Three Doctors Masked and in the Operating Theater

Women and Newborn Health Service



King Edward Memorial Hospital for Women (KEMH)

Ethics & Research Governance

Notice to all researchers

This website was changed on 1st August 2013 to accommodate the new ethics/governance application forms and processes that are part of the WA Health Research Governance Framework. Old WNHS research ethics and governance application forms can no longer be submitted.

WHNS Scientific Advisory Sub Committee Terms of Reference

About the WNHS Ethics Committee

The WNHS Ethics Committee operates under the Guidelines of the NHMRC National Statement on Ethical Conduct in Research Involving Humans (2007) and the WA Health Research Governance Framework. The primary function of the Ethics Committee is to advise upon and carry out the ethical review of all research involving the staff, patients or resources of the Women and Newborn Health Service (WNHS), primarily encompassing research conducted at KEMH and affiliated organisations. Research cannot commence without formal approval from the WNHS Ethics Committee.

Assessment of scientific content & quality, clinical implications, and adverse events monitoring are performed by the Scientific Advisory Sub-Committee (SASC), a sub-committee of the WNHS Ethics Committee. The SASC Chair is Professor Jeffrey Keelan (Tel: [08] 9340 1880; email:

The WNHS HREC has particular expertise in the areas of Women’s and Newborn’s Health, including neonatology, obstetrics and gynaecology, and midwifery research.

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WA Health Research Governance Framework

WA Health effectively manages the scientific, ethical and governance review, approval, conduct and monitoring of human research through the implementation of its Research Governance Framework. This is to ensure that human research:

  • is ethically and scientifically sound;
  • is conducted by authorised personnel with appropriate professional qualifications, credentials and institutional approvals;
  • is conducted in a safe and responsible manner according to regulatory and professional standards and complies with relevant national and State legislation, guidelines and codes of conduct;
  • is subject to ethical and governance review and monitoring in a manner that is transparent, accountable, efficient and timely, and minimises duplication and risk; and
  • is authorised by the Chief Executive or delegate before commencement.

The framework's and the procedures and policies governing the approval, governance and conduct of research in WA are outlined in detail in the WA Health Research Governance Policy and Procedures 2012 (Operational Directive 411/12). The policy and procedures apply to human research conducted within WA Health by WA Health employees and non-WA Health employees (including clinical and non-clinical university academics) who propose to undertake, manage, review and govern human research; and/or involving participants, their tissue or data accessed through WA Health.

Research must undergo a) ethical and scientific review and b) research governance review before approval can be given and research commence. The two arms of the review process occur independently, but usually in parallel. For research conducted in and originating from the WNHS, this review is carried out by a) the WNHS HREC and b) the Research Governance Office (RGO).

Note: A Research Governance Service (RGS) IT system is being designed for implementation mid-2014 to allow on-line completion and submission of all application forms, approvals, reports, monitoring and outcome assessment. Processes for accommodating a single-ethical review process for multi-centre studies will be implemented when the RGS IT system is operational.

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Quality Improvement or Research?

Assistance in determining whether your project is "quality improvement" or "research" is available on page 42 (Section 3.1) of the WA Health Research Governance Policy and Procedures 2012.

Projects deemed to be quality improvement or audit should be entered into the QI database via the GEKO website for approval. Advice regarding this process can be obtained from the GEKO website, or from the Performance Review and Audit Coordinator on KEMH extension 1540.

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Contact Details

 Ethics OfficeResearch Governance Office
Name Jayne Jarvis Helen Atkinson
Position Ethics Committee Secretary Research Governance Officer

King Edward Memorial Hospital
O Block
Entrance off Hensman Rd

King Edward Memorial Hospital
O Block
Entrance off Hensman Rd
Postal address

King Edward Memorial Hospital
PO Box 134
Subiaco, Perth,
WA 6904

King Edward Memorial Hospital
PO Box 134
Subiaco, Perth,
WA 6904

Telephone (08) 9340 1667 (08) 9340 1667
Availability Tuesday, Wednesday and Thursday Mornings of Monday, Wednesday, Friday and all day Tuesday
  On other days please leave a telephone message, and we will return your call as soon as possible.

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Meetings and Submission Deadlines

The WNHS Ethics Committee meets on the first Tuesday of the month, February to December (there is no meeting in January).

The WNHS Ethics Committee currently consists of 12 members, together with an Ethics Committee Secretary. The membership conforms to the requirements set out in the NHMRC National Statement on Ethical Conduct in Research Involving Humans and includes 5 members from outside the Health Service. The WNHS HREC can approve WA Health multi-centre studies within its specific area of expertise or site jurisdiction.

Schedule for Dates of Meetings and Deadlines for Submissions for 2016

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Application and Approval Process

Single-centre research

Most research carried out at KEMH/WNHS originates locally and is based on a single site under the authority of the WNHS HREC (i.e. does not fall into the “multi-centre” category). For these projects the principle investigator is the coordinating researcher and will be responsible for submitted both the ethics and governance application forms and subsequent reports. The application and approval process is summarised in a simple flow diagram.

WNHS single centre applications require submission of a

  • WA Health Ethics Application form (or, if preferred, a NEAF plus a WA Module form)
  • WNHS patient information and consent forms
  • WA Health Site-specific assessment form (SSA) *
  • WA Health Research Conflict of Interest form.

*If the research requires access to WA Health patients or personnel (or their tissues/data) but is not being conducted on-site or on the participants directly (e.g. requires access to participants’ tissues or data, or distribution of letters/leaflets), then a WA Health Access Request form should be submitted instead of the SSA form. See section 2.5 of the WA Health Research Governance Policy and Procedures 2012.

A research protocol can be submitted with the application but is not compulsory. Confidentiality agreements may be required under some circumstances. Studies that fall under the category of clinical trials must be lodged on a clinical trials registry (e.g. ACT, ANZCTR) and accompanied by the appropriate TGA forms (CTN or CXN). A Clinical Trial Research Agreement or similar plus other documentation may also be required, depending on the nature of the study and its funder/sponsor. Full details are in section 2 of WA Health Research Governance Policy and Procedures 2012.

The approval process for a local single-centre research proposal is as follows:

  • A completed, signed application is submitted to the HREC Secretary and, provided all the necessary documentation has been included, it is registered;
  • The study is included on the agenda for the Scientific Advisory Sub-Committee (SASC) meeting where the scientific content is reviewed. These meetings are held as per listed schedule;
  • The SASC gives feedback to the investigators as to any amendments required;
  • If approved by the SASC, the study, together with any amendments following SASC recommendations, is included in the next WNHS HREC agenda;
  • If the SASC requires extensive changes to be made the study may have to be resubmitted for further review by SASC before proceeding to the HREC;
  • The study is reviewed at the HREC meeting and is either approved with no changes; approved subject to specific amendments being made; resubmitted to HREC for further review following receipt of requested amendments, or rejected.
  • While ethical review takes place, the Research Governance Office (RGO) reviews all applications to ensure they comply with the RGO Guidelines.
  • The RGO will liaise with the investigators if it receives inadequate or insufficient documentation regarding the proposed study is received.
  • All research governance requirements must be met before the application receives final approval from WNHS Chief Executive for the project to proceed.
  • Upon ratification of the recommendations of the HREC and RGO by the Chief Executive, a formal letter of approval (valid for up to 3 years) is sent to the investigators of approved studies.

Multi-centre studies

WA Health is committed to a single ethical review process for all multi-centre human research conducted in WA. WA Health will, as soon as possible, implement the Western Australian and "National Approach to Single Ethical Review of Multi-Centre Research" and the "National Mutual Acceptance of Ethical and Scientific Review for Multi-Centre Clinical Trials Conducted in Public Health Organisations". These processes will accommodate the scientific and ethical approval of research by a single lead HREC (which may or may not be in WA), while research governance approval will be required from the relevant RGOs at each WA site.

For multi-centre studies (e.g. large national or international clinical trials) the coordinating principle investigator is responsible for organising submission of documents for scientific and ethical review by an appropriate lead HREC. Principle investigators at each site must submit applications for governance review and will be responsible for local approvals and compliance. Multi-centre studies submitted for ethics approval in WA, whether originating from WA or other States, must be submitted on a NEAF and be accompanied by the WA-Specific Module together with the appropriate research governance forms.

Full details are outlined in WA Health Research Governance Policy and Procedures 2012, including details of exceptions and exclusions to the policies outlined above.

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Post Approval Monitoring

  • The principle investigator is required to submit a progress report to the HREC & RGO annually which is reviewed by the SASC and a summary sent to the HREC.
  • All amendments/changes or request for extension of time must be submitted to the HREC for approval.
  • All Adverse Events (AE) and Serious Adverse Events (SAE) must be reported to the Ethics Committee within 24 hours.

The forms to be used to lodge reports are on the WA Health Research Governance website.

This site also contains the forms for notification of amendments, protocol violations and annual progress/final reports.

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Forms for Approval of Research Projects

Most of the required forms are available via the Research Ethics and Governance website. Some WNHS-specific forms are also available via the WNHS Ethics page (below).

Ethics application forms:

  • WA Health Ethics Application form – recommended for single-centre projects
  • NEAF (National Ethics Application Form) – for multi-centre studies
  • Western Australian-Specific Module – for multi-centre studies with NEAF
  • Research protocol templates - optional
  • Amendment and monitoring forms

Note: Applicants are advised to use the WNHS information/consent forms (below) rather than the NHMRC Patient Information Consent Form.

Governance application forms:

  • WA Health Site Specific Assessment Form1 (SSA) – for most WNHS research
  • WA Health Site Specific Assessment Form (SSA) for Low and Negligible Risk Research (not recommended for WNHS-based research)
  • WA Health Access Request Form
  • WA Health Research Conflict of Interest Form (for all investigators)
  • WA Health Declaration of Confidentiality2 (for research personnel and students who are not employees of WA Health)
  • Clinical Trial/Investigation Research Agreements
  • Insurance/indemnity documents (primarily for commercial clinical trials)
  • Confidentiality Agreement (primarily for clinical trials)
  • Governance amendment and monitoring forms

1Section 16.3 of the SSA form requires completion of a Table with resource and budgetary information. An Excel template has been created to help with the completion of this section. The SSA form also contains detailed guidelines.

2The Declaration of Confidentiality is not project specific and is only required to be signed once, then filed to cover all research conducted at KEMH/WNHS.

Additional WNHS Research Ethics and Governance forms

Recruitment Letter (TICHR)

3The PIS has been designed to accommodate most research studies. However, some projects may require additional headings and content depending on the nature of the study and participants. The NHMRC Human Research Ethics Portal has a number of standardised participant information and consent forms from which section headings and text may be used to populate the PIS as required.

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Research Submission Instructions

Applications should be submitted electronically (i.e. scanned where necessary to include signatures) to WNHS Research Ethics and Governance Office, O Block KEMH by email  Hard copies can also be submitted, either by mail or in person. Please note office hours, above.

Please send all electronic documents as separate pdfs (do not bundle documents together). Remove all instructions from the start of the forms prior to converting to pdfs for submission.

Each document should be clearly labelled, in the footer, with the name of the document, the version number and the date of the version. For example:

Ethics Application V1 18Feb2016

Consent Form V1 18Feb2016

Participant Information Form V1 18Feb2016

Protocol V1 18Feb2016

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Submission Fees

Applications by individual researchers for non-sponsored projects or for competitive grant applications will not attract a fee.

Application for projects which are sponsored by commercial agencies (e.g. Pharmaceutical companies or other industry bodies) will attract a submission fee. Fees are payable on submission; further fees may be charged for amendments:

List of application fees
New application fee $5500
Administrative amendments No fee
Minor protocol amendments $640
Major protocol amendments or introduction of a sub-study within an existing approval $2750

Major protocol amendments are substantial amendments that introduce major new aims (i.e. a new primary or secondary objective) or which introduce major new safety considerations and which require extended scientific and/or ethical review.

Industry and non-industry submission of incomplete applications requiring significant additional administrative workload may be subject to additional fees both for sponsored and non sponsored studies.

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Important Publications for Researchers

The following NHMRC publications may be of interest to researchers and are available at the NHMRC website (

  1. Guidelines for Ethical Review of Research Proposals for Human Somatic Cell Gene Therapy and Related Therapies (effective 1 January 2000).
  2. Guidelines for Genetic Registers and Associated Genetic Material (effective from 1 January 2000).
  3. Ethical Guidelines on assisted reproductive technology (1996).
  4. Ethical aspects of qualitative research methods in health research (1995).
  5. Recommendations for limiting exposure to ionizing radiation (1995).
  6. Ethical issues in organ donation (1997) - 4 discussion papers:
    • Paper 1 - Donating organs after death: ethical issues.
    • Paper 2 - Ethical issues in donation of organs or tissues by living donors.
    • Paper 3 - Ethical issues raised by allocation of transplant resources.
    • Paper 4 - Certifying death: the brain function criterion.

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