Exemption N N Incl Incl: Multi Overall Y Tigger error for new and If the Human Subjects E Jan 2017 NIH, V1.3 renewal applications, if and number 1-6 Involved question on the Release. CDC, E4 is the only exemption Overall component is FDA, selection in the Overall Rule Yes with exemption 4, AHRQ Do not trigger rule: If the trigger Other then all other Overall has a selection updated Project components with human VA, of E4 AND an additional subjects must also use USU exemption. exemption 4. Exemption N N Incl : Incl: Multi Overall Y For Revision and Human Subjects W NIH, V1.3 and number 1-6 Resubmission exemption number is CDC, applications, provide a typically not allowed on FDA, warning if Overall the Overall component AHRQ Other Human Subject is Yes unless exemption is Project and Exception code is selected for all VA, E4 and all Components components that include USU with Human Subject is Human Subjects. Yes and Exception code is different than E4 or not any are selected Exemption N N Incl: Excl: Excl: Both Provide warning if You have answered W New NIH, 1.4 T15, and number 1-6 applicant selected Yes to "Yes" to the Human Rule, CDC, T32, Human subjects with an Subjects Involved FDA, T34, as part Exemption Number not question on the AHRQ T35, of Forms Other equal to on the Research & Related ‘4’ USU T36, D. Project Research & Related Other Project K12, Sprint 29, Other Project Information Information form, but T37, B-03610. D71, form, but has not have not included either Needs to D43, selected either the PHS a PHS Inclusion be in U2R, Inclusion Enrollment Enrollment Report with UAT on T01, Report with an an Enrollment Type = February T02, 19th and
and Other Project Exemption number 1-6 N N Incl NIH, CDC, FDA, VA, USU Incl: V1.3 Multi Overall Y Tigger error for new and renewal applications, if E4 is the only exemption selection in the Overall Do not trigger rule: If the Overall has a selection of E4 AND an additional exemption. If the Human Subjects Involved question on the Overall component is Yes with exemption 4, then all other components with human subjects must also use exemption 4. E Jan 2017 Release. Rule trigger updated and Other Project Exemption number 1-6 N N Incl : NIH, CDC, FDA, VA, USU Incl: V1.3 Multi Overall Y For Revision and Resubmission applications, provide a warning if Overall Human Subject is Yes and Exception code is E4 and all Components with Human Subject is Yes and Exception code is different than E4 or not any are selected Human Subjects exemption number is typically not allowed on the Overall component unless exemption is selected for all components that include Human Subjects. W and Other Project Exemption number 1-6 N N Incl: NIH, CDC, FDA, USU Excl: 1.4 Excl: T15, T32, T34, T35, T36, K12, T37, D71, D43, U2R, T01, T02, Both Provide warning if applicant selected Yes to Human subjects with an Exemption Number not equal to ‘4’ on the Research & Related Other Project Information form, but has not selected either the PHS Inclusion Enrollment Report with an You have answered "Yes" to the Human Subjects Involved question on the Research & Related Other Project Information form, but have not included either a PHS Inclusion Enrollment Report with an Enrollment Type = W New Rule, as part of Forms D. Sprint 29, B-03610. Needs to be in UAT on February 19th and AHRQ AHRQ AHRQ
eSub-validations-draft-09-12-2017.docx