Dianne N. Irving
March 28, 2018
Reproduced with Permission
- [Note: This recent essay of mine, just published in The SAGE Encyclopedia of Educational Research, Measurement, and Evaluation (2018), is about crimes against humanity. It denotes (briefly) how the protections proclaimed in the international research ethics standard known as the Nuremberg Code for researchers to follow when using human subjects in research have been slowly diluted over the years with the various Declarations of Helsinki and the "birth of BIOethics" (the Congressionally mandated 1979 Belmont Report; see especially article by Marcia Angell, "Medical Research: The Dangers to the Human Subjects", in the references below). The Nuremberg Code was the final declaration of the international Nuremberg Trials that investigated the Nazi medical research war criminals who had so horrifically abused human subjects in their research -- such research designated by the Nuremberg Trials as "crimes against humanity". [My interests in the abuse of human subjects in research began many decades ago when, as a biochemistry major, I wrote my thesis on a scientific analysis of the infamous Mengele twin experiments -- which never used legitimate "informed consent", were often based on fake "data", designs of his protocols and analyses of his "data" were atrocious, etc.; see: "Me and Mengele" (October 18, 2003), at: http://www.lifeissues.net/writers/irv/irv_136meandmengele.html; also published Dec. 4, 2013 on Renew America, at: http://www.renewamerica.com/columns/irving/131204).] Thankfully, and finally, intellectually honest scientists in recent organizations such as Retraction Watch have been identifying articles in journals rejected due to an epidemic of the intentional use of false scientific "data" (scientific fraud) and other scientific misconduct -- all of which eventually end up dangerously affecting the health and even lives of human subjects used in clinical trials (therapeutic research) that are based on that fake "data" -- which constitutes abuse of those human subjects -- as well as abusing the health and well-being of millions of consumers who use drugs and devices based on all that fake scientific "data". Time for another International Tribunal to identify and prosecute these more recent crimes against humanity -- committed by scientists et al who are likewise abusers of human beings used in research (including experimental and therapeutic researchers, Big Pharma, and private and governmental organizations that fund them) -- and, a return to the Nuremberg Code, indeed, legally requiring its directives. If not, no complaints, please. -- DNI]
March 28, 2018
How the "ethics" of research using human subjects has changed since the Nuremberg Code
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:
-
The voluntary consent of the human subject is essential.
-
The experiment must be necessary for the good of society unattainable by other means, not random or unnecessary
-
The experiment should be designed based on results of animal experimentation and knowledge of the disease, and that results will justify the performance of the experiment.
-
The experiment should avoid all unnecessary physical and mental suffering and injury.
-
If reason exists that death or disabling injury will occur the experiment should not be conducted -- except perhaps when the physician researchers themselves are the subjects.
-
The degree of risk should never exceed the humanitarian importance of the problem to be solved.
-
Proper preparations and adequate facilities should be provided to protect the human subject against even remote possibilities of injury, disability or death.
-
The experiment should be conducted only by scientifically qualified and skilled persons.
-
The human subject should be free to bring the experiment to an end if he/she determines the continuation of the experiment is impossible.
-
The scientist in charge must be prepared to end the experiment at any stage if he/she has probably cause to believe that a continuation of the experiment is likely to result in injury, disability or death to the human subject.
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
.
Professor Dr. Dianne Nutwell Irving, M.A., Ph.D.
See also
45 CFR part 46, Belmont Report, Conflict of Interest, Declaration of Helsinki, Falsified Data Historical Cases of, Federally Sponsored Research and Programs, Human Subjects Protections, Informed Consent
Further Readings
-
Nuremberg Code. Retrieved from
http://www.hhs.gov/ohrp/archive/nurcode.html
.
-
Declaration of Helsinki. Retrieved from
http://www.wma.net/en/30publications/10policies/b3/
.
-
Code of Federal Regulations, Title 45, Part 46:
Protection of Human Subjects
. Retrieved from
http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html
.
-
"The Nuremberg Race Laws", United States Holocaust Memorial Museum. Retrieved from
https://www.ushmm.org/outreach/en/article.php?ModuleId=10007695
.
-
Angell, M.
(2015). Medical Research: The Dangers to the Human Subjects.
The New York Review of Books
. Retrieved from
http://www.nybooks.com/articles/2015/11/19/medical-research-dangers-human-subjects/
.
-
Annas, G. and Grodin, M. (ed.) (1992).
The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation
(Oxford University Press, 1992).
-
Beecher, Henry K. (1966). Ethics and Clinical Research.
The New England Journal of Medicine
, Vol. 274, No. 24.
Top