RD159 - Report to the Commissioner: Activities of the Virginia Department of Health Institutional Review Board for Calendar Year 2010


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, updated in March 2005 and then again in December 2010.

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 research that present little or no risk to human subjects (non-vulnerable subjects) do not require ongoing monitoring and review by an IRB. However, IRB staff, in consultation with an IRB chair, must make the determination that the study does indeed meet the criteria for exemption before the research study may commence. This type of review is called “exemption review”. If the risks to human subjects appear questionable or the project does not fit into the federally defined categories for exemption, the IRB will notify the investigator that he/she must submit the study as a new protocol for either full or expedited review. If a study falls into one of the exempt categories, researchers still have ethical responsibilities to protect participants' rights.

Under Federal regulations [45 CFR 46.101 (b)], certain categories of research involving no more than minimal risk as well as minor changes to approved research, qualify for what is called “expedited review”. In these instances, the IRB Chair or a designated voting member or group of voting members review the proposed research rather than the entire IRB.

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”.

The following is a summary of the activities and actions of the VDH IRB as per State regulations for the conduct of human research (12 VAC 5-20-10) during calendar year 2010.