Definitions

Determination of Research Category

There are three categories of human research review conducted by the IRB at Concordia University Wisconsin. The three categories are Exempt, Expedited and Full Board Review.


A. Guidelines for Exempt Research

Definition of Exempt Review: Exempt researchprojects presentrisks so benign to the humansubjects who participate in them,that thefederal regulations say such projects are exempt fromreview.

At CUW, exempt research:

  1. can be reviewed at any time
  2. does not require full review at regularly scheduled IRB meeting
  3. does not need to be reviewed annually under 45 CFR 46.109 (e).

Categories of Research Activities that are Exempt from Review:

Note: Research Involving Minors (individuals under the age of 18): The following 8 categories of research activity may also apply to minors with the following exceptions:

  1. Survey research
  2. Interview research
  3. Observations of public behavior when the investigator participates in the activities of being observed.

In other words, research involving minors cannot be classified as exempt if the research involves surveys, interviews, or observations of public behavior when the investigator participates in the activities being observed.

  1. Exemption For Education:
    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 is exempted.
  2. Exemption For Research Involving Educational Tests:
    Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement) is exempted, 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 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.
  3. Exemption For Survey or Interview Procedures:
    Research involving survey or interview procedures is exempted unless (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifier's linked to the subjects; and (ii) any disclosure of the 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.
  4. Exemption For Research Involving Observation of Public Behavior:
    Research involving observation is exempted 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 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.
  5. Exemption For Research Involving Elected or Appointed Public Officials or Candidates for Public Office:
    Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempted under exemption #2, #3, and #4 above is exempted 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.
  6. Exemption For Collection or Study of Existing Data:
    Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens is exempted, 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.
  7. Exemption for Research and Demonstration Projects Conducted by or Subjectto Approval of Federal Departments or Agencies:
    Research and demonstration projects which are conducted by or subject to the approval of department or agency heads are exempted if they 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.
  8. Exemption for Taste and Food Quality Evaluation and Consumer Acceptance Studies:
    Taste and food quality evaluation and consumer acceptance studies are exempted if, (i) wholesome foods without additives are consumed; or (ii) 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.


B. Expedited Review

At CUW Expedited Review:


C. Guidelines for Full Board Review

  1. Minimal Risk Research
    If your project is not "exempt" and the risk of harm anticipated in the research is not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests, your project is minimal risk.
  2. 2. Risk/Deception Research
    If your project involves more than "minimal risk" to subjects (e.g., risk of harm anticipated in the research is greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests) or utilizes deception, your project is categorized as risk or deception.

All of the information reguired for full board review is submitted by using the protocol submission document availabel through IRBNet.