On the matter of Informed Consent and Human Clinical Trials.
Informed consent to medical treatment
10.47 At common law, all competent adults can consent to and refuse medical treatment. If consent is not established, there may be legal consequences for health professionals. Under the law of trespass, patients have a right not be subjected to an invasive procedure without consent or other lawful justification, such as an emergency or necessity. At the international level, the CRPD expresses this in terms of a ‘right to respect for his or her physical and mental integrity on an equal basis with others’.[35]
10.48 ‘Informed consent’ refers to consent to medical treatment and the requirement to warn of material risk prior to treatment. As part of their duty of care, health professionals must provide such information as is necessary for the patient to give consent to treatment, including information on all material risks of the proposed treatment. Failure to do so may lead to civil liability for an adverse outcome, even if the treatment itself was not negligent.[36]
[35] UN Convention on the Rights of Persons with Disabilities, opened for signature 30 March 2007, 999 UNTS 3 (entered into force 3 May 2008) ART 17.
[36] Rogers v Whitaker (1992) 175 CLR 479.
The Australia Commission on Safety and Quality in Health Care states that "ensuring informed consent is properly obtained is a legal, ethical and professional requirement on the part of all treating health professionals and supports person-centred care."
The Australia Commission on Safety and Quality in Health Care further states that informed consent is a person’s decision, given voluntarily, to agree to a healthcare treatment, procedure or other intervention that is made:
Following the provision of accurate and relevant information about the healthcare intervention and alternative options available; and
With adequate knowledge and understanding of the benefits and material risks of the proposed intervention relevant to the person who would be having the treatment, procedure or other intervention.
This Commission holds the belief that informed consent is a key quality and safety issue, where good clinical practice involves ensuring that informed consent is validly obtained and appropriately timed, and where informed consent is integral to the right to information in the Australian Charter of Healthcare Rights, and recognised in Professional Codes of Conduct. Additionally, the National Safety and Quality Health Service Standards require all hospitals and day procedures services to have informed consent processes that comply with legislation, lawful requirements and best practice.
With specific concern to the COVID-19 vaccines, it should be made clearly known that these vaccines have not been approved by the Therapeutic Goods Administration (TGA), and have only received provisional approval to be used in an officially declared pandemic. This provisional approval has only been made on the basis of short term efficacy and safety data, while continued approval depends on the evidence of longer term efficacy and safety from the ongoing and post-market assessment. As these clinical trials are expected to end in April 2023, all participants are subjects of an experiment, whether they understand this, or not. As Greg Hunt, Australian Minister for Health and Aged Care stated to David Speers:
"The world is engaged in the largest clinical trial, the largest global vaccination trial ever..."
It should be here noted that it is a major breach of the Australian Code for the Responsible Conduct of Research to have Research Without Consent conducted, when it constitutes forced, or coerced (under duress) human experimentation.
If a person, medico, or otherwise, undertaking forced human experimentation, subjects a person to cruel inhuman treatment, against their expressed wish, not only does this constitute a servitude offense under The Australian Crimes Act, it is also assault.
BREACH OF THE NUREMBERG CODE
I now draw the attention of the Court to the Nuremberg Code.
The Nuremberg Code is a critical element of medical ethics after the Second World War atrocities that were conducted. The first line of this states “The voluntary consent of the human subject is absolutely essential.” The Code then goes on to state that the consent should be “without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion”.
Refusing employment, and wages to workers who refuse to participate in this clinical trial, is a clear form of financial duress and coercion (and also over-reaching, and an abuse of position, by the Victorian State Government). Some families rely on this work to enable or assist them to provide for their family, and to deny access to employment is coercion of these conscientious objectors to subject themselves to a medical procedure. Even if these conscientious objector “agree” to the medical procedure because they cannot afford to not be employed, this is still not consent.
The principle of valid consent spawns from the Nuremberg Code. The Nuremberg Code explicitly rejects the moral argument that the creation of benefits for many justifies the sacrifice of the few. The right of individuals to control their bodies trumps the interest of others in obtaining knowledge or benefits from them.
“The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision.”
The Australian Immunisation Handbook reflects the Nuremberg Code in requiring valid consent as a pre-cursor to vaccination. Specifically:
“For consent to be legally valid, the following elements must be present:
1. It must be given by a person with legal capacity, and of sufficient intellectual capacity to understand the implications of being vaccinated.
2. It must be given voluntarily in the absence of undue pressure, coercion or manipulation.
3. It must cover the specific procedure that is to be performed.
4. It can only be given after the potential risks and benefits of the relevant vaccine, risks of not having it and any alternative options have been explained to the individual.
5. The individual must have sufficient opportunity to seek further details or explanations about the vaccine(s) and/or its administration.”
Choice is critical given the absence of a vaccine injury compensation scheme in Australia.
BREACH OF AUSTRALIAN MEDICAL ASSOCIATION CODE OF ETHICS
The Australian Medical Association Code of Ethics
Section 1.1.k states “Respect your patient’s right to choose their doctor freely, to accept or reject advice and to make their own decisions about treatment or procedures.” If patients were to subject themselves to vaccination due to the duress and coercion of this 'mandate', this hardly provides informed consent. As such, a doctor must respect a Social Services Legislation Amendment (No Jab, No Pay) Bill 2015 Submission 511 - patients’ choice and could therefore not administrate this vaccination. Likewise, the Government does not have the right to dictate what medical procedure a natural born man, or natural born woman of Australia must undertake. This is not informed consent.
BREACH OF VICTORIAN CHARTER OF HUMAN RIGHTS AND RESPONSIBILITIES
Here in Victoria, within the Victorian Charter of Human Rights and Responsibilities there is specific item which is also clearly violated “Everyone is entitled to equal and effective protection against discrimination, and to enjoy their human rights without discrimination.”
To enforce this 'mandate' would be to clearly discriminate against people who have chosen not to vaccinate due to their research, family history, choices and beliefs.
CHOICE BASED ON THE MEDICAL ETHICS
A cornerstone of medical ethics is “informed consent”. This means that the recipient of the medical procedure must be informed of all the potential risks associated with the procedure. With the poor state of medical research, the research into the risks is very poor. Richard Horton, the editor-in-chief of The Lancet medical journal, stated “The case against science is straightforward: much of the scientific literature, perhaps half, may simply be untrue.”* The second aspect of informed consent - is consent. If a vaccination is a made mandatory, there is no consent. It’s that simple. Therefore the politics behind this 'mandate' has become more about human rights than vaccination. If we allow the Premier of Victoria to violate human rights in order to pursue a policy which has no basis in objective science, and may be found untrue after careful, transparent, and critical investigation, we risk subjecting all Victorians to human rights abuses for all generations to come. No Victorian, let alone any human upon the face of this earth, should be forced to participate in any risky medical procedures mandated by any government, which violates ethical medical practice, and a person's right to body autonomy, and self determination.