Guide OPTI development beyond organizational differences.

698 • JAOA • Vol 101 • No 12 • December 2001 sponsible for communicating with IRBs/IECs, for ensuring that the approved procedures of obtaining informed consent are followed, for determining that protocols are followed, and for reporting adverse events. IRBs/IECs are responsible for scrutinizing proposed research and ascertaining that both the work and the workers comply with agreed-upon standards, and for monitoring ongoing studies for safety and responsible conduct. Academic institutions must act responsibly in allocating appropriate funding for the protection of human subjects, and by providing IRBs/IECs and other institutional bodies with the stature, authority, and resources required to do the job. The unfortunate events described in this report remind us that ongoing vigilance and effort and continuing education are all required, here in the United States and in overseas settings, to protect those who volunteer to participate in clinical research.