IRB Protocol Review

This first module provides an overview of the regulatory approval criteria for research (the 111 criteria) per the U.S. Department of Health and Human Services (HHS). We discuss how to apply such criteria to review a research protocol that involves participants in human subjects research. Further, we explore how IRB reviewers can evaluate a study’s potential risks of harm relative to its potential benefits.

Recommended Use: Required
ID (Language): 21144 (English)
Author(s): Linda Mayo, BA, CIP - The University of New Mexico; Ilene Wilets, PhD - Icahn School of Medicine at Mount Sinai

This module, part of a two-module set that learners should select based on their area of expertise and the research the IRB reviews, provides a biomedical (Biomed) research case study to practice asking the right questions to perform a thorough review of a proposal submitted to an IRB. It provides a “how-to” guide that IRB reviewers can use when reviewing a research protocol.

Recommended Use: Supplemental
ID (Language): 21145 (English)
Author(s): Ilene Wilets, PhD - Icahn School of Medicine at Mount Sinai

This module, part of a two-module set that learners should select based on their area of expertise and the research the IRB reviews, provides a social-behavioral-educational (SBE) research case study to practice asking the right questions to perform a thorough review of a proposal submitted to an IRB. It provides a “how-to” guide that IRB reviewers can use when reviewing a research protocol.

Recommended Use: Supplemental
ID (Language): 21146 (English)
Author(s): Linda Mayo, BA, CIP - The University of New Mexico

This module provides a deeper dive into the review of informed consent. We touch on regulatory requirements and critical areas of IRB review of informed consent. We provide a framework for an IRB’s consent review, starting with reviewing the consent form for its content and consistency with the protocol. Following the form, we discuss reviewing the protocol’s proposed process for obtaining consent. Lastly, we consider waivers and alterations of consent and waivers of documentation and the IRB’s role in making those determinations.

Recommended Use: Supplemental
ID (Language): 21147 (English)
Author(s): Cecilia Brooke Cholka, PhD, CIP - Weill Cornell Medicine

This module prepares IRB members and research staff to define medical devices, determine when IDE regulations apply, and distinguish between significant risk and nonsignificant risk device studies. Learners build practical competency in applying these criteria during IRB review, understanding the interplay with the Common Rule, and identifying appropriate regulatory pathways and oversight responsibilities for device research.

Recommended Use: Supplemental
ID (Language): 21148 (English)
Author(s): Carley Benham Emerson, MS, CIP - The University of North Carolina at Chapel Hill ; Amanda Matthews, AA, CIP - Children's Mercy Research Institutes

This module builds core competencies in defining drugs and biologics, understanding why they are regulated, and identifying IND types and applicability criteria under FDA regulations. Learners develop practical skills to apply these concepts during IRB review—evaluating IND requirements and exemptions, understanding alignment with the Common Rule, and assessing real‑world scenarios such as new indications, first‑in‑human studies, and expanded access requests.

Recommended Use: Supplemental
ID (Language): 22455 (English)
Author(s): Carley Benham Emerson, MS, CIP - The University of North Carolina at Chapel Hill ; Amanda Matthews, AA, CIP - Children's Mercy Research Institutes