Creating a New Pathway to Differentiate QI and Human Subjects’ Research


Abstract Description
In an era of rapid advancement in technology and science, increasing emphasis is placed on the development and implementation of initiatives to improve healthcare delivery. Distinguishing such QI initiatives from HSR is often challenging as both may involve common methodologies and have overlapping goals. Federal regulations define HSR but do not define QI. The Office for Human Subjects Protections guidance contemplates that some QI initiatives may not qualify as HSR and therefore may not require IRB review. The lack of consensus on the definition of QI and the review process needed to establish a project as QI causes uncertainty on the part of QI project leaders, operational leaders, and IRB staff.

In early 2014, the IRB launched a pilot initiative to develop a process to distinguish QI projects from improvement projects that qualify as HSR requiring IRB review. The IRB in collaboration with faculty who lead QI initiatives developed an application process for submitters seeking an IRB determination. Institution-wide individuals were encouraged to submit projects to the IRB for evaluation. Once submitted, a team of IRB senior staff assessed the project with input solicited from operational leaders and IRB Chairs, as needed. After a year of pilot implementation period, the QI application process was refined; a QI guidance document, improved application, and process flowchart were created.

This poster will report on data from the initial pilot period and follow-on period post release of the revised QI determination materials. Data to be presented will include: 1) total applications received; 2) the number of applications assessed as QI or research; 3) the review level established for projects determined to qualify as research; 4) the disciplines represented; 5) results of a 2015 user satisfaction survey; and 6) process flowchart. Separate handouts of the application and guidance will be included.

This mechanism helped our institution to establish a process through which QI activities could be evaluated uniformly and distinguished from research requiring IRB review. Factors contributing to success include: 1) collaboration with faculty experienced in leading QI activities; 2) engagement of IRB chairs and institutional leaders in assessment of complex projects; and 3) using team-based approach within the IRB.

Early results indicate that many project leaders seek IRB determination; operational leader input and a guidance document/process flowchart are critical for success.

A similar approach could be adopted at other sites and tailored to address the types of projects typically performed in those sites.