6. What Type of Human Research meets the Criteria for Exemption?
Only studies that meet the six specific categories of exempt activities as delineated by HHS Regulations 45 CFR 46 (101) (b) are eligible to be given exempt status. When the activity is deemed to be exempt from IRB review a Request For Exemption form must be completed and submitted to the IRB. The IRB will generate a written Approval Letter. All project activities should begin after receipt of the written IRB approval.
Additional guidance on Exempt Human Research Determination can be found at Decision Making Charts.
IRB Exemption Determination is completed per IRB SOP FO-302.