Important Changes for Submission & Post Submission of NIH Grant Applications

Last summer, the NIH released new policy requirements for submission of NIH grant applications to be effective January 25, 2017. While we suspect that most NIH-savvy applicants have probably read a summary of these forthcoming changes when they were first published, we also suspect that many will have forgotten these over the time span leading to their actual enactment. Since applicant non-adherence to these changes has the potential to result in an application being returned without review, or that important (and allowable) information may not be submitted, we have concluded that a review of some of the key changes to be instituted in less than a month would merit review at this time. In this blog, we will focus on allowable appendices material and submission of supplemental material after the application has been submitted.

Specifically with respect to the former issue regarding appendix material, the NIH has increasingly restricted the amount and types of appendix material allowable to be submitted with applications. These are not at all complicated (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-129.html) and most applicants will probably elect not to submit appendix material. Allowable materials include:

For applications proposing clinical trials (unless the FOA provides other instructions for these materials):
• Clinical trial protocols
• Investigator’s brochure from Investigational New Drug (IND), as appropriate

For all applications:
• Blank informed consent/assent forms
• Blank surveys, questionnaires, data collection instruments
• FOA-specified items.

If appendix materials are required in the FOA, review criteria for that FOA will address those materials, and applications submitted without those appendix materials will be considered incomplete and will not be reviewed.

Important Note: Applications submitted for due dates on or after January 25, 2017 will be withdrawn and not reviewed if they are submitted with appendix materials that are not specifically listed in this Notice or the FOA as allowed or required.

For materials submitted after the initial grant application has been submitted, there is actually a rather extensive list of allowable items (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-130.html), many of which relate to changes that would materially affect the environment and/or resources available to an applicant. These would include:

• Revised budget page(s) (e.g., due to new funding or institutional acquisition of equipment)
• Adjustments resulting from change of institution (e.g., Program Director/Principal Investigator [PD/PI] moves to another university)
• Adjustments resulting from natural disasters (e.g., loss of an animal colony)
• Approval by the NIH Stem Cell Registry of a human embryonic cell line(s) after submission of the application (see NOT-OD-12-111)

Allowable materials related specifically to either the Principal Investigator or key personnel include:
• Biographical sketches (e.g., due to the hiring, replacement, or loss of an investigator)
• Letters of support or collaboration due to the hiring, replacement or loss of an investigator
• News of professional promotion or positive tenure decision for any PD/PI or Senior/Key Personnel

Inclusion of actual data in post-submission applications is quite restrictive and includes only materials e.g.
• Videos, within defined limits, that demonstrate devices and experimental data with a temporal element, which refers to the need to show how something functions or occurs over time, or demonstrates movement or change. Applicants must follow the directions in NOT-OD-12-141 for submitting videos to accompany grant applications

News of an article accepted for publication since submission of the application must include only:
• List of authors and institutional affiliations
• Title of the article
• Journal or citation (if available)
Copies of articles, links to articles, or any other materials related to an article accepted for publication will not be accepted as post-submission materials, unless specified in the Funding Opportunity Announcement (FOA).

We trust that this reminder will help our readers to avoid having their NIH applications withdrawn and returned without review.