Developing and Submitting a Proposal
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 serve as PIs, if allowed by the funding program and approved by the Office of Grants and Contracts.
Types of awards (grants, cooperative agreements, contracts, and clinical trials agreements)
- Grants provide assistance to the investigator with relatively few restrictions. The PI is responsible for deciding the direction of the research program on a day-to-basis, 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 more focused Requests for Applications (RFAs). Purchased equipment generally 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 terms of the award determine ownership of purchased equipment, intellectual property rights, and the (generally greater) reporting requirements.
- 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 scopes of work are established by the sponsor. The contract specifies applicable 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. The latter 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. Multi-site studies may be managed by a clinical research organization (CRO) under contract from the sponsor. Reimbursements in clinical trials agreements often are driven by the number of patients enrolled, specific study visits/procedures/evaluations, and data forms completed. Multi-site study data are controlled by the sponsor, though the University retains the right to publish reports based on subjects enrolled at its own site. Intellectual property generated within the scope of the protocol generally is owned by the company; title to other IP belongs to the University, generally with the sponsor receiving an option to negotiate an exclusive license.
There are many ways to collaborate with industry. Each carries responsibilities that differ from the traditional relationship between academic institutions and foundations, professional associations, or government agencies. Unless otherwise indicated, the SOM contact for these agreements and collaborations is the Office of Grants and Contracts. The most common agreements with industry are:
- Sponsored Research. Investigator-initiated research projects supported by industry. The Office of Grants and Contracts will negotiate a research agreement covering ownership and licensing of intellectual property (IP), publication rights, confidentiality, and ownership of data.
- Collaboration Agreement. Projects in which University and company both contribute to the development and performance of the scope of work.
- Subcontract. Company asks PI to perform a specified subproject embedded within a larger project. If the subcontract will be awarded by a company in which the faculty member has ownership or other financial interest (e.g., SBIR or STTR), 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. The Clinical Trials Office can help with budget development and post-award monitoring.
- Clinical Services Agreement. A fee-for-service arrangement such as radiograph review, MRI screening, specialized clinical laboratory assay.
- Materials Transfer Agreement (MTA). The company provides materials required for your research, or vice versa. If outgoing UVA materials are covered by an invention disclosure, the UVA Licensing and Ventures Group will participate in the negotiation process. Ownership of derivatives and modifications of the original material may slow negotiations; this is less problematic if the agreement does not allow the recipient to create derivatives or modifications of the original material.
- 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 exercise care that their level of consulting activities remains 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 Licensing and Ventures Group 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 per UVA policy. When in doubt, contact the Office of Grants and Contracts. Gifts generally are donated to the Health System Development Office.
Whom to notify, and when, during proposal development
The following proposals require that you notify one or more administrative offices 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 conduct internal competitions when the number of potential applicants exceeds the allowable number of nominees. 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 Dean’s Office.
- Proposals with unusual requirements, 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 support letter.
Help with proposal development
- With your research mentor, develop a strategy for obtaining funding, a timeline for seeking funds, and the structure of your proposals. Arrange an in-house pre-review of your proposal prior its submission.
- Your department/center research administrator can help develop required forms, the budget, and 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, statistical design, assistance in developing clinical trials proposals (budgets, protocol design, IRB issues), and study coordination for clinical trials.
- The Office for Research administers internal competitions for limited funding opportunities and provides letters of institutional support for applications.
- The 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).
- NIH RePORTER allows you 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 would 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.
Resources for proposal development and writing
- NIH has posted videos associated with the peer review process: What Happens to Your NIH Grant Application.
- Also see the NIH site on grant writing tips.
- The NIH Center for Scientific Review has posted a “CSR Insider’s Guide to Peer Review for Applicants,” which includes a video designed to help applicants better navigate the peer review process.
- Attend the SOM grant and research support workshop, conducted by the Office for Research and Office of Grants and Contracts, under the auspices of SOM Faculty Affairs and Faculty Development. 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.
Timeline for proposal development
The following schedule was adapted from SK Inouye & DA Fiellin 2005 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 must review clinical studies budgets to ensure proper billing to study vs. insurance providers.
- 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.
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).
Clinical study budgets
The Clinical Trials Office (924-8530; email@example.com) assists investigators and clinical coordinators in the development of clinical studies budgets and budget negotiation.
Help with other NIH-required sections
- Human subjects: See NIAID’s Human Subjects Resources.
- Use of animals. See NIAID’s How to Write an Application Involving Research Animals. Contact the IACUC office for help with crafting particular sections of a protocol.
- Sharing of biomedical research resources. The NIH Office of Technology Transfer provides 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. Model plans are posted by the NIH Office of Extramural Research and NIAID. Tailor your plan to the specifics of your project.
- Sharing of model organisms for biomedical research: see the model plans posted at the NIH Office of Extramural Research.
- Intellectual property (IP) plans (required for NIH-supported projects that entail product development). Model IP plans are posted at the NCI Technology Transfer Center.
- Scientific rigor. NIH requires that many applications for research or training awards describe how scientific rigor will be maintained, addressing: scientific premise of proposed research, rigorous experimental design, consideration of sex and other relevant biological variables, and authentication of key biological and/or chemical resources. The agency has posted sample sections at http://grants.nih.gov/reproducibility/index.htm#resources. Additional resources: NIH-developed training modules to enhance data reproducibility; NIH Office of Disease Prevention methodological resources for developing clustered randomized clinical trials, including best practices for calculating sample sizes; and Medical Research Council Experimental Design Assistant for pre-clinical research involving laboratory animals.