Exempt Research

All human subjects research at UIUC, whether exempt or not, must be conducted in accordance with UIUC policies and Assurances, applicable federal guidelines, and the ethical principles set forth in the Belmont Report.

Research may be exempt from the review of a convened IRB if the only involvement of human subjects will be in one or more of the six categories described in this section, unless prisoners or certain activities with children are involved.

How the Exemption Decision is Made

The determination of exemption may not be made by the investigator. All human subjects research, whether or not eligible for an exemption, may be submitted on an IRB-1 form or on the Application for Exemption form and must be reviewed and approved by an appropriate IRB review committee or the IRB Office. No involvement of human subjects may take place prior to formal, written approval from the appropriate body. .

The final determination of exemption is made by the reviewing body after a complete review of the research protocol, associated measures and addenda, the consent process and relevant forms, and after careful consideration of the risks, benefits, confidentiality, voluntariness, and other features of the research.

Research involving more than minimal risk is not exempt and certain minimal risk projects might not be exempted if, in the opinion of the reviewing body, the research contains procedures that should be periodically re-reviewed.

Time Required for Approving Exempt Research

Most projects that qualify for an exemption can be reviewed and approved in the IRB Office in about a week's time, unless the application is lacking essential components or unless questions arise that cannot be answered promptly by the Responsible Project Investigator (RPI). If it's determined that a project is not exempt, the project will receive expedited review or review by the Full Board. The RPI should be aware of these guidelines and plan accordingly.

Approval Period for Exempt Research

Approval of research under an exemption is given for an indefinite time period—re-review is not required unless or until the investigator proposes modifications to the project. All research modifications, including those made to projects approved under an exemption, must be submitted on a Research Amendment form, reviewed, and approved prior to implementation.

Certain modifications to exempt projects may cause the research become nonexempt. The project will then require approval of a convened IRB or via expedited review. Such modifications are reviewed at the next available expedited review or convened IRB meeting (see Board Calendar), as appropriate and as allowed by the relevant meeting agenda. The RPI should be aware of these guidelines and plan accordingly.

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Exemption Categories

The following exemption categories are from Title 45, Part 46 of the Code of Federal Regulations for the Protection of Human Subjects (45 CFR 46 ).

  1. Title 45, Code of Federal Regulations §46.101(b)(1) exempts research conducted in established or commonly accepted educational settings, involving normal educational practices, such as
    1. research on regular and special education instructional strategies, or
    2. research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

  2. Title 45, Code of Federal Regulations §46.101(b)(2) exempts research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless
    1. information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
    2. 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.

Exemption 2 does not apply to the following types of research involving children: surveys, interviews, and observations of public behavior when the investigator is a participant in the activities being observed.

  1. Title 45, Code of Federal Regulations §46.101(b)(3) exempts 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
    1. human subjects are elected or appointed public officials or candidates for public office; or
    2. federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
  1. Title 45, Code of Federal Regulations §46.101(b)(4) exempts 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.
  1. Title 45, Code of Federal Regulations §46.101(b)(5) exempts research and demonstration projects that are conducted by or subject to the approval of department or agency heads, and that are designed to study, evaluate, or otherwise examine
    1. public benefit or service programs;
    2. procedures for obtaining benefits or services under those programs;
    3. possible changes in or alternatives to those programs or procedures; or
    4. possible changes in methods or levels of payment for benefits or services under those programs.

Exemption 5 cannot be made if prior review is specifically required by statute, or if the Secretary of HHS determines that a research or demonstration project presents a danger to the physical, mental, or emotional well-being of a participant or subject of the research or demonstration project.

The standard requirements for informed consent may be waived under Exemption 5 if the research could not practicably be carried out without the waiver, and certain other HHS requirements are met and documented (see 45 CFR §46.116(c)).

  1. Title 45, Code of Federal Regulations §46.101(b)(6) exempts taste and food quality evaluation and consumer acceptance studies,
    1. if wholesome foods without additives are consumed; or
    2. 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 (FDA) or approved by the Environmental Protection Agency (EPA) or the Food Safety and Inspection Service of the US Department of Agriculture (USDA).

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