Ethics and Money Talk

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 62 Ethics and Money Talk This case raises several issues that merit discussion. Since it is unclear from the case as to its location, I am taking the liberty of analysing it from the developing world perspective. The first issue is that of incentives for recruitment. In this case the researcher is being paid a direct fee of $800 per participant enrolled, and in addition to that, is being offered a bonus of $5,000 for reaching the desired number of recruitments. This would add up to $37,000 which, certainly in the developing world context, is excessive. The issue that one can encounter with remunerations of this level is that of conflict of interest, especially when one considers the fact that this incentive may be several times the amount of money that the researcher may otherwise have been able to earn in that given period of time, were he to limit himself to clinical practice alone. Researchers may be paid for the additional work that they take on while conducting research in addition to their routine work (taking care of patients, in this case), but the remuneration should be appropriate and proportional to additional work. A disproportionate incentive can serve to change the focus of the researcher from that of scientific advancement alone, to that of making a lot of money quickly. Mrs L clearly wishes to join the study in order to get relief from the drug under test. What may not be readily apparent to her is that because of randomisation, she may never get the drug XTX007, since it is a double-blind study. Since the PI is himself unaware of the randomisation, he cannot guarantee that she will receive the drug she seeks or that she will be randomised into the placebo arm. And even if she gets the drug, there is no guarantee that it will help her, since this is still a product under research. All these issues get even more complicated with the changing status of her physician into that of a researcher. The sole focus of her physician in treating the patient was her well being, whereas when he approaches her as a researcher, C A S E C O M M E N T A R Y 62–63 Asian Bioethics Review December 2008 inaugural edition 63 E t h i c s a n d M o n e y Ta l k A a m i r J a f a r e y she becomes a research participant among many others. His focus is much broader, that of achieving the research objectives. This is a situation that leads to therapeutic misconception when the participant still considers herself to be the centre of attention and receiving therapy from her trusted physician rather than participating in research with no certainty of benefit. In light of the data safety monitoring board’s (DSMB) directives for enhanced vigilance of the participants, Mrs L’s request for inclusion is even trickier because of her recent liver problems. She is already ineligible to participate and her insistence to do so may be because she considers the principal investigator (PI) to be her benefactor from whom she can perceive no danger in accepting a drug that he prescribes. This, compounded by the fact that the PI could make an inordinately large amount of money by ignoring her history of liver disease and proceeded to recruit her for the trials, makes this case extremely problematic. In order to carry on this project, certain modification can be recommended. The monetary benefits for the PI should be revised to a reasonable range so that money does not become an influence in participant recruitment. It is also critical that the advice of the DSMB should be enforced, implying that Mrs L should be excluded. She should be told that this is a clinical trial in which there is no certainty...