February, 2003
© 2000, 2001, 2003 Scott S. Emerson, M.D., Ph.D.
Session 1- Overview: 35
Ethical Issues
Mechanisms for ensuring ethical treatment of study subjects
Before starting the study:
·Institutional review board (IRB)
·
During conduct of the study:
·Data safety monitoring board (DSMB)
·
After studies completed
·Regulatory agencies (e.g., FDA)