Human Research Ethics Committee (HREC)

Scientific and Ethical Review

The Sir Charles Gairdner Osborne Park Health Care Group (SCGOPHCG) Human Research Ethics Committee (HREC), and its subcommittees, seek to ensure that research is conducted in accordance with the high scientific and ethical standards expected by the institution and the Australian public.

The SCGOPHCG 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, the others being Child and Adolescent Health Service HREC and South Metropolitan Health Care Service HREC.

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.

Due to the variety and volume of research submitted at this site, the HREC delegates review of the scientific merit and integrity to the: 

The Subcommittee reviews research involving the administration of a drug, non-drug research and all applications undergo statistical design review.

All research conducted at Sir Charles Gairdner Hospital and Osborne Park Hospital can only commence once institutional approval has been granted by the Research Governance Office. 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).

 

National HREC Guidance Documents

The National Statement on Ethical Conduct in Human Research (external site)
The Australian guidance document for the ethical conduct of research.
National Statement Update: On 1 January 2024, the 2007 National Statement will be replaced with the 2023 National Statement (external site). After 1 January 2024, the 2007 National Statement will remain available for reference and for historical purposes on the National Statement information webpage (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.

 

Approved Proposals

 

HREC Operating Documents

 

Review Committee Meeting dates

2024 Meeting Dates (PDF)

The committees meet 11 times a year. The subcommittees will meet January to November and the HREC will meet February to December.

 

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: 11/04/2024