Applying for funding
Office of Sponsored Programs (OSP) Projects Guidebook. OSP has prepared a comprehensive guide for UVA investigators and research administrators that spans the life of sponsored research awards. Chapters include internal proposal routing, budget preparation, animal use in research, account review, and so on.
Eligibility as Principal Investigator on proposals. The UVA policy Grants and Contracts - Definition, Solicitation, Clearance, and Acceptance states that proposals may only be submitted by elected members of the faculty: Professors, Associate and Assistant Professors, Instructors and Lecturers. Other individuals may be PIs, if allowed by the funding program and approved by the Office of Grant and Contract Administration.
Grants, cooperative agreements, contracts, and clinical trials agreements. Grants provide assistance to the investigator with few restrictions. In general, the PI is responsible for deciding the direction of the research program on a day-to-basis, as long as it remains within the general scope approved by the sponsor. The sponsor believes that the proposed work scope can be accomplished. Federal grant opportunities are announced by program announcements, with some falling under the Request for Applications (RFA) mechanism. The latter is a means of funding research in a focused area, such as the mechanisms of immune modulation, or collaborative research on tinnitus (both announced recently by NIH). Equipment purchased from these funds vests with the grantee; any intellectual property developed during the course of the research is owned by the grantee institution, and may be developed and licensed by it to other entities.
Cooperative agreements are similar to grants, and are announced via RFAs. By contrast with grants, the sponsor's project officer is substantially involved in assisting or managing the cooperative agreement. Sponsor and awardee responsibilities are spelled out in the notice of award. The title to equipment varies, depending on the award. The notice of award also describes intellectual property rights and will the (greater) reporting requirements of the cooperative agreement.
Contracts are agreements with clearly defined work copes, the results of which ("deliverables") are generated for the direct benefit or use of the sponsor. By accepting a contract, the awardee is agreeing to provide those deliverables. Contract opportunities are announced via the Request for Proposals (RFP) mechanism. Contract scopes of work are established by the sponsor. Notices of award specify regulations, reporting requirements, approvals that must be obtained prior to initiating any subproject, review of manuscripts prior to submission for publication, title to equipment, and so on. Reporting requirements for contracts generally are more substantial than for cooperative agreements or grants. Reimbursement is effected by invoicing the sponsor.
Clinical trials agreements are contracts for the study, in human subjects, of devices, therapies, or preventatives for a particular disease or medical condition. Clinical trials may be investigator- or, more commonly, sponsor-initiated. They are required for the licensure of a product for sale to the public. The scope of work and study procedures are defined in the study protocol, which must be approved by the IRB for Health Sciences Research prior to the onset of recruitment. Larger studies may be carried out at up to dozens of sites and can be overseen by a clinical research organization under contract from the corporate sponsor. Reimbursements in clinical trials agreements tend to be driven by the number of patients enrolled, specific study visits made/procedures performed, and data forms completed. Multi-site study data are controlled by the sponsor, though the University retains the right to publish reports based on patients enrolled at its own site. Intellectual property generated within the protocol's scope of work generally is owned by the company; title to other IP would belong to the University, with a license option granted to the sponsor. Title to equipment purchased using such funds vests with the University.
Collaborations with industry. Faculty have several avenues of collaboration with industry. Each of the arrangements described below includes a set of responsibilities that differs from the traditional relationship between academic institutions and foundations, professional associations, or government agencies. The most common agreements with industry (with potential pitfalls and how to avoid them):
- Sponsored Research. Investigator-initiated research projects supported by industry. PI should contact the Office of Grants and Contracts, who will negotiate a research agreement. Ownership of intellectual property (IP), publication rights, and ownership of data may require negotiation. Companies generally agree to the concept of company-, University-, and jointly-developed IP, and will negotiate license options. The PI should allow negotiations to be carried out by the University and the company, and not agree to provisions that the University might not be able to accept.
- Collaboration Agreement. PI and company both contribute to the development and performance of the scope of work. Contact the Office of Grants and Contracts to review and negotiate. Same potential pitfalls as above, though the likelihood of resulting company-owned IP is greater than for sponsored research.
- Subcontract. Company asks PI to perform a specified project representing a subset of a larger project. This includes subcontracts under NIH SBIR/STTR grants. Contact the Office of Grants and Contracts. Same potential pitfalls as above. If the award is from a company in which the faculty member has ownership or other financial provision, may require a conflict-of-interest waiver or management plan.
- Clinical Trial. PI evaluates safety, pharmacokinetics, or efficacy of a company product using an industry-generated protocol. Contact the Office of Grants and Contracts, to negotiate a trials agreement, and the Clinical Trials Office, for help with budget development and post-award monitoring. IP usually is not developed during the course of clinical trials. Restriction of publication is a critical issue, due to UVA and federal regulations and public sensitivity. Ownership of data may delay negotiations. Multi-center clinical trials require rapid approval of both contract and protocol.
- Clinical Services Agreement. Fee-for-service arrangement such as radiograph review, MRI screening, specialized clinical laboratory assay. Contact the Office of Grants and Contracts to negotiate such an agreement.
- Materials Transfer Agreement (MTA). Company provides materials required for your research, or, more rarely, the opposite. Contact the Office of Grants and Contracts. If the materials are covered under an invention disclosure to UVA, the Patent Foundation will participate in the process. Potential pitfalls: ownership of derivatives and modifications of the original material. This is less problematic if the scope of use for the materials does not allow either derivation or modification. Use by a company of UVA-derived materials, for commercial purposes, may require a license agreement [see below].
- Consulting Agreement. PI provides expertise to the company. All consulting agreements must be reviewed by the Contact the Office of Grants and Contracts, per the SOM consulting policy. Such agreements may be routed through the University (in which case UVA facilities may be utilized) or as a direct agreement between faculty and company ( who not utilize UVA resources, staff, space, etc.) Potential problems: conflict of commitment, due to consulting activities occurring more often than allowed by the UVA policy; inappropriate remuneration rates; use of University or Medical Center facilities; training of outside personnel.
- Licensing Agreement. Company licenses the use of UVA intellectual property, often for further development. Contact the UVA Patent Foundation. Inventors should help identify potential licensees for the invention. Once a licensee has been identified, inventors should work only with the Patent Foundation.
- Gift. Industry provides funds or equipment for use in faculty research. Gifts may not be associated with the requirement of deliverables such as reports or data, use of human subjects or animals, or assignment of rights to intellectual property. See the UVA policy, "Determining if an Award is a Gift or Sponsored Project." When in doubt, contact the Office of Grants and Contracts.
Whom to notify, and when. Certain proposals require that you notify one or more administrative offices prior to their submission. These include:
- Complex projects such as NIH Program Project Grants, center grants, or research contracts. Contact the Office for Research for logistic support during proposal preparation and the Office of Grant and Contracts, which may require an extended review period prior to submission.
- Proposals requiring additional space. Contact the Senior Associate Dean for Finance & Administration.
- Funding programs allowing a restricted number of proposals per institution. Contact Dr. Steven Wasserman, Assistant Dean for Research. Generally, the Office for Research or the Office of the VP for Research and Graduate Studies will conduct an internal competition if the number of potential applicants exceeds the allowable number of proposals. Pre-proposals are due to one of these offices approximately two months prior to the agency deadline.
- Proposals requiring increases in numbers of research animals. Because vivarium utilization is high, you must discuss your potential animal needs with Dr. Sanford Feldman, Director of the Center for Comparative Medicine and written approval from the Senior Associate Dean for Finance & Administration.
- Proposals containing unusual constraints, such as restrictions on publication or on intellectual property. Contact the Office of Grant and Contracts as soon as possible.
- Proposals requiring institutional support or a letter from the Dean. Contact the Office for Research as soon as possible.
Help with proposal development
- Your research mentor. Discuss a broad strategy for obtaining funding, a timeline for seeking funds, and the structure of each of your proposals. Arrange an in-house review of proposals prior to their submission. (Many departments/centers have such a program in place.)
- Your research administrator. Your administrator can provide you with guidance and help in developing required forms and the budget/justification. For "boilerplate" descriptions of resources such as core facilities and computer network capabilities, look under "Materials for the development of grant proposals" here.
- The Health Sciences Library. This facility provides expertise in searching the scientific literature, production of graphics, interlibrary loan, etc.
- Clinical Trials Office. This office can provide support in budget development, assistance in developing clinical trials proposals (budgets, protocol design, IRB issues) and study coordination for clinical trials.
- Office for Research. This office can help with the development of complex proposals and securing institutional support. It also administers internal competitions for limited funding opportunities. The office also provides help in the development and submission of complex proposals (program projects, cooperative agreements, R&D contracts; contact Steven Wasserman).
- Office of Grant and Contracts. This office provides advice on agency regulations and requirements; securing inter-institutional agreements (e.g., Materials Transfer Agreements, consortium agreements) prior to submission; etc. Development and submission of complex proposals (program projects, cooperative agreements, R&D contracts). The Office for Research (contact Steven Wasserman) and Office for Grant and Contracts (contact Stewart Craig) have considerable experience in the development of such proposals. They can assist in this process, and are happy to transfer this know-how to Department/Center administrators.
- Graduate Programs Office. For training grant proposals, the GPO maintains databases containing much of the documentation required for such submissions. Click here for details (UVA intranet access only).
Resources for proposal development and writing
- The UVA Claude Moore Health Sciences Library has developed "Grant Writing Tips," which guides users through identifying prior research, application forms, grant writing, obtaining UVA approvals, etc.
- The National Institute of Allergy and Infectious Diseases (NIAID) has developed an excellent resource titled "All About Grants Tutorials," including an annotated R01 grant application.
- The American Association of Medical Colleges has posted several grant-writing tools to its Web site.
- The SOM runs a grant and research support workshop annually in March. This workshop is designed to help participants prepare effective grant proposals, and includes strategies for writing applications, identifying available NIH and foundation grants, grant submission procedures, and human subjects and animal use requirements. Contact the Office for Research early in the year for additional details.
Timeline for proposal development. The following schedule was adapted from SK Inouye & DA Fiellin 2005 ("An evidence-based guide to writing grant proposals for clinical research," Ann. Intern. Med. 142:274-282). Their timeline is appropriate for programs with predictable annual cycles, such as foundations or NIH Program Announcements. NIAID suggests an alternative, shorter timeline, which is appropriate for more experienced investigators.
- 1 year before submission. Conceptualize the project. Begin generating preliminary data. Discuss the broad outlines of your proposal with the program officer, your mentor, and colleagues. It may be useful to develop your specific aims at this point. The program officer can determine whether his/her program is appropriate to your project, and may offer advice on how to shape your proposal to increase its chance of being funded.
- 10 to 12 months before submission. Obtain and review program guidelines and forms.
- 10 to 11 months before submission. Review recent awards from the funding agency and determine potential reviewers. Abstracts of NIH grants can be obtained using CRISP.
- 10 months before submission. Outline and draft your proposal.
- 8 to 9 months before submission. Consult with your mentor and collaborators; obtain statistical input (also useful in designing preliminary experiments).
- 6 months before submission. Apply for necessary regulatory approvals (IRB, IACUC, radiation safety), if necessary. Check whether your funding program requires these approvals prior to submission: some do not.
- 3 months before submission. Develop budget/justification. If your scope of work changes later, revisit both to ensure appropriate funding before routing it to the Office of Grants and Contracts. For clinical studies, the SOM Clinical Trials Office can help with budget development.
- 2 months before submission. Complete the working draft and abstract and have them reviewed by your mentor, collaborators, and other experienced investigators. Some departments or centers require that the PI participate in a structured review session before submission. Continue to revise the proposal.
- Two weeks before submission. Begin the internal approval process.
- Other. Inform your research administrator of your intention to submit the proposal (including agency, program, and deadline), as early as possible. He or she may recommend different administrative timelines than the above.
Developing and writing your proposal
The Claude Moore Health Sciences Library's Grant Writing Toolkit guides users through identifying prior publications, application forms, grant writing tips, and obtaining UVA approvals, etc. Additional resources are listed below.
The School of Medicine Grant and Research Support Workshop is designed to help participants prepare effective grant proposals, and includes strategies for writing applications, identifying available NIH and foundation grants, grant submission procedures, and human subjects and animal use requirements. The next session will be held in March 2008.
UVA Office of Sponsored Programs Research Projects Guidebook covers pre-award (proposal preparation and submission) and post-award activities.
English language writing support for non-native speakers. The UVA Center for American English Language and Culture provides writing classes and one-on-one support for individuals whose first language is not English. These resources can be helpful in the preparation of grant proposals, abstracts, and manuscripts. See the Center's listing of graduate-level courses and, in particular, LING 114 ("Academic Communications Seminar for Researchers - Writing Skills Component").
Avoiding problems with the UVA approval process
- Bring your department administrator into the process as soon as possible. Divide the responsibilities between the two of you: you will be responsible for writing the technical proposal, abstract, budget justification, and updating your own biosketch; he or she can prepare sections such as resources/environment, cover page, checklist, etc.; together, you should generate the budget.
- Follow the agency instructions for application preparation (document length, font size/spacing, structure, required forms).
- Justify extraordinary budget increases among years.
- Include full indirect costs or include agency restrictions with your submission to the Office of Grants and Contracts.
- Make sure that all signatures, including your collaborators' chairs and subcontracting institutions, have been obtained.
- Allow sufficient time for departmental and Grants and Contracts review before the funding deadline.
Pre-review of grant proposals. With NIH R01 paylines falling, the School of Medicine has developed suggestions for maximizing success in obtaining and renewing external funding (UVA intranet).
The NIH application cover letter. NIH proposals generally are submitted to the Center for Scientific Review (CSR), which conducts the review process. After logging in the proposal, CSR staff decide which Institute or Institutes are most appropriate to administer your project, if awarded. They also determine the study section best suited to review your proposal. By default, these decisions are made on the basis of your title and abstract. You can influence these decisions by including with your proposal a cover letter describing which Institute(s) and study section(s) you feel are most appropriate. Remember to justify such a request. Names and areas of scientific interest for study sections can be found on the CSR Web site. Your letter also can list individuals who should not review your proposal due to conflicts of interest. Finally, cover letters can be used to justify late submission of a proposal (e.g., due to inclement weather or participation on an NIH study section).
NIH limits on resubmission of proposals. NIH policy limits the number of proposal revisions (called resubmissions) to two. Successful funding of a new award or renewal of an expiring award, therefore, must be accomplished no later than the original application and two subsequent revisions. The 2006 clarification of this policy is specific in what constitutes a new proposal (and not an A3 resubmission). Note the passages in boldface:
A new application should include substantial changes in all sections of the Research Plan, particularly in the Specific Aims and the Research Design and Methods sections. There should be fundamental changes in the questions being asked and/or the outcomes examined. Changes to the Research Plan should produce a significant change in direction and approach for the research project. What constitutes "significant" and "substantial" is inevitably a scientific judgment for which no set of universally applicable examples can be provided. Rewording of the Title and Specific Aims or incorporating minor changes in response to comments of reviewers in the most recent Summary Statement does not constitute substantial changes in scope, direction or content. Requests for review by a different review committee or funding consideration by a different NIH institute are not sufficient reasons to consider an application as new.
New proposals are checked against previous resubmissions by the Center for Scientific Review, Institute/Center program staff, and reviewers. NIH has provided an FAQ site that contains additional information.
Budget development. This section is under construction. Please refer to the Office of Sponsored Programs document on budget preparation.
Clinical study budgets. The Clinical Trials Office can assist investigators and coordinators in the development of clinical studies budgets and budget negotiation. They can be contacted at 924-8530 or uvaclintrials@virginia.edu.
Other required sections (for NIH proposals)
- Human subjects. Most programs require a section describing the proposed use of animal subjects. For NIH proposals, refer to the NIAID tutorial titled "How to Write a Human Subjects Application" on its Web site.
- Use of animals. If you plan to use animals in your project, check out the NIAID Web site for a tutorial titled "How to Write an Application Involving Research Animals." Dr. Patricia Foley, Director of Animal Program Training (924-1884, plf6z@virginia.edu), will work one-on-one with new investigators on crafting an animal use section for grant proposals.
- Sharing of biomedical research resources. Guidelines for implementation of this policy, which addresses "terms for disseminating and acquiring unique research resources developed with federal funds and is intended to assist recipients in complying with their obligations under the Bayh-Dole Act and NIH funding policy," can be found at the NIH Office of Technology Transfer Web site.
- Data sharing plans. The NIH Office of Extramural Research has posted several model plans at its Web site. NIAID also lists a model plan on its site. Make sure to tailor your plan to the particulars of your project.
- Sharing of model organisms for biomedical research. A description of this policy and several model plans can be found at the NIH Office of Extramural Research Web site.
- Intellectual property (IP) plans. NIH-supported projects that entail product development (e.g., cooperative agreements) often require the filing of an IP plan. The NCI Technology Transfer Branch has posted several model IP plans.
Electronic proposal submission procedures (NIH and other funding agencies). NIH currently is migrating its grant proposal submission process from paper to electronic format (see timeline). The Office of Grants and Contracts Web site provides information concerning the grants.gov submission site and implementation of this process at UVA.