proposed study of does not why the constitute human subject does research has not not been provided. involve human subject PHS If Yes 034.2.3 N N NIH, 1.0 Both Provide error if If you answered E New response to to the question Rule Human to “Are “Yes” Human Subjects Human October “Are Subject Human Subjects 2017 Involved” Involved” and Subject question is on the Other Project Release “Yes” Clinical on the Other Information form, a Trial Project Yes response to the Does Information form question the “Does the and a Yes proposed research response is also involve human given to the specimens and/or question is not a valid ‘Does data” the proposed response. research involve involve human human specimens and/or is data’ provided with or without an and/or explanation data and/or
of why the does not involve human subject proposed study does not constitute human subject research has not been provided. PHS Human Subject and Clinical Trial If Yes to Human Does the involve human and/or data and/or 034.2.3 N N NIH, 1.0 Both Provide error if response to “Are Human Subjects Involved” question is “Yes” on the Other Project Information form and a Yes response is also given to the question ‘Does the proposed research involve human specimens and/or data’ is provided with or without an explanation If you answered “Yes” to the question “Are Human Subjects Involved” on the Other Project Information form, a Yes response to the question “Does the proposed research involve human specimens and/or data” is not a valid response. E New Rule October 2017 Release Subject
eSub-validations-draft-08-21-2017.docx