Resources

Your primary point person at either side of a move to another institution should be your department/center administrator, who can help you negotiate legal and regulatory hurdles and make the move somewhat smoother.  Please consider the following:

• Personnel.  If research staff will accompany you to UVA, your administrator and UVA Human Resources will ensure appropriate hiring and onboarding.
• External research awards.  If you will transfer active sponsored awards, the SOM Office of Grants and Contracts and its counterpart at your current institution will work with the sponsor to transfer them to/from UVA.  Initiate this process as soon as you have accepted your offer to reduce disruptions in support.  See specific information on transfer of NIH awards between institutions.
• Equipment.  Transfer of research equipment to another institution depends on the source of funds used to purchase it.  In general, UVA allows the transfer of equipment purchased using federal funds if the project will continue at the new institution, but not the transfer of equipment purchased with institutional funds or state.  Use UVA Form P-1 to request transfer of equipment from UVA (contact:  Office of Grants and Contracts).
• Research animals.  Contact the  Center for Comparative Medicine (CCM) if you intend to ship animals to or from the University.  Animals arriving at UVA must undergo quarantine to reduce the risk of pathogens entering our vivaria.  The CCM web site provides procedures for shipments to UVA and shipments to other institutions. Shipments of research animals to other institutions require material transfer agreements (contact the Office of Grants and Contracts).  The Genetically Engineered Murine Model Core can cryopreserve animal lines, for subsequent reconstitution.
• Data.  In general, data generated at an academic institution are owned by that entity.  If you wish to transfer data to UVA, check with your current institution concerning its policies.  Under UVA policy Laboratory Notebook and Record keeping, the Vice President for Research must approve the transfer of any data.  Please note that information (in whatever format) that you received under a confidentiality agreement may not be taken with you – your new institution should work with the originating entity to create a new confidentiality agreement if you wish to access those documents after you leave UVA.  Similarly, if you wish to transfer clinical research data, contact the cognizant IRB concerning restrictions and procedures.
• Intellectual property (IP).
  • Transfer of IP you developed at your current institution requires a Material Transfer Agreement (MTA; contact office:   Office of Grants and Contracts).
  • Your own IP that has been licensed to a company, but which you wish to continue to use in your non-commercial research:  the UVA Licensing and Ventures Group will work on a license to/from UVA.
  • IP that has been partially developed at your current institution, but will continue to be developed at your new institution:  same contacts as above; the two institutions will negotiate sharing of ownership and license income from existing vs. future IP.
  • IP that you previously had received under MTA, and wish to move to your new institution:  your new institution should request these materials from the original source, rather than effecting a secondary transfer.  Make a list of the materials that you wish to transfer, their originating institutions and contact investigators, and work with SOM Grants and Contracts and the technology office at your other institution to negotiate new MTAs.

Making the Right Moves,” published by The Burroughs Wellcome Fund and The Howard Hughes Medical Institute, covers negotiating one’s employment contract, the structure of academic institutions, staffing a research group, time and project management, etc.  A must-read for postdoctoral fellows and young faculty.

The School of Medicine supports several state-of-the-art core facilities for its investigators.  A portion of the operating budget for each is obtained from the School of Medicine ; the remainder is generated by user fees.  These facilities are overseen by Jay W. Fox, PhD (Associate Dean for Research Infrastructure); their descriptions and web sites are listed at the Office of Research Core Administration.

The  Center for Comparative Medicine maintains AAALAC-accredited facilities to support research involving animals.  Services include training, veterinary support, animal housing, embryonic cryopreservation (via the Gene Targeting and Transgenic Facility), etc.  The Institutional Animal Care and Use Committee (IACUC) oversees all animal use, approves animal use protocols, inspects both laboratories and vivaria, and provides training in the use of animals in research.

The UVA Cross Campus Grid (XCG) can run applications that need to be executed thousands of times, or jobs that are too large to run on your current computer system.  Jobs on the XCG are distributed to processors throughout the Grid and are executed concurrently.  The XCG has access to approximately 1700 cores and can run jobs compiled statically in C/C++, Fortran, or Matlab. It can also run small parallel jobs that use the MPI (Message passing Interface) libraries.

The University has a service contract with NovaMed, which covers a wide range of research equipment.  Equipment covered by this contract includes:  refrigerated ultracentrifuges; microcentrifuges; HPLCs; beta scintillation counters; gamma counters; low temperature freezers/coldrooms; autoclaves; diagnostic imaging equipment; ice machines; dishwashers; and dish dryers.

NovaMed:

The SOM Graduate Programs Office maintains an updated list of current and pending NIH T-series training grants supporting pre- and post-doctoral fellows and other documents that are useful in the development of federal training grant proposals (click on “UVA School of Medicine Training Grant Support”).

Contact the UVA Office of Records Management for additional information.

Grant & contract records.  NIH generally requires that files resulting from sponsored research be retained for at least three years after the final financial report has been filed.  Commonwealth of Virginia record retention regulations are more strict and require that such records be retained five years after filing of the final financial report of a funding period (e.g., a four-year R01).  See the paragraph on retention, below.

In addition to maintaining accurate and complete records for data analysis, investigators must manage other records relating to the conduct of the project, such as management of research funds, and the development of intellectual property.  There are four aspects of data management and protection that are critical to the responsible conduct of research:

• Ownership.  All forms of data resulting from University sponsored projects are the property of the University.  If an investigator leaves UVA, he or she may transfer the data to another institution, if approved by the Vice President for Research.
• Collection.  Data may be collected in a number of ways:  electronically, manually, by taped interview, etc.  It is critical that the original recording and subsequent transcriptions of those data be accurate and reliable.  You and your staff should agree upon data recording and transcription techniques.  Standard Operating Procedures (detailed instructions permitting uniformity in performing specific activities) are helpful to maintain consistency across members of a research group.
• Security.  Make sure that your data are backed up, with a copy stored off-site.  (If your computer is on a local area network, your files already are being backed up routinely by your LAN administrator.)  Protection of data also includes restricting unauthorized access to clinical data, and ensuring that such data are used only as approved by the IRB.  UVA policy IRM-015 defines the conditions under one may electronically store highly sensitive data, including PHI.
• Sharing.  Investigators must balance the reasons not to share (i.e., to protect intellectual property rights, allow priority in publication, or protect the privacy of research subjects) with the benefits of sharing data (to move the field ahead, allow replication of experiments, or satisfy legal or funding agency requirements).  It is generally agreed that prior to publication, investigators are not required to share proprietary materials.  After publication, unless constrained contractually, investigators should share with their colleagues at other institutions.  Certain journals require that authors share with members of the scientific community for noncommercial purposes any biological materials that are newly described in a publication.  For policies governing NIH-sponsored research, see its data sharing policy site.
• Retention.  UVA data must be retained to confirm research findings, establish priority of inventorship, for potential fraud investigations, for use in the FDA licensure process, etc.  UVA policy requires that raw data be retained for at least five years after project completion (i.e., publication or termination of research support, whichever comes first) unless otherwise required by contract, law, regulation.  Do not underestimate the benefits of retaining data or specimens:  for example, the gene sequence of pandemic Spanish influenza in 2005 was derived, in part, from preserved lung tissue retained at the Armed Forces Institute of Pathology since 1918!  Please refer to the UVA records management site.

FDA regulations require that clinical study documents be retained until at least 2 years after the last approval of a marketing application and there are no pending or contemplated marketing applications, or at least 2 years have elapsed since clinical development of the product has been discontinued.  Regulatory requirements or contractual agreement with the sponsor may increase this interval.

This office, a service of the Medical Center, supports clinical drug trials in many ways, from study design and submission of IND applications, to drug preparation, storage, logging, and dispensing.

Hours of Operation: Monday – Friday, 7:00 am – 6:00 pm

Phone: (434) 982-1048

When a PI decides to transfer to or from UVA, it is important that their research funding transfer with them as efficiently as possible.  The PI moving to a new institution should notify both the funding agency and the grants offices in both institutions to initiate this process.  Transfers of contuing awards require the submission of a transfer application by the new institution.  The transfer application is reviewed administratively to determine (1) if the transfer is appropriate and (2) the level of NIH funding to be sent to the new institution.

Decisions to authorize transfer of grants are based upon the following criteria:

• The original grantee institution is willing to relinquish the grant;
• The facilities and resources at the new institution allow for the successful performance of the project; and that
• The investigator plans no significant changes in research objectives or increases in the direct costs previously authorized by the agency.

The agency may decide to terminate the original grant and and forward the replacement application for peer review against other new applications.  Budget periods with fewer than 6 months remaining, or awards in a no-cost extension phase, will be only be transferred only under very unusual circumstances.

To request continued support at a new institution and to accomplish close-out at the original institution, the following must be submitted:

From the investigator’s current institution

• Form PHS 3734, Official Statement Relinquishing Interest and Rights in Public Health Service Research Grant  Research Grant.  A relocation application will not be processed until this form, signed by the proper institutional officials, has been received at NIH, Grants Management Branch.  This form provides the effective date of relinquishment, estimated direct and F&A costs for the current budget period only, and a statement of intent concerning the transfer of equipment. (Do not include automatic carryover amounts from prior year unobligated balances on the relinquishing statement unless identified separately).
• Form HHS 568, Final Invention Statement and Certification.  This form should be submitted to the Grants Management Branch no later than 90 days following termination of the grant at the original institution.  This report covers the entire period of the grant and must list all inventions that were developed during the performance of work on the supported project (whether or not previously reported).  Each statement will require the signature of the principal investigator and an official authorized to sign on behalf of the original grantee organization.
• Financial Status Report.  This form should be submitted to the Grants Management Branch no later than 90 days after the end of the final budget period at the original institution.  The final report of expenditures covers the final budget period, must have no unliquidated obligations, and must indicate the exact balance of unobligated funds.  At UVA The Office for Sponsored Programs is responsible for submitting this form.
• Equipment Transfer is addressed in part by the Official Relinquishing Statement, listing equipment purchased with the grant funds with an acquisition cost of $5,000 or more, which will be transferred with the project.

From the new investigator’s new institution

• Form PHS 398, Grant Application Forms.  The new institution must submit an application with “CHANGE OF GRANTEE INSTITUTION” typed in capital letters across the top of the face page and budget pages.  This application should be sent to the responsible Grants Management official at the awarding institute.  If the original award was the result of a modular application, modular procedures also apply to the request for change of grantee.  It should include the following:
  • Face Page
  • For applications made under modular procedures:  Narrative budget information, including total direct costs for the current budget period, and if future budget periods remain, information regarding the number of modules should be based upon the previously recommended levels.  In the event of a mid-budget transfer, the initial budget should be based upon the direct costs being relinquished by the original institution as reflected on Form PHS 3734. (Do not include carryover amounts from the previous year on the narrative budget for the initial budget period. If there are any carryover amounts, provide a separate statement on the narrative budget justification, Note: carryover funds should be included in Box 9 of the final FSR)
  • For applications made under awards other than modular procedures – A detailed budget for the initial (transfer) budget period and, when future commitments exist, categorical budgets for those periods. Follow instructions above for mid-budget transfer.
  • Biographical sketches for all new key personnel
  • Updated other support pages for all new key personnel
  • Resource page describing the facilities at the new institution and the probable effect of the move on the project
  • List of equipment (which was purchased in whole or in part with grant funds and has an acquisition cost of $5,000 or more) to be transferred from the original grantee institution. The listing in the application represents the new institution’s acceptance of title to equipment transferred and accountability for it at the end of the newly established project period
  • A progress report summary, which will serve in lieu of a final progress report at the original grantee institution. The progress report should be a brief presentation of the accomplishments on the research project during the reporting period.
  • A statement concerning the current research plan and an indication of whether the original plan has changed. If changed, provide appropriate details.
  • Completion of all assurances identified on the CHECKLIST in the PHS 398, and as required by policy, Human, and Animal subjects, Debarment and Suspension, Lobbying, Indirect Costs, etc.
• Application requesting the transfer of previously recommended support may be    submitted without regard to the deadline dates indicated in the PHS 398 instructions.  The application should, however, be submitted as early as possible to allow for administrative review (approximately 4- 6 weeks before requested start at the new grantee institution).

This procedure specifically refers to the transfer of PHS/NIH research grants.  Other agencies have their own procedures for grant transfers.  It is also important to note that there are many other issues to address when moving to a new institution, such as the transfer of equipment, intellectual property and other materials. New faculty coming to UVA should consult our ” new faculty” page.  Departing faculty should follow the UVA Provost’s departure checklist.   Please contact the Office of Grants and Contracts directly concerning departing or arriving so the office can assist you in the transfer process.  Please contact your departmental contact via e-mail or by calling 924-84

In addition to PHS requirements, UVA also has procedures for the transfer of equipment (UVA policy, SOM policy) when such transfer will further the departing faculty member’s research and not handicap the UVA department or other faculty. The PI must prepare and submit a University of Virginia Equipment Inventory Change Request (P-1).  All equipment items must be referenced by the UVA Asset Tag #, a brief description of the item, its current location on Grounds as well as the proposed new location must be provided.  Please note: if the source of funds from which the item was initially purchased as well as the original purchase price and current market value are also requested so that we can ensure that the equipment transfer is allowable.  An approved list showing All equipment the investigator is transferring (purchased either from research grants or with other funds) must be submitted to the Office of Grant and Contract Administration for further administrative action.  This list should be endorsed by the Department Chair, and the SOM Assistant Dean for Research Administration, indicating their approval and include kind of equipment, purchase price, source of funds for purchase and UVA equipment inventory number.

• Clinical Trials Office
• School of Medicine Clinical Research Unit
• Institutional Review Boards (IRBs)
• Investigational Drug Service
• Compliance and training (radiation, chemical, biosafety, conflict of interest, misconduct, etc.)
• Material Transfer Agreements
• Intellectual property and entrepreneurial activities

• SOM core facilities
• Core facilities handbook 2013
• Moving your lab within UVA (Environmental Health & Safety checklist for decommissioning labs
• Intellectual property management plans site (NIH site)
• Model organism sharing plans (NIH site)
• NIH Genomic Data Sharing Policy (and guidance for developing GWAS data-sharing plans)
• UVA institutional information for proposals
•  Federal rate agreement (F&A and fringe benefits rates)
• Proposal preparation and submission checklist
• Help with grants.gov electronic submissions
• Internal pre-review of grant proposals: a best-practices document
• Descriptions of NIH study sections (NIH Center for Scientific Review)
• The NIH application cover letter
• NIH “All About Grants Podcast”
• Help with other NIH-required sections (animals, research subjects, resource sharing plans, etc.)

• Assistance with developing clinical study budgets (Clinical Trials Office)
• Developing NIH clinical research proposals (NHLBI site)
• Navigating UVA regulatory compliance requirements

• The proposal approval process at UVA
• NIH limits on resubmission of proposals
• Video of an NIH mock study section (NIH site)
• Contracts and clinical trials agreements

Contracts checklist and required internal paperwork

Material Transfer Agreements

Confidential Disclosure Agreements (CDAs, also known as Nondisclosure Agreements)

CDA Request Form (to accompany requests to for Grants and Contracts review)

Consulting agreements 

Recommended Practices for Institutional Cost Recovery on Industry Sponsored Clinical Trials

Billing Coverage Analysis Template (for clinical trials agreements being processed for the Clinical Trials Office)

If you are planning to submit a grants.gov electronic proposal, please contact the grants administrator assigned to your department/division in advance.  We want to ensure that you have appropriate information needed to compose your application (ie., software, correct Funding Opportunity Announcement, institutional information required for on-line applications, formatting requirements for attachments, etc.).

The NIH estimates that it will take approximately 40 hours to prepare an electronic application.  If you contact our office we can help you wade through the administrative requirements of the application so that you can spend your time on the more important components of your application. Please note that the NIH Division of Receipt and Referral (DRR) in the Center for Scientific Review, (office that receives all grant submissions) is becoming increasingly strict.  Failure to follow specific guidelines provided in the PA or RFA, for example, could result in the rejection of the proposal submission.

All applications must be complete and ready to be submitted electronically when received by our office.  Starting January 2011 due to the two-day error correction window being eliminated we will need the completed packages seven business days before the deadline. We cannot guarantee that we will be able to process proposals that are incomplete or arrive less than five business days in advance of the deadline.  The Office of Grants and Contracts will be date and time stamped upon receipt. To be considered compliant with this policy, all components must be final and have a signed internal proposal approval form.  Late applications will be held by the Director, Office of Grants & Contracts. Only after compliant grants have been submitted will the Director release late applications to grant administrators for review. Successful submission cannot be assured. Periodic reports of late applications will be provided to the Dean.

Route two paper copies and a goldenrod (proposal approval) form.  Although the application will be submitted electronically, our business practices remain the same.  Our goal is a paperless environment; until we reach that goal, we appreciate your providing copies for the Office of Sponsored Programs and the Office of Grants and Contracts.

The preferred mechanism to transmit your on-line application to our office is to save the application to the SOM Z: drive.  Your SOM department has one or two designated staff with access to that drive. Grants and Contracts will access and submit your application directly from the Z: drive.

Every application is validated first in the grants.gov system and then by the NIH eRA Commons.  The validation involves computer checking and matching of numerous fields.  An error message will stop your application from being processed; a warning will allow the proposal to be forwarded on for peer review.  It is important to check your proposal online as soon as possible to make sure that it is a complete and appropriate version.  Below is a listing of the most common errors and warnings PIs receive.  Please do not wait until the last minute to contact Grants and Contracts for help.

The NIH now allows multiple PIs on research grants; however, this option is available only on certain Funding Opportunities.  Do not assume you may use the multiple PI option on an unsolicited R01; multiple PI applications will only be accepted by the system in response to an FOA that allows it.  If you are planning to submit a multiple PI proposal , please:

• Identify a “Contact PI” on the goldenrod.  The contact is the PI responsible for coordinating the submission.  Although a separate project will be established for each PI, the overall account structure will be based on the owning org of the Contact PI.
• Provide a goldernrod and separate budget for each PI.  The budgets are for internal purposes and will be used to establish the accounts in the hopeful event an award is made.

The SOM policy on multi-PI proposals may be accessed here.

PI responsibilities.  PIs are responsible for logging onto the NIH eRA Commons site within 48 hours of proposal submission and to proactively check the status of their proposal.  Check for error messages and contact Grants and Contracts immediately if a problem exists.  If you leave town after the proposal has arrived at Grants and Contracts, make sure you inform your Grants and Contracts contact with information on an individual who can contact you in an emergency and/or has access to the files used to create your proposal.

Proposals may be corrected and resubmitted up to the submission deadline with no explanation: however if a correction is needed after the deadline has passed due to system identified errors/warnings the PI must write a letter to their Program Officer to be co-signed by the Authorized Business Official explaining why the proposal needs to be resubmitted (i.e. exceeding page limit, eRA commons user name missing for PI, transposed DUNS #, etc).  Include information from any previous cover letter(s), since that information is not retained.  That letter needs to be uploaded into the corrected proposal.

Allow up to 1 weekday from the time NIH has retrieved the application from Grants.gov for the status to appear in the NIH Commons.  The NIH Electronic Submission websites and the application guide are excellent sources for questions about errors and warnings. See, in particular, the NIH sites on applying electronically and preparing an electronic application.

Remember, errors are fatal:  your application will not be accepted until all errors are resolved and the ARO submits a complete Corrected/Changed application through grants.gov.  Warnings must be reviewed and may require corrective action; if not acted on, your proposal may be forwarded for peer review, but may result in the proposal having to be withdrawn at a later date.  PIs most most commonly receive these errors and warnings.

PIs and department administrators are advised to check proposal status carefully and to notify their grants administrator in the Grants and Contracts immediately to resolve questions or concerns.

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.

• 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 the UVA consulting 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 UVA Health Foundation.

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.

• 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. You can request descriptions of core facilities from core directors.
• 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.
• 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.
• NIH RePORTER allows you to search current or previously-funded NIH projects. Searches can be filtered 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.
• Federally negotiated F&A and fringe benefits rates and the current rate agreement can be accessed on the Office of Sponsored Programs web site (click on “Rates” at the top of the page).

• The National Institute of Allergy and Infectious Diseases (NIAID) has developed an excellent resource titled ” All About Grants Tutorials,” including sample applications and summary statements.  Also see this more consolidated NIH site on grant writing tips.
• 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 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.

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.

• Notify your department administrator of your intent to submit a proposal and its deadline as soon as possible; coordinate your responsibilities for each section of the proposal.
• Follow sponsor instructions for application preparation (document length, font size/spacing, structure, required forms).
• Justify extraordinary budget changes among years.
• Include full F&A costs in your budget 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.

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).

The Clinical Trials Office (924-8530; uvaclintrials@virginia.edu) assists investigators and clinical coordinators in the development of clinical studies budgets and budget negotiation.

• Human subjects:  See  NIAID’s Human Subjects Resources.
• Use of animals. See NIAID’s How to Write an Application Involving Research Animals. Contact the ACUC 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.

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 proposal approval sheet (also known as “the goldenrod,” after its former color). We have posted a version for the SOM version. Your research administrator should help you complete this form, though you, as Principal Investigator, are responsible for reviewing and approving its contents. Forward the approval sheet, technical proposal, budget, justification, and other supporting documents to your Chair and then to Grants and Contracts (who require at least seven 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.

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 an at-risk 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.

• Funding opportunities (SOM)
• VPR Funding Opportunities site
• Health Sciences Library funding discovery site
• Pivot (funding discovery tool)
• GrantForward (funding discovery tool)

Three general resources for postdoctoral fellows:

• UVA Postdoctoral Office (Vice President for Research & Graduate Studies). Provides information on internal funding sources, benefits, training in English as a second language and writing, seminar series, professional development, and more. The site includes a postdoctoral handbook describing stipends, benefits, etc.
• National Postdoctoral Association. Statistics and comparative policies from academic institutions, information on career development and for international scholars, etc.
• “Making the Right Moves” (Burroughs Wellcome Fund and Howard Hughes Medical Institute) covers topics as diverse as negotiating one’s contract, structure of academic institutions, staffing a research group, time and project management, etc. A must-read for postdoctoral fellows and new faculty.

Foundations and professional organizations. Many foundations and professional organizations support postdoctoral fellowships in basic or clinical research. Discuss such opportunities with your research mentor.

Federal sources. Ruth L. Kirschstein National Research Service Awards for Individual Postdoctoral Fellows (NIH F32 awards) provide support of up to three years for U.S. citizens or Permanent Residents. The National Science Foundation administers a Postdoctoral Research Fellowships in Biological Informatics program.

Because NIH is comprised of 24 different grant-awarding Institutes and Centers (ICs) which provide funding, there is no simple answer to this question. However, if you are talking to an NIH Program Official about your idea or potential research project, you are already on the right track to receiving NIH funding.

While NIH awards many grants specifically for research, we also provide grant opportunities that support research-related activities, including: construction, training, career development, conferences, resource grants and more. Specifically, we encourage projects that have the three following qualities:

Learning more about projects already funded by NIH can be a great help when you are preparing your grant proposal. Using the Research Portfolio Online Reporting Tool (RePORT), you can craft a comprehensive search of all NIH funding activities according to your specific interests. This search will result in a list of funded projects, for each of which you will be able to view an abstract and statement of public health relevance, as well as contact information for the project’s PI.

Connection to NIH funding activities is just a few clicks away. Head to the RePORT homepage and click on NIH CRISP. Here you can filter your search according to key words, general topics, sponsoring Institutes or Centers, geographical locations, and fiscal years. As you read through project descriptions, keep in mind that one of NIH’s primary goals is to develop, maintain, and renew biomedical resources that will improve our nation’s health. Think about how your work might build upon projects that NIH has already funded, and highlight in your proposal how your scientific work will be relevant to public health. You might also consider using CRISP to locate potential collaborators or mentors.

Help reviewers find exactly what they are looking for in your research plan by breaking your proposal down according to the primary review criteria: significance, investigator(s), innovation, approach, and environment. Begin each section with clear, descriptive headers that effectively frame your research plan.

A succinct introduction should address the significance of your project, weighing its impact on your field and related fields, as well its impact in the greater context of public health. Consider the following questions from the Enhanced Review Criteria chart:

• Does the project address an important problem or critical barrier to progress in the field?
• If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?
• How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Next, address how PD/PIs, collaborators, and other researchers are suited to the project. Outline appropriate experience and training, and highlight any accomplishments that have encouraged advancements in the field(s). If the project is collaborative or multi-PD/PI, show that investigators have complementary and integrated experience.

Now reflect on the innovation that project offers. Keep in mind that even if a project not, by nature, innovative, it may nonetheless be essential to advancing a field. Discuss how your work will challenge or improve current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches, or methodologies, instrumentation, or interventions or by refining the use of these concepts, approaches, methodologies, or instrumentation.

A thorough description of the approach you will take is critical. Show how well-reasoned and appropriate your overall strategy, methodology, and analyses are to accomplishing the specific aims of your project.

Following the details of your approach, include a profile of the environment in which the work will be done. Consider the adequacy of resources such as institutional support and equipment. Also take into account how the project will benefit form any unique features of the scientific environment, subject populations, or collaborative arrangements.

Finally, add a section that addresses items of ethical concern applicable to your project-for example the use of vertebrate animals or human subjects (including gender and minority representation or the inclusion of children).

From Extramural Nexus, NIH Office of Extramural Research
Published 2009*

This site searches a large number of federal and non-federal sources; can save searches and request e-mail notifications of opportunities that match your search.  Requires virginia.edu domain log-in.

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Similar to Pivot, but accesses a slightly different set of funding sources.

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Not-for-profit sponsors and requests for proposals.  This subscription service requires assistance by the Foundation and Corporate Relations Office (Health System Development).  Please contact Dr. Steven Wasserman (ssw3an@virginia.edu) in the Office for Research if you wish to have a search conducted.

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Search for federal grant and contract opportunities.

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Information on federal government contracts.

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