IRB Protocol Review

Learn how to review nonexempt human subjects research protocols for regulatory compliance with the Common Rule.

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About this Course

This course guides IRB protocol reviewers to “ask the right questions” to enable an informed and comprehensive protocol review in keeping with 45 CFR 46, Subpart A.

This first module dives into the IRB review criteria at 45 CFR 46.111 (frequently called the 111 criteria). Learners can then review case study modules (Biomed Case Study and SBE Case Study). These modules address asking the right questions as an IRB reviewer based on the type of research. The final module discusses how to review the informed consent process and documentation practices for regulatory compliance.

This course is meant to be role-specific and go beyond basic human subjects research training covered in CITI Program’s Human Subjects Research (HSR) series. The intent of this course is to train IRB members in the process of effective protocol review based on regulatory criteria.

Note: This course does not cover making non-human-subjects-research determinations nor the specifics of exempt and expedited review processes and criteria. This course also does not cover the review of research regulated by the U.S. Food and Drug Administration (FDA).

Course Preview:

Language Availability: English

Suggested Audiences: IRB Administrators, IRB Chairs, IRB Directors, IRB Members/Reviewers

Organizational Subscription Price: $675 per year/per site for government and non-profit organizations; $750 per year/per site for for-profit organizations
Independent Learner Price: $99 per person

Demo Instructions

Course Content

IRB Regulatory Review Criteria

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

Asking the Right Questions for Effective Protocol Review – Biomed Case Study

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

Asking the Right Questions for Effective Protocol Review – SBE Case Study

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

IRB Review of Informed Consent

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

FAQs

Who should take the IRB Protocol Review course?

The IRB Protocol Review course is for those individuals directly involved in IRB review of nonexempt human subjects research protocol in keeping with the Common Rule.

What are the benefits of the IRB Protocol Review course?

Learners in this course will gain a deeper understanding of how to review a research protocol for regulatory compliance and ethical considerations. This course provides second-level training from the basic human subjects courses and provides substantive guidance for understanding the process of IRB review. Learners should be able to apply the IRB regulatory review criteria to their protocol reviews by the end of this course.

The course is online, asynchronous and on-demand so learners may revisit topics as needed. The course also provides regulatory handouts to be used as tools in review. Case studies allow the learner to apply knowledge to realworld examples.

How long will the course take to complete?

The IRB Protocol Review course consists of four modules. Completion of all modules, as well as the corresponding quizzes should take approximately 2 hours.

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