Additional Exemption Categories for Non-Federally Supported Research

In September 2013, the IRB released Exemption Category 7 as a non-federal exemption category.  As of February 3, 2014, the IRB is introducing Exemption Categories 8-11 as additional non-federal categories. These five categories were created based upon commonly accepted, minimal risk research practices
  
All five non-federal exemption categories are available on the IRB website at: IGS Exempt Research

In order to qualify as “non-federally supported or otherwise federally regulated,” a study must meet the following criteria:

1. Research is not subject to FDA regulations;
2. Research is not federally funded;
3. Research is not contractually or otherwise subject to federal research requirements, including but not limited to research conducted under the Department of Veterans Affairs or under an NIH Certificate of Confidentiality;
4. Research does not involve prisoners as participants;
5. Research meets the University’s ethical standards governing the conduct of the research, including appropriate provisions for the protection of privacy and confidentiality when identifiable and coded information are used.

As a reminder:

• Exempt research requires a full IRB application in ERICA.  The IRB must make the exemption determination.  
• Exempt research does not require continuing review in ERICA.  
• Exempt research requires the submission of substantive amendments in ERICA.
• Exempt research requires the submission of possible unanticipated problems and possible serious/continuing non-compliance in ERICA.  
• Exempt research must be closed when complete.  

Additional Information: Memo for Background and Justification of Exemption Policy Change