The Role of a Clinical Investigator

A s i a n B i o e t h i c s R e v i e w D e c e m b e r 2 0 0 8 i n a u g u r a l e d i t i o n 70 The Role of a Clinical Investigator The case at hand presents an ethical dilemma which is often faced by a clinical investigator who also happens to be the physician responsible for the primary care of a potential research subject. Obviously, the physician–investigator in this case is put in a somewhat untenable ethical position, there is a conflict of interest in the role of the physician–investigator, that is, as a scientist and as a physician. However, if the physician–investigator is very clear of his role, there is every reason to refuse the patient’s willing participation in the study and reject the enticing offer of the pharmaceutical company of a bonus payment of $5000 as added payment if the study finishes on time with the required 40 participants. The conflicting ethical demands from the physician–investigator reflect the conflict between rights-based moral theories and utilitarianism. The moral theory based on Immanuel Kant argues that since human beings have a capacity for rational thinking, they therefore have dignity and thus, human beings should not be treated as a means to an end but always as ends in themselves. In this context, the interests of the patient should take priority over that of gathering a body of scientific data. In contrast, utilitarianism in the thoughts of John Mill asserts that the end determines the moral quality of an action and defines what is right as the greatest good for the greatest number. In this context, human beings can be a means to an end. Thus, utilitarianism asks a physician–scientist to sacrifice the interests of his (40) patients for the sake of gathering scientific information which will eventually benefit the society. The utilitarian argument in this case is problematic. Utilizing the patient for this trial in fact, will negate the value of the “greatest end” which is the body of scientific data. How can the data obtained from this patient be included in the scientific analysis and be of any good to the society if in the first place the patient’s medical history of a viral hepatitis 3 months ago is explicitly stated C A S E C O M M E N T A R Y 70–72 Asian Bioethics Review December 2008 inaugural edition 71 T h e R o l e o f a C l i n i c a l I n v e s t i g a t o r S a l o m e N i c d a o - Vi o s as an exclusion criterion. Setting inclusion and exclusion criteria are ways to control experiments which are necessary to make the scientific endeavour valid for the eventual application to the conduct of a sound medical practice. Thus, including the patient in the trial would invalidate the body of data and make them not credible. If he includes the patient in this study, his body of data is not truthful and sound. How then can the trial results claim scientific and ethical validity? While utilitarianism disregards the distribution of risks and benefits as of no moral consequence, the physician–investigator by virtue of his unique relationship with his patient, who is a potential subject, is concerned with the distribution of risks and benefits. The physician–investigator cares that his patient accrues the minimum risks and maximises the benefits and rightly so in this case, considering that the relationship between the physician and the patient has existed for the past seven years. The physician–investigator is aware that the data safety monitoring board (DSMB) has asked for an increase in the intensity of drug surveillance due to concerns about drug-related serious adverse events. He knows that the patient is elderly with possible age-associated reduction in functional reserve capacity and homeostatic mechanisms on top of a history of viral hepatitis and possibly with other co-morbid conditions that may...