IRB Exemption Categories

Research activities in which the only involvement of human subjects will be in one or more of the following categories may be given a determination of exemption. A Principal Investigator must still submit an Exempt IRB Protocol Application in order to receive this determination.

Exempt Research Involving Minors

Research involving minor children may be exempt only as it applies to categories 1, 4, 5, 6, 7 and 8. Research involving minors which falls under category 2 may be exempt for educational tests and observation (when the investigator does not participate in the activities being observed). Research involving survey or interview procedures may not be exempted for minors. Research activities in which the only involvement of human subjects will be in one or more of the following categories will qualify for an exempt review. Research involving prisoners may not be exempted.

Category 1

Research conducted in established or commonly accepted educational settings that specifically involves normal educational practices and does not impact students’ opportunity to learn the required educational content, or impact the assessment of educators providing the instruction, 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.

Category 2

Research on adults involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior (including visual or auditory recording) uninfluenced by the investigator if:

information obtained is recorded in such a manner that human subjects cannot be identified, directly or through identifiers linked to the subjects; OR
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, educational advancement or reputation; OR
a Limited IRB Review is done for data that can be linked with identifiers.

Research can be conducted with minors, only if it is limited to educational tests (cognitive, diagnostic, aptitude, achievement) or observation of public behavior where the researcher does NOT participate in the activity observed.

Category 3

Research involving the use of benign behavioral (non-medical) interventions in conjunction with the collection of information from an adult subject. Information obtained must be collected in such a way that:

the identity of the human subjects cannot readily be ascertained directly or through identifiers; or
any public disclosure of the responses would not reasonably place the subject at risk of criminal or civil liability, be damaging to the subjects’ financial standing, educational advancement, or reputation; OR
a Limited IRB Review is conducted for data that can be linked with identifiers.

Category 4

Secondary research for which consent is not required. This can include identifiable private information or identifiable bio-specimens, if at least one of the following conditions are met:

the identifiable private information or identifiable bio-specimens are publicly available;
information (including about bio-specimens) is recorded in such a way that the identity of the subjects cannot be readily ascertained directly or through identifiers, and the investigator will not contact subjects or attempt to re-identify subjects;
the research involves only information collection and analysis involving the investigator’s use of identifiable health information for the purpose of “health care operations”; or
research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for non-research purposes if maintained per compliance with section 2(b) of the E-Government Act of 2002.

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 at least one of the following:

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 pro

In order fall under category 5, the project must be published on a publicly accessible Federal website prior to commencing the research and conducted pursuant to a specific federal department or agency.

Category 6

Taste and food quality evaluation and consumer acceptance studies:

if wholesome foods without additives are consumed; or
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. Department of Agriculture.

Category 7

Storage or maintenance of identifiable private information or identifiable bio-specimens for use in secondary research when broad consent has been obtained, appropriately documented, or waived in accordance with the regulations regarding informed consent. If a change is made for research purposes in the way the identifiable private information or identifiable bio-specimens are stored or maintained, adequate provision must be made to protect the privacy of subjects and maintain the confidentiality of the data.

A Limited IRB Review of research conducted under this category is required.

Category 8

Research involving the use of identifiable private information or identifiable bio-specimens for secondary research use can be conducted if broad consent for storage, maintenance, and secondary research use was obtained in accordance with the regulations regarding informed consent, documentation of informed consent is in place, or a waiver of documentation of informed consent was obtained. The investigator cannot include returning individual research results to subjects as part of the study plan, except in cases required by law.