Three Doctors Masked and in the Operating Theater

Women and Newborn Health Service

General

 

King Edward Memorial Hospital for Women (KEMH)


Ethics & Research Governance

Research Ethics & Governance

WA Health Research Governance Framework

REGO contact details

Location
O Block KEMH, Hensman Road

Office hours
Monday: 9 am – 5 pm;
Tuesday-Thursday: 8 am – 4 pm;
Friday: 9am – 12.30 pm.

Contact numbers
6458 1667/6458  1880

Email addresses
KEMHethics@health.wa.gov.au
ResearchGovernanceOffice.KEMH@
health.wa.gov.au

Jeff.keelan@uwa.edu.au

Key REGO contacts
Ms. Jayne Jarvis
Ethics Administrative Officer
6458 1667

Dr. Helen Atkinson
Research Governance Officer
6458 1667

Prof. Jeffrey Keelan
REGO Director/SASC Chair
6458 1880

Key GEKO contact
Ms. Nina Hughes
Performance Review and Audit (GEKO) Coordinator
6458 1540

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. 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 (EDMS) 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 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.

The Research Governance Service (RGS) was introduced in December 2016 and, from January 2017, will be 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 & 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 & governance applications within WA Health must be registered on RGS in order to participate in the application review and approval process (see below).

Research must undergo both an ethical & scientific review and 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 WNHS Governance Officer; both processes occur within the Research Ethics & Governance Office (REGO). Detailed guidelines on the application process, submission requirements and deadlines can be found in the next section below.

The WNHS Human Research Ethics Committee (HREC) 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) conducted at KEMH and affiliated organisations. Assessment of scientific content & 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’s Health, including neonatology, obstetrics and gynaecology, and midwifery research.

Research at WNHS cannot commence without formal authorisation from the Executive Director Medical Services subsequent to Research Ethics and Governance approval, and must comply with the conditions of the approval - including all reporting requirements.

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 guidance manual on the GEKO website, or from the Performance Review and Audit Coordinator (Nina Hughes) on KEMH extension 1540.

Research Ethics & Governance Applications

Application and Approval Process

Research ethics and governance applications are submitted to the Research Ethics & Governance Office (REGO) via the recently introduced Research Governance System (RGS). Research Governance assessment commences following receipt of the Governance forms and takes place independently of the Ethics application process. The WNHS Human Research Ethics Committee (HREC) meets on the first Tuesday of the month, February to December (there is no meeting in January). The date of the HREC meeting is the deadline for submission for consideration at the next meeting’s agenda. SASC assessment occurs 1 week after the submission deadline (see schedule, right).

The WNHS HREC considers single-site applications and can approve WA Health multi-centre studies within its specific area of expertise or site jurisdiction. The application process requires access to RGS and registration as a research user. This site also contains the forms for research governance assessment (see here). Monitoring and reporting will be accomplished via RGS in the latter half of 2017 (phase II); until then the old forms will continue to be used.

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

For WNHS-based projects, where the coordinating principal researcher (CPI) will be responsible for submitting both the ethics and governance application forms and subsequent reports, the application and approval process is summarised in a simple flow chart. WNHS single site applications typically require completion of the following application forms:

  • WA Health Ethics Application form (completed electronically via RGS)
  • WNHS Participant Information and Consent forms (note these differ from the standard WA Health versions; see Supplementary links, right)
  • WA Health Research Protocol Template (for clinical trials or non-clinical trials)
  • WA Health Site-specific assessment form (SSA) – completed electronically via RGS*
  • WA Health Research Conflict of Interest form.
  • WA Health Declaration of Confidentiality (for non-WA Health employees)**

*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.

**The Declaration of Confidentiality is not project specific and is only required to be signed once; it is then 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 on-line 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 2 of WA Health Research Governance Policy and Procedures 2012.

The ethics and governance approval process

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 rejected. While ethical review takes place, the Research Governance Officer reviews all applications to ensure they comply with the 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. A budgetary template is available from the RGS site here.

NOTE: 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 Executive Director Medical Services, a formal letter of approval will be sent to the investigators of approved studies. Research can then commence.

Multi-centre studies

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.

For multi-centre studies (e.g. large national or international clinical trials) the coordinating principal 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.

Post Approval Monitoring

  • The principal investigator is required to submit a progress report to the HREC & REGO annually which is reviewed by the SASC and 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.

Links to useful external sites and documents

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