Ethical issues concerning therapeutic studies in inflammatory bowel disease.

Physicians often take on responsibilities beyond medical care regarding their patients with ulcerative colitis and Crohn's disease: they serve as the patients' advocates to nonmedical entities and individuals, including insurance companies, schools, employers, companions, and family members. These responsibilities create a more complex relationship between the patient and their IBD physician. In addition, these responsibilities may accentuate ethical issues for the physician who is also engaged in clinical treatment trials for inflammatory bowel disease (IBD). Ethical issues include therapeutic misconception, clinical equipoise, and financial and nonfinancial conflicts of interest. Physicians who refer patients with IBD to enroll in treatment trials, as well as clinician investigators who conduct studies should consider measures to clarify the separation between clinical care and participation in a therapeutic study, and to ensure the ethical treatment of patients. These precautionary measures may include payment of participants to emphasize that the research study is different from clinical care, consent by an investigator other than the treating physician, and care to disclose conflicts of interest to the patient and the medical community in presentations and publications. If the financial conflict is too great, a physician should not participate in the clinical trial.