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Exempt Categories Help

The Federal Government has developed 6 categories of research that involve almost no risk and that can be exempted from continuing review by the Institutional Review Board (IRB). Exemption is determined by the Chair of the IRB or his designees. The Office of Research Compliance pre-screens applications for exempt status to determine eligibility.

An Exempt Application must be completed and submitted to the Office of Research Compliance and validation of exemption must be received by the Principal Investigator (PI) prior to initiation of the research project. Please submit this application by email to Laura Moll (lmoll@clemson.edu). To qualify the application as a signed electronic submission, the submission must come from the PI’s email address. Alternatively, the application may be delivered in paper form with an original signature to the Office of Research Compliance, 223 Brackett Hall, Clemson, SC 29634-5704.

Research involving deception or prisoners does not qualify for Exempt status. Research involving other vulnerable subject populations may not qualify as Exempt. Please contact the Office of Research Compliance to discuss the specifics of your research study.

Exemption is determined only by the Chair of the IRB or his designees. As per federal guidance, determinations of exemption are not to be made by the investigator. Exemption waives the need for initial and continuing review by the IRB. It does not waive the need for obtaining the consent of research participants or adherence to federal and institutional requirements of voluntary participation. In most cases, an informational letter explaining the research study will be appropriate for use in obtaining the informed consent of participants in Exempt research.

Investigators may contact Laura Moll at 656-6460 or lmoll@clemson.edu for assistance and information.

The Federal Code [45 CFR 46 (46.101)] permits research activities in the following six categories to be exempted from continuing review by the IRB.

Categories of Research Activities Exempt from Continuing Review
Category
B1:

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.
Category
B2:

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 participants can be identified, directly or through identifiers linked to the participants; AND,
  2. 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.

NOTE: Survey and interview techniques which include minors are not exempt. Observation of the public behavior of minors, if the researcher is not a participant, is exempt.
Category
B3:

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 Category 2, IF:

  1. the human participants 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.
Category
B4:

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.

PLEASE NOTE: To qualify for this exemption the data, documents, records, or specimens must be in existence before the project begins. The principle behind this policy is that the rights of individuals should be respected; participants must consent to participation in research.
Category
B5:

Research and demonstration projects which are conducted by or subject to the approval of appropriate Federal Department or Agency heads, and which are designed to study, evaluate, or otherwise examine:

  1. public benefit or service programs; or
  2. procedures for obtaining benefits or services under those programs; or
  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.
Category
B6:

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 Services of the U.S. Department of Agriculture.

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