LAWS REGARDING CLINICAL TRIALSThe law governing clinical trials involving "live human subjects" i.e. "live humanexperiments"
The use of face masks, testing equipment, and the so-called COVID-19 vaccines for children
are entirely experimental and amount to a "live human experiment" on "live human subjects."
The so-called COVID-19 vaccines are still in clinical trial stage until 2023 and is a "live humanexperiment" as is using the RT-PCR test and the wearing of face masks by children in school tocombat the SARS-CoV-2 virus. As such, conducting such a live human experiment using
children as the live human subjects in these clinical trials, constitutes a prima facie breachof International, European and UK civil and criminal laws and codes of medical ethics - unlesslawful, legal, moral and ethical informed consent - freely given - is provided by the individual
child who has the competence and the capacity to provide their consent to be experimented
upon, having been informed of all the material risks of the experiment, including the material
risk of DEATH, SERIOUS INJURY, INJURY, HARM, INCONVENIENCE and the LONG TERMCONSEQUENCES to their health, fertility, immune system, heart, nervous system and majororgans and to their well being.; andWHEREAS, you have a duty of care and a legal statutory duty, and a moral and ethical duty
to avoid all harm, loss, injury, suffering and death and all adverse events associated withthese NPIs and PIs.; andThe legal, lawful, ethical and moral requirement for Informed Consent - freely given - by theindividual to medical treatment or procedures or live human experiments
WHEREAS, other than in exceptional circumstances, conducting a live human experiment on
a living man, woman or child or conducting medical procedures or treatment on an individualliving man, woman or child without obtaining their informed consent - freely given - to taking
part in the live human experiment or to receiving medical treatment or procedures is aviolation of their fundamental, inalienable lawful, legal and constitutional rights. Voluntary
consent for any medical treatment is a fundamental part of the laws of the UK andinternational laws. It is legally, lawfully, ethically, and morally wrong to coerce, threaten,
intimidate, sanction, fine, punish, guilt-trip, shame, pressurise, or use any other form ofmeans to obtain consent from a living man, woman or child to participate in a clinical trial
or to receive medical treatment and or medical procedures - see below; andWHEREAS, the duty to obtain an individual's informed consent freely given to taking part ina live human experiment and or medical treatment or medical procedure is a lawful, legal,
moral and ethical duty, necessity and requirement because individual living men, womenand children have a fundamental inalienable human right to bodily integrity, that being
autonomy and self - determination over their own body without unconsented physical ormental intrusion - "Voluntas Aegroti Suprema Lex" - "Over his or her own mind and body,the individual is Sovereign"- (John Stuart Mill, On Liberty, 1859).
- https://thegreatthinkers.org/mill/major-works/liberty-2/; andWHEREAS, "Over his or her own mind or body the individual is sovereign" - Voluntas Aegroti
Suprema Lex- is a fundamental principle of law that binds you. An individual has sovereignty

over their own mind and body i.e. they have the right to bodily integrity. This fundamental
right cannot be limited or derogated from, other than in accordance with the law. Salus populi
suprema lex esto (Latin: "The health (welfare, good, salvation, felicity) of the people shouldbe the supreme law", "Let the good (or safety) of the people be the supreme (or highest)
law", or "The welfare of the people shall be the supreme law") is a maxim or principle foundin
Cicero's
De
Legibus
(book
III,
part
III,
sub.
VIII).
http://www.thelatinlibrary.com/cicero/leg3.shtml. Cicero (3 January 106 - 7 December 43 BC)
was a Roman statesman, lawyer, scholar, philosopher. This evidences that this principle of law
has been enshrined in our common law system and in our codes of medical ethics since atleast pre-ancient and Roman times; andWHEREAS, this right to bodily integrity includes the individual's right to life, and the right not
to be tortured or given inhumane, cruel or degrading treatment or punishment, which
includes the right not to be experimented upon or to be given medical or other treatment
without providing their informed consent - freely given, (see below) and the right not tohave their psychiatric integrity breached through psychological techniques or methods suchas psychological warfare (see below), the right to self determination and the right to privacy(see below) ; andLive human experiments
WHEREAS, there are extensive lawful, moral, ethical and legal obligations governing theparticipation of a live human subject in a live human experimental clinical trial, including theduty to obtain fully informed consent, freely given from the live human subject to participate
in the live human experiment in accordance with the Rule of Law - Informed Consent, freely
given, is a legal, lawful, moral and ethical requirement for all individuals participating in aclinical trial. It is unlawful to enrol anyone in a clinical trial without full and informed consent,
freely given - see below and see Exhibit: Nuremburg Code [1947] which sets down 10
principles which must be followed by researchers in a clinical trial involving live humansubjects. The British Medical Journal states the following in relation to the Nuremburg Code:"The judgment by the war crimes tribunal at Nuremberg laid down 10
standards
to which physicians must conform when carrying out
experiments on human subjects
in a new code that is now accepted worldwide.
This judgment established a new standard of ethical medical behaviour for the post
World War II human rights era. Amongst otherrequirements, this document enunciates
the requirement of voluntary informed consent of the human subject. The principle ofvoluntary informed consent protects the right of the individual tocontrol his
own body.
This code also recognizes that the risk must be weighed against thebenefit, and that unnecessary pain and suffering must
be avoided.

expected

This code recognizes that doctors should avoid actions that injure human patients.
The principles established by this code for medical practice now haveextended into general codes of medical ethics."(emphasis added) ; andbeenhttp://www.cirp.org/library/ethics/nuremberg/
https://famous-trials.com/nuremberg/1903-doctortrial
https://crimeofaggression.info/documents/6/1946_Nuremberg_Judgement.pdf; andWHEREAS, clinical trials involving live human subjects are defined as a "live humanexperiment" with "live human participants". Therefore the International obligations to protect
the live human participants in a live human experiment must be upheld including those set
out in, inter alia, the Nuremburg Code [1947], the Helsinki Declaration [1964], the Oviedo
Convention [1997], the Universal Declaration on Bioethics and Human Rights [2005], applies.
Under UK Statute law, clinical trials involving "medicines for human use" engage the Medicinesfor Human Use (Clinical Trials) Regulations 2004. All these governing codes, conventions,declarations and statutes require the "informed consent, freely given" of the live humansubject to participate in a live human experiment and or clinical trial; andWHEREAS, the Declaration of Helsinki [1964] is defined in Part 1 of Schedule 1 of theMedicines for Human Use (Clinical Trials) Regulations 2004 as follows:"SCHEDULE 1
CONDITIONS AND PRINCIPLES OF GOOD CLINICAL PRACTICEPROTECTION OF CLINICAL TRIAL SUBJECTS

AND

FOR

THE

PART 1APPLICATION AND INTERPRETATION"2. In this Schedule—“Declaration of Helsinki” means the Declaration of Helsinki adopted by theWorld Medical Assembly in June 1964, as amended by the General Assemblyofthe Association in October 1975, October 1983, September 1989 andOctober 1996."
https://www.legislation.gov.uk/uksi/2004/1031/schedule/1/made; andWHEREAS, the Declaration of Helsinki [1964] is incorporated into PART 2 of Schedule 1 of theMedicines for Human Use (Clinical Trials) Regulations 2004 as follows:"PART 2
CONDITIONS AND PRINCIPLES WHICH APPLY TO ALL CLINICAL TRIALS
Principles based on International Conference on Harmonisation GCP
1.

Clinical trials shall be conducted in accordance with the ethicalprinciples that have their origin in the Declaration of Helsinki, andthat are consistent with good clinical practice and the requirements

Guideline

of these Regulations."
https://www.legislation.gov.uk/uksi/2004/1031/schedule/1/made; andLegal Statutory duty to apply the conditions and principles specified in Part 2 of the 2004
Regulations
WHEREAS, section 1 of PART 1 of Schedule 1 of the Medicines for Human Use (Clinical Trials)
Regulations 2004 states as follows:
"1.—

(1)

The conditions and principles specified in Part 2 apply to allclinical trials.

(2)

If any subject of a clinical trial is—(a)(b)

an adult able to give informed consent, oran adult who has given informed consent to taking part inthe clinical trial prior to the onset of incapacity,
the conditions and principles specified in Part 3 apply in
relation to that subject.
(3)

If any subject of a clinical trial is a minor, the conditions andprinciples specified in Part 4 apply in relation to that subject.
(emphasis added)(4)

If any subject—(a)is an adult unable by virtue of physical or mental incapacity
to give informed consent, and(b)
did not, prior to the onset of incapacity, give or refuse togive informed consent to taking part in the clinical trial,
the conditions and principles specified in Part 5 apply in
relation to that subject.
(5)

If any person—(a)(b)

is an adult unable by virtue of physical or mental incapacity
to give informed consent, andhas, prior to the onset of incapacity, refused to giveinformed consent to taking part in the clinical trial,that person cannot be included as a subject in the clinical
trial."

https://www.legislation.gov.uk/uksi/2004/1031/schedule/1/made; andLegal statutory definition of Informed Consent which must be provided by an individual
participant in a clinical trial
WHEREAS, the definition of "informed consent" which must be provided by the individual
participant in a clinical trial in the UK is defined in the definitions section of Part 1 of theMedicines for Human Use (Clinical Trials) Regulations 2004 as follows:“informed consent” shall be construed in accordance with paragraph 3
Schedule 1".
https://www.legislation.gov.uk/uksi/2004/1031/part/1/made; andof Part 1 ofLegal statutory requirements for informed consent to participate in a clinical trial under the
Medicines for Human Use (Clinical Trials) Regulations 2004
A person gives informed consent to take part in a clinical trial ONLY
decision is(a)

if

his/her

given freely after that person is informed of
(i)
(ii)
(iii)

the nature,
the implications, andthe risksof the trial; and(b)

has either:(i)provided evidence of their written consent,
dated and signed, or(ii)
provided their consent orally in the presence ofat least one witnesse and recorded in writing.
WHEREAS, paragraph 3 of Part 1 of Schedule 1 of the Medicines for Human Use (Clinical Trials)
Regulations 2004 provides the definition of "informed consent" as follows:"3.—(1)For the purposes of this Schedule, a person gives informed
consent to take part, or that a subject is to take part, in aclinical trial only if his decision—(a)
is given freely after that person is informed of the nature,significance, implications and risks of the trial; and(b)either—(i)
is evidenced in writing, dated and signed, or otherwise
marked, by that person so as to indicate his consent, or
(ii)

(2)

if the person is unable to sign or to mark a document
so as to indicate his consent, is given orally in thepresence of at least one witness and recorded inwriting.

For the purposes of this Schedule, references to informed consent—(a)shall be construed in accordance with paragraph (1); and(b)

include references to informed consent given or refused by an
adult unable by virtue of physical or mental incapacity to give

informed consent, prior to the onset of that incapacity."
https://www.legislation.gov.uk/uksi/2004/1031/schedule/1/made ; andThe legal statutory duty to conduct clinical trials in accordance with "Good Clinical Practiceand Protection of Clinical Trial Subjects" - section 28 of Part 4 of Schedule 1 of the Medicinesfor Human Use (Clinical Trials) Regulations 2004.
WHEREAS, Section 28, entitled "Good clinical practice and protection of clinical trial subjects"
states:"Good clinical practice and protection of clinical trial subjects
28.—(1) No person shall—(a)conduct a clinical trial; or(b)perform the functions of the sponsor of a clinical trial(whether that person is the sponsor or is acting underarrangements made with that sponsor),otherwise than inaccordance with the conditions and principles ofgood clinical practice.

(2)

Subject to paragraph (5), the sponsor of a clinical trial shall put
and keep in place arrangements for the purpose of ensuring thatwith regard to that trial the conditions and principles of goodclinical practice are satisfied or adhered to." (emphasis added)- https://www.legislation.gov.uk/uksi/2004/1031/part/4/made; andWHEREAS, Part 2 of Schedule 1 of the Medicines for Human Use (Clinical Trials) Regulations
2004 engages the conditions and principles which apply to all clinical trials, including ethics
requirements for an ethics committee, as set out in the Declaration of Helsinki [1964] https://www.wma.net/what-we-do/medical-ethics/declaration-of-helsinki/doh-jun1964/for all subjects participating in clinical trials as follows:"PART 2
CONDITIONS AND PRINCIPLES WHICH APPLY TO ALL CLINICAL

TRIALS

Principles based on International Conference on Harmonisation GCP
https://ichgcp.net/
1.
Clinical trials shall be conducted in accordance with the
ethical principles that have their origin in the Declaration of
Helsinki, and that are consistent with good clinical practicethe requirements of these Regulations.
2.
Before the trial is initiated, foreseeable risks andinconveniences have been weighed against the anticipatedbenefit for the individual trial subject and other present andfuture patients.

Guideline -andA trial should be initiated and continued only if the
anticipated benefits justify the risks.
3.
The rights, safety, and well-being of the trial subjects aremost important considerations and shall prevail overinterests
science and society .
4.
The available non-clinical and clinical information on an
investigational medicinal product shall be adequate to support
clinical trial.

the
of

the

5.
Clinical trials shall be scientifically sound, and described in aclear, detailed protocol.
6.
A trial shall be conducted in compliance with the protocolthat has a favourable opinion from an ethics committee.
7.
The medical care given to, and medical decisions made on
behalf of, subjects shall always be the responsibility of an
appropriately qualified doctor or, when appropriate, of aqualified dentist.
8.
Each individual involved in conducting a trial shall be
qualified by education, training, and experience to performor her respective task(s).
9.
Subject to the other provisions of this Schedule relating toconsent, freely given informed consent shall be obtained
every subject prior to clinical trial participation.

his

from

10.

All clinical trial information shall be recorded, handled, andstored in a way that allows its accurate reporting, interpretationand verification.
11.
The confidentiality of records that could identify subjects shallbe protected, respecting the privacy and confidentiality rulesinaccordance with the requirements of the Data Protection
Act 1998 and thelaw relating to confidentiality.
12. Investigational medicinal products used in the trial shall be—

13.

(a)

manufactured or imported, and handled and stored, in
accordance with the principles and guidelines of good
manufacturing practice, and(b)used in accordance with the approved protocol.

Systems with procedures that assure the quality of every aspect of

the trial shall be implemented." (emphasis added)
https://www.legislation.gov.uk/uksi/2004/1031/schedule/1/made; andMINORS PARTICIPATING IN CLINICAL TRIALS – VACCINATION OF MINORS
Legal statutory duties in relation to conditions and principles which apply in relation to a
Minor participating in a clinical trial and to obtain Parental Consent for a Child under 16
years old WHEREAS, Part 4 of Schedule 1 of the Medicines for Human Use (Clinical Trials) Regulations
2004 which sets the minimum of providing a more exacting test of informed consent forminors, which must apply to emergency approval treatments that have not completed clinical
trials, and sets the minimum of requiring parental consent for a minor aged under 16 - inaccordance with "Good clinical practice" - see Condition number 4 in Part 4 of the 2004
Regulations (below). ; andWHEREAS, under Schedule 1, Part 4 of the Medicines for Human Use (Clinical Trials)
Regulations 2004, it states, inter alia:"PART 4
CONDITIONS AND PRINCIPLES WHICH APPLY IN RELATION TO A

MINORConditions
1.
Subject to paragraph 6, a person with parental responsibility
for the minor or, if by reason of the emergency nature of thetreatment provided as part of the trial no such person can becontacted prior to the proposed inclusion of the subject in thetrial, a legal representative for the minor has had an interview
with the investigator, or another member of the investigating
team, in which he has been given the opportunity tounderstand the objectives, risks and inconveniences of thetrial and the conditions under which it is to be conducted.
2.
That person or legal representative has been provided with acontact point where he may obtain further information about
trial.
3.
That person or legal representative has been informed of theright to withdraw the minor from the trial at any time.
4.
That person or legal representative has given his informed
consent to the minor taking part in the trial.
5.

That person with parental responsibility or the legal
representative may, without the minor being subject to any
resulting detriment, withdraw the minor from the trial at any
time by revoking his informed consent.
6.

The minor has received information according to histhecapacity of understanding, from staff with experience withminors, regarding
the trial, its risks and its benefits.
7.
The explicit wish of a minor who is capable of forming an
opinion and assessing the information referred to in theprevious paragraph to refuse participation in, or to bewithdrawn from, the clinical trial at any time is considered byinvestigator.
8.

No incentives or financial inducements are given—(a)(b)

to the minor; orto a person with parental responsibility for that minor or, as
the case may be, the minor’s legal representative,
except provision for compensation in the event of injury or
loss.

9.

The clinical trial relates directly to a clinical condition from which theminor suffers or is of such a nature that it can only be carried out on
minors.

10.

Some direct benefit for the group of patients involved in the clinical
trial is to be obtained from that trial.

11.

The clinical trial is necessary to validate data obtained—
(a)
(b)

12.

in other clinical trials involving persons able to give informed
consent, orby other research methods.

The corresponding scientific guidelines of the European Medicines
Agency are followed.

Principles
13.

Informed consent given by a person with parental responsibility or alegal representative to a minor taking part in a clinical trial shallrepresent the minor’s presumed will.

14.

The clinical trial has been designed to minimise pain, discomfort, fear
and any other foreseeable risk in relation to the disease and theminor’s stage of development.

15.
The risk threshold and the degree of distress have to be speciallydefined and constantly monitored.
16.

The interests of the patient always prevail over those of science andsociety. (emphasis added).

thehttps://www.legislation.gov.uk/uksi/2004/1031/schedule/1/made; andWHEREAS, no other person such as a family member, friend or carer and no organisation cangive or refuse consent to a health or social care service on behalf of an individual living man,woman or child who lacks capacity to consent unless they have specific legal authority to dosohttps://www.hse.ie/eng/about/who/qid/other-quality-improvementprogrammes/consent/national-consent-policy-hse-v1-3-june-2019.pdf; andLegal statutory definition of "Parental Responsibility"
WHEREAS, “parental responsibility" is defined in PART 1 of Schedule 1 of the Medicines for
Human Use (Clinical Trials) Regulations 2004 as follows:"(a)in relation to England and Wales, has the same meaning as in theChildren Act 1989,(b)in relation to Scotland, has the same meaning as in the Children(Scotland) Act 1985, and(c)in relation to Northern Ireland, has the same meaning as in theChildren (Northern Ireland) Order 1995"

https://www.legislation.gov.uk/uksi/2004/1031/schedule/1/made; andWHEREAS, the legal statutory definition of "parental responsibility" is defined in section 3 of
the Children Act 1989, which states:"3

Meaning of “parental responsibility”.

(1)
In this Act “parental responsibility” means all therights, duties, powers, responsibilities and authority
which by law a parent of a child has in relation to thechild and his property.
(2)

It also includes the rights, powers and duties which a
guardian of the child’s estate (appointed, before thecommencement of section 5, to act generally) would
have had in relation to the child and his property.

(3)
The rights referred to in subsection (2) include, inparticular, the right of the guardian to receive or recoverin his own name, for the benefit of the child, property ofwhatever description and wherever situated which thechild is entitled to receive or recover.
(4)
The fact that a person has, or does not have, parental
responsibility for a child shall not affect—(a)any obligation which he may have in relation to thechild (such as a statutory duty to maintain the child);
or
(b)

(5)

any rights which, in the event of the child’s death, he(or any other person) may have in relation to thechild’s property.

A person who—(a)does not have parental responsibility for a particularchild; but(b)

has care of the child, may (subject to the provisions of
this Act) do what is reasonable in all the circumstancesof the case for the purpose of safeguarding or
promoting the child’s welfare."https://www.legislation.gov.uk/ukpga/1989/41/section/3; andCompetence and Capacity to provide Informed Consent
WHEREAS, consent to medical treatment or to participation in a live human experimentcannot be provided by a living man, woman or child who lacks the competence or thecapacity to provide their informed consent, freely given to such medical treatment or
participation in a live human experiment.; andWHEREAS, capacity and competency of an adult or child to consent to or refuse medical
treatment is decision-specific, child-specific and made on the specific factual context in
mind, and based on the available evidence.; andWHEREAS, the law in the UK, states that a "minor" is a child under the age of 18 for the
purposes of capacity to consent to or to refuse medical treatment. A "minor" is deemed tolack the capacity to consent to or refuse medical treatment unless the child is found to be"Gillick competent" in accordance with the "Fraser Guidelines" set out in the UK case of Gillick
v West Norfolk and Wisbech Health Authority [1986]
https://www.casemine.com/judgement/uk/5a8ff8c960d03e7f57ecd66a; andWHEREAS, a child's competence and capacity to consent MUST be formally assessed PRIOR
to the medical treatment and PRIOR to their participation in a live human experiment- as
required by the law - see the UK case law of the House of Lords in the case of Gillick v West
Norfolk and Wisbech AHA (1986). This test for a child's competence to consent to medical
treatment is known as "Gillick competence" after the case of Gillick cited.
- https://www.casemine.com/judgement/uk/5a8ff8c960d03e7f57ecd66a; andWHEREAS, the General Medical Council (the "GMC"), and Department of Health and Social
Care (the "DHSC") provide guidance on informed consent. The government's Green Book on
vaccination opines that Gillick Competency is not automatic. It states in Chapter 2 that
"Where immunisations are routinely offered in the school setting, consent
differs
depending on the age and competence of theindividual child or young person."; andETHICS COMMITTEE
Legal requirement for authorisation and ethics committee opinion
WHEREAS, under Part 3 of the Medicines for Human Use (Clinical Trials) Regulations 2004, it
states, inter alia:"Requirement for authorisation and ethics committee opinion
12.— (1) No person shall—(a)(b)

start a clinical trial or cause a clinical trial to be started; orconduct a clinical trial, unless the conditions specified inparagraph (3) are satisfied.

(2) No person shall—(a)(b)

recruit an individual to be a subject in a trial;
issue an advertisement for the purpose of recruiting
individuals to be subjects in a trial, unless the condition
specified in paragraph (3)(a) has been satisfied.

(3)

The conditions referred to in paragraphs (1) and (2) are—(a)an ethics committee or an appeal panel appointed under
Schedule 4 has given a favourable opinion in relation to theclinical trial; and(b)the clinical trial has been authorised by the licensing
authority." (emphasis added)- https://www.legislation.gov.uk/uksi/2004/1031/part/3/made; andGENERAL CLINICAL TRIAL
Legal requirement for "urgent safety measures" to be taken to protect the subjects of aclinical trial against any "immediate hazard to their health or safety".
WHEREAS, section 30 of PART 4 of Schedule 1 of the Medicines for Human Use (Clinical Trials)
Regulations 2004 entitled "Urgent safety measures" states that:"30.—(1)The sponsor and investigator may take appropriate urgent
safety measures in order to protect the subjects of a clinical
trial against any immediate hazard to their health or safety.
(emphasis added)(2)

If measures are taken pursuant to paragraph (1), the sponsor
shall immediately, and in any event no later than 3 days fromthe date the measures are taken, give written notice to thelicensing authority and the relevant ethics committee of themeasures taken and the circumstances giving rise to thosemeasures."https://www.legislation.gov.uk/uksi/2004/1031/part/4/made; ; andREPORTING OF SERIOUS ADVERSE EVENTS
Legal requirement to notify/report any "serious adverse event" which occurs in a subject ata trial site.
WHEREAS, PART 5 of Schedule 1 of the Medicines for Human Use (Clinical Trials) Regulations
2004 entitled "PHARMACOVIGILANCE", section 32 requires reporting any "serious adverse
event" as stated:"Notification of adverse events
32.—(1)(2)(3)

An investigator shall report any serious adverse event which
occurs in a subject at a trial site at which he is responsible forthe conduct of a clinical trial immediately to the sponsor.
An immediate report under paragraph (1) may be made orally
or in writing.

Following the immediate report of a serious adverse event,the investigator shall make a detailed written report on theevent."
https://www.legislation.gov.uk/uksi/2004/1031/part/5/made; andLegal requirement to record and notify/report "suspected unexpected serious adverse
reactions" which is "fatal or life-threatening"
WHEREAS, PART 5 of Schedule 1 of the Medicines for Human Use (Clinical Trials) Regulations
2004 entitled "PHARMACOVIGILANCE", section 33 requires "Notification of suspected
unexpected serious adverse reactions" as stated:"Notification of suspected unexpected serious adverse reactions"33.—(1)

A sponsor shall ensure that all relevant information about asuspected unexpected serious adverse reaction which occurs
during the course of a clinical trial in the United Kingdom andis fatal or life-threatening is—(a)recorded; and(b)reported as soon as possible to—(i)the licensing authority,(ii)
the competent authorities of any EEA State,other than the United Kingdom, in which thetrial is being conducted, and(iii)
the relevant ethics committee, and in any event
not later that 7 days after the sponsor was firstaware of the reaction." (emphasis added)

https://www.legislation.gov.uk/uksi/2004/1031/part/5/made; and