IRB Review of Expedited Research

This module introduces the expedited review process by explaining what expedited review means, how it differs from exempt and convened IRB review, and the key regulatory and risk considerations reviewers must evaluate when making expedited determinations.

Recommended Use: Required
ID (Language): 22448 (English)
Author(s): Beth Irwin, MA, LPC, CIP - University of California San Francisco; Casey Mumaw, MA, CIP - Indiana University

This module explains when clinical studies of drugs, medical devices, and blood collection procedures qualify for expedited review, with a focus on minimal risk thresholds and FDA regulatory requirements.

Recommended Use: Required
ID (Language): 22449 (English)
Author(s): Beth Irwin, MA, LPC, CIP - University of California San Francisco; Casey Mumaw, MA, CIP - Indiana University

This module explores noninvasive biological specimen and data collection methods, highlighting practical considerations that affect risk, eligibility for expedited review, and participant protections.

Recommended Use: Required
ID (Language): 22450 (English)
Author(s): Beth Irwin, MA, LPC, CIP - University of California San Francisco; Casey Mumaw, MA, CIP - Indiana University

This module examines commonly reviewed research designs—such as studies using existing data, recordings, surveys, and interviews—while addressing privacy, identifiability, and ethical considerations that may increase risk.

Recommended Use: Required
ID (Language): 22451 (English)
Author(s): Beth Irwin, MA, LPC, CIP - University of California San Francisco; Casey Mumaw, MA, CIP - Indiana University

This module focuses on continuing review under expedited procedures, including long‑term follow‑up, data analysis‑only activities, and conditions for transitioning studies from convened to expedited review.

Recommended Use: Required
ID (Language): 22452 (English)
Author(s): Beth Irwin, MA, LPC, CIP - University of California San Francisco; Casey Mumaw, MA, CIP - Indiana University

This module reviews informed consent requirements, including assent, parental permission, electronic consent, and regulatory standards for waivers or alterations of consent, as well as documentation.

Recommended Use: Required
ID (Language): 22453 (English)
Author(s): Beth Irwin, MA, LPC, CIP - University of California San Francisco; Casey Mumaw, MA, CIP - Indiana University

This final module integrates all expedited review categories and approval criteria, guiding learners through case studies to practice making defensible, well‑documented IRB determinations.

Recommended Use: Required
ID (Language): 22454 (English)
Author(s): Beth Irwin, MA, LPC, CIP - University of California San Francisco; Casey Mumaw, MA, CIP - Indiana University