Exempt Review

All USC human subjects research projects must undergo review and approval by an IRB prior to initiating research activities. The Federal Regulations for  Protection of Human Research Subjects (45 CFR 46) specify three categories of review (exempt, expedited, and full board) that an IRB can use to make a determination regarding human subjects research.

Exempt reviews are conducted by at least one experienced member of the IRB. In order to qualify for review via exempt procedures, the research must not be greater than minimal risk and must fall into at least one of the exempt categories defined by federal regulations.

Minimal risk is defined by the federal regulations as the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.

Summary of Exempt Categories:

  1. Education research
  2. Surveys, interviews, educational tests, public observations (that do not involve children)
  3. Studies of public officials
  4. Analysis of previously-collected, anonymous data
  5. Public benefit or service program
  6. Consumer acceptance, taste, and food quality studies

Exempt Categories in Detail

Category 1

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.

Examples:

  • 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

Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation 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.

Examples:

  • 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

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

Example:

  • Interviewing public officials about a local or global issue.

Category 4

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.

Example:

  • Analyzing existing tissue samples or data set which are recorded by the investigator without identifiers

Category 5

Research and demonstration projects which 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; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.

See OHRP’s guidance regarding this category

Category 6

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 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. (See also FDA’s Exempt Category)

FDA Exempt Categories 21 CFR 56.104

  1. Any investigation which commenced before July 27, 1981 and was subject to requirements for IRB review under FDA regulations before that date, provided that the investigation remains subject to review of an IRB which meets the FDA requirements in effect before July 27, 1981.
  2. Any investigation commenced before July 27, 1981 and was not otherwise subject to requirements for IRB review under Food and Drug Administration regulations before that date.
  3. Emergency use of a test article, provided that such emergency use is reported to the IRB within 5 working days. Any subsequent use of the test article at the institution is subject to IRB review.
  4. Taste and food quality evaluations and consumer acceptance studies, if wholesome foods without additives are consumed or 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

Research that does not qualify for Exempt Review

What type of research does not fall into the exempt category? In general, your research is not exempt (and you must use the Expedited/Full Board application) if:

  • is greater than “minimal risk” (Federal regulations define “minimal risk” as the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.)
  • involves children or adolescents as subjects (less than 18 years of age)
  • involves collecting identifiable information from subjects
  • involves administration or use of drugs or devices
  • involves prisoners as subjects