World of Compliance Module

Relevant Regulations

Regulations governing inspections are under the Code of Federal Regulations (CFR) Title 21 - Food and Drugs. (http://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfcfr/CFRSearch.cfm)

The relevant parts include, but are not limited to:

Part 50: Protection of Human Subjects

This part of the regulation deals with informed consent as it pertains to human subject protection. Basically, it requires that each participant is informed:

• About the research project and their basic rights
• About potential risks or discomforts
• About available compensation or medical treatments
• About any benefits from the trials
• Of alternative procedures or course of action
• That participation is voluntary, and subjects can withdraw at any time.