RD350 - Annual Report on Human Research State Fiscal Year 2017 – October 2017


Executive Summary:
Report Mandate

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 at least annually a 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.

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, VDSS contractors, and VDSS-licensed facilities.

The VDSS IRB reviews social or 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, or to a lesser extent, the potential of psychological harm associated with sensitive questions on surveys.

State Fiscal Year 2017 IRB Oversight Activities

During the fiscal year, ten studies came before the IRB. These studies are summarized in this section.

1. Two annual continuing reviews were approved (SFY 2014-04 & SFY 2016-06). IRBs must periodically review the conduct of research that continues beyond the initial approval period [45 CFR 46.109(e)]. For minimal risk studies, the review must be conducted no less than annually.

2. A resubmitted study (SFY 2016-03) to examine perceived barriers to accessing healthy food in SNAP households and determining adequate SNAP payment allotments was approved. The IRB had previously tabled this study on August 8, 2016. (Tabled means the IRB requires additional information and changes to study procedures and/or consent process before the study can be approved.)

3. One initial review application was withdrawn (SFY 2016-08) by the investigator after it was tabled by the IRB. The study, which pilots a new method for collecting information on eating and food acquisition behaviors in SNAP households, was tabled because the investigator did not provide sufficient information to the VDSS IRB and was unwilling to change its consent procedures to be in compliance with federal regulations.

4. The IRB coordinated with Virginia Commonwealth University (VCU) to make arrangements for an IRB reliance agreement, which was signed on 6/2/2017. (“Reliance agreement” is a contract between IRBs from multiple institutions that are involved in the same human subjects research study. The agreement allows these institutions to cede IRB oversight, monitoring, investigator responsibilities and other institutional requirements to one IRB. This provides a reasonable method of joint or cooperative review that reduces duplication of effort and improves efficiency.) VDSS will defer to the VCU IRB for review of study SFY 2017-01. The study was approved by the VCU IRB on April 17, 2017.

5. The IRB made two exempt research determinations (SFY 2017-02 & SFY 2017-05). This means that the research is not required to comply with the requirement of federal IRB policy (45 CFR 46 et seq.). The study involved assessment of training delivered to child care providers.

6. Another initial review application (SFY 2017-03) was withdrawn by the investigator after the VDSS declined to participate in the study. The investigator submitted a request to do semi-structured interviews with local department of social services' child welfare staff who participate in quality improvement case reviews using a specific process. However, the investigator was informed that the state and local family services staff no longer use that process.

7. Rutgers University approved study number SFY 2017-04 by expedited review. VDSS IRB accepted Rutgers' review and has on file Rutgers University approval documents (Protocol # 17-210M). VDSS IRB independent approval is not required as the study involved release of VDSS non-identifying client data. The VDSS IRB reviewed Rutgers IRB documents and participated in the development of the terms for data sharing (Memorandum of Understanding).

8. On January 23, 2017, study number SFY 2016-06 (“EleVaAte Supplemental Nutrition Assistance Program (SNAP) Employment and Training (E&T) Program”) was suspended. This action was taken because the IRB discovered that informed consent was not being
documented using the IRB approved Spanish language consent form as required by HHS regulations (45 CFR 46. l 17(a)). The investigators completed the required corrective actions and the IRB lifted the suspension on January 31, 2017.

9. The IRB convened once during the fiscal year. The purpose of the meeting was to review changes made to a study (SFY 2016-08) the IRB tabled during the prior fiscal year.

10. At the close of the fiscal year, action was pending for a federally-funded study – “Evaluation of the Procedural Justice Informed Alternatives to Contempt (PJAC) Demonstration.” Assignment of a VDSS IRB number is pending determination of the role of the VDSS
Division of Child Support Enforcement in support of the evaluation.

Study details are provided, in chronological order by study number, beginning on Page 5.