Informed consent: Timely issues from the past. Factors motivating patients with advanced cancer to participate in phase II trials

Abstract

e20669 Background: The current regulatory burden is well intentioned, but hampers both the conduct and recruitment to clinical trials. What factors actually motivate patients to become research subjects? After “informed consent” is obtained, what is the subject's understanding of the study, and its risks and benefits? Methods: In 1973 data were collected on the factors motivating 50 consecutive patients with advanced cancer to participate in Phase II trials. The data had not been previously analyzed. Now, 35 years later, the data obtained seem surprisingly current. These patients were interviewed a few days after obtaining “informed consent”. The 60 minute interviews were semi-structured, and included the factors motivating participation, the purpose of the trial, potential side effects, and treatment options. Results: Patients seldom expressed a single reason for participation. The motivating factors fell into 5 categories. (1) Hope that the new treatment would help control their disease; expressed by all 50. (2) Avoidance of regret; i.e, if they declined they would regret not having participated (19 of 50). (3) Altruism was expressed by 29 of the 50. (4) Trust that a physician-investigator would not have suggested the trial unless he thought it might help (10 of 50). (5) Being trapped by a lack of therapeutic alternatives (14 of the 50). Potential risks and side effects were minimized or forgotten. Many developed a sense of commitment to a cause; their morale improved even if their disease did not. Conclusions: The factors motivating patients with advanced cancer to participate in Phase II trials are complex, but evolve primarily around their personal disease status rather than their understanding of the trial. Truly informed consent in this vulnerable patient population may not be possible. The ultimate responsibility for the protection of human subjects lies not with the IRB, but with the physician investigator. No significant financial relationships to disclose.