Summary and quick links

Office of Sponsored Programs (OSP) Projects Guidebook
Eligibility as PI on grant and contract proposals
Types of awards (grants, cooperative agreements, contracts, and clinical trials agreements)
Types of collaborations with industry
Whom to notify, and when, during proposal development
Help with proposal development
NIH resource:  "Tips for great grant writing"
Resources for proposal development and writing
Timeline for proposal development
NIH proposal submission deadlines
English language writing support for non-native speakers 
Successfully negotiating the UVA approval process
Pre-review of grant proposals:  a best-practices document for SOM faculty
The NIH application cover letter 
NIH limits on resubmission of proposals 
Clinical study budgets
Application forms and related documents
Other required sections (for NIH proposals)
The award process at UVA
Electronic proposal submission procedures (federal proposals)

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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.

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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 Contracts. 

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Types of awards (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 or Requests for Applications (RFAs).  The latter is used to fund research in a focused area.  Purchased equipment vests with the grantee.   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.  The sponsor's technical contact is substantially involved in assisting or managing the agreement.  Sponsor and awardee responsibilities are spelled out in the notice of award.  The title to purchased equipment depends on the terms of the award.  The notice of award also describes intellectual property rights and the (generally greater) reporting requirements of the cooperative agreement.
• Contracts are agreements with clearly defined work scopes, 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.  The contract document specifies regulations, reporting requirements, approvals that must be obtained prior to initiating work, 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 UVA IRB for Health Sciences Research prior to the onset of recruitment.  Larger studies may be carried out at up to dozens of sites and may be managed by a clinical research organization (CRO) under contract from the corporate sponsor.  Reimbursements in clinical trials agreements often are 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 belongs to the University, with an option to negotiate an exclusive license granted to the sponsor.  Title to equipment purchased using such funds vests with the University.

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Types of collaborations with industry.  Faculty have several avenues of collaboration with industry.  Each carries responsibilities that differ from the traditional relationship between academic institutions and foundations, professional associations, or government agencies. The most common agreements with industry:

• Sponsored Research. Investigator-initiated research projects supported by industry. PI should contact the Office of Grants and Contracts, who will negotiate a research agreement covering ownership of intellectual property (IP), publication rights, ownership of data, and licensing provisions.
• 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.
• Subcontract. Company asks PI to perform a specified project embedded within a larger project. This category includes subcontracts under federal SBIR/STTR grants. Contact the Office of Grants and Contracts. If the subcontract will be awarded by a company in which the faculty member has ownership or other financial provision, a conflict-of-interest waiver or management plan must be obtained to comply with the Virginia conflict of interest statute.
• Clinical Trial. Industry-generated protocol to evaluate safety, pharmacokinetics, or efficacy of a company product. Contact the Office of Grants and Contracts to negotiate a clinical trials agreement, and the Clinical Trials Office for help with budget development and post-award monitoring. Concerns:  potential restriction of publication by the sponsor; ownership of data; rapid approvals of protocol and agreement are required for multi-center clinical trials.
• 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 vice versa. Contact the Office of Grants and Contracts. If outgoing UVA materials are covered by an invention disclosure, the Patent Foundation will participate in the negotiation process. Ownership of derivatives and modifications of the original material may slow negotiations; this is less problematic if the scope of use for the materials does not allow either derivation or modification.
• Consulting Agreement. PI provides professional expertise to the company. All consulting agreements must be approved by one's chair and the Office of Grants and Contracts, per SOM consulting policy. Proposed consulting agreements may be routed through the University (allowing the use of UVA facilities) or as a direct agreement between faculty and company (proscribing the use of UVA resources, staff, space, etc.)  Faculty should be careful that consulting activities are consistent with out-of-office allowances under UVA policy and that remuneration rates reflect fair market value.
• Licensing Agreement. Company licenses the use of UVA intellectual property, often for further commercial development. Contact the UVA Patent Foundation if you receive such a request. 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 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.  Gifts generally are donated to the Health System Development Office or the Medical Alumni Association.

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Whom to notify, and when, during proposal development.   The following proposals require that you notify one or more administrative offices prior to submission:

• Complex projects such as NIH Program Project Grants, center grants, or research contracts. Contact Angela Sherman, Office of Grants and Contracts, for logistic support during proposal preparation and to discuss whether it will require an extended review period prior to submission.
• Proposals requiring additional space. Contact the Office for Research.
• Funding programs allowing a restricted number of proposals per institution. Contact Dr. Steven Wasserman, Assistant Dean for Research. The Office for Research or the Office of the VP for Research will conduct an internal competition if the number of potential applicants exceeds the allowable number of proposals. Pre-proposals will be requested approximately two months prior to the agency deadline.
• Proposals requiring increases in numbers of research animals. Discuss your potential animal needs with Dr. Sanford Feldman, Director, Center for Comparative Medicine and then obtain written approval from the Senior Associate Dean and COO, Brad Haws.
• Proposals with unusual constraints, such as restrictions on publication or on intellectual property. Contact the Office of Grants and Contracts.
• Proposals requiring institutional support or a letter from the Dean. Contact the Office for Research with sufficient time to review your request for support and to generate a suppor letter.

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Help with proposal development

• Your research mentor can help develop a strategy for obtaining funding, a timeline for seeking funds, and the structure 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 help develop required forms and the budget/justification.  The Office for Research has developed  "boilerplate" descriptions of resources such as core facilities and computer network capabilities.  Also see "Materials for the development of grant proposals" on that page.
• The Health Sciences Library  provides expertise in searching the scientific literature, production of graphics, interlibrary loan, etc.
• Clinical Trials Office provides support in budget development, assistance in developing clinical trials proposals (budgets, protocol design, IRB issues) and study coordination for clinical trials. 
• Office for Research.  Administers internal competitions for limited funding opportunities and provides letters of institutional support for applications.
• Office of Grants and Contracts.  Provides advice on agency regulations and requirements; negotiates inter-institutional agreements (e.g., Materials Transfer Agreements, consortium agreements) prior to submission, etc.  Contact:  Stewart Craig.  The office also can provide assistance in the development and submission of complex proposals (program projects, cooperative agreements, R&D contracts); contact Angela Sherman. 
• Graduate Programs Office.  The GPO maintains databases containing much of the documentation required for federal training grant proposals.
• NIH RePORTER.  Use this site to search current or previously-funded NIH projects.  You can filter a search by key words, general topics, sponsoring Institutes/Centers, year of award, etc.  Consider how your proposal will build on prior or current NIH projects, and how your work will be relevant to public health.  The site also can be used to locate potential collaborators.

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Resources for proposal development and writing

• The 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.
• Also see this more consolidated NIH site on grant writing tips.
• The UVA Office of Sponsored Programs Research Projects Guidebook covers pre-award (proposal preparation and submission) and post-award activities. 
• Attend the SOM grant and research support workshop, held 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.

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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.  More experienced investigators can work on a shorter timeline.

• 1 year before submission. Conceptualize the project. Begin generating preliminary data.  It may help to start developing your specific aims.  Discuss the broad outlines of your proposal with the agency's program officer, your mentor, and colleagues. The program officer may offer advice on how to shape your proposal to increase its chance of being funded or refer you to other programs that better fit its direction and scope.
• 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 awards can be obtained using the NIH RePORTER system.
• 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. Check whether your funding program requires regulatory approvals (IRB, IACUC, radiation safety) prior to submission.  If so, apply to the appropriate committee(s).
• 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. The SOM Clinical Trials Office can help with clinical studies budget development.
• 2 months before submission. Have your working draft and abstract reviewed by your mentor, collaborators, and colleagues. 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.

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Hints for successfully negotiating the UVA approval process

• Bring your department administrator into the process as soon as possible and coordinate responsibilities for each section of the proposal.
• Follow sponsor instructions for application preparation (document length, font size/spacing, structure, required forms).  Note:  NIH page limits and proposal structure have changed dramatically.
• Justify extraordinary budget increases among years.
• Include full F&A costs or document sponsor restrictions on F&A when routing the proposal 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 department and Grants and Contracts review before the funding deadline.

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The NIH application cover letter.   NIH proposals generally are submitted to the Center for Scientific Review (CSR), which conducts the review process.  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 cover 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).

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NIH limits on resubmission of proposals.  Successful funding of a new award or renewal of an expiring award must be accomplished no later than the original application and one subsequent revision.  If your proposal is not funded after the first revision, make sure you understand how NIH defines defines new vs. rewritten proposals ( full source):

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.

The agency compares new proposals against previous resubmissions.  NIH has provided an FAQ site containing additional information.

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Budget development.  This section is under construction.  Please refer to the Office of Sponsored Programs document on budget preparation.

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Clinical study budgets.  The Clinical Trials Office assists investigators and clinical coordinators in the development of clinical studies budgets and budget negotiation.  Contact the office at 924-8530 or uvaclintrials@virginia.edu.

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Help with other NIH-required sections

• Human subjects.  See the NIAID tutorial titled "How to Write a Human Subjects Application" on its web site.
• Use of animals.  See the NIAID web site for a tutorial titled  "How to Write an Application Involving Research Animals."  Dr. Patricia Foley, Director of Animal Program Training (x4-1884, plf6z@virginia.edu), will work direcly with new investigators on crafting an animal use section for grant proposals.
• Sharing of biomedical research resources.  See the NIH Office of Technology Transfer for more information on 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."
• Data sharing plans.  See model plans posted on the NIH Office of Extramural Research and NIAID web sites.  Tailor your plan to the specifics 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.
• Intellectual property (IP) plans.  NIH-supported projects that entail product development often require the filing of an IP plan.  Model IP plans are posted at the NCI Technology Transfer Branch web site.

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The proposal approval process at UVA.   All grant and contract proposals must be approved by the University before submission to the sponsor.  At the SOM, proposals must be endorsed by the Principal Investigator, Chair, and the Office of Grants and Contracts.

The fiscal/administrative description of the proposal and approval signatures are collected on a four-page proposal approval sheet (also known as the "goldenrod," after its former color).  Grants and Contracts has posted a version for NIH e-SNAP proposals and a generic SOM version.  Your research administrator should help you complete this form, though you, as Principal Investigator, are responsible for reviewing and approving its contents.  The approval sheet, technical proposal, budget, justification, and other supporting documents are forwarded to your Chair and then to Grants and Contracts (who require at least five working days before the submission deadline).  Grants and Contracts may ask additional questions concerning the project or information on the approval form before it is signed and ready for submission to the funding agency.  Grants and Contracts performs all electronic submissions of proposals to grants.gov (see notes and reminders for submissions to grants.gov).  See detailed information on the proposal submission process and how to avoid pitfalls.  You can follow the progress of your grant proposal at the Grants and Contracts tracking log.

If your NIH proposal is likely to be funded, you will be asked to submit just-in-time documentation of other grant support, IRB or IACUC approvals, etc.  You can send these directly to NIH, or via Grants and Contracts.

Sponsors generally notify both the PI and either Grants and Contracts or Sponsored Programs.  Sponsored Programs then creates an internal account in the Oracle system, which may take a few weeks to complete.  To avoid delays in initiating your project, ask your department administrator to request a preliminary Oracle account as soon as it is likely that your project will be funded.  This will allow you to encumber and spend funds in a timely manner.

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