In reading Nuremberg, The Belmont Report, and now the Helsinki Declaration, I can say that up to 2020, US had far lower ethical standards for human subjects research than WMA. Now? None.
Both WHO and the US HHS suffer from a form of ethical blindness when it comes to vaccine research. Foregoing long-term vaccine safety studies in favor of retrospective analysis of real-world data, these agencies fail to recognize that post-marketing (and post-EUA) studies are de facto uncontrolled, non-randomized prospective clinical trials conducted without proper consenting procedures.
If you’ve read the Nuremberg Code, the Belmont Report, and the Declaration of Helsinki, you’d know that protections are supposed to be in place not for some people undergoing some clinical studies, but instead are considered to be required to be in place for all people undergoing any clinical studies.
Right now, in our Medical Ethics, Informed Consent, and Human Rights course @ IPAK-EDU, having completed our readings and discussions of The Nuremberg Code and the Belmont Report, we’re reading and discussing The Declaration of Helsinki.
Nuremberg focused primarily on the rights of patients’ protection from harm by doctors performing “human experiments”. Helsinki changed the langued to “clinical research”, but the intention was the same. The Belmont Report was an early draft of a guidance-type document in the US meant to inform professionals of the general expectations of normative standards; it is now only considered a “historic” document.
Nuremberg, Helsinki and Belmont carry no legally enforceable language in the US. Instead, Nuremberg and Helsinki were meant to provide international standards by which individual countries could gauge their governance and regulation of clinical, human subjects research. It takes a while, but comparing the Helsinki Code to the US policies in play prior to 2020 (before COVID) shows that US researchers (meaning US-based pharmaceutical companies) wanted to weaken the concept of beneficence - the principle that all involved in a trial should benefit from being part of a clinical trial.
Where the US had departed (prior to 2020) from the rest of the countries that backed Helsinki (WMA) and participated in its updates included, according to Kimmelman et al. (2009) included:
Disclosure of conflict of interest;
- Public disclosure of study design;
- Benefit for populations in which research is conducted (beneficence);
- Reporting of accurate results and publication of negative findings;
- Access to treatment after research has been conducted, and
- Restriction of use of placebo in a control group where effective alternative treatment is available.
