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individual and which the individual can reasonaxpect will federal statute(s) require(s) out exception that the confiden- not be made public (for example, a school health record).] tiality of the personally identifiable information will be main- tained throughout the research and thereafter. B. Exemptions. (4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic Research activities in which the only involvement of human specimens, if these sources are publicly available or if the in- subjects will be in one or more of the following six categories of formation is recorded by the investigator in a manner that sub - exemptions are not covered by the regulations: jects cannot be identified, directly or through identifiers linked . to the subjects. (1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, (5) Research and demonstration projects which are conducted such as (a) research on regular and special education instruc- by or subject to the approval of department or agency heads, and tional strategies, or (b) research on the effectiveness of or the which are designed to study, evaluate, or otherwise examine: comparison among instructional techniques, curricula, or class- (a) public benefit or service programs; (b) procedures for obtain - room management methods. ing benefits or services under those programs; (c) possible changes in or alternatives to those programs or procedures; or (2) Research involving the use of educational tests (cognitive, (d) possible changes in methods or levels of payment for bene- diagnostic, aptitude, achievement), survey procedures, interview fits or services under those programs. procedures or observation of public behavior, unless: (a) infor- mation obtained is recorded in such a manner that human sub- (6) Taste and food quality evaluation and consumer acceptance jects can be identified, directly or through identifiers linked to studies, (a) if wholesome foods without additives are consumed the subjects; and (b) any disclosure of the human subjects' re- or (b) if a food is consumed that contains a food ingredient at or sponses outside the research could reasonably place the subjects below the level and for a use found to be safe, or agricultural at risk of criminal or civil liability or be damaging to the sub- chemical or environmental contaminant at or below the level jects' financial standing, employability, or reputation. If the found to be safe, by the Food and Drug Administration or ap- subjects are children, this exemption applies only to research proved by the Environmental Protection Agency or the Food involving educational tests or observations of public behavior Safety and Inspection Service • of the U.S Department of when the investigator(s) do not participate in the activities be- Agriculture. ing observed. [Children are defined as persons who have not attained the legal age for consent to treatments or procedures Copies of the Department of Education's Regulations for the involved in the research, under the applicable law or jurisdiction Protection of Human Subjects, 34 CFR Part 97 and other per- in which the research will be conducted.] tinent materials on the protection of human subjects in re- search are available from the Grants Policy and Oversight (3) Research involving the use of educational tests (cognitive, Staff (GPOS) Office of the Chief Financial and Chief Infor- diagnostic, aptitude, achievement), survey procedures, interview mation Officer, U.S. Department of Education, Washington, procedures or observation of public behavior that is not exempt D.C., telephone: (202) 708 - 8263, and on the U.S. Department under section (2) above, if the human subjects are elected or of Education's Protection of Human Subjects in Research appointed public officials or candidates for public office; or Web Site at http : / /ocfo.ed.gov/humansub.htm.