IRB Review of Exempt Research
Determine if your activity is research, involves human subjects, and exempt from full IRB review.
Exemption Doesn't Mean You Don't Apply
Examples of Exempt Research Activities
Examples of Non-Research Activities
Common Issues with Exempt Submissions
Exemption Doesn't Mean You Don't Apply
DHHS Guidelines (45 CFR Part 46.101(b) and (c)) define research as exempt from further IRB review when the research involves no risk to the subject. Research that is considered exempt from Committee review must still be filed with the IRB and screened for exempt status.
Some minimal risk research is exempt from full IRB review. Exemption waives only the need for full IRB review and does not negate the need for the consent of subjects where applicable.
The authority to determine and confirm exempt status rests with the IRB and not with the investigator nor student advisor. Thus, an Exempt Screening Application Form is required for your exemption to be confirmed and granted by the IRB.
Examples of Exempt Research
Survey interview research with adult subjects; the use of nonidentifiable laboratory specimens; review of nonidentified existing records; observation of the public behavior of subjects where there is no manipulation of the subject; and some educational testing and classroom activity.
Category 1
- Evaluating the use of accepted or revised standardized tests
- Testing or comparing a curriculum or lesson
- A program evaluation of pharmacy continuing education
Category 2
- Surveying teachers, nurses, or doctors about a technique or an outcome
- Interviewing managers about a management style or best practice
- Conducting a focus group about an experience or an opinion of a community program
Category 3
- Interviewing public officials about a local or global issue
Category 4
- Analyzing de-identified tissue samples or data set
- Analyzing de-identified national test scores
- Analyzing census data about aging or housing
Category 6
- Taste testing whole grain food products
- Comparing taste or smell of molasses, cheese or milk
- Sampling texture of ice cream
Examples of Non-Research Activities
- Quality assurance activities or evaluation projects designed for self-improvement or program evaluation, not meant to contribute to "generalizable" knowledge. However if you are completing evaluation project for graduation/academic requirement, then IRB review is needed.
- Interviews of individuals where questions focus on things not on people (eg. questions about policies, general facts about an organization or business).
- Searches of existing literature or analysis of aggregate or public data that cannot be linked to a living individual (e.g. data sets available on the web that do not require any sort of privacy/confidentially agreement or special request procedure, newspaper accounts, census data held in public libraries, published school test scores). However, if access to the data is limited to researchers, and not publicly available, then IRB review is needed.
- Single case studies in which all data already exists. However, if this includes medical record review, there may be obligations under HIPAA privacy law.
Common Issues with Exempt Submissions
- Always submit an appendix J as they are required with every exempt application, regardless of category. This appendix can be sent by student if advisor is cc’d or sent directly from advisor.
- Remember to submit your supplemental materials along with your application and appendices (common are A, M, K). The materials often include recruitment scripts/flyers/letters of invitation, consent forms, interview questions, focus group questions, surveys, documentation of approval from other IRBs or overseeing committees.
- Be sure to send your submission by email, including all materials as attachments from your University of Minnesota email account and cc your advisor.
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Reports and Articles
Recomended Reading for Exempt Researchers
Category Specific Advice
There are few common areas that researchers need to address for each type of exempt research. Here are a few common points of emphasis provided from an exempt study reviewer
Download Exempt Forms
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