Managing the Science of your Award


Summary and quick links

Moving your research to or from UVA
An excellent resource book ("Making the Right Moves")
UVA research core facilities
Animal facilities 
Training grants at UVA
Data management and record retention
Clinical research-specific topics:
       Clinical Trials Office 
       General Clinical Research Center
       Institutional Review Boards (IRBs) 
       Investigational Drug Service 
       Retention of clinical study documentation
       Managing a clinical research project (link to NHLBI Web site)
Training (radiation, chemical, biosafety, etc.)
Intellectual property and entrepreneurial activities

Moving your research to/from UVA.  Your primary point person at either side of a move to another institution should be your local administrator.  S/he can help you to negotiate any legal and regulatory hurdles and make the move somewhat smoother.  The main areas that you should consider are:

  • Personnel.  If you wish to bring laboratory or clinical staff to UVA, your administrator will work with UVA Human Resources to ensure appropriate hiring and that these individuals are entered into the payroll and benefits systems.
  • External research awards.  If you hold externally-funded research awards, the School of Medicine Office of Grants and Contracts, its counterpart at your other institution, and the sponsor will help transfer them to/from UVA.  This process should be initiated as soon as you have accepted your offer.  See the Grants and Contracts Web site for details on how NIH awards are transferred between institutions.
  • Equipment.  Transfer of research equipment among institutions depends on the source of funds used to purchase it.  Most institutions will allow the transfer of equipment purchased using federal funds, if the project will continue at the new institution, but usually will not allow the transfer of equipment purchased with institutional funds.  Contact the School of Medicine Office of Grants and Contracts.
  • Research animals.  Contact The Center for Comparative Medicine 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.  See the CCM Web site for detailed procedures for shipments to UVA and shipments to other institutions.  The Gene Targeting and Transgenic Facility can cryopreserve animal lines prior to their shipment, for reconstitution at another institution.
  • Intellectual property (IP).
    • IP that you developed at your current institution should be moved under a materials transfer agreement (MTA).  Contact the Office of Grants and Contracts to move this process forward.
    • 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 Patent Foundation will work on a license to/from UVA.
    • IP that has been partially developed at your 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, de novo, rather than having your current institution create an MTA allowing a secondary transfer.  Create a list of the materials that you wish to bring, their originating institutions and investigators, and contact the Office of Grants and Contracts and the technology office at your other institution to negotiate new MTAs.

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An excellent resource for managing one's career and research group is "Making the Right Moves," which is published by The Burroughs Wellcome Fund and The Howard Hughes Medical Institute.  This document covers topics as diverse as negotiating one's contract, structure of academic institutions, staffing a research group, time and project management, etc.  This is a must-read for postdoctoral fellows and young faculty.

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UVA research core facilities.  The School of Medicine supports several state-of-the-art core facilities that are available to 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 administered by Jay W. Fox, Ph.D., Assistant Dean for Research Support, and include:

Animal facilities.   The Center for Comparative Medicine maintains the University's AAALAC-accredited facilities supporting biomedical research using 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, and inspects both laboratories and vivaria.  The IACUC also provides training in the use of animals in research.

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Training grants at UVA.  The SOM Graduate Programs Office maintains an updated list of current and pending NIH T-series training grants supporting pre- and post-doctoral fellows.  (UVA intranet; click on “UVA School of Medicine Training Grant Support.”)

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Data management and record retention

Grant & contract records.  NIH generally requires that files resulting from research awards be retained for at least three years after the final financial report has been filed. 

Research data.  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, provided that the Vice President for Research and Graduate Studies approves this transfer.
  • 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.  Collection and transcription of clinical research records are governed by Good Clinical Practice (see http://www.fda.gov/cder/guidance/959fnl.pdf).
  • Protection.  Data in all forms should be backed up, with a copy stored off-site.  (If your computer is on a local area network, your files are being backed up routinely by your LAN administrator, to off-site disks or tapes.)  Protection of data also means not allowing unauthorized access to clinical data, and ensuring that such data are used only as approved by the IRB.
  • 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 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 (e.g., American Society for Microbiology journals) require that authors share any biological materials newly described in the article with members of the scientific community for noncommercial purposes.
  • Retention.  All UVA data must be retained to confirm research findings, establish priority (of inventorship), in case of fraud investigation, and (with respect to clinical trials) for use in the FDA licensure process.  The UVA recordkeeping policy states that all raw data must 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:  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 our guidance document on retention and destruction of public records, which lists the requirements for the most commonly encountered documents at the School of Medicine.

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Clinical Trials Office.  The CTO offers support in the preparation of clinical trials proposals (budgets, protocol design, IRB issues), training of clinical research staff, and conducts audits of regulatory and clinical forms resulting from clinical trials.

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General Clinical Research Center.  Since 1968, the GCRC has provided investigators with specialized resources necessary to conduct advanced clinical research, including ten inpatient beds, research nurses, core assay laboratory, metabolic kitchen, outpatient facilities, computing and statistical consultants and facilities, and sleep and exercise physiology laboratories.  The facilty can be contacted by phone (924-2394) or e-mail (GCRC@virginia.edu).

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Institutional Review Boards.  The IRB-HSR (Institutional Review Board - Health Sciences Research) is responsible for review and approval of studies involving biomedical/invasive procedures, which comprise the majority of clinical research initiated at the School of Medicine .  The IRB-SBS (Institutional Review Board - Social and Behavioral Sciences) is responsible for approving and overseeing non-invasive studies involving human subjects (e.g., survey studies).  Contact their administrators or Web sites for information on on-line applications, help in crafting proposals, and the review and approval processes.

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Investigational Drug Service.  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.  Investigators considering the use of the IDS should contact them at x2-1048.

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Retention of clinical study documentation.  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.  Again, regulatory requirements or contractual agreement with the sponsor may increase this interval.

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