IRB Protocol Review & Research Compliance

300+ Protocols Audited: Rigorous Human-Subjects Compliance

Institutional Review Boards (IRBs) are too often treated either as rubber-stamp administrative hurdles or obstructionist bottlenecks. Director Adam Ian Stratmeyer, J.D. served as Graduate Compliance Officer in the Office of Research at the University of South Dakota, reviewing over 300 human-subjects protocols and serving as an alternate IRB member.

We audit research programs with deep operational literacy in 45 CFR 46 (The Common Rule), FDA regulations (21 CFR 50 & 56), and the foundational ethical mandates of the Belmont Report: Respect for Persons, Beneficence, and Justice.

Audit & Review Specializations

• Protocol Architecture & Vulnerability Screening: Rigorous examination of protocol methodology, deceptive research frameworks, and protections for vulnerable populations (minors, prisoners, impaired subjects).
• Informed Consent Design: Elimination of therapeutic misconception, coercive clinical framing, and incomprehensible legalistic boilerplate.
• Expedited & Exempt Determinations: Procedural verification to ensure studies qualify legally for expedited review without exposing the institution to OHRP sanctions.
• AI & Digital Data Ingestion Ethics: Auditing modern digital research where passive subject tracking, algorithmic analysis, or automated interventions challenge traditional Common Rule boundaries.

The Written Record

A policy that cannot be reconstructed from the written record is not a control. We reconstruct the actual paper trail of your institution before regulatory bodies or audit inspectors do.