Projects that may be Considered Exempt from the Federal Regulations

IRB administrative review request

ALL research projects involving the use of human subjects must have documentation filed with the North Carolina State University Institutional Review Board for the Use of Human Subjects in Research. However, some research may be considered "exempt" from the federal regulations that govern the use of human subjects in research. These projects must still meet basic ethical standards, and must be reviewed by the IRB office via adminsitrative review and found to meet the federal criteria for exemption. If you believe that your research is exempt from the regulations stated in 45CFR46, then please read the guidance below and submit an IRB administrative review request to the IRB office.

This request includes information that the IRB needs in order to verify that a research project is exempt. SUBMISSION OF THIS DOCUMENTATION DOES NOT CONSTITUTE AN IRB APPROVAL. If your research qualifies for exemption, then the IRB office will send you a letter declaring your project exempt from the regulations and a copy of your exemption request will be kept on file in the IRB office.

Studies that are considered exempt do not need to undergo annual continuing review. However, the IRB office must approve any changes to the research prior to implementation, and any problems or complaints encountered during the course of the research must be reported to the IRB office.

Below find an excerpt from the Code of Federal Regulations Title 45 - Part 46 - Protection of Human Subjects, that outlines the criteria for exemption. (A link to the full text of this code can be found at bottom of the IRB Home Page). In order to declare a research project exempt, the IRB office must find that these criteria are met. Notes from NC States IRB office are included to help clarify the requirements. Please use this code as a reference, but be aware that the Office for Human Research Protections advises that the final decision about the exemption status of your protocol must be made by the IRB office.

45CFR 46.101(b) - To what does this policy apply?

"...Research activities in which the only involvement of human subjects will be in one or more of the following categories, are exempt from this policy [NOTE according NCSU IRB policy, any study that poses more than minimal risk to a participating subject may not be considered exempt from the regulations]:

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, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
2. 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. [NOTE this category does not apply to research involving minors, unless the study only involves observation, and the researchers do not have any direct contact with the children].
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 (b)(2) of this section, if: (i) the human 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 personally identifiable information will be maintained throughout the research and thereafter.
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.
5. Research and demonstration projects, which are conducted by or subject to the approval of [federal] 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.
6. 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."