Exempt Review

• Overview
• Requirements for Exempt Research
• What Does Exempt Review Mean?
• Submitting an Exempt Research Application
• Category 1
• Category 2
• Category 3
• Category 4
• Category 5
• Category 6

Exempt research is human subjects research that meets specific criteria under 45 CFR 46.104. Exempt research is generally no more than minimal risk, and all research activities must qualify under one or more applicable exemption categories. An exemption does not mean the project is not human subjects research.

At BYU, the Institutional Review Board for Human Subjects (IRB) makes the official exemption determination. Investigators must submit their study and receive that determination before beginning research activities; investigators may not independently determine that their study is exempt.

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Research involving greater than minimal risk does not qualify for exemption. Minimal risk is defined at 45 CFR 46.102(j).

The exemption categories do not apply to research involving prisoners, except research aimed at a broader subject population that only incidentally includes prisoners.

Only certain exemption categories apply to research involving children. Categories 1, 4, 5, and 6 may apply when their conditions are met. Under Category 2, only certain educational tests and observation of public behavior may qualify, and Category 2(iii) does not apply. Category 3 applies only to adults. See the restrictions immediately below and the full category conditions.

Of the six exemption categories implemented by BYU, only Category 6 may apply to FDA-regulated research.

All research procedures must fit within one or more exemption categories implemented by BYU. BYU does not implement broad-consent exemption Categories 7 and 8.

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An exempt determination means a study qualifies for an exemption from certain Common Rule IRB requirements. Exempt research generally does not require continuing IRB review. Some exemption pathways require limited IRB review to evaluate privacy and confidentiality protections.
For exempt studies involving interaction with human subjects, BYU expects investigators to provide consent information that explains the research, identifies the investigator and affiliation, describes procedures and future data use, states participation is voluntary, and provides contact information for questions or concerns.

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Submit the appropriate human subjects research application in OneAegis before initiating research. There is no separate exempt research application. The IRB reviews the submission and issues the official determination.
Research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from certain IRB requirements:

Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction.

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Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:

• (i) the information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects.
• (ii) any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation.
• (iii) the information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).

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Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and the following criteria is met:

• (A) the information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects.
• (B) any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation.
• (C) the information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects.
  
  • An IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).

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Secondary research for which consent is not required. Secondary research uses of identifiable private information or identifiable biospecimens, if the following criteria is met:

• (i) the identifiable private information or identifiable biospecimens are publicly available.
• (ii) The information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects.
  
  • The investigator does not contact the subjects.
  • The investigator will not re-identify subjects.
• (iii) The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under HIPAA (45 CFR parts 160 and 164, subparts A and E), for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b).
• (iv) When the research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for non-research activities.
  
  • If the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501.
  • Note: if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.

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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: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.

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Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) 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 Food Safety and Inspection Service of the Department of Agriculture.

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Brigham Young University's IRB does not utilize broad consent, and the exemption categories associated with broad consent (categories 7-8) are not applicable at BYU. The exemption categories are posted on Brigham Young University’s IRB website.