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UK Law Regarding Vaccine trials.

 
Anonymous Coward
User ID: 72884611
United Kingdom
05/22/2020 02:39 PM
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UK Law Regarding Vaccine trials.
[link to www.legislation.gov.uk]

"Rights safety and well-being

The rights, safety and well-being of the trial subjects shall prevail over the interests of science and society."

The Medicines for Human Use (Clinical Trials) Regulations 2004
Anonymous Coward (OP)
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05/22/2020 02:41 PM
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Training and qualification

Each individual involved in conducting a trial shall be qualified by education, training and experience to perform their tasks.

Science and ethics

Clinical trials shall be scientifically sound and guided by ethical principles in all their aspects.

Quality

The necessary procedures to secure the quality of every aspect of the trial shall be complied with.

MP information

The available non-clinical and clinical information on an Investigational Medicinal Product (IMP) shall be adequate to support the proposed clinical trial.

Declaration of Helsinki

Clinical trials shall be conducted in accordance with the principles of the Declaration of Helsinki.

Protocol

The protocol shall provide for the definition of inclusion and exclusion of subjects participating in a clinical trial, monitoring and publication policy.

Guidance

The investigator and sponsor shall consider all relevant guidance with respect to commencing and conducting a clinical trial.

Data and confidentiality

All clinical information shall be recorded, handled and stored in such a way that it can be accurately reported, interpreted and verified, while the confidentiality of records of the trial subjects remains protected.

Risks and benefits

Before the trial is initiated, foreseeable risks and inconveniences have been weighed against the anticipated benefit for the individual trial subject and other present and future patients. A trial should be initiated and continued only if the anticipated benefits justify the risks.

Medical care

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 a qualified dentist.

Authorisation and compliance

A trial shall be initiated only if an ethics committee and the licensing authority comes to the conclusion that the anticipated therapeutic and public health benefits justify the risks and may be continued only if compliance with this requirement is permanently monitored.

Data Protection Act

The rights of each subject to physical and mental integrity, to privacy and to the protection of the data concerning him in accordance with the Data Protection Act 1998 are safeguarded.

Insurance

Provision has been made for insurance or indemnity to cover the liability of the investigator and sponsor which may arise in relation to the clinical trial.
Anonymous Coward (OP)
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05/22/2020 02:45 PM
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Re: UK Law Regarding Vaccine trials.
There is talk of foregoing proper trials regarding a covid19/sars2cov vaccine.

Even talk that the trials will be done on the public at large.

Mandatory vaccinations are illegal.
Anonymous Coward
User ID: 78854264
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05/22/2020 02:47 PM
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Any compulsory ID tracking of, or coercion to track, an individual to prove a person is vaccinated would violate privacy law. Good to know
Anonymous Coward (OP)
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05/22/2020 02:50 PM
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Any compulsory ID tracking of, or coercion to track, an individual to prove a person is vaccinated would violate privacy law. Good to know
 Quoting: Anonymous Coward 78854264


there is a lot more there that will help us defend our rights in case this turns sour.
Anonymous Coward (OP)
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05/22/2020 03:06 PM
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bump
Anonymous Coward (OP)
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05/22/2020 04:30 PM
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Supply of investigational medicinal products for the purpose of clinical trials
13.—(1) Subject to paragraphs (3) and (4), no person shall, in the course of a business carried on by him, sell or supply any investigational medicinal product to—

(a)an investigator,
(b)a health care professional who is a member of an investigator’s team,
(c)a person who provides or is to provide health care under the direction or control of a person referred to in sub-paragraphs (a) and (b), or
(d)a subject,
for the purpose of administering that product in a clinical trial, unless the conditions specified in paragraph (2) are satisfied.

(2) The conditions referred to in paragraph (1) are—

(a)the licensing authority has authorised the clinical trial for the purposes of which the product is sold or supplied;
(b)in the case of an investigational medicinal product manufactured or assembled in an EEA State, other than in accordance with the terms of a marketing authorization relating to that product, or imported into an EEA State—
(i)the product has been manufactured, assembled or imported in accordance with the terms of—
(aa)a manufacturing authorisation, or
(bb)an authorisation referred to in Article 13 of the Directive granted by a competent authority of an EEA State other than the United Kingdom, and
(ii)the production batch of investigational medicinal products of which the product is a part has been checked and certified by a qualified person pursuant to Article 13(3) and (4) of the Directive.
(3) If an investigational medicinal product has been manufactured or imported prior to 1st May 2004—

(a)the condition specified in paragraph (2)(b)(i) shall apply only in relation to any assembly of that product which takes place on or after that date; and
(b)the conditions specified in paragraph (2)(b)(ii) shall not apply.
(4) The restriction in paragraph (1) shall not apply to the sale or supply of a medicinal product in accordance with the terms of a marketing authorisation relating to that product, other than a marketing authorisation issued by the competent authority of an EEA State other than the United Kingdom.


They are already breaking the law with the oxford vaccine trials.
Anonymous Coward
User ID: 78943126
Australia
05/22/2020 04:35 PM
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We need to shut this shit down ASAP.
It'll be mandatory in the UK first and then rest of the world
Anonymous Coward (OP)
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05/22/2020 04:58 PM
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According to the law, those monkeys being shown to have adverse side effects would constitute suspension of the trial.

Suspension or termination of clinical trial
31.—(1) If, in relation to a clinical trial—

(a)the licensing authority have objective grounds for considering that—
(i)any condition, restriction or limitation which applies to the conduct of the trial and is set out in the request for authorisation or the particulars or documents accompanying that request, or
(ii)any condition imposed by the licensing authority under regulation 18(2) or (6), 19(8), 20(5), 24(4) or Schedule 5,is no longer satisfied (either generally or at a particular trial site); or
(b)the licensing authority have information raising doubts about the safety or scientific validity of the trial, or the conduct of the trial at a particular trial site,
the licensing authority may, by a notice served in accordance with paragraph (2), require that the trial, or the conduct of the trial at a particular trial site, be suspended or terminated.

(2) A notice in accordance with paragraph (1) shall be served—

(a)in a case where the suspension or termination applies to the trial generally, on—
(i)the sponsor, or
(ii)the investigator at each trial site;
(b)in a case where the suspension or termination applies to the conduct of a trial at a particular trial site, on—
(i)the sponsor, or
(ii)the investigator at that trial site.
(3) The notice shall specify—

(a)whether the notice applies to the trial generally or to one or more of the trial sites;
(b)whether the notice requires suspension or termination of the trial;
(c)if the notice requires suspension of the trial—
(i)whether the suspension applies until further notice from the licensing authority or for such period as may be specified in the notice, and
(ii)any conditions which are to be satisfied before the trial or, as the case may be, the conduct of the trial at a particular site, may be recommenced; and
(d)whether suspension or termination is to take effect immediately on receipt of the notice or on such date as may be specified in the notice.
(4) If the licensing authority issues a notice under paragraph (1), they shall forthwith inform—

(a)where the notice has not been served on the sponsor, the sponsor;
(b)competent authorities of each EEA State, other than the United Kingdom;
(c)the relevant ethics committee;
(d)the European Medicines Agency; and
(e)the European Commission.
(5) Subject to paragraph (6), at least one week before issuing a notice under paragraph (1) the licensing authority shall, by a notice in writing to the sponsor or the investigator—

(a)inform him that the authority is minded to issue a notice suspending or terminating the trial, or the conduct of a trial at a particular site, and of the reasons why they are so minded; and
(b)advise him that they may, within one week of the date of the notice, furnish the authority with written representations as to whether the trial, or the conduct of the trial at a particular site, should be so suspended or terminated.
(6) Paragraph (5) shall not apply where it appears to the licensing authority that there is an imminent risk to the health or safety of any of the subjects of the clinical trial.

(7) A person on whom a notice has been served in accordance with paragraphs (1) and (2) may, within 28 days, or such extended period as the licensing authority may in any particular case allow, of the notice being given, give notice of his wish to make written or oral representations to the appropriate committee or, if for the time being there is no such committee, the Medicines Commission.

(8) Schedule 5 shall have effect to regulate the procedure for reference to the appropriate committee or, as the case may be, the Medicines Commission(1) following receipt of a notice in accordance with paragraph (7).

(9) Where the notice of suspension or termination is referred to an appropriate committee or the Medicines Commission it shall remain in force unless revoked in accordance with Schedule 5.
Anonymous Coward (OP)
User ID: 72884611
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05/22/2020 05:02 PM
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Re: UK Law Regarding Vaccine trials.
all we need to do is make the licensing authority aware of
information raising doubts about the safety or scientific validity of the trial, or the conduct of the trial at a particular trial site in order for the trial be suspended or terminated.
Anonymous Coward (OP)
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05/22/2020 05:20 PM
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bump
Anonymous Coward (OP)
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05/22/2020 06:15 PM
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Crater

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05/22/2020 06:32 PM
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Re: UK Law Regarding Vaccine trials.
In the uk they want you to put the tracking app on your phone when you arrive on a flight into the uk otherwise up to £1100 in fines
So
Anonymous Coward (OP)
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05/22/2020 06:57 PM
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Anonymous Coward (OP)
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05/22/2020 06:58 PM
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Re: UK Law Regarding Vaccine trials.
In the uk they want you to put the tracking app on your phone when you arrive on a flight into the uk otherwise up to £1100 in fines
 Quoting: Crater


how do they plan on enforcing that fine for foreigners?
Anonymous Coward (OP)
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05/22/2020 07:02 PM
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I think the reason they are rushing this now is that vaccine trials phases 2,3 and possibly 4th can only be conducted on people who are ill from the disease they are trying to treat.

meaning that if covid-19 disappears before the end of the trial, they have no one to trial it on and thus the approval for use can not be given.
Anonymous Coward (OP)
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05/22/2020 07:11 PM
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Re: UK Law Regarding Vaccine trials.
[link to www.gov.uk (secure)]
Anonymous Coward (OP)
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05/22/2020 07:18 PM
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Re: UK Law Regarding Vaccine trials.
because the latest vaccines are going to modify dna, they will not be classified as vaccines, but instead some coronavirus vaccines may be classified as gene therapy.

gene therapy isn't currently exempt from being sued for damages.

therefore i suspect that a change in legislation regarding gene therapy is on the cards.. watch out for this.
Anonymous Coward (OP)
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05/22/2020 07:36 PM
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Terrebonne

User ID: 78928292
United States
05/22/2020 10:35 PM

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Re: UK Law Regarding Vaccine trials.
In the uk they want you to put the tracking app on your phone when you arrive on a flight into the uk otherwise up to £1100 in fines
 Quoting: Crater


How do they plan on enforcing that fine for foreigners?
 Quoting: Anonymous Coward 72884611


How do they plan on enforcing this law for people without a cellphone or older cellphones that don't have the capability to take app, like my self?

scratching


.
INFJ; We are the protectors; One Percent of the population.

We put a lot of energy into identifying the best system for getting things done, and constantly define and re-define the priorities.

We know things intuitively, without being able to pinpoint why, and without detailed knowledge of the subject at hand. We are usually right, and we usually know it.

[link to www.personalitypage.com]

.
Anonymous Coward
User ID: 70930157
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05/23/2020 03:17 PM
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Anonymous Coward
User ID: 70930157
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05/23/2020 03:18 PM
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Re: UK Law Regarding Vaccine trials.
In the uk they want you to put the tracking app on your phone when you arrive on a flight into the uk otherwise up to £1100 in fines
 Quoting: Crater


How do they plan on enforcing that fine for foreigners?
 Quoting: Anonymous Coward 72884611


How do they plan on enforcing this law for people without a cellphone or older cellphones that don't have the capability to take app, like my self?

scratching


.
 Quoting: Terrebonne


perhaps you will just have to go back home or they will give you a phone?
Anonymous Coward
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05/24/2020 11:42 AM
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Anonymous Coward
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Sweden
05/24/2020 11:46 AM
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 Quoting: Anonymous Coward 70930157
Anonymous Coward
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05/25/2020 05:25 AM
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Lime Flavoured Redux

User ID: 20428114
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05/25/2020 05:29 AM
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Re: UK Law Regarding Vaccine trials.
Theres nothing to stop them passing emergency regulations saying "the 2004 regulations shall not apply to vaccines for Covid-19".

It probably wouldnt be quite *that* wide, but it would be easy to do.





GLP