Revised Federal Regulations (known as the Common Rule) governing the protection of human subjects participating in research will become effective on January 19, 2019.
Please note that this will require changes in VDH IRB Procedures.
One of the many ways the Virginia Department of Health (VDH) serves the public and fulfills its mission is through research. VDH frequently conducts research that involves human subjects, and the protection of human subjects is as important as the methodology, research findings, or any other component of the research project.
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 subjects research.
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). 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 at least annually for projects approved prior to January 21, 2019 or as appropriate for projects approved on January 21 or thereafter. 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.
Below is a link to a presentation that will provide the answers to the most frequently asked questions, including why we have IRBs, what needs to be reviewed, what type of review is needed, the review process and criteria, and investigator responsibilities: