Full, Expedited, and Exempt Review

Full, Expedited, and Exempt Review

There are three levels of IRB review for human subjects research: full, expedited, and exempt. If you have verified that you are, in fact, doing human subjects research, the next step is to determine if your research must undergo review and approval through the IRB process and what level of review is required. 

Full Board Review

Research may qualify for a full review if it involves more than minimal risk to the study participants and is not eligible for expedited or exempt review. It is possible that a research study that only has minimal risk, but involves a vulnerable population, may require a full review. A full review is usually completed by a convened IRB board where the diverse membership of the IRB reviews the proposed research. A full review can be a lengthy process, check with your local IRB to determine if your project is human subjects research and what kind of review it qualifies for.

Expedited Review

If a research study poses no more than minimal risk to the participants, it may qualify for an expedited review.  Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Follow this link for a description of some of the social and behavioral research activities that are commonly eligible for expedited review.

Exempt Review

There are six categories of research with human subjects that are exempt from ongoing IRB oversight. These categories are detailed in full in Title 45, Part 46, Subpart A, the Common Rule.  Research exempt from review includes research in commonly accepted educational settings that involves accepted educational practices, research using existing documents or records if they are publicly available and subjects cannot be identified, and taste and food quality research.

Follow this link for more on research that qualifies for exempt review: Title 45, Part 46, Subpart A.
If you are conducting research with children there are special cases where you may qualify for exempt review. There are six categories of research with children that may be exempt. Check with your institution for further information about what kinds of research qualifies for an exempt review.

 

Quick Facts about Exempt Review

  • Research conducted in educational settings, involving normal educational practices
  • Research about educational tests
  • Observations of children in public settings, providing the researcher does not participate
  • Studies using existing data about children, (a) if the data are publicly available, or (b) if they are recorded in such a way by the investigator that the identity of the children cannot be determined
  • Studies conducted by federal departments or agencies about government programs
  • Taste and food quality evaluations

 

Research Involving Vulnerable Populations

Any research study involving vulnerable populations may require additional safeguards.

 

Vulnerable populations can include

  • Pregnant women, fetuses, and neonates
  • Children
  • Prisoners
  • Persons at risk for suicide
  • Persons with impaired decisional capacity

 

Working with minors (youth under the age of 18), for example, requires obtaining consent from parents or legal guardians or from the youth themselves if they are old enough to consent voluntarily. Follow this link to read about additional regulations for vulnerable populations as outlined by the Department of Health and Human Services.

Research in Schools

Often research in schools qualifies for “exempt review” as outlined in Title 45, Part 46, Subpart A, the Common Rule. Exempt research is not federally required to have IRB oversight. Examples of exempt research include research done in an educational setting on instructional strategies, educational tests, or on publicly available data. When working with children in public schools, there are additional policies that guide research. These policies include:

•    FERPA:  Family Education Rights and Privacy Act. This act gives parents and students (who are
                    18 years old or older), specific rights as to who sees their education records. FERPA
                    also outlines what records can be released and to whom without obtaining prior consent.

•   PPRA:     The Protection of Pupils Rights Amendment. This amendment provides rights to parents to
                    approve certain research (surveys, development of instructional materials) being
                    conducted by third parties. Parental approval is required for research pertaining to eight
                    identified sensitive topics. Follow this link to learn more about the topics that are considered sensitive.

Research with Tribal Communities

Because Native American Tribal Communities are sovereign entities, research conducted with tribes must be done in accordance with local protocols and procedures.  Approval to conduct research with tribal communities must be obtained from the tribe (or be near approval) prior to submitting your proposal to an institutional or commercial IRB. The University of Arizona Native Peoples Technical Assistance Office has more information if you are conducting research with Arizona tribes. Check with your institution for further information regarding working with Native American populations.

 

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