Designing Inclusion and Exclusion Criteria
Brianna Hornberger, Sneha Rangu
Abstract
Effective inclusion and exclusion criteria create the ideal pool of participants to generate high quality data for the study. An inclusion/exclusion list should balance criteria that are both broad and specific. Excessively narrow inclusion/exclusion criteria can undermine a study’s recruitment feasibility, while overly broad criteria can compromise the data integrity. Including a general medical exclusion statement can prevent needing to go to the Institutional Review Board (IRB) for unique, isolated medical exclusions. Referring to studies with similar goals in your literature review will help ensure your criteria are feasible to incorporate into your study’s purpose and aims. Training research staff on criteria is crucial to ensure high-quality data from each participant.