Informed consent, capitation, and conflicts of interest in clinical trials: views from the field.

Abstract

The beliefs of research team members about informed consent practices are not well studied, especially in regard to financial aspects of research such as capitation fees. Sponsors of research offer capitation fees for the enrollment of subjects, and although this money is intended to cover the costs of the research it can sometimes be used in other ways. There is no clear consensus about whether this financial aspect of trials should be part of the informed consent process or whether it represents a potential conflict of interest. We presented several hypothetical cases to members of the American College of Surgeons Oncology Group (ACOSOG) at a semi-annual meeting. ACOSOG is a federally funded clinical trials group evaluating surgical and adjuvant methods of cancer treatment. The meeting included surgeons, nurses, case managers, and others involved in clinical surgical trials. We found that most respondents believed that it would be a violation of the protocol to enroll a subject who showed lack of recall about the study. Most respondents also favored disclosure of capitation fees, especially if those fees went into discretionary accounts, but there was some disagreement about the benefit of that disclosure to potential participants. This study shows the need for greater work in ensuring that research team members share common understandings about informed consent. It also shows that most of these research team participants are prepared to make more disclosure about financial aspects of research than current standards in fact require.