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Institutional Review Board Glossary of Terms

IRB reviews research involving human subjects.  To that extent, IRB uses the definitions provided in 45 CFR 46.102, as amended in January 2017.

“Research” means:

  1. A systematic investigation, including:
    1. Research development
    2. Testing and evaluation
  2. Designed to
    1. Develop or
    2. Contribute to
  3. Generalizable knowledge.
  1. Exceptions:
    1. Scholarly and journalistic activities including
      1. The collection and use of information
      2. That focus directly
      3. On the specific individual
      4. About whom the information is about.
      5. E.g., Oral history, journalism, biography, literary criticism, legal research, and historical scholarship.
    2. Public health surveillance activities including
      1. The collection and testing
      2. Of information or biospecimen
      3. By a public health authority
      4. When necessary to
        1. Identify
        2. Monitor,
        3. Assess, or
        4. Investigate
      5. Potential
        1. Public health signals
        2. Onset of disease outbreaks
        3. Conditions of public health importance
        4. E.g., trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products.
      6. Activities include
        1. Providing timely situational awareness
        2. Priority setting
          1. During
          2. An event or crisis
          3. That threatens
          4. Public health
    3. Collection and analysis of information, biospecimens, or records by and for a criminal justice agency for activities
      1. Authorized by law or
      2. Court order
      3. Solely for
        1. Criminal justice or
        2. Criminal investigation purposes.
    4. Operational activities in support of
      1. Intelligence
      2. Homeland security
      3. Defense or
      4. Other national security missions.

 

“Human Subject” means:

  1. A living individual
  2. About whom an investigator conducting research either:
    1. Obtains information or biospecimen through
      1. Intervention or
      2. Interaction
      3. With the individual; and
      4. And the information or biospecimen is
        1. Used,
        2. Studied, or
        3. Analyzed.
    2. Identifiable private information or identifiable biospecimen is
      1. Obtained
      2. Used
      3. Studied
      4. Analyzed, or
      5. Generated

 

“Private Information” includes

  1. Information
    1. About behavior
    2. That occurs in a context
    3. In which an individual
    4. Reasonably Expects
      1. No observation; or
      2. Recording
      3. Is taking place
  2. And information provided
    1. For specific purposes
    2. By an individual
    3. And the individual
    4. Can reasonably expect
    5. Will not be made public

 

“Public health authority” means

  1. An agency or authority of
    1. The United States, a state, a territory, a political subdivision thereof, an Indian tribe, or a foreign government, or
    2. A person or entity acting under a grant of authority from such a public agency
  2. That is responsible for public health matters
  3. As part of its official mandate.

 

“Identifiable private information” means

  1. Private information for which
  2. The identity of the subject
  3. Is or
  4. May be readily
  5. Ascertained
  6. By the investigator, or
  7. Associated with
  8. The information

 

 

“Intervention” includes:

  1. Physical procedures
    1. By which information or biospecimen
    2. Is gathered
    3. From the subject individual.
  2. Manipulation
    1. Of the subject individual or
    2. The subject individual’s environment
    3. For research purposes.

 

“Interaction” includes:

  1. Communication or
  2. Interpersonal contact
  3. Between
    1. Investigator and
    2. Subject individual

 

“Minimal Risk” means:

  1. The probability and magnitude
    1. Of harm
    2. Or discomfort
  2. Anticipated
  3. In the research
  4. Are not greater (in and of themselves) than
  5. Ordinarily encountered
    1. In daily life
    2. Or during the performance of
      1. Routine
        1. Physical or
        2. Psychological
      2. Examinations or
      3. Tests.