F31, Announcement, OR other than K’s F32, the study is exempt Plans and AND F’s F33, from Federal when response F37, Regulations Is to question 1.2a F38, (Question 1.2a = this a is (Is this “No” FI2, yes). study exempt from Federal study Regulations?). that will use the Note: N/A is same only a valid protocol selection for, to Career K05, conduct Development, K07, K08, and Fellowship K18, applications K22, human K23, subjects at K26, more than K76, one K43 site? PHS Section 034.7.4 N N NIH, 1.0 Excl: Both Provide error if a Since you answered E New D43, Rule Human 3 response to the Yes to the question – K12 October Subject question yes, regarding multi-site “If 2017 and and describe the studies, a single IRB Release Clinical single IRB plan attachment is plan” Trial is not provided when the
Plans Is this a study that will use the same protocol to conduct human subjects at more than one site? F31, F32, F33, F37, F38, FI2, K05, K07, K08, K18, K22, K23, K26, K76, K43 other than K’s and F’s AND when response to question 1.2a is “No” (Is this study exempt from Federal Regulations?). Note: N/A is only a valid selection for, Career Development, and Fellowship applications Announcement, OR the study is exempt from Federal Regulations (Question 1.2a = yes). PHS Human Subject and Clinical Trial Section 3 – and 034.7.4 N N NIH, 1.0 Excl: D43, K12 Both Provide error if a response to the question “If yes, describe the single IRB plan” is not provided when the Since you answered Yes to the question regarding multi-site studies, a single IRB plan attachment is E New Rule October 2017 Release