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Exempt Review

The federal regulations for protecting research subjects list six categories of research activity that are exempt from the provisions of the regulations, such as the requirement for annual review.

Eligible Research: Federal Regulations	Research in educational settings. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. Surveys, interview procedures, observations of public behavior, educational tests. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, observation of public behavior, unless the information is obtained and recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects; and any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation. Research when the subjects are elected or appointed officials or candidates for public office. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, or observation of public behavior that is not exempt under item (2) above; if the human subjects are elected or appointed public officials or candidates for public office; or federal statute(s) require without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. Research involving the collection or study of existing data, documents, and records. 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 subjects cannot be identified directly, or through identifiers linked to the subjects. Research and demonstration projects which are conducted by or subject to the approval of Federal Department or Agency heads. 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 methods and procedures of public benefit or service programs. Taste and food quality evaluation and consumer acceptance studies. Taste and food quality evaluation and consumer acceptance studies, if wholesome foods without additives are consumed, or a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or an agricultural chemical or environmental contaminant at or below the level found to be safe, by the FDA^* or approved by the EPA^* or the USDA^*.
Duke Restrictions	Exemptions cannot be secured for research using the following populations: Pregnant women when they are the targeted subject population Students participating in the Psychology Subject Pool Students if the investigator is their instructor Employees if the investigator is their supervisor Most research with children Prisoners Exemptions cannot be secured for research that uses: Deception Experimental manipulations
Submission Deadlines	Any time
Review Process	The Program Director, Lorna Hicks, has the authority to approve exemption. A staff member may pre-review the request and provide feedback.
Approximate Review Time	Five to seven business days depending upon the work load of the IRB^*, the completeness of the application, and whether the researcher's certification is up-to-date.

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