Developing an NIH research grant typically involves several key components, including the preparation of a detailed research plan, budget justification, and supporting documents. But PIs should not forget to familiarize themselves with both NIH and internal requirements and regulations that must be adhered to. These are in place to ensure that the grant application process is fair, transparent, and follows ethical guidelines.
These guidelines cover a wide range of topics, including human subjects research, animal welfare, biohazards, and conflicts of interest. It is the submission of (and/or attestation for) these regulatory documents/pre-reviews that often require the involvement of multiple institutional or department offices, which may not be able to be completed on submission day.
A failure to proactively contact these offices to begin the process for completing such actions or obtaining forms/attestations is often a stumbling block if not done with sufficient lead time. Knowing which offices or contacts at your institution handle what can save you from these common hurdles to submission that you do not want to face at 4:55pm on deadline day!
Grants Office/Institutional Signatory’s Office: Recall that grants are submitted by your institution as the grantee, not the PI, therefore you must understand the step(s) to get your application to the institutional signatory (VP of Research, grants manager, etc.) as part of your timeline.
Institutions usually have required internal routing, review, and approval processes.
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- Is there an internal review process within your grants office, individual department, or both?
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- Is there a grants submission policy timeline? Many institutions require completed grants be submitted 3-5 business days prior to the deadline or they will not submit.
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- Is your chair’s sign-off required on your grant before submission?
Searching out the gatekeepers of these approval processes should not be done on deadline day.
eRA Commons ID: Personnel named in the grant require Commons IDs, which must be obtained through your institution’s Commons account.
Frequently your central research administration office will be where IDs can be requested unless department administrators have been granted access by your institutional signatory.
Research subjects: Projects with vertebrate animal or human subjects may require a pre-review of a protocol with the proposal grant research.
This includes obtaining approval from an Institutional Review Board (IRB) to ensure that the study meets ethical standards and protects the rights and welfare of the participants.
When it comes to animal welfare, the NIH has strict guidelines in place to ensure that animals used in research are treated humanely and that their welfare is protected.
Internally these are managed by Institutional Animal Care and Use Committees (IACUC).
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- What are the internal steps and timelines in your IRB or IACUC Offices for such reviews.
Biosafety/Biohazards: In addition to human subjects research and animal welfare, the NIH also has regulations regarding biohazards.
Researchers must follow appropriate safety protocols when working with hazardous materials, such as infectious agents or radioactive substances. This includes obtaining the necessary permits and approvals, implementing proper containment measures, and ensuring the safety of both researchers and the environment.
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- Hazardous materials use and laboratory biosafety attestations from your Institutional Biosafety Committee (IBC) may also be required both internally and as associated with a NOFO.
Conflict of Interest: Researchers must disclose any financial or personal relationships that could potentially bias their research or create a conflict of interest. This transparency is crucial to maintain the integrity and credibility of the research.
It is your institution’s responsibility to certify there are no grant personnel financial conflict of interests (FCOIs) or that existing ones that are being managed.
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- Does your research center have a Compliance Office?
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- Does your institution require a pre-submission FCOI review?
Intellectual Property: Applicants must address issues related to patents, copyrights, and other forms of intellectual property that may arise from their research. They should outline their plans for protecting and managing intellectual property rights, including any potential licensing or commercialization strategies.
Many institutions have a pre-submission requirement for confirming that no sensitive IP will be included or that patents for such discoveries have been applied for.
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- These reviews sometimes live in a Technology Development Office since IP can take the form of new technologies and may require Material Transfer Agreements (MTAs).
In conclusion, submitting an NIH grant application involves navigating through various regulatory requirements that frequently do not rest in a central research administration office. It behooves PIs to identify early on offices and contacts for processing these. Your Grants Manager may be able to direct you to the where, who, and how.
It is essential for applicants to carefully review and address each requirement to increase their chances of a successful application.
