RD220 - Report to the Commissioner: Activities of the Virginia Department of Health Institutional Review Board for Calendar Year 2009


Executive Summary:
Regulations for the conduct of human research, developed and approved by the Board of Health, became effective on July 1, 1993. According to those regulations, prior to the initiation of a human research project by any institution or agency funded or licensed by the health department, a description of the proposed human research project shall be submitted to a research review committee for review and approval. VDH subsequently appointed an Institutional Review Board (IRB). In addition, a policy document, The Institutional Review Board (IRB) of the Virginia Department of Health (VDH): Guidelines and Procedures for Obtaining Review, was developed and approved by the Commissioner in January 2001 and updated in March 2005.

The Office for Human Research Protections (OHRP), within the U.S. Department of Health and Human Services, is responsible for ensuring the safety and welfare of people who participate in HHS-sponsored research. VDH has voluntarily registered and has applied for and received Federalwide Assurance for its IRB from OHRP. Registration with OHRP facilitates DHHS’s effort to establish effective communication with IRBs. In addition, receiving an assurance from OHRP formalizes an institution’s commitment to protect human subjects.

Depending on the level of risk of the research protocol and the participant population, IRBs may conduct either exemption review, expedited review or full board review.

Under Federal regulations [45 CFR 46.101 (b)], certain categories of activity are considered research but may be declared exempt from review by the IRB. This determination must be made by the IRB prior to the research being conducted. If a study falls into one of the exempt categories, researchers still have ethical responsibilities to protect participants' rights.

For certain kinds of research involving no more than minimal risk, and for minor changes in approved research, the IRB Chair or a designated voting member or group of voting members review the proposed research rather than the entire IRB. This type of review is called “expedited review”.

When full board review is necessary, the research proposal is presented and discussed at a meeting at which a quorum of IRB members is present. For the research to be approved, it must receive the approval of a majority of those voting members present. This is considered “full board review”.