Perspectives in Biology and Medicine

Perspectives in Biology and Medicine 43.3 (2000) 362-372

Law and Public Policy in Human Studies Research

Barbara Mishkin *

Symposium: Medical Research Ethics at the Millennium: What Have We Learned?

Laws embody public policies which, in turn, reflect generally accepted standards of behavior. When conflicts exist or very sensitive issues must be resolved, commissions are frequently created to seek a consensus on what public policy ought to be. As I will explain, there has been good concordance throughout the 20th century between U.S. law and bioethics.

Previous papers have discussed the Nuremberg Code, which of course was the culmination of a criminal trial [1]. But there are other court cases that have been landmarks in the United States and form the backdrop for any discussion of bioethics and public policy, because what ought to be done--or ought not be done--must be viewed within the parameters of what the law permits or requires.

Historical Cases

Lawyers usually begin reviews of cases on human studies research by quoting Judge Cardozo, who in 1914 wrote that "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" [2]. Since 1914, that principle has been reaffirmed in many of the landmark cases involving patients' rights in the context of (for example) contraception, abortion, and the right to refuse treatment [3].

Other cases in the decades since 1914 have further elaborated the principle of informed consent in the area of health care, which of course is what Judge Cardozo was referring to in Schloendorff: physicians may not perform medical procedures on patients without their consent. In the 1950s, a case against Stanford University more particularly described the physician's duty to inform, and made clear that consent based on inadequate information is not valid [4]. [End Page 362]

A 1965 Canadian case, Halushka v. University of Saskatchewan, is the first in which the plaintiff was a normal volunteer [5]. While participating in research involving heart catheterization under general anesthesia, Halushka experienced cardiac arrest. He survived--but with cognitive impairments that resulted in his withdrawal from the university. Evidence at trial revealed that he had not been told of the risks of general anesthesia, nor had he been told that the catheter (which he understood was going into his arm) would be advanced all the way up to and into his heart. Accordingly, the court ruled in his favor, finding that the duty to inform a research subject is as great, if not greater, than the duty to inform a patient receiving medical care.

At about the same time, physicians at the Jewish Chronic Disease Hospital in New York injected cancer cells into patients for research purposes [6]. The research was supported in part by a Public Health Service grant, and therefore required informed consent based on a full explanation of the purpose, risks, and methods of the research. The New York Attorney General brought a license revocation proceeding against the physicians who conducted the research, and the licensing board concluded that: "These patients and their families have the human right to decide what would be done with their bodies" (paraphrasing Cardozo). As a result, the physicians' licenses were suspended for one year, but the suspension was stayed and they were put on probation.

The next landmark decision was a 1972 Washington, D.C., case, Canterbury v. Spence, which shifted the information standard for consent from that which a physician in that same specialty and location normally would disclose, to that which a reasonable patient would want to know in order to decide whether to accept a proposed treatment [7].

Federal Policies and Regulations

The NIH policies have been in the forefront in the protection of human subjects since 1953, when the NIH Clinical Center introduced prior review by medical committees of all research that would involve human subjects [8]. That requirement was extended to extramural research by...