Human experimentation is part of everyday medicine and surgery. All diagnostic and therapeutic procedures demand that the physician balance the danger of performing or not performing a diagnostic study or treatment against its potential benefit to the patient. Within every modality that the physician uses or does not use, uncertainty as to the result is a given. The element of doubt and danger is always present. People react differently to any given program. Because of this variable, all forms of therapy and diagnostic tests, from taking one's temperature to removing a brain tumor, are part of an ongoing human experimentation program through the accumulation of necessary data. The statistical significance of any treatment or test must be determined. The true relationship of an approach to a disease process can only be determined by long-term, continuous observation. It is only through continuous evaluation of new as well as commonplace drugs that we slowly determine efficacy, variation in dosage factors, and the common or uncommon side effects of these medications. Even the daily use of aspirin is still part of a human experimentation program that has been going on for decades. We still do not know all there is to know about aspirin. Every operation is to some extent part of a human experiment. The experimental aspect of the surgical procedure may at times be more significant than simply enlarging a database. It has been a standard practice for me as a neurosurgeon to modify my surgical technique regarding a brain or spinal lesion to see if a new angle of approach, a newly designed instrument, or a change in the timing of surgery may be of value to the patient. These slight new changes, or new instruments, are used without specific prior discussion with the patient. It is part of the everyday surgical amphitheater. This is not the type of human experimentation that demands an amplified consent. But one must be aware that there may be a fine line to be drawn as to when the new instrument to be used or the new approach warrants disclosure to the patient. This depends upon the significance of the variation. At the present time we are testing a new type of brain retractor support.

It is similar in principle to present devices. This new design is theoretically easier for the surgeon to control and safer for the patient. Since it is essentially a variation of existing designs, although it is new and therefore experimental, there does not appear to be any need to discuss it with the patient before or after surgery. However, the experimental use of the eximer laser to ream out obstructed arteries to the heart was and is dangerous enough that detailed informed consent was necessary before it could be used. Patients had to understand the risks involved, especially that of burning a hole in the side of the artery, which could produce serious bleeding. The decision as to whether the degree of difference between the procedure, drug, or instrument that is to be tried is significantly different from what is commonly used, or in common practice, will vary with the integrity, the aggressiveness, and the attitude of the experimenter.

Since modern medical care is the direct result of human experimentation, all who receive medical care have gained from prior human testing. But this does not imply that those who have benefited owe a debt that demands participation in human experimentation. Prior experiments were not authorized or requested by those who now reap the benefits. Fundamentally, there is no ethical imperative directing any member of society to participate in a risky scientific experiment, but there is the concept that "people should do good." This carries with it a soft obligation to present and future society to participate or to support such efforts.

Scientists have the right to pursue knowledge and to experiment. But this does not include the right to experiment upon others without consent. To do so would be an invasion of privacy and an assault upon their person...

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