• The research is conducted in established or commonly accepted educational settings. 

• The research involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction, such as:
  • Research on regular and special education instructional strategies. 
  • Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. 
• The research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners. 
• The research is not regulated by the US FDA. 

• The research only involves interactions involving one or more of the following:
  • Educational tests (cognitive, diagnostic, aptitude, achievement). 
  • Survey procedures. 
  • Interview procedures. 
  • Observation of public behavior (including visual or auditory recording). 

• One of the following conditions are met:
  • The information obtained is recorded in such a manner that participants cannot be identified, directly or indirectly through identifiers linked to the participants.
    • When the research involves children, this exemption only applies to educational tests or the observation of public behavior when the investigator(s) do not participate in the activities being observed. 
  • Any disclosure of the participants’ responses outside the research would not reasonably place the participants at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, or reputation.
    • When the research involves children, this exemption only applies to educational tests or the observation of public behavior when the investigator(s) do not participate in the activities being observed. 
  • The information obtained is recorded by the investigator in such a manner that the identity of the human participants can readily be ascertained, directly or through identifiers linked to the participants, and an IRB or EC conducts a limited IRB or EC review of the research, and determines whether there are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data. (See Element II.2.C.).
    • This condition cannot be applied when research involves children. 
  • The research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners. 
  • The research is not regulated by the US FDA. 

Research involving benign behavioral interventions in conjunction with the collection of information from an adult participant through verbal or written responses (including data entry) or audiovisual recording if the participant prospectively agrees to the intervention and information collection. 

• Benign behavioral interventions are:
  • Brief in duration, 
  • Harmless, 
  • Painless, 
  • Not physically invasive, and 
  • Not likely to have a significant adverse lasting impact on the participants. 
• The researcher has no reason to think the participants will find the interventions offensive or embarrassing. 
• At least one of the following criteria is met:
  • The information obtained is recorded by the investigator in such a manner that the identity of the human participants cannot readily be ascertained, directly or through identifiers linked to the participant; or 
  • Any disclosure of the human participants’ responses outside the research would not reasonably place the participants at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, educational advancement, or reputation; or 
  • If the information obtained is recorded by the investigator in such a manner that the identity of the human participants can readily be ascertained, directly or through identifiers linked to the participants, an IRB conducts a limited IRB review and determines, when appropriate, there are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data. 

• If the research involves deception of participants regarding the nature or purposes of the research:
  • The participant authorizes the deception through a prospective agreement to participate in research in circumstances in which the participant is informed that he or she will be unaware of or misled regarding the nature or purposes of the research. 
• The research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners. 
• The research is not regulated by the US FDA. 

Secondary research for which consent is not required, that uses of identifiable private or identifiable biospecimens, if at least one of the following criteria are met: 

• The identifiable private information or identifiable biospecimens are publicly available. 

• Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects. 
• The research involves only information collection and analysis involving the researcher’s use of identifiable health information regulated under HIPAA for the purposes of “health care operations” or “research” or “public health activities and purposes” as defined in HIPAA. 
• The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for non-research activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 or Privacy Act of 1974, 5 U.S.C. 552a., and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 
• The research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners. 
• The research is not regulated by the US FDA. 

• The project is a research or demonstration project. 
• The research is conducted by or subject to the approval of a US federal government Department or Agency head (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects). 
• The research is designed to study, evaluate, improve, or otherwise examine a program that delivers a public benefit (e.g., financial or medical benefits as provided under the Social Security Act) or service (e.g., social, supportive, or nutrition services as provided under the Older Americans Act) and includes one or more of the following:
  • Procedures for obtaining benefits or services under those programs. 
  • Possible changes in or alternatives to those programs or procedures. 
  • Possible changes in methods or levels of payment for benefits or services under those programs. 
• The research is conducted pursuant to specific statutory authority of the US federal government. 
• There is no statutory requirement that an IRB or EC review the research. 
• For US government agencies, the agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site a list of research and a list of the research and demonstration projects prior to commencing the research involving human subjects. 
• The research does not involve significant physical invasions or intrusions upon the privacy of participants. 
• The research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners. 
• The research is not regulated by the US FDA. 

• The research involves taste and food quality evaluation or is a consumer acceptance study. 
• Either of the following is true:
  • Wholesome foods without additives are consumed. 
  • If a food is consumed that contains a food ingredient or an agricultural chemical or environmental contaminant, the food ingredient or agricultural chemical or environmental contaminant is at or below the level and for a use found to be safe by one of the following:
    • The Food and Drug Administration. 
    • The Environmental Protection Agency. 
    • The Food Safety and Inspection Service of the U.S. Department of Agriculture. 
• The research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners. 

Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use, if the research has undergone limited IRB or EC review.  

Note: UTD will not adopt Category 7. 

Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use if the following criteria are met: 

• Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained. 
• Documentation of consent or waiver of documentation of consent was obtained. (See Elements II.3.F. and II.3.G.) 
• The research has undergone limited IRB review by an IRB or EC member, who determines:
  • There are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data 
  • The research to be conducted is within the scope of the broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens 
• When some or all of the participants are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these participants, when appropriate. 
• The research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners. 
• The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual results. 

Note: UTD will not adopt Category 8.