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Exempt Review

1. Criteria for Exemption





1. Criteria for Exemption

Research with human subjects may qualify for exemption if, and only if, a) the project does not involve any of the populations or procedures listed under “Restrictions,” AND b) all research procedures fall within the “Exemption Categories” listed below.

  • a. Restrictions:

    Research cannot be exempt if any of the following are involved.

    1. prisoners, fetuses, pregnant women or human in vitro fertilization;
    2. survey or interview techniques with minors;
    3. research involving the observation of public behavior of minors if the researcher participates in the activities being observed;
    4. the review of health care records or other archival data records if information is recorded in such a way that individuals can be identified, either directly or through identifier linked to the individual;
    5. deception of participants; OR
    6. procedures which expose participants to greater than minimal risk.

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What is Exempt Review?

According to Federal Regulations, certain types of research activities may be determined to be Exempt from IRB Review. However, the Regulations specify that Investigators cannot determine that their own research is Exempt; this determination must be made by someone else.  At LUC the IRB Board Chair, and/or designee, is responsible for making all Exemption determinations.  In order for research at LUC to be determined to be Exempt from IRB review, an Investigator must submit an Application for Exemption to the IRB Board Chair for review.  Research at LUC is not Exempt from IRB Review unless the IRB Board Chair approves the Application for Exemption.  If the IRB Board Chair determines that a project meets the criteria for Exemption, the project will be approved as Exempt research. 

  

What types of research are Exempt?

Research with human subjects may qualify for exemption if, and only if, a) the project does not involve any of the populations or procedures listed under “Restrictions,” AND b) all research procedures fall within the “Exemption Categories” listed below.

  • a. Restrictions:

Research cannot be exempt if any of the following are involved:

  1. prisoners, fetuses, pregnant women or human in vitro fertilization;
  2. survey or interview techniques with minors;
  3. research involving the observation of public behavior of minors if the researcher participates in the activities being observed;
  4. the review of health care records or other archival data records if information is recorded in such a way that individuals can be identified or if the Investigator has access to a key that can be used to link the records to individuals
  5. deception of participants; OR
  6. procedures which expose participants to greater than minimal risk.
  • b. Exemption Categories:

All research procedures must fall into one or more of the following categories in order to qualify for Exempt review.

Exempt Review Categories
1.  Research conducted in established or commonly accepted educational settings, involving normal education 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.

NOTE: Research in this category may include minors. However, if the research introduces instructional strategies that are not commonly used and well accepted or adds assessment procedures that are not routinely used, it does not fit in this category.

2.  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’ response 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.

NOTE: Surveys or interviews with children are never exempt. In addition, observations of the public behavior of children are not exempt if the observer participates in the activities being observed.

3.  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 (#2) of this section, is exempt 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 be maintained throughout the research and thereafter.

4.  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 in such a manner that subjects cannot be identified, either directly or through identifiers linked to the subjects.

NOTE: Please note that to qualify for this category all data, documents, records, or specimens to be used in the research must be in existence at the time of IRB review and must have been collected for purposes other than the proposed research.

5.  Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads which are designed to study, evaluate, or otherwise examine:

  • (i) Public benefit or service programs;
  • (ii) procedures for obtaining benefits or services under these 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.
6.  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.


Download: Application for Exemption

Submitting an Application for Exemption

An investigator may apply for exemption by completing the Application for Exemption and submitting one copy of the completed application form plus supporting materials to the Research Services Compliance Manager.

Applications for exemption may be submitted at any time and are typically reviewed within eight business days of submission.

 

Federal Regulations indicate that, unless otherwise required by a Department or Agency, certain types of research activities may be exempt from IRB review. The determination that a research project is “exempt” is made by the Compliance Manager and/or designated reviewers; this decision cannot be made by the investigator.

If, after an initial review of the criteria and categories listed below, an investigator believes a project meets criteria for exemption, he or she should complete the Application for Exemption. Investigators are cautioned to complete all screening materials and make a decision about applying for exemption carefully. If an application for exemption is made and a project does not qualify for exemption, the application will be denied. The project will need to be submitted to the IRB as a full or expedited review application. If an investigator is uncertain about whether a project is eligible for exemption, the investigator is welcome to consult with the Compliance Manager or the Board Chair.

If a project is determined to be exempt, the project is not subject to continuing IRB review.    The investigator (and faculty sponsor, if applicable), remain responsible for conducting the research with the utmost regard for University policies, ethical standards, and the welfare of human participants.

The investigator is responsible for ensuring that the research is conducted exactly as outlined in the Exemption Application. The investigator must seek IRB approval prior to implementing any changes that might alter the exempt status of the research.

Download: Application for Exemption



1. Criteria for Exemption





1. Criteria for Exemption

  • b. Exemption Categories:

    All research procedures must fall into one or more of the following categories.

    1. Research conducted in established or commonly accepted educational settings, involving normal education 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.

      NOTES: Research in this category may include minors. However, if the research introduces instructional strategies that are not commonly used and well accepted or adds assessment procedures that are not routinely used, it does not fit in this category.

    2. 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’ response 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.

      NOTES: Surveys or interviews with children are never exempt. In addition, observations of the public behavior of children are not exempt if the observer participates in the activities being observed. Furthermore, any procedures which involve audiotaping or videotaping participants are not exempt.

    3. 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 (#2) of this section, is exempt 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 be maintained throughout the research and thereafter.
    4. 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 in such a manner that subjects cannot be identified, either directly or through identifiers linked to the subjects.

      NOTES: Please note that to qualify for this category all data, documents, records, or specimens to be used in the research must be in existence at the time of IRB review and must have been collected for purposes other than the proposed research.

    5. Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under these 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.
    6. 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.

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2. Submitting an Application for Exemption

2. Submitting an Application for Exemption

All Applications must be submitted to the IRB by email from an LUC email account by a Faculty Member. If you are a student, your Faculty Sponsor must submit your application on your behalf. Applications should be emailed to irb@luc.edu. Applications for exemption may be submitted at any time and are typically reviewed within two weeks of submission.

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