IRB FAQ:  EXPEDITED vs. EXEMPT STUDIES

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. This FAQ, however, 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 side by side chart gives a general comparison of expedited and exempt studies.

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” and “research” (see SU IRB Policies and Procedures: Section I). 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.

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
 
 

POINTS TO CONSIDER

EXPEDITED

EXEMPT

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

 


Full Board Submissions Closed for Academic Year

 


The IRB will hold one summer full board meeting on Aug. 8. Protocols
requiring full board review must be submitted by July 25.

 

Submissions for EXEMPT & EXPEDITED REVIEWS may occur any time. The above deadline does not apply.

EXEMPT & EXPEDITED REVIEWS take approximately two weeks to complete but turnaround may be slightly longer over the summer months due to limited reviwer availability.

FULL BOARD SUBMISSIONS 
involving prisoner research or research
with minors may require additional review time.

* All deadlines are subject to change. Check here for the latest information.

Questions?

Email: irb@seattleu.edu