Institutional Review Board

Institutional Review Board (IRB)

A major component of the process for ensuring the protection of the rights and welfare of human subjects involved in VDH research is the Institutional Review Board (IRB). IRBs are committees that reviews proposed and ongoing research involving human subjects.

• Research protocols must be either approved or granted an exemption by the IRB before human subjects can begin participation.
• The IRB also conducts continuing review of approved protocols as appropriate.
• The IRB may modify, suspend or terminate approval of research that has been associated with serious harm to subjects or is not being conducted in accord with the IRB’s decisions, stipulations, and requirements.

About IRBs

• Overview of Human Subjects Research and the VDH IRB Process provides answers to the most frequently asked questions including:
  • Why we have IRB
  • What needs to be reviewed
  • What type of review is needed
  • What is the review process and criteria
  • What are investigator responsibilities

• VDH has developed policies and procedures to ensure that the rights and welfare of human subjects involved in research are protected and consistent with both State (12 VAC 5-20-10) and Federal (45 CFR Part 46) regulations.
• The Office for Human Research Protections (OHRP), under the U.S. Department of Health and Human Services (HHS) Assistant Secretary for Health, is responsible for ensuring the safety and welfare of people who participate in HHS-sponsored research.
• Policies, guidelines, regulations and ethical principles from OHRP provided the framework for the development of the Virginia regulations, and provide the structure for VDH review and approval of human subject research.