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