Plan NIH, is Other Project Subjects attachment is ‘yes’,on Plan Attachments: CDC, Information form within the required if the response to Protection of FDA, same component the Human Subjects Human AHRQ question on the Other Subjects Project Information is ‘Yes’. PHS Research N N Incl : Both Both Required if Human Subjects is The Inclusion of Women and E Plan NIH, yes and Exemption is not E4 Minorities attachment is Plan Attachments: CDC, on Other Project Information required if the response to Inclusion of FDA, form within the same the Human Subjects Women and AHRQ component question on the Other Minorities Project Information is ‘Yes’ and the Exemption Number is not 4. PHS Research N N Incl : Both Both Required if Human Subjects is The Inclusion of Children E Plan NIH, yes and Exemption is not E4 attachment is required if the Plan Attachments: CDC, on Other Project Information response to the Human Inclusion of FDA, form within the same Subjects question on the Children AHRQ component Other Project Information is and the Exemption ‘Yes’ Number is not 4. PHS Research N N Incl : Excl: Both Both Required if Vertebrate The Vertebrate Animals E Plan NIH, S10 Animals Used Question is Yes attachment is required if the Plan Attachments: CDC, on Other Project Information response to the Vertebrate FDA, form within the same Vertebrate/Animals Subject Animals AHRQ component Used question on the Other Project Information is ‘Yes’ PHS Research 010.11 N N Plan Plan Attachments: Select Agent Research PHS Research N N Incl : Both Overall Required if multiple PD/ PIs The Multiple PI Leadership E Plan NIH, are included with the Plan attachment on the PHS Plan Attachments: CDC, submission 398 Research Plan must be Multiple PI FDA, included if multiple PD/PIs Leadership AHRQ have been included on the Plan Senior/Key Person Profile. PHS Research N N Incl : Both Overall Return error if Leadership For multiple PD/PI E Plan NIH, Plan is included and there is applications, be sure to mark Plan Attachments: CDC, only one PD/PI identified with each PD/PI with a project Multiple PI FDA, the submission role of PD/PI on the
Plan Plan Attachments: Protection of Human Subjects NIH, CDC, FDA, AHRQ is ‘yes’,on Other Project Information form within the same component Subjects attachment is required if the response to the Human Subjects question on the Other Project Information is ‘Yes’. PHS Plan Research Plan Attachments: Inclusion of Women and Minorities N N Incl : NIH, CDC, FDA, AHRQ Both Both Required if Human Subjects is yes and Exemption is not E4 on Other Project Information form within the same component The Inclusion of Women and Minorities attachment is required if the response to the Human Subjects question on the Other Project Information is ‘Yes’ and the Exemption Number is not 4. E PHS Plan Research Plan Attachments: Inclusion of Children N N Incl : NIH, CDC, FDA, AHRQ Both Both Required if Human Subjects is yes and Exemption is not E4 on Other Project Information form within the same component The Inclusion of Children attachment is required if the response to the Human Subjects question on the Other Project Information is ‘Yes’ and the Exemption Number is not 4. E PHS Plan Research Plan Attachments: Vertebrate Animals N N Incl : NIH, CDC, FDA, AHRQ Excl: S10 Both Both Required if Vertebrate Animals Used Question is Yes on Other Project Information form within the same component The Vertebrate Animals attachment is required if the response to the Vertebrate/Animals Subject Used question on the Other Project Information is ‘Yes’ E PHS Plan Research Plan Attachments: Select Agent Research 010.11 N N PHS Plan Research Plan Attachments: Multiple PI Leadership Plan N N Incl : NIH, CDC, FDA, AHRQ Both Overall Required if multiple PD/ PIs are included with the submission The Multiple PI Leadership Plan attachment on the PHS 398 Research Plan must be included if multiple PD/PIs have been included on the Senior/Key Person Profile. E PHS Plan Research Plan Attachments: Multiple PI N N Incl : NIH, CDC, FDA, Both Overall Return error if Leadership Plan is included and there is only one PD/PI identified with the submission For multiple PD/PI applications, be sure to mark each PD/PI with a project role of PD/PI on the E
eSub-validations-draft-2-5-2016.docx