Research Project Exempt 004.2.1 N N Incl : Incl: Both Both If Human Subjects Used If the answer to Human Subject Used is E NIH, V1.3 Question is true, the Project an answer to the Project Exempt and from Federal ‘Yes”, CDC, Exempt from Federal Regulations from Federal Regulations must be Related Regulations FDA, question cannot be blank provided. Other AHRQ, Project VA Research Exemption 004.3.1 N N Incl : Incl: Both Both If Project Exempt from Federal If the answer to Project Exempt from E NIH, V1.3 Regulations is True, the Federal Regulations is an Exemption and number 1-6 ‘Yes’, CDC, Exemption number cannot be Number must be provided. Related FDA, blank. Other AHRQ, Project VA Research Exemption 004.3.2 N N Incl : Incl: Multi Y For New and Renewal If the Human Subjects Involved question E NIH, V1.3 applications, if Overall Exemption and number 1-6 on the Overall component is Yes with CDC, number is 'E4' and all Related exemption 4, then all other components FDA, Components Human Subject is Other with human subjects must also use AHRQ, 'Yes' with no exemption number Project exemption 4. VA checked or an Exemption number not equal to provide error. ‘E4’, Research Exemption 004.3.3 N N Incl : Incl: Multi Y For Revision and Resubmission Human Subjects exemption number 4 is W NIH, V1.3 and number 1-6 applications, provide a warning if typically not allowed on the Overall CDC, Related Overall Human Subject is Yes component unless exemption 4 is selected FDA, Other and Exception code is E4 and all for all components that include Human AHRQ, Project Components with Human Subject Subjects. VA is Yes and Exception code is different than E4 or not any are selected Research IRB review 004.4.1 N N Incl : Incl: Both If IRB review pending? Is false If the answer to E ‘IRB Review Pending’ NIH, V1.3 and pending? and project exempt from question is the IRB Approval Date and ‘No’, CDC, Related regulation is No, IRB approval Human Subject Assurance Number must FDA, Other date and Human subject AHRQ,
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 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 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 Related Other IRB review pending? 004.4.1 N N Incl : NIH, CDC, FDA, AHRQ, Incl: V1.3 Both If IRB review pending? Is false and project exempt from regulation is No, IRB approval date and Human subject If the answer to ‘IRB Review Pending’ question is ‘No’, the IRB Approval Date and Human Subject Assurance Number must E
eSub-validations-draft-2-5-2016.docx