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Penn State’s mass testing of healthy students and staff violates Nuremberg Code and CFR Title 45 Part 46 requiring informed consent for participants in human experiments.
The mass testing program should be stopped immediately. It never should have started.
At least one Penn Stater is attempting to fight back against Penn State’s mass testing program, and Penn State has deployed a Milgram functionary in response.
A few days ago, a healthy Penn Stater got an instruction to appear for a Covid test.
His/her first response was to point out to his/her supervisors that there is no medical or epidemiological reason for people without symptoms to get PCR tests for Covid; that he/she has no symptoms and is healthy and that his/her physician has not requested or authorized any medical tests. He/she specifically told his/her supervisor that he/she does not consent to this testing.
The supervisor did not respond, but the original notice listed an email address (email@example.com) to which Penn Staters could send questions.
The healthy Penn Stater sent a list of questions, paraphrased and including (but not limited to):
Is this a medical test? If so, who is the doctor who ordered the test and will I get to speak with the doctor?
By whose or what specific authority do you "require" this test of randomly chosen persons?
….What is the scientific basis for conducting a medical test on people who do not have any symptoms of illness from Covid-19?
Who is paying for this testing at Penn State and what is the budget for it?
Who is the vendor from which Penn State is purchasing the PCR test kits, how many cycles or iterations do they use when processing each sample and do they report the number of cycles used in their reporting of the results?
When did PSU begin random Covid-19 testing of students and employees?
How much data has been collected to-date and what has been ascertained from this data?
What is your threshold on sample returns below which you regard Covid-19 as “no longer a concern”? How much longer do you intend to continue this program?
Who is in charge of analyzing the data and preparing results?
To whom does the data analyst report?
Who is the person who makes the decision to stop testing?
Is this testing part of a study? If so, who is in charge of the study, what is its purpose, how is the data to be analyzed and when will the study conclude?
Given the fact that the PCR test was never designed or intended to be used as the kind of diagnostic tool as has been employed for Covid 19, how do you justify the validity of any of the results you obtain from this test?
According to the CDC and FDA, “…no quantified virus isolates of the 2019-nCoV were available for CDC use at the time the test was developed.” What evidence do you have that the PCR test is legitimately “detecting” Covid-19 when the test isn’t even based on the actual virus itself?
Upon Biden’s inauguration, the World Health Organization (WHO) suddenly announced that its previous recommended 45 “amplification” cycles of the PCR test to determine whether someone was positive for COVID or not, was leading to many false positives. Has PSU therefore corrected its earlier data collection to reflect the degree to which the PCR test was leading to too many false positives?
Has PSU taken measures to ensure that whomever is analyzing the nasal swab samples is using the new, lower recommended cycling thresholds?
PCR assays are not designed to be used as diagnostic tools, as they can’t distinguish between inactive viruses and “live” or reproductive ones, and therefore they only have meaning when paired with clinical data and clinical observations. If there is no clinical presentation of illness in a person, why does Penn State employ the PCR test at all?
If I went to my doctor and asked for a tuberculosis test, the doctor would say, “why? You have no symptoms of tuberculosis,” and the doctor would not authorize such a test nor would insurance cover such a non-essential and pointless test. Why is PSU acting in a medical doctor’s capacity and ordering a medical test for persons not presenting any symptoms of illness?
The WHO states: “disease prevalence alters the predictive value of test results; as disease prevalence decreases, the risk of false positive increases.” What is the prevalence of Covid-19 in Centre County and what data do you have to support that the prevalence here is sufficient to warrant continued PCR testing under these conditions?
With the WHO’s above caution about use of the PCR test, the only relevant data at this time should be those who have clinical expression of Covid-19 symptoms AND test positive via the PCR test. Is this data being collected, monitored and displayed to the PSU community, in addition to the meaningless asymptomatic Covid-19 tests results you now report?
Is Penn State’s COVID-19 Asymptomatic Random Testing Program monitoring the psychological impact this testing is having on not just those selected and required to get tested, but the broader university community?…
This morning, the Penn Stater received an email from a woman representing Penn State, answering none of the questions presented by the experimental subject, flatly stating:
…I am an infectious disease epidemiologist, and I am part of the scientific team leading the Penn State testing effort. Your email was forwarded to me.
Participation in random testing is required by Penn State University. The test you will receive is a PCR test for COVID-19 and will be processed by a CLIA-certified lab on Penn State campus.
Penn State's testing strategy is based on the scientific community's current knowledge of COVID-19 and is in alignment with recommendations from all major public health organizations.
Given that your original window to schedule your test has closed, I will re-issue your invitation today.
This response uses the Milgram experiment prods, as I quoted here at Bailiwick News a few weeks ago:
As in the Milgram experiment, the authorities give clear instructions or “prods” to those who try to question the efficacy and ethics of this mass experiment, or express a desire to stop participating in it.
We are repeatedly told:
Please continue or Please go on.
The experiment requires that you continue.
It is absolutely essential that you continue.
You have no other choice; you must go on or You have no other choice but to continue
This “epidemiologist” and Penn State as her supervising institution are both violating the Nuremburg Code, and also federal law: Code of Federal Regulations Title 45 Part 46, regulations issued by the U.S. Department of Health and Human Services for the ethical treatment of human subjects, and used by Institutional Review Boards (IRBs).
Specifically, Penn State is currently engaged in unlawful coercion of human beings for the purposes of forcing them to participate in a medical experiment without their consent, and at least one Penn Stater is declining the “invitation,” refusing consent and simply being told that compliance “is required.”
The “epidemiologist” no doubt believes she is in the right, by “just following orders” under the Nuremberg Defense.
Eichmann thought so too.
But others made different choices, belying the defense theory.
Individual human autonomy matters.
45 CFR § 46.116 - General requirements for informed consent.
…(b) Basic elements of informed consent. Except as provided in paragraph (d), (e), or (f) of this section, in seeking informed consent the following information shall be provided to each subject or the legally authorized representative:
(1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures that are experimental;
(2) A description of any reasonably foreseeable risks or discomforts to the subject;
(3) A description of any benefits to the subject or to others that may reasonably be expected from the research;…
(7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject;
(8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled…
It would be interesting to know which, if any, Institutional Review Board originally authorized mass testing of healthy Penn Staters, for what specific purpose and duration, and whether that authorization has expired.
Unfortunately, it seems that the only penalty which Penn State might eventually pay for violating informed consent principles is loss of IRB authorization and loss of federal funding for the experiment.
States and municipalities may have laws on informed consent for human subjects participating in experiments, but only one state (California) attaches civil penalties to proven violations.
In other words, experimenting on human subjects without their informed and voluntary consent — as Penn State has been doing since the middle of 2020 — is not a crime.