Institutional Review Board
Review and Approval Process

Exempt Protocols

  • For researchers, understanding whether a protocol falls under expedited or exempt status can often be confusing. “Exemption” does not mean a project is exempt from evaluation: all human subjects studies, without exception, must be submitted to the IRB for a final status determination. The information below will help investigators reflect on the distinction between expedited and exempt studies. The section “How does the IRB decide whether a project is expedited or exempt?” offers insight into the thought process the IRB might use when reviewing a study. The Exempt vs. Expedited chart below gives a general comparison of expedited and exempt studies.

    After reviewing the checklist and FAQ sheet, if you believe your study qualifies as exempt, please complete and submit the Application for Exemption from IRB Review.  You do not need to complete CITI human subjects training to submit an application for exemption. However, if it is determined that your protocol needs a higher level of review, you will be required to complete a new protocol submission and include certification of CITI training. Exemption applications usually take no more than 2-3 business days to process and issue an exemption letter (unless it is determined that the study should be elevated to a higher level of review).

    How Does the IRB Decide if a Protocol is Expedited or Exempt?   

    First, the IRB Administrator will look at the abstract and methodology and determine if the protocol submission meets the Federal definition of both “human subjects research" (see explanation on IRB Home page). If the study does not meet both definitions, the IRB will notify the researcher that the protocol is determined Not Human Subjects Research (NHSR), although the researcher may still be responsible for HIPPA, local regulations, and best ethical practices.

    If the project meets both definitions, and involves data or specimens with no individual identifiers (see SU IRB Policies and Procedures: Appendix B) or no identifying link to participants available to the investigator, then these projects are also NHSR according to DHHS “Coded Specimen Guidance.” A letter to that effect is provided.

    To qualify as exempt, research activities must (1) present no more than minimal privacy, psychological, and/or physical risk to human subjects, and (2) involve only procedures listed in one or more of the following categories:

    Category 1

    • Evaluating the use of accepted or revised standardized tests
    • Testing or comparing a curriculum or lesson
    • A program evaluation of pharmacy continuing education

    Category 2

    • Surveying teachers, nurses, or doctors about a technique or an outcome
    • Interviewing managers about a management style or best practice
    • Conducting a focus group about an experience or an opinion of a community program
    • If you are completing evaluation project for graduation/academic requirement, then IRB review is needed

    Category 3

    • Interviewing public officials about a local or global issue

    Category 4

    • Analyzing de-identified tissue samples or data set
    • Analyzing de-identified national test scores
    • Analyzing census data about aging or housing

    Category 5

    • Research conducted in established or commonly accepted educational settings outside of Seattle University, involving normal educational practices
    •  research on regular and special educational instructional strategies
    •  research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.  

    Category 6

    • Taste testing whole grain food products
    • Comparing taste or smell of molasses, cheese or milk
    • Sampling texture of ice cream

    If a project is still not eliminated, the next step is to see whether it fits one of the six exemption categories. Once a potential exemption category is determined, the following questions will be asked: 

    1. Are vulnerable subjects involved (for example: children or prisoners)
    2. Will the investigator collect or keep identifiers?
    3. Is the information to be gathered of a private or sensitive nature?
    4. Does the collection of this data pose any risk to participants?

    If the answer to any of these questions is YES, or if the project does not appear to fit any exempt category, it will be processed as expedited or full board.

    Points to consider: (This chart provides general guidelines only: exceptions may occur) Expedited Exempt
    Is it Human Subjects Research?
    Meets Federal definition of "Human Subjects" X X
    Meets Federal definition of  "Research" X X
    Research Categories
    Project meets one or more of the expedited research categories X  
    Project meets one or more of the exempt research categories    X
    Number of Interactions with Participants & Type of Data
    Data only: no interaction with human subjects – Anonymous or de-identified data; NO identifiers maintained (may qualify as "Not Human Subjects Research" or Coded Specimen Research)   X
    One-time interaction (e.g., single anonymous survey) – NO retention of personal / contact information   X
    Interaction more than once (i.e. design requires repeated interactions) – Retains personal / contact information for additional interaction or follow-up X  
    Data linked to personal information X  
    Level of Risk
    Minimal – risks not greater than those encountered in daily life, or routine physical / psychological exams / tests X  
    None or less than minimal – risks that is less than minimal (e.g., questionnaire about favorite foods, number of vacations in past year, etc.)   X
    Annual IRB Review Status
    Continuing Review is Required X  
    Continuing Review is NOT required   X
    Are the data (questions) collected (asked) sensitive in nature, or involve identifiable private information?
    Sensitive – data could put subject at risk (e.g., job loss, marriage, reputation, etc.) X  
    Not sensitive – includes innocuous data/questions (e.g., food preferences, cell phone usage)   X
    Identifiable Private Information – collected data includes identifiers (name/address, etc.), information about behavior occurring in a private context, information gathered for specific purposes where the individual expects the information to be kept private (e.g., medical records). NOTE: some identifiable information can qualify as exempt if the information is innocuous. X X
    Intent or Use of Information Gathered
    Generalizable – intend to share information to benefit society or field of knowledge X X
    Not intended to contribute to generalizable knowledge – if involving human subjects, submit protocol for IRB determination NA NA
    Who are the subjects?
    Children – Exempt categories 1 and 3 - 6 (45CFR46) can apply to research with children or adults. *Exempt category 2 is allowable in studies with children, only when there is passive observation and no interaction with the children. X *X
    Pregnant Women (45CFR46 Subpart B) – Exempt research is allowable with pregnant women. Expedited research with pregnant women requires extra considerations (45CFR46.204). X X
    Prisoners – research with prisoners cannot be exempt (45CFR46 Subpart A). X  
    Informed Consent Process
    Informed Consent – includes all required elements of informed consent, signature required X  
    Waiver of Consent, if applicable – request to waive entire consent process in some cases (i.e., no consent / no signature required) *will typically require full-board review *X  
    Waiver of Written Consent, if applicable – request to waive signature requirement in some cases (i.e. consent without signature) X  
    Alteration of Consent (alternative / shortened consent ) – "alternative" consent (i.e. contains some elements of informed consent, no signature obtained) NOTE: Information sheets usually apply to exempt research, but may be used in expedited research with an appropriate and approved waiver of consent. X X