Ethical trials to determine the risks and benefits of radiation exposure from coronary CT angiography.

This essay discusses the ethical implications of medical research using ionizing radiation in the diagnostic imaging range. Coronary CT angiography will be used as an example. Since coronary artery disease is the most common cause of death in the United States, any change in the work-up or management of patients with coronary artery disease has enormous clinical and economic implications. Risks of diagnostic radiation differ from those encountered in routine medical research as radiation-related cancers and heritable genetic damage can manifest in the irradiated individual or in subsequent generations. The risk to research subjects is ethically troubling because the research may not offer direct benefit to participants, although the benefits to society and future patients could be considerable. The American College of Radiology has a mandate to lead in the discussion of how to best minimize the risks of diagnostic radiation exposure in clinical research while encouraging studies likely to maximize benefits for future patients.