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EXEMPT DETERMINATIONS


Exempt research is a specific sub-set of “research involving human subjects” that does not require ongoing IRB oversight. Research can qualify for an exemption if it is no more than minimal risk and all of the research procedures fit within one or more of the exemption categories defined by federal regulations. Studies that qualify for exemption must be submitted to the IRB for review before initiation of the research. Pursuant to LSUHSC-NO policy, investigators do not make their own determination as to whether a research study qualifies for an exemption - the IRB issues exemption determinations.


Exemption Categories & Restrictions

Although the HHS regulations list eight exemption categories, LSUHSC-NO has opted to only implement categories 1-6 at this time. The eight exemption categories are listed here.

Exempt research or specific categories are restricted in the following manner:

  • Studies that are greater than minimal risk do not qualify for exemption.
  • Exemptions do not apply to research with prisoners, except for research aimed at involving a broader subject population that only incidentally includes prisoners. [45 CFR 46.104(b)(2)].
  • Exemption 2(iii) and Exemption 3 do not apply to research with children.
  • Exemptions other than Exemption Category 6 do not apply to FDA-regulated research.


Respect for Persons

The Belmont principle of Respect for Persons generally requires that subjects be given the opportunity to choose whether or not to participate in research. For this reason, voluntary informed consent should be obtained from participants for any exempt research where the investigator will be collecting data through interaction with participants. Under these circumstances, LSUHSC institutional standards require investigators to provide a brief description of the research that includes the basic elements of informed consent.  This typically is accomplished via an information sheet/cover letter or an oral script. Instructions for preparing, and an information sheet template is provided under “Resources” below.


Modifications to Exempt Research

Changes in research procedures, participant characteristics, the content or scope of information to be collected, privacy or confidentiality measures, etc., must be submitted for approval by the IRB. Significant changes that increase the risk or new activities that do not meet the boundaries of the exemption categories that the IRB found were applicable may result in loss of Exempt status. Accordingly, IRB review of modifications focuses on verifying that the project continues to be eligible for Exempt status. 


How to Submit for an Exempt Determination

Submit a new protocol in Kuali Research and select Exempt Research under “Protocol Type.” Additional instructions for submitting a study for exempt determination are available in the Kuali Quick Guide - Exempt Research.


Resources

  • Kuali Quick Guide - Exempt Research
     
  • Exempt Research Categories 
     
  • Information Sheet Instructions & Template