Written by Katie Traversino and Edited by Josephine Chan
While many are aware of the issue of discrepancy in the treatment of different races in the world, some may be unaware of how this exists within the health field as well. A 2017 data study that surveyed Black, European, and Hispanic individuals from twenty different areas around the U.S. suggested that the levels of distrust healthcare correlated with an individual’s ethnicity rather than their region [1]. This apparent inconsistency in the quality of treatment is alarming because every individual should receive equal, standard medical care. Unfortunately, the reason for this distrust is influenced by past atrocities and prompted the formation of regulatory groups such as the Institutional Review Board (IRB), a committee tasked with evaluating the ethics of research studies in the U.S.. The goal of the IRB is to prevent the repetition of similar transgressions committed in the past against humans and animals, and to ensure that the risks of the trial will be outweighed by the benefits to society.
Clinical trials are experiments or observation studies that involve human participants, and aim to produce results that will benefit mankind directly, such as drug testing for new medications [2]. However, since these trials include human subjects, the extent that scientists can perform experiments becomes complicated in the realm of ethics and right versus wrong. Regulations by the IRB aim to moderate researchers and require them to abide by certain rules, including but not limited to obtaining the informed consent of participants, thoroughly documenting trials, reporting changes to the IRB, maintaining equipment and techniques that are approved by the Food and Drug Administration (FDA), and maintaining their certifications to conduct these experiments [3]. In particular, the IRB provides protection for vulnerable groups, such as pregnant women, prisoners, and children against being targeted for clinical experimentation [3]. The IRB was established in 1974 by the National Research Act and was updated in accordance with principles outlined in the 1979 Belmont report, which outlined three ethical principles: respect for individuals, integrity, and societal contribution, in response to the Tuskegee Syphilis Study [2]. This study took place in Alabama from 1932 to 1972, and took advantage of black men who had syphilis, a bacterial infection usually transmitted through sexual contact, contaminated blood, or from mother to child during childbirth [4]. In its early stages, the infection manifests as sores or a rash, before going dormant with little to no symptoms until years later, at which point the internal organs, such as the heart and brain, are severely damaged. Participants in this study were not informed that the purpose of the study was to test medication designed to treat the infection, despite the discovery of penicillin, an antibiotic, that was found to be an effective treatment. All 439 affected men that were studied were never treated for their bacterial infection, nor were their spouses and children, leading to the deaths of at least 16 individuals [4].
The most infamous event that reverberated through the field of clinical experimentation was the Holocaust in the 1940s. In the aftermath, during the Nuremberg Trials, Nazis were indicted for their war crimes and the unethical experimentation on individuals in concentration camps.. The discovery of these actions prompted the creation of the Nuremberg Code, which was the first of its kind to place regulations on the basis of ethics. The Nuremberg Code declared the requirement of participant consent and created the policy that the benefits of the trials must exceed the risks during any experiment, aiming to protect participants worldwide [2].
While these horrendous acts transpired some decades ago, it is important to acknowledge the long-lasting effects of the studies, even to current times. Many of the uninformed participants of the Tuskegee Study and their children are still alive now and suffering from the consequences. From these, amongst other events, researchers are required to comply with both international and national policies in order to maintain their labs Considering the fact that there is still prevalent distrust among various groups of people and healthcare professionals around the nation, it is important to continue developing the principles of respect and value for human life to gain the trust of the U.S. populace and better help every individual.
References
- Armstrong, K., Ravenell, K.L., McMurphy, S., Putt, M. (2007). Racial/Ethnic Differences in Physician Distrust in the United States. Am J Public Health. 97: 1283-1289.
- Mandal, J., Acharya, S., Parija, S.C. (2011). Ethics in human research. Tropical Parasitology. 1:2-3.
- “Institutional Review Board Written Procedures: Guidance for Institutions and IRBs (2018).” HHS.gov, 13 June 2018.
- Reverby, S.M. (2012) Ethical Failures and History Lessons: The U.S. Public Health Service Research Studies in Tuskegee and Guatemala. Public Health Reviews. 34: 4-7.