An investigator may submit any number of such items, but must follow the page limits specified in the policy. That is, for post-submission materials that are not required on a form page, each explanation or letter is limited to one page. For example, if a research team lost a member after the application was submitted, and the PD/PI wanted to replace that individual with two substitute personnel, he could submit a one-page explanation and biographical sketch for each new person, plus a revised budget page(s).
NIH will accept news of all articles that were accepted for publication after the application was submitted and are relevant to the proposed project. News of an article accepted for publication since submission of the application must include only: a list of the authors and their institutional affiliations, the title of the article, and the journal or citation (if available).
The purpose of the policy is to provide an even playing field across the agency, types of applications, and study sections in terms of when the reviewers have access to information and in terms of the types of information they receive. The thirty-day window before a review meeting is time when reviewers are concentrating on the applications and their critiques, and SROs are making preparations for the meetings. In most cases, reviewers are asked to submit their preliminary critiques, criterion scores, and impact scores a week before the meeting.
In most cases NIH expects that news of an article accepted for publication will be in reference to an article authored by the investigators submitting the grant application, but news of an article authored by other investigators could be accepted if the SRO determines that it directly affects the work proposed in the application.
In most cases, the time from submission to the review meeting date is two-three months, and reviewers gain access to the applications five-six weeks before the review meeting date. Therefore, only a few weeks are left in that window in which new data could be gathered, analyzed, and submitted.
Yes. The AOR and PI may submit citations of issued patents as post-submission materials, but copies of patent applications or patents, or any other materials related to a patent application or granted patent will not be accepted as post-submission materials, unless specific in the Funding Opportunity Announcement (FOA) for which the application was submitted or in a special Guide Notice. See NOT-OD-17-066 for the recommended citation format.
No. The status of IND and IDE exemptions will be assessed at the time of award, if an application is considered for funding. Therefore, such updates should be sent to the Program Officer assigned to the application.
No. Budget considerations are not typically included in assessing the scientific and technical merit of the proposed work, but can be negotiated at the time of award. Therefore, an applicant who learns of local underwriting efforts should notify the Program Officer for the application, but not the SRO.
Yes. The mentor/sponsor may notify the SRO that the notice of grant award was received, limited to the “project title, funding source (e.g., NIH grant number), a brief description of specific aims, and relevance to the fellowship or career development application under review”.