The Women’s is working towards the closure of the Women’s Human Research Ethics Committee (HREC) single site approval in late 2024, due to the increasing need for National Mutual Acceptance (NMA) ethics approvals.
All existing Women’s single site HREC approved projects will be transferred under the umbrella of the Royal Melbourne Hospital HREC by late 2024. Until the transfer, all Women’s approved projects will remain under the Women’s HREC.
Ethics processes
Not accepting new applications
The Women’s HREC is no longer receiving new applications. The last Women’s HREC was held on Wednesday 19 June 2024.
All existing Women’s single site HREC approved projects will stay under the Women’s HREC until the transfer.
All post-approval reporting, minor / administrative amendments, progress and final reports, safety and adverse event reports and serious breaches will continue to be submitted to the Women’s Research Office via the Ethical Review Manager (ERM) platform.
Submission of new ethics applications
There are 7 NHMRC certified National Mutual Acceptance (NMA) Scheme 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 and Monash Health.
All of these committees charge fees related to HREC submissions and amendments for commercially sponsored and non-commercially sponsored / investigator-initiated projects. For more information, please visit the individual HREC websites. Fees are incurred at the cost of the researcher.
The Women’s will accept NMA HREC approved projects that have the Women’s listed as a site.
More details of the NMA Scheme are available at Clinical Trials and Research in Victoria.
Which NMA HREC committee should I submit to?
Researchers can submit their ethics application to any of the NHMRC approved NMA HREC committees.
Note: The Women’s needs to be listed as a site in the approved application.
The Women’s Research Office recommends:
- submission to the Royal Melbourne Hospital (RMH) HREC. We are working closely with the RMH Office for Research, with many processes being aligned between the offices.
- specialised projects should submit to specialised HRECs e.g. newborn research to the Royal Children’s Hospital HREC, cancer research to Peter MacCallum Cancer Centre HREC.
The Women's Human Research Ethics Committee
The Women’s HREC is no longer accepting applications.
The Women’s is working towards the closure of the Women’s Human Research Ethics Committee (HREC) single site approval in late 2024.
The current HREC sub-committee oversees all post-approval reporting, minor/administrative amendments, progress and final reports, safety and adverse event reports and serious breaches.
The members of the Women's HREC sub-committee:
A/Prof Alex Polyakov
Chairperson
Kerri Felemonow
Member (knowledge and experience in professional care or treatment of people)
Corinne Sklavos
Research Office
The Royal Women's Hospital Human Research Ethics Committee (HREC) sub-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.
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.
Date reviewed: 18 September 2024
Date reviewed: 18 September 2024