The Ethical Dilemma of U.S. Healthcare: When Principles Don’t Meet Practice

Whilst social issues are oftentimes seen in everyday scenarios from marriage equality to civil rights, there is a less known moral flaw that affects everyone who seeks any sort of medical assistance and treatment. Before the treatment is FDA-approved and the public can begin to seek assistance, there must be ample biomedical research to ensure the safety of medical procedures. However, when safety isn’t prioritized first, the question must be asked: What are our guiding principles for health research/ procedure experimentation? When were these principles born, and does healthcare fall short of what is expected because of the absence of ethicality in BioMedical research?

Nazi Doctors in Germany: The Nuremberg Trial

When it comes to ethicality and what is classified as ethical conduct in medical research, there are many history lessons that need to be taught. In a nutshell, there is one main historical cause and 2 main effects/ organizations that are at play in regard to the question of ethicality. Our story starts with the tragedy of the Holocaust in Pre-world War II Nazi Germany where Nazi doctors committed egregious actions. They used convicts of different crimes for human experimentation.

After the Nazi doctor matters were settled, the Nuremberg code set in place some ethical principles. It was the first international code that put regulation and requisites on research/ clinical trials for people. It laid out ten ethical principles to help restrict these awful acts from happening again. These ethical principles worked to make voluntary consent required and made it possible for any subjects in a study to withdraw at any time if they no longer feel comfortable participating in the studies.

Ethical principles in Medicine Today

There are four main ethical principles that are mainly considered in healthcare today: beneficence, nonmaleficence, justice, and autonomy. They are all crucial to establishing a framework for healthcare and biomedical research today. These principles take a step back to determine what it is exactly that healthcare is looking to achieve. While curing and helping treat people may be the obvious goal, there are thousands of ways to actually do this, so determining ethical principles helps to cross some of the worst approaches off the list.

Beneficence is the first and arguably the most obvious ethical principle used to dictate how a physician/ researcher should act. The principle itself entails that physicians/ researchers should work to benefit their patients. This can be done in many ways, such as removing painful conditions, informing patients of procedures and treatment plans, and, most importantly, doing the actual procedures.

Nonmaleficence is the second ethical principle that is often mentioned by physicians and researchers. It explains the actual intent that they should have. There is a reason doctors must “first do no harm” and nonmaleficence is the warrant for it. The ethical principle itself entails that a researcher or physician should never initially aim to harm their patients.

As interpreted by Immanuel Kant, autonomy is based on the belief that every person has intrinsic and irrefutable value. Because every person has value, autonomy protects every persons’ right to their own being without infringement from outside sources. In terms of research, it dictates what kind of actions can and cannot be taken based on one's own ability to rule their own body and mind. When it comes to healthcare, this instils the right of refusal against bodily harm or any negatively perceived procedure. Regardless of the stats and safety, the right to refuse actions against one's own body remains to be warranted by autonomy.

Justice is an ethical principle that instead of dictating how treatment or research should be conducted, dictates equality of service. Equity, balance, and consistency are terms associated with justice. This ethical principle exists to ensure discrimination does not take over in healthcare or research. Justice in health care remains to be the topic of discussion in America today.

Confidentiality also plays an active role in news highlights today, as violations remain common. Confidentiality is essentially the guarantee of privacy for a patient. It is the belief that patients and subjects should have a right to privacy to keep their health information from being disclosed to non-stakeholders.

How do these principles line up with the American healthcare system?

Whereas the 4 main ethical principles are followed to a high regard in medicine, there is a substantial issue with unethical incidents happening in the latter ethical principles previously discussed (confidentiality/ privacy). Proportionality and confidentiality may appear to be the two most sought after ethical principles in medicine (after safety). However, there are still, to this day, high numbers of privacy breaches and disproportionate representation of people in clinical studies proving that what goes on in treatment is definitely not synonymous with how ethical the biomedical research studies were.

Confidentiality/ privacy in medicine has gotten better in America with HIPAA and PHI (protected health information) under new standards that have laid line-by-line standards. As of today, HIPAA laws in America outline two types of stakeholders. The outline mentions two organizations, covered entities (CE) and business associates (BA). CE is defined as those providing healthcare. They are therefore the primary guardians of PHI. The inferior, but still crucial, organization outlined is BE, which can be defined as those who run into PHI. People running PHI data bases, IT, or essentially anyone who has professional work that requires them coming into contact with patient PHI.

Estimated guesses might assume that physicians/ CE’s would not be the culprit in privacy breaches, yet this is not the truth. An observation-based research published by BMC Med Ethics finds that not only do physicians fall responsible for privacy breaches, but they might also be repeat offenders with “9.5% of physicians” being observed to commit multiple privacy breaches that resulted in both severe and non-severe consequences.

Proportionality, another ethical principle that is crucial to bioethics, plays a significant role in justice. Proportionality can be used as a unity/ benchmark to see if justice is truly being implemented as a principle. In health today, we can see a prime example of the lack of proportionality in the Covid-19 vaccine production. More specifically, the lack of racial diversity in the Covid-19 vaccine trials.

Global health solutions require diverse backgrounds of people included in trials to harness the best results possible. However, when facing the Covid-19 pandemic today, racial diversity is lacking, risking the health of the corresponding backgrounds. Racial diversity in Covid-19 vaccine trials included primarily white people. White people made up 78% of the subjects selected as volunteers for the trials. Minority groups, however, have significantly less representation. African American people were a mere 11%, Hispanic people made up 12%, and American Indians/ Alaska natives only made up .4% of all subjects included in the vaccine trials. While the Covid-19 pandemic hit minority groups especially hard, the lack of representation acted as a force multiplier that disproportionately affected minority groups in America in a negative way.

While these disparities are incredibly egregious in terms of public health justice, it is only the tip of the iceberg as other demographics were also underrepresented. Age, for example, proved to be a demographic of people that wasn’t fully accounted for. People aged 65 and older (perhaps the most at risk demographic) only held 12% of participants in vaccine trials. It is because of the intersection of social issues and public health that ethical principles need to be implemented and enforced not only in America, but the world.

What can I, as a reader, do to help?

As readers, you have the power to influence people who might have not volunteered in biomedical research studies. This also means that you can have initial influence over those who you may talk to. If you are talking to adults of underrepresented/ minority groups, this can come in handy to help not only them but people who fall under the same minority group. This can be an indirect result of more representation in the study which then goes on to make treatments more inclusive to people of different backgrounds. These backgrounds may include but are not limited to race, gender, ability, or pre-existing medical conditions.

Fear may be the only thing stopping potential participants from participating in studies, but by educating others, you can lift the burden of feeling overwhelmed off their shoulders. A good start to the education approach is reading them the Bill of Rights for Research Participants. These rights range from the right to not be pressured by the organization running the study to the right to quit the study at any time. Just remember, the initial impression you make on these potential participants will shape the future world of Medicine in not only America, but the world.

Sources

Varkey, Basil. “Principles of Clinical Ethics and Their Application to Practice.” FullText - Medical Principles and Practice 2021, Vol. 30, No. 1 - Karger Publishers, 2021, www.karger.com/Article/FullText/509119.

“New Study Highlights Lack of Diversity and Inclusion in Vaccine Clinical Trials.” Fred Hutch, 19 Feb. 2021, www.fredhutch.org/en/news/releases/2021/02/new-study-highlights-lack-of-diversity-and-inclusion-in-vaccine-.html.

“Confidentiality Breaches in Clinical Practice: What Happens in Hospitals?” PubMed Central (PMC), 2016, www.ncbi.nlm.nih.gov/pmc/articles/PMC5009672.

“Bill of Rights for Research Participants | Human Subjects Office.” University of Iowa Human Subjects Office, 2000, hso.research.uiowa.edu/bill-rights-research-participants.