Ethical issues in the use of tumor markers in clinical investigation of the management of bladder cancer

The use of marker tumors in clinical research on bladder cancer raises three significant ethical issues. The first concerns the management of risk in the design and conduct of clinical investigation. The use of tumor markers meets recognized ethical requirements for identifying and managing such risk and also meets the condition of equipoise. The second concerns the informed consent process, which should include provision to potential subjects of information about why a tumor marker is being used, risk of progression, and how subjects will be monitored to manage risk of progression. The third concerns monitoring of clinical trials. The use of a Data and Safety Monitoring Bord adds an important, additional level of protection for research subjects.