Biomedical Research: The Nuremberg Code

The original intentions behind The Nuremberg Code, which some credit as being the first set of ethical guidelines for the conduct of biomedical research, were to not only prevent the cruelty of the experiments mentioned during the Nuremberg Trials from being repeated, but also to have a future set of rules for investigators to be able to follow, and potentially prosecute, if it came it came to it again. While it is often regarded as being the first document of its kind, The Nuremberg Code was very heavily based in the Guidelines for Human Experimentation of 1931 (1931 Guidelines): a trend that has continued with each new set of ethical guidelines that is produced. The Nuremberg Code paved the way for the subsequent set of ethical guidelines,
The Declaration of Helsinki, created by the World Medical Association (WMA), and was also intended to provide guidance to researchers; however, it attempted to strike a balance weighing the importance between maintaining the wellbeing of research subjects and helping to further scientific knowledge. Like those before it, The Belmont Report was created for a specific purpose: in its case, as a reaction to previous violations of human rights. Each of the afore mentioned documents should ascribe some credit to their predecessors, because they all played a large role in creating the current framework for biomedical research guidelines.
Conclusion:
The 1931 Guidelines were passed by the German government, and -again- they weren’t completely original. There was an antecedent, the Berlin Code 1900, but there isn’t much information to be found about it. The 1931 Guidelines required consent, but didn’t specify that it had to be completely informed consent, just that consent from the subject or their legal representation is necessary; it did however, allow the experiment to continue even if there wasn’t consent if the subject would undergo serious harm without it or if there wasn’t an early opportunity for them to have given consent. It also went into detail about the experimentation on minors. It also forbade the exploitation of social hardship (i.e. offer them lots of money if they are poor) to encourage or force them to participate. It says human experimentation must be avoided if if it’s possible to be replaced by animal studies, and if not they must have been tested in advance. A paper also had to be written, explaining the details of the experiment. Also, the clinical trials can only be held by licensed physicians acting as or under direct orders of the physician in charge. One of the problems I found within this was that it seemed to condone studies that endangered the life of the subject, if the researcher was also participating in the study. The 1931 Guidelines, were again, very similar to those set in The Nuremberg Code. Both focus completely on the human rights of the research subjects. The Nuremberg Code stresses the need for a subject to give consent, and brings up the importance of informed consent. It also created a new principle wherein the subject can withdraw at any time. The Declaration of Helsinki (DoH) was first adopted in 1964.
While it doesn’t explicitly credit -or even acknowledge- The Nuremberg Code, the similarities between them are undeniable. It is regularly updated and reviewed, and focuses on the obligations to the research subjects. Both The Nuremberg Code and the DoH are models for current U.S. research regulations, which will be further discussed later, in that they all require informed consent (from the subject or a proxy), and a prior peer research of research protocols (Shuster, "Fifty Years Later: The Significance of the Nuremberg Code"). While they are similar, there are some stark differences; The Nuremberg Code requires consent from the subject and The Declaration of Helsinki is more allowing, permitting a proxy to consent in their place. The differences aren’t just between The Nuremberg Code and the DoH, it’s also between the original (pre published) copy of the DoH and the then final copy. The unedited copy said that the subject could leave the experiment at any time they feel unable to wholly physically or mentally finish it, while the revised version specified that the researchers had an obligation to bring the experiment to an end if they felt it could hurt the subject, as well as the subject or proxy being able to pull out at any time (Carlson, Kenneth, & David, ““The Revision of the Declaration of Helsinki: Past, Present and Future”). While the DoH did have some relatively drastic edits between its creation and
its publication, it has continued to be revised and reviewed. The only major change was made over a decade after its publication, and it required that an independent committee review the research protocols. The majority of the other changes were editorial. These changes are proof that human ethics has an ever evolving nature, evidence of improving human values. The Belmont Report was created by The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
This committee was created by Congress in 1974 in response to the public reaction to the Tuskegee Syphilis experiments. They were required to identify the ethical principles and develop guidelines for the conduct of ethical research involving human subjects. Five years later, they had The Belmont Report drafted (“The Belmont Report”). It defined the boundaries between research and practice, and recognized the three most important principles: autonomy, beneficence, and justice. Each principle had a different group assigned to it so there was no risk of failure of compliance. Of course each of these sets of guidelines had their own limitations, and problems. None of them were perfect. Ethical guidelines could never, and will never be perfect. Ethics is a matter of opinion, what one person may find completely ethical, might be completely atrocious, and off putting to another. And even what is already set in stone, what is already fairly unspecific and ambiguous, can be completely switched around. Some adults (18+) may have the maturity of a child, and agree to a trial that they might not completely understand, even if it is explained to
them. While there may never be a completely perfect set of rules for researchers to follow, they definitely have been getting closer. It’s vital for us to continue the search, too many situations have occurred where -even with these rules- people, subjects, have had their trust and human rights violated. All of this is without considering making the guidelines into a law, which would make them infinitely more effective, although would prove very difficult. Each of these documents were created for a reason, and were incredibly important and public when they were initially released, and are still important today because they are a stepping stone to what we have today.