The Treating Physician as Researcher: Introduction

I. INTRODUCTION

On August 15, 1947, the International Military Tribunal formulated the Nuremberg Code in response to the atrocities that the Nazis perpetrated, in the name of science, in concentration camps during World War II. The Nuremberg Code represented the foundation for the ethics of human medical research. In the first trial conducted by the Military Tribunal after the war, the defendants were twenty-three Nazis accused of conducting medical experiments on concentration-camp inmates. Often, these experiments resulted in death or mutilation. The Tribunal accused these defendants of murder and torture. Twenty of the twenty-three defendants were doctors. These individuals were well-educated, and some were renowned scientists prior to the war. At the conclusion of the trial, sixteen defendants were found guilty and seven executed. The Tribunal then set forth the Nuremberg Code, which provided guidelines for ethical medical research.

This code empowers the subject in human research to decide whether or not to participate. Informed consent is an absolute requirement. No longer is the physician/researcher the exclusive guide to research ethics, nor is the Hippocratic Oath the sole protection of human research subjects. The subject’s free will to give informed consent is an additional protection of the individual. Given the Nazi experimentations, it is clear that society cannot rely on physicians/researchers to self-regulate and pursue research ethically. The physician’s tenant of “do no harm” does not apply to research in the same manner as it does to treatment. Human rights protection in medical research is woefully inadequate. As history all too frequently demonstrates, society cannot rely solely on the conscientious, ethical researcher to protect human research subjects.

This article will examine the factors involved in medical research, particularly the aspect of informed consent as applied to research performed by physicians. The issue of major concern will be the subject’s ability to give truly informed consent in situations where the treating physician assumes the dual role of researchers. This article will ask if physicians can assume this dual role without violating the Nuremberg Code; and whether individuals can be both subjects and patients without sacrificing their free will and autonomy. This article will argue that the tensions in these dual roles are at odds with the fundamental values of law and society, and that current federal regulation and judicial remedies are inadequate to protect research subjects. This article proposes a per se rule that prohibits treating physicians from assuming the dual role of researcher. Society must reassess its values to protect individual subjects, but also allow science and medicine to progress. Above all, society should never allow individuals to be treated merely as means to an end, or allow researchers “to treat their fellow human beings as less than beasts.”

Part I of this article will explore the importance of informed consent and its basis in law and society. Part II will discuss the definition of informed consent and its legal implications. Part III will analyze the history of informed consent, its abuses, and the judiciary’s legal responses. Part IV will explore the problems with the current legal requirements for informed consent in medical investigation and will suggest changes that will satisfy the requirements of the Nuremberg Code.

SOCIETY

The requirement of informed consent prior to medical treatment or investigation allows for individual autonomy and self-determination. These values are fundamental in society and government. The interest of society cannot be placed above individual freedoms unless an overriding state interest exists. It is unacceptable to sacrifice the rights of one individual for the benefit of others, or the benefit of society as a whole. As a society, we do not embrace utilitarian principles, but instead we believe that liberty, autonomy, and self-determination should guide law and society. The preamble of the United States Constitution stresses liberty. The Fourth and Fourteenth Amendments of the US Constitution establish individual rights and exemplify the fundamental importance of individual autonomy in society, government, and history.

The United States Supreme Court generally upholds the fundamental rights of individual autonomy and self-determination. The Court recognized the pregnant woman’s right of autonomy in Planned Parenthood of Southeastern Pennsylvania v. Casey and in Thornburg v. American College of Obstetricians and Gynecologists. In the “right to die” cases, Washington v. Glucksberg and Cruzan v. Director, Missouri Department of Health, the Court recognized autonomy and self-determination as fundamental rights. The Court created a notable exception to the protection of individual rights in the military context. In United States v. Stanley, the majority found that the LSD experiments, conducted by the military with soldiers as un-informed subjects, were not open to judicial intrusion. Justice Brennan dissented, stressing the violation of individual rights. Brennan argued that, without a showing of an overriding governmental interest, these experiments could not be justified.

In United States history and in current society, autonomy and self-determination are guiding principles. The regulation of potentially dangerous activities and social funding illustrate their importance.The choice of whether or not to engage in hazardous activities belongs to the individual. While the state or federal government may require disclosure or regulation of certain risks, the government does not proscribe dangerous activities. Granted, some legislation is paternalistic, but only when a governmental interest overrides the individual’s right to autonomy. Society allows individuals to make lifestyle decisions, such as choices about whether or not to seek health care. One is free to undergo or to refuse treatment for disease or injury, even if such a decision results in death. After examining history and current law, it is clear that autonomy and self-determination are highly valued and fundamental rights in the United States.

The advancement of medical knowledge, specifically in scientific investigation, is not a fundamental right in our society. While the federal government spends money to spur medical research, neither funding nor scientific research is a recognized right. In fact, federal funding spurs federal regulation to limit research to comply with current ethical and legal standards. Congress, through the Department of Health and Human Services, further restricts research under the Commerce Clause’s authority. Congress can thus regulate all experiments involving medical devices or drugs not yet approved by the FDA, regardless of who funds the investigation. The right to experiment is not automatic. This right must be earned by following the appropriate federal regulations, which are an attempt to protect individual subjects physically and to preserve their free will and autonomy. This situation is different than the rules governing the fundamental rights of self-determination and autonomy, which are automatic, unless an opposing, compelling governmental interest exists.

• Introduction
• The Definition of Informed Consent and Its Legal Implications
• Abuses of Informed Consent and Responses to the Abuses
• Deficits in the Current Regulatory Scheme
• Summary

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