Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:

1. research on regular and special education instructional strategies, or
2. research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

Note: This category may be applied to research involving children.

Examples of exempt research:

• Evaluating the use of accepted or revised standardized tests
• Testing or comparing a curriculum or lesson

Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:

1. information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
2. any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.

Note: Surveys on sensitive or personal topics which may cause stress to study participants are not exempt from IRB review.

This category may apply to research with children only when the investigator observes public behavior but does not participate in that behavior or activity. This section is not applicable to survey or interview research involving children.

Examples of exempt research:

• Surveying college students on homework practices
• Interviewing shoppers at a farmers market about local food preferences

Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (2) of this section, if:

1. the human subjects are elected or appointed public officials or candidates for public office; or
2. Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

Examples of exempt research:

• Interviewing public officials about a local or global issue

Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

OHRP: Guidance on Research Involving Coded Private Information or Biological Specimens (pdf)

Examples: Existing Data, Records Review, Pathological Specimens

All records or specimens included in research under exempt 4 must exist at the time of IRB submission. If you are collecting data prospectively, this study does not qualify for exemption.

If the dataset or specimens being researched have been de-identified, or if the data is coded and the researcher does not have access to a link to identifiers, the research does not meet the federal definition of human subjects research and does not need to be reviewed or approved by the University of Minnesota IRB.

Inclusion of fetal tissue in the pathological specimens category of exempt research is prohibited by regulation and requires IRB review.

Examples of exempt research:

• Analyzing existing tissue samples labeled with identifying data, or containing a link to identifying data, when the researcher does not record identifying data or link to identifying data.
• Reviewing existing medical or educational records when the researcher does not record identifying data or a link to identifying data.

Taste and food quality evaluation and consumer acceptance studies,

1. if wholesome foods without additives are consumed or
2. if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

    45 CFR 46.101 (b); 21 CFR 56.104 (c)-(d)

Note: This category may be applied to research involving children; however, University policy requires written parental consent to include children in taste testing studies.

Examples of exempt research:

• Taste testing whole grain food products
• Comparing taste or smell of molasses, cheese or milk
• Sampling texture of ice cream