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Where is the Office for Human Research Protections?


Recent posts on the Brownstone site have done an excellent job of exposing the professional, ethical, public health, governmental, ideological, and political lapses (to put it very politely) in handling what has been the nation’s COVID pandemic response, which has been a total disaster. 

Concurrently, I was engaged in email dialogue with Brownstone contributors covering a couple of players in this horror show that have managed to avoid the spotlight completely. I’m referring to the Office for Human Research Protections (OHRP) and Institutional Review Boards (IRBs), and the way these entities interact. 

My go-to site to obtain COVID-related information and to occasionally ask questions or make comments is Brownstone Institute. I have found this site to be extremely reliable, and my queries always receive a very timely response directly from Jeffrey Tucker. 

On October 2nd, I used the Brownstone Contact link to post the following:

I am chair of an Institutional Review Board (IRB) at a small private-not-for-profit agency that does research in which vulnerable populations are recruited. As such, I’m well aware that the foundational documents from which the Office for Human Research Protections (OHRP) developed the regulatory framework under which IRBs operate are the Nuremberg Code and the Belmont Report. The Nuremberg Code primarily covers the requirements for adequate informed consent, and the Belmont Report emphasizes three basic ethical principles, one of which covers bodily autonomy.

Under Emergency Use Authorization (EUA); the American people, in effect, became Phase III research subjects when it came to the mRNA vaccine. Therefore, OHRP protections, by regulation, should have been in effect. It was clear to me early on that informed consent was not properly performed. I subsequently found out, through Brownstone, that the Nuremberg Code was actually suspended! In addition, vaccine mandates utilizing an experimental pharmaceutical violates the Belmont Report’s absolute requirement that bodily autonomy must be respected.

Like a light bulb going off; it suddenly occurred to me that I haven’t heard a peep out of OHRP! In view of the fact that I receive email communications from OHRP, someone in my position would have seen it had it occurred. The silence is deafening, and it raises the question as to whether OHRP has been complicit in the censorship. Does anyone have any information relative to this matter?

As I mentioned earlier, Jeffrey Tucker is the person who has responded to me and he’s done so within 12-24 hours. However, in this case, he must have quickly forwarded my email to several of his colleagues, since two of them responded directly to me within about 30 minutes. Clearly, I had hit a nerve! The first response was from Meryl Nass, MD. Her response was as follows:

EUAs are an attempt to carve out a gray area between drugs used in experiments and licensed drugs, in which the law pertaining to neither applied.  EUAs were invented in 2005, possibly in order to force anthrax vaccines immediately after my group got the anthrax vaccine license revoked.

I looked into the EUA extensively 3 years ago. I think IRBs were cut out of the EUA process, as was informed consent; instead, a Fact Sheet was required, and it was to provide any “significant known” adverse events. It also allowed people to opt out, but be informed of “consequences” for doing so.

The language of “consequences” was thought by most before 2020 to mean medical consequences of refusal, but the language was clever and covered employment and educational consequences, as interpreted by the government.

It is important to contextualize this with the fact that vaccines are required for education and employment despite the laws and norms on informed consent and bodily autonomy. In my humble opinion, we in the US have conflicting laws and the ability to mandate vaccines has won in the court of public opinion, at least until the COVID era.

Something to keep in mind regarding the last paragraph above is that the mandates have historically been for vaccines that (1) have completed all phases of the research process, and (2) have been approved and licensed for use. The COVID vaccine has not yet reached either of these two milestones in the US to date. However, Dr. Nass subsequently added that there were, and still are many people, including healthcare professionals, who believed, and still believe that they were getting a licensed product. That’s because of a bait-and-switch, where one version of the product was licensed, but the licensed version was never distributed in this country.

A few minutes after Dr. Nass responded, Harvey Risch, MD, PhD emailed the following:

This worked because the national security state controlled the pandemic management, not the public health infrastructure.  So the vaccines are not vaccines, they are “countermeasures.” Informed consent is not needed when you tell a soldier to go to the front and fight, and this was run the same way. Pandemic management was a “bio-weapon” military operation from six days after the emergency was declared.

As a person who lost family members in the Holocaust, and chairs an IRB with members and prospective research subjects that are racially and geographically connected to the victims of Tuskegee, I viewed these government actions as abhorrent. What’s particularly disturbing is the fact that the entire handling of the pandemic has been reminiscent of the tactics used by the Nazis during the 1930s against the Jews. These tactics were also used for decades in the Jim Crow South against the Black population. Yet, there was nothing from OHRP! 

Dr. Risch followed up with the following:

I started saying mid-2020 that the Big Lie propaganda against hydroxychloroquine (HCQ), the fear mongering, etc. were right out of Germany 1935. And then Australia and Canada built camps, and NY Governor Hochul is still fighting in court to imprison anyone she chooses, without any evidence, for an indeterminate time, with no method of appeal except to go to court.  The atrocities are everywhere in front of our eyes today.

You are the first IRB person that I have heard to object to the violation of IRB principles in the COVID vaccine era. Where are all of the IRB personnel across the country? I have dealt with my Yale IRB people on a personal and professional level for >30 years. During COVID, they were business as usual. Not a peep about Yale’s vaccine mandates, including mandating students, who have about no conceivable benefit from the shots. If your job is to be ethical, isn’t it a fail in your job not to object to unethical policies in which you are immersed?

Note the 1st sentence in the 2nd paragraph above. It didn’t surprise me, but should terrify all of us. Over the ensuing week, email communication continued covering a range of related issues, which raised another important aspect of OHRP and IRB interactions. In addition to sweeping aside bedrock IRB principles regarding informed consent and bodily autonomy, the COVID vaccine pushers either never developed a Data & Safety Monitoring Plan (DSMP), a standard practice when doing this type of research or did so, but never released the findings. 

In fact, the first sentence of the third paragraph of the Introduction to the National Institutes of Health (NIH) guidelines for DSMPs states that NIH requires data and safety monitoring, generally, in the form of a Data & Safety Monitoring Board (DSMB) for Phase III clinical trials. Did EUA sweep this away, as well? Or was it the fact that the head of the Department of Bioethics at the National Institutes of Health Clinical Center (what is essentially the NIH’s IRB) is none other than Christine Grady, the wife of Anthony Fauci? So much for conflict-of-interest considerations!

As we’ve seen, leaving safety evaluations to the Vaccine Adverse Event Reporting System (VAERS) or other similar surveillance systems has provided plausible deniability for what I believe is the likelihood that the jabs helped virtually nobody, while already causing massive damage. Considering the fact that it will take several more years for the full impact of this vaccine to be seen, there’s every reason to believe that there are other shoes that are going to drop. 

The worst part of all this is that creating confusion was a deliberate strategy, with all sectors of the administrative state colluding to implement this strategy. Once again, where was OHRP, or at least a whistleblower from that agency? 

As a result of my interaction with Dr. Risch, he invited me to be on his podcast, America Out Loud PULSE. The title is: Where Did Medical Ethics Go During COVID-19? It was recorded October 12th and aired October 13th. Here’s the link:

Getting back to OHRP and IRBs, it is clear to me that if regular order had been observed, proper informed consent would have been done, and millions of people who took the vaccine when it was first available would have refused it. 

Further, if proper data and safety monitoring had been done, the vaccine would very likely have been removed from the market by the late spring of 2021, prior to being considered for children under the age of 18. While Dr. Nass informs us that EUA swept aside OHRP, I believe we need much more detail as to how that happened, and how other elements of OHRP/IRB policies and practices developed over decades were swept aside.

It raises the specter that there are other research projects in the IRB dockets at other institutions where corners are being cut in order to force approval. The resultant and potential carnage demands answers; otherwise the expression, “Never again” becomes nothing but an outdated anachronism.  

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  • Steven Kritz

    Steven Kritz, MD is a retired physician, who has been in the healthcare field for 50 years. He graduated from SUNY Downstate Medical School and completed IM Residency at Kings County Hospital. This was followed by almost 40 years of healthcare experience, including 19 years of direct patient care in a rural setting as a Board Certified Internist; 17 years of clinical research at a private-not-for-profit healthcare agency; and over 35 years of involvement in public health, and health systems infrastructure and administration activities. He retired 5 years ago, and became a member of the Institutional Review Board (IRB) at the agency where he had done clinical research, where he has been IRB Chair for the past 3 years.

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