Skip Ribbon Commands
Skip to main content

WA Specific Information

Adults with Impaired Capacity or Unable to Consent

Where an adult is not capable of giving consent to participate in health and medical research, researchers and Human Research Ethics Committees (HRECs) should ensure that recruitment is in accordance with the ethical requirements set out in the National Statement on Ethical Conduct in Human Research, 2007 (updated 2018) (National Statement). However, in every instance relevant jurisdictional laws must be taken into account.

National Statement

The National Statement, Chapter 4.4, references the ethical requirements for research involving people highly dependent on medical care who may be unable to give consent. The relevant sections relating to consent include 4.4.1, 4.4.9, 4.4.10, 4.4.13 and 4.4.14.

The National Statement, Chapter 4.5, references the ethical requirements for research involving people with a cognitive impairment, an intellectual disability or a mental illness.  The relevant sections relating to consent include 4.5.1, 4.5.5, 4.5.6, 4.5.7, 4.5.8, 4.5.9, 4.5.10 and 4.5.11.

The Guardianship and Administration Act 1990 (Western Australia)

In WA, the Guardianship and Administration Act 1990 (Act) was amended on 7 April 2020 to provide pathways for the participation of adults who do not have the capacity to consent in health and medical research. The relevant section is Part 9E.

Therer are two potiential enrolment pathways:

  • Medical Research with consent of Research Decision-Maker
  • Urgent Medical Research without consent

The WA Department of Health Guidance Document: Involving Incapacitated Adults in Health and Medical Research must be consulted regarding the requirements of the Act and its application, before completing either the WA Specific Module (WASM) or the WA Health Ethics Application Form (WAHEAF).

The Guidance Document and associated forms are available from the RGS Document Templates page.

Relevant links

Office of the Public Advocate - Making Medical Research Decisions

Department of Health Data Collections and Data Linkage

The Department of Health is responsible for the statewide health data collections that contain summaries of personal health information collected from WA Health patients. The Department of Health Information About Health Data website provides information about the data collections. The Department of Health Data Linkage Branch maintains the WA Data Linkage System (WADLS), which comprises a system of linkages connecting data about the health events of Western Australians. The WADLS is used to link the statewide health data collections and some other organisations. The Data Linkage WA website and the Department of Health, WA Data Linkage Branch Access and Charging Policy, 2015 provides details about the WADLS. Investigators wishing to access personal health information for research from the Department of Health data collections must consult with the relevant Data Custodian or with the Data Linkage Branch Project Officer about the data application process (including relevant forms and supporting documentation) before applying for the data or requesting Department of Health WA HREC approval.

Information regarding the data application, ethics and governance approval processes are available from Data Linkage WA , and the Department of Health WA HREC websites. The use or disclosure of personal information from the Department of Health data collections for use in research must be approved by the Data Steward following a reccomendation from the Data Custodian and approval by the Department of Health WA HREC. Following Data Steward approval, the Department of Health RG Office will undertake a governance review and make a recommendation to the Department's Chief Executive or delegate to grant site authorisation for the project. Once this is received, a research project can commence.

​​WA Health Biobanks

Investigators requiring access to WA Health biobanks, or the project involves the establishment or use of material from human tissue collections and their associated data should refer to the Department of Health, Guidelines for human biobanks, genetic research databases and associated data, 2010. This forms part of an overarching governance and regulatory framework for WA biobanks and should be used in conjunction with existing guidelines, laws and regulations.

Aboriginal People

The WA Aboriginal Health Ethics Committee (WAAHEC) is registered with the National Health and Medical Research Council's Australian Health Ethics Committee and sits within the Aboriginal Health Council of WA. WAAHEC exists to promote and support good ethically based health and medical (or the determinants of health) research, which will benefit Aboriginal people. In addition to the Lead HREC approval it is a requirement of WAAHEC to approve the conduct of health and medical research in WA where the research project involves relevant categories.

Refer to the Aboriginal Health Council of Western Australia website for contact details and ethics application information.

The use of the term 'Aboriginal' refers to Australians of both Aboriginal and Torres Strait Islander people.




Copyright © Department of Health WA  |  Terms of Use  |  Privacy Policy

Technical Assistance:

Hours: 8.00am to 4.00pm AWST (Mon - Fri)
WA Health employees: Contact your Service Desk for password issues only
Non WA Health employees: Email