In addition to clinical experience and medical training, education
and training in the ethical conduct of human research is essential to protect
the rights and welfare of human subjects participating in clinical trials.
Schulman's 
Research
Site Submission Form requires a detailed description of the education
and training that study personnel (principal investigator, sub-investigators
and study coordinators) have received in Good Clinical Practice and Human
Subject Protection. At a minimum, all investigators and staff should review the
Belmont Report, ICH Good Clinical Practice Guidelines and FDA Information
Sheets before beginning the study.
Education and training in Human Subject Protection is available in many formats, including a variety of in-service and web-based activities, such as the Collaborative IRB Training Initiative Program in the Protection of Human Research Subjects. Study personnel conducting clinical research funded by federal grants are required to show a certificate of completion of a module on Human Subject Protection before final approval of the study can be granted.