Ethics First: The Importance of an IRB when Working with Pediatric Populations

Objective: This IRB application was approached with a unique perspective due to its focus on a complex pediatric population, which may have determinants that create healthcare disparities. These populations are particularly vulnerable, making it paramount to ensure voluntary and honest participation.

Methods: Prior to recruiting or conducting a human study, research teams are required to get approval from this board, which consists of five or more members, including both those with scientific and nonscientific backgrounds, to ensure impartiality. All research personnel must also receive training in the basics of research ethics. The IRB application outlined every aspect of the project we intend to carry out, which included a brief literature review and rationale explaining the significance of the study, the process for recruitment and screening, consent and assent documents for both caregivers and their children, the surveys used to collect data, and how this data will be used in statistical analysis. IRB applications must also include protocols for how all collected data is stored and handled to ensure participant confidentiality is maintained at all times. Once the IRB application has been submitted, the board will review and return it with revisions and feedback before approving the final revised copy.

Results: The IRB drafting process established a comprehensive research protocol that addressed participant protection, confidentiality, and ethical recruitment within a vulnerable pediatric population.

Conclusions: As professional students, participating in drafting an IRB helped us understand the intricacies of ethical protocols and the importance of confidentiality. Furthermore, developing this application allowed us to participate in a research project from start to finish. Overall, this experience highlighted the important role of ethical oversight in conducting responsible and equitable human subjects research.