45 - Revising the IRB Submission Form: Lessons Learned From the Design Process

Background:  Electronic submission systems are the norm, and most IRB review platforms employ branching and skip logic to allow institutions to customize submission forms. Submission forms are the first step in the review process, and how they are constructed and deployed can have an immense impact on the IRB review experience.

Program

Description:  A few years after implementation of a new electronic IRB system, it was determined that significant updates were needed to improve the efficiency of review. The form was not capturing all necessary information, resulting in extended rounds of pre-review revisions. Implementation challenges were identified, as a more detailed form will be a significant departure from the current IRB review experience. The form was revised, with the goals of capturing more relevant information up front through asking the right questions in the form, while also focusing the form to meet regulatory and institutional requirements without engaging in mission or scope creep.

When evaluating whether a question or field should be added to the form, these design questions were asked:
1.Is the form, as constructed, currently collecting the information needed to effectively and efficiently conduct IRB review?
2.Does all relevant information have a sensible place within the submission form to be collected?

Program

Assessment:  A draft revised initial submission form was created. The design leans heavily on branching and skip logic to create different form “pathways” based on the nature of the research (i.e., separate form pathways for NHSR determinations, exempt studies, and non-exempt research). In addition, branching logic is utilized to display in-line guidance text intended to assist users in answering form questions fully.

Once a draft of a revised submission form was completed, initial feedback was sought from a group of IRB stakeholders using a simple Google form and 1:1 discussions. Feedback indicated that the new submission form is an improvement over the existing form, though refinement is necessary before implementation. Comments from feedback mainly centered around the best ways to include instructional text without getting too text-heavy, and how to structure questions to elicit quality information. Feedback was synthesized, and the form is being revised to address concerns identified in the feedback process, prior to implementation.

Limitations: Limitations to this work involve the labor- and time-intensive nature of a complete form overhaul. Competing priorities and needs from various stakeholders also means a “perfect form” is not possible, and choices must be made that may not be able to please all parties.

Discussion:  An important lesson learned in the development process of a new submission form is that there will be no perfect form, so it is necessary to determine when feedback saturation has been reached and further feedback will not be helpful. When reviewing feedback, it is necessary to triangulate common concerns or suggestions, to differentiate between personal preferences and potential problems with the form. Future work in this area will focus on the implementation process for the new form. We expect to see turnaround time reductions and increased investigator satisfaction, validating the effort necessary for this project.