NIH policy for unsolicited applications with budgets of $500,000 or more in direct costs in any year requires that you submit documentation with your application stating you have discussed it with an NIH (NIAID) program officer, and the Institute (NIAID) has agreed to accept it.
For applications submitted in response to a request for applications (RFA), the RFA will explicitly state in Section IV.6 if an application must include the letter of acceptance from the program officer.
You must seek approval from the program officer at least six or more weeks before applying, as identified in the NOFO. Your program officer will send you an acceptance letter to include with your application. See the Big Grants SOP.
Clinical trial applications follow their process—go to Investigator-Initiated Clinical Trial Resources for more information.
Work with your program officer—submitting a big grant application is best approached as a team effort.
It's much better to call or write while still planning your application, so your program officer can advise you. Read the Big Grants SOP for more information.
Without program staff approval, you face the following consequences:
- If you don't include a big grant acceptance letter, the NIH Center for Scientific Review will reject your application without a review.
- If you don't contact program staff before applying, they cannot be your advocate and you cannot benefit from their advice.