There are many regulations, outlined in the Code of Federal Regulations (CFR), and guidance in the field of research. OSF HealthCare expects investigators and research staff to understand and comply with the regulations and guidance that apply to their research.

Before investigators begin any research, they should thoroughly understand these rules to ensure that their studies are conducted in compliance with applicable laws and other requirements.

At a minimum, investigators conducting research in the United States should be familiar with the following.

Department of Health and Human Services (DHHS) Regulations and Guidance

• 45 CFR Part 46 - Protection of Human Subjects
• Office for Human Research Protections (OHRP) Guidance
  

Food & Drug Administration (FDA) Regulations and Guidance

• 21 CFR Part 50 - Protection of Human Subjects
• 21 CFR Part 54 - Financial Disclosure by Clinical Investigators
• 21 CFR Part 56 - Institutional Review Boards
• 21 CFR Part 312 - Investigational New Drug Application
• 21 CFR Part 812 - Investigational Device Exemptions
• FDA Information Sheet Guidance
  

Good Clinical Practice (GCP)

• GCP Consolidated Guidance for Industry
• FDA Regulations Relating to GCP and Clinical Trials