Do vaccines violate the Nuremberg Code?

An RFK Jr. tweet claims that the FDA and Congress have weakened the Nuremberg Code’s protections by allowing vaccine manufacturers to bypass informed consent for minimal-risk studies, arguing that they have undermined ethical standards in medical research.

The Nuremberg Code, established after World War II, sets ethical standards for human experimentation, emphasizing voluntary consent. However, the Code is not legally binding; rather, it has influenced the development of more comprehensive and enforceable regulations, such as the Declaration of Helsinki and U.S. regulations for human research.

The U.S. regulatory framework, including the Common Rule and FDA regulations, mandates informed consent in almost all research involving human subjects. There are specific cases where full informed consent isn’t required if the research involves minimal risk and getting consent is either impractical or would affect the study’s results. This isn’t a break from ethical rules but a way to ensure that research can still be done effectively while considering ethical issues. Recent updates are about clarifying and adjusting these rules to fit new research needs, like large-scale studies that pose little risk to participants.

Institutional Review Boards (IRBs) are groups that include scientists, non-scientists, and community members. They work to protect the rights and well-being of research participants. The idea that IRBs are easily influenced by pharmaceutical companies isn’t accurate and ignores the strict review processes and ethical guidelines they follow.

The claim that experimental Emergency Use Authorization (EUA) vaccines were given without informed consent is also incorrect. Even under EUA, which is used in emergencies, people are provided with information about the vaccine, including any risks and benefits, so they can make an informed choice. The rules make sure that, even during emergencies when special vaccine authorizations are given, people are still provided with all the information they need to understand the vaccine and make a choice. This process of informed consent is a fundamental part of ethical medical practice.