Ethics processes

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). 

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.

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)
  • Signature requests and submission in ERM: DOWNLOAD
• A completed Victorian Specific Module (VSM) signed by Principal Investigator (PI)
• All investigators must provide:
  • Certification of Good Clinical Practice training
  • Curriculum vitaes (CVs)
  • Evidence of relevant professional registrations

Guidance: How to upload documents in ERM 

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).

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.

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:

• National Statement on Ethical Conduct in Human Research and the
• National Health and Medical Research Council requirements for Ethical Considerations in Quality Assurance and Evaluation Activities.

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.

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.

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

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.

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)