Standards For Human Test Subjects
May 4, 2021 0:05:53 GMT -5
Post by Berean on May 4, 2021 0:05:53 GMT -5
There is a great deal of pressure being put on people to take one of the vaccines. scorn, coercion, threat of loss of job, inability to go on airlines or to places that would have a vaccine policy to enter. this is fyi for readers, USA. by having all the vaccines distributed and given under "Emergency Use Authorization", the protections and explanations that would usually be required, even follow up of every test subject to make sure protocols were followed and individual oversight of how each subject is following the intervention, that is how the subject is following the giving of vaccine, is not being done. when a person is sick enough following the vaccine, they go to a doctor, or self report if they want to an adverse event, but this is not the same as oversight given to test subjects in phase trials for other medicines or treatments used on human subjects.
Standards for consent and standards for using humans as test subjects have not been explained to the public.
Institutional Review Boards (IRBs) and Protection of Human Subjects in Clinical Trials
www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/institutional-review-boards-irbs-and-protection-human-subjects-clinical-trials
Electronic Code of Federal Regulations
www.ecfr.gov/cgi-bin/text-idx?SID=31042205817afb0b7dcd59f9bbab69c4&mc=true&node=pt21.1.50&rgn=div5
Subpart B—Informed Consent of Human Subjects
§50.20 General requirements for informed consent.
Except as provided in §§50.23 and 50.24, no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.
Standards for consent and standards for using humans as test subjects have not been explained to the public.
Institutional Review Boards (IRBs) and Protection of Human Subjects in Clinical Trials
www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/institutional-review-boards-irbs-and-protection-human-subjects-clinical-trials
Electronic Code of Federal Regulations
www.ecfr.gov/cgi-bin/text-idx?SID=31042205817afb0b7dcd59f9bbab69c4&mc=true&node=pt21.1.50&rgn=div5
Subpart B—Informed Consent of Human Subjects
§50.20 General requirements for informed consent.
Except as provided in §§50.23 and 50.24, no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.
