Exemptions

January 2019

The federal Common Rule identifies eight categories of research that may be eligible for exemption from IRB review (45 CFR 46.104(d)(1-8)). At the moment, UW-Madison IRBs permit the application of exemption categories 1-6 and apply these categories only to studies determined to be no more than minimal risk. Exemptions do not apply to FDA-regulated research or research involving prisoners (45 CFR 46, Subpart C). All of the exemptions listed above are applicable to pregnant women, human fetuses and neonates involved in research (45 CFR 46, Subpart B). If an investigator thinks their project does not constitute human subjects research, they should skip to the Not Human Subjects Research section of this page. 

Per UW-Madison's Exempt Research Policy, research that qualifies as exempt under one of the federal categories must nonetheless satisfy the UW-Madison's ethical standards for the protection of human research participants. Investigators engaged in exempt studies must complete human subjects protection training, comply with the the campus Conflict of Interest policy, and provide adequate training and oversight of study personnel, as outlined on the Brief Summary of Investigator Responsibilities Related to the Protection of Human Subjects for Exempt Research page. 

If an investigator believes his or her research falls into one of these exemption categories, he or she must still submit an application to an IRB. Only an IRB can determine whether the research is exempt from review. The IRB has the right not to exempt a study and to require full review by the convened IRB or expedited review by an IRB member or IRB subcommittee, particularly if the research involves a sensitive population or sensitive topic. For a exemption category decision tool, please see our Guidance on Exemption Categories under the Revised Common Rule .

If a study is determined to be exempt from review, it is not subject to continuing review or other rules governing human research, such as rules on obtaining written consent. Although not required by federal regulations, UW institutional policy requires a consent process for exemptions when there is some kind of interaction with subjects. Additionally, changes of protocol and reportable events should be submitted for exempt studies when necessary. 

However, the HIPAA Privacy Rule (45 CFR Parts 160 and 164) applies to all exempt research that uses protected health information (PHI). Privacy Rule requirements do not apply to exempt research using information that has been de-identified. For more information on human subjects research and the HIPAA Privacy Rule, see UW-Madison's HIPAA Compliance website.


Guidance on Exemption Categories

Category 1

  • Definition:

    Research conducted in established or commonly accepted educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

Category 2
  • Definition:

    Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior (including visual or auditory recording).
  • Notes:

    The following is not allowed under this exemption category:
    • Interventions
    • The collection of biospecimens
    • Linking to additional personally-identifiable data
    • Research with children, except for research involving educational tests (cognitive, diagnostic, aptitude, achievement) or observation of public behavior if the investigator does not participate in the activities being observed
  • Related Guidance:

Category 3

  • Definition:

    Research involving benign behavioral interventions (i.e., brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on or be offensive or embarrassing to the subjects) with adult subjects who prospectively agree to the intervention and collection of information through verbal or written responses (including data entry) or audiovisual recording.
  • Notes:

    The following is not allowed under this exemption category:
    • Research with children
    • Deception, unless prior is agreement obtained
    • Physiological data collection methods (e.g., EEG; wearable devices; blood pressure monitors)
    • Linking to additional personally-identifiable data
Category 4
  • Definition:

    Secondary research uses of identifiable private information or identifiable biospecimens.
  • Notes:

    Research involving certain datasets may not need IRB review. For more information, see UW-Madison De-Identified Publicly Available Datasets Policy for determining when publicly-available social science datasets may be used without prior IRB approval.

Category 5
  • Definition:

    Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of the department or agency heads, that are designed to study, evaluate, or otherwise examine:
    1. procedures for obtaining benefits or services under those programs;
    2. possible changes in or alternatives to those programs or procedures; or
    3. possible changes in methods or levels of payment for benefits or services under those programs.
  • Notes:

    The OHRP has issued additional guidance on applying this exemption.

Category 6
  • Definition:

    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 approve by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture (45 CFR 46.101 (b)(6) and 21 CFR 56.104 (d).

Category 7 - Not implemented at this time
  • Definition:

    Storage or maintenance for secondary research for which broad consent is required. Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and can find that there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
  • Notes:

    The UW-Madison will not implement this category at this time because the definition and implications of Broad Consent are unclear and the tracking requirements may be burdensome and impracticable.

Category 8 - Not implemented at this time
  • Definition:

    Secondary research for which broad consent is required. Research involving the use of identifiable private information or identifiable biospecimens for secondary research use.
  • Notes:

    The UW-Madison will not implement this category at this time because the definition and implications of Broad Consent are unclear and the tracking requirements may be burdensome and impracticable.

FAQs

Frequently Asked Questions

Not Human Subjects Research

Research not involving human subjects

Some projects may be research studies that do not involve human subjects as defined by the Common Rule, such as research involving decedents, de-identified data or specimens, or organizational level data.

  • Related Guidance:

  • Projects that do not constitute research

    Some projects fall outside the definition of research, such as such as quality improvement, quality assessment and program evaluation. If you believe that your project does not constitute research, but are required by UW-Madison policy or a publisher to obtain an IRB determination, this application type (i.e. exempt from ongoing IRB oversight as not research) is appropriate.

  • Related Guidance:

  • Glossary Terms

    Exemption ARROW Terms

     

     

     




    Keywords:exemptions   Doc ID:88896
    Owner:Monica E.Group:Health Sciences IRBs
    Created:2019-01-08 14:32 CDTUpdated:2019-02-07 12:02 CDT
    Sites:Health Sciences IRBs
    Feedback:  1   1