Where a person is not capable of giving consent to participate in medical research, investigators and Human Research Ethics Committees (HRECs) should ensure their participation is guided by the ethical requirements set out in the National Statement on Ethical Conduct in Human Research, 2007 (National Statement). However, in every instance relevant jurisdictional laws must be taken into account.
In WA, the Guardianship and Administration Act 1990 (WA) (the Act) does not include a provision for consent by a substitute decision maker for a person to participate in medical research. Consent under the Act may only be provided by a substitute decision maker for a person to participate in treatment which is in the best interests of the patient.
Consent to treatment under the Act can be given by the patient if the patient has made an appropriate advance health directive, by an appointed enduring guardian, a guardian, or another responsible person as defined in section 110ZD and prioritised in section 110ZJ of the Act. See the Public Advocate's Statement on Decisions about Treatment.
Once the provisions of the Act have been satisfied such that the research is treatment which is in the best interests of the patient and the appropriate substitute decision maker under the Act has been identified, then the guidelines in the National Statement have application.
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.
If the research project intends to recruit persons in WA who may be deemed incapable (either mentally or physically) of providing consent the investigator will be required to provide the reviewing HREC with sufficient details to make an assessment of whether the provisions of the Guardianship and Administration Act 1990 (WA) and the ethical requirements set out in the National Statement have been met. This should be documented in the Western Australian Specific Module which accompanies the Human Research Ethics Application (HREA).
That is, where a person is not capable of providing consent to participate in medical research, a substitute decision maker may only provide consent for that person to participate in treatment which is in the best interests of the patient. In the case of a clinical trial or medical research that is not normally considered treatment, it may be difficult to establish that participation in the medical research is of direct therapeutic benefit to the individual person and therefore in their best interests.
If the medical research project meets the requirements of the Guardianship and Administration Act 1990 (WA) and the National Statement the substitute decision maker should be provided with sufficient information and opportunity to ask questions to reach an adequate understanding of the proposed research and the implications of the incapacitated patient participating in it. At the end of the process, if the substitute decision maker is willing to consent, then the substitute decision maker should be asked to sign an information and consent form. This form should require the substitute decision maker to record that there is no reason to believe that, were the participant to be informed of the proposal, he or she would be unwilling to consent. More than one information and consent form may need to be approved by the HREC to accommodate all potential participants (e.g. participants who have had a stroke and may comprehend the information provided but may physically not be able to sign a form. In this case, ways of obtaining consent from the participant may need to be explored to involve the participant in the consent process).
There should also be a process for reviewing, during the research, the participant's capacity to consent and to participate in the research. Consideration should be given to how consent will be obtained once the participant becomes able to give consent during the project. In research involving people with a mental illness, cognitive impairment or intellectual disability, the persons' medical practitioner should make a judgement on their capacity to give informed consent to participate in the research.
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 , the Department of Health WA HREC and Department of Health Research Governance (RG) Office 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.
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.
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.
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