Thread by @WAPFLondon

Any medical trial in UK such as COVID-19 vaccination & tests on emergency approval must comply with the @medwma's Declaration of Helsinki by virtue of s.1, of Part.2 of Sch.2 of The UK's "Medicines for Human Use (Clinical Trials) Regulations (2004)". wma.net/policies-post/…

These provide amongst other things at Para.25 to 32 a more exacting measure of valid informed consent, the breach of which causes the treatment to be unlawful battery at common law.
@GOVUK's conduct therefore likely renders most test subjects victims of civil rights violations.

3. The Declaration of Geneva of the WMA binds the physician with the words, “The health of my patient will be my first consideration,” and the International Code of Medical Ethics declares that, “A physician shall act in the patient’s best interest when providing medical care.”

4. It is the duty of the physician to promote and safeguard the health, well-being and rights of patients, including those who are involved in medical research. The physician’s knowledge and conscience are dedicated to the fulfilment of this duty.

7. Medical research is subject to ethical standards that promote and ensure respect for all human subjects & protect their health & rights
8. While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the individual rights

9. It is the duty of physicians who are involved in medical research to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects.

The responsibility for the protection of research subjects must always rest with the physician or other health care professionals and never with the research subjects, even though they have given consent.

10. Physicians must consider the ethical, legal & regulatory norms & standards for research involving human subjects in their own countries as well as applicable international norms & standards.

No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this Declaration.

14. Physicians who combine medical research with medical care should involve their patients in research only to the extent that this is justified by its potential preventive, diagnostic or therapeutic value

and if the physician has good reason to believe that participation in the research study will not adversely affect the health of the patients who serve as research subjects.

15. APPROPRIATE COMPENSATION AND TREATMENT FOR SUBJECTS WHO ARE HARMED AS A RESULT OF PARTICIPATING IN RESEARCH MUST BE ENSURED.

16. In medical practice and in medical research, most interventions involve risks and burdens.

Medical research involving human subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects.

17. All medical research involving human subjects must be preceded by careful assessment of predictable risks & burdens to the individuals & groups involved in the research in comparison with foreseeable benefits to them and to other individuals or groups affected,,

18. Physicians may not be involved in a research study involving human subjects unless they are confident that the risks have been adequately assessed and can be satisfactorily managed.
(@GOVUK has not released risk assessments)

When the risks are found to outweigh the potential benefits or when there is conclusive proof of definitive outcomes, physicians must assess whether to continue, modify or immediately stop the study.

19. Some groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged or of incurring additional harm.

All vulnerable groups and individuals should receive specifically considered protection.

20. Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group & the research cannot be carried out in a non-vulnerable group. This group should stand to benefit,,

Informed Consent

25. Participation by individuals capable of giving informed consent as subjects in medical research must be voluntary.

Although it may be appropriate to consult family members or community leaders, no individual capable of giving informed consent may be enrolled in a research study unless he or she freely agrees.

26. In medical research involving human subjects capable of giving informed consent, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher,

the anticipated benefits and potential risks of the study and the discomfort it may entail, post-study provisions and any other relevant aspects of the study. The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent

to participate at any time without reprisal. Special attention should be given to the specific information needs of individual potential subjects as well as to the methods used to deliver the information.

After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject’s freely-given informed consent, preferably in writing.

If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed.

All medical research subjects should be given the option of being informed about the general outcome and results of the study.

27. When seeking informed consent for participation in a research study the physician must be particularly cautious if the potential subject is in a dependent relationship with the physician or MAY CONSENT UNDER DURESS.

In such situations the informed consent must be sought by an appropriately qualified individual who is completely independent of this relationship.

28. For a potential research subject who is incapable of giving informed consent, the physician must seek informed consent from the legally authorised representative. These individuals must not be included in a research study that has no likelihood of benefit for them

unless it is intended to promote the health of the group represented by the potential subject, the research cannot instead be performed with persons capable of providing informed consent, and the research entails only minimal risk and minimal burden.

29. When a potential research subject who is deemed incapable of giving informed consent is able to give assent to decisions about participation in research, the physician must seek that assent in addition to the consent of the legally authorised representative.

The potential subject’s dissent should be respected.

30. Research involving subjects who are physically or mentally incapable of giving consent, for example, unconscious patients, may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research group.

In such circumstances the physician must seek informed consent from the legally authorised representative. If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent

provided that the specific reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in the research protocol & the study has been approved by a research ethics committee.

Consent to remain in the research must be obtained as soon as possible from the subject or a legally authorised representative.

31. The physician must fully inform the patient which aspects of their care are related to the research. The refusal of a patient to participate in a study or the patient’s decision to withdraw from the study must never adversely affect the patient-physician relationship.

32. For medical research using identifiable human material or data, such as research on material or data contained in biobanks or similar repositories, physicians must seek informed consent for its collection, storage and/or reuse.

There may be exceptional situations where consent would be impossible or impracticable to obtain for such research. In such situations the research may be done only after consideration and approval of a research ethics committee.

Use of Placebo
33. The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention(s),
(Ivermectin, hydroxychloroquine, vitamin D, etc?)

except in the following circumstances:
Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or
Where for compelling and scientifically sound methodological reasons the use of any intervention less effective than the best proven one, the use

of placebo, or no intervention is necessary to determine the efficacy or safety of an intervention
and the patients who receive any intervention less effective than the best proven one, placebo,

or no intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention.
Extreme care must be taken to avoid abuse of this option.

Post-Trial Provisions
34. In advance of a clinical trial, sponsors, researchers & host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial.

This information must also be disclosed to participants during the informed consent process.

Research Registration and Publication and Dissemination of Results
35. Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject.

36. Researchers, authors, sponsors, editors & publishers all have ethical obligations with regard to the publication & dissemination of the results of research.

Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. All parties should adhere to accepted guidelines for ethical reporting.

Negative & inconclusive as well as positive results must be published or otherwise made publicly available. Sources of funding, institutional affiliations & conflicts of interest must be declared in the publication.

Reports of research not in accordance with the principles of this Declaration should not be accepted for publication.

Unproven Interventions in Clinical Practice
37. In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient

or a legally authorised representative, may use an unproven intervention if in the physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering.

This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, where appropriate, made publicly available.