Proportion of subjects with an ethically acceptable reason for enrolling in a phase I trial

2512 Background: Concern persists that phase I subjects, who frequently enter trials for personal benefit, are deluded. They may suffer from therapeutic misconception (TM) - conflating research and clinical care, or from therapeutic misestimation (TMis) - misestimating benefits or risks. Methods: To estimate the proportion of phase I subjects who have an ethically acceptable reason for participation, we both interviewed and surveyed subjects to obtain qualitative and quantitative data. Ethically acceptable reasons included 1) Altruism (sole motive for entering trial was to help others or advance science); 2) Self-regarding motives but no TM (correctly identifying that the trial mostly intends to help research and gain knowledge, the study decides the treatments and the subjects get different doses of drug); 3) Self-regarding motives, TM but no TMis (chance of benefit < 20% and chance of risk > 0%); or 4) Self-regarding motives, TM, overestimation of benefits but broad view of benefit (with collateral benefits like getting careful disease monitoring or access to an academic center listed) and chance of risk > 0%. This generous interpretation of ethically acceptable reasons hinges on the view that subjects at least must recognize there is some risk, that chance of disease benefit is not high and that collateral benefits count. Results: The 86 subjects were mostly white, male, with incomes more than $60,000. 49% were college educated with a mean age of 60. 53.5% had an ethical reason for participation, with 10.5% altruistic, 16.3% no TM, 8.1% TM but no TMis, and 18.5% overestimating benefit but including collateral benefits. In both univariate and multivariate analyses age younger than 60 yo and having at least a college education were the only characteristics significantly correlated with having an ethically acceptable reason for participation. Those who reported strong religious beliefs (p = 0.01) were significantly more likely not to have an ethically acceptable reason. Conclusions: With almost half of participants lacking an ethically acceptable reason for participation, interventions are necessary to bolster understanding. Older participants lacking a college education are particularly at risk and could be the target for an intervention trial. No significant financial relationships to disclose.