Bass, Berry & Sims attorneys Clint Hermes, Niya Mack and Morgan Tandy created a guide examining the requirements and procedures for Institutional Review Board (IRB) review of research, now part of the LexisNexis Clinical Trials Resource Kit.
In the guide, the authors discuss the history and regulatory framework of IRB review under the federal Common Rule, regulations of the Food and Drug Administration, and HIPAA. The guide also addresses IRB composition and decision-making processes, requirements for informed consent and continuing review, exemptions from IRB review, and best practices. This guide is a valuable reference for attorneys advising life sciences and healthcare clients on IRB-related and incorporates the authors’ insights from decades of advising and serving on IRBs.
The Institutional Review Boards content was published by LexisNexis in April 2025 and is available online.