human and/or you Clinical Subject data?”, specimens must provide an Trial and/or data is explanation why the and an application does not “Yes” If yes, explanation involve human provide detailing why the subject research. an proposed study does not of constitute human subject why the research has not been provided. does not 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 a response to “Yes” Does Information form the question “Does the and a the proposed “Yes” response is also research involve given to the human specimens question and/or is not a ‘Does data” the proposed valid response. research involve involve human human specimens and/or is data’ provided with or
Clinical Trial If yes, provide an of why the does not involve human subject human specimens and/or data is “Yes” and an explanation detailing why the proposed study does not constitute human subject research has not been provided. and/or data?”, you must provide an explanation why the application does not involve human subject research. PHS Human Subject and Clinical Trial If Yes to Human Does the involve human 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 If you answered “Yes” to the question “Are Human Subjects Involved” on the Other Project Information form, a “Yes” a 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 Subject