Ethical review

The WA Health Central HREC provides ethics reviews of research involving humans, their biospecimens and/or their information and is bound by state and national policies, legislation and is governed by the terms set out by the NHMRC in the National Satement on Ethical Conduct in Human Research 2023 (external site).

All research within WA Health needs to be submitted via the Research Governance Service website (external site).

The WA Health Central Human Research Ethics Committee page (external site) on the WA Health website provides further information about their processes.

If you have any queries, please contact HREC@health.wa.gov.au

Support

For assistance with document preparation or your application submission, email SCGH.ResearchNavigation@health.wa.gov.au

For queries regarding the current ethics review process, email HREC@health.wa.gov.au

For assistance with the system, email RGS.Support@health.wa.gov.au

Tips for completing an ethics application

Addressing the waiver of consent

A waiver of consent may only be granted by a HREC for research using personal information in medical research, or personal health information.

It is important that each criterion outlined in section 2.3.10 of the National Statement is addressed substantively to justify the requirement for a waiver of consent.

A common mistake is simply reiterating the wording of each section without articulating how that determination has been made.

Addressing the Data Management Plan

Recent updates to Section 3 of the National Statement focus on the collection, use and management of data and information, and the management of study findings or results. Section 3.1.44 of the National Statement provides an overview of details to include in a data management plan.

Participant Information and Consent Forms

WA Health investigators are encouraged to utilise the National Health and Medical Research Council's standard PICFs (external site).

Additional considerations

WA Aboriginal Human Ethics Committee (WAAHEC)

Applications involving Aboriginal and Torres Strait Islander people in project results must obtain WAAHEC approval. It is advised WAAHEC approval is submitted as part of your ethics application.

Children and adolescents

National Mutual Acceptance applications involving children and adolescents should be directed to CAHS HREC (external site).

Non HREC activity

Authorised prescriber

The HREC is occasionally asked to provide support for applications under the Therapeutic Goods Administration (TGA) Authorised Prescriber scheme. Applications from medical practitioners seeking to become an authorised prescriber of an ‘unapproved’ therapeutic good should not be submitted via the RGS.

The medical practitioner’s application for HREC approval to apply for authorised prescriber status with the TGA must be made in writing and provide sufficient evidence to justify the use of the ‘unapproved’ therapeutic good. More information on applying to be an authorised prescriber can be found on the TGA website (external site).

Case reports or series

Reporting individual or a series of cases is an important mechanism by which to inform peers of novel or noteworthy clinical phenomena, suggest directions for future research and provide an opportunity for early career medical staff to participate in academia.

There is no consistency in the approach to case reporting within Australia with many institutions providing exemptions, alternate or no pathways for review or approval. Case reports provide detail on the treatment, disease or other clinical phenomena related to the care of individuals within SCGOPHCG. As such, the SCGOPHCG feel that a review is warranted to ensure that such reports align with the requirement of the National Statement on Ethical Conduct in Human Research and the hospitals policy and legislative obligations. Activity which is eligible for review as a case report or series is considered via a non-HREC process through Quality Improvement.

For further information visit the SCGOPHCG Quality Improvement page (internal staff only).

Where consent cannot be obtained, guidance must be sought from HREC@health.wa.gov.au.