As outlined in NIH GPS Section 8.1.3, you must send NIH a request, signed by your Authorized Organizational Representative, to the Chief Grants Management Officer of the awarding NIH institute (a full list of contacts can be found online). Your NIH program official is not authorized to approve the change; only the grants management officer can … Continue reading “How Do We Request Prior Approval from NIH When Senior or Key Personnel Are Withdrawn from a Project?”

Yes. As described in NIH Grants Policy Statement Section 8.1.2.6, prior approval from NIH is required for a change in status such as withdrawal from the project during a no-cost extension. This applies only if the senior or key personnel are named on the Notice of Award sent by NIH. For more frequently asked questions … Continue reading “During a No-Cost Extension, is Prior Approval Still Required if Senior or Key Personnel Withdraw from a Project?”

Experiencing a system issue with ASSIST, Grants.gov, SAM, or eRA Commons that you believe threaten your ability to submit on time? Don’t panic. NIH will not penalize applicants who experience confirmed system issues that are beyond their control. However, it is imperative that you follow our Guidelines for Applicants Experiencing System Issues. This process includes contacting the eRA Commons Help Desk by the due date…

No. If you are appealing the initial peer review of your application, then the appeal must be resolved before you submit that application as either a resubmission (A1) or new application (A0).

Looking for more information on NIH’s resubmission policy? Visit our frequently asked questions about resubmission.

A resubmission application, also known as an “A1” application, requires a one-page introduction that addresses the comments from the review of the prior A0 application as well as marked changes in the text of the Research Strategy. You are permitted one resubmission of an unfunded application to address reviewer comments, and that resubmission must be submitted to an appropriate due date no longer than 37 months ….

Yes. In any case in which HHS determines that an NIH-funded clinical research project’s purpose is evaluating the safety or effectiveness of a drug, medical device, or treatment, and that intervention has been designed, conducted, or reported by an investigator with a conflicting interest that was not managed or reported by the grantee organization as … Continue reading “Is it True That There are Special Requirements for Addressing FCOI in Clinical Research?”

As described in the 2011 revision, FCOI regulations apply to each institution applying for or receiving NIH grant or cooperative agreement funding, and to investigators who are planning to participate or are participating in NIH-supported research. However, this regulation does not apply to Small Business Innovative Research (SBIR) and Small Business Technology Transfer (STTR) Phase I applicants and recipients.

It’s important to remember that the regulatory definition of “investigator” is not limited to ….

Have a question about NIH’s grant application submission policies and don’t know where to turn? Bookmark our submissions policy page for answers to questions about when might we accept late applications, what happens if the application due date falls on a weekend or holiday, what application information you can update post submission, and more.

You may know that the R01 is NIH’s standard research project grant. But what about the hundreds of other activity codes NIH uses? Activity codes differentiate between the wide variety of grant programs we offer. Our types of grant programs page can be a huge help in deciphering our lingo. ….

Unless the funding opportunity announcement instructs otherwise, the page limit is 6 pages for Letters of Support from collaborators, contributors, and consultants in addition to the 6 pages allowed for the Statements of the Mentor and Co-Mentor(s).