ETHICAL ASPECTS OF BIOMEDICAL RESEARCH P. Riis, M.D.

For the following purpose ethics are defined as the theoretical base of the moral, and the moral as the application of distinction between right and wrong. Ethics are naturally considered when basic scientific (for instance psysiological) experiments on human beings are planned. The same is true for controlled clinical studies of ncw tratments or new diagnostic tools. So far, patients, general practitioners, clinical specialists and basic scientists agree almost completely. T h e patients, i.e. the community, expect biomedical science to advance, especially the clinical and other patient-oriented disciplines (but to some extent expect the same for basic biomedical science, because it is correctly considered a source of necessary innovation). Strangely enough ethics are almost never considered dealing with the many diagnostic and therapeutic clinical routines, of which no scientific rationale exists. These old methods, that infiltrate clinical medicine throughout the world, are generally accepted for historical reasons instead of being considered strong incentives (even containing a strong ethical stimulus) for more controlled clinical investigations. I t is generally accepted that ethics related to the individual patient means aiming a t a n optimal ratio between conditioned probabilities for positive and negative results of a given diagnostic or therapeutical procedure. (A positive result is a true positive or negative diagnosis or a successful treatment, a negative result is a false diagnosis or a side-effect of treatment). The only way to substantiate the conditioned probibilities is by means of controlled clinical studies. On this background it is astonishing that the ethical demand is only made on the clinical investigator and not on clinicians applying non-proven methods routinely. Because of the necessity for more basic biomedical research and for more controlled clinical investigations, heads of departments, editors and members of research councils have to consider the ethics of both the patient as a pure research subject and of the patient in a clinical study, comprising both new and old, and both diagnostic and therapeutic remedies. Because ethics are still (falsely) considered more complicated when dealing with established clinical methods, research councils have an obligation to stimulate controlled studies soon after the appearance of new clinical methods. Medical scientists have as a whole adopted the principles of the Helsinki Declaration when planning experiments and studies on human beings. Unfor90

tunately the Declaration is not unequivocal and does not cover the field completely. T h e following comments are considered necessary for the practical application of the Declaration’s principles: 1) The distinction between “clinical research in which the aim is essentially therapeutic for a patient, and clinical research the essential object of which is purely scientific and without therapeutic value to the person subjected to the research” is neither clear nor clinically relevant. Controlled studies should never be conducted if the fundamental question is not un-answered, i.e. patients taking part in a study have somewhat equal chances of sharing a new and beneficial procedure and avoiding a new and non-beneficial procedure. By “clinical research the essential object of which is purely scientific - -” the Declaration seems not to denote clinical research but rather basic biomedical research, for instance physiological or patho-physiological performed in patients. I n the Declaration’s Chapter I1 the concepts are even more obscure, when it is stated: “ I n the treatment of the sick person the doctor must be free to use a new therapeutic measure - - -”. This situation seems to have nothing to do with medical research, but covers the clinician’s obvious right (and duty) to choose the best therapy for his patient, even if it is newly introduced. Part 2 says that “the doctor can combine clinical research with professional care, the objective being the acquisition of new medical knowledge, only to the extent that clinical research is justified by its therapeutic value for the patient”. Again, it seems necessary that one knows the outcome of the study before it is started! ‘The Declaration speaks of therufieutic value and clinical research as synonyms. I t should be remembered that diagnostic procedure are as important parts of clinical research, and that the need for systematic studies within this field is even more urgent. Chapter 111, Part 1 deals with “purely scientific application of clinical research carried out on a human being”, socalled “non-therapeutic clinical research”. This obviously covers for instance biochemical, physiological and patho-physiological research, from which the patient - a t least indirectly could take advantage in some cases, whereas his role in others would be the pure experimental subject’s. Summing up these conceptual strata: 11, 1 deals with non-scientific, individual clinical situations 11, 2. deals with the controlled (successful!) clinical study and 111, 1 deals with the patient in a fundamental research project or in a combined clinicalilaboratory study. Chapter I, Part 3 and 4 mention the comparison between the benefits and risks, but do not distinguish clearly between neither the individual, a group of patients or the society, nor between experimental subjects and patients. Informed consent is not always practicable, for instance in double-blind stu91

dies, and in trials on cancer therapy. Besides, the information might well be delivered correctly, but is not fully comprehended by the patient (with special problems dealing with minors and the mentally deficient). These critical remarks do not intend to invalidate the many positive aspects of the Declaration. Among these are the demand on scientific qualification of the person responsible for the investigation. Research councils must however broaden this point-of view: By qualification should be meant a thorough knowledge of the relevant scientific literature on a n international scale and of scientific methodology (i.e. the art of planning, accomplishing and interpreting scientific investigations, including the logic concepts and the numerical analyses). A methodologically bad trial is always unethical, at methodologically good one on the contrary is not in itself ethical. It is proposed to divide patients and the related ethical problems in a way that differs from that of the Helsinki Declaration: A) Those who will not personally benefit from the study, i.e. patients acting as experimental subjects (like healthy volunteers) and B) those patients who might to some extent benefit from the study of a certain disease, whether patho-physiological, diagnostic or therapeutical. In group A the risks must be evaluated absolutely, and must approximate zero. In cases of doubt the responsible clinician or research council member must apply “the uncle test”, placing a close relative in the patient’s place. The interests of society can never constitute a supplementary weight on this scale. In group B the risks must be evaluated relatively, which is difficult in pathophysiological studies, but rather easy in case of diagnostic or therapeutical procedures, where the reference of evaluation should be the proven risks and benefits of the methods up till the time of the investigation (if such methods exist, otherwise the use of placebo is ethical). In group A the subjects ought to be secured by insurance, irrespective of guilt in a legal sense. Besides their legal rights the subjects in group B should obtain a maximal degree of clinical vigilance during the trial, i.e. should have easy access to the responsible clinician, clinic or hospital department. Finally, the moral question of distributing scientific results will be touched. Of course the individual scientist is - and has always been - obliged to publish his results, whether in accordance with his original belief, personal interests and so on. But besides it is necessary to consider the scientist’s moral commitment to secure that his results reach the parts of society dependent on compentent scientific information: clinicians, university teachers, authorities, politicians etc. - in other words all who by individual or principal decisions influence patients’ access to optimal diagnostics and therapy.

Ethical aspects of biomedical research.

ETHICAL ASPECTS OF BIOMEDICAL RESEARCH P. Riis, M.D. For the following purpose ethics are defined as the theoretical base of the moral, and the moral...
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