Exempt

All USC human subjects research projects must undergo review and approval by an IRB prior to initiation of research activities. There are 3 categories of review (exempt, expedited, and full board) defined by the Federal Regulations for  Protection of Human Research Subjects (45 CFR 46).

Exempt reviews are conducted by at least one reviewer. To qualify for review at the exempt level, the research must not be greater than minimal risk* and must fall into one or more of the exempt categories described below.

—————————-

*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.


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 – Education research

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 – Surveys, interviews, educational tests,
public observations

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 – Studies of public officials

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 – Analysis of previously-collected, anonymous 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.

Example:

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

Category 5 – Public benefit or service program

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.


Category 6 – Consumer acceptance, taste, and food quality 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 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 doesn’t fit an Exempt Category

What if a research activity does not fall into on of the exempt categories?
The research is probably not exempt and must be submitted for Expedited / Full Board review.
Research is not exempt if it:

  • is greater than minimal risk *
    * minimal risk means the probability and magnitude of harm or discomfort anticipated in the research are not greater 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 collection of identifiable information from subjects
  • involves administration or use of drugs or devices
  • involves prisoners as subjects