September 4th, 2013

The Department of Health and Human Services has identified categories of research involving human subjects that qualify for exemption from certain federal regulations applicable to research. At the University of Utah, the IRB makes federal exemption determinations according to 45 CFR 46.101.

This policy change proposes one additional non-federal exemption category, which may be applied to non-federally supported or otherwise federally regulated studies.  This new category was created based upon commonly accepted, minimal risk research practices.  This category reads as follows:

Research involving the collection or study of existing data, documents, records, pathological specimens or diagnostic specimens, where this information is personally identifiable or coded.

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.

Updated policy can be viewed online here:
IRB SOP 401B Research Activities Exempt from IRB Review

New Policy for Exemption Umbrella Protocol Applications

The IRB now accepts Exemption Umbrella Protocol Applications.  These applications allow for multiple, similar research projects to be conducted under one IRB application.  This group of projects must be similar in purpose and fit within the same individual exemption category or combination of categories.

Instructions for creating and maintaining an Exemption Ubrella Protocol Application.

A current list of exemption categories can be viewed online here: https://stage.irb.umc.utah.edu/wp-content/uploads/sites/65/formidable/13/igs-exempt_research_version_030624.pdf

For umbrella protocols under the new exemption category 7, you are highly encouraged to attend the following RATS classes:

• Registries, Databases and Secondary Data Analyses in Human Subject Research
• Best Practice Roundtable: Establishing an Umbrella IRB Application for Secondary Data Analyses – Special Events