subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research. Does the research involve deception? Yes No If so, will subjects prospectively to be unaware of or misled regarding the nature of the research? Yes No If yes to b), but no to c), the research will not qualify under this category. Please complete the IRB Protocol Form for expedited review. Does the research involve minors? Yes No If the research will involve minors, the research does not qualify under this category. Use the IRB Protocol Form. Exemption Category 4: Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens. Please use the IRB Application for Exemption: Secondary Research for which consent is not required. Exemption Category 5: Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended. NOTE: Exemption under Category 5 is only permitted upon Federal Agency approval AND after being published on a federal website. Exemption Category 6: Taste and food quality evaluation and consumer acceptance studies: (i) If wholesome foods without additives are consumed, or (ii) If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research. Does the research involve deception? Yes No If so, will subjects prospectively to be unaware of or misled regarding the nature of the research? Yes No If yes to b), but no to c), the research will not qualify under this category. Please complete the IRB Protocol Form for expedited review. Does the research involve minors? Yes No If the research will involve minors, the research does not qualify under this category. Use the IRB Protocol Form. Exemption Category 4: Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens. Please use the IRB Application for Exemption: Secondary Research for which consent is not required. Exemption Category 5: Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended. NOTE: Exemption under Category 5 is only permitted upon Federal Agency approval AND after being published on a federal website. Exemption Category 6: Taste and food quality evaluation and consumer acceptance studies: (i) If wholesome foods without additives are consumed, or (ii) If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
2018_Exempt_Application.docx