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Chapter IX - Determination That an Activity is Exempt From the Common Rule

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Research involving human participants are exempt from the Federal Policy for the Protection of Human participants (Common Rule, 32 CFR 219.101) when the ONLY involvement of human participants falls within one or more of the following 6 categories:

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

  • Research on regular and special education instructional strategies; OR
  • Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

EXEMPTION CATEGORY 2
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:

  • Information obtained is recorded in such a manner that human participants can be identified, directly or through identifiers linked to the participants; AND
  • Any disclosure of the human participants’ responses outside the research could reasonably place the participants at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, or reputation.

EXEMPTION CATEGORY 3
Research not exempt under “2” above may be exempt if:

  • The human participants are elected or appointed public officials or candidates for public office; OR
  • Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

EXEMPTION 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 participants cannot be identified, directly or through identifiers linked to the participants. (Note: To qualify for this exemption, the data, documents, records, or specimens must exist before the project begins.)

EXEMPTION 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:

  • Public benefit or service programs;
  • Procedures for obtaining benefits or services under those programs;
  • Possible changes in or alternatives to those programs or procedures; OR
  • Possible changes in methods or levels of payment for benefits or services under those programs.

EXEMPTION CATEGORY 6
Taste and food quality evaluation and consumer acceptance studies

  • If wholesome food 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 US Department of Agriculture.

It is important to remember that projects that meet exemption categories are research involving human participants and as such, these studies need to meet ethical standards in accordance with research involving human participants as outlined in the Belmont Report.

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