Exempt from Annual IRB Review

Jump to …
Category 1
Category 2
Category 3
Category 4
Category 5
Category 6

Under U.S. Department of Health and Human Services (HHS) regulations, some research is exempt from the requirements in the regulations (45 CFR 46.101). Review of proposed research is done by an Institutional Review Board (IRB) Chair or a designated voting member rather than by the entire IRB Committee. This type of review is carried out for studies which involve no risk or minimal risk to subjects and fit into an expedited review category of research. Exempt submissions are reviewed on a rolling basis.

Minimal Risk means 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(i) and 21 CFR 56.102).

Research acknowledged under one of the exempt categories is not required to be reviewed by the IRB on an annual bases.

Categories

Category 1

Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:

  (i) Research on regular and special education instructional strategies

  (ii) Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods

This category should be limited to the study of normal educational practices. It should not include radically new instructional strategy or instructional methods, or research involving deception.

Category 2

Research involving the use of educational tests (i.e., cognitive, diagnostic, aptitude, and 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 either directly or through identifiers linked to the subjects

  (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

This category should not be used when tests, surveys, or interviews could potentially cause the subject discomfort or distress. For example, if the testing is psychologically invasive in nature.

Research involving survey or interview procedures in children are not exempt. Research involving observations of public behavior in children are not exempt unless the investigator(s) do not participate in the activities being observed.

Return to Top

Category 3

Research involving the use of educational tests (i.e., cognitive, diagnostic, aptitude, or achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if:

  (i) The human subjects are elected or appointed public officials or candidates for public office

  (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter

This category is an extension of Category 2, but without the same level of privacy protections for public officials. However, the IRB will consider the risks associated with the information to be collected in making a determination about exempt status.

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 either directly or through identifiers linked to the subjects. Existing data means that the data or specimens exist at the time the research study is submitted to the IRB. Research that involves the ongoing (i.e., prospective) collection of specimens and/or data is not exempt under this category.

Publicly available means information that is available to the general public, such as census data.

Non-public data or specimens must be de-identified according to the Health Insurance Portability and Accountability Act (HIPAA) standards, and may not be linked to identifiers by a code available to the investigator(s). If the investigator(s) intend to retain a link to re-access any identifiers, the research project is not exempt under this category.

Return to Top

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:

  (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

  (iv) Possible changes in methods or levels of payment for benefits or services under those programs

This category allows research on public benefit or service programs such as welfare, Medicaid, unemployment benefits, and Social Security. However, research in these categories may involve vulnerable populations who require additional protections.

Category 6

Taste and food quality evaluation and consumer acceptance studies if:

  (i) Wholesome foods without additives are consumed; or

  (ii) 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 U.S. Food and Drug Administration (FDA) or approved by the U.S. Environmental Protection Agency (EPA) or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Research in this category should be limited to taste and food quality studies that do not involve a type or volume of food that could pose any risk to subjects. Studies that involve consumption of alcohol, vitamins, or supplements do not qualify for exempt status.

Return to Top