Abstract

The lack of strict regulations on the use of human subjects in clinical studies, in the past, and perhaps in this present time, in developing countries, is inhumane, unethical and an act of neglect to civility. It is due to the egregious nature of the past, and probably the act of solace to the outcry and clarion calls regarding the lack thereof in clinical research regulations that prompted the creation of several codes, acts and regulations for clinical trial studies. One of the first world recognized clinical trial regulation that was enacted by the world body was the Nuremberg code in 1948 following the infamous Nazi concentration camp experimental trials conducted on human subjects without their informed consent. The 1964 Declaration of Helsinki in Finland, the 1978 Belmont report in Maryland, and so many other codes and regulations that stemmed from these codes in the evolution of clinical trials has been readily adopted to control and disallow unethical human research practices (Drewry, 2004). The main purpose of this article is to outline some of the major incidents that spurred the unquestionable and necessary enactment of codes to regulate clinical research involving human subjects and thus, how it advocates for a stronger ethical medical research as the beacon for an essential sine qua non to any ethical clinical research practices.

Historical Events and the Ethical Treatment of Human Subjects.

Although there had been other gross inhumane clinical trials such as the Tuskegee experiment which started in 1932 before the Nazi clinical trials, the secrecy that clouded some of these antecedent and brutal clinical experiments involving human subjects at the time made it almost impossible to understand the objectives and purpose of some of the experiments (WaldenU, 2012). Apparently, in the advent of the world judicial criminal trial held in Nuremberg against 23 defendants in the infamous Nazi experiments with human subjects in 1945; it became clearer to the world’s governing bodies and the general public that humans are faced with inevitable danger if clinical trials are not regulated and conducted in a humane and deontological manner (Grady, 2008). The enactment of the Nuremberg code stemmed from the atrocious crimes committed by the Nazi during the 1945 World War II clinical trials (WaldenU, 2012). There were several inherent human and civil right violations in the Nazi orchestrated human subject clinical trials. Some of these crimes include but not limited to lack of informed consent, torture, injustice and unjustified clinical trial practices to mention but a few (WaldenU, 2012). The Nuremberg code covers some key concept of human rights in respect to the use of human subject in any clinical trial which includes but not limited to the initiation and concept of informed consent, sound rationale, risk-benefit assessment, moral justification and the autonomy clause which empowers participants to willfully discontinue and withdraw from any clinical trial at any time (Grady, 2008).

In 1961, Stanley Milgram having been inspired and fascinated by the Nazi experiment, conducted electric shock experiment on human subjects in Yale in quest of answers to the role of negative reinforcement in learning. Unfortunately, the experiment involves torture and omitted unambiguous informed consent (Drewry, 2004). To restore the integrity of medical practices, the world medical association (WMA) came together in Finland in 1964 and proposed or rather drafted “The Declaration Helsinki.” The document is rooted with a fundamental principle which strengthens the Nuremberg code. In addition, it became the operational document for human subject protection, safety and welfare (Drewry, 2004). The world and the medical organizations embraced the efforts and good medical practices recommended in the document, and thus it has prompted and influenced other national and regional medicinal acts and regulations (Drewry, 2004).

In 1966, despite all the efforts and codes enacted to protect human subjects from inhumane, cruel, deceitful, and coerced clinical research practices, Henry Beechev (a Harvard physician) reported several unethical practices with human subjects. Consequentially, the world health organization (WHO) recommended stricter rules against physicians and principal investigators that abuses their medical practices, in order to, once again, protect human subjects from harm (Beechev, 1966).

Moreover, the United States’ congress passed the National Research Act of 1974 and also created the National commission for the protection of human subjects (NCPHS), and demanded that all human research be approved by the department before it moves forward. In the Beechev’s report, he recommended 3 basic principles that must be followed to protect human subjects, which includes informed consent, having responsible, conscientious and compassionate investigators, and ensuring a clear risk-benefit assessment (Beechev, 1966). In other words, the benefits outweighs the risks of the clinical trial in question. Therefore, based on these recommendations and principles, in 1978 the National Commission of the Protection of the Human Subjects of Biomedical and Behavioral Research (NCPHSBBR), created the Belmont Report in Maryland (WaldenU, 2012). The Belmont Report has 3 basic and fundamental principles, respect for human subjects, justice or justification of clinical research rationale, and beneficence to the subjects (Grady, 2008).

In light of all these efforts, to improve clinical trial quality by implementing codes and regulations to guide scientific discoveries, and as scientific innovation advances to more optimistic techniques and technologies, the rapid advancement in science and technology pushes for revision and add-ons to the existing clinical research codes and regulations (Woo, 2000).

References

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Woo, S. (2000). Gene therapy researchers react to fields pitfalls and promises. FDA. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/11590795.