Human Research Ethics Committee

The Human Research Ethics Committee operates in accordance with the National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research and other relevant federal and state legislation and regulations.

All applications to The Royal Women's Hospital Research Committee, The Royal Women's Hospital Human Research Ethics Committee and The Royal Women's Hospital Animal Ethics Committee are to be submitted using the prescribed forms as explained below.

For further advice, please contact the Research and Ethics Secretariat.

Research proposal applications

Investigators should refer to the information included in the Instructions and Guidelines document below in order to satisfactorily complete and submit an application for ethics approval.

Also see the National Health and Medical Research Council document 'When does Quality Assurance in Health Care Require Independent Ethical Review?' Quality Assurance (QA) / Audit vs Research

Research applications are to be submitted using the following forms and enclosing all relevant information.

1. Proforma from the Scientific Review Panel or Departmental Research Advisory Group (DRAG) - Pre-Submission Peer Review Proforma 

2. Forms accessed via the Victoria Government Department of Health Homepage:

   • Human Research Ethics Application (HREA) 
   • Victoria Specific Module & Participant Information and Consent Form
3. Research Protocol Instructions
4. Research Protocol Cover Sheet (Departmental Approval Form), together with a detailed research protocol including all relevant information / forms as required
5. Research Application Checklist

​Please also check information on this website 'Conducting Clinical Trials'.

Victorian Government Department of Health Information

All other necessary forms are available at the Victoria Government Department of Health website, including:

• Renewal & Amendment applications
• Progress & Final Reports
• Adverse Event (AE) & Serious Adverse Event (SAE) Reports
• Protocol Deviation & Violation Reports
• Complaints Reports

Additional information

The NHMRC has a range of Guidelines and tools for specific research including:

• assisted reproductive technology
• clinical ethics
• embryo research, stem cells and human cloning\
• organ and tissue donation and transplantatio
• privacy
• research involving Aboriginal and Torres Strait Islander peoples
• quality assurance activities.

Please visit the NHMRC website for guidelines specific to your research: Ethical issues and resources

Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities

Research at the Women’s involving Aboriginal and Torres Strait Islander peoples, adheres to the principles outlined in the National Health and Medical Research Council publication: Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders

Encouraging the recruitment of participants whose primary language is other than English (LOTE)

Persons whose primary language is other than English (LOTE) are frequently excluded from participation in primary research. Lack of resources to provide for the use of interpreters and to translate research documents and tools are the main reasons given by Researchers for these exclusions.

An important principle of ethical conduct in human research is that of justice, which requires equity in recruitment and access to benefits as well as a fair burden of participation. A large proportion of RWH patients come from a LOTE background and the Human Research Ethics Committee (HREC) strongly encourages Researchers to include such participants whenever possible.

The HREC is cognisant of the limited resources available for research and the lack of funding for support of LOTE participants.  However, Researchers are urged to be proactive in including these participants. The HREC regards inclusion of persons from a LOTE background as particularly important in areas of research in which there is possible correlation between research outcomes and the ethnic or socioeconomic status of participants. For such projects the HREC will be strongly influenced by considerations of equity of access when making decisions regarding approval of research.

Expedited review

The Royal Women's Hospital Human Research Ethics Committee may undertake expedited review of research.

In so doing, the review of such research may depart from the normal review process, that is, review firstly by the Royal Women's Hospital Research Committee and if found satisfactory, progressed to the Royal Women's Hospital Human Research Ethics Committee for consideration.

For more information download the Expedited review guidelines below.

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