2.6 Exempt Research

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for determining if a research proposal is eligible for exemption under 45 CFR 46.104(d) and 21 CFR 56.104, with appropriate protections in place for research subjects.


2.0 Policy

It is the policy of the Organization that:


3.0 Categories of Exemption


4.0 Limitations on Categories of Exemption


5.0 Procedures


6.0 Criteria for Approval of Exempt Research


7.0 Actions


8.0 Review by Other Organizational Committees


DOCUMENT HISTORY:

 Written: 1/5/2016 (Approved: 1/5/2016) - original author not recorded

 Revised: 2/5/2018 - revision not documented

 Revised: 8/11/2020 - Clarified eligibility of children for exemption category 2, clarified requirement for documentation of informed consent for exempt research

 Revised: 10/7/2020 - Deleted exempt categories from pre-2019 Rule (section 3.1); other minor clarifications and corrections

 Revised: 2/28/2022 - Corrected typographic errors; deleted references to pre-2019 Rule; other stylistic changes {Approved Russell McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Revised: 1/7/2024 – Addition of 3.1.4 (iv) to comply with revised Common Rule {Approved Russell McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}


Revision #13
Created 24 October 2019 21:27:34 by Autumn M Eberly
Updated 23 January 2024 19:35:30 by Robert A Lewis