PHS 398 Cover Human N N Incl : V 2.0 Both Both A response is required You must answer the E Update to “Does Page Embryonic NIH, for Human Embryonic the proposed project involve existing rule Supplement Stem Cells CDC, Stem Cells (HESC) human embryonic stem (modified (HESC) FDA, Involved (Y/N) question. language on cells?” Involved AHRQ error (Y/N) message), Forms D, March 2016 Release PHS 398 Cover Human N N Incl : V 2.0 Multi Overall Y If Human Embryonic The Human Embryonic Stem E Page Embryonic NIH, Stem Cells (HESC) Cells (HESC) Involved on the Supplement Stem Cells CDC, Involved is Yes on any Overall must be marked as (HESC) FDA, Other Component, then "Yes", in order for any Human Involved AHRQ the answer must be Yes Embryonic Stem Cells (Y/N) on the Overall (HESC) Involved in any Component component to be marked as "Yes". PHS 398 Cover Human N N Incl : V 2.0 Multi Overall Y Human Embryonic Stem Cells E For New and Renewal Page Embryonic NIH, (HESC) Involved must be No Human applications, If Supplement Stem Cells CDC, on the Overall section of the Embryonic Stem Cells (HESC) FDA, application, if Human (HESC) Involved is No Involved AHRQ Embryonic Stem Cells on all Other (Y/N) (HESC) Involved is No for all Components, then the other components of the answer must also be No application. on the Overall Component PHS 398 Cover Human N N Incl : V 2.0 Multi Overall Y For Revision and Answering to HESC W ‘Yes’ Page Embryonic NIH, Resubmission Involved on the Overall Supplement Stem Cells CDC, applications, If Human component and to HESC ‘No’ (HESC) FDA, Embryonic Stem Cells Involved on all other Involved AHRQ Involved is No on all components is typically not (Y/N) components of the allowed unless your Revision application and the application (or Resubmission Overall if Human Embryonic Stem Cells of a Revision) does not Involved is Yes, provide include the components that Warning involve Human Embryonic Stem Cells.
PHS 398 Cover Page Supplement Human Embryonic Stem Cells (HESC) Involved (Y/N) N N Incl : NIH, CDC, FDA, AHRQ V 2.0 Both Both A response is required for Human Embryonic Stem Cells (HESC) Involved (Y/N) You must answer the “Does the proposed project involve human embryonic stem cells?” question. E Update to existing rule (modified language on error message), Forms D, March 2016 Release PHS 398 Cover Page Supplement Human Embryonic Stem Cells (HESC) Involved (Y/N) N N Incl : NIH, CDC, FDA, AHRQ V 2.0 Multi Overall Y If Human Embryonic Stem Cells (HESC) Involved is Yes on any Other Component, then the answer must be Yes on the Overall Component The Human Embryonic Stem Cells (HESC) Involved on the Overall must be marked as "Yes", in order for any Human Embryonic Stem Cells (HESC) Involved in any component to be marked as "Yes". E PHS 398 Cover Page Supplement Human Embryonic Stem Cells (HESC) Involved (Y/N) N N Incl : NIH, CDC, FDA, AHRQ V 2.0 Multi Overall Y For New and Renewal applications, If Human Embryonic Stem Cells (HESC) Involved is No on all Other Components, then the answer must also be No on the Overall Component Human Embryonic Stem Cells (HESC) Involved must be No on the Overall section of the application, if Human Embryonic Stem Cells (HESC) Involved is No for all other components of the application. E PHS 398 Cover Page Supplement Human Embryonic Stem Cells (HESC) Involved (Y/N) N N Incl : NIH, CDC, FDA, AHRQ V 2.0 Multi Overall Y For Revision and Resubmission applications, If Human Embryonic Stem Cells Involved is No on all components of the application and the Overall if Human Embryonic Stem Cells Involved is Yes, provide Warning Answering ‘Yes’ to HESC Involved on the Overall component and ‘No’ to HESC Involved 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 Embryonic Stem Cells. W
eSub-validations-draft-9-14-2016.docx