Research Human Subjects 004.1.6 N N Incl : Incl: Multi Y For New and Renewal If Human Subjects Involved is "No" on all E NIH, V1.3 applications, If Human Subject components of the application, then "No" and Involved? CDC, Involved is No on all components must be selected for the Overall Related FDA, of the application and the Overall component Other AHRQ, if Human Subject Involved is Yes, Project VA provide Error Research Human Subjects 004.1.7 N N Incl : Incl: Multi Y For Revision and Resubmission Answering to Human Subjects on the W ‘Yes’ NIH, V1.3 applications, If Human Subject Overall component and to Human and Involved? ‘No’ CDC, Involved is No on all components Subjects on all other components is Related FDA, of the application and the Overall typically not allowed unless your Revision Other AHRQ, if Human Subject Involved is Yes, application (or Resubmission of a Revision) Project VA provide Warning does not include the components that involve human subjects. Research Human Subjects 004.1.8 N N Incl : Incl: Incl: Single Provide warning if Human Subject The answer to the Human Subjects W New rule NIH, V1.3 S10, is true. Involved should be for this application. and Involved? ‘No’ CDC, S21, Related FDA, S22, Other AHRQ, Project VA Research Human Subjects 004.1.9 N N Incl : Incl: Incl:R50 Single Provide error if Human Subjects is The answer to the Human Subjects E New Rule NIH, V1.3 true Involved should be for this application. and Involved? ‘No’ CDC, December Related FDA, 2015 Release Other AHRQ, Project VA
Research and Related Other Project Human Subjects Involved? 004.1.6 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Multi Y For New and Renewal applications, If Human Subject Involved is No on all components of the application and the Overall if Human Subject Involved is Yes, provide Error If Human Subjects Involved is "No" on all components of the application, then "No" must be selected for the Overall component E Research and Related Other Project Human Subjects Involved? 004.1.7 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Multi Y For Revision and Resubmission applications, If Human Subject Involved is No on all components of the application and the Overall if Human Subject Involved is Yes, provide Warning Answering ‘Yes’ to Human Subjects on the Overall component and ‘No’ to Human Subjects on all other components is typically not allowed unless your Revision application (or Resubmission of a Revision) does not include the components that involve human subjects. W Research and Related Other Project Human Subjects Involved? 004.1.8 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Incl: S10, S21, S22, Single Provide warning if Human Subject is true. The answer to the Human Subjects Involved should be ‘No’ for this application. W New rule Research and Related Other Project Human Subjects Involved? 004.1.9 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Incl:R50 Single Provide error if Human Subjects is true The answer to the Human Subjects Involved should be ‘No’ for this application. E New Rule December 2015 Release
eSub-validations-draft-2-5-2016.docx