Changes to Exempt Research Policy
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:
- Research is not subject to FDA regulations;
- Research is not federally funded;
- 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;
- Research does not involve prisoners as participants;
- 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:
Updated guidance can be viewed online here:
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 Umbrella Protocol Application can be viewed online here:
A current list of exemption categories can be viewed online here:
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 <https://education.research.utah.edu/class_details.jsp?offeringId=211>
- Best Practice Roundtable: Establishing an Umbrella IRB Application for Secondary Data Analyses <https://education.research.utah.edu/special_events.jsp?event_only=110#anchor110>
The VA administrative review has been incorporated into ERICA's new study review process.
The IRB has updated a number of consent and parental permission document templates.
Due to changes in HIPAA regulation released in March 2013, participation in the tissue bank must be optional for treatment/intervention trials.
The IRB has reviewed studies where the sponsor section of the application is blank, even when the study has a sponsor.
This policy change proposes one additional non-federal exemption category, and outlines the new Exemption Umbrella Protocol procedures.
Effective Monday, April 29, 2013, the ERICA system will be updated.
The IRB is pleased to announce two new Coordinators have been selected!
There will be several IRB staff changes in the coming weeks.