Butler IRB Exemption Guidelines

The US Department of Health and Human Services (HHS) Office for Human Research Protections indicates there are six (6) exempt categories of research involving non-incarcerated adult human subjects.  *Note:  Research involving children or incarcerated adults are subject to different requirements, allowances, and restrictions. Please contact BCC’s IRB for additional guidance.

To qualify for an exemption, the research must fall into one or more of the following categories and be of minimal risk to the subjects.

According to the HHS, "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" (45 CFR 46.102 Definitions. Section i).

Unless otherwise required by BCC leadership, research in one or more of the six exempt categories that is of minimal risk to the adult, non-incarcerated research subject(s) does not require IRB approval. 

Summary of Six Exempt Categories:

1. Education research that does not contain subject identifiers (i.e. individual subjects cannot be identified)
2. Surveys, interviews, educational tests, public observations that do not contain identifiers (i.e. individual subjects cannot be identified)
3. Studies of public officials (elected or candidates for office) involving educational tests, surveys, interviews, or observations of public behavior.
4. Analysis of previously-collected, anonymous data that is publically available and does not contain identifiers (i.e. individual subjects cannot be identified)
5. Public benefit or service program.
   *Note: Special guidance applies to this category from the Office for Protection from Research Risks (OPRR)
6. Consumer acceptance, taste, and food quality studies that do not contain subject identifiers (i.e. individual subjects cannot be identified).*Note:Special guidance applies to this category from the Food and Drug Administration (FDA)

More Information on Exempt Categories

Category 1 Education research that does not contain subject identifiers (i.e. individual subjects cannot be identified)

“Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods” [§46.101 (b) (1)].

Examples that qualify under this category:

• Evaluating different types of class activities or projects
• Testing different learning activities
• Program evaluations or surveys of program experiences provided no subject identifiers are collected

 

Category 2 Surveys, interviews, educational tests, public observations that do not contain identifiers (i.e. individual subjects cannot be identified)

“Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) 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” [§46.101 (b) (2)].

Examples that qualify under this category:

• Surveying college faculty and staff about a training outcome
• Interviewing supervisors about “best practices” in training or management techniques
• Holding a focus group to collect opinions about a campus or community program

 

Category 3 Studies of public officials (elected or candidates for office) involving educational tests, surveys, interviews, or observations of public behavior.

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 Category 2, if: (i) the subjects are elected or appointed public officials or candidates for public office; or (ii) Federal statute(s) require(s) without exception that the confidentiality of the identifiers be maintained during and after the investigation is complete [§46.101 (b) (3)].

Examples that qualify under this category:

• Interviewing public officials about a local or global issue.
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• Testing candidates for office about their knowledge of local or national issues.

 

Category 4 Analysis of previously-collected, anonymous data that is publically available and does not contain identifiers (i.e. individual subjects can’t be identified)

“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” [§46.101 (b) (4)]

Examples that qualify under this category:

• Analyzing existing tissue samples or data set which are recorded without direct or indirect identifiers
• Collecting anonymous data through a survey tool
• Observing public behavior without collecting identifying information (e.g. watching behaviors on a busy street)

 

Category 5 Public benefit or service program

“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” [§46.101 (b) (5)]. 

Note:  The OPRR further directs that the following criteria must also be satisfied to qualify for Exemption Category 5 "Public benefit or service programs."

1. The program under study must deliver a public benefit (e.g., financial or medical benefits as provided under the Social Security Act) or service (e.g., social, supportive, or nutrition services as provided under the Older Americans Act).
2. The research or demonstration project must be conducted pursuant to specific federal statutory authority.
3. There must be no statutory requirement that the project be reviewed by an IRB.
4. The project must not involve significant physical invasions or intrusions upon the privacy of subjects or participants.

Examples that qualify under this category:

• Collection of statistics for a low-income income supplemental program (e.g. How many people in Kansas apply for food stamps each year)
• Passively watching a computer kiosk and timing people who fill out applications for Social Security benefits or other public service programs
• Surveying public service program participants regarding ease of use of the program

 

 

Category 6 Consumer acceptance, taste, and food quality studies that do not contain subject identifiers (i.e. individual subjects cannot be identified)

“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 the Food Safety and Inspection Service of the U.S. Department of Agriculture” [§46.101 (b) (6)].

*Note:  The FDA further directs that the following criteria must also be satisfied to qualify for Exemption Category 6 "Consumer acceptance, taste, and food quality studies that does not contain subject identifiers” (21 CFR 56.104).

FDA Exempt Categories

1. Any investigation which commenced before July 27, 1981 and was subject to requirements for IRB review under FDA regulations before that date, provided that the investigation remains subject to review of an IRB which meets the FDA requirements in effect before July 27, 1981.
2. Any investigation commenced before July 27, 1981 and was not otherwise subject to requirements for IRB review under Food and Drug Administration regulations before that date.
3. Emergency use of a test article, provided that such emergency use is reported to the IRB within 5 working days. Any subsequent use of the test article at the institution is subject to IRB review.
4. Taste and food quality evaluations 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.S. Department of Agriculture

 

Research that does NOT qualify for Exempt Review

In general, research is not exempt and requires IRB approval if:

• it is greater than “minimal risk” to the research subjects
• it does not qualify under one of the six exempt categories
• it involves children under age 18 as subjects
• it involves collecting identifiers or information that may reveal the identity of research subjects who are not public officials or candidates for office
• it involves giving subjects medications or requires subjects to use medical devices or equipment
• it involves incarcerated adults as subjects
• it will be carried out in part or in whole at a location outside the United States

 

BCC leadership retains final judgment on whether or not a particular activity requires IRB approval. BCC leadership may also

Full policy requirements and guidelines published by the HHS may be found online.