The Guardian and Administration Amendment (Medical Research) Bill 2020 came into operation on 6 April 2020.
Prior to this, if a person had lost capacity to make his or her own treatment decisions, even if only for a short period, medical practitioners were not authorised to seek consent for medical research from that person’s enduring guardian, guardian or next of kin.
This amendment was recommended as part of a statutory review of the Act tabled by the Liberal-National government in 2015, but the recommendations specifically dealing with consent to medical research were deemed, in the current environment, crucial.
In particular, these amendments will allow all Western Australians to have the opportunity to participate in research and experimental treatments specifically targeted at combating the COVID-19 coronavirus.
What constitutes medical research under the Act?
The Act defines medical research as research conducted with or about individuals, or their data or tissue, in the field of medicine or health and includes an activity undertaken for the purposes of that research.
Medical research includes research activities such as the administration of pharmaceuticals or placebos, the use of equipment or a device and the provision of health care that has not yet gained the support of a substantial number of practitioners. It is a broad and inclusive definition which also includes activities such as observational studies, survey, interviews, focus groups and non-intrusive examinations.
The inclusion of “provision of health care that has not yet gained the support of a substantial number of practitioners” means that the amendments will also extend to novel and experimental treatments as well as more traditional research practices.
Medical research does not include research conducted about individuals, or their data or tissue, that only involves analysing data about the individuals and does not result in the disclosure or publication of personal information and does not include any other activity prescribed by the regulations not to be medical research.
Who can be appointed a research decision-maker?
As with consent to medical treatment, the Act now provides an order of priority to determine who is eligible to act as a research decision-maker.
In the first instance, the research decision maker will be the person’s enduring guardian who is authorised to make research decisions, is reasonably available and is willing to make the research decision. An appointed plenary guardian is authorised under the Act to make research decisions. However, a limited guardian will need to have decisions with respect to research specifically referred to in their appointment.
If no such person is available, the research decision will be referred to a substitute decision-maker who has full legal capacity to make the research decision.
There is a hierarchy of potential substitute decision-makers, who must be over 18 in order to be eligible to act as a decision-maker. The Act providers that the hierarchy is:
- a spouse or de facto partner who lives with or maintains a closing personal relationship with the person;
- a child who maintains a close personal relationship with the person;
- a parent who maintains a close personal relationship with the person;
- a sibling who maintains a close personal relationship with the person;
- a person who is the primary provider of care and support for the person but is not remunerated for providing that care and support (including emotional support). A paid professional carer will not be eligible to act as a decision-maker under this provision, but a person who is in receipt of any Commonwealth or State or Territory financial support in relation to their caring may still be eligible;
- any other person who maintains a close personal relationship with the person and who is in frequent contact of a personal nature and takes a genuine interest in the person’s welfare. The requirement that this individual must be in a close personal relationship with a person is intended to exclude those who might maintain professional relationship with the person, such as a business partner.
If there are two or more research decision-makers (of the same level of priority) they will be joint decision-makers for the person. If the joint decision-makers cannot agree on the research decision, then the person who is next in the order of priority will be the research decision-maker.
When can a research decision-maker give consent on behalf of a person?
A research decision can only be made on behalf of someone who lacks the capacity to make the decision, whether temporarily or permanently. Nothing in the amendments overrides a person’s inviolable right to consent to (or refuse) medical treatment or research if they can do so.
Furthermore, before a research decision-maker can consider giving consent the proposed research must have been approved by a Human Research and Ethics Committee (HREC) and in the opinion of an independent medical practitioner, the research candidate is not likely to make such judgments within the timeframe for the research approved by the HREC.
The decision-maker must also have regard to the determination of an independent medical practitioner as to whether the person’s participation in the research will be in the best interests of the person or not adverse to the interests of the person.
An independent medical practitioner will be one who is:
- not involved in providing treatment to the person;
- not involved in or connected with the research, beyond having a professional interest in the area of research;
- not a spouse or de facto partner, parent, grandparent, sibling, child or grandchild of the person; and
- not a member of the approving HREC.
The Act also prescribes the factors that must be taken into account by a decision-maker when determining whether participation in medical research is in the best interest of a person, including:
- the wishes of the person;
- the likely effects of participation, including the existence, likelihood and severity of any potential risks, and whether those risks are justified by any likely benefits of the research;
- any other consequences if the person is not involved in the research;
- any alternative treatments available to the person; and
- any other prescribed matters.
When making a research decision, the research decision-maker must have regard to the wishes of the person as the paramount consideration. If the proposed medical research is inconsistent with any Advance Health Directive (AHD) in place, the decision-maker must make decisions in accordance with the AHD and is unable to consent to the research.
If the research goes beyond observation or non-invasive examinations, treatments or procedures, then the research decision-maker cannot consent to participation unless the research will not involve:
- any known substantial risks to the person;
- any known substantial risks greater than the risk associated with existing treatment; or
- any substantial risk greater than if the person did not participate in the research.
A research decision-maker cannot consent to medical treatment for the purpose of the sterilisation of the represented person or to electroconvulsive therapy being performed on the person.
If a person regains the ability to make reasonable decisions about their involvement in medical research, the previous decision to participate as made by the research decision-maker will cease to have effect.
When can an independent medical practitioner give consent on behalf of a person?
If a person requires treatment to urgently save the person’s life, prevent serious damage to their health or prevent significant pain or distress and it is not practicable to obtain consent from a research decision-maker within an appropriate time frame, a researcher can carry out research on a person who is otherwise unable to give consent if an independent medical practitioner has determined that:
- the person is not capable of making a reasonable decision in respect of the medical research for themselves;
- in the opinion of the independent medical practitioner, the person is unlikely to regain capacity to give consent within a timeframe for the research specified by the HREC;
- it is not practicable to obtain consent from a person responsible; and
- the research is in the best interest of the person or is not adverse to the interests of the person by increasing his or her medical risks.
The research must have been approved by a properly constituted HREC.
Who is responsible for reviewing research decisions?
The Act vests the State Administrative Tribunal with additional powers to ensure that a person may apply to the tribunal for review of a decision made under the medical research provisions.
If the tribunal considers that a review is warranted, it may, effectively, set aside a decision made by the research decision-maker, but only with prospective effect, and without effecting the validity of anything done by the researcher in reliance upon the decisions prior to the tribunal’s decision.
This will have the effect of protecting a researcher acting upon the basis of a research decision but allows for the prospect of the tribunal intervening to correct a research decision that ought not to have been made.
The right of review will be of less utility in cases if the research has been wholly carried out in urgent circumstances prior the opportunity for a review application to be made.
Will the amendments be reviewed?
Given that the amendments have been passed in direct response to the urgency created by the COVID-19 pandemic, a review clause has been included that requires the operation and effectiveness of amendments to be reviewed after one year initially and every three years thereafter, with the resulting reports to be tabled in Parliament.
A copy of the Act as amended can be found here.
