RD693 - Annual Report on Human Subjects Research State Fiscal Year 2022

Executive Summary:

Section 63.2-218 of the Code of Virginia requires the Virginia Department of Social Services (VDSS) human research committee to submit to the Governor, the General Assembly, and the Commissioner an annual report on the human research projects reviewed and approved by the committee. The Code also requires the human research committee to report any significant deviations from the proposals as approved.


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.


Change in IRB Leadership and Membership

The IRB membership changed extensively in SFY 2022. The chairperson role transitioned from Dr. Eleanor Brown to Dr. Gail Jennings upon Dr. Brown’s retirement in December 2021. Dr. Danny Avula was appointed by Governor Youngkin to be the new Commissioner of the Virginia Department of Social Services in January 2022. The Commissioner serves as the Signatory Official for any research conducted by the agency. Furthermore, the IRB recruited six additional members to increase its diversity in terms of demographics and subject matter expertise. A list of the IRB members is included in the appendices.

Board Meetings

The VDSS IRB met virtually on April 21, 2022, thus fulfilling the Commonwealth’s regulation that the IRB meet at least once annually. The meeting minutes are included in the appendices.

Studies Approved

A summary of each study submitted and reviewed by the VDSS IRB in SFY2022 are described in more detail in the appendices. We briefly summarize them here.

• The VDSS IRB did not receive, review or approve any studies requiring full board review, as no studies submitted posed more than minimum risk to participants under state and federal codes (respectively, 22VAC40-890 and 45CFR46).

• The IRB reviewed and approved seven (7) projects, multiple modifications to an existing research project, and one continuation of an existing research project under Expedited Review procedures described in 22VAC40-890 and 45CFR46. While these procedures include a review of all elements required of a full Board Review, only two IRB members (including the Acting Chairperson) are required to conduct the review.

• Four (4) research projects were deemed Exempt from IRB Review, under conditions described in 22VAC40-890 and 45CFR46.


All research approved by the IRB in SFY 2022 satisfied the regulatory definition of minimal risk and involved activities such as surveys, interviews, program evaluations, or use of administrative data. There were significantly more studies submitted, reviewed, and approved by the VDSS IRB in SFY 2022, compared to SFY 2021 when the Commonwealth was experiencing the early stages of the COVID-19 Public Health Emergency. Priorities for SFY 2023 are as follows:

• Work with the Office of the Attorney General to revise certain sections of the state Code (e.g., 22VAC40-890-30, 22VAC40-890-80) to better align them with recent changes to the federal regulations (2018 Common Rule). The revisions will provide additional clarity and appropriate flexibility in conducting human subject research reviews.

• Promote use of the Collaborative Institutional Training Initiative (CITI) training platform for VDSS and LDSS staff who are involved in departmental research; continue to provide this training opportunity to new and continuing IRB members.

• Increase awareness of human subjects research protections among VDSS staff who use Qualtrics.XM, the agency-supported cloud-based, online survey tool, for data collection.

• Streamline VDSS IRB procedures and forms; investigate developing electronic submission forms.

• Set up a Microsoft Teams site to facilitate IRB communication and and meetings.

• Make updates to the content of the VDSS IRB website, as necessary.