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Exempt Status

Application process

Researchers should Create a New Study in ERA for research projects that fall under any exempt category as defined by 45 CFR 46.101(b). Studies that fall under an exempt category MUST be submitted for review by the IRB. For more information, please review the Exempt Guidelines Grid.

Exempt categories

Research activities in which the only involvement of human subjects will be in one or more of the following categories:

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

    1. research on regular and special educational instructional strategies, or

    2. 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:

    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.

  3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, if:

    1. The human subjects are elected or appointed public officials or candidates for public office: or

    2. federal statue(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 department or agency heads, and which 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.

  6. 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 or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

applicability

An exemption cannot be granted for research that uses the following subject populations:

  • research involving prisoners;
  • some research involving children (The exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or observation of public behavior, does not apply to research with children, except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed).
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