IRB State & Federal Regulations

Applicable State Laws

• Chapter 5.1 of the Code of Virginia expresses the applicability of federal regulations to human research conducted in Virginia. Generally, state law conforms to federal law
  State law also provides useful detail on the issue who can be a legally authorized representative of minors in research for the purposes of informed consent.
• Under state law, minors are persons under the age of 18. 

Federal Regulations

• Revised Common Rule: 45 CFR 46
• Ethical Guidelines
  • Nuremberg Code
  • Declaration of Helsinki
  • Belmont Report
• FDA-Regulated Research
  • 21 CFR Part 50 Human Subjects Protections (informed consent) and Additional Safeguards for Children in Clinical Investigations
  • 21 CFR Part 56 Institutional Review Boards
  • 21 CFR Part 312 Investigational New Drug Application 

Office for Human Research Protections (OHRP)

The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). OHRP is part of the Office of the Assistant Secretary for Health in the Office of the Secretary of HHS.

• Office for Human Research Protections (OHRP)

• Join OHRP's mailing list

• Decision Charts: 2018 Requirements

• FAQs about Human Research Topics

• Training Checklist for Someone Working with IRBs (pdf)

• Educational Resources for Investigators (pdf)

• Checklist of Resources for Learning about Research and Research Participation (pdf)

• OHRP Training Resources

Office of Research Integrity (ORI)

The Office of Research Integrity (ORI) promotes integrity in biomedical and behavioral research supported by the Public Health Service (PHS) at about 4,000 institutions worldwide. ORI monitors institutional investigations of research misconduct and facilitates the responsible conduct of research through educational, preventive, and regulatory activities.