Other AHRQ, Subject Involved is Yes, provide Warning components is typically not allowed VA unless your Revision application (or Project Resubmission of a Revision) does not include the components that involve human subjects. Research Project Exempt 004.2.1 N N Incl : NIH, Incl: Both Both If Human Subjects Used Question is true, the If the answer to Human Subject Used E CDC, V1.3 Project Exempt from Federal Regulations is an answer to the Project and from Federal ‘Yes”, FDA, question cannot be blank Exempt from Federal Regulations Related Regulations AHRQ, must be provided. Other VA Project Research Exemption 004.3.1 N N Incl : NIH, Incl: Both Both If Project Exempt from Federal Regulations is If the answer to Project Exempt from E CDC, V1.3 True, the Exemption number cannot be blank. Federal Regulations is an and number 1-6 ‘Yes’, FDA, Exemption Number must be provided. Related AHRQ, Other VA Project 004.3.2 N N Incl : NIH, Incl: Multi Overall Y For New and Renewal applications, if Overall E Research Exemption If the Human Subjects Involved CDC, V1.3 Exemption number is 'E4' and all Components and number 1-6 question on the Overall component is FDA, Human Subject is 'Yes' with no exemption Related Yes with exemption 4, then all other AHRQ, number checked or an Exemption number not Other components with human subjects VA equal to provide error. ‘E4’, Project must also use exemption 4. Research Exemption 004.3.3 N N Incl : NIH, Incl: Multi Overall Y For Revision and Resubmission applications, Human Subjects exemption number 4 W CDC, V1.3 and number 1-6 provide a warning if Overall Human Subject is is typically not allowed on the Overall FDA, Related Yes and Exception code is E4 and all component unless exemption 4 is AHRQ, Other Components with Human Subject is Yes and selected for all components that VA Project Exception code is different than E4 or not any are include Human Subjects. selected Research IRB review 004.4.1 N N Incl : NIH, Incl: Both Overall If IRB review pending? Is false and project If the answer to E ‘IRB Review Pending’ CDC, V1.3 and exempt from regulation is No, IRB approval date question is the IRB Approval ‘No’,
Other Project AHRQ, VA Subject Involved is Yes, provide Warning components is typically not allowed unless your Revision application (or Resubmission of a Revision) does not include the components that involve human subjects. Research and Related Other Project Project Exempt from Federal Regulations 004.2.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Both Both If Human Subjects Used Question is true, the Project Exempt from Federal Regulations question cannot be blank If the answer to Human Subject Used is ‘Yes”, an answer to the Project Exempt from Federal Regulations must be provided. E Research and Related Other Project Exemption number 1-6 004.3.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Both Both If Project Exempt from Federal Regulations is True, the Exemption number cannot be blank. If the answer to Project Exempt from Federal Regulations is ‘Yes’, an Exemption Number must be provided. E Research and Related Other Project Exemption number 1-6 004.3.2 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Multi Overall Y For New and Renewal applications, if Overall Exemption number is 'E4' and all Components Human Subject is 'Yes' with no exemption number checked or an Exemption number not equal to ‘E4’, provide error. 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 Research and Related Other Project Exemption number 1-6 004.3.3 N N Incl : NIH, CDC, FDA, AHRQ, VA 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 4 is typically not allowed on the Overall component unless exemption 4 is selected for all components that include Human Subjects. W Research and IRB review 004.4.1 N N Incl : NIH, CDC, Incl: V1.3 Both Overall If IRB review pending? Is false and project exempt from regulation is No, IRB approval date If the answer to ‘IRB Review Pending’ question is ‘No’, the IRB Approval E