RD327 - Annual Report on Human Research State Fiscal Year 2016 – October 2016

Executive Summary:
This report on human research studies reviewed and approved by the Virginia Department of Social Services' (VDSS) human research committee is in response to the mandate in section 63 .2-218 of the Code of Virginia.

Research involving VDSS clients generally involves minimal risk observational, behavioral or opinion studies. The potential risk for these types of studies most often involves issues of client privacy, confidentiality and, to a lesser extent, psychological harm (for example, from surveys that include sensitive questions). It is the role of the human research committee, known as the Institutional Review Board (IRB), to ensure proposed studies will be conducted in accordance with federal and state regulatory requirements governing human research.

During SFY 2016, 10 studies were submitted for approval to the VDSS IRB.

1. Two minimal risk studies were reviewed at convened IRB meetings. Of those, one was approved. The other study was tabled by the VDSS IRB and subsequently, the United States Department of Agriculture suspended the study before the IRB could take final action (Study # 2016-03).

2. Eight studies were reviewed by the IRB Chair and/or at least one other board member. Of those, two were closed without IRB action (SFY 2016-01 & SFY 2016-10), five survey studies were approved by exempt review and one study was tabled because it requires revisions to the consent process. The investigator was notified in writing of the modifications required to secure IRB approval.

Of the two studies closed without IRB action, study number SFY 2016-01 was a request for access to client identifiable data. The proposed study did not directly relate to administration of the Temporary Assistance for Needy Families (TANF) program. Thus, the data request was inconsistent with the Code of Virginia (§ 63.2-102) which limits the disclosure of client information to purposes directly related to the administration of each program. The second study closed without IRB action was the evaluation of the Child Nutrition Hunger Demonstration Project (Virginia 365 Project). The evaluation organization determined that access to client Supplemental Nutrition Assistance Program (SNAP) data was not essential to the evaluation of the 365 demonstration project.

The Chair convened the IRB four times during the fiscal year. The first meeting concerned violation of the terms of study approval (Study# 2014-06). Two of the remaining three meetings were for initial review of proposed research and the fourth meeting was to re-consider a previously tabled initial review.