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Source: The Conversation (Au and NZ) – By Holly Seale, Associate professor, UNSW

People opposing vaccine mandates, or COVID vaccines more broadly, have claimed the vaccines violate the Nuremberg Code.

They say COVID vaccines are experimental and people have been coerced into vaccination. They say this breaches the ethical code drawn up after the second world war to guide medical research and human clinical trials.

But this argument is flawed. Here’s why the Nuremberg Code doesn’t apply, and how to correct this misunderstanding.

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What is the Nuremberg Code?

The Nuremberg Code was a direct response to atrocities Nazi doctors performed in concentration camps during WWII. They perpetrated this so-called medical experimentation on people with no capacity to consent, and this frequently led to lifelong disability, or death.

The doctors who performed these experiments were tried in Nuremberg in 1947.

The doctors’ defence argued their experiments were not significantly different to other research practices. So two American doctors working for the prosecution produced a document that aimed to draw together what made for ethical research.

This document identified three ethical, legal, and scientific requirements for conducting human experiments, which were later expanded to ten. This ten-point document became known as the Nuremburg Code.

It details the process of seeking legally valid voluntary consent, covers the need to establish the humanitarian nature and purpose of the experiment, as well as ensuring the scientific integrity and obligations of the investigator to the subjects’ welfare.

However, the Nuremberg Code is no longer used to guide research ethics. The World Medical Association’s Declaration of Helsinki replaced it in 1964. And there’s been more ethical guidance since.

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No, COVID vaccines are not experimental

Online commentary says COVID vaccines are “experimental”.

But COVID vaccines have been thoroughly tested, and they have been shown to work. Their side-effects have been extensively examined. They have been approved for use around the world and have been credited for saving many lives.

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So COVID vaccines are not “experimental”. Now COVID vaccines are part of standard public health response, it is not appropriate to refer to codes or documents developed to guide clinical trials and other research studies.

How do you convince someone?

If you come across someone claiming COVID vaccines are experimental, you can try the “truth sandwich” to try to myth bust.

If you imagine two pieces of bread, then the filling in the middle, you are on your way to using the truth sandwich.

First, we take a piece of bread, where we state the truth:

COVID vaccines have been tested in pre-clinical and clinical trials, and their efficacy and effectiveness has been proven, and their side effects profiles have been extensively examined.

Then we come to the filling in the middle, where we talk about a false claim and how it relates to the truth:

You may have heard someone suggest the COVID-19 vaccine program infringes people’s rights under the Nuremberg Code. But the claim that COVID-19 vaccines are experimental is simply not true. Regulatory authorities have approved these vaccines nationally and internationally. Safety monitoring is ongoing, but these processes are routine and commonly used for other vaccines or drugs. Check out AusVaxSafety.

Our final piece of bread comes next, repeating the truth:

The Nuremberg Code focuses on clinical research on humans. Therefore, it is no longer relevant once a vaccine moves beyond the clinical trial phase and has been authorised or approved for use globally.

The issue of informed consent

Online commentary usually cites the first clause of the Nuremberg Code about the need for informed consent in human experiments:

The voluntary consent of the human subject is absolutely essential.

This argument is used as evidence there’s something unethical about using COVID vaccines or introducing mandates.

Indeed, voluntary informed consent is an ethical bedrock for clinical research. Any form of compulsion is unacceptable because clinical research has inherent risks and can’t be quantified precisely. Research also may not have any direct benefit for participants, which again requires consent.

To be ethical, therefore, researchers must ensure participants in clinical trials understand potential risks and benefits, and give voluntarily consent to participate.

How do you convince someone?

Again, we can use the “truth sandwich” to myth bust.

Take your first piece of bread, stating the truth (the facts):

The Nuremberg Code relates to research, where the emphasis of informed consent is on “preventing research participants from being used as a means to an end”. The need for informed consent is still required for receiving a COVID-19 vaccine (or any vaccine) but the need does not stem from the Nuremberg Code.

Here’s the filling (the false claim and how it relates to the truth):

The introduction of a vaccine mandate is not medical research but rather a public health intervention. In every setting where COVID vaccines are mandated, no-one is being forced to be vaccinated against their will or consent. Informed consent is still sought before vaccination, and people retain the right to choose whether to be vaccinated.

However, in these settings, the public health goal of COVID-19 vaccination is seen as outweighing the rights of the individual to remain un-vaccinated. Other people in these settings have a right to health and security. Therefore there are outcomes for those who don’t comply. Exemptions are provided for those who cannot receive the vaccine for medical reasons.

If you want to expand further:

Mandates of this nature have previously been used in occupational settings to reduce the risk from vaccine preventable diseases for the employee and for the people they come into contact with, whether they be hospital patients or aged care residents. Beyond these settings, we have accepted vaccines as requirements of travel (such as yellow fever) both to protect ourselves and to reduce any risk of bringing this infection back to Australia.

Final piece of bread (repeating the truth):

There has been misinformation about linking COVID-19 vaccination, and/or the requirements within some occupations to the Nuremberg Code. The code relates to research and claims that mandates violate it are not accurate.

Why is this important?

This type of misinformation often thrives in situations where feelings are manipulated. And emotional posts on social media referring to Nazi doctors and Nuremberg are more likely to be shared.

We can keep fact checking. But it’s also time for every one of us to get out there with our truth sandwiches.

The Conversation

Holly Seale is an investigator on research studies funded by NHMRC and has previously received funding for investigator driven research from NSW Ministry of Health, as well as from Sanofi Pasteur and Seqirus. She is the Deputy Chair of the Collaboration on Social Science and Immunisation.

Ben Harris-Roxas is an investigator on projects funded by the Cancer Institute NSW, the National Health and Medical Research Council (NHMRC), the Sydney Partnership for Health Education Research & Enterprise (SPHERE), and NSW Health. In the past he has received funding from the Australian Research Council, the World Health Organization, the Australian Government Department of Health, the Public Health Agency of Canada, the Heart Foundation, NPS MedicineWise, the Sax Institute, and the City of Gold Coast.

Bridget Haire has received funding from National Health and Medical Research Council (NHMRC)

ref. COVID vaccines don’t violate the Nuremberg Code. Here’s how to convince the doubters –