Human Research Ethics Committee (HREC)

Scientific and Ethical Review

The Sir Charles Gairdner Osborne Park Health Care Group (SCGOPHCG) Human Research Ethics Committee (HREC) is certified by the National Health and Medical Research Council (NHMRC) to provide ethical approval for research nationally under the National Mutual Acceptance (NMA) scheme. This HREC is one of three with certification in Western Australia, and the only one within the North Metropolitan Health Service (NMHS).

SCGOPHCG HREC is certified to review the following research categories:

  • Clinical trials of drugs and devices Phases I - IV
  • Clinical interventional research other than clinical trials
  • Population health and/or public health
  • Qualitative research.

All research conducted at SCGOPHCG can only commence once Institutional approval has been granted. Ethics and governance applications can be submitted simultaneously.

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

Due to the variety and volume of research submitted at this site, the HREC delegates review to the following subcommittees:

Scientific Review Subcommittee (SRSC)

The SRSC reviews the scientific merit and integrity of research involving the administration of a drug, non-drug research and applications that undergo statistical design review.

Minimal and Low Risk Ethics Committee (MLREC)

Minimal and Low Risk Research Projects undergo an expedited review by the MLREC in the form of weekly panel review sessions. The Minimal and Low Risk Cover Sheet is to be completed and submitted via RGS as part of your application.

Where the committee members have any comments or queries surrounding your project, you will still receive and AIR letter via RGS requesting the additional information.

You will find attached the following documents:

 

Review Committee Meeting dates

  

HREC Operating Documents

 

National HREC Guidance Documents

The National Statement on Ethical Conduct in Human Research (external site)

The National Certification Scheme (external site)
Information regarding the NHMRC certification process for national single ethical review.

The Australian Code for the Responsible Conduct of Research (external site)
The code that articulates the requirements for researchers, ethics committees and institutions involved in the conduct of research.

 

Support

If you require assistance with document preparation or your application submission, please reach out to SCGH.ResearchNavigation@health.wa.gov.au.

If you require assistance with the system, we recommend reaching out to 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 when a project is of low or minimal risk. It is important that each item 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.

The following document acts as a guide for how to address each criterion of the waiver of consent outlined in section 2.3.10 of the National Statement

Request for Waiver of Consent Template (Word)

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.

Data Management Plan Template (Word)

Participant Information and Consent Forms

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

 

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 SCGOPHCG HREC application.

Children and adolescents

Applications involving children and adolescents should be directed to CAHS HREC (external site).

Mental Health

Applications involving mental health research should be directed to the NMHS Mental Health 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 (AP) scheme. Information about this scheme, how to apply and a template consent from are provided below:

 

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 the Sir Charles Gairdner Osborne Park Health Care Group. 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. However, this review should be short and not be overly burdensome. As such, activity which is eligible for review as a case report is considered via a non-HREC process.

 

Submission

In order to seek endorsement for a case report the following must be submitted to the HREC office. The application and documents should be emailed to scgh.hrec@health.wa.gov.au.

  • Application form (Word)
  • A cover letter including:
    • The reports title
    • The author’s names and titles
    • Whether the subject/s of the report have provided consent; and
    • Whether personal data or images will be included in the publication.
  • An appropriately detailed summary of the proposed case report or a draft manuscript, if available
  • The consent form (Word)
  • Evidence of approval from an appropriate authority for publication of the report. This may be the head of department or co-director (an email of support is sufficient evidence to support endorsement)

Please note: case reports that include the publication of personal information or images without consent are unlikely to be endorsed by the institution. The disclosure of personal health information without consent may undermine public trust in the integrity of the health service and breach the Health Services and Privacy Acts. More information can be found in Defining 'personal information' (PDF).

A consent form for case report template (Word) based upon the Medical Journal of Australia version has been developed for use.

 

Review

The above documents will undergo a review to ensure the proposed publication aligns with the requirements of the National Statement on Ethical Conduct in Human Research and meets the institutions policy and legal obligations regarding disclosure of health information. However, this review will not consider or comment upon the quality or merit of the content of the report beyond these matters. Review Process (PDF).

 

Approval

Provided there are no extant ethical issues and the institutions obligations are not contravened the report will be endorsed and a letter provided to support publication within five working days from receipt of a complete application being received.

In instances in which consent has not been obtained from the subject of the report approval may take slightly longer as approval from the SCGOPHCG Executive Director (or their delegate) may be required.

Last Updated: 18/12/2024