REPORT MANDATE
Title 63.2-218. Board to adopt regulations.

The Board shall adopt such regulations, not in conflict with this title, as may be necessary or desirable to carry out the purpose of this title. Before the Board acts on a regulation to be published in the Virginia Register of Regulations pursuant to § 2.2-4007.05, the Board shall examine the potential fiscal impact of such regulation on local boards. For regulations with potential fiscal impact, the Board shall share copies of the fiscal analysis with local boards prior to submission of the regulation to the Department of Planning and Budget for purposes of the economic impact analysis under § 2.2-4007.04. The fiscal impact analysis shall include the projected costs and savings to the local boards to implement or comply with such regulation and, where applicable, sources of potential funds to implement or comply with such regulation.

The Board also may adopt such regulations to authorize local boards to destroy or otherwise dispose of such records as the local boards in their discretion deem are no longer necessary in such offices and that serve no further administrative, historical or financial purpose.

BACKGROUND

The VDSS human research committee, known as the Institutional Review Board (IRB), ensures research will be conducted in compliance with federal (45 CFR 46 et seq.) and state (§ 32.1-162 and 22VAC40-890 et seq.) statutes. The IRB reviews, approves, and monitors research conducted or authorized by VDSS, local departments of social services (LDSS), VDSS contractors, and VDSS-licensed facilities as well as any studies that utilize or seek to gather information about VDSS and/or LDSS clients and/or employees.

The VDSS IRB reviews social-behavioral studies or evaluations of client services or benefit programs. Potential harm associated with these types of studies is categorized as minimal risk. Primarily, the IRB deals with issues of privacy, confidentiality, equitable treatment, client informed consent and, to a lesser extent, the potential of psychological harm associated with sensitive questions on surveys or interviews. To meet the responsibilities of federal and state statutes defined above, the VDSS is guided by practices provided by the Office of Human Research Protections, in the U.S. Department of Health and Human Services (USDHHS) at https://www.hhs.gov/ohrp/regulations-and-policy/guidance/index.html.

ACTIVITIES OF THE VDSS IRB IN SFY 2023
Change in IRB Staffing

The VDSS IRB is overseen by the VDSS Office of Research and Planning (ORP), under the direction of Dr. Jeff Price. Dr. Danny Avula, the VDSS Commissioner, serves as the Signatory Official for the agency. In addition to her job as a policy research analyst in ORP, Dr. Gail Jennings serves as the Chairperson and is the chief administrator for the VDSS IRB.

There were two noteworthy changes in staffing that impacted IRB operations in SFY 2023. First, due to significant increases in IRB submissions, the ORP Director assigned Dr. Aline Jesus Rafi and Mr. Andrew Sell, both policy research analysts in ORP, to help Dr. Jennings with the increased workload. With additional staffing, the IRB has continued to run smoothly and efficiently.

Second, Dr. Jeff Price, the Director of ORP, who also served as Ombudsman for VDSS since 2013, resigned from VDSS in June 2023 to take a position at another state agency. Recruitment for the ORP director position is underway. In the interim, Dr. Jesus Rafi serves as Acting Director. After the director position is filled, VDSS leadership will determine who should serve as the Ombudsman for the agency.

Change in IRB Membership

Two members of the IRB – Dr. Dhara Amin of the Virginia Department of Juvenile Justice (DJJ) and Dr. Jessica Marcon Zabecki of the Virginia Department of Education (VDOE) -- resigned their positions in the IRB. Dr. Amin, who had been an IRB member since 2018, left in August 2022. Dr. Zabecki, a research analyst at VDOE, joined the IRB in March 2023 but left three months later. The IRB Chair contacted DJJ and VDOE to identify suitable replacements. Both agencies have identified individuals, and their appointments will be made in SFY 2024. For the latter half of SFY 2023, the IRB had ten members plus the IRB Chair (Dr. Jennings), the co-Administrators (Dr. Jesus Rafi and Mr. Sell), and the Agency Ombudsman (Dr. Price). The roster of VDSS IRB members is in Appendix A.

Board Meetings

The VDSS IRB met on October 11, 2022, thus complying with state regulations that the IRB meet at least once yearly. A quorum of members attended the virtual meeting, during which a full board review was conducted. The IRB reconvened on December 2, 2022, to discuss developing clearer guidance about participation of foster children in human research. The minutes of both meetings are in the appendices.

Studies Approved

The VDSS IRB reviewed a total of 35 human subjects research studies – a significant increase from the year before. Procedures determining which type of review is conducted are determined by state and federal codes (e.g., 22VAC40-890 and 45 CFR 46). A summary of each study submitted and reviewed by the VDSS IRB in SFY2023 are described in more detail in the appendices. Here is a summary of the number of reviews conducted by the VDSS IRB.

• One study required a Full Board review because it potentially posed more than minimal risk to human participants.

• Eleven studies received an Expedited review by the IRB Chairperson or by one or more other experienced reviewers designated by the Chair.

• Nine studies underwent an exemption determination and were deemed Exempt from most federal regulations under 45 CFR 46.

• The Chair (or a designee) approved Modifications submitted by ten previously approved studies and Continuances of four previously approved studies. Starting in SFY 2023, new studies initially approved under an expedited review procedure do not require a continuing review unless the IRB decides otherwise.

Other Activities

During SFY 2023, the IRB Chairperson initiated the periodic review process for state codes 22VAC40-890 (Human Subject Research Regulations) and 22 VAC 40-910 (General Provisions for Maintaining and Disclosing Confidential Information of Public Assistance, Child Support Enforcement, and Social Service Records). The Chair recommended more extensive revisions to 22VAC40-890 to bring it in compliance with 2018 changes to the federal code (45 CFR 46). Minor changes were recommended for 22VAC40-910. Both chapters are currently at different stages of the fast-track review process.

In addition, the IRB Chairperson and Administrators started and/or completed the following projects:

• Developed clear, more detailed guidance regarding participation of foster children in human subjects research and who may provide informed consent on behalf of foster children.

• Established a new policy requiring principal investigators and their research staff to show evidence of completion of human research protection training.

• Developed a human subjects research decision-making tool for new investigators.

• Investigated ways to modernize the IRB’s recordkeeping system and streamline the submission and review processes. We identified at least one IRB management solution on the market.

CONCLUSION

All research approved by the IRB in SFY 2023 satisfied the regulatory definition of minimal risk and involved activities such as surveys, interviews, program evaluations, or secondary data analysis using DSS program administrative data. Priorities for SFY 2024 are as follows:

• Continue to promote Collaborative Institutional Training Initiative (CITI) as a source for human research protection training for DSS staff, IRB members, and new investigators.

• Release the new Human Subjects Research decision-making tool.

• Incorporate information about the IRB in a new survey training video designed for DSS employees.

• Purchase a cloud-based IRB management solution; complete set-up and user training in SFY 2024.

• Add new IRB members to serve the interests of vulnerable populations (e.g., young and school-age children, incarcerated or detained individuals).