Does My Research Qualify as Exempt Research?
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.
If you are conducting research with human subjects where the only involvement of human subjects will be in one or more of the following six categories of exemption not covered by 45 CFR 46, your research is exempt. Exempt research still requires review and a determination that it is exempt by the IRB.
Exempt Category #1
Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
- research on regular and special education instructional strategies, or
- research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
Note: This category may be applied to research involving children.
Exempt Category #2
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
- Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
- Any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.
Note: Surveys on sensitive or personal topics which may cause stress to study participants are not exempt from IRB review.
This category may apply to research with children only when the investigator observes public behavior but does not participate in that behavior or activity. This section is not applicable to survey or interview research involving children.
Exempt Category #3
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (2) of this section, if:
- The human subjects are elected or appointed public officials or candidates for public office.
- Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
Exempt Category #4
Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
Examples: Existing Data, Records Review, Pathological Specimens
Inclusion of fetal tissue in the pathological specimens category of exempt research is prohibited by regulation and requires IRB review.
NOTE: This Category is NOT available to individuals. Please contact HRPP if you believe your research falls into this category.
Exempt Category #5
Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine:
- Public benefit or service programs.
- Procedures for obtaining benefits or services under those programs
- Possible changes in or alternatives to those programs or procedures
- Possible changes in methods or levels of payment for benefits or services under those programs.
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.
If you believe your research meets the above criteria for one of the six categories of exemption, complete the IRB application form and Appendix A – Exempt Research and include in your submission on IRBNet.