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)
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).
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.
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. 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.
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.
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.
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
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.
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.
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.