22 - Supporting Social, Behavioral and Educational Researchers with Study Compliance: Providing an on-demand tool for researchers to self-assess and to facilitate reaching out to the IRB-SBS for help.

Background:  The IRB for the Social and Behavioral Sciences (SBS) introduced an optional on-demand Compliance Check-up tool to help support researchers in assessing the compliance status of their studies, offer links to available educational material, and as a method to quickly reach out to the IRB staff for assistance when needed.

Program

Description:  In response to feedback from researchers that they support ongoing compliance for their studies but are unsure how to assess whether they are accomplishing this goal, the Post-Approval Monitoring and Education team for the IRB-SBS developed the Compliance Check-up tool. This online tool offers guidance in a survey style format for researchers to complete at their convenience, while including background educational material from our website and an easy help button to contact staff if they have any questions. In communicating with researchers about the tool, our team makes clear that the purpose is to support their autonomous assessment and that should they need assistance, to use the help button to reach out to the team. In the last 11 months that the Compliance Check-up tool has been advertised as available to researchers, over 60 study teams have voluntarily used the tool to independently self-monitor the compliance status of their study.

Program

Assessment:  The Human Research Protection Program (HRPP) has been satisfied with these early results for the first year since the Compliance Check-up tool has been implemented at our institution. It has improved the relationship with our researchers by taking a proactive, supportive stance in offering this optional tool and encouraging its voluntary use. In addition to assisting in self-assessment, the tool disseminates knowledge by providing asynchronous education to study teams. Offering compliance education on-demand to researchers has been a time-efficient solution that has allowed our team to redirect their efforts away from routine inquiries and focus attention on IRB tasks such as supporting study teams with more time spent on pre-review. Finally, if the researcher finds issues, the help button lowers the barrier to ask for aid. Overall, our HRPP has used this tool to create a more positive narrative by increasing transparency for the compliance assessment process, demonstrating trust in researchers to voluntarily utilize this tool, and solving for time constraints by finding a win-win solution for researcher and the IRB compliance team.

Limitations: The limitations encountered are the classic project limitations of time, budget, and scope. This tool was developed at minimal cost with a survey platform available at our organization, and work hours on the project occurred secondary to operational work duties. Using this low-cost model for development, the tool could be further developed in the future. However, currently, we are maximizing the resource for minimal energy input.

Discussion:  This low-cost, timesaving, optional compliance tool could be developed at other sites and refined to meet the specific needs of the local institution. While the compliance tool offers support to researchers for self-monitoring, education, and reaching out for help, the key component that this tool offers is the ability to establish a more collegial relationship between study teams and the IRB. Creating a positive narrative of support and trust within the research environment is of utmost importance to establish when growing a healthy HRPP. The ultimate aim is to create a cooperative environment for researcher success.