So It’s Clear This Is A Medical Experiment, All National and Global Laws, Codes, Conventions and Regulations Have Been Violated!

Now That We Know The Extent Of The Crime, What Will We Do Australia?

Will we let history repeat? This can only continue if we allow it! Here’s some legal context for the nature of the crimes committed against humanity. We welcome and are calling on all freedom lovers to consider sharing ways we can move foreword as one people of the land. We are ready to take this to the next level and are calling on you to be apart of it.

Letter sent last March, they were warned! They can’t say they were just doing their job this time and it’s time they were held accountable.

https://docs.google.com/document/d/1koXe2gMQoOeWJCnpZ53nfWTD7gI2iiM40tWoR6LFJpI/edit

Hippocratic Oath

First and foremost, now is the perfect time to be reminded of the Hippocratic Oath taken. Which can be found here –

https://www.pbs.org/wgbh/nova/doctors/oath_modern.html

Against this historical background, it can be seen how conceptions of justice are relevant to research involving human subjects. For example, the selection of research subjects needs to be scrutinized in order to determine whether some classes (e.g., welfare patients, particular racial and ethnic minorities, or persons confined to institutions) are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied. 

Finally, whenever research supported by public funds leads to the development of therapeutic devices and procedures, justice demands both that these not provide advantages only to those who can afford them and that such research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research. Belmont Report

Read more –

https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html#xethical

States must protect people from potential harms arising from and during scientific research. States have the obligation to protect people from being used or exploited in harmful scientific experiments, as well as the obligation to set safeguards to prevent harm caused by research or experimentation.

The length of this letter is due to the extensive use of direct extracts from various official documents. All the legal information regarding informed consent is here and it is in you and your centre’s/departments best interest to heed this warning. A media release outlining the contents of this letter, as well as the intent behind sending it, will be sent to all major and community media outlets for the sake of transparency.

As we have seen in the past, medical professionals can be held criminally responsible for their role in medical experiments gone wrong. It is for this reason we are sending this letter to inform you today and our only intention is to save lives by ensuring medical professionals are doing their best to adhere to the applicable laws and do no harm during this mass clinical trial. Medical professionals don’t always get it right, but we hope that, armed with this information, unnecessary mistakes will be avoided.

From the outset, we need to be clear on an important aspect of the vaccine rollout: the federal minister for health, Greg Hunt has described the vaccine rollout as the “largest clinical trial, the largest global vaccination trial ever”.

Full transcript here – https://www.health.gov.au/ministers/the-hon-greg-hunt-mp/media/interview-with-david-speers-on-abc-insiders-on-the-covid-19-vaccine-rollout

Video –

https://m.facebook.com/watch/?v=434714824280997

Therefore the usual informed consent requirements like the ones listed below (from the Australian Immunisation Handbook), does not apply where subjects of medical experiments are concerned. Language barriers need to be addressed to the point that communities understand that the vaccination is part of a clinical trial, understand the ingredients list and allergy status as well as risks and what to do in case of an adverse event.

The COVID-19 risk of ADE should have been and should be prominently and independently disclosed to research subjects currently in vaccine trials, to those being recruited for the trials and to future patients after vaccine consent, in order to meet the medical ethics standard of patient comprehension for informed consent.

https://pubmed.ncbi.nlm.nih.gov/33113270/

Trespass to the Person

Intentional interference with a person is also known as Trespass to the Person. This is classified as any unwanted, offensive, or unjustified interference with a person’s body, liberty or rights. Charges of interference do not necessarily burden the plaintiff with proving damages, rather with proving intent to commit the offense.

As modern medicine progress, it is worth bearing in mind that the more elective and discretionary the procedure is, the greater responsibility there is on the doctor to provide information about risks. It is not enough for a doctor to just sign a paper; they must sit down with the patient and make sure that the patient understands the risks involved.

There is case law in Australia about informed consent. Each state and territory also has guardianship and/or medical treatment legislation about capacity and consent. This legislation is different in each state and territory, and can be complex.

QLD –

“A reasonable person in the patient’s position, if warned of the risk, would be likely to attach significance to it; or if the medical practitioner is or should be reasonably aware that the particular patient if warned of the risk would be likely to attach significance to it.”

Criminal Trespass of Person

At common law a trespass was not criminal unless it was accomplished by violence or breached the peace. Some modern statutes make any unlawful entry onto another’s property a crime. When the trespass involves violence or injury to a person or property, it is always considered criminal, and penalties may be increased for more serious or malicious acts. Criminal intent may have to be proved to convict under some statutes, but in some states trespass is a criminal offense regardless of the defendant’s intent.

Meaning of Intent:

In tort law, intent is a classification element for charges of assault, battery and infliction of mental distress. Intent is the desire and deliberate planning to do something. Tort law defines an intentional tort as a civil wrong knowingly committed by the offender. This is contrasted with a tort of negligence, which results from lack of concern or responsibility on behalf of the offender.

Damages awarded in tort cases when intent is proven are generally larger and more successful than negligence cases.

Liability in the absence of consent – The absence of a valid consent is a determining factor in establishing liability for civil assault or trespass.

The Queensland Criminal Code s.245 definition of assault is:

“(1) A person who strikes, touches or moves or otherwise applies force of any kind to the person of another, either directly or indirectly, without the other person’s consent, or with the other person’s consent if a consent is obtained by flawed, or who by any bodily act or gestures attempts or threatens to apply force of any kind to the person of another without the other person’s consent, under such circumstances that the person making the attempt or threat has actually or apparently a present ability to affect the person’s purpose, is said to assault that other person and the act is called an assault.”

The informed consent process for the medical experiment involving the covid-19 vaccine is incompatible with the human rights set out in the charter (Charter of Human Rights and Responsibilities Act 2006). Furthermore, the bill is incompatible with The Australian Constitution Section 10. Protection from torture and cruel, inhuman or degrading treatment.

A person must not be—

(a) subjected to torture; or

(b) treated or punished in a cruel, inhuman or degrading way; or

(c) subjected to medical or scientific experimentation or treatment without his or her full, free and informed consent.

The Nuremberg Code, the first of its kind, was created to prevent a recurrence of the horrors committed in Nazi Germany, and it paved the way for the development of medical ethics and greatly influenced the evolution of human rights law.

The later Declaration of Helsinki, adopted in 1964, reaffirmed the need for informed consent in all research and warned that the “interest of science and society should never take precedence over considerations related to the wellbeing of the subject.”

In 1978, the Belmont Report framed these issues into “broader ethical principles [to] provide a basis on which specific rules may be formulated, criticized, and interpreted,” and focused on three main principles: respect for persons, beneficence, and justice.

The International Coalition of Medicines Regulatory Authorities (ICMRA) provides a global architecture to support enhanced communication, information sharing, crisis response and address regulatory science issues.

International Coalition of Medicines Regulatory Authorities (ICMRA) is acting as a forum to support strategic coordination and international cooperation among global medicine regulatory authorities.

The aim of these activities is to expedite and streamline the development, authorisation and availability of COVID-19 treatments and vaccines worldwide. ICMRA members also work towards increasing the efficiency and effectiveness of regulatory processes and decision-making.

In June 2020, ICMRA members committed to stepping up the global collaboration and prioritisation of COVID-19 clinical trials, with the aim of expediting COVID-19 medicine and vaccine development and approval based on robust scientific evidence.

ICMRA statement on clinical trials: International regulators provide guidance on prioritisation of COVID-19 clinical trials

In the joint statement on clinical trials, ICMRA members:

Set out concrete actions that stakeholders involved with COVID-19 clinical trials should take to collect, analyse and report the data required to determine which investigational or repurposed medicinal products would be safe and effective for the treatment or prevention of COVID-19;

Emphasise their commitment to cooperate, expedite and share the evaluation of all COVID-19 trial results submitted to them;

Pledge to provide clear and transparent benefit-risk analyses in order to support the approval of effective and safe medicines, biologics, and vaccines against COVID-19.

http://www.icmra.info/drupal/strategicinitiatives/vaccines/statement_general_public

With the Nuremberg Code, the Helsinki Declaration, the Belmont Report, and the International Ethical Guidelines for Biomedical Research Involving Human Subjects as the instruments to be followed, there is a noticeable need for legally enforceable norms to protect the rights of research participants.

It is important to note the international standards for human subject research in the light of norms enshrined in human rights treaties.

We have attached relevant national international ethics and standards around medical research involving human subjects, so there is no reason for those in positions of power to claim they were unaware. We plan to make further enquiries about the safety and suitability of this vaccine and if this notice is ignored we will also consider filing a federal injunction as a class action to put a stop to the unlawful and negligent medical practices on all Australians.

Covid-19: politicisation, “corruption,” and suppression of science

Politicians and governments are suppressing science. They do so in the public interest, they say, to accelerate availability of diagnostics and treatments. They do so to support innovation, to bring products to market at unprecedented speed. Both of these reasons are partly plausible; the greatest deceptions are founded in a grain of truth. But the underlying behaviour is troubling.

Science is being suppressed for political and financial gain. Covid-19 has unleashed state corruption on a grand scale, and it is harmful to public health. Politicians and industry are responsible for this opportunistic embezzlement. So too are scientists and health experts. The pandemic has revealed how the medical-political complex can be manipulated in an emergency—a time when it is even more important to safeguard science.

https://www.bmj.com/content/371/bmj.m4425/rr-3

Important Information for anyone giving the covid-19 vaccine to First Nations peoples.

Some of the information you must be sure patients are aware of to properly attain free, full, prior informed consent. Please read up on current laws and legislation to stay informed. We have compiled what we can to help.

The plan to immunise First Nations People because they are considered “vulnerable”, would breach the provisions by various human-rights instruments in force in Australia, as well as the Constitution itself, of inalienable freedom of informed choice to refuse medical products and procedures.

The plan to inject untested substances into Aboriginal or Torres Strait Islanders people who die almost 10 years earlier than non Aboriginal or Torres Strait Islanders, can meet its putative intent only by violating the most fundamental medical ethic, which forbids experimentation by imposition of the risk of a medical procedure on one person for the sake of another.

https://www.aihw.gov.au/reports/australias-health/indigenous-life-expectancy-and-deaths

Human research is not exempt from restrictions necessary to guarantee respect for human rights. We urge you all to proceed with great caution. Before you do anything, it is in everyone’s best interest to learn about Research ethics on Aboriginal and Torres Strait Islanders in particular.

Currently, the National Statement requires all research with Aboriginal and Torres Strait Islander people to be subject to ethics review by a human research ethics committee with relevant skills and experience.

AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research

The AIATSIS Act (1989) mandates AIATSIS to provide leadership in the field of ethics and protocols for research related to Aboriginal and Torres Strait Islander peoples and collections.

The AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research (The AIATSIS Code) ensures that research with and about Aboriginal and Torres Strait Islander peoples follows a process of meaningful engagement and reciprocity between the researcher and the individuals and/or communities involved in the research.

https://aiatsis.gov.au/research/ethical-research

Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders

Responsibility is reflected through:

• Inflicting no harm. There is a clear responsibility for researchers to do no harm to Aboriginal and Torres Strait Islander individuals or communities or to those things that they value. The risk of harm, discomfort or inconvenience to participants and to others must be assessed; and research is ethically acceptable only when its potential benefits justify any risks involved in the research. Information about assessing risk and benefit can be found in Chapter 2.1 of the National Statement.

• Establishing processes to ensure researchers’ accountability to individuals, families and communities, particularly in relation to the cultural and social dimensions of Aboriginal and Torres Strait Islander life. When engaging Aboriginal and Torres Strait Islander people and communities in research, researchers carry responsibilities in addition to the science of their research. The connection between their research and community life brings responsibilities for which the researchers or members of the community may be held accountable. Ethical research occurs when harmony between the sets of responsibilities is established, participants’ rights are protected, trust is maintained and mutual accountability is clear. Information about building relationships can be found in Keeping research on track II 2018.

Demonstrating responsibility

Examples of demonstrating responsibility in research with Aboriginal and Torres Strait Islander people and communities could include:

• Providing all relevant information for the participants prior to seeking consent, so participants and researchers can consider and manage potential implications of research participation for individual participants, communities, and the partners or family members of participants.

• Ensuring that risk management strategies are in place and that these strategies cover all aspects of the research project.

• Engaging participants and communities in monitoring and evaluating ethical research practice to minimise the likelihood of any unintended consequences arising from or occurring after the research project.

https://www.nhmrc.gov.au/file/8981/download?token=hrxHs075

In the field of humanitarian law, the legal framework includes the Geneva Conventions that specify the prohibition of biological experiments on wounded or sick members of armed forces and the ban on medical or scientific experiments on prisoners of war not justified by the prisoner’s need. Moreover, its Additional Protocols applicable to victims of armed conflict forbid experiments on wounded, sick, or shipwrecked persons even with their consent, and on persons who are interned, detained, or held.

International standards for human subject research

The Universal Declaration of Human Rights (UDHR) was adopted in 1948, proclaiming that “All human beings are born free and equal in dignity and rights…endowed with reason and conscience” and recognizing that “No one shall be subjected to torture or to cruel, inhuman or degrading treatment.” While not legally binding, the UDHR set the ground for the adoption of the International Covenant on Civil and Political Rights (ICCPR) and the International Covenant of Economic, Social and Cultural Rights (ICESCR).

The ICCPR provides that “no one shall be subjected without his free consent to medical or scientific experimentation.” When analysing its drafting history, one can clearly identify that Article 7 was the result of the broad consensus of participants to explicitly include the prohibition as a response to the atrocities committed in concentration camps during the Second World War. The UN Human Rights Committee later interpreted Article 7 as requiring “special protections” and provided that the prohibition in article 7 relates not only to acts that cause physical pain but also to acts that cause mental suffering to the victim. Moreover, the prohibition extends to corporal punishment, including excessive chastisement ordered as punishment for a crime or as an educative or disciplinary measure.

The Convention on the Rights of the Child (CRC) requires States parties to ensure that the views of the child are given “due weight… in all matters affecting the child” and that parents and guardians act in the “best interests of the child.”

The Convention Against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment (CAT) defines “torture” as “any act by which severe pain or suffering, whether physical or mental, is intentionally inflicted on a person for such purposes as obtaining from him or a third person information or a confession.”   Article 1.1. Moreover, Article 16 sets the state’s obligation to prevent cruel, inhuman, or degrading treatment which do not amount to torture as defined in Article 1, under its jurisdiction.

With regards to persons with disabilities, the Convention on the Rights of Persons with Disabilities (CRPD) recognizes that States must provide them with equal recognition of legal capacity and protection against non-consensual experimentation, as well as prohibit exploitation and respect physical and mental integrity.

Attached for you and staff are the relevant sections and information from the Australian National Standards, International ethical guidelines for biomedical research involving human subjects, TGA articles on Informed Consent of Trial Subjects, the Nuremberg code and the Belmont Report.  These are only excerpts of the appropriate sections, a link is included to read on.

We’ve also attached links to informative  videos about covid-19 vaccines (one that we produced),  an example of a lawful consent form, information sheet and info graphics; for those interested in learning more or providing more information to community.

We hope that with by providing you with up- to- the minute legal and moral guidelines, that  your staff are fully aware of  their obligations. We have tried to provide you with as much relevant information available to do this.

Again, please do not let history be repeated. We hope this information will help save lives.

Respectfully,

Kaiyu Bayles

Blackfulla Independent Media

List of Attachments

– The AIATSIS Code 

– Australian Code for the Responsible  Conduct of Research 2018

– National Statement on Ethical Conduct in Human Research

– National Standards

– TGA Guidelines for Informed Consent of Trial Subjects

– International ethical guidelines for biomedical research involving human subjects

–  Ethical Principles and Guidelines for the Protection of Human Subjects of Research

– Ethical Principles and Guidelines for the Protection of Human Subjects of Research

– WHO-ICMRA joint statement on the need for improved global regulatory alignment on COVID-19 medicines and vaccines

– Video Link “Urgent Message To The Mob”

– Link to video covering death of two people in Australia following covid vaccines

– State and territory contacts details

– An example of a lawful consent form

– Info Graphics

The AIATSIS Code 

This Code forms part of the Australian framework for ethical and responsible conduct of research, established under the Australian Code for the Responsible Conduct of Research7 and including the 

National Statement on Ethical Conduct in Human Research8 (referred to throughout as the Code for Responsible Research and the National Statement, respectively). This Code provides further guidance on the application of those standards in Aboriginal and Torres Strait Islander research. The AIATSIS Code of Ethics should be read in conjunction with the United Nations Declaration on the Rights of Indigenous 

Peoples 2007 (the Declaration), the Code for Responsible Research and the National Statement.

Within this framework, this Code sets consistent national standards for the ethical and responsible conduct of all Aboriginal and Torres Strait Islander research. 

Informed consent

1.9 Aboriginal and Torres Strait Islander peoples have a right to determine what research is and is not carried out in their communities. Before any research is undertaken, plans for research projects must show evidence of free, prior and informed consent of the relevant Indigenous peoples.

a. informed consent of a group or people (in addition to individual participants within that group), is required where the collective rights, interests or knowledge of Indigenous peoples are involved.

b. collective consent may be evidenced through partnership agreements and collaboration agreements with Indigenous research partners or other documentation of Indigenous engagement in the design, governance and conduct of the research.

c. an agreement to consent to the research can be given and recorded verbally, in writing or in a form that is consistent with the method (for example online surveys) and is culturally appropriate.

1.10 Researchers are responsible for understanding the meaning of free, prior and informed consent (FPIC), and the steps that must be taken to give it effect. (See 

Guide: 2.1. Obtaining informed consent.)

a. agreement to participate in or support 

research must be obtained prior to research being undertaken.

b. agreement must be voluntarily given, free from coercion, duress or pressure.

c. participants and partners in research must understand the proposed research and its implications as well material details, as set out in the National Statement.

1.11 Collective consent does not remove the requirement to respect individual rights to participate in Aboriginal and Torres Strait Islander research and individual consent requirements as set out in the 

Australian Code for the Responsible Conduct of Research 2018

The 2018 Code should be read alongside the Guide to Managing and Investigating Potential Breaches of the Australian Code for the Responsible Conduct of Research, 2018 (the Investigation Guide) – see ‘Download’ below. This guide outlines a model process for institutions to use to manage and investigate potential breaches of the 2018 Code.

Responsibilities of institutions

Responsible research conduct is fostered and underpinned by the research culture of the institution. Institutions have an obligation to encourage and support responsible research conduct. They are accountable to funding organisations and the Australian community for how research is conducted. To foster responsible research conduct, institutions will:

R1 Establish and maintain good governance and management practices for responsible research conduct.

R2 Identify and comply with relevant laws, regulations, guidelines and policies related to the conduct of research.

R3 Develop and maintain the currency and ready availability of a suite of policies and procedures which ensure that institutional practices are consistent with the principles and responsibilities of the Code.

R4 Provide ongoing training and education that promotes and supports responsible research conduct for all researchers and those in other relevant roles.

R5 Ensure supervisors of research trainees have the appropriate skills, qualifications and resources.

R6 Identify and train Research Integrity Advisors who assist in the promotion and fostering of responsible research conduct and provide advice to those with concerns about potential breaches of the Code.

R7 Support the responsible dissemination of research findings. Where necessary, take action to correct the record in a timely manner.

R8 Provide access to facilities for the safe and secure storage and management of research data, records and primary materials and, where possible and appropriate, allow access and reference.

R9 Facilitate the prevention and detection of potential breaches of the Code.

R10 Provide mechanisms to receive concerns or complaints about potential breaches of the Code. Investigate and resolve potential breaches of the Code.

R11 Ensure that the process for managing and investigating concerns or complaints about potential breaches of the Code is timely, effective and in accord with procedural fairness.

R12 Support the welfare of all parties involved in an investigation of a potential breach of the Code.

R13 Base findings of investigations on the balance of probabilities and ensure any actions are commensurate with the seriousness of the breach.

Researchers will uphold the principles of responsible research conduct in all aspects of their research. To this end, researchers will:

R14 Support a culture of responsible research conduct at their institution and in their field of practice.

R15 Provide guidance and mentorship on responsible research conduct to other researchers or research trainees under their supervision and, where appropriate, monitor their conduct.

R16 Undertake and promote education and training in responsible research conduct.

R17 Comply with the relevant laws, regulations, disciplinary standards, ethics guidelines and institutional policies related to responsible research conduct. Ensure that appropriate approvals are obtained prior to the commencement of research, and that conditions of any approvals are adhered to during the course of research.

R18 Ensure that the ethics principles of research merit and integrity, justice, beneficence and respect are applied to human research.

R19 Engage with Aboriginal and Torres Strait Islander peoples and respect their legal rights and local laws, customs and protocols.

R20 Ensure that the 3Rs (Replacement, Reduction and Refinement) are considered at all stages of research involving animals and minimise the impacts on animals used in research and in so doing support the welfare and wellbeing of these animals.

R21 Adopt methods appropriate to the aims of the research and ensure that conclusions are justified by the results.

R22 Retain clear, accurate, secure and complete records of all research including research data and primary materials. Where possible and appropriate, allow access and reference to these by interested parties.

R23 Disseminate research findings responsibly, accurately and broadly. Where necessary, take action to correct the record in a timely manner.

R24 Disclose and manage actual, potential or perceived conflicts of interest.

R25 Ensure that authors of research outputs are all those, and only those, who have made a significant intellectual or scholarly contribution to the research and its output, and that they agree to be listed as an author.

R26 Acknowledge those who have contributed to the research.

R27 Cite and acknowledge other relevant work appropriately and accurately.

R28 Participate in peer review in a way that is fair, rigorous and timely and maintains the confidentiality of the content.

R29 Report suspected breaches of the Code to the relevant institution and/or authority.

Guide to Managing and Investigating Potential Breaches of the Australian Code for the Responsible Conduct of Research, 2018 (the Investigation Guide) 

8.3 Safety issues

If at any time it becomes apparent that the complaint relates to an activity that could harm humans, animals or the environment, immediate action must be taken to minimise the risk of harm. This action is at the discretion of the institution and is independent of the Code investigation.

These matters may require referral or notification to an appropriate agency (e.g., regulatory agencies, WorkSafe). They may also trigger other institutional responsibilities and processes.

National Standards

Australian Charter of Rights in Healthcare, the National Safety and Quality Health Service Standards, the National Framework on Advance Care Directives, publications on communication with patients and the national codes of conduct of health practitioners.

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.

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. 

Good clinical practice involves ensuring that informed consent is validly obtained and appropriately timed.

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.

Informed financial consent is an important but separate consent process. Consumers required to pay directly for health services should be consented to before receiving care.

Key principles for informed consent

■ Other than in exceptional circumstances, adults have the right to determine what will be done to their bodies and what healthcare treatments and interventions they will undergo

■ Where a person lacks legal capacity, the framework for obtaining substitute consent that applies in each state or territory must be used to obtain consent to treatment

■ Any healthcare treatment, procedure or other intervention undertaken without consent is unlawful unless legislation in a state or territory, or case law, permits the treatment, procedure or other intervention without consent. For example, treatment provided in an emergency, or for certain mental health interventions

Healthcare providers have a duty to warn about the material risks of the treatment, procedure or other intervention as part of obtaining a person’s consent.

Failure to adequately warn a person of these risks is a breach of the healthcare provider’s duty of care

■ A person has the right to refuse treatment (with some legislated exceptions) or withdraw consent previously given prior to treatment

■ It is important to contemporaneously document consent discussions and include written consent forms (where appropriate) in the person’s healthcare record

■ Any healthcare treatment, not just operations and other procedures, requires valid consent either verbally, written, or implied. This includes prescribing drugs and other therapeutic substances.

How to obtain valid informed consent

Informed consent is achieved through a process of communication, discussion, and shared decision making. It involves understanding the person’s goals and concerns, and discussing with the person (or their substitute decision-maker) their options for treatment, the potential outcomes (positive, negative and neutral), risks and benefits and what this might mean for them. The person or their substitute decision-maker will make an informed decision based on this information.

Informed consent in health care

For there to be valid informed consent, the person consenting must:

■ Have the legal capacity to consent

■ Give their consent voluntarily

■ Give their consent to the specific treatment, procedure or other intervention being discussed

■ Have enough information about their condition, treatment options, the benefits and risks relevant to them, and alternative options for them to make an informed decision to consent.

This includes the opportunity to ask questions and discuss concerns.

Read more – https://www.safetyandquality.gov.au/sites/default/files/2020-09/sq20-030_-_fact_sheet_-_informed_consent_-_nsqhs-8.9a.pdf 

National Statement on Ethical Conduct in Human Research

Purpose

The purpose of this National Statement is to promote ethically good human research. Fulfilment of this purpose requires that participants be accorded the respect and protection that is due to them. It also involves the fostering of research that is of benefit to the community.

The National Statement is therefore designed to clarify the responsibilities of:

institutions and researchers for the ethical design, conduct and dissemination of results of human research; and review bodies in the ethical review of research.

The National Statement will help them to meet their responsibilities: to identify issues of ethics that arise in the design, review and conduct of human research, to deliberate about those ethical issues, and to justify decisions about them.

Read more here: https://www.nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018#toc__48 

A must read for all staff administering vaccines – guidance from the TGA.

4.8 Informed Consent of Trial Subjects

4.8.1 In obtaining and documenting informed consent, the investigator should comply with the applicable regulatory requirement(s), and should adhere to GCP and to the ethical principles that have their origin in the Declaration of Helsinki. Prior to the beginning of the trial, the investigator should have the IRB/IEC’s ? written approval/favourable opinion of the written informed consent form and any other written information to be provided to subjects.

4.8.2 The written informed consent form and any other written information to be provided to subjects should be revised whenever important new information becomes available that may be relevant to the subject’s consent. Any revised written informed consent form, and written information should receive the IRB/IEC’s approval/favourable opinion in advance of use. The subject or the subject’s legally acceptable representative should be informed in a timely manner if new information becomes available that may be relevant to the subject’s willingness to continue participation in the trial. The communication of this information should be documented.

4.8.3 Neither the investigator, nor the trial staff, should coerce or unduly influence a subject to participate or to continue to participate in a trial.

4.8.4 None of the oral and written information concerning the trial, including the written informed consent form, should contain any language that causes the subject or the subject’s legally acceptable representative to waive or to appear to waive any legal rights, or that releases or appears to release the investigator, the institution, the sponsor, or their agents from liability for negligence.

4.8.5 The investigator, or a person designated by the investigator, should fully inform the subject or, if the subject is unable to provide informed consent, the subject’s legally acceptable representative, of all pertinent aspects of the trial including the written information and the approval/ favourable opinion by the IRB/IEC.

4.8.6 The language used in the oral and written information about the trial, including the written informed consent form, should be as non-technical as practical and should be understandable to the subject or the subject’s legally acceptable representative and the impartial witness, where applicable. 

4.8.7 Before informed consent may be obtained, the investigator, or a person designated by the investigator, should provide the subject or the subject’s legally acceptable representative ample time and opportunity to inquire about details of the trial and to decide whether or not to participate in the trial. All questions about the trial should be answered to the satisfaction of the subject or the subject’s legally acceptable representative.

4.8.8 Prior to a subject’s participation in the trial, the written informed consent form should be signed and personally dated by the subject or by the subject’s legally acceptable representative, and by the person who conducted the informed consent discussion.

4.8.9 If a subject is unable to read or if a legally acceptable representative is unable to read, an impartial witness should be present during the entire informed consent discussion. After the written informed consent form and any other written information to be provided to subjects, is read and explained to the subject or the subject’s legally acceptable representative, and after the subject or the subject’s legally acceptable representative has orally consented to the subject’s participation in the trial and, if capable of doing so, has signed and personally dated the informed consent form, the witness should sign and personally date the consent form. By signing the consent form, the witness attests that the information in the consent form and any other written information was accurately explained to, and apparently understood by, the subject or the subject’s legally acceptable representative, and that informed consent was freely given by the subject or the subject’s legally acceptable representative.

4.8.10 Both the informed consent discussion and the written informed consent form and any other written information to be provided to subjects should include explanations of the following:

(a) That the trial involves research. 

b) The purpose of the trial

(c) The trial treatment(s) and the probability for random assignment to each treatment.

(d) The trial procedures to be followed, including all invasive procedures.

(e) The subject’s responsibilities.

(f) Those aspects of the trial that are experimental.

(g) The reasonably foreseeable risks or inconveniences to the subject and, when applicable, to an embryo, fetus, or nursing infant.

(h) The reasonably expected benefits. When there is no intended clinical benefit to the subject, the subject should be made aware of this.

(i) The alternative procedure(s) or course(s) of treatment that may be available to the subject, and their important potential benefits and risks.

(j) The compensation and/or treatment available to the subject in the event of trial related elated injury.

(k) The anticipated prorated payment, if any, to the subject for participating in the trial.

(l) The anticipated expenses, if any, to the subject for participating in the trial.

(m) That the subject’s participation in the trial is voluntary and that the subject may refuse to participate or withdraw from the trial, at any time, without penalty or loss of benefits to which the subject is otherwise entitled. 

(n) That the monitor(s), the auditor(s), the IRB/IEC, and the regulatory authority(ies) will be granted direct access to the subject’s original medical records for Historical document 20 verification of clinical trial procedures and/or data, without violating the confidentiality of the subject, to the extent permitted by the applicable laws and regulations and that, by signing a written informed consent form, the subject or the subject’s legally acceptable representative is authorizing such access.

(o) That records identifying the subject will be kept confidential and, to the extent permitted by the applicable laws and/or regulations, will not be made publicly available. If the results of the trial are published, the subject’s identity will remain confidential.

(p) That the subject or the subject’s legally acceptable representative will be informed in a timely manner if information becomes available that may be relevant to the subject’s willingness to continue participation in the trial.

(q) The person(s) to contact for further information regarding the trial and the rights of trial subjects, and whom to contact in the event of trial-related injury.

(r) The foreseeable circumstances and/or reasons under which the subject’s participation in the trial may be terminated.

(s) The expected duration of the subject’s participation in the trial.

(t) The approximate number of subjects involved in the trial. 

4.8.11 Prior to participation in the trial, the subject or the subject’s legally acceptable representative should receive a copy of the signed and dated written informed consent form and any other written information provided to the subjects.

During a subject’s participation in the trial, the subject or the subject’s legally acceptable representative should receive a copy of the signed and dated consent form updates and a copy of any amendments to the written information provided to subjects.

4.8.12 When a clinical trial (therapeutic or non-therapeutic) includes subjects who can only be enrolled in the trial with the consent of the subject’s legally acceptable representative (e.g., minors, or patients with severe dementia), the subject should be informed about the trial to the extent compatible with the subject’s understanding and, if capable, the subject should sign and personally date the written informed consent. *TGA comment: 

More detailed information about requirements for obtaining informed consent in special cases can be found in the NHMRC National Statement on Ethical Conduct in Research Involving Humans, as follows: children (section 4); persons with intellectual or mental impairment (section 5); persons highly dependent on medical care (section 6) and persons in dependent or unequal relationships (section 7).

4.8.13 Except as described in 4.8.14, a non-therapeutic trial (i.e. a trial in which there is no anticipated direct clinical benefit to the subject), should be conducted in subjects who personally give consent and who sign and date the written informed consent form. 

4.8.14 Non-therapeutic trials may be conducted in subjects with consent of a legally acceptable representative provided the following conditions are fulfilled: (a) The objectives of the trial cannot be met by means of a trial in subjects who can give informed consent personally. (b) The foreseeable risks to the subjects are low. (c) The negative impact on the subject’s well-being is minimized and low. Historical document 21 (d) The trial is not prohibited by law. (e) The approval/favourable opinion of the IRB/IEC is expressly sought on the inclusion of such subjects, and the written approval/ favourable opinion covers this aspect. Such trials, unless an exception is justified, should be conducted in patients having a disease or condition for which the investigational product is intended. Subjects in these trials should be particularly closely monitored and should be withdrawn if they appear to be unduly distressed.

Read more here- https://www.tga.gov.au/sites/default/files/ich13595an.pdf?fbclid=IwAR0dAaPCeh60faI-DGW6s66bAaI_VXAFydq7OmWlcDxdTDG_pv1mmeGqKVk 

Following are the international standards for human subject research in the light of norms enshrined in human rights treaties.

The Declaration of Helsinki

International ethical guidelines for biomedical research involving human subjects –

Prepared by the Council for International Organizations of Medical Sciences

(CIOMS) in collaboration with the World Health Organization (WHO). CIOMS, Geneva 2002. The text of the guidelines reproduced here does not include the commentary provided in the full document. This can be found at http:\\www.cioms.ch\frame_guidelines _nov_2002.htm

Guideline 1: Ethical justification and scientific validity of biomedical research involving human beings

The ethical justification of biomedical research involving human subjects is the prospect of discovering new ways of benefiting people’s health. Such research can be ethically justifiable only if it is carried out in ways that respect and protect, and are fair to, the subjects of that research and are morally acceptable within the communities in which the research is carried out.

Moreover, because scientifically invalid research is unethical in that it exposes research subjects to risks without possible benefit, investigators and sponsors must ensure that proposed studies involving human subjects conform to generally accepted scientific principles and are based on adequate knowledge of the pertinent scientific literature.

Guideline 5: Obtaining informed consent: Essential information for prospective research subjects

Before requesting an individual’s consent to participate in research, the investigator must provide the following information, in language or another form of communication that the individual can understand:

1. that the individual is invited to participate in research, the reasons for considering the individual suitable for the research, and that participation is voluntary;

2. that the individual is free to refuse to participate and will be free to withdraw from the research at any time without penalty or loss of benefits to which he or she would otherwise be entitled;

3. the purpose of the research, the procedures to be carried out by the investigator and the subject, and an explanation of how the research differs from routine medical care;

4. for controlled trials, an explanation of features of the research design (e.g. randomization, double-blinding), and that the subject will not be told of the assigned treatment until the study has been completed and the blind has been broken

5. the expected duration of the individual’s participation (including number and duration of visits to the research centre and the total time involved) and the possibility of early termination of the trial or of the individual’s participation in it;

6. whether money or other forms of material goods will be provided in return for the individual’s participation and, if so, the kind and amount;

7. that, after completion of the study, subjects will be informed of the findings of the research in general, and individual subjects will be informed of any finding that relates to their particular health status;

8. that subjects have the right of access to their data on demand, even if these data lack immediate clinical utility (unless the ethical review committee has approved temporary or permanent non-disclosure of data, in which case the subject should be informed of, and given, the reasons for such non-disclosure);

9. any foreseeable risks, pain or discomfort, or inconvenience to the individual (or others) associated with participation in the research, including risks to the health or well-being of a subject’s spouse or partner;

10. the direct benefits, if any, expected to result to subjects from participating in the research;

11. the expected benefits of the research to the community or to society at large, or contributions to scientific knowledge;

12. whether, when and how any products or interventions proven by the research to be safe and effective will be made available to subjects after they have completed their participation in the research, and whether they will be expected to pay for them;

13. any currently available alternative interventions or courses of treatment;

14. the provisions that will be made to ensure respect for the privacy of subjects and for the confidentiality of records in which subjects are identified;

15. the limits, legal or other, to the investigators’ ability to safeguard confidentiality, and the possible consequences of breaches of confidentiality;

16. policy with regard to the use of results of genetic tests and familial genetic information, and the precautions in place to prevent disclosure of the results of a subject’s genetic tests to immediate family relatives or to others (e.g., insurance companies or employers) without the consent of the subject;

17. the sponsors of the research, the institutional affiliation of the investigators, and the nature and sources of funding for the research;

18. the possible research uses, direct or secondary, of the subject’s medical records and of biological specimens taken in the course of clinical care;

19. whether it is planned that biological specimens collected in the research will be destroyed at its conclusion, and, if not, details about their storage (where, how, for how long, and final disposition) and possible future use, and that subjects have the right to decide about such future use, to refuse storage, and to have the material destroyed;

20. whether commercial products may be developed from biological specimens, and whether the participant will receive monetary or other benefits from the development of such products;

21. whether the investigator is serving only as an investigator or as both investigator and the subject’s physician;

22. the extent of the investigator’s responsibility to provide medical services to the participant;

23. that treatment will be provided free of charge for specified types of research-related injury or for complications associated with the research, the nature and duration of such care, the name of the organization or individual that will provide the treatment, and whether there is any uncertainty regarding funding of such treatment;

24. in what way, and by what organization, the subject or the subject’s family or dependants will be compensated for disability or death resulting from such injury (or, when indicated, that there are no plans to provide such compensation);

25. whether or not, in the country in which the prospective subject is invited to participate in research, the right to compensation is legally guaranteed;

26. that an ethical review committee has approved or cleared the research protocol.

Guideline 6: Obtaining informed consent: Obligations of sponsors and investigators

Sponsors and investigators have a duty to:

• refrain from unjustified deception, undue influence, or intimidation;

• seek consent only after ascertaining that the prospective subject has adequate understanding of the relevant facts and of the consequences of participation and has had sufficient opportunity to consider whether to participate;

• as a general rule, obtain from each prospective subject a signed form as evidence of informed consent—investigators should justify any exceptions to this general rule and obtain the approval of the ethical review committee;

• renew the informed consent of each subject if there are significant changes in the conditions or procedures of the research or if new information becomes available that could affect the willingness of subjects to continue to participate; and,

• renew the informed consent of each subject in long-term studies at pre-determined intervals, even if there are no changes in the design or objectives of the research.

Guideline 7: Inducement to participate

Subjects may be reimbursed for lost earnings, travel costs and other expenses incurred in taking part in a study; they may also receive free medical services. Subjects, particularly those who receive no direct benefit from research, may also be paid or otherwise compensated for inconvenience and time spent. The payments should not be so large, however, or the medical services so extensive as to induce prospective subjects to consent to participate in the research against their better judgement (“undue inducement”). All payments, reimbursements and medical services provided to research subjects must have been approved by an ethical review committee.

Guideline 8: Benefits and risks of study participation

For all biomedical research involving human subjects, the investigator must ensure that potential benefits and risks are reasonably balanced and risks are minimized.

• Interventions or procedures that hold out the prospect of direct diagnostic, therapeutic or preventive benefit for the individual subject must be justified by the expectation that they will be at least as advantageous to the individual subject, in the light of foreseeable risks and benefits, as any available alternative. Risks of such “beneficial” interventions or procedures must be justified in relation to expected benefits to the individual subject.

• Risks of interventions that do not hold out the prospect of direct diagnostic, therapeutic or preventive benefit for the individual must be justified in relation to the expected benefits to society (generalizable knowledge). The risks presented by such interventions must be reasonable in relation to the importance of the knowledge to be gained.

Guideline 10: Research in populations and communities with limited resources

Before undertaking research in a population or community with limited resources, the sponsor and the investigator must make every effort to ensure that:

• the research is responsive to the health needs and the priorities of the population or community in which it is to be carried out; and

• any intervention or product developed, or knowledge generated, will be made reasonably available for the benefit of that population or community.

Guideline 13: Research involving vulnerable persons

Special justification is required for inviting vulnerable individuals to serve as research subjects and, if they are selected, the means of protecting their rights and welfare must be strictly applied.

Guideline 19: Right of injured subjects to treatment and compensation

Investigators should ensure that research subjects who suffer injury as a result of their participation are entitled to free medical treatment for such injury and to such financial or other assistance as would compensate them equitably for any resultant impairment, disability or handicap. In the case of death as a result of their participation, their dependants are entitled to compensation. Subjects must not be asked to waive the right to compensation.

Guideline 21: Ethical obligation of external sponsors to provide health-care services

External sponsors are ethically obliged to ensure the availability of:

• health-care services that are essential to the safe conduct of the research;

• treatment for subjects who suffer injury as a consequence of research interventions; and,

• services that are a necessary part of the commitment of a sponsor to make a beneficial intervention or product developed as a result of the research reasonably available to the population or community concerned.

Read more – https://www.who.int/bulletin/archives/79(4)373.pdf 

The Belmont Report

Ethical Principles and Guidelines for the Protection of Human Subjects of Research

The National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research

Basic Ethical Principles

The expression “basic ethical principles” refers to those general judgments that serve as a basic justification for the many particular ethical prescriptions and evaluations of human actions. Three basic principles, among those generally accepted in our cultural tradition, are particularly relevant to the ethics of research involving human subjects: the principles of respect of persons, beneficence and justice.

1. Respect for Persons. — Respect for persons incorporates at least two ethical convictions: first, those individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy.

An autonomous person is an individual capable of deliberation about personal goals and of acting under the direction of such deliberation. To respect autonomy is to give weight to autonomous persons’ considered opinions and choices while refraining from obstructing their actions unless they are clearly detrimental to others. To show lack of respect for an autonomous agent is to repudiate that person’s considered judgments, to deny an individual the freedom to act on those considered judgments, or to withhold information necessary to make a considered judgment, when there are no compelling reasons to do so.

However, not every human being is capable of self-determination. The capacity for self-determination matures during an individual’s life, and some individuals lose this capacity wholly or in part because of illness, mental disability, or circumstances that severely restrict liberty. Respect for the immature and the incapacitated may require protecting them as they mature or while they are incapacitated.

Some persons are in need of extensive protection, even to the point of excluding them from activities which may harm them; other persons require little protection beyond making sure they undertake activities freely and with awareness of possible adverse consequence. The extent of protection afforded should depend upon the risk of harm and the likelihood of benefit. The judgment that any individual lacks autonomy should be periodically re-evaluated and will vary in different situations.

In most cases of research involving human subjects, respect for persons demands that subjects enter into the research voluntarily and with adequate information. In some situations, however, application of the principle is not obvious. The involvement of prisoners as subjects of research provides an instructive example. On the one hand, it would seem that the principle of respect for persons requires that prisoners not be deprived of the opportunity to volunteer for research. On the other hand, under prison conditions they may be subtly coerced or unduly influenced to engage in research activities for which they would not otherwise volunteer. Respect for persons would then dictate that prisoners be protected. Whether to allow prisoners to “volunteer” or to “protect” them presents a dilemma. Respecting persons, in most hard cases, is often a matter of balancing competing claims urged by the principle of respect itself.

2. Beneficence. — Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being. Such treatment falls under the principle of beneficence. The term “beneficence” is often understood to cover acts of kindness or charity that go beyond strict obligation. In this document, beneficence is understood in a stronger sense, as an obligation. Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and minimize possible harms.

The Hippocratic maxim “do no harm” has long been a fundamental principle of medical ethics. Claude Bernard extended it to the realm of research, saying that one should not injure one person regardless of the benefits that might come to others. However, even avoiding harm requires learning what is harmful; and, in the process of obtaining this information, persons may be exposed to risk of harm. Further, the Hippocratic Oath requires physicians to benefit their patients “according to their best judgment.” Learning what will in fact benefit may require exposing persons to risk. The problem posed by these imperatives is to decide when it is justifiable to seek certain benefits despite the risks involved, and when the benefits should be foregone because of the risks.

The obligations of beneficence affect both individual investigators and society at large, because they extend both to particular research projects and to the entire enterprise of research. In the case of particular projects, investigators and members of their institutions are obliged to give forethought to the maximization of benefits and the reduction of risk that might occur from the research investigation. In the case of scientific research in general, members of the larger society are obliged to recognize the longer term benefits and risks that may result from the improvement of knowledge and from the development of novel medical, psychotherapeutic, and social procedures.

The principle of beneficence often occupies a well-defined justifying role in many areas of research involving human subjects. An example is found in research involving children. Effective ways of treating childhood diseases and fostering healthy development are benefits that serve to justify research involving children — even when individual research subjects are not direct beneficiaries. Research also makes it possible to avoid the harm that may result from the application of previously accepted routine practices that on closer investigation turn out to be dangerous. But the role of the principle of beneficence is not always so unambiguous. A difficult ethical problem remains, for example, about research that presents more than minimal risk without immediate prospect of direct benefit to the children involved. Some have argued that such research is inadmissible, while others have pointed out that this limit would rule out much research promising great benefit to children in the future. Here again, as with all hard cases, the different claims covered by the principle of beneficence may come into conflict and force difficult choices.

3. Justice. — Who ought to receive the benefits of research and bear its burdens? This is a question of justice, in the sense of “fairness in distribution” or “what is deserved.” An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly. Another way of conceiving the principle of justice is that equals ought to be treated equally. However, this statement requires explication. Who is equal and who is unequal? 

What considerations justify departure from equal distribution? Almost all commentators allow that distinctions based on experience, age, deprivation, competence, merit and position do sometimes constitute criteria justifying differential treatment for certain purposes. 

It is necessary, then, to explain in what respects people should be treated equally. There are several widely accepted formulations of just ways to distribute burdens and benefits. Each formulation mentions some relevant property on the basis of which burdens and benefits should be distributed. These formulations are (1) to each person an equal share, (2) to each person according to individual need, (3) to each person according to individual effort, (4) to each person according to societal contribution, and (5) to each person according to merit.

Questions of justice have long been associated with social practices such as punishment, taxation and political representation. Until recently these questions have not generally been associated with scientific research. 

However, they are foreshadowed even in the earliest reflections on the ethics of research involving human subjects. For example, during the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed primarily to private patients. 

Subsequently, the exploitation of unwilling prisoners as research subjects in Nazi concentration camps was condemned as a particularly flagrant injustice. In this country, in the 1940’s, the Tuskegee syphilis study used disadvantaged, rural black men to study the untreated course of a disease that is by no means confined to that population. These subjects were deprived of demonstrably effective treatment in order not to interrupt the project, long after such treatment became generally available.

Against this historical background, it can be seen how conceptions of justice are relevant to research involving human subjects. For example, the selection of research subjects needs to be scrutinized in order to determine whether some classes (e.g., welfare patients, particular racial and ethnic minorities, or persons confined to institutions) are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied.

Finally, whenever research supported by public funds leads to the development of therapeutic devices and procedures, justice demands both that these not provide advantages only to those who can afford them and that such research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research.

Read more – https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html#xethical

ICMRA

ICMRA provides a global architecture to support enhanced communication, information sharing, crisis response and address regulatory science issues.

WHO-ICMRA joint statement on the need for improved global regulatory alignment on COVID-19 medicines and vaccines

In their joint statement, ICMRA members and WHO:

reiterate that therapeutics and vaccines against COVID-19 can only be rapidly approved if applications are supported by robust and sound scientific evidence that allows medicine regulators to conclude on a positive benefit-risk balance for these products; pledge to take concrete actions to ensure equitable access to safe, effective and quality-assured medicines for the treatment or prevention of COVID-19 around the world.

The proposal to create an ICMRA is an anchored in the recognition that a Heads of Agency (HoA) leadership is needed to address current and emerging human medicine regulatory and safety challenges globally, strategically and in an ongoing, transparent, authoritative and institutional manner. 

In May 2012, before the 65th World Health Assembly in Geneva, more than 30 medicines regulatory authorities participated in a seminar promoted by Brazil aimed at stimulating a debate among health officials and the diplomatic community on how to improve cooperation among medicines regulatory authorities. The discussion highlighted the importance of better promoting and coordinating international cooperation among medicines regulatory authorities in order to strengthen dialogue, facilitate the wider exchange of reliable and comparable information, encourage greater leveraging of the resources/work products of other authorities, and promote better informed risk-based allocation of authorities’ resources. These efforts would strengthen the quality, safety and efficacy of medicinal products globally.

http://www.icmra.info/drupal/en/covid-19

Two men die in Port Macquarie after receiving Pfizer jab. TGA sees no connection. The evidence is mounting that the experimental Covid vaccine program is dangerous and deadly.

https://www.facebook.com/watch/?v=194574332126236

Video – Urgent Message To The Mob 2021

https://rumble.com/vemi9h-urgent-message-to-the-mob-2021-dont-get-the-killshot.html

State and territory contacts details:

ACT Public Trustee and Guardian 02 6207 9800 http://www.ptg.act.gov.au 

NSW Civil & Administrative Tribunal Guardianship Division 1300 006 228 and press 2 13 14 50 (interpreter service) Email: gd@ncat.nsw.gov.au http://www.ncat.nsw.gov.au 

NT Office of the Public Guardian 1800 810 979 Email: public.guardian@nt.gov.au http://publicguardian.nt.gov.au 

QLD Office of the Public Guardian 1300 653 187 Email: publicguardian@publicguardian.qld.gov.au  http://www.publicguardian.qld.gov.au

SA South Australian Civil and Administrative Tribunal

1800 723 767 Email: sacat@sacat.sa.gov.au http://www.sacat.sa.gov.au

TAS Guardianship and Administrative Board Tasmania 1300 799 625

Email: guardianship.board@justice.tas.gov.au http://www.guardianship.tas.gov.au 

VIC Office of the Public Advocate 1300 309 337 mail: opa_advice@justice.vic.gov.au http://www.publicadvocate.vic.gov.au 

WA Office of the Public Advocate 1300 858 455 or 08 9278 7300 Email: opa@justice.wa.gov.au http://www.publicadvocate.wa.gov.au

Sources –

https://www.google.com/url?sa=t&source=web&rct=j&url=https://www.crc.gov.my/wp-content/uploads/documents/International%2520ethical%2520guidelines%2520for.pdf&ved=2ahUKEwiZxIvk3LbvAhW49nMBHSn7AJ0QFjAUegQIBxAC&usg=AOvVaw27xYPx82BcrNAKeVb0BgbW

https://www.tga.gov.au/sites/default/files/ich13595an.pdf?fbclid=IwAR0dAaPCeh60faI-DGW6s66bAaI_VXAFydq7OmWlcDxdTDG_pv1mmeGqKVk

https://www.mauriceblackburn.com.au/about/media-centre/newsletters/medical-law/autumn-2012/legal-aspects-of-consent-to-treatment/

https://immunisationhandbook.health.gov.au/vaccination-procedures/preparing-for-vaccination#accordion-para-11276-189034

https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html#xethical

https://www.nhmrc.gov.au/about-us/publications/australian-code-responsible-conduct-research-2018

https://www.tga.gov.au/sites/default/files/cmi-comirnaty-bnt162b2-mrna.pdf#page3

Good News!!!!

We now have somewhere to share all the creations from out bush

Our online marketplace is now live!

Merch available here-

https://marrukakilikan.company.site

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We’re volunteering our time to keep you up to date n ahead of the game. Work with us to continue doing what nobody else can, shout us a coffee please if you appreciate our work and want to see more from us.

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For a decade we have maintained the website and over 10 pages and groups on social media unassisted. If you appreciate the big stories, digs and urgent actions we get out please support our work, subscribe by hitting the black button or donate here – paypal.me/kaiyumoura  In these days especially out bush, a little goes a long way, so please dig deep and share.

Thank u and love u all in advance

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Our Journey So Far

https://thrival.international/2022/01/19/urgent-callout-mob-on-tribal-land-working-towards-food-sovereignty-need-help-with-power-and-water/

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1 Comment (+add yours?)

  1. Trackback: Every person jabbed against their will has been ‘assaulted’ according to Queensland criminal law | ajmarciniak

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A little about page admin Kaiyu Moura (Bayles)

Now living in QLD raising her children on their traditional country, gathering food, learning the old art of building shelters, dance and the local language. For the past 20 years with her late Grandmother Maureen Watson and a dance group with 6 of her sisters Kaiyu travelled schools, festivals, events etc sharing the beauty of First Nations Culture through song and dance, stories, art, theatre, nursery rhymes, poetry etc and engaging all ages in different projects that inspire positive change. Also a poet, documentary maker, songwriter, artist, event organiser, media consultant, testing the waters of micro social enterprise by starting her own tshirt and sublimation printing business and with her own label, Kaiyu creates what she calls Freedom Threads.

After building their own home on Tribal Sovereign land, Kaiyu is now homeschooling and teaching the kids about making our own tinctures, learning about bushtucker and mushrooms, growing food, building with aircrete, setting up wind turbines, composting toilets and ram water pumps... Really learning what it truly means to thrive. This is our Group where we share alot of what we do

Kaiyu and the Tribe
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