Current Epidemic of Scientific Fraud and the Nuremberg Code

Dianne N. Irving
© November 12, 2016
Reproduced with Permission

False scientific data and misconduct lead to false medical data, which leads to false clinical trial data, which leads to fake drugs and related products. Aside from the enormous waste of money that could have been used for good research with reliable outcomes and cures, among other problematic consequences are those to the vulnerable innocent human subjects of research in clinical trials involved, as well as to consumers in the marketplace, such as physical and psychological harm, diseases, and even death.

Given the current epidemic of scientific fraud and misconduct, as evidenced lately through the efforts of Retraction Watch ( ) and several other similar organizations and journal efforts, it might be time to revisit the hard-won international research ethics principles of the Nuremberg Code .

Subsequent to the discriminatory Nuremberg Laws passed by the Nazis in Germany 1935 and the massive atrocities involving the torture and deaths of millions of innocent human beings that ensued, the Nuremberg Code was finally issued at the Nuremberg Trials at the end of World War II. The Nuremberg Code is a voluntary international guideline listing ten basic principles that must be met to satisfy moral, ethical and legal concerns involving the use of any human subjects in research -- including those participating in research in education. The Code consists of the following principles (paraphrased), focusing on the physical and mental safety of the human subjects involved -- not on the "greater good of society": ( )

The Nuremberg Code

Since informed consent was considered so ethically fundamental, research on children and others not capable of deciding for themselves (e.g., the mentally ill) is prohibited .

In 1964 the Nuremberg Code was followed by the voluntary international Declaration of Helsinki guidelines issued by the World Medical Association and have been revised multiple times since then. In 1991 the United States Department of Health and Human Services issued its own guidelines for the Protection of Human Subjects in research involving federal funding, also revised over time.

Critics warn that the latter two efforts have seriously diluted the Nuremberg Code's protection of human subjects in research and are thus unethical . Given that there is an inherent tension between the search for scientific answers and concern for the rights and welfare of human subjects, they note the shift of focus from the protection of human subjects to the interests of governments, organizations and industry -- often justified by the utilitarian-based bioethics created by Congress in the 1978 Belmont Report .

As many critics point out, including Dr. Marcia Angell ( ), a member of the faculty of Global Health and Social Medicine at Harvard Medical School and former Editor-in-Chief of The New England Journal of Medicine , the long history of blatantly unethical research in clinical trials on human subjects by the government and private organizations since World War II to the recent past is testament to their concerns. (See extensive documentation of the abuse of human subjects in research before, during and after World War II to the present in the work of Vera Sharav, founder, Alliance for Human Research Protection , "The Dark Side of Science: Unconscionable Human Experiments, A Chronology", at: ).

Long past time to confront the current epidemic of scientific and medical fraud and misconduct that has become so serious now that many within the fields of science and medicine themselves are calling for such "malpractices" to be acknowledged as crimes and such researchers held legally accountable . (See many such efforts in articles at Retraction Watch). Perhaps this is the only way left to prevent the concurrent epidemic of harm to, disease and death of innocent living human subjects of research and millions of consumers. "Professionalism" has obviously not worked.