Ethical challenges in stroke research.

BACKGROUND Ethical issues are a critical consideration in the design and conduct of clinical research. SUMMARY OF REVIEW A number of completed trials of proposed stroke treatments raise classical ethical issues in challenging ways. The combination of acutely ill and vulnerable patients, the use of potentially toxic drugs, and very short time frames for decision making and drug administration demand an especially careful evaluation of risk and benefit, the process of consent, and the permissible treatment of control patients. CONCLUSIONS The study of acute stroke treatments may require more complex safeguards than other neuroclinical trials.