from Regulations for the Protection of Human Subjects.) If there are no activities involving human subjects planned at any time during the proposed project at any performance site or collaborating institution, you may check and skip to Item 2. “No” Is the Project Exempt from Federal Regulations? If all human subject activities are exempt from Human Subjects regulations, then you may check You are required “Yes.” to answer this question if you answered to the first question Human Subjects “yes” “Are Involved?” If you answer to the question the Project Exempt from Federal Regulations?” “yes” “Is you are required to the appropriate exemption number box or boxes corresponding to one or more of the exemption categories. The six categories of research that qualify for exemption from coverage by the regulations are described on the U.S. Department of Education’s website . Provide an Exempt Research on Human Subjects Narrative at Item 12 of this form (see ). If you answer to the question the Project Exempt from Federal Regulations?” “no” “Is you will be prompted to answer questions the Institutional Review Board (IRB) review. If no, is the IRB review pending? Answer either or “Yes” “No.” If you answer because the review is pending, then leave the IRB approval date “yes” blank. If you answer because the review is not pending, then you are required to “no” enter the latest IRB approval date, if available. Therefore, you should select only if “No” a date is available for IRB approval. Note: IRB Approval may not be pending because you have not begun the IRB process. In this case, an IRB Approval Date will not be available. However, a date must be entered in this field if is selected or the application will be rejected with errors by “No” Grants.gov. Therefore, you should check to the question the IRB review “Yes” “Is pending?” if an IRB Approval Date is not available. If you answer to the question the Project Exempt from Federal Regulations?” “no” “Is provide a Non-Exempt Research on Human Subjects Narrative at Item 12 of this form (see ). Human Subject Assurance Number: Leave this item blank. Item 2 Are Vertebrate Animals Used? whether or not vertebrate animals will be used in this project. Item 3 Is proprietary/privileged information included in the application? Patentable ideas, trade secrets, privileged or confidential commercial or financial information, disclosure of
from Regulations for the Protection of Human Subjects.) If there are no activities involving human subjects planned at any time during the proposed project at any performance site or collaborating institution, you may check “No” and skip to Item 2. Is the Project Exempt from Federal Regulations? If all human subject activities are exempt from Human Subjects regulations, then you may check “Yes.” You are required to answer this question if you answered “yes” to the first question “Are Human Subjects Involved?” If you answer “yes” to the question “Is the Project Exempt from Federal Regulations?” you are required to the appropriate exemption number box or boxes corresponding to one or more of the exemption categories. The six categories of research that qualify for exemption from coverage by the regulations are described on the U.S. Department of Education’s website . Provide an Exempt Research on Human Subjects Narrative at Item 12 of this form (see ). If you answer “no” to the question “Is the Project Exempt from Federal Regulations?” you will be prompted to answer questions the Institutional Review Board (IRB) review. If no, is the IRB review pending? Answer either “Yes” or “No.” If you answer “yes” because the review is pending, then leave the IRB approval date blank. If you answer “no” because the review is not pending, then you are required to enter the latest IRB approval date, if available. Therefore, you should select “No” only if a date is available for IRB approval. Note: IRB Approval may not be pending because you have not begun the IRB process. In this case, an IRB Approval Date will not be available. However, a date must be entered in this field if “No” is selected or the application will be rejected with errors by Grants.gov. Therefore, you should check “Yes” to the question “Is the IRB review pending?” if an IRB Approval Date is not available. If you answer “no” to the question “Is the Project Exempt from Federal Regulations?” provide a Non-Exempt Research on Human Subjects Narrative at Item 12 of this form (see ). Human Subject Assurance Number: Leave this item blank. Item 2 Are Vertebrate Animals Used? whether or not vertebrate animals will be used in this project. Item 3 Is proprietary/privileged information included in the application? Patentable ideas, trade secrets, privileged or confidential commercial or financial information, disclosure of
2018_84324B.docx