Research ethics and governance at KEMH

The review, approval and monitoring of human research at KEMH is governed by WA Health’s Research Governance Framework (external site) in conjunction with national guidelines and international conventions. Research ethics and governance applications are submitted and processed via the Research Governance Service (RGS) (external site) platform. Administration and monitoring of approved research ethics and governance applications is carried out by the WNHS Research Ethics and Governance Office (REGO).

The process of ethical approval and monitoring of research within the Women and Newborn Health Service is detailed in the WNHS Human Research Ethics Standard Operating Procedures (PDF). Ethics applications are reviewed at the HREC meeting and either approved with no changes, approved subject to specific amendments being made, resubmitted to HREC for further review following receipt of requested amendments or not approved. While ethical review takes place, the Research Governance Officer reviews all applications to ensure they comply with WA guidelines and have the appropriate approvals and documentation. The REGO will liaise with the investigators if inadequate or insufficient documentation regarding the proposed study is received. Research must undergo both an ethical and scientific review and research governance review before approval can be given and research commenced. The two arms of the review process occur independently, but usually in parallel.

WA Health Research Governance Framework

WA Health effectively manages the scientific, ethical and governance review, approval, conduct and monitoring of human research in public hospitals through the implementation of its Research Governance Framework (external site). 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.
  • Is authorised by the Chief Executive or delegate (Director of Clinical Services) before commencement.

The framework and the procedures and policies governing the approval, governance and conduct of research in WA are outlined in detail in the Research Governance Policy (MP 0162/21) (external site). 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; that is, research involving participants, their tissue or data accessed through WA Health.

WA Health is committed to a single ethical review process for all multi-centre human research conducted in WA. This process entails the scientific and ethical approval of research by a single lead HREC (which may or may not be in WA). However, research governance approval will be required from the relevant Research Governance Officers at each WA site. Check the Multi-Centre Research Information Page (external site) for more information.

For research conducted in and originating from KEMH, this review is carried out by a) the WNHS HREC and b) the WNHS Research Governance Officer; both processes occur within the Research Ethics and Governance Office (REGO). The application, review and approval process for single-site projects is summarised in this simple flow chart. Link to flow chart in drive.

NOTE: All research governance requirements must be met before the application receives final authorisation by the WNHS Director of Clinical Services for the project to proceed. Upon ratification of the recommendations of the HREC and Research Governance Office by the WNHS Director of Clinical Services, a formal letter of approval will be sent to the investigators of approved studies. Research can then commence.

Research Governance Service (RGS)

The Research Governance Service (RGS) (external site) is the portal through which research ethics and governance applications are submitted, processed, assessed and approved. The RGS supports the framework and single ethical review of multi-centre research, by hosting standard ethics and governance forms and agreements, as well as facilitating the research governance approval and monitoring process of projects.

All researchers and others involved in assessing and approving research ethics and governance applications within WA Health must be registered on RGS to participate in the application review and approval process (see below). Most ethics and governance forms (for both application and monitoring) are built-in to RGS and can only be accessed once a project has been created on RGS.

Ethics

The WNHS Human Research Ethics Committee (HREC) operates under the Guidelines of the NHMRC National Statement on Ethical Conduct in Research Involving Humans (2007) – Updated 2018 (external site) and the WA Health Research Governance Framework (external site) and in accordance with the WNHS HREC Terms of Reference (PDF). 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) conducted at KEMH and affiliated organisations.

Assessment of scientific content and quality, clinical rationale and safety, and adverse events monitoring are performed by the Scientific Advisory Sub-Committee (SASC), a sub-committee of the WNHS HREC. The WNHS HREC has recognised expertise within WA in the areas of women’s and newborn health, including neonatology, obstetrics, gynaecology and midwifery research.

The WNHS HREC meets on the first Tuesday of the month, February to December (no January meeting). The date of the HREC meeting is the deadline for submission for consideration at the next meeting’s agenda. SASC assessment occurs one week after the submission deadline (see schedule (PDF)).

Research that has already been approved by a Lead WA Health HREC or a non-WA Health, NHMRC-Certified HREC, does not require WNHS HREC approval to be conducted at KEMH. However, the research will still require site authorisation to be conducted at KEMH. See Governance below for more information.

Applications involving Aboriginal Australians as a specific focus will require Western Australian Aboriginal Health Ethics Committee (WAAHEC) (external site) approval in addition to WNHS (or other Lead) HREC approval. All projects using linked data also require approval from the Department of Health WA Human Research Ethics Committee (external site).

Any research project which requires access to clinical tissue or samples collected for diagnostic purposes must consult with PathWest regarding access and analysis prior to submission of their application.

Ethics applications will usually require the following forms and documents:

  • WA Health Ethics Application form – completed electronically via the applications tab on RGS.
  • WNHS Participant Information and Consent forms (see links for templates, right – note these differ from the standard WA Health versions).
  • WA Health Research Protocol (templates for clinical trials or non-clinical trials available on RGS).

Governance

Research at WNHS cannot commence without formal site authorisation from the Director of Clinical Services. Site authorisation will only be granted after ethics approval and a successful governance review by the Research Governance Officer. The research must comply with the conditions of the Ethics approval – including all reporting requirements.

Research governance assessment takes place independently of, and often in parallel with, the ethics application process. We recommend submitting your governance application after being notified that your ethics application has been recommended by the SASC, but before final ethics approval is received, to prevent unnecessary delays.

Governance applications at KEMH will usually require the following forms and documents, completed electronically via RGS:

  • WA Health Site-specific assessment form (SSA).*
  • WA Health Budget Form.
  • WA Health Research Conflict of Interest form.
  • WA Health Declaration of Confidentiality (for non-WA Health employees).**

*If the research requires only distribution of letters / flyers and/or access to patient tissue or data, with no direct contact with patients or personnel and the project is not being conducted on-site, then a WA Health Access Request form should be submitted instead of the SSA form. See section 7 of the Research Governance Procedures (PDF).

**The Declaration of Confidentiality is not project specific and is only required to be signed once. It’s filed to cover all research conducted at WNHS.

Clinical trials must be lodged on a clinical trials registry and, if not already TGA approved, accompanied by a CTN template to allow online submission of a CTN application by the REGO (see Supplementary links, right). 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 20 of the Research Governance Procedures (PDF).

Neonatology research projects may require site authorisation from both CAHS (PCH) and WNHS (KEMH), depending on what access is required in carrying out the research project e.g. patients, staff, data, samples, facilities. Read the Research Governance Requirements for Neonatology Projects (PDF) for more information.

Post approval monitoring

A progress report must be submitted to the HREC (by the Coordinating Principal Investigator) and Research Governance Office (by the Principal Investigator) annually for review by SASC and HREC. For WNHS-based projects, one individual may act as both the CPI and the PI.

All amendments/changes or request for extension of time must be submitted to the HREC for approval. Site-specific changes must be submitted as a Governance Only Amendment to the Research Governance Office.

All Significant Safety Issues (SSIs) must be reported to the Research Governance Office within 72 hours. For comprehensive safety reporting requirements, refer to the NHMRC Guidance: Safety Monitoring and reporting in Clinical Trials Involving Therapeutic Goods (external site).

Quality improvement or research

Assistance in determining whether your project is quality improvement or research is available in the Is it Research or QI document (PDF).

Projects deemed to be quality improvement or audit should be entered into the QI database via the GEKO website (external site) for approval. For advice on this process, please see the guidance manual on the GEKO website or from the Performance Review and Audit Coordinator on (08) 6458 1540.

Complaints

If you have any complaints or concerns about a researcher or the conduct of a research project within WNHS, contact the Director of Clinical Services on (08) 6458 1440 who will bring it to the attention of the Ethics Committee monitoring the study.

If you are a researcher and have any complaints or concerns about the conduct of the HREC in the consideration of your research proposal, contact the Director of Clinical Services on (08) 6458 1440.

Last Updated: 17/12/2021