How NIH’s Simplified Peer Review Framework Affects the Approach Section

As of January 2025, the National Institutes of Health (NIH) introduced a simplified peer review framework for research project grants, altering how proposals are evaluated—particularly the Approach section. Now situated under Factor 2, “Rigor and Feasibility,” the Approach section continues to receive a numerical score but must address more integrated and stringent criteria. Applicants are required to justify study design choices, including outcome measures, controls, and sample sizes, while also demonstrating robust plans for minimizing bias and ensuring analytic rigor. Additionally, feasibility is now equally emphasized, with investigators expected to present clear timelines, recruitment strategies, and contingency plans that underscore the project’s practicality. A significant structural change is the incorporation of previously separate review elements—such as inclusion plans and study milestones—into the core evaluation criteria. This shift transforms these components from compliance checks into direct contributors to scientific merit. Consequently, the Approach section must now function not only as a technical outline but also as a comprehensive narrative of project execution. Investigators must effectively integrate rigor, feasibility, and inclusivity into a cohesive plan. This report details the new expectations and offers guidance on aligning proposal content with the revised review priorities to enhance competitiveness under the NIH's updated framework.