2018 Common Rule Guidance

• Limited IRB Review: Forthcoming once OHRP provides guidance
• Summary of changes relevant to member reviews (DOCX)
• Reviewer Guidance for Exempt Categories (PDF)

From OHRP Website

In order to understand the regulatory text of the revised Common Rule, OHRP recommends reviewing the preamble and regulatory text from:

• The final rule to revise the Common Rule - PDF (published January 19, 2017)
• The interim final rule to delay the effective date and general compliance date of the revised Common Rule to July 19, 2018 - PDF (published January 22, 2018), and
• The final rule to further delay the general compliance date of the 2018 Requirements to January 21, 2019, while permitting the use of three burden-reducing provisions of the 2018 Requirements during the delay period - PDF (published June 19, 2018)