The post-submission materials policy states that “the only post-submission grant application materials that the NIH will accept are those resulting from unforeseen administrative issues”, and lists the following acceptable post-submission materials:
Revised budget page(s) (e.g., change in budget request due to new funding or institutional acquisition of equipment)
Biographical sketches (e.g., change in senior/key personnel due to the hiring, replacement, or loss of an investigator)
Letters of support or collaboration resulting from a change in senior/key personnel due to the hiring, replacement, or loss of an investigator
Adjustments resulting from natural disasters (e.g., loss of an animal colony)
Adjustments resulting from change of institution (e.g., PI moves to another university)
News of an article accepted for publication (a copy of the article should not be sent)
May I submit any number of such items, or only one?
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, and are not covered by one of the exceptions such as an RFA or institutional training mechanism, each explanation or letter is limited to one page. Therefore, 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).
Will NIH accept articles that have been accepted for publication and did not result from an unforeseen administrative issue?
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 is considered another category of acceptable post-submission materials, separate from information being submitted from unforeseen administrative issues.) For each article accepted, you may submit only the following: Authors, institutional affiliations, title of the article, the journal that accepted it, and the expected time of publication.
Why is there a 30-day cutoff for notification that a paper has been accepted?
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.
Must the article accepted for publication be authored by the investigators submitting the grant application?
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.
Why aren’t late-breaking research findings allowed as post-submission material?
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. For those mechanisms in which the time from submission to the review meeting date may be longer, such as applications submitted in response to Requests for Applications, or institutional training grant applications, the policy provides exceptions to accommodate this additional time.
May I submit news of speakers accepting or declining invitations to participate in a conference grant application (R13 or U13)?
Yes, within the one page limit for each explanation. That is, the PI may consider submitting a one-page explanation of all speakers who accepted invitations to participate in the proposed conference after the application was submitted, plus a one-page explanation of all speakers who declined such invitations after the application was submitted. Alternatively, the PI may consider submitting a one-page explanation for each plenary slot on the agenda.
May I submit newly-received patent approvals relevant to my application as post-submission materials?
No. The status of patents pending or approved is not considered during the peer review process. However, the PI may submit such information to the Program Officer assigned to the application.
May I submit updates on FDA IND and IDE exemptions that were not available when the application was submitted?
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.
If I submitted a multi-component application, may I submit as post-submission materials acknowledgment of a newly-announced local (e.g., State) underwriting of efforts with no change in the application budget?
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.
If I submitted a paper application on time, but found out later that some pages are missing, may I submit the missing pages before the 30 day-before-review deadline?
No, if the master (original signature) copy of a paper application is incomplete on the due date, then missing pages or sections will not be accepted as post-submission materials.
If the master (original signature) copy of a paper application is intact and complete on the due date, but one or all of the copies is missing pages due to a copying problem, may I send in the missing pages?
Yes, the NIH does not view fixing a copying problem to be submitting post-submission material, as long as the master copy that was submitted by the due date was intact and complete.
If I have figures or photographs in a paper application, may I submit original copies to the Scientific Review Officer after the due date?
No, the PHS398 instructions for applicants state that PDF images of material such as electron micrographs or gels may be included in the Appendix; however, a photocopy of each must also be included within the page limits of the Research Strategy. Therefore, applicants should include in the Appendix original copies of figures that may not reproduce well if scanned.
D. Fellowship (F), Career Development (K) and Training Grant (T) Applications
NOT-OD-11-036: Advanced Notice of Change in Policy on the Submission of Letters of Reference for Kirschstein-NRSA Fellowship (F) and Career Development (K) Applications NOT-OD-11-047: Notice of Change in Policy on the Submission of Reference Forms (Letters of Reference) for Kirschstein-NRSA Fellowship (F) Applications
With the elimination of the five-day grace period for Reference Forms (F) and Reference letters (K) in support of fellowship and career development applications, do my referees have to submit their Reference Forms (F) or letters (K) before the receipt date for the application?
Yes. An application that does not have the minimum of three Reference Forms (F) or letters (K) in the eRA Commons on the due date will be considered incomplete and not reviewed.
If I plan to submit a fellowship or career development application on the due date, but I don’t see that all three referees have submitted their Reference Forms (F) or letters (K), what should I do?
An applicant getting ready to submit a fellowship or career development application should check the eRA Commons listing for the application a week or so in advance, and check with the individuals who have agreed to serve as referees. If they are unable to meet the deadline, or cannot be reached, the applicant should consider asking another individual to submit a Reference Form (F) or letter (K) instead.
If a mentor/sponsor for a fellowship or career development candidate obtains notice of a grant award after the fellowship or career development application is submitted, can the mentor/sponsor notify the Scientific Review Officer (SRO) and may the SRO accept that information as post-submission material?
Yes. The mentor/sponsor may notify the SRO that the notice of grant award was received, and the SRO may accept that information, but it must adhere to the one-page limit for transmitting that information.
If an F or K applicant/candidate obtains notice of a grant award after the fellowship or career development application is submitted, can the applicant/candidate notify the Scientific Review Officer (SRO) and may the SRO accept that information as post-submission material?
Yes. The applicant/candidate may notify the SRO that the notice of grant award was received, and the SRO may accept that information, but it must adhere to the one-page limit for transmitting that information. However, note that for certain mechanisms, receipt of another NIH award, e.g., as a PD/PI on an R03, renders the applicant/candidate no longer eligible for the fellowship or award, and the application would be withdrawn.
I am in charge of the institutional training program for my university, and serve as the PD/PI on a T32 application that is pending review. After the application was submitted, the university filled a faculty slot and our new faculty member will fit quite nicely into the training program. May we submit information of his recruitment and his biosketch as post-submission material?
Yes. The policy includes "appointments and/or achievements" among the allowable post-submission materials for institutional training grant applications.
E. Missing Human Subjects or Vertebrate Animals Sections
If an application is missing the Human Subjects and/or Vertebrate Animals section, but the cover page indicates that human subjects and/or vertebrate animals will be used in the proposed research, will I be allowed to submit those sections after the due date?
No. The application must be complete on the due date or it will not be reviewed.