Ethical Concerns Related to Testing Human Subjects and Consent

Alia Palmer

The current regulations for research that involves human subjects are based on a complicated history of ethics and studies that went wrong. This article will present the history of the current regulations which include the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report. In addition to the regulations, the article will highlight the horrific studies that were done with no ethics. These studies will include the Tuskegee Syphilis Study, HeLa cells and Henrietta Lacks, and the Stanford Prison Experiment. This article will also highlight the importance of consent within these research studies and the direct impact on the testing subjects.

Throughout the history of ethics, there have been many definitions of what ethics should be defined as perspectives of how the term is defined. Ethics is derived from the Greek word of “ethos”, which means character, spirit, or custom. The current regulations for research are based on the history of studies that went wrong as well as the idea of ethical thought. Human research is conducted for or about people to contribute to the greater good. Research that involves human subjects can face the possibility of risks and things to go wrong. Even with the best planning in a study, there is still a chance that things can go in the wrong direction. This may include small technical errors, ethical concerns, or neglect. Throughout the history of human subject research, it began with the violation of human beings because no ethics were applied. In the early 1900s, there were no regulations nor laws that included ethics in human subjects in research. Now, ethical thought has helped shape regulations in research. These regulations in research can help researchers accomplish their goals and tasks.

Regulations and Principles

The Nuremberg Code

The Nuremberg Code has served as the crucial foundation for ethics in research since its creation 73 years ago. The Nuremberg Code was the first international document that included the idea of ethics and informed consent (Shuster, 1998). In the article,

“The Nuremberg Code – A Critique”, Ravindra B. Ghooi highlights that this document developed, “in response to the horrors of human experimentation done by Nazi physicians” (2011). The document was a direct response to when the American military conducted criminal proceedings against German physicians and doctors who participated in crimes with no ethics involved. These horrific medical experiments were conducted on thousands upon thousands of concentration camp prisoners without their consent (Ghooi, 2011). Most of the human subjects involved in the experiments died or were permanently disabled as a result. After the terrible things that happened and were brought to light, the Nuremberg Code was established in 1948. The document includes a very important statement, “The voluntary consent of the human subject is absolutely essential.” (Mitscherlich, 2003). The Nuremberg Code created a framework for all future research and experiments.

The Declaration of Helsinki

The Declaration of Helsinki is currently the “living” document that is constantly evolving in research. In the article, "Ethics in Human Research”, the authors state that the World Medical Association established this document in 1964 “after constant concerns from medical doctors in research involving human subjects” (Mandal et al., 2011). The Declaration of Helsinki defines research ethics and rules internationally for research practices. The major issues that the document highlights are: “Research protocols should be reviewed by an independent committee prior to initiation”; “Informed consent from research participants is necessary”; “Research should be conducted by medically/ scientifically qualified individuals” (Mandal et al., 2011). The document has been revised multiple times and serves as the basis of ethical practices in research today.

The Belmont Report

In 1979, the Belmont Report was published to summarize ethical principles. The document is another fundamental piece in research, it provides guidelines that help with establishing ethics with human subjects (Perlman, 2004). Three basic principles are established within the document are • Respect for person Incorporates the idea that human subjects are entitled to protection and that the subjects enter the research study voluntarily • Beneficence Emphasizes that human subjects should not be harmed, and the research should minimize any possible harm to the subjects

• Justice Explains that the benefits and risks of the study/research must be distributed fairly. All three ethical principles are the cornerstones of current regulations in research today.

Research Abuses Tuskegee Syphilis Study

One of the major turning points in the development of ethics in research was the Tuskegee Syphilis Study (19321972) that was conducted by the US Public Health Service (Daram, 2016).

This study highlighted the tragic effects of what can go wrong in research if little to no ethics are involved. From the beginning of the study, 400 out of the six hundred lowincome, Black males, were infected with syphilis (Mandal et al., 2011). They were “monitored” for the next 40 years and received free medical exams, but they were not told about the disease that they had nor the possible side effects. In the article, “Ethical Issues in Sociological Research”, K. Daram explains that after the introduction of a proven cure of penicillin in the 1950s, the study kept going until 1972 (2016). The study was supposedly supposed to last about six months, but the researchers insisted to continue (Mandal et al., 2011). The study continued and the participants in the study were denied treatment to receive penicillin. The study became unethical because the researchers did not offer the subjects the cure – penicillin. Some of the subjects tried to get other medical doctor’s help, but the researchers intervened and prevented treatment; as a result of lack of treatment for the subjects, many women and children contracted syphilis from them (Daram, 2016). In 1973, word got out publicly and exposed the wrongdoings that were going on in the study and the government immediately closed it. After the creation of the publicity surrounding the study, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was formed and drafted the foundation of the Belmont Report (Mandal et al., 2011).

The Creation of HeLa Cells

The story of Henrietta Lacks and the creation of HeLa cells have been an example as a catalyst for change for ethics in research. Henrietta Lacks was a 30-year-old African American woman and a mother of five kids. Dr. Laura Beskow, the author of the article "Lessons from HeLa Cells: The Ethics and Policy of Biospecimens”, states that in 1951, Lacks was “diagnosed with a never seen type of cervical cancer” (2016). Without her knowledge nor consent, “tissue samples were taken during her diagnosis and treatment, and... were passed along to a researcher” (Beskow, 2016). Although this was a very common practice during that time, this is highly unethical. Researchers conducted hundreds of tests and found out that her cells (“HeLa cells”) could grow and survive outside the body which, was the first time in history that they were able to accomplish this. (Beskow, 2016). Lacks soon died from aggressive cancer, but her cells were still used, and some are still “living” today. Although the HeLa cells have been used in numerous experiments around the world for the future of biomedical research, the Lacks family has received no financial benefits. (Beskow, 2016) The majority of the Lacks family line has continued to live in poverty with no access to health care. The story of Henrietta Lacks created national attention on the importance of informed consent and ethics for human subject research. Henrietta lacks serves as an example of the importance of respecting every human subject in any type of research. Although the HeLa cells provided a breakthrough for medical research, there were no ethics involved and the researchers looked at Henrietta and

her family as specimens for a cure, not humans.

Stanford Prison Experiment

The Stanford Prison experiment of 1971 is one of the most controversial studies in the history of modern psychology. The experiment was supposed to last 14 days but ended just after six days (Mcleod, 2017). The creator of the experiment, Professor Philip Zimbardo, was interested in finding out if the brutality reported among guards in the prison system was due to their personalities or the prison environment (Zimbardo, 2007). In the experiment, the students were randomly divided into “prisoners” and “guards” in a simulated prison environment in the basement of the Stanford University Psychology building. At the beginning of the experiment, the guards immediately began to harass the prisoners and used physical punishment over petty orders (Konnikova & Lemann, 2015). Push –ups were used as a punishment to dehumanize the prisoners; guards would step or sit on their backs during the exercise (Mcleod, 2017). One prisoner was immediately released after 36 hours because of uncontrollable crying. The prisoners had numerous mental breakdowns and conducted a hunger strike, and Zimbardo didn’t do anything nor tell the guards to back off (Konnikova & Lemann, 2015). After the prisoners began to show extreme signs of stress and anxiety, Zimbardo’s colleagues advised him to end the experiment early. As the prisoners did not give their informed consent on the harsh conditions they would experience, this is a form of deception. Also, the study did not immediately stop when the participants were experiencing psychological and physical harm. More in-depth ethical guidelines were developed as a result of the Stanford Prison experiment, which took into consideration the potential psychological harm of the human subjects (Zimbardo, 2007). This experiment is a prime example of what can go wrong when ethics are not applied for human subject research.

Conclusion

Throughout the history of ethics, there have been many interesting definitions and theories about what ethics are. This article examined a small portion of the history of ethics in research. The theories used provide an outlook on what researchers need to do. Any research conducted on human subjects should have ethics applied throughout the entire experiment. The research should be conducted should not compromise the well-being of the subjects. It is important to adhere to all the ethical principles to protect the rights of the human subjects involved in the research. Any research involving humans should be reviewed by an ethics committee and board to make sure that all the standards are being conducted correctly.

References

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Ghooi, R. B. (2011, April). The Nuremberg Code-A critique. Perspectives in clinical research. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3121268/.

Konnikova, M., & Lemann, N. (2015, June 15). The Real Lesson of the Stanford

Prison Experiment. The New Yorker. https://www.newyorker.com/science/maria-konnikova/the-real-lesson-of-thestanford-prison-experiment.

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