Determination Of Exemption from IRB Review
Protocol ID
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Protocol Title
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Reviewer Name
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First Name
Last Name
Email
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Does the research involve pregnant women, fetuses, human in vitro fertilization or prisoners? If Yes, then research may not be exempt.
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Yes
No
Research activities involving human subjects are exempt from the requirements of federal law only when the only involvement of human subjects will be in one or more of the categories below:
Category 1 – Educational Settings
1) Is the research only conducted in established or commonly accepted educational settings?
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Yes
No
2) Does the research study involve only normal educational practices? If Yes to both 1 and 2, then the research is eligible for exemption.
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Yes
No
Category 2 – Tests, Surveys, Interviews, Public Behavior
1) Does the research only involve the use of educational tests, survey procedures, interview procedures or observations of public behavior? If Yes to both 1-a or 1-b, then the research is not eligible for exemption.
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Yes
No
1-a) Is the information obtained recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects?
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Yes
No
1-b) Could any disclosure of the human subjects’ responses outside the research reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation?
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Yes
No
2) Does the research involve children and will the investigator participate in the activities being observed? If Yes, then the research is not eligible for exemption.
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Yes
No
Category 3 – Public Officials or Federal Statute
1) Does the research only involve human subjects that are elected or appointed public officials or candidates for public office?
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Yes
No
2) Does any Federal statute require without exception that the confidentiality of personally identifiable information will be maintained throughout the research and thereafter?
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Yes
No
3) Does the research only involve the use of educational tests, survey procedures, interview procedures or observations of public behavior? If Yes, then research is eligible for exemption
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Yes
No
Category 4 – Existing Data, Documents, Specimens
1) Does the research only involve the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens? (Must exist before exemption is requested.)
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Yes
No
1-a) Are these sources publicly available?
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Yes
No
1-b) Will information be recorded by the investigator in such a manner that the subjects cannot be identified, directly or through identifiers linked to the subjects? If Yes to either 1a or 1b, then research is eligible for exemption.
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Yes
No
Category 5 – Public Benefit or Service Program
1) Is the research or demonstration project conducted or approved by Department or agency head?
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Yes
No
2) Does the research or demonstration project involve only the study, evaluation, or examination of: Check each answer that applies - If Yes to either then research is eligible for exemption.
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Public benefit or service programs
Procedures for obtaining benefits or services under public benefit or service programs
Possible changes in or alternatives to public benefit or service programs or to procedures for obtaining benefits or services under public benefit or service programs
Possible changes in methods or levels of payment for benefits or services under those public benefit or service programs?
Category 6 – Food Taste and Acceptance Studies
1) Does the research involve only a taste and food quality evaluation or a food consumer acceptance study?
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Yes
No
1-a) Are only wholesome foods without additives consumed?
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Yes
No
1-b) Does the food consumed contain a food ingredient, agricultural chemical, or environmentalcontaminant at or below the level found to be safe by the FDA or approved by the EPA or the Food Safety and Inspection Service of the US Department of Agriculture?
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Yes
No
SUBMIT
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