May 1994 XV/9
INFORMED CONSENT:
THERAPEUTIC & NONTHERAPEUTIC TRIALSThe federal agency which protects human research subjects from harm recently criticized a clinical research study at the University of California at Los Angeles (UCLA). (1) In the study, persons under treatment for schizophrenia were withdrawn from their medication in order to determine whether they would do better without their medication. Several of the patients had more than one severe relapse, including hallucinations and paranoia while one participant even committed suicide. All of the participants signed informed consent documents. Some critics of the research program, especially family members of patients in the program, thought the research should never have been approved. This case presents an opportunity to examine the ethical norms of informed consent, especially the ethical norms for informed consent in clinical trials.
Principles
The ethical mandate of informed consent arises from the goals of the physician-patient relationship. The remote goal of this relationship is the overall well-being of the patient. The proximate goal is the health of the patient. This means, as Leon Kass, a physician-philosopher at the University of Chicago, maintains, that the physician is concerned with "the well-working of the enlivened body and its power to sense, think, feel, desire, move, and maintain self." As result of an examination of the enlivened body, the physician offers the patient a medical diagnosis as the first step in striving for the proximate goal of their relationship, the health of the patient. But in order to further the quest for the proximate goal of the physician-patient relationship, the physician also offers a plan of medical or surgical therapy designed to preserve or restore health. The diagnosis and prognosis must be presented to the patient in language the patient can understand. But the remote goal of the relationship, the patient's overall well- being, must also be considered. A person who understands the diagnosis and prognosis may determine that the medical plan is too expensive or would interfere with other important goods and goals which contribute to his overall well-being. For this reason, the patient renders the final decision in regard to the use of' medical or surgical procedures. That is, the patient, either implicitly or explicitly, compares the particular goods associated with striving for health with the other goods for which the patient habitually strives. Suppose for example, a woman has been striving for years to save money to educate her grandchildren. Informed that she would have to devote all her savings to a medical plan to overcome a recently diagnosed cancer, she decides to forego medical treatment and let "nature take its course," thus assuring the good of a college education for her grandchildren. As we posit that the ultimate responsibility for decision making rests with the patient, let us also emphasize that the role of the physician involves more than simply presenting options to the patient. The physician is dedicated to the good of the patient. Thus, the options presented to the patient should be presented in light of the patient's health and overall well-being.
Another way to envision the informed consent process is to realize that each person has biological, emotional, social, and creative (spiritual) functions. Physicians are experts in regard to the biological and emotional functions. But patients are experts in regard to their social and creative functions which are the integrating and value centered functions of human well-being. While physicians will have some general notions about the social and creative goods which integrate most persons' quests for well-being, they will not possess accurate knowledge about a particular person's values and goods insofar as social and creative needs are concerned. Thus, the patient has freedom to accept or reject the physician's recommendations in accord with his habitually determined goods and goals.
In contemporary America, the purpose and process of informed consent is often described as an effort to "assure patient autonomy." Actually, this is a limited and misleading concept of informed consent. If we envision the informed consent process as a collaborative process with a twofold purpose, then the process is concerned with more than autonomy on the part of the patient. Does the ethical responsibility to work for the good of particular patients pertain as well to physicians engaged in clinical research? Physician-researchers are physicians first and foremost, and researchers only secondarily. Physicians-researchers should not envision their research subjects as a large group who may be subjected to harm in order to obtain general information. One expert in legal and medical ethics sums up the responsibility of the physician in clinical research trials by stating: "The subject should be no worse off in a clinical trial than if using accepted therapy." (2)
Discussion
Does the foregoing imply that a subject in a research program may never be allowed to accept a risk of harm or injury. To answer this question, we must involve a classic distinction between therapeutic and nontherapeutic research. Therapeutic research or clinical research aims at striving for the health and well-being of particular patients. It is a combination of therapy and research. (3) The goal of therapy, benefit for an individual patient, must always take precedence in clinical research. Risk of harm or injury is an intrinsic factor in any therapeutic intervention. Often the risk of harm or injury is so minimal it is not considered by the researcher or patient. At other times, the risk of harm may be more serious. The patient may accept or reject the more serious risk comparing it with other goods of life as mentioned before. However, even though risks are included in the protocol, the protocol for clinical research should never involve a therapy which of itself offers less than standard treatment. Even if a double blind protocol is employed, the patients in the control group, the group that does not receive the drug or therapy being evaluated, should receive a drug or therapy which meets the norms for standard treatment.
Nontherapeutic research has an entirely different purpose. While therapeutic research or clinical research aims at preserving or restoring the health of the individual participants in the research program, nontherapeutic research aims at obtaining knowledge which will be utilized for the health of people in the future. While nontherapeutic research is an important humanistic endeavor it aims at the well-being of the community, not the health or well-being of the individual. The ethical norms for nontherapeutic research do allow a subject to accept a risk of harm. But in these cases, the subject should be informed clearly that the research protocol is nontherapeutic. Subjecting oneself to serious harm in a nontherapeutic research project is an act of altruism and self-giving. While a proxy may give consent in order to benefit a ward, the proxy does not have the right to place a ward at risk on the grounds of altruism or self abnegation. For this reason, selecting subjects for nontherapeutic research is a very stringent process. Subjects in nontherapeutic research projects which involve risk of serious harm or injury should not be miners or persons who are impaired insofar as making competent judgments are concerned. The tendency of the researcher is to confuse the two types of research, and to apply the ethical norms for nontherapeutic research to therapeutic research as the Tuskeegee study, which deprived black men suffering from syphilis of penicillin which would have cured their disease, and the study under discussion in this essay indicate.
Conclusion
In sum, it seems that the researchers studying the effect of withdrawing medicine from persons suffering from schizophrenia did not design a protocol to help the individuals enrolled in the program. If any benefit was derived from this research project it would mainly be for people in the future. The Institutional Review Board, the internal study group which evaluates all research projects, at UCLA should not have approved this project. Not only did the project allow patients to be worse off than they would be under standard therapy, it also subjected people who were doubtfully capable of offering informed consent to serious harm in nontherapeutic research.
Kevin O'Rourke, OP
Footnotes 1. Philip Hilts, "Agency faults a UCLA study for suffering of mental patients," New York Times, March 9, 1994.
2. Jay Katz, "Human experimentation and human rights," St. Louis Law Review, (Fall 1993) p.30.
3. The definition between therapeutic and nontherapeutic research was explained by Pius XII in 1952. Cf. "Research on Human Subjects" Sources of Catholic Teaching, DC: Georgetown University Press, 1993, p.273.
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