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Medical Research and the Human Subject

No one will deny that there have been problems of consent and control in the use of human subjects in medical research on both sides of the Atlantic in the post-war world. The existence of these problems is evident from the work of Papworthl and Beecher.2 There is general agreement in the literature as to the remedy for these problems. This remedy rests upon the insistence on free, informed consent as a bulwark against research malpractice. Paul Ramsey’s response in The Patient as Person is typical: ‘An informed consent alone exhibits and establishes medical practice and investigation as a voluntary association of free men in a common c a ~ s e . ’ ~ This recipe for preventing research subjects being made use of by others for the sake of the common good has attained the status of a dogma in medical ethics. It is now almost unchallengeable in respectable company (but not quite as we shall see below). For Ramsey consent on the part of the subject of research provides the deontology which checks the otherwise dominant teleological reasoning which will govern the thinking of the medical researcher. Consent is the means by which fidelity to the interests of the research subject can act as a control to the simple calculation of the overall balance of good and evil to be achieved in any research undertaking. In fact the consent requirement is not the sole means by which consideration of the interests of the research subject limits the way in which medical advance is pursued. For there are many conceivable research procedures which it is wrong to inflict on a research subject even if that subject consents to them; it will be wrong to propose them to a subject for his or her consent. Somerville4 sums up the conditions under which medical interventions become licit in the Common Law tradition as follows: there must be consent from or on behalf of the patient, an expectation of benefit to the patient and a reasonable degree of skill in those performing any such interventions. We can ignore the last condition for our purposes seeing it as part of the means by which the second can be fulfilled. In the case of medical research this second condition can be fulfilled in a number of ways. Therapeutic research procedures (i.e., such procedures as are designed to medically