Raising the Bar: Improving Quality of Research Conduct Through a Study Initiation Program


Abstract Description
The SIP was developed in collaboration between the HRPP and the Human Research Quality Assurance Program. The SIP takes a proactive approach to providing protocol specific, on-site education to investigators new to the institution or conducting investigations subject to unfamiliar regulation or policy. To better collaborate with investigators in these contexts, each SIP visit is tailored to address the complexities and nuances of their specific protocol. This program has become an essential part of improving awareness of human subjects protections and enhancing direct communication between investigators, research staff, and compliance offices at our institution. 

The SIP visit occurs after IRB approval, but prior to the implementation of study procedures. Candidates for the program are identified during the IRB submission process and through referrals by staff and/or investigators. The standard SIP visit addresses common issues of compliance with the approved IRB application, reporting and monitoring policies, recruitment and consent procedures, study documentation, and best practices for study conduct. In addition to the standard SIP visit, the program offers specialized tracks for: Multi-site Management; Food and Drug Administration Sponsor-Investigator responsibilities; Department of Defense funded research; and the transition of a protocol to a new principal investigator. Modular print materials have been developed for each component of the program and are tailored to each specific visit. 

A key component of the SIP is the set of evaluation measures that have been built into the program. The initial SIP was developed through a compilation of compliance findings and interviews with investigators/key research staff. Now, program attendees are given a Research Electronic Data Capture hosted survey post-visit in order to provide structured and free text feedback. In addition, detailed data on visit types, triggers, and attendee demographics are collected to demonstrate program effectiveness as it correlates to observable improvement of study conduct. 

This poster will specifically describe program development and quality indicators, including a brief program evaluation based on two years of study data. Since the SIP is a program built into our HRPP, it could be duplicated at institutions of any size and tailored further to local needs.