New Application:

Research activities in which the involvement of human participants constitutes no more than minimal risk and falls within one or more of the exempt categories described in 45 CFR 46.101 (see below) may be eligible for exemption certification (see decision charts in Appendix A).  Research activities may be deemed exempt from this policy (but not from IRB review) if one of the following is true.

• Research is to be 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.
• Research involves 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.
• Research involves the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt  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.
• Research involves 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.
• Research and demonstration projects to be  conducted by or subject to the approval of Offical 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 (iv) possible changes in methods or levels of payment for benefits or services under those programs.
• 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.

Only the IRB may certify that the proposed research meets the exemption criteria. 

The IRB Chairperson, after initial review from the college-level IRB member, may take one of the following actions:

• Certify the research project as exempt and requiring no further IRB review, unless modifications are proposed which are outside the exemption categories.  The PI is sent an exemption certification letter.
• Require additional information or modification(s).  The IRB Chairperson or designee will contact the PI to request the required additional information or modification(s).  If the IRB Chairperson is satisfied that the protocol meets the exemption criteria, the research project is certified as exempt and an exemption certification letter is sent to the PI.
• Deny exemption certification.  If the protocol does not fall within one or more of the exemption categories, as deemed by the IRB Chairperson the application is considered for expedited or full review.

Modification Request:
If a study is certified as exempt, the PI must request approval from the IRB Chairperson for any proposed modifications to the research project’s protocol or informed consent or assent forms.  The modifications must be approved by the IRB Chairperson prior to implementation.