Res_Informed_Consent - Mac

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RESERVATION OF INFORMED CONSENT FOREWORD AND CAVEATS This form is for educational purposes only and is not legal advice to do or even not do one thing or the other, and is only an account of how I am personally handling this situation if it arises. Employers Who Have Forms For Me To Sign If an employer “offers” a medical intervention to me, I am going to first ask them if I could get fired for not taking part in it, and press them for a yes, no, or even a maybe. Once I get the answer from them, they usually have their own internal forms to sign. If they answered, “yes”, or “maybe”, then i will print in a space before the signature, “signed under duress in fear of reprisal”, then my signature, and then after the signature, “without prejudice”, which means, “Without any loss or waiver of rights or privileges”. This is because signatures under duress are not valid agreements contractually, and not prejudicing one’s rights reserves them for any future actions. Does My Company or Current Health Insurance Carrier Cover Vaccine Injuries ? I will contact either the current or prospective health insurer to see if they cover vaccine injuries AND if they cover “Emergency Use Authorization” interventions. I will probably do both snail mail and email, but either way I will demand a response in writing on their letterhead with a signature. If stonewalled, I will follow up three times, with the last follow up stating that they are evading answering the inquiry, and that I will have to construe that they do not cover vaccine injuries AND “Emergency Use Authorization” interventions. If still in process, I will also write HR to contact the insurance company for the same information. I will then make a record with HR to put in my file that the insurance company does not cover vaccine injuries AND “Emergency Use Authorization” interventions. RESERVATION OF INFORMED CONSENT Thank you for offering the opportunity in the administration of an FDA Emergency Use Authorized (EUA) product. It is my understanding that the current EUA for the Pfizer, Moderna, and Johnson and Johnson (J&J) products are considered to be unapproved by the FDA pursuant to their respective FACT SHEETS FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE. 1, 2, 3 Further, it is my understanding that any one of the three EUA/unapproved products are also still within two years of clinical trials and titled to the effect of, “STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY…”. Since any one of the clinical trial sheets for these products are referred to as a “study” in the title, and with , “TO EVALUATE…”, then such constitutes yet to be completed medical research in which the “safety, tolerability, immunogenicity, and efficacy” of such products will not be fully evaluated at least into 2022 or beyond, and also until such products are officially FDA approved. 4, 5, 6 Therefore , in taking any one of these FDA un-approved products, the undersigned could unwittingly be a research participant, and the one administrating the unapproved product - possibly an unwitting investigator for the manufacturer by proxy. Because of this yet to be disclosed and possibly implied investigator-research participant relationship, the undersigned would be unable to recover damages even if not being properly or completely informed of the risks and dangers of any of said FDA un-approved products which are still within a two year trial. While the undersigned is not refusing the administration of aforementioned product, the rights to informed consent are hereby reserved, and volunteering for such will be considered after the trials have been completed, and after the FDA approvals for said products have been secured. Pursuant to DECLARATION OF HELSINKI, the undersigned should not be subject to reprisal by________________________________in any form. 7 Respectfully submitted and without prejudice, _____________________________ , ___/___/______ (see back of page for references) PRINT: RESERVATION OF INFORMED CONSENT (1) “The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Janssen COVID-19 Vaccine” EMERGENCY USE AUTHORIZATION (EUA) OF THE JANSSEN COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19) https://www.fda.gov/media/146304/download (2) “The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, MODERNA COVID-19 VACCINE” EMERGENCY USE AUTHORIZATION (EUA) OF THE MODERNA COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 , https://www.fda.gov/media/144637/ download (3) “The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Pfizer-BioNTech COVID-19 Vaccine” EMERGENCY USE AUTHORIZATION (EUA) OF THE PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19), https://www.fda.gov/media/144413/download (4) “8.11.2.6. Visit 6 – 24-Month Follow-up Visit: (714 to 742 Days After Visit 2)”, pg. 92 A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE- FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS, https://media.tghn.org/medialibrary/2020/11/ C4591001_Clinical_Protocol_Nov2020_Pfizer_BioNTech.pdf (5) “All participants may have up to 7 scheduled clinic visits, including Screening, Day1, Day29, Day 57, Day 209, Day 394, and Day 759”. pg. 8. A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older, https://www.modernatx.com/sites/default/files/mRNA-1273-P301-Protocol.pdf (6) “The end-of-study analysis will be performed when all participants have completed the visit 24 months post-vaccination or discontinued earlier”, p. 23 A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older, https://www.jnj.com/coronavirus/ensemble-1-study-protocol (7) “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.” WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects, https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical- research-involving-human-subjects/