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PHS398: Human Subjects and Vertebrate Animals Ravi-Shankar.Devaraj 30 Apr 2004 17:04 EST

I've a few questions related to Human Subjects Research and Vertebrate Animals pertaining to PHS 398 forms:

If multiple Clinical Research Studies are involved for Human Subjects (that requires filing multiple 'Targeted/Planned Enrollment Table Format page),

(1) Does the 'Human Research Exempt Number' (Item 4a in Face page) change per study or does it remain the same across all studies?

(2) Is the 'Human Subjects Assurance Number' (Item 4b in Face page) change per study or does it remain the same across all studies?

(3) Is there a case where the  'Human Research Exempt Number'  and/or the 'Human Subjects Assurance Number' remain the same for the entire applicant organization and doesn't vary by application.

For Vertebrate Animals,

(1) Can there be multiple Clinical Research Studies like the Humans?

(2) If 'yes', then does the 'IACUC Approval Date' (Item 5a in Face page) and the 'Animal welfare assurance number' (Item 5b in Face page) change per study or does it remain the same across all studies?

(3) Is there a case where the  'IACUC Approval Date'  and/or the 'Animal welfare assurance number' remain the same for the entire applicant organization and doesn't vary by application.

Thank you in advance for answering these questions!
Ravi Shankar

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