Human Subjects: 
Does My Research Qualify as Exempt Research?

On January 21, 2019, the current federally-defined exemption categories for human subjects research and the URI exemption review process will change, with:

  • Use of Abbreviated Exempt Research Applications
  • Modification to most existing categories
  • Expansion in scope to several existing categories
  • Addition of new categories 

These changes reflect the recent trends in research oversight to reduce administrative burden on investigators and IRBs for minimal-risk research. 

Prior to submitting a research protocol for exempt review, please review the Exempt Category Guidance Documents below. If you have questions regarding the applicability of an exemption category to your proposed research, contact the URI IRB Administrator, Mary Riedford for assistance prior to completing the IRB application. 

“Exempt” human subjects research is a sub-set of research involving human subjects that does not require comprehensive IRB review and approval because the only research activity involving the human subjects falls into one or more specific exemption categories as defined by the 45 CFR Part 46 (Common Rule)

All human subjects research at URI, whether exempt or not, must be conducted in accordance with URI policies and assurances, applicable federal guidelines and the ethical principles set forth in the Belmont Report. Exempt research still requires review and a determination that it is exempt by the IRB.

  • Exempt projects are not subject to continuing review
  • Amendments are required only if changes to the project could alter the exempt determination
  • An exempt determination does not lessen the investigator’s ethical obligations, including the completion of human subjects protections training (i.e., CITI training)

The following lists the high-level changes for each exemption category.  Review the revised Final Rule on Exempt Research (45 CFR 46.104)

Exempt Category 1 – Educational Exemption

Exempt Category 1 covers research conducted in educational settings that involves normal educational practices, so long as the research is not likely to adversely affect (a) students’ opportunity to learn required content or (b) the assessment of teachers. 

What’s New:  A new ineligibility criterion has been added to this interaction/intervention exemption for research that involves possible “adverse effects” on student learning of the required education content and/or on the assessment of educators. For more information on the Educational Exemption, see the Exempt Category 1 Guidance.

Examples of research studies that are exempt under category #1:

  • Development and testing of a science curriculum that meets state standards but is presented in an innovative manner. Data are collected via tests, student attitude surveys, and classroom observations.
  • Research on the use of electronic “clickers” in the classroom to elicit immediate feedback from students on their understanding of course concepts.

Exempt Category 2 – Surveys, Interviews, Educational Tests, and Observations of Public Behaviors

Exempt Category 2 applies to studies that collect data using one or more of the following research methods:

  • Surveys
  • Interviews (including cognitive interviews)
  • Focus groups
  • Educational tests (e.g., cognitive, diagnostic, aptitude, achievement)
  • Observation of public behavior (i.e., behavior that occurs in a public place where there is no expectation of privacy and where no special permission is required to observe others such as a public street, or park.

What’s New: The scope will be expanded to include the collection of sensitive and identifiable data.  However, the following is not allowed:

  • Interventions
  • The collection of biospecimens
  • Linking to additional personally-identifiable data
  • Research with children (except for educational tests or some public observation)

For more information on the Educational Exemption, see the Exempt 2 Guidance.

Exempt Category 3 – Benign Behavioral Intervention (New)

A “benign intervention” is defined as one that is brief in duration, harmless, not physically invasive, painless, not embarrassing or offensive, and not likely to have a lasting adverse impact.

Examples of benign behavioral interventions:

  • Performing cognitive tasks
  • Providing educational materials to participants with the intention of changing their behavior
  • (e.g. smoking cessation, eating habits)
  • Playing an online game
  • Playing economic games
  • Being exposed to stimuli such as color, light or sound at safe levels
  • Solving puzzles under various noise conditions

What’s New:  This new exemption permits data collection via an interaction (e.g., survey, interview, audio/visual recording) from adult subjects with prospective agreement.  However, the following is not allowed:

  • Research with children
  • Deception, unless prior agreement obtained
  • Physiological data collection methods (e.g., EEG; wearable devices, such as FitBit™; blood pressure monitors)
  • Linking to additional personally-identifiable data

The current federal exemption #3 will be eliminated. For more information on the Educational Exemption, see the Exempt 3 Guidance.

Exempt Category 4 – Secondary Research (Identifiable Private Information/Biospecimens) 

What’s New: The scope of this exemption will be expanded to allow:

  • Prospective data review
  • Maintenance of identifiers, if all study data is protected health information (PHI)
  • Research that is conducted by, or on behalf of, a Federal department/agency or using government-generated or government-collected information obtained for non-research activities

Exempt Category 5 – Public Benefit/Server Program Research (Federal Demonstration Projects)

What’s New:  A new eligibility criterion for this interaction/intervention exemption will be that the project must be published on a federal website.

Note:  URI will continue to apply Exempt 5 to public benefit and service programs sponsored by the State of Rhode Island.

Exempt Category #6 Taste and food quality evaluation and consumer acceptance studies. 

  • If wholesome foods without additives are consumed
  • 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 approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Note: This category may be applied to research involving children; however, University policy requires written parental consent to include children in taste testing or odor studies.

Exempt Category 7 – Storage/Maintenance of Identifiable Data/Biospecimens Obtained with “Broad Consent” (New)

What’s New:  This new exemption allows for the storage of data and/or specimens in a repository, with identifiers maintained, that were collected under an approved IRB protocol with “Broad Consent” for future secondary use research. 

URI will not implement Exemption #7 at this time

Note:  Previous Exempt 7 will be retired due to the Common Rule change regarding continuing review.

Exempt Category 8 – Use of Identifiable Data/Biospecimens Obtained with “Broad Consent” (New)

What’s New:  This new exemption allows for secondary research use/analysis of identifiable data/biospecimens that were collected under an approved IRB protocol with “Broad Consent”.

URI will not implement Exemption #8 at this time.