Academic journal article Bulletin of the World Health Organization

Ethics and Clinical Research(*)

Academic journal article Bulletin of the World Health Organization

Ethics and Clinical Research(*)

Article excerpt

HUMAN experimentation since World War II has created some difficult problems with the increasing employment of patients as-experimental subjects when it must be apparent that they would not have been available if they had been truly aware of the uses that would be made of them. Evidence is at hand that many of the patients in the examples to follow never had the risk satisfactorily explained to them, and it seems obvious that further hundreds have not known that they were the subjects of an experiment although grave consequences have been suffered as a direct result of experiments described here. There is a belief prevalent in some sophisticated circles that attention to these matters would "block progress." But, according to Pope Plus XII,(1) " ... science is not the highest value to which all other orders of values ... should be subordinated."

I am aware that these are troubling charges. They have grown out of troubling practices. They can be documented, as I propose to do, by examples from leading medical schools, university hospitals, private hospitals, governmental military departments (the Army, the Navy and the Air Force), governmental institutes (the National Institutes of Health), Veterans Administration hospitals and industry. The basis for the charges is broad.([double dagger])

I should like to affirm that American medicine is sound, and most progress in it soundly attained. There is, however, a reason for concern in certain areas, and I believe the type of activities to be mentioned will do great harm to medicine unless soon corrected. It will certainly be charged that any mention of these matters does a disservice to medicine, but not one so great, I believe, as a continuation of the practices to be cited.

Experimentation in man takes place in several areas: in self-experimentation; in patient volunteers and normal subjects; in therapy; and in the different areas of experimentation on a patient not for his benefit but for that, at least in theory, of patients in general. The present study is limited to this last category.

REASONS FOR URGENCY OF STUDY

Ethical errors are increasing not only in numbers but in variety -- for example, in the recently added problems arising in transplantation of organs.

There are a number of reasons why serious attention to the general problem is urgent.

Of transcendent importance is the enormous and continuing increase in available funds, as shown below.

MONEY AVAILABLE FOR RESEARCH EACH YEAR

MASSACHUSETTS   GENERAL HOSPITAL      NATIONAL INSTITUTES OF HEALTH(*)

1945            $ 500,000([dagger])                 $701,800
1955            2,222,816                         36,063,200
1965            8,384,342                        436,600,000

(*) National Institutes of Health figures based upon decade averages,
excluding funds for construction, kindly supplied by Dr. John Sherman,
of National Institutes of Health.

([dagger]) Approximation, supplied by Mr. David C. Crockett, of
Massachusetts General Hospital.

Since World War II the annual expenditure for research (in large part in man) in the Massachusetts General Hospital has increased a remarkable 17-fold. At the National Institutes of Health, the increase has been a gigantic 694-fold. This "national" rate of increase is over 36 times that of the Massachusetts General Hospital. These data, rough as they are, illustrate vast opportunities and concomitantly expanded responsibilities.

Taking into account the sound and increasing emphasis of recent years that experimentation in man must precede general application of new procedures in therapy, plus the great sums of money available, there is reason to fear that these requirements and these resources may be greater than the supply of responsible investigators. All this heightens the problems under discussion.

Medical schools and university hospitals are increasingly dominated by investigators. …

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