I have a PI submitting to NIH who is is using existing human subjects
data for a project with data that is already collected, but does need to
go through full IRB review as a condition of using the data set. For
submission via Grants.gov, I am wondering if I should submit the
Inclusion Enrollment Report, describing the demographics of the existing
human subjects data?

In the past we would submit an Inclusion Enrollment Report with an "N/A"
as it was required if you attached the other Human Subjects narrative
sections, or we would get an error. Now with the new NIH Application
Form (C) it is an optional form.

Thanks for your thoughts!

--
Marina Aloyets
Assistant Director
Office of Research&  Sponsored Programs
Montclair State University
1 Normal Avenue, College Hall 309
Montclair, NJ 07043
xxxxxx@mail.montclair.edu
973.655.5367 (tel)
973.655.5150 (fax)

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