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. Benign behavioral interventions
  4. Analysis of previously-collected, identifiable info/specimens
  5. Federal research/demonstration projects
  6. Taste and food evaluation studies

Exempt Categories in Detail


Category 1 – Education research

Research conducted in established or commonly accepted educational settings, involving normal educational practices that are not likely to adversely impact students’ opportunity to learn or assessment of educators

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 and:

  • Recorded information cannot readily identify the subject (directly or indirectly/linked) OR
  • Any disclosure of responses outside of the research would NOT reasonably place subject at risk (criminal, civil liability, financial, employability, educational advancement, 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 – Benign Behavioral Interventions

Research involving Benign Behavioral Interventions through verbal, written responses, (including data entry or  audiovisual recording) from adult subjects who prospectively agrees and ONE of following met:

  • Recorded information cannot readily identify the subject (directly or indirectly/linked) OR
  • Any disclosure of responses outside of the research would NOT reasonably place subject at risk (criminal, civil liability, financial, employability, educational advancement, reputation)

Example:

  • Solving puzzles under various noise conditions
  • Playing an economic game
  • Being exposed to stimuli such as color, light or sound (at safe levels)
  • Performing cognitive tasks

Category 4 – Secondary Research Uses of Identifiable Private Information or Identifiable Biospecimens

Secondary research with identifiable Information/specimens collected for some other initial activity, if ONE of following:

  • Biospecimens or information is publically available
  • Information recorded so subject cannot readily be identified (directly or indirectly/linked); investigator does not contact subjects and will not re-identify the subjects
  • Collection and analysis involving Investigators Use of identifiable health information when use is regulated by HIPAA “health care operations” or “research” or “public health activities and purposes”
  • Research information collected by or on behalf of federal government using government generated or collected information obtained for non-research activities

Example:

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

Category 5 – Federal research or demonstration projects

Research and demonstration projects supported by a Federal Agency/Dept. AND designed to study, public benefit or service programs.

  • Federal agencies must publish a list of projects covered by this exemption prior to research commencing

Category 6 – Taste and food quality evaluation studies

Taste and food quality evaluation 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 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. or;
  • involves administration or use of drugs or devices