Federal Funding of Vaccine Research

Since the widespread outbreak of smallpox, there has been continued research and subsequent development worldwide of vaccines to provide protection against a multitude of infectious diseases. In 2006, the World Health Organization’s Institute forVaccine Research identified nearly 200 new vaccines in the research and development stages. And, with innovations in science and identification of new diseases, particularly in the past decade, the public market for vaccines, as well as the quest to provide them, intensifies.

In the U.S., the National Institutes of Health (NIH) has devoted more than $1.6 million to vaccine-related research in the fiscal year 2011 alone, not including funding for HIV/AIDS research. Each fiscal year, Congress provides the NIH’s budget for 215 different research areas and, in turn, the NIH provides funding to those research projects that are most urgent to our nation’s health. The National Institutes for Allergy and Infectious Diseases (NIAID) is a department of the NIH that supports research in the areas of existing and emerging infectious, immunologic and allergic diseases. Forecasting two years ahead, NIAID, along with focus groups, looks at which areas of health are worthy of research and development funding. These focus areas are further refined by NIAID staff, looking at relevancy, merit, priority, budget and funding before finalizing, authorizing and making funding announcements for grant applications to the public.

Securing grant funding in the area of vaccine research is a straightforward yet daunting process. And the competition for funding is fierce, as thousands of applications are received yearly.

Searching for Available Funding

The NIH supports two types of research: specialized studies requested through specific funding opportunity announcements (FOAs) and investigator-initiated studies requested through general “parent FOAs,” with the majority of the grant budget going to the latter. When considering the types of research to fund, the NIH looks for applications that focus on areas it considers to be most relevant to its mission: to foster innovative research that will prevent disease.

While those interested in grants through the NIH can search the www.grants.gov website, they also can begin their search directly through the NIH and its Institutes and Centers (IC), which are separated by area of research. Each IC lists research priorities and application requests, as well as any specific instructions for applications. Specific instructions found in the FOA supersede any instructions found elsewhere.

Once a grant opportunity with a good fit to the proposed area of research is identified, it takes approximately three to five days to complete an application, assuming all necessary information is on hand and the requested information is correctly submitted and received by the NIH. Grant administrators (those who submit the grant applications) are encouraged to make contact with an IC program official with any questions prior to submitting an application to ensure their application is complete.

Applying for a Federal Grant

Prior to applying for a grant, registration at both Grants.gov and the Electronic Research Administration (eRA) Commons at commons.era.nih.gov/commons is required. Again, this registration process can take days to weeks, depending on the readiness at hand of the required information.

The “Commons,” as the eRA Commons is popularly known, is a portal for grant applicants, recipients and NIH extramural grantee organizations to transmit information about the administration of biomedical research. It works in tandem with Grants.gov to process grant applications from the time of submission through monetary award.

Preregistration requirements. Before registering at www.grants.gov, an organizational or personal data universal number system (DUNS) number is required, which provides the Office of Management and Budget better oversight of which organizations receive grant money and how that money is dispersed. A DUNS number can be obtained at no charge on the Dun and Bradstreet website at fedgov.dnb.com/webform.

Once a DUNS number has been obtained, it is necessary to register at the Central Contractor Registration (CCR) office (www.ccr.gov), a registry of vendors doing business with the federal government, for a CCR number. This will require either an IRS employment identification number (EIN) or taxpayer identification number (TIN). Registration should take a matter of business days, unless an EIN or TIN needs to be obtained from the IRS, which can increase the total processing time by as much as a few weeks.

After obtaining the DUNS and CCR numbers, registration for an application at www.grants.gov is possible. Then, after registration is completed and approved, and the grant opportunity has been identified, the application package is available for download and may, in turn, be electronically submitted when complete.

Funding eligibility. Each grant has its own eligibility requirements. In general, nonprofits, which include state and local governments, educational research institutions and Indian tribal governments and organizations, are eligible. In some cases, for-profit organizations are not authorized to apply for a grant, and in other cases, for-profits may be permitted, but they may not profit from federal cooperative agreement funds.

Research projects that will use human subjects must follow additional steps to meet Health and Human Services (HHS) requirements for the protection, safety and ethical treatment of the study participants. First, they must obtain an assurance number from the Office of Human Research Protection (OHRP) in accordance with the Code for Federal Regulations, Title 45, Part 46, which protects human subjects. While there are four types of assurances, the OHRP suggests registering for a Federalwide Assurance because it is the easiest to complete and covers the broadest range of studies. A registration form and instructions for applying for an assurance can be accessed at www.washington.edu/research/hsd/topics/Federalwide+ Assurance+(FWA).

Applicants also must register with the Institutional Review Board (IRB) that has agreed to review research in their area of study. The NIAID recommends consulting the IRB first before making a determination to use human subjects. If it is determined that human subjects will not be used, an explanation needs to be provided for each project involved in the research.

It’s important to note that the NIH offers FOAs tailored to new investigators, such as the NIH Director’s New Innovator Award. So, filing for an application under the new researcher’s name rather than under an established organization’s name may help. New applicants are given greater consideration by reviewers of their proposals, more so than organizations that have a research track record for which the new applicant works. However, new investigators must prove they have resources for the study, institutional support and the ability to lead the investigation.

Application process. It can take as long as 10 months from the time an application is submitted to receive notification of an award, so it is important to plan early. Exceptions to this timetable are grants for AIDS research funding, which have an expedited review process.

The application should be viewable in the Commons before it is finalized. If the grant administrator submitting the packet is unable to view it, NIH will not be able to view it either.

Once an application is confirmed to be compliant with NIH policies, as well as with federal research policies, the application is referred to the Division of Receipt and Referral in the Center of Scientific Review (CSR) which will, in turn, assign it to an IC and a Scientific Review Group (SRG)for it to assign reviewers for consideration.

Generally, there are three funding cycles yearly, and it can take at least six months from the start of the initial review to a start date for the research. For example, in cycle one, the application due date is between February and March, depending on the specific area of the application. The Scientific Merit Review will take place between June and July, and the Advisory Council will meet roughly in August or October, with an earliest projected start date, once funding has been approved, between September and December.

Applicants should also take note of when the application is due. If submitting by mail, some FOAs require an application be postmarked by a certain date, while others require the application be received by a certain date.

Application evaluation. Grant applications to the NIH are evaluated in a multi-step, dual peer-review process in accordance with section 492 of the Public Health Service Act and federal regulations governing “Scientific Peer Review of Research Grant Applications and Research and Development Contract Projects.”

SRG scientists who have a specialty in the area of the grant will evaluate the application based on the criteria in the FOA. The IC National Advisory Councils or Boards also will evaluate the application.

Review process. SRG reviewers will provide a priority or impact score, which addresses the projected impact of the research on the long-term influence of the field involved. They will ask questions such as:

• Will the research address a particular problem in the field, and if so, how will the field be impacted?
• Are those involved in the study qualified and well-suited to the subject?
• Will the research address the problem in a new way with innovative methodologies or concepts?
• Is the methodology to be used appropriate to the question at hand? • Will the work of the study be done in an environment that will promote success?

Reviewers also will be looking at the ethics of the study, the safety of study participants, any biohazards, etc. The application does not need to be strong in each area to receive a favorable review. Prior to peer group meetings, each individual reviewer will provide a priority score for each criteria, as well as a summary statement, both available to the applicant via the Commons whether or not the proposal moves forward in the process. The reviewers also will provide an overall impact score based on the criteria, which will decide which applications go forward for further review.

Then, the IC council reviews the application, impact scores and summary statements for each application against its needs. The IC director makes final funding decisions based on the council’s information. Both SRGs and IC peer groups must recommend the proposed study for it to be approved.

Notification

Should the application be funded, the IC will send a Notice of Award, and the IC will work closely with the applicant on the administration of the program. Should an application for funding be denied, the NIH offers resources and processes for resubmission, unless the grant application is for a specific initiative with specific money set aside for it.

The Funding Is There

With proper planning, an eye for detail, procedure and organization, obtaining a federal grant is just a few mouse clicks and several months away. The keys to being awarded a grant are to 1) make sure the area of study is not only in a high-priority area, but that it specifically addresses those areas of need; 2) prepare for the application by obtaining necessary registrations; and 3) pay close attention to detailwhen submitting the application. The NIH and specific ICs are available to help. It is, after all, their hope to fund research that leads to the next breakthrough in protecting our nation’s health.