Institutional Review Board Insights: Tips for Submission to the Institutional Review Board.

Abstract

The institutional review board (IRB) is an essential collaborator in the pediatric research process. Research must be scientifically and ethically sound to produce meaningful results, and it is the IRB's responsibility to review and approve human subjects' research while protecting the subjects' rights, minimizing research risks, and maximizing the benefits. Understanding the research approval process is important for any clinician investigator hoping to conduct human subjects' research. Although IRB requirements can, and often do, vary by site, there are important overarching requirements that apply to all institutions. We aim to provide general, practical guidance on how to navigate a study through the IRB process in 3 sections: what to consider before starting your study documents, what to consider while drafting documents, and what happens after you submit. Our hope is that these helpful hints lead to efficient IRB review of proposed research and successful science.