Lecturing Academic, Med'l MS illum.

AS an introduction to this article I would like to add a brief pastoral reflection based on an experience in 2008.  A young man's father was dying of metastatic cancer.  All treatment options had been exhausted and the family and patient were preparing for the patient's demise.  The patient was hospitalized at a major medical center associated with a school of medicine, and both he and his family, were approached with a request that the patient give consent for the use of an experimental drug.  The researcher explained that the drug would not benefit the patient in an any way, but that the results of the study might benefit future patients with the same type of cancer.  After consulting with his family the patient gave consent.

In speaking with the young man privately I was surprised and dismayed to discover that the family and patient had some hope that the experimental drug might prolong the patient's life or improve his condition.

I asked the young man whether the researcher had been clear with them in regard to what they could expect.  He replied, "Yes Father, he told us the drug would not help my father.  But we all know that they are required to say that.  We also know his doctor would never recommend anything that does not offer at least some hope of helping him."

I am forced to conclude that in some settings truly free and informed consent for experimental protocols may be impossible.  As long as the patient and family have absolute trust in their physician they will simply not believe that the physician would ever recommend anything that does not have some potential for helping the dying patient.


F. J. Ingelfinger, M.D.

N Engl J Med 1972; 287:465-466, August 31, 1972, DOI: 10.1056/NEJM197208312870912

The trouble with informed consent is that it is not educated consent. Let us assume that the experimental subject, whether a patient, a volunteer, or otherwise enlisted, is exposed to a completely honest array of factual detail. He is told[:]

[1] of the medical uncertainty that exists and that must be resolved by research endeavors,

[2] of the time and discomfort involved,

[3] and of the tiny percentage risk of some serious consequences of the test procedure.

[4] He is also reassured of his rights and given a formal, quasilegal statement to read.

[5] No exculpatory language is used.

With his written signature, the subject then caps the transaction, and whether he sees himself as a heroic martyr for the sake of mankind, or as a reluctant guinea pig dragooned for the benefit of science, or whether, perhaps, he is merely bewildered, he obviously has given his "informed consent." Because established routines have been scrupulously observed, the doctor, the lawyer, and the ethicist are content.

But the chances are remote that the subject really understands what he has consented to in the sense that the responsible medical investigator understands the goals, nature, and hazards of his study. How can the layman comprehend the importance of his perhaps not receiving, as determined by the luck of the draw, the highly touted new treatment that his roommate will get? How can he appreciate the sensation of living for days with a multi-lumen intestinal tube passing through his mouth and pharynx? How can he interpret the information that an intravascular catheter and radiopaque dye injection have an 0.01 per cent probability of leading to a dangerous thrombosis or cardiac arrhythmia? It is moreover quite unlikely that any patient-subject can see himself accurately within the broad context of the situation, to weigh the inconveniences and hazards that he will have to undergo against the improvements that the research project may bring to the management of his disease in general and to his own case in particular. The difficulty that the public has in understanding information that is both medical and stressful is exemplified by the report starting on page 433 — only half the families given genetic counseling grasped its impact.

Nor can the information given to the experimental subject be in any sense totally complete. It would be impractical and probably unethical for the investigator to present the nearly endless list of all possible contingencies; in fact, he may not himself be aware of every untoward thing that might happen. Extensive detail, moreover, usually enhances the subject's confusion. Epstein and Lasagna showed that comprehension of medical information given to untutored subjects is inversely correlated with the elaborateness of the material presented.1 The inconsiderate investigator, indeed, conceivably could exploit his authority and knowledge and extract "informed consent" by overwhelming the candidate-subject with information.

Ideally, the subject should give his consent freely, under no duress whatsoever. The facts are that some element of coercion is instrumental in any investigator-subject transaction. Volunteers for experiments will usually be influenced by hopes of obtaining better grades, earlier parole, more substantial egos, or just mundane cash. These pressures, however, are but fractional shadows of those enclosing the patient-subject. Incapacitated and hospitalized because of illness, frightened by strange and impersonal routines, and fearful for his health and perhaps life, he is far from exercising a free power of choice when the person to whom he anchors all his hopes asks, "Say, you wouldn't mind, would you, if you joined some of the other patients on this floor and helped us to carry out some very important research we are doing?" When "informed consent" is obtained, it is not the student, the destitute bum, or the prisoner to whom, by virtue of his condition, the thumb screws of coercion are most relentlessly applied; it is the most used and useful of all experimental subjects, the patient with disease.

When a man or woman agrees to act as an experimental subject, therefore, his or her consent is marked by neither adequate understanding nor total freedom of choice. The conditions of the agreement are a far cry from those visualized as ideal. Jonas would have the subject identify with the investigative endeavor so that he and the researcher would be seeking a common cause: "Ultimately, the appeal for volunteers should seek... free and generous endorsement, the appropriation of the research purpose into the person's [i.e., the subject's] own scheme of ends."2 For Ramsey, "informed consent" should represent a "covenantal bond between consenting man and consenting man [that] makes them... joint adventurers in medical care and progress."3 Clearly, to achieve motivations and attitudes of this lofty type, an educated and understanding, rather than merely informed, consent is necessary.

Although it is unlikely that the goals of Jonas and of Ramsey will ever be achieved, and that human research subjects will spontaneously volunteer rather than be "conscripted,"2 efforts to promote educated consent are in order. In view of the current emphasis on involving "the community" in such activities as regional planning, operation of clinics, and assignment of priorities, the general public and its political leaders are showing an increased awareness and understanding of medical affairs. But the orientation of this public interest in medicine is chiefly socioeconomic. Little has been done to give the public a basic understanding of medical research and its requirements not only for the people's money but also for their participation. The public, to be sure, is being subjected to a bombardment of sensation-mongering news stories and books that feature "breakthroughs," or that reveal real or alleged exploitations — horror stories of Nazi-type experimentation on abused human minds and bodies. Muckraking is essential to expose malpractices, but unless accompanied by efforts to promote a broader appreciation of medical research and its methods, it merely compounds the difficulties for both the investigator and the subject when "informed consent" is solicited.

The procedure currently approved in the United States for enlisting human experimental subjects has one great virtue: patient-subjects are put on notice that their management is in part at least an experiment. The deceptions of the past are no longer tolerated. Beyond this accomplishment, however, the process of obtaining "informed consent," with all its regulations and conditions, is no more than an elaborate ritual, a device that, when the subject is uneducated and uncomprehending, confers no more than the semblance of propriety on human experimentation. The subject's only real protection, the public as well as the medical profession must recognize, depends on the conscience and compassion of the investigator and his peers.

  F. J. Ingelfinger, M.D.

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