Possible Positions to Avoid Conflict of Interest

67 P o s s i b l e P o s i t i o n s t o Av o i d C o n f l i c t o f I n t e r e s t E v a S a n t o s Possible Positions to Avoid Conflict of Interest As principal investigator, my loyalty of course must be to uphold the integrity of the research, which means that I should follow the protocol diligently and faithfully, including the proper recruitment of participants, and reporting of all serious adverse events (SAEs). Equally important should be to advise the sponsor of any doubts or discomfort on my part regarding these SAEs. The monetary compensation should never be a factor for decisions at this point. Hence, I will not even consider recruiting my patient who had viral hepatitis because this violates the recruitment policy. The trial is just a month from completion and the results will be out soon enough for me to make a proper judgment on whether to give her the treatment or not later. Meanwhile, if she has been suffering from this condition for the past seven years and has never had any of the SAEs mentioned in this case, I will not be remiss if I continue just treating her with thus far approved regimen. This decision regarding my patient (Mrs L) is also reached upon realisation that seven patients out of 37 thus recruited and participating in the trial had adverse reactions which I may consider alarming. Not only are the reactions (myocardial infarction, cardiac rhythm abnormality, acute liver dysfunction) relatively rare in cases of irritable bowel syndrome and constipation which may not even be under active treatment; but also because, presuming that one of the exclusion criteria was heart disease, it is easy to deduce that these could not be due to the placebo. However, I will have to go over the history and clinical presentation of the participants who manifested these adverse effects and find out if there is a chance that the side effects could not be drug related. If my thorough review of these cases convince me that they are indeed drug related, then I will request the sponsors to stop the recruitment now, especially C A S E C O M M E N T A R Y Asian Bioethics Review December 2008 inaugural edition 67–69 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 68 if the recruited number so far can lead to statistically significant results. If the recruitment could be possibly stopped now, I will recommend decoding the side arms (investigational drug and placebo) for the 37 patients so that I could continue treating them accordingly, like using standard care for the condition. If I find that the SAEs were indeed drug related, but that the reactions are more due to dosage, administration, and not with the active ingredient itself (an ingredient which in the literature and in previous animal studies and phase 1 trials may have been shown to be effective in treating the condition it purported to treat), then I can suggest a modification of dose and administration, and make stricter inclusion/exclusion criteria and suggest, as the data safety monitoring board (DSMB) suggested, stricter surveillance, and an altogether new if not amended protocol. I am just wondering why the Ethics Review Committee (ERC), which is supposed to be receiving SAE reports and protecting participants, has not stepped in to suspend recruitment! In summary, these are my possible positions: • Position 1. I will stop the recruitment. If I am an ethical investigator, I will not even think of the $7,400 I stand to lose (I have been paid or stand to be paid almost $30,000 anyway!) as a condition to continue looking for the last three participants. This is because I am alarmed by the SAEs, although honestly, I think they are either drug- or placebo-related...