confirmation that the REDCap survey has been completed for your project.

3.  QA and Clinical Informatics Assessment

All new projects must submit a clinical informatics assessment to assess the feasibility of obtaining data from EPIC-EMR.

As part of your ethics submission, you are required to include an acknowledgement email from Haustine Panganiban in Clinical Informatics Analyst Research.

If you have queries, please email Haustine Panganiban.

Membership - the Women's Research Committee

The Women's Research Committee functions as an advisory committee to the ethics committee.

All research projects involving humans and the use of animals must receive approval by the Research Committee before they are progressed to the ethics committee (for consideration and approval.

The members of the Women's Research Committee are.

Associate Professor Martin Healey
Chair  
Head of Gynaecology 2 Clinic, the Women's 

Professor Shaun Brennecke
Deputy Chair
Director, Pregnancy Research Centre, the Women's

Corinne Sklavos
Secretary 

Dr Gerald Murray
Centre for Women's Infectious Diseases, the Women's 

Dr Samuel Phillips 

Dr Genia Rozen
Reproductive Services Consultant and MIVF Fertility Specialist

Huda Ismail / Dr Wirawan Jeong
Deputy Director of Pharmacy, the Women's 

Bill Kalionis  
Research Fellow, Pregnancy Research Centre, the Women's  

Associate Professor Marta Thio
Newborn Research Centre, the Women's

Fiona McLardie-Hore / Rebecca Hyde
Midwifery & Maternity Services Research Unit, the Women's

Sandra Mazzone
Social Worker, the Women's

Associate Professor Ricardo Palma-Dias
Director of Ultrasound and Fetal Medicine Specialist, the Women's

Professor Peter Rogers
Director of Research, the Women's

Terms of Reference - the Women's Research Committee

Please find below the Terms of Reference of the Women's Research Committee:

Reporting relationship

The Royal Women's Hospital Research Committee is a sub-committee of the Royal Women's Hospital Human Ethics Committee.

The Royal Women's Hospital Research Committee reports to the Royal Women's Hospital Human Research Ethics Committee (HREC).

The HREC is responsible and reports directly to the Chief Executive of the Women's. Through the Chief Executive, the Committee reports to the Board of Directors.

Membership

The Royal Women's Hospital Research Committee shall be constituted as follows:

1. The Dunbar Hooper Professor of Obstetrics and Gynaecology (ex-officio)

2. The Chair or Deputy Chair of the Senior Medical Staff of the Royal Women’s Hospital

3. The Clinical Director of Women’s Services (or equivalent)

4. The Director of Women’s Services (or equivalent)

5. Such other persons as may be appointed for their specific expertise, on the recommendation of the Research Committee

6. Other persons may be co-opted for specific purposes, on a one-off basis, as required.

Members, other than ex-officio members and co-opted members, shall be appointed for a period of three (3) years, but be eligible for reappointment.

All the more active researcher groups within the hospital should be represented on the Research Committee. This is to ensure that their views of research relevant to their area are discussed fairly, as well as to facilitate the governance of research on the campus, a responsibility that should be shared by all researchers. The membership should have expertise in broader issues involving research projects, such as cultural or racial diversity or health literacy, for example.

One member shall be appointed as Chair and three members as Deputy Chairs. 

Frequency of meetings

The Committee shall meet not less than six (6) times per year.

Terms of Reference

1. The function of the Committee is to ensure that research undertaken at the Women’s is of high quality and scientific merit.

2. The Committee shall examine all proposals for research to be undertaken at the Women's and evaluate these in terms of scientific merit, feasibility, methodology, statistical validity, potential benefit or risk to patients or the Hospital, financial costs and benefits to the Hospital, effects on the workload of staff of the Hospital and on the Hospital’s normal functioning. This evaluation would be undertaken following written submission in the prescribed format and, where necessary, by personal interview of at least the principal investigator. Where appropriate, investigators will be required to indicate what measures have been taken to protect intellectual property. The Committee may communicate with other relevant bodies, including other research and/or ethics committees, in the interests of facilitating high quality, ethical research.

3. The Committee shall submit to the Royal Women's Hospital Human Research Ethics Committee all projects recommended for approval, together with a summary of the project and a statement of any ethical implications of which the Research Committee might be aware.

4. The Committee shall seek annual reports from investigators of the results of completed projects including publications arising from approved research projects and annual interim reports on ongoing projects.

5. The Committee shall ensure that approved research projects include procedures and protocols for the reporting and consideration of any adverse clinical events arising from the research.

6. The Committee shall appraise scientific aspects of proposed procedures to ensure that they comply with the relevant Code of Conduct and government regulations governing research involving experimental animals, genetically modified organisms, Occupational Health & Safety issues and radiation safety.

7. All deliberations of the Committee shall be in confidence and members shall be required to sign an appropriate Confidentiality Agreement.

8. The Committee will make available to interested parties an annual summary which is to include a listing of the membership of the Committee, the frequency of attendances of the members at meetings of the Committee, the total number of applications considered by the Committee, the outcome of the applications, and the principal reasons most commonly found by the Committee to be responsible for the rejection of applications or a delay in the progression of the applications to the Ethics Committee.

9. The Women's will provide a secretariat to support the activities of the Research Committee including the human and physical resources necessary to produce and appropriately maintain the committee’s documents.

10. All projects must have prior peer-review before submission. A Scientific Review Panel is available to facilitate prior peer review.

Membership - the Women's Human Research and Ethics Committee

The members of the Women's Human Research and Ethics Committee are:

Dr Ben Cebon
Chairperson

A/Prof Alex Polyakov 
Deputy Chairperson

Corinne Sklavos
Secretary

Vanessa Baic
Member (qualified lawyer)

Georgia Brown
Member (broader community) 

Rev Angela Cook
Member (pastoral care)

Anja Ellwood
Member (qualified lawyer)

Kerri Felemonow
Member (knowledge and experience in professional care or treatment of people)

Sam Funnell
Member (qualified lawyer)

Sarah Heynemann
Member (current research experience)

Anusha Hingalagoda
Member (broader community)

Dr Ling Lee
Member (current research experience)

Peter Pick
Member (broader community)

Terms of Reference - the Women's Human Research and Ethics Committee

Reporting relationship

The Royal Women's Hospital Human Research Ethics Committee is responsible and reports directly to the Chief Executive Officer of the Hospital.

Through the Chief Executive Officer, the Committee reports to the Board of Directors.

Membership

The Committee shall consist of members to be appointed by the Hospital / Board.

The minimum membership shall also be in accordance with the requirements proclaimed from time to time by the National Health and Medical Research Council (NHMRC).

1. One member shall be appointed as Chairman

2. One member shall be appointed as Deputy Chairman

3. At least one member shall be a member of the Board if so required

4. At least six (6) members shall be independent of the Hospital*

5. Such other persons as the Board considers appropriate

Each member of the Committee shall be appointed for a period of twelve (12) months but be eligible for reappointment except that no member shall serve for more than six (6) years except in circumstances considered by the Board to be special.

*In accordance with NHMRC National Statement on Ethical Conduct in Human Research (2007), the minimum membership of a Human Research Ethics Committee is eight members comprising

  • a chairperson
  • a layman 
  • a laywoman
  • a person with knowledge of, and current experience in, the professional care, counselling or treatment of people
  • a person who performs a pastoral care role in a community
  • a lawyer, and
  • two persons with current research experience that is relevant to research proposals to be considered at the meetings they attend.

Quorum

The quorum for a meeting of the Committee is:

  • where there is an odd number of members, a majority of members
  • where there is an even number of members, the half of the number of members plus one.

Frequency of meetings

The Committee shall meet not less than four (4) times per year.

Terms of Reference

1. It is the purpose of the Committee to review on the basis of ethical principles the research undertaken by The Royal Women’s Hospital. Its deliberations should take into account the fact that the Hospital has a commitment to develop and assess new methods of treatment and to contribute to medical research and education for the benefit of the community.

2. The Committee shall consider and advise the Hospital / Board on the ethical suitability of all projects approved by the Royal Women's Hospital Research Committee and on any other matters of ethics relating to research referred by the Hospital / Board or raised by the Committee itself.

3. The Committee shall consider and advise the Hospital / Board on the development of guidelines and policies relating to the ethical aspects of research at The Royal Women’s Hospital.

4. The Committee shall:

a. Conform to the NHMRC National Statement on Ethical Conduct in Research Involving Humans and other guidelines on research and particular fields that may be published from time to time.

b. Take account of local cultural and social attitudes in making decisions.

c. Ensure that procedures relating to obtaining consent are observed.

d. Ensure that no members of the Committee adjudicated on proposals in which they may be personally involved.

e. Ensure that while accepting that doctors, nurses and other allied health professionals have a duty to advance knowledge by research, the rights of individual patients, or subjects of research, take precedence over the expected benefits to human knowledge or to the community.

5. The Committee shall:

a. Provide for surveillance of research projects until completion so that the Committee may be satisfied that they continue to conform with approved ethical standards

b. Maintain a record of all proposed research projects, so that the following items of information are readily available:

i. Project identification number

ii. Principal Investigator(s)

iii. Title of Project

iv. Ethical approval or non-approval, with date

v. Date(s) designated for review vi. Where the principal investigator is not a member of the Hospital staff, the name of the institution where they will be carrying out research should be recorded.

vii. Protocols of research proposals shall be preserved in the form in which they are approved.

c. Establish and maintain communication with the NHMRC’s Australian Health Ethics Committee and provide access, upon request, to information in the Ethics Committee’s records.

6. The Committee shall consider non-research matters (other than matters of clinical ethics)which require consideration by a formally constituted Human Research Ethics Committee, e.g. as specified by the Therapeutic Goods Administration.  

7. The Committee shall receive reports from the Women's Research Governance Office in relation to:

a. multicentre research involving clinical trials to be conducted at the Royal Women's Hospital, and

b. the national HoMER (Harmonisation of Multi-Centre Review) scheme.

8. Where appropriate, the Committee will consider and advise on any ethical implications relating to commercial revenue-raising activities being considered by the Hospital.