IRB Review of Exempt Research

The IRB Review of Exempt Research course provides an overview of the exempt categories of research per 45 CFR 46.104 and discusses considerations for making an exempt determination per regulatory criteria.

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About this Course

This advanced course provides a comprehensive overview of the categories of research exempt from IRB review under 45 CFR 46.104. Designed for IRB administrators and IRB members responsible for making exemption determinations, the course explores each exemption category in detail, including the regulatory criteria and key considerations for applying them. Each module presents real-world examples to illustrate how specific types of research align with exemption categories. The final module features interactive case studies across all exemption types, allowing learners to apply their knowledge and practice making determinations in accordance with federal regulations.

Course Preview:

Language Availability: English

Suggested Audiences: Faculty, HRPP Staff, IRB Administrators, IRB Chairs, IRB Members, Postdocs, Research Personnel, Researchers, Students

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

Course Content

Overview of Exempt Research

This module distinguishes non-human subjects research from research that is exempt, discusses what exemption means, and explains the limitations of the exemption categories for research that falls under Subparts B, C, and D.

Recommended Use: Required
ID (Language): 21907 (English)
Author(s): Linda Reuter, MS, CIP - BRANY

Exempt Research Categories 1-3

This module examines exempt categories 1-3 and defines their applications and limitations. It also takes a close look at what is meant by the term “benign behavioral interventions.”

Recommended Use: Required
ID (Language): 21908 (English)
Author(s): Linda Reuter, MS, CIP - BRANY

Exempt Research Categories 4-6

This module explores exempt categories 4-6, with a detailed focus on secondary research and how it intersects with HIPAA requirements.

Recommended Use: Required
ID (Language): 21909 (English)
Author(s): Linda Reuter, MS, CIP - BRANY

Broad Consent and Limited IRB Review

This module provides an in-depth look at the exempt research categories that require limited IRB review. Learners will explore the regulatory conditions for these exemptions, the purpose and process of limited IRB review, and the role of broad consent in secondary research.

Recommended Use: Required
ID (Language): 21910 (English)
Author(s): Linda Reuter, MS, CIP - BRANY

Putting it all Together: Make the Exempt Determination

This module allows learners to apply their knowledge of the exempt categories by analyzing case examples, assessing whether each meets the necessary criteria, and identifying the appropriate exemption category.

Recommended Use: Required
ID (Language): 21911 (English)
Author(s): Linda Reuter, MS, CIP - BRANY

FAQs

Who should take the IRB Review of Exempt Research course?

The IRB Review of Exempt Research course is designed specifically for IRB administrators, IRB members, and other designated individuals who need to apply the exemption categories under 45 CFR 46.104.

What are the benefits of the IRB Review of Exempt Research course?

This advanced course provides a detailed explanation of the regulatory criteria for each exemption category, followed by practical examples and case studies to help learners apply those criteria with confidence and accuracy. Key benefits include improving the accuracy of exemption determinations, supporting consistent practices across an institution, and enhancing the overall efficiency of the IRB review process.

How long with the IRB Review of Exempt Research course take to complete?

The IRB Review of Exempt Research course consists of five modules. Completion of all modules, as well as the corresponding quizzes, should take approximately two and a half hours.

Is the series eligible for CME credits?

No, the series is not eligible for CME credits at this time.

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