3f- If the applicant is in the Department of General Surgery, then the Major Subdivision might be Plastic Surgery or Orthopaedic Surgery (if it is not a department). Alternatively if the PI is a rheumatologist, then the department is internal medicine.
3h. If the PI has ever submitted an NIH proposal or has been a Co-Investigator on any NIH proposal, then they must have this name. If they have not, they should leave it blank.
4. If the research proposal involves human beings, then check yes and continue with 4. If it involves animals, then check no and move onto 5.
4a. There are rare situations where the studies are exempt and still involve humans. Most often, this box should be checked no.
4b. All universities have this number assigned to them. The PI should be able to obtain this from the university administration.
4c. Does this involve a clinical trial? If so, then check yes.
4d. This defines if it is a Phase III study- meaning that the animal studies have already been done (phase I) and the human safety studies (phase II) have also been done. For phase III clinical trial, the PI is determining efficacy of the intervention.
5. If the research plan involves animals, then check yes
5a. If animals are being used, then the PI must submit an IACUC protocol and this is the date that the study was approved.
5b. All universities have this number assigned to them. The PI should be able to obtain this from the university administration.