Research ethics and governance

Research and innovation activities supported by the Future Health Research and Innovation (FHRI) Fund are required to meet all applicable legislative and policy provisions regarding research ethics and integrity. This page provides general information about research ethics and governance.

 

Research governance is a framework that guides the processes used by institutions that ensure the human research they sponsor, or permit, is safe, ethical and of high-quality. The aims of research governance include:

  • ensuring that participants in research are protected in terms of their rights, safety and dignity
  • that the research to be conducted is scientifically sound and of high quality
  • monitoring research as it progresses to ensure that it is being conducted appropriately
  • ensuring that appropriate approvals are in place for the duration of the research
  • reducing risk for all parties involved in the research
  • enabling good research practices.

 

Elements of research governance include:

  • ethical approval
  • compliance with legislation, regulations, guidelines and codes of practice
  • legal matters, including contracts, and indemnity/insurance frameworks
  • financial management, risk management and site-specific assessment
  • institutional policies and procedures for responsible research conduct and managing research misconduct
  • management of collaborative research

 

In WA, the WA Health Research Governance Framework (external site) governs the scientific, ethical and governance review, approval, conduct and monitoring of human research within WA public health organisations.

 

Research Governance Service 

 

The Research Governance Service (RGS), supports the WA Health Research Governance Framework. The RGS is a centralised web-based information system for investigators, project members, sponsors, Hospital Administrators/sites, Human Research Ethics Committees and Research Governance Offices to complete, submit, administer, track and report on ethics and governance documentation throughout the lifecycle of a project, including authorisation, monitoring, closure and publications.
All WA public health system research project ethics and governance applications must be submitted via RGS.

Human research refers to all research that involves, or is about, people, including their data and tissues. Human research ethics aims to ensure that research involving humans is conducted in an ethically acceptable way, with appropriate checks and balances. All human research in the WA public health system must be conducted in accord with the National Health and Medical Research Council’s National Statement on Ethical Conduct in Human Research 2007 (updated 2018) (the National Statement). The National Statement is intended to provide more than just a checklist for the ethical conduct of research, it involves “acting in the right spirit, out of an abiding respect and concern for one’s fellow creatures”.

Obtaining human research ethics approval is one step in the research governance process. Site-specific authorisation is also required before research can commence at a site within the WA public health system.

For all human research to be conducted in the WA public health system, approval from an appropriate Human Research Ethics Committee (HREC) is required. An appropriate HREC must review and approve all human research to ensure the research is:

  • ethically sound according to the principles of merit, integrity, justice, beneficence and respect as specified in the NHMRC National Statement; and
  • scientifically sound, designed using methods appropriate for achieving the aims of the research proposal and based on a thorough study of current and historical literature.

 

In WA, the Animal Welfare Act 2002 (WA) governs the use of vertebrate animals (other than humans and fish) for scientific purposes. National guidelines for the use of any animal – including fish – for scientific purposes are provided in the Australian Code for the Care and Use of Animals for Scientific Purposes – 8th edition. This code sets out four governing principles that should be applied in all situations:

  1. Respect for animals must underpin all decisions and actions involving the care and use of animals for scientific purposes.
  2. The care and use of animals for scientific purposes must be subject to ethical review.
  3. A judgement as to whether a proposed use of animals is ethically acceptable must be based on information that demonstrates the principles in Clause 1 [above], and must balance whether the potential effects on the wellbeing of the animals involved is justified by the potential benefits.
  4. The obligation to respect animals, and the responsibilities associated with this obligation, apply throughout the animal’s lifetime, including acquisition, transport, breeding, housing, husbandry, use of the animal in a project, and provisions for the animal at the conclusion of their use.

The Animal Welfare Act 2012 provides that in order to be licensed to use animals for scientific and research purposes, all institutions must have an acceptable Animal Ethics Committee. Before an animal can be lawfully used for research purposes, the proposed use must have been reviewed and approved by an acceptable Animal Ethics Committee. The role of Animal Ethics Committees is to ensure that the use of animals for scientific or research purposes is justified, the welfare of the animals is provided for, there will be ongoing monitoring activities and the application incorporates the principles of Replacement, Reduction, and Refinement (the ‘3Rs’ of animal research). The 3Rs principles are aimed at promoting the use of non-animal models wherever possible (Replacement), using the minimum number of animals necessary to achieve the research objectives (Reduction), and steps must be taken throughout the research to support and safeguard animal welfare (Refine).

Last Updated: 11/09/2020