Today’s correspondent asks:
Can Paramedics and or Emergency First Responders randomly select and conduct “Phase 0,1,2,3 or 4 Medical Research Clinical trials” on patients (humans) under the Guardianship and Administration Act 1986 Part 4A—Medical and Other Treatment Division 3—Emergency treatment 42A Emergency medical or dental treatment and or under any other State / Territory or Commonwealth legislation?
I infer from parts of the question, omitted from the above, that my correspondent comes from Victoria. The Guardianship and Administration Act 1986 (Vic) has been repealed and replaced with the Guardianship and Administration Act 2019(Vic). Provisions relating to consent to medical treatment are now found in the Medical Treatment Planning and Decisions Act 2016 (Vic). This Act (s 3) defines a ‘medical research procedure’ as:
(a) a procedure carried out for the purposes of medical research, including, as part of a clinical trial—
(i) the administration of pharmaceuticals; or
(ii) the use of equipment or a device; or
(b) a prescribed medical research procedure—
but does not include any of the following—
(c) any non-intrusive examination including—
(i) a visual examination of the mouth, throat, nasal cavity, eyes or ears; or
(ii) the measuring of a person’s height, weight or vision;
(d) observing a person’s activities;
(e) undertaking a survey;
(f) collecting or using information, including either of the following—
(i) personal information within the meaning of the Privacy and Data Protection Act 2014;
(ii) health information;
(g) any other procedure prescribed not to be a medical research procedure;
Section 53 says:
Medical treatment and medical research procedures in an emergency
(1) Subject to subsection (2), a health practitioner may administer medical treatment (other than electroconvulsive treatment) or a medical research procedure to a person without consent under this Part or without consent or authorisation under Part 5 if the practitioner believes on reasonable grounds that the medical treatment or medical research procedure is necessary, as a matter of urgency to—
(a) save the person’s life; or
(b) prevent serious damage to the person’s health; or
(c) prevent the person from suffering or continuing to suffer significant pain or distress.
(2) A health practitioner is not permitted to administer medical treatment or a medical research procedure to a person under subsection (1) if the practitioner is aware that the person has refused the particular medical treatment or procedure, whether by way of an instructional directive or a legally valid and informed refusal of treatment by or under another form of informed consent.
(3) Nothing in subsection (2) requires a health practitioner to search for an advance care directive that is not readily available to the practitioner if the circumstances set out in subsection (1) apply to the person to whom medical treatment or a medical research procedure is being administered.
The term ‘health practitioner’ includes a paramedic (s 3 definitions of ‘health practitioner’ and ‘registered health practitioner’).
Research in an emergency may involve the administration of a new drug, or the application of a new technique to see if that is beneficial. These things are not done, of course, just on someone’s waking up and thinking ‘this may be a good thing’. There would need to be scoping reviews to look at the evidence, perhaps animal trials, trials outside the emergency environment that show promise and suggest that if the treatment can be administered earlier it will be beneficial etc. A person conducting the research will need to obtain ethics approval from the Human Research Ethics Committee associated with their institution and any other health institutions involved eg a university researcher may need ethics clearance from their university and Ambulance Victoria if they intend to conduct their research with the assistance of AV (see Medical Treatment Planning and Decisions Act 2016 (Vic) s 75 and s 84 which makes it an offence to administer a research procedure that has not ‘been approved by the relevant human research ethics committee’).
The National Statement on Ethical Conduct in Human Research 2025 recognises that sometimes research needs to be conducted without consent, and also that it is not possible to get consent when looking at emergency medical care because of the time constraints involved (see in particular [2.3.9] to [2.3.12] ‘Waiver’ and [4.5.17] to [4.5.24] ‘Consent for emergency care research and intensive care research’).
Where time does permit a practitioner to obtain consent then ‘A medical treatment decision maker … must make the medical treatment decision that the medical treatment decision maker reasonably believes is the decision that the person would have made if the person had decision-making capacity’. If they believe the person would have consented to being part of the research, then they can give that consent.
Even if it is not an emergency a person can be admitted to a clinical trial without consent if there is no medical treatment decision maker and (s 80):
(a) the medical research practitioner believes on reasonable grounds that inclusion of the person in the relevant research project, and being the subject of the proposed procedure, would not be contrary to the following—
(i) the person’s values, whether—
(A) expressed by way of a values directive or otherwise; or
(B) inferred from the person’s life;
(ii) any other relevant preferences that the person has expressed, having regard to the circumstances in which those preferences were expressed;
(iii) the personal and social wellbeing of the person, having regard to the need to respect the person’s individuality; and
(b) the medical research practitioner believes on reasonable grounds that the relevant human research ethics committee has approved the relevant research project in the knowledge that a person may participate in the project without the prior consent of—
(i) the person; or
(ii) a medical treatment decision maker; and
(c) the medical research practitioner believes on reasonable grounds that—
(i) one of the purposes of the relevant research project is to assess the effectiveness of the procedure being researched; and
(ii) the medical research procedure poses no more of a risk to the person than the risk that is inherent in the person’s condition and alternative medical treatment; and
(d) the medical research practitioner believes on reasonable grounds that the relevant research project is based on valid scientific hypotheses that support a reasonable possibility of benefit for the person as compared with standard medical treatment.
(2) A medical research practitioner must continue to take reasonable steps to identify and contact the person’s medical treatment decision maker to seek consent to the continuation of the procedure on the person.
Conclusion
If there is a research trial in place, that has obtained the necessary ethical clearance in accordance with the National Statement on Ethical Conduct in Human Research 2025 then paramedics who are taking part in that trial can allocate patients to the trial in accordance with the trial protocol.
This blog is a general discussion of legal principles only. It is not legal advice. Do not rely on the information here to make decisions regarding your legal position or to make decisions that affect your legal rights or responsibilities. For advice on your particular circumstances always consult an admitted legal practitioner in your state or territory.
Australian Emergency Law 
the act Medical Treatment Planning and Decisions Act 2016 (Vic) this also states “”medical research practitioner” means—
(a) a registered medical practitioner;
(other than as a student)
I’m referring back to some of your earlier posts on: – “Doctors delegating authority to carry drugs August 20, 2014 and Ambulance, Health Professional Registration, Paramedics Date: May 25, 2021 and Health Professional Registration, Paramedics Date: October 29, 2018
would this not exclude any Paramedic or First Responders from engaging in any “Medical Research Procedure’s” being carried on patients, including in an emergency” under the legislation?
would this make it an offense if asked by the Medical Research Practitioner (a Registered Medical Practitioner) to administer Medical Research Procedure on a patient?, including in an emergency under: –
“PART 5–MEDICAL RESEARCH Division 3–Medical research procedures without consent”
“MEDICAL TREATMENT PLANNING AND DECISIONS ACT 2016 – SECT 53 Medical treatment and medical research procedures in an emergency”
“MEDICAL TREATMENT PLANNING AND DECISIONS ACT 2016 – SECT 85 Offence to administer medical research procedure without consent or authorisation
Subject to section 53, a medical research practitioner must not administer a medical research procedure to a person who does not have decision-making capacity to consent to the procedure unless—
(a) the person has consented, by an instructional directive, to the procedure being administered; or
(b) the person’s medical treatment decision maker has consented to the procedure; or
(c) the procedure is authorised under Division 3 or otherwise by law.”
You ask “would this not exclude any Paramedic or First Responders from engaging in any “Medical Research Procedure’s” being carried on patients, including in an emergency” under the legislation?”
Not in my view. First the provision on emergency care (s 53) refers to a ‘health practitioner’ not a ‘medical research practitioner’ so if there is a medical research trial going on to determine if a particular treatment has a patient benefit then the treatment can be given.
And your right about s 85 requiring consent or authorisation under another law and that other law is either s 53 or 80. Section 80 does require the ‘medical research practitioner’ to believes ‘on reasonable grounds that inclusion of the person in the relevant research project’ meets the requirements of the Act, but not every step in a medical research program is undertaken by the doctor running the research. They will always rely on the assistance of other practitioners, nurses, paramedics, other doctors etc to actually conduct the treatment.
So if a ‘medical research practitioner’ has developed an hypothesis that treatment ‘x’ will be better than treatment ‘y’ for condition ‘a’, has gone through the process of getting Human Research Ethics Approval for the treatment protocol identifying how people will be selected for the trial, the process to monitor the outcome, etc and they have got the cooperation of say Ambulance Victoria to be part of that research, then I think that s 80 would be an authorisation that would allow AV paramedics to treat people in accordance with that protocol even if the paramedics are themselves not the ‘medical research practitioner’. Note again that s 80 refers to the medical research practitioner having the necessary beliefs to include the person in the treatment protocol.
Does this now create ambiguity within the Charter of Human Rights and Responsibilities Act 2006, with the bill & legislation, between Emergency Treatment and Part 5—Medical research- Division 3—Medical research procedures without consent to be undertaken by a Medical Research Practitioner (registered medical practitioner)
The introduction of the Medical Treatment Planning and Decisions Bill 2016 (Vic) was prior to Paramedics being registered 1 Dec 2018.
Because Paramedic’s are not defined as a “Medical Research Practitioner” nor as a “Registered Medical Practitioner” 2011-current nor can they use the protected title of Registered Medical Practitioner during a Medical Research Clinical Trial (2011 – 2018),
nor were paramedics registered under legislation until 1 Dec 2018
Paramedics became registered under AHPRA on 1 December 2018
Hence my question, Can Paramedic’s and or First Responders engage in randomly selecting and performing on an unconscious patient “Experimental Medical research procedures“ without consent and or without the Medical Research Practitioner (registered medical practitioner) being present supervising the paramedic performing “Medical research procedures” under the direct supervision of the Medical Research Practitioner (registered medical practitioner)?
A statement of incompatibility with the Charter of Human Rights and Responsibilities Act 2006 (Vic) does not make the law invalid (ss 28 and 31) but the statement of compatibility, which you have partially quoted, did not say the Bill was incompatible with the Charter … Act. The Minister for Health said:
The power to provide for reasonable and justified derogation from listed rights is found in s 7(2). An individual may disagree with that statement, ie you may think the derogation is not reasonable and justified, but that is not the point at this stage. From the Parliament’s perspective the Minister filed a statement of compatibility as required and the Parliament passed the Act, so it is the law. If a person, in court proceedings, may argue that the provisions in the Medical Treatment Planning and Decisions Act 2016 (Vic) are inconsistent with the Charter. The matter can then be referred to the Supreme Court (Charter of Human Rights and Responsibilities Act 2006 (Vic) s 33). The Supreme Court, if it agrees, may make a declaration of inconsistent interpretation. The declaration must be drawn to the attention of the Attorney-General who must in turn deliver it to the Minister responsible for the legislation involved. The Minister, and ultimately the Parliament, can then consider whether they want to change the law (s 36). A declaration of inconsistent interpretation does not mean the law is invalid nor does it give rise to any right or remedy for the litigant.
The fact that paramedics were not registered health professionals in 2016 is irrelevant; they are now.
You’re quoting some paper that says ‘This paper describes the methodology for a definitive multi-centre, randomised, controlled trial’ but you have not identified the paper or where you found it so I cannot see what it is or what it says. Further it refers to the Medical Treatment Act 1988 and the Guardianship and Administration Act 1986 both of which have been repealed so it is out of date. In any event it did explain, according to the quoted material, that people can be enrolled in research without consent in limited circumstances. That is consistent with the Medical Treatment Planning and Decisions Act 2016 (Vic).
It is not the case that the Medical Research Practitioner has to be present to see every patient as the research may be much too wide to allow that happen. The principal researcher running a ‘multi-centre, randomised, controlled trial’ could not be at every centre whenever a person is identified as appropriate for enrolment in the trial.
That current Act allows for inclusion in medical research without consent in ss 53 and 80. If the requirements in those sections are met, and the research has been approved by a Human Research Ethics Committee, then it can proceed. If that involves paramedics making decisions within that protocol then that can also proceed. Ideally paramedics wouldn’t know who is being included, eg if it was to test the efficacy of a drug, some people would be given the drugs and some a placebo but the paramedic wouldn’t know which was which. Alternatively every 2nd patient would be treated with the trial drug etc. If the paramedic has to personally decide whether or not to include a person in the trial then that is not a well-designed trial as the researchers couldn’t control for the paramedic’s decision making biases but that is a matter for the principal researchers and the ethics committee.
As a matter of law, yes paramedics can be involved in a research trial that involves people unable to give consent provided the criteria in s 50 or 83 are met, the research is approved by a Human Research Ethics Committee and the paramedic is acting as required by that approved research protocol.
See also the comment by ‘O’, above.
In an over simplified explanation:
In clinical trials, studies will have a principal investigator which is generally a medical practitioner.
As part of the clinical trial protocol there will be a delegation log (or similar) in which certain tasks of the trial are delegated to other people and whether those tasks are blinded or unblinded.
In ambulance services it can be inferred that the delegation log will have “all operational advance life support and/or intensive care paramedics that have completed the relevant training” or words to that effect and this log will also likely be updated with each paramedic’s name and role once they have completed the training.
Lots of clinical trials don’t have a medical practitioner administering the treatment/procedure, it could be a researcher, nurse, paramedic, pharmacist, different medical practitioner to the PI, etc.
Generally as long as the person who has been delegated the task is a trained and competent individual there is no issue as to who administers the medication because they have been delegated the responsibility appropriately within the protocol of the trial which has HREC approval to be conducted that way.
(Source: Professional knowledge and experience on how clinical trials are conducted)