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 research projects present risks so benign to the human subjects who participate in them, that the federal regulations say such projects are exempt from review.
At CUW, exempt research:
- can be reviewed at any time
- does not require full review at regularly scheduled IRB meeting
- does not need to be reviewed annualy under 45 CFR 46.109 (e).
Categories of Research Activities that are Exempt from Review:
Note: Individuals under the age of 18 constitute a protected class. Consequently, all projects involving minors will require full board review and are not exempt under Concordia University IRB policy.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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Exemption for Research and Demonstration Projects Conducted by or Subject to 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.
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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.
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Checklist For Exempt Status.
This checklist is for your own use to help you in determining whether your research qualifies for exempt review.
1. It is clear that the nature of the proposed research fits one of the exempt
categories listed above.
2. No implications for criminal or civil liability, employability, or damage to subject’s
financial standing or reputation would exist if data were known outside of the study.
3. The research does not employ a protected group as subjects (for example fetuses,
pregnant women, prisoners, cognitively disabled, or minors).
4. The study does not present more than a MINIMAL RISK to the subjects.
5. The study does not involve DECEPTION.
6. Appropriate informed consent procedures will be followed.
Yes answers to all of the above are required to qualify for a exemption from IRB review.
| EVEN THOUGH AN INDIVIDUAL RESEARCHER MAY DETERMINE THAT AN INVESTIGATION FALLS WITHIN THE CATEGORY OF EXEMPT RESEARCH, IT IS STILL NECESSARY TO FOLLOW THE PROCEDURES SPECIFIED IN THE PROTOCOL SUBMISSION DOCUMENT |
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B. Guidelines for Expedited Review
Definition for Expedited Review: To refer to research as expedited, is to ONLY describe the method of review it receives. At CUW, a subcommittee of central board members is assigned by the Administrator to review the protocol. The subcommittee may exercise all of the authorities of the IRB, except that it may not disapprove the research. The subcommittee may either approve the protocol or submit it to the Full Board for review and discussion.
At CUW Expedited Review:
- can be reviewed at any time
- does not require full review at regularly scheduled IRB meetings
The following projects may be submitted to CUW IRB for expedited
review:
- Continued review of a project already approved by the CUW IRB
- Initial review of a project approved by another institution's IRB
Please note: Investigators submitting projects for
CUW IRB approval that have been approved at another
institution do not need to complete the Protocol Submission
Document. Investigators must submit one copy of the letter of
approval from the chair of the IRB from the outside institution
along with a copy of the protocol.
- Institutional data collected for non-research purposes. For example, quality assurance projects.
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C. Guidelines for Full Board Review
- 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. 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 REQUIRED FOR FULL BOARD REVIEW IS SUBMITTED BY USING THE PROTOCOL SUMISSION DOCUMENT
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