When human experimentation is criminal.

• Author: Richardson, L. Song

I. INTRODUCTION

An unacknowledged problem exists in the realm of human subject experimentation: criminal acts are being committed seemingly without consequence. The individuals escaping punishment are no ordinary individuals; rather, they are medical researchers whose exalted social status combined with the social benefits of their research appear to immunize them from punishment. Consider the following examples: (1)

Pregnant women become unwitting guinea pigs in an experiment testing a medication to prevent miscarriages. As a result, their daughters and sons are at higher risk for cancer. The researchers are never prosecuted. (2)

A patient becomes an unwitting participant in an experiment to test the safety and effectiveness of an ocular implant. Before implanting the device, the researcher tells him that it is "quite safe" and a "tried and true method" of vision correction, rather than the truth--that the FDA has not approved the device. The victim suffers permanent damage to his eye) The researcher is never prosecuted.

A healthy twenty-four-year-old woman participates in an asthma study. Doctors ask her to inhale a drug without telling her that this is an experimental use of the drug, previous inhalations resulted in death, and the FDA has not approved the procedure. She dies. (4) The researchers are never prosecuted.

This Article addresses the significant, yet largely unexplored, question of why medical researchers escape criminal punishment: Whereas other actors who violate bodily integrity and autonomy are routinely punished with convictions for assault, fraud, and homicide, researchers walk away from similar crimes unsanctioned. (6) This Article is meant to begin a conversation that considers why criminal sanctions are not utilized in the context of human subject research and scrutinizes whether criminal punishment is an important, but overlooked, mechanism for protecting the dignitary interests of human subjects. Given the rise in human subject experimentation as a result of biotechnology research, this is a critical and timely question.

This Article examines two forms of intentional misconduct. Each, like the illustrations above, involves a researcher's purposeful and deliberate failure to obtain consent, thereby violating an individual's interest in self-determination and autonomy. The first type of misconduct is that of researchers who conduct experiments on individuals without their knowledge. The second is that of researchers who deliberately fail to disclose to individuals the known and obvious risks of participation in an experiment. This occurs, for example, when a researcher intentionally fails to utilize, or significantly alters, an approved informed consent document. The misconduct involves acts that the criminal law typically punishes: intentional, deceptive, and non-consensual contact with the person of another. (7) These acts are customarily prosecuted because they violate one of our most cherished entitlements--freedom from intentional and nonconsensual contacts with our person. (8)

There is no question that informed consent is lacking in these cases. (9) I focus upon these "easy" cases of non-disclosure in order to center full attention on the question I seek to consider: why culpable acts in human experimentation, which eliminate an individual's right to make informed choices about what will be done to her body, are not punished. While other forms of misconduct in human subject research exist, (10) and will be the subject of future articles, the fact that these straightforward cases of misconduct do not result in criminal punishment demonstrates the need to explore the initial question of why the criminal sanction is overlooked.

This Article provides the first framework for understanding why research misconduct in the form of deceit and violations of bodily integrity currently escapes criminal punishment. The framework has two components, which I label "idealization bias" and "social benefit bias." (11) Idealization bias refers to the difficulty individuals may have in viewing researchers, who are often doctors, (12) as criminals deserving of punishment. Social benefit bias refers to the hypothesis that research misconduct is often ignored or forgiven because of the perceived societal value of the research.

This Article posits that idealization and social benefit bias may affect decision-making in ways that can result in researchers being immunized from criminal punishment. This implicit immunity is harmful because the state's failure to punish researchers creates expressive harms by displaying attitudes towards victims and perpetrators that negatively affect the values of autonomy and dignity in medical research. While sanctions outside the criminal context do exist, these alternatives not only lack the same expressive impact, but also may inadequately police criminal harm.

This Article unfolds in five parts. Part II discusses idealization and social benefit bias. Part III scrutinizes the expressive role of criminal punishment and the shortcomings of alternative sanctions. Part IV discusses the utility of imposing punishment. Part V addresses arguments against use of the criminal sanction and examines considerations that can guide policy. The Conclusion argues that criminal punishment can restore the protection of dignity and autonomy in human subject research.

II. THE TWO BIASES

This Part explores whether cognitive biases can explain why culpable medical researchers escape criminal punishment. It draws from the lessons of social cognition research, which contribute to our understanding of how individuals process information and draw conclusions. (13) The research demonstrates that people regularly employ "schemas" to quickly categorize and assimilate information. (14) A schema can be "conceptualized as a mental structure which contains general expectations and knowledge of the world." (15) It "represents knowledge about a concept ..., including its attributes...." (16) Stereotypes are the best-known example of a schema. (17) Essentially, schemas provide a mechanism for people to make quick predictions, decisions, or judgments about the overwhelming amount of information they encounter. (18)

Despite the necessity of employing schemas, they create the risk of biased decision-making because they "guide what we attend to, what we perceive, what we remember and what we infer." (19) The two subparts that follow delineate two possible biases that may result from the schema we apply to researchers and to the work that they perform. These biases create the risk of faulty decision-making in the human subject research context and, thus, may explain the failure to utilize the criminal sanction to punish culpable medical researchers. The purpose of identifying these potential biases is to call attention to the possibility of their existence and encourage further empirical inquiry. Idealization bias is explored in Subpart A; Subpart B discusses social benefit bias. The words doctor and researcher are used interchangeably in this Part because the researchers engaged in human subject research are more often than not medical doctors. (20)

1. IDEALIZATION BIAS

   "[D]octors are revered as nearly godlike...." (21)

   Role schemas, as the name suggests, help people decide what conduct to expect from those in certain roles. (22) Generally, people do not expect criminal behavior from a doctor, despite substantial documentation of the commercialization of science and medicine (23) and the incentives this creates for misconduct. (24) Instead, doctors are often placed on a pedestal. (25) They are perceived as healers and altruistic, honest actors who toil tirelessly for the betterment of mankind. Evidence of this schema can be seen in television portrayals and public opinion polls. (26) In 2006, for example, a nationwide public opinion poll found that doctors and scientists are amongst the most trusted of occupations and professions. (27) In fact, doctors are the most trusted occupation and scientists among the top three, above police officers and professors. (28)

   The role schema applied to doctors and researchers creates the risk of an idealization bias. This bias may affect how the acts of researchers are judged. Individuals may interpret the culpable acts of researchers as innocent mistakes or, at most, negligence, rather than as criminal. Hence, the idealization of doctors may explain the reluctance to prosecute them when they are involved in research misconduct.

   The evolution of tort doctrine in informed consent cases provides some evidence of this bias. Prior to the 1960s, courts strongly protected an individual's autonomy interests by recognizing the torts of assault or battery against doctors who either failed to adequately inform their patients about the risks of treatment or failed to abide by the consent obtained. (29) The attitude of courts during this period is best expressed by Justice Cardozo's oft-quoted language: "Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient's consent commits an assault, for which he is liable in damages." (30)

   By recognizing the torts of assault or battery in informed consent cases, courts placed the individual's right to self-determination at the fore. Doctors were held liable for violations of consent, whether or not the patient suffered any physical harm, because "the essence of the plaintiff's grievance consists in the offense to the dignity involved in the unpermitted and intentional invasion of the inviolability of his person...." (31) The doctor's good or bad faith was irrelevant because the injury justifying compensation was to the patient's right to be free from non-consensual contact with her person. (32)

   However, in the 1960s and 1970s, courts began to shield doctors from battery liability because they presumed that doctors were...