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2022 PRIM&R Annual Conference

IRB Basics

Flexibility and Innovation in Research Oversight Processes

E13 - Rigor Rules! How IRBs Assess Sound Research Design

Wednesday, December 14, 2022
1:30 PM – 2:30 PM ET
Location: On-Demand
CSP Icon On-Demand Session CIP Accredited Human Subjects Research Deep Dive Series

    Presenter(s)

  • Ilene F. Wilets, PhD

    Program for the Protection of Human Subjects
    Icahn School of Medicine at Mount Sinai
    New York, New York

  • Stephanie C. Reed, PhD, CIP (she/her/hers)

    New York State Psychiatric Institute/Columbia University Irving Medical Center
    Columbia University Vagelos College of Physicians & Surgeons
    New York, New York

The Common Rule 111 criteria requires minimizing research risk through the use of sound research design and, similarly, NIH has placed rigor and reproducibility at the forefront of its goals for ensuring scientific merit. However, there are no clear and consistent guidelines as to how IRBs should review studies to assess research quality and rigor. This session, by way of a case-based approach, will discuss key indicators of study rigor and present them within a framework to standardize the IRB review process.

Learning Objectives:

  • Recognize the Common Rule criteria and NIH requirements for addressing research rigor
  • Understand common basic study designs, the significance of clearly iterated purposes, and how purpose dictates the outcome measures for the study
  • Identify other indicators of research quality and rigor inherent in different study designs, and learn how to incorporate a rigor assessment framework into standard IRB practice for protocol review