What should my application contain if it deals with human subjects, clinical trials or vertebrate animals?
If the study deals with human subjects, you must answer all parts of item 4 on the face page of the PHS 398 Form (Revised 11/2007) application. NIH requires documentation of Institutional Review Board (IRB) approval at the time of award. The application should also address the points concerning Gender and Minority Inclusion and Inclusion of Children as Participants, OR provide sufficient information/justification for exemptions. This information can be found in the Human Subjects Research section of the instructions for preparing a PHS 398 Form (Revised 11/2007) application. If the study involves a clinical trial, you will need to include an abbreviated data and safety-monitoring plan showing that the sponsoring institution does have an operational mechanism for data and safety monitoring of clinical trials. If you are using vertebrate animals, you must answer all parts of item 5 on the face page of the PHS 398 Form (Revised 11/2007) application and follow the instructions in the Verte
Related Questions
- Is it a problem if I submit an application using either Human or Vertebrate Subjects without having the institution approval documents in place?
- Does the 10-page limit for the concept protocol include Human Subjects, Vertebrate Animals and bibliography?
- What if my project involves human subjects, vertebrate animals, or rDNA or biohazards?
