Good afternoon,

Does anyone know…

If a PI is planning to use an existing dataset only without new enrollment but does NOT think their study will qualify for IRB exemption 4, is a response required to question 2.8 Enrollment of the First Participant on the PHS Human Subjects and Clinical Trials Study Record?  Question 2.8 requires the applicant to select either “Anticipated” or “Actual” and then enter a date for enrollment of the 1^st study participant.

The latest NIH SF424 Application Guide (forms G) seems to say that the question does NOT require a response if you mark “Using an Existing Dataset or Resource” on the Inclusion Enrollment Report: “Do not complete this field if you will answer "Yes" to the question "Using an Existing Dataset or Resource" in the Inclusion Enrollment Report.”  This makes sense to me. However, the SF424 Validations posted on the NIH website seem to indicate otherwise, so I am apprehensive about advising the PI to leave it blank.

Does anyone have any experience with leaving this question blank for a study with existing dataset only (and no IRB exemption 4)?  Did you get an error upon submission?  I know that if we submit early, we should find out soon enough, but my PIs rarely submit early.

Thanks,

Holly Cieslikowski

Proposal Manager, College of Health & Public Service

xxxxxx@unt.edu | (940) 565-2237