Toolkit: Exempt Research

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Frequently Asked Questions/FAQs

• Coming soon

Flow Charts

• Exempt Category 1  (July 25, 2018)
• Exempt Category 2  (January 14, 2020)
• Exempt Category 3   (July 25, 2018)
• Exempt Category 4  (July 24, 2018)
• Exempt Category 5   (December 20, 2018)
• Exempt Category 6   (July 25, 2018)
• Exempt Category 7   (July 25, 2018)
• Exempt Category 8  (July 25, 2018)
• Limited IRB Review  (July 26, 2018)

Guidance Documents

• Coming soon

Memorandums

• Clarification of ORO's Requirements for the Review of Reportable Events in Exempt Human Subjects Research- VHA Handbook 1058.01 (August 7, 2019)

Templates

• Exempt Research – Roles and Responsibilities (February 3, 2020)
• Broad Consent Attestation (April 22, 2020)
• Exempt Reviewer Checklist (April 22, 2020)
• Exempt Determination Letter (Includes Limited IRB Review) (April 22, 2020)
• Exemption Request Form (April 22, 2020)
• Status Report Update for Studies Not Requiring IRB Continuing Review(1-24-2019) (January 24, 2019)
• Limited IRB Review Approval Letter (January 21, 2019)
• Limited IRB Review Reviewer Worksheet/Checklist (April 22, 2020)
• Waiver of HIPAA Authorization (April 22, 2020)

Webinars

• Revised Common Rule: Changes to Exempt Categories Limited IRB Review (September 19, 2018)
• Exempt Research – Categories 1-4  (March 14, 2019)
• R&D Committee Workshop Series: Initial Review and Approval of Exempt Research (Part 1)  (February 19, 2020)
• R&D Committee Workshop Series: Initial Review and Approval of Exempt Research (Part 2) - Capstone Case (April 9, 2020)

Questions about the R&D website? Email the Web Team.

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