RD480 - Report to the Commissioner: Activities of the Virginia Department of Health Institutional Review Board Calendar Year 2016
Regulations for the conduct of human research, developed and approved by the Virginia Board of Health, became effective on July 1, 1993 and were most recently updated on January 14, 2016. The regulations apply to the department, including any local health department and to any facility operated, funded or licensed by the department which conducts or which proposes to conduct or authorize research which uses human participants. According to those regulations, prior to the initiation of a human research project a description of the proposed project shall be submitted to a research review committee for review and approval. The Virginia Department of Health (VDH) subsequently appointed an Institutional Review Board (IRB). In addition, a guidance document, Virginia "Department of Health Institutional Review Guidelines and Procedures" was developed and updated in March 2016.
The Office for Human Research Protections (OHRP), within the U.S. Department of Health and Human Services (DHHS), 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 “exempt 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, a designated IRB member or group of members reviews the proposed research rather than the entire IRB with final review and approval by the IRB Chair.
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".
In March 2016, Dr. Adrienne McFadden, Director of the Office of Health Equity was appointed to serve as Interim VDH IRB chair following the resignation of Dr. Dev Nair.