Informed Consent: Legal Rights For People Of Color

The history of informed consent is complex and multifaceted, with its evolution influenced by various cultural, legal, and ethical factors. While the concept of informed consent is now widely recognized as a fundamental principle in medical ethics and law, its application and enforcement have varied across different regions and historical periods.

In the United States, the legal framework for informed consent has evolved through a combination of judicial decisions, regulatory changes, and influential research studies. The earliest cases establishing the legal precedent of patient autonomy and informed consent can be traced back to the early 20th century, with landmark cases such as Mohr v Williams, Pratt v Davis, and Schloendorff v Society of New York Hospital. These cases affirmed the right of patients to make decisions regarding their own bodies and set a precedent for requiring informed consent in medical procedures.

However, the term informed consent was not legally recorded until the 1957 case of Salgo v Leland Stanford Jr University Board of Trustees, which focused on the need for physicians to disclose potential risks and benefits of medical procedures. The development of informed consent in the US was also significantly influenced by the revelation of unethical medical experiments conducted during World War II, leading to the Nuremberg Code in 1947 and the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1974.

The Tuskegee Syphilis Study, conducted by the US Public Health Service from 1932 to 1972, further highlighted the importance of informed consent and led to the publication of the Belmont Report in 1979. This report outlined three critical ethical principles for conducting research: respect for persons, beneficence, and justice.

In the context of people of color, the infamous Tuskegee Study serves as a stark example of the historical denial of informed consent to marginalized communities. The study involved the deceptive and non-consensual experimentation on a group of African American men, many of whom were poor and uneducated, to study the progression of untreated syphilis. This study had devastating consequences for the participants and brought to light the urgent need for ethical guidelines to protect vulnerable populations.

Since then, there have been ongoing efforts to strengthen the legal and ethical framework surrounding informed consent, particularly in the context of medical research. The Common Rule, first adopted in 1991 and revised in 2018, provides comprehensive guidelines for protecting human subjects in research, including the requirement for informed consent. Additionally, the 21st Century Cures Act, enacted in 2016, allows researchers to waive the requirement for informed consent in certain low-risk clinical trials.

While the legal and ethical landscape of informed consent has evolved significantly, ensuring its application and enforcement across diverse communities remains a challenge. The vulnerability of marginalized groups, including people of color, persists, and addressing this issue requires continuous advocacy, awareness, and the development of culturally sensitive approaches to obtaining informed consent.

The Nuremberg Code and Nazi human experimentation

The Nuremberg Code is a set of ethical research principles for human experimentation that arose from the Subsequent Nuremberg trials held after the Second World War. The Code was created by the court in U.S. v Brandt, one of the trials that sought to hold members of the Nazi party responsible for war crimes.

During the trial, several of the accused argued that their human experiments were no different from those conducted before the war, and that there were no laws differentiating between legal and illegal experiments. This prompted Andrew Ivy and Leo Alexander, who worked with the prosecution, to submit a memorandum outlining six points for legitimate medical research. An early version of the Nuremberg Code, known as the Memorandum, was drafted on 9 August 1947. It stated that explicit voluntary consent from patients is required for human experimentation.

On 20 August 1947, the judges delivered their verdict, reiterating the Memorandum's points and revising the original six points to ten. The ten points became known as the Nuremberg Code, which includes principles such as informed consent, the absence of coercion, properly formulated scientific experimentation, and beneficence towards experiment participants. The Code is considered to have been mainly based on the Hippocratic Oath, interpreted as endorsing the experimental approach to medicine while protecting the patient.

The Nuremberg Code is significant because it is the first explicit attempt to regulate the ethical conduct of research experiments with human subjects, with a particular emphasis on voluntary consent. The Code has influenced global human rights and has been described as the most important document in the history of clinical research ethics. However, it has not been officially accepted as law by any nation or as official ethics guidelines by any association.

In the United States, the Code influenced the drafting of regulations to ensure the ethical treatment of human research subjects, known as the Common Rule, now codified in Part 46 of Title 45 of the Code of Federal Regulations. The International Covenant on Civil and Political Rights, adopted by the United Nations in 1966, also reflects the principles of the Nuremberg Code by prohibiting experiments conducted without the "free consent" of the subject.

The concept of informed consent has evolved significantly and is now a fundamental principle in medical ethics, medical law, and other fields. It requires that individuals have sufficient information and understanding before making decisions about accepting risk, such as in their medical care or participation in research. While the specific standards for informed consent vary across different systems and contexts, the principle generally applies broadly to various situations, including medical interventions, research, disclosure of medical information, and participation in high-risk activities.

The Tuskegee Syphilis Study

The study was done at a time when there was no known cure for syphilis, and the participants, who were primarily poor and illiterate sharecroppers, were offered free medical care, rides to and from the clinics, meals on examination days, and free treatment for minor ailments. They were told they were being treated for "bad blood", a term used locally to refer to a variety of ailments including anemia, fatigue, and syphilis. However, the study involved no actual treatment, and the men were only monitored and given placebos such as aspirin and mineral supplements.

In 1947, around 15 years into the study, penicillin became the recommended treatment for syphilis. Still, the researchers withheld this treatment from the participants and even convinced local physicians in Macon County not to treat them. As a result, by the time the study was ended in 1972, 28 participants had died from syphilis, over 100 had passed away from related complications, at least 40 spouses had contracted the disease, and 19 children had been infected at birth.

The study was highly unethical and resulted in drastic changes to standard research practices. The researchers did not obtain informed consent from the participants, and the participants were not offered available treatments, even after penicillin became widely available. Additionally, there was no choice given to the participants to quit the study when penicillin was discovered as a cure. An Ad Hoc Advisory Panel was convened to review the study, and it was concluded that the study was "ethically unjustified".

The public revelation of the study in 1972 by journalist Jean Heller led to international public outcry and a series of actions initiated by U.S. federal agencies. In 1973, Attorney Fred Gray filed a class-action lawsuit on behalf of the men in the study, their wives, children, and families, resulting in a settlement of over $9 million. In 1997, President Clinton issued a formal apology and announced the establishment of The National Center for Bioethics in Research and Health Care at Tuskegee University.

The Belmont Report

• Respect for Persons: This principle incorporates the ethical convictions that individuals should be treated as autonomous agents and that persons with diminished autonomy are entitled to protection. Autonomous persons should be given weight to their considered opinions and choices, while their freedom to act on those judgments should not be obstructed. To show a lack of respect for an autonomous agent, one must repudiate their considered judgments, deny them the freedom to act on those judgments, or withhold information necessary for them to make an informed decision.
• Beneficence: This principle states that persons should be treated ethically by respecting their decisions, protecting them from harm, and making efforts to secure their well-being. Two general rules have been formulated as complementary expressions of beneficent actions: (1) do no harm, and (2) maximize possible benefits and minimize possible harms.
• Justice: This principle raises the question of who ought to receive the benefits of research and bear its burdens. It is concerned with fairness in distribution or what is deserved. Injustice occurs when a benefit to which a person is entitled is denied without good reason, or when a burden is imposed unduly. Another conception of justice is that equals ought to be treated equally, but this requires further explication regarding who is considered equal and unequal.

Additionally, the Belmont Report addresses the issue of informed consent, which is derived primarily from the principle of respect for persons. It identifies three elements of the consent process: information, comprehension, and voluntariness. The report emphasizes the importance of providing sufficient information, ensuring comprehension through clear and organized presentation, and obtaining voluntary agreement without coercion or undue influence.

Overall, the Belmont Report provides a framework for resolving ethical issues arising from research involving human subjects and sets out guidelines for conducting such research in an ethical manner.

The Common Rule

The 2018 revisions to the Common Rule introduced two new general requirements for the consent process:

• The "reasonable person" standard is used to clarify the level of information that potential subjects would want to know before deciding if they'd like to participate. Potential subjects should have the opportunity to engage in ongoing discussions with the research staff to ensure understanding.
• The consent form must begin with a brief and focused summary of the information that is most relevant to the decision-making process. This summary should include a statement that the subject's participation is voluntary, an explanation of the purpose of the research, and a description of the procedures, as well as how long the subject will be involved in the study, the risks, the benefits, and the alternatives if the subject decides not to participate.

The Indian Council of Medical Research's ethical guidelines

The Indian Council of Medical Research (ICMR) has released three versions of its ethical guidelines for biomedical and health research involving human participants: in 2000, 2006, and 2017. The guidelines are not a law, but researchers are expected to follow them to protect the dignity, rights, safety, and well-being of research participants. The guidelines are also meant to improve the quality of biomedical and health research.

The 2017 guidelines propose substantial changes and modifications compared to the previous versions. These include the introduction of broad consent, ethical issues related to deception, review of multi-centric research by a single ethics committee, and ethical issues involved in implementation research and other issues related to public health research.

The 2017 guidelines also incorporate modifications and minor changes to the previous version. For example, the guidelines now include four categories of risk instead of three: less than minimal risk, minimal risk, minor increase over minimal risk or low risk, and more than minimal risk or high risk. The guidelines also specify that women may consider consulting their husbands or family members whenever necessary.

The ICMR's ethical guidelines are quite exhaustive and have been included in the international database prepared by the U.S. Department of Health and Human Services. They are the only ethical guidance listed from a developing country.

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