Exempt Categories

Category 1: Research conducted involving normal educational practices, such as: (i) research on regular and special education instructional strategies; or (ii) research on the effectiveness of, or comparison among, instructional techniques, curricula, or classroom management methods. [46.101 (b)(1)]

Category 2: Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless:  (i) information obtained is recorded in such a manner that the human participants can be identified, directly or through identifiers linked to the participants; AND (ii) any disclosure of the human participants' responses outside the research could reasonably place them at risk of criminal or civil liability or be damaging  to their financial standing, employability, or reputation. [46.101 (b)(2)]

Category 3: 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 46101(b)(2), if: the human subjects are elected or appointed public officials or candidates for public office; or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. [46.101 (b)(3)]

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. [46.101 (b)(4)]

Category 5: Research and demonstration projects which are conducted by or subject to the approval of US Government Agencies, and which are designed to study, evaluate, or otherwise examine (i) public benefit or service programs;  (ii) procedures for obtaining benefits or services under those programs;  (iii) possible changes in or alternatives to these programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs. [46.101 (b)(5)]

Category 6: Taste and food quality evaluation and consumer acceptance studies that meet safety requirements set forth by government agencies or local laws. [46.101 (b)(6)

Prepared by the University of the District of Columbia Institutional Review Board (UDC IRB) with reference to the Institutional Review Board Guidebook (http://www.hhs.gov/ohrp/irb/irb_guidebook.htm).  The UDC IRB acknowledges the assistance of the College of Charleston, which shared its web materials, on which UDC’s materials are based.  The UDC IRB is also indebted to many other fine university web sites which it has visited in the course of preparing these materials, and in particular commends the design and content of the University of Maryland Baltimore Campus website.