form, and a question Human “Are Study Record or Subjects Onset Involved” or Delayed on the Other Project Study Onset Study Information form. Record is provided. PHS If No to 034.2.1 N N NIH, 1.0 Both Provide error if If you answered E New “No” response to to the question Rule Human Human “Are “Are Human Subjects Human Subjects October Subject Subject on the 2017 Involved” Involved?” and question is Other Project Release “No” Clinical on the Other Information form, you Does Trial Project must answer the the Information form the proposed “Does and a response research involve to the question human specimens the and/or “Does data?” proposed question. research involve involve human human specimens and/or data?” has not been provided. and/or data? PHS If No to 034.2.2 N N NIH, 1.0 Both Provide error if If you answered E New response to to the question Rule Human Human “Yes” the the proposed October “Does “Does Subject Subject proposed research involve 2017 and research involve human specimens Release Clinical human and/or data, you If yes, Trial specimens must provide an provide and/or data is explanation why the an and an application does not “Yes” explanation involve human detailing why the subject research.
Onset Study form, and a Study Record or or Delayed Onset Study Record is provided. question “Are Human Subjects Involved” on the Other Project Information form. PHS Human Subject and Clinical Trial If No to Human Does the involve human and/or data? 034.2.1 N N NIH, 1.0 Both Provide error if response to “Are Human Subjects Involved” question is “No” on the Other Project Information form and a response to the question “Does the proposed research involve human specimens and/or data?” has not been provided. If you answered “No” to the question “Are Human Subjects Involved?” on the Other Project Information form, you must answer the “Does the proposed research involve human specimens and/or data?” question. E New Rule October 2017 Release PHS Human Subject and Clinical Trial If No to Human If yes, provide an 034.2.2 N N NIH, 1.0 Both Provide error if response to “Does the proposed research involve human specimens and/or data is “Yes” and an explanation detailing why the If you answered “Yes” to the question “Does the proposed research involve human specimens and/or data, you must provide an explanation why the application does not involve human subject research. E New Rule October 2017 Release Subject Subject
eSub-validations-draft-08-21-2017.docx