Saving lives, not sacrificing them: the inevitable clash between medical research and the protection of medical subjects.

Throughout history, medical practitioners have been admonished to do nothing in treating their patients that might result in harming them. It was not until the 20th century that such teaching was codified in specific legislation. Spurred on by the perversity of Nazi doctors during the Holocaust, world leaders produced the Nuremberg Code in 1947 and the Declaration of Helsinki in 1964. Revelations about other egregious acts in the guise of legitimate medical research led to other measures to prevent such mistreatment. Regulations to ensure physician competency and responsibility have mushroomed in the succeeding years. While such measures were coming into being, some of the greatest advances in medicine were being achieved, not least among them those in cardiovascular surgery. Ironically, much of this valuable research would likely not have been approved under regulatory measures now firmly in place. Given the nature of medical research, more often than not a certain degree of risk in all patients entering such trials may be unavoidable. There is always a balance to be maintained between risk and potential benefit.