Exempt Review Categories and Examples

The categories for exempt level of review are listed below. These categories are taken from federal regulations put forth by the Department of Health and Human Services (HHS), see 45 CFR 46.101 for reference. Research which falls into one of these categories can be reviewed and approved by the IRB chair if the study presents minimal or no risk to subjects. If your research does not fall into any of these categories, you may need to complete an application for expedited or full review.

Category 1: Normal Educational Practices and Settings

Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

Category 2: Anonymous Educational Tests, Surveys, Interviews, or Observations

Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observations of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified directly or through identifiers linked to the subjects; and (ii) 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.

Category 3: Identifiable Subjects in Special Circumstances

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 (b)(2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) the federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

Category 4: Collection or Study of Existing Data

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.

Category 5: Public Benefit or Service Programs

Research and demonstration projects that are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; and (iv) possible changes in methods or levels of payment for benefits or services under those programs.

Category 6: Taste and Food Evaluation and Acceptance Studies

Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level for 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.

Exempt Level of Review Example #1

Research Subject and Method
An online, anonymous survey of teachers who work with K-12 students. 
  
Why does this qualify for exempt review?
The population does not target a vulnerable population, the survey likely asks low-risk questions, and the survey method ensures the anonymity of all participants. 

Exempt Level of Review Example #2

Research Subject and Method
An analysis of records from a public housing agency to determine how many clients had positive experiences with the program. The records have been de-identified by agency officials before being given to the researcher.

Why does this qualify for exempt review?
The existing data is from human subjects, but does not include any private, identifying information, making the subjects are anonymous. The research poses minimal risk to the population since they are not being contacted in any way by the researcher.