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Decision Tree for Protection of Human Subjects from Research Risk

Decision Tree for Protection of Human Subjects from Research Risk. Are Human Subjects involved (even if exempted under 45 CFR 46) ?. YES. NO. Is exemption from regulations claimed?. (Regulations do not apply) . Does the study fit an allowed Exemption ?

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Decision Tree for Protection of Human Subjects from Research Risk

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  1. Decision Tree for Protection of Human Subjects from Research Risk Are Human Subjectsinvolved (even if exempted under 45 CFR 46) ? YES NO Is exemption from regulations claimed? (Regulations do not apply) Does the study fit an allowed Exemption? Does the applicant provide a justification with sufficient information about the involvement of human subjects to allow a determination that the designated exemption is appropriate. NO YES Does the application adequately and appropriately address: Risk to subjects, adequacy of protection against risks, potential benefits of the research to subjects and others, and the importance of knowledge to be gained. Does the applicant address the Human Subjects Risk and Protection Issues (see Glossary) Identified in Sectione of the 398 instructions? NO YES NO EXEMPT State which exemption fits Code: E1-E6 UNACCEPTABLE exemption not applicable Negative impact on score. Explain why exemption does not fit. ABSENT No Information NO YES ACCEPTABLE acceptable risks and/or adequate protections UNACCEPTABLE Information not present APPLICATION NOT REVIEWED Contact Scientific Review Administrator UNACCEPTABLE Unacceptable Risks and/or Inadequate Protections Negative impact on score. Explain nature of concern, may also comment about other issues below the level of “concern”. • Summary of Reviewer Choices: • Human subjects not involved • Human subjects involved, ACCEPTABLE • Human subjects involved, UNACCEPTABLE • Human subjects involved and exempt claimed • Exemptions (see Glossary) • E1 -- Instructional strategies in established educational settings • E2 -- Educational tests unlinkable to individuals and no risks from disclosure • E3 -- Educational tests on public officials, or absolute confidentiality federally mandated • E4 -- Existing data/specimens, publicly available or unlinkable to individuals • E5 -- Demonstration projects concerning public benefit or service programs • E6 -- Taste and quality evaluation of foods without additives exceeding regulated levels NIH/OER April 5, 2002

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