DOI: 10.1097/01.all.0000225148.06909.61

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PMID: 16670502

Issn Print: 1528-4050

Publication Date: 2006/06/01


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Outcome measures: linking science and ethics in clinical research

Theresa A O'Lonergan; Henry Milgrom

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Author Information: School of Medicine, Department of Pediatrics, Pediatric General Clinical Research Center, University of Colorado at Denver Health Sciences Center, Denver, Colorado, USA

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Ethical evaluation of human subject research cannot be separated from the evaluation of scientific validity and value. No amount of risk to human research participants is justifiable if the resulting knowledge does not further the proper aims of clinical investigation and medicine. Of interest here are the pragmatic aims of the reduction of morbidity and mortality and the maintenance of health. These aims of research and medicine require the consideration of outcome measurements.
Traditionally, ethical evaluation of clinical research has focused upon adherence to the deontological principles of nonmaleficence, beneficence, autonomy and justice. Deontological principles are absolute and inviolable. Typically they do not admit to relative negotiation between and among principles. Foremost among deontologists is Immanuel Kant whose formula of the end in itself is the most articulate and comprehensive expression of the overarching principle of respect for persons. ‘Act so that you treat humanity … always as an end and never as a means only’ [1]. From this standard, the commonly recognized principles of biomedical ethics – nonmaleficence, beneficence, justice and autonomy – arise. All are necessary conditions in the conduct of research but not (as a set) sufficient.
In addition to respecting these absolute principles, one must also adhere to the principle of utility: the foundation of utility-based ethics. The principle of utility is the assertion that ‘… actions are right in proportion as they tend to promote happiness, and wrong as they tend to produce the reverse of happiness. By ‘happiness,’ is intended pleasure, and the absence of pain; by ‘unhappiness,’ pain and the privation of pleasures’ [2]. Calculation of an action's utility includes consideration of both the intensity and duration of the happiness (or good) resulting from the action. Fecundity is the third consideration: the propensity of an action to compound good across time. Clearly, adherence to the principle of utility after satisfying the requirements of the important deontological principles is not only compatible with but furthers the aims of medicine. Further, utility ought to be one of the essential conditions in the ethical evaluation of clinical research.
Respecting persons and promoting utility (in that order) are the essential considerations in the ethical evaluation of clinical research. That is, deontological principles act as a minimum threshold that must be achieved and beyond the achievement of which one is properly focused on the maximization of utility. Once the absolute value of respect for persons is honored and protected, one must focus on maximizing the usefulness of the expenditure of research efforts and resources. From this foundation, clinical research may be not only permissible, but ethically obligatory [3].
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