Cancer gene transfer is a relatively novel intervention strategy. In part because of this novelty, trials often present greater uncertainties than those investigating more conventional approaches. In the following review, I examine how this greater uncertainty might affect how clinical studies are designed, when they are initiated, their degree of risk, and whether such risk can be justified in terms of therapeutic benefit. The review also discusses two other ethical issues presented by gene transfer clinical research: fairness in subject selection and communications with the public. I conclude with a series of recommendations directed toward researchers, policymakers, and ethics committee members.
