Informed Consent: History and Principles

Abstract

Informed consent is a doctrine that has developed and evolved over the last two centuries into a solid health practice. Informed consent has a vast history dating back to ancient Greece but today it is a hugely important topic in the field of public health. It was long believed that patients should leave all decision making up to the doctors and surgeons. This resulted in a great deal of harm and undue stress on subjects over the years. From these instances of malpractice and negligence (that was once common practice), this new doctrine was born, adopted, and spread throughout the health community. There are three guiding principles: respect for autonomy, justice, and beneficence. Whether it is a physician treating a patient in a hospital or a medical researcher conducting HIV prevention research, informed consent must always be a part of the methods and procedures. It has now become a primary focus of some public health researchers and practitioners to ensure that not only is the information being dissemination before major action is taken, but that the information is digested and thoroughly understood by the subject before treatment is administered.

Introduction

Informed consent is a core principle of public health, law, social and behavioral sciences, and even philosophy (Medline Plus, 2017). The history and evolution of informed consent is vast and potentially overwhelming, but it is an absolutely necessary and important aspect of the public health and medical community. Informed consent is loosely defined as transparent communication between a practitioner and a patient regarding possible consequences of treatment to the fullest and safest possible extent (CDC, 2019). Breaking it down even further, consent is the permission for something to occur or happen. The principle of informed consent is based on the successful communication between practitioners and patients. There are strict guidelines that outline appropriate actions to obtaining informed consent, as well principles that help to define its importance. This paper will delve into the history of the subject, while also outlining said principles and guidelines to truly capture the gravity of informed consent as a concept in public health.

History of Informed Consent

For thousands of years, dating back to ancient Greece, informed consent was not relevant to the health field (Murray, n.d.). It was often considered undesirable or unimportant for patients to participate in medical treatment decision making process (Clayton, Lorenz, Wolf, 2018). It was understood that while the physicians should inspire the confidence of the patient in the procedure that was going to be undergone, but it was not required to disclose the possible outcomes, negative or positive, of the procedures because the unknown could lead to distrust in the physician by the patient. Well into the Enlightenment Era a certain air of deception was included in the health care process (Murray, n.d.). The concept of informed consent did not really gain foothold until the twentieth century. This was a time of legislation and litigious arguments, leading to the foundation of informed consent that we know today.

In the case of Luka v. Lowrie in 1912, a young boy received an emergency amputation on his leg, after the surgeon consulted fellow physicians, but did not consult the parents on the matter before performing the procedure. The court ruled in favor of the physicians, but this case marked the first informed consent case to be taken to court. The case that likely had the biggest impact on the informed consent doctrine is Schoendorff v. Society of New York Hospital. Supreme Court Justice, Benjamin Cardozo, argued that every human being had a right to decide what was to be done with or on their own body. He believed that any surgeon that operated with consent should be held liable for damages. These litigious battles continued throughout the twentieth century, leading to the expansion and potential acceptance of informed consent as a doctrine of health and medicine (Murray, n.d.). The greatest pushback initially came from medical practitioners, but with the support of the public and the Supreme Court, informed consent was transformed into common practice

There were many cases over the years where informed consent was either ignored entirely or otherwise not practice purely. The infamous Tuskegee syphilis experiment was a prime example of informed consent being absent from health and medical proceedings. The U.S. Public Service conducted, what has now been deemed, an extremely unethical study that spanned 40 years beginning in 1932. They intended to observe untreated syphilis, but the participants were not told of their true intent and many people died accordingly. This is one of many unethical studies where informed consent was compromised. Research studies, like other medical treatments and operations, also now requires informed consent. Actions like the ones that occurred in Tuskegee during that 40-year time period are frowned upon by the research and health community today.

Principles of Informed Consent

Within the realm of informed consent, there are three major guiding principles. Respect for Autonomy is the first and likely the most well-known principle. In the western world, personal freedom and liberty is so emphasized and demanded, making Respect for Autonomy is often times the principle that leads a lot of arguments when the rules of informed consent appear to be broken (Burr & Gibson, 2017). The freedom to choose and make one’s own choices is an essential human right that is held very highly in the United States. There is a huge emphasis between just being autonomous and being respected within your autonomy.

Beneficence is seen as the promotion of a person’s welfare (Burr & Gibson, 2017). It can be defined as the value of benefitting the person and ultimate brining no harm to the person if at all possible. This can be seen as the cure, removal, or prevention of pain by a health care professional if at all possible. The outcomes and risks of procedures must always be weighed against the benefits for the subjects and also public interest in general.

Justice is the last of the three principles. This principle hinges on social cooperation. Justice calls for the treatment of people with what is fair, due, or owed (Burr & Gibson, 2017). There should be no denial of any necessary services if the person is due them, and this also works the other way around where no services should be provided unless required or deemed necessary. The major argument relevant to informed consent is that it would be deemed unjust for a physician to withhold vital treatment and information to a patient who needs it.

Guidelines to Practicing Informed Consent

The American Medical Association has outline strict guidelines that must be followed for informed consent to be achieved effectively and correctly. The subject must be assessed for their ability to understand medical jargon and the implications of treatment options in order for them to make their own voluntary decision. The information must be presented to the subject accurately and sensitively. The physician should always make sure to include the most up to date information on the diagnoses, the purpose and potential outcomes of possible interventions, and this should always include the burden of health involved in these different intervention options (American Medical Association, 2019). For legal reason, informed consent must be documented. This includes the conversation had between the practitioner and the subject but should ultimately conclude with specific written informed consent from the patient before any medical or health intervention is pursued.

Public Health Implications

The issue of informed consent is still as important and relevant today as it was in years past during its rise to acceptance and expectance. The principle of informed consent is hugely relevant to the field of public health in particular. The spread of HIV as brought informed consent to the forefront of public health policy design. Informed consent attempt to ensure that subjects have free choice in their health and also that health professionals are acting responsibly under their licenses (Goldman, Hunt, Kole, 2018). The quality of the understanding by the patient is an issue that public health professionals have begun to focus on to better improve the practice of informed consent. A study was recently performed in African to test the effectiveness of informed consent counseling being offered to subjects that are at high risk to contracting HIV. They found that the understanding of the issue was not being greatly improved through the counseling and that many subjects did not now much at all about the disease that afflicted them and so many others within their communit. This led to the conclusion that much of what was being done in terms of treatment and prevention was actually being done without informed and voluntary consent. While the researchers and practitioners were offering the information and education to understand the disease, the public was not grasping the concept and the gravity of the issue, and many women felt that they had been pressure into the testing procedure. Thus, any decisions being made on their health regarding HIV could not have been compliant with the informed consent guidelines.

Conclusion

This is just one of many examples of how the public health community is focusing on informed consent. From here they can develop and target new ways of disseminating information about HIV. Perhaps there is a language barrier that is disrupting the medical jargon, or maybe it is more of a cultural issue that is keeping the consent from being truly informed and voluntary. Informed consent, while extremely necessary, is not yet a perfect science. There is a great deal of more work to be done to ensure that all physicians, practitioners, and researchers are providing quality and accurate information, and also that all subjects and patients are actually absorbing that information before making important health decisions.

The health field has come a long way from thinking that medical and health decisions were to only be decided by physicians, but it still has a long way to go. The twentieth century provided the greatest jump in knowledge and implementation of the doctrine, and now during the twenty-first century the focus should be to further improving the patient-physician communication and understanding of it. The principles laid out encourage basic implementation and have proved to be efficient in guiding interaction. Building on these principles can allow for a more complete practice of informed consent. Moving forward will require deeper research into what methods work and don’t work in terms of informing patients on potential outcomes and treatment methods. This research, similar to the one previously discussed will yield vital information as to what needs to be changed in order to have a health community that is truly based on voluntary and informed consent.

References

• American Medical Association (2019). Informed Consent. Retrieved from https://www.ama-assn.org/delivering-care/ethics/informed-consent
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