ALS (Amyotrophic lateral sclerosis, Lou Gehrig’s disease) is very severe but rare, with a prevalence of approximately 4 cases per 100,000 individuals. ALS is approximately twice as common among Veterans, especially those with a history of deployment in certain regions, and unfortunately an effective therapy is still needed. VBRI investigators continue to uncover key factors that are involved in this neuromuscular disorder by studying ALS samples and model systems. The results are pointing to molecular regulators that can be modulated to achieve neuroprotection and are helping to advance the field towards the goal of arresting or reversing neurodegenerative disorders.

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This section of our site provides the Veterans we serve with supplementary materials for specific programmatic initiatives through the medical research and education programs at VBRI.

To access content specific to a study or research program, please click the appropriate link below and enter the password when prompted.

If you do not have the password, lost your password, or were not provided the password to access these materials by affiliated program staff, please fill out the form below and a member of our support team will be in contact with you as soon as possible.

• Purchasing
• Meeting and Conferences
• Consultant Services
• Travel

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• Holiday Schedule
• Payroll Schedule
• Personnel Action Form
• Position Description
• Timesheet

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Diabetes affects between one-fifth and one-fourth of the Veteran population, its incidence increases with advancing age, and it can cause a near doubling in a person’s risk for heart disease, nerve damage, loss of eyesight and other serious medical complications.

Diabetes research at VANJHCS encompasses multi-center, national and international clinical trials involving testing of new medications to treat diabetes. Current studies provide important information about the effect of glucose-lowering or blood-pressure lowering on the progression of cardiovascular or kidney complications in adult-onset diabetes.

In addition, one focus of our diabetes research has been understanding biological mechanisms responsible for the clustering of specific diabetic complications in the same patient. For example, why do patients suffering with kidney problems frequently also suffer with eye disease, heart problems or mental health issues? Is there a single cause for the clustering of these particular complications?

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VBRI supported research aims to identify the effects of exposure to potentially harmful materials while serving in the military, e.g. burn pits, dust/sand storms, and toxin exposures, that have been implicated in symptoms of fatigue, cognitive difficulty, chronic pain and breathing problems. For example, our research program investigates both the reasons for and treatment of Veterans with multiple, unexplained chronic symptoms (i.e. Gulf War Illness). VBRI supported researchers are additionally exploring the long-term effects of these exposures on cardiovascular and lung function, which may underlie many of the symptoms reported in deployed Veterans.

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Suicide rates have been rising in the US since the new millennium. US military Veterans have been more likely to die of suicide than the civilian US population. In 2019, over 6,000 US military Veterans died by suicide, representing 13.7% of all deaths by suicide among US adults, despite representing <7% of the total US adult population.

As a result, suicide prevention is the top clinical priority at the Veterans Healthcare Administration. Hope is offered by the fact that recent years have begun to witness a decline suicides, both by Veterans and their civilian counterparts. These decreases coincide with an unprecedented amount of research and system-wide effects to address the problem. The reasons for the reduction are still being understood and some racial/ethnic groups continued to experience increased rates, despite the overall recent decreases. The need for continued research, special programs, and healthcare system-wide initiatives is clear. Researchers at VA New Jersey have randomized clinical trials in various stages of completion examining treatment approaches for individuals suffering with the despair that leads to suicide. VA New Jersey researchers are also studying objective indicators of cognitive functioning that can be used to assess and detect when individuals are at increased risk of suicide, and help explain the thinking changes that lead individual to make a suicide attempt.

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Medical advances prior to Operations Enduring Freedom, Iraqi Freedom, and New Dawn led to the survival of many causalities who previously would have died from traumatic brain injury (TBI). In addition to TBI, other injuries sustained from IED blast exposures include impact on pulmonary function. We now need to help blast survivors live a viable post-deployment life with their blast-related injuries.

We are supporting research that is focused on understanding the long-term effects of blast exposure. Cardiopulmonary symptoms of shortness of breath and decreased exercise tolerance after return from deployment are a major concern for many Veterans of Iraq and Afghanistan. While much of the focus has been on burn pit exposure and particulate matter as causal factors, there is growing evidence supporting a contributing role of blast-related lung injury. Acute blast overpressure (BOP) lung injury resulting in gross injury is well established. We are supporting research aimed at addressing the less known, possible long-term, or latent effects of less severe BOP lung injuries.

Other work is also being conducted in the neurology and neurobehavioral laboratories, which is focused upon identifying long-lasting chemical changes in the brain following TBI and novel targets for treatment.

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VBRI accepts funds in support of the research and education mission of the VA New Jersey Health Care System. All funds deposited in the Institute and all equipment purchased with Institute funds are the property of the Institute and are subject to policies and procedures established by the Board of Trustees. Such policies and procedures will be consistent with applicable federal and state statutes and regulations.

The Institute may only invest in instruments backed by the full faith and credit of the U.S. Government. Interest earned on these investments are deposited into the Administration account.

Grantors or donors may send funds by check or electronic transfer. For deposit directly to VBRI’s account, the Executive Director will provide the necessary information.

All checks or other funds directed to VBRI should be made payable to the Veterans Bio-Medical Research Institute, Employer Identification Number (EIN) 222995785. Checks made payable to other individuals or organizations cannot be accepted.

If funds are received in support of a specific research proposal, no funds directly related to the scientific activities of the study may be expended until that project has received approval from the VANJHCS R & D Committee.

If funding is received in support of a specific educational or training activity, no funds may be expended until that activity has received approval from the VANJHCS Education Committee.

Sources of Revenue: The general categories for revenue are: (A) voluntary health agency and private foundation research grants; (B) corporate sponsored grants or studies or gifts; (C) federally-funded programs; (D) transfer funds and (E) miscellaneous. The administration of funding may vary depending on stipulations of the funding source. Funds derived from indirect support provided by sponsored research or education activities administered by the Institute will be used to support the operations of the Institute. These institutional funds may also be used to respond to needs for direct or indirect research costs or educational and training support as identified by the VBRI Board of Trustees. The Board of Trustees must approve all support provided. All support will be reviewed on a quarterly basis.

1. Voluntary Health Agency/Private Foundation Research Studies

   Funding in this category is derived from nonprofit entities to support a specific research or education proposal or career development award. Indirect cost reimbursement rates vary among sponsors. Some sponsors in this category do not provide overhead costs or have set limits for this support. The investigator should review the proposal and budget with VBRI prior to submission to the sponsor. If required, funds may be accepted and administered by VBRI with less than the approved indirect cost rate.

2. Federal Programs

   Grants or contracts from federal agencies, including the National Institutes of Health or Department of Defense, are included in this category. An indirect cost rate is negotiated with the cognizant agency, generally the Department of Health and Human Services. The indirect costs are provided to the grantee institution in addition to the direct costs provided for support of the studies.

3. Corporate-Sponsored Research or Education Grants/Gifts

   Funding in this category is usually provided by pharmaceutical or other commercial sponsors involved in the development of new drugs or devices, or in the support of medical research or education. The studies may be investigator initiated or sponsored by the pharmaceutical company. Negotiations for this type of award should ensure that the VBRI indirect cost rate is provided as an additional cost to the funding required for the study. The applicable rate should be reviewed with VBRI administrative staff.

   All agreements must be reviewed by VBRI. The Executive Director or designee has the authority to sign for VBRI. Investigators cannot sign agreements that bind VBRI or VANJHCS. In general, the parties to these agreements are VBRI and the sponsor. The investigator should not be named as a party to the agreement.

4. Transfer Funds

   Investigators may transfer funds from accounts in other nonprofit institutions to VBRI. Indirect costs may have already been deducted or may not have been requested on these funds. Such exemption does not extend to funds in support of an active project being transferred; rather, project funds will follow the stipulations or guidelines of the funding agency or institution.

5. Miscellaneous Support

   Sources for funding in this category are broad and include speaker fees, and other miscellaneous donations.

The following additional information on acceptance of this category of donations has been compiled in conjunction with the National Association of Veterans Research and Education Foundations (NAVREF).

VA investigators often choose to have an honorarium or speaker fee directed to a nonprofit corporation as a donation in lieu of accepting it personally. Unfortunately, the nonprofit cannot accept any donations in the form of an honorarium.

Investigators sometimes also believe they will not be assessed personal income taxes on a speaker fee if they instruct the payer to send the check to a nonprofit. However, the IRS is likely to view as income amounts earned any time there is a quid pro quo – an exchange of goods or services for payment – or when an individual exercises control over dispensation of payment. Such payments may be taxable to that individual regardless of whether payment goes to a nonprofit or the individual accepts it personally.

VBRI is not responsible for monitoring VA employees’ ethics except in regard to conflicts of interest. Nor does VBRI give tax advice. However, VBRI can help prevent violations of federal ethics regulations by requiring investigators to complete a simple form regarding donations of honoraria. This form must be filled out when donating speaker fees, writer’s fees or other similar funds.

Alternatively, a letter from VBRI to the sponsor can be sent requesting an unrestricted donation to VBRI in lieu of an honorarium. These funds may be deposited into general funds. Use of the funds will be under the control of the Board of Trustees. Special requests for use of these funds can be directed to the Board.

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After research study closeout or completion of an educational activity, residual funds may remain. If residual funds remain after completion of the project, all expenses have been paid, and there is no requirement by the sponsor to return unexpended grant funds, these monies may be transferred to a general research account (“0”) to be used by the project Investigator for general research and education expenditures for a 12 month “bridge” period. After the 12th month following post-study closure, the unused residual funds will be automatically transferred into the VBRI general support fund to benefit VA research and education at VANJHCS. VBRI Principal Investigators and associated VA staff can make requests to the VBRI Board for use of general support funds to cover the costs of research or education activities of importance to VANJHCS.

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Active Projects

If the investigator is moving to an academic nonprofit or other nonprofit research institution, or VAMC, to continue an ongoing VA-approved research project, remaining VBRI funds attributable to that project may be transferred to that institution at the discretion of the VBRI Board of Trustees. Equipment purchased with VBRI funds attributable to that project may also be transferred at the discretion of the Board of Trustees. Sponsor notification and approval is usually required.

If such funds retain donor-imposed restrictions, VBRI may be required to return remaining funds to the donor.

If an investigator resigns before a project is completed, the investigator may request that another VBRI investigator assume responsibility for research or education activities with VBRI funding. This request requires either R&D Committee approval or EDUCATION COMMITTEE approval, and may require the approval of the VBRI Board of Trustees and sponsor approval.

Residual Funds

Residual funds may exist after study completion and grant closeout if there are unexpended grant funds that do not require return to a sponsor subject to funding agency policies and guidelines. Any residual funds and equipment attributable to completed research projects or educational activities must continue to benefit VA research or education. Residual funds and equipment belong to the institution and their use is at the discretion of the VBRI Board. See Policy III. Residual Fund Accounts.

The Board may consider a request to transfer these funds or equipment to another VA-affiliated nonprofit corporation established under 38 U.S.C. §§7361-7368 if the investigator is transferring to another VA medical center. If a VBRI investigator is retiring or transferring to a non-VA institution, any remaining residual funds will be transferred to the VBRI general support fund to benefit VA research and education at VANJHCS. VBRI Principal Investigators and associated VA staff can make requests to the VBRI Board for use of funds to support research or education activities of importance to VANJHCS.

No funds or equipment may be transferred to for-profit organizations.

For all transfers, the investigator should submit a written request to the Board of Trustees for review including an explanation of the intended use of funds or equipment to benefit VANJHCS research or education. This request should be sent through the Executive Director as soon as possible in order to obtain necessary information for review by the Board.

If the request is approved, the transfer will be completed within a reasonable time. For transfer amounts above $25,000 a longer period of time may be required to complete the transaction. Investigators are encouraged to notify VBRI well in advance of the need for major fund transfers.

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Equipment purchased with VBRI funds are property of VBRI and will be classified according to the depreciation policy as defined below.

In addition, the acquisition of any equipment requiring space, utilities or other resources not available in the investigator’s assigned research space must be reviewed by VANJHCS R&D administration prior to placement of the order. Equipment to be purchased as part of an educational activity must be explicitly included in the proposal as approved by the EC.

Investigators should advise VBRI of any equipment purchase prior to placing the order to assure sufficient funds are available. Note that VBRI is not exempt from New Jersey state sales tax and the appropriate amount must be included in your cost estimate.

Equipment Inventory and Depreciation

1. Fixed Assets

   1. Durable, non-expendable items with an acquisition cost of $5,000 or more with a useful life of more than a year will be considered equipment. All such equipment, including furniture, purchased at $5,000 or more will be VBRI property and listed as a fixed asset.
   2. GAAP (Generally Accepted Accounting Principles) require that such fixed assets be depreciated over a reasonable term or the estimated useful life. Therefore, fixed assets will be depreciated using the straight-line method at a term set uniformly at five (5) years.
   3. The equipment or furniture listed as part of the Institute’s fixed assets will be affixed with an VBRI property tag and tracked biennially for location and condition.
   4. The acquisition cost will include all reasonable components that allow the equipment to function. The acquisition date will be the date of the invoice.

2. Inventory

   1. Durable items (equipment/furniture/computer systems) purchased with VBRI funds for greater than $2,500 will be listed on the VBRI inventory and affixed with an VBRI property tag in order to maintain an inventory record.
   2. These inventory items will be tracked annually for location or status, but will not be depreciated as fixed assets by VBRI.
   3. Individual components purchased for $2,500 or more and added to an existing computer system will be tagged as VBRI inventory, if reasonable to do so.
   4. A durable item purchased for less than $2,500 will not be tagged or listed as inventory.

If an investigator transfers an active research project to another 501(c)(3) research institution, s/he may direct a request to the Board of Trustees to transfer fixed assets or inventory items purchased with VBRI funds.

An investigator may request VBRI-purchased items be donated to VANJHCS for research support, except for equipment purchased with Federal Funds.

Payment for durable items listed as equipment or inventory must be requested on an Check Request Form. Section 10 “Equipment/Capital Goods” must be completed on this form when submitted for reimbursement or payment.

Durable items ordered through VBRI will ordinarily be delivered to VANJHCS and will be subject to acceptance based on available facilities and safety policy.

High Technology Sales/Use Tax Deferral

VBRI has received a certificate from the state allowing sales/use tax deferral for qualified machinery and equipment for the year starting 9/10/2004 awarded November 30, 2004 under RCW 82.63.

To excerpt from the state documentation:

1. Qualified machinery and equipment includes machinery and equipment that are an integral and necessary part of a pilot scale manufacturing or qualified research and development operation. The equipment is to be used exclusively for or in support of qualified research and development or pilot scale manufacturing.
2. Taxes are deferred under this program if the business uses the investment project for qualified research and development or pilot scale manufacturing during the year in which the investment is certified as operationally complete, and the next seven calendar years.

The equipment must be > $5,000 and be expected to last for 8 years. Tax is deferred in increments over the minimal 8 year life of the equipment. Therefore, if the tangible item does not last for 8 years, sales/use tax will be owed proportional to the remaining years. That is, if the equipment last 6 years, 2/8 of the total sales tax will be owed to the state. The amount deferred annually will need to be tracked for all qualifying equipment.

IT Equipment

VBRI funds may be used to purchase desktop and notebook computers for use in or support of VA-approved research. Purchase in support of an educational activity must be within the scope of the proposal as approved by the Education Committee for all education activities.

VA purchased computers/ laptops are defined as any computers purchased with VBRI funds and must have completed a form for “Personal Equipment put in VA use at the convenience of the user”.

All computers purchased must be shipped to the VBRI Office c/o the investigator. Once received the equipment must be tagged by IRM with the appropriate VA form completed as above before it is released for use. Computers that will be accessing the VA network will be encrypted by IRM.

Any questions concerning this procedure please contact the Executive Director and the President.

Notebook computers require a specific rationale for purchase that explains the need for a laptop.

Computers purchased with VBRI funds may in turn be donated to the VA for use unless this is specifically forbidden by the sponsor. Forms for this donation would indicate “equipment put in VA use” on the VBRI website. Specifically, this can not apply for items purchased with Federal Funds.

VBRI funds may not be used for the purchase of cell phone equipment unless specifically approved by the Board of Directors. In general it is not allowed.

Other specialty devices or electronic items such as digital cameras may have a valid research rationale, but due to the potential personal use should be pre-approved before purchase and with written justification.

Equipment Disposal

After 5 years, if equipment is obsolete, it must be turned into VBRI for disposal, or for large equipment disposal must be arranged. For equipment purchased with federal funds, disposition must be arranged with the sponsor. If the equipment has a hard drive, it will be removed and turned in to IRM. Exceptions include where the PI can continue to make use of the equipment beyond the 5 year period.

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VBRI was established under 38 USC §§7361-7368. Section 7366 requires that each VA-affiliated institution submit an annual report to the VA with specific information provided. The report includes information for both research and education revenue and expenditures. The report also includes copies of the Institute’s IRS 990 form and annual audited financial statements.

VBRI assists the VANJHCS R&D office in submitting the annual Research and Development Information System (RDIS) Report on Expenditures, which is due for the government fiscal year October 1 thorough September 30. This report lists expenditure data for all projects.

VBRI has to maintain its status as a state incorporated nonprofit and files a report annually with the New Jersey Secretary of State for the Nonprofit Corporation Registration. The state also requires an annual filing with the Charities Division as well as the Secretary of State.

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Initiation and Approval

All educational activities must be approved by the VANJHCS Education Committee (EC. The Education Committee will base its recommendations for proposed nonprofit education activities on applicable VA Education Manual policies pertaining to conflict of interest and appropriateness to VA’s education missions as well as the definition of education and training established by PL 106-117, Section 204 (Title 38, Section 7362).

No educational activity can be initiated until approval of the Education Committee has been received.

Post Award

Funds received in support of educational programs usually have explicit restrictions on their use.

Educational grants and activities will be tracked separately by VBRI and will have a designated fund number and name. Financial reports will be provided monthly to the responsible member or designee.

The Board of Trustees will require an annual report on ongoing activities. For one-time events, the Education Committee will notify the responsible member or designee for the necessary report. The financial data for the report will be provided by VBRI.

Generally, funds received in support of an accredited program have additional restrictions. If some funds remain after the initial approved activity, these remaining funds cannot be used in support of other similar accredited programs unless it is allowed for in the grant agreement.

Closeout

As indicated above, educational grants are usually received with explicit restrictions to a particular program or activity. Therefore, funds remaining at the end of an activity may have to be returned to sponsor or used only as allowed for education in the same fashion as original donation. If possible, VBRI will include wording in all requests that will allow as broad usage as possible for educational activities.

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Objectivity in Research

1. Introduction:

   The purpose of this policy is to promote objectivity in research by establishing standards that provide an expectation that the design, conduct, and reporting of research will be free from bias resulting from Investigator financial conflicts of interest. This policy is consistent with the Public Health Service (PHS) regulations, “Objectivity in Research,” 42 CFR Part 50 Subpart F and 45 CFR Part 94.

2. Purpose:

   Veterans Bio-Medical Research Institute, Inc. (VBRI) established standards to prevent principal investigators from using their decision making authority for purposes that are, or give the appearance of being, motivated by a desire for private financial gain while performing VBRI administered research.

3. Applicability:

   This policy is applicable to VBRI and each Investigator (see definitions) who is planning to participate in, or is applying for, receives, or participates in PHS research funding by means of a grant or cooperative agreement. This policy applies to prime awards and subawards administered by VBRI. This policy also applies to funding from other sources who adopted the PHS Financial Conflict of Interest (FCOI) regulations.

4. Definitions:

   1. Disclosure – A complete listing of financial and employment relationships between the investigator, their immediate families (spouse and dependent children), and (1) the sponsor of a project or (2) a profit or not-for-profit entity with a potential financial interest in the conduct or outcome of the research.
   2. Financial Conflict of Interest (FCOI) – A Financial Conflict of Interest exists when the Institution, through its designated official(s), reasonably determines that an Investigator’s Significant Financial Interest is related to a research project and could directly and significantly affect the design, conduct or reporting of the research.
   3. Institutional Responsibilities – An Investigator’s professional responsibilities on behalf of VBRI, in the conduct of VBRI administered research projects.
   4. Investigator – The Project Director or Principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research, which may include, for example, collaborators or consultants. It is not intended to apply to individuals who provide primarily technical support or who are purely advisory and without direct access to data (e.g., control over its collection or analysis), unless they are in a position to influence the study’s design, reporting or results or have privileged information as to the outcome. Senior or key personnel identified on a grant application or progress report, consultants, and post-doctoral fellows may or may not be included as Investigators.
   5. Significant Financial Interest (SFI) –
      1. A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities:
         With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock options (valued on best estimate on the day of submission of Financial Conflict of Interest Disclosure), or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;
         1. With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock options (valued on best estimate on the day of submission of Financial Conflict of Interest Disclosure), or other ownership interest); or
         2. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
      2. Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their institutional responsibilities; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a federal, state, or local government agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.
      3. A significant financial interest does not include:
         1. Salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights;
         2. Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made by these vehicles;
         3. Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education; or
         4. Income from service on advisory committees or review panels for a federal, state, or local government agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.

5. Responsibilities:

   1. Investigator

      1. It is the responsibility of the Principal Investigator to submit the Disclosure forms for all project Investigators, annually or in sufficient time prior to expenditure of applicable grant funds, to allow for review of projects in which an investigator has disclosed a significant financial interest.
      2. Investigators must disclose, in writing, all SFIs which must include:
         1. Any financial arrangement between the investigator and sponsor in which the value of the compensation to the investigator could be influenced by the outcome of the study
         2. Any significant payment of other sorts from the sponsor of the study, such as a grant to fund ongoing research, compensation in the form of equipment, retainer for ongoing consultation, or honoraria
         3. Any proprietary interest in the tested product held by any investigator involved in a study
         4. Any significant financial interest in the sponsor of the study held by any investigator involved in a study

   2. VBRI-Administration

      1. 1. VBRI is responsible to complete all necessary initial and annual reports to the funding agency.
      2. VBRI will conduct a retrospective review in those cases of non-compliance with the regulation. As required by the funding agency, VBRI will notify the funder promptly and submit a report only in cases where bias is found. The report will address the impact of the bias on the research project and the actions the Institution has taken, or will take, to eliminate or mitigate the effect of the bias.
      3. VBRI will implement and maintain training requirements as required per regulation.
      4. VBRI will implement and maintain procedures to adequately communicate and monitor adherence to regulatory FCOI requirements in its collaboration and participation with its subrecipient(s) on applicable funded research.
      5. Potential conflicts of interest for research for VBRI administered studies are reviewed through the VANJHCS Research and Development (R&D) Committee. The committee reviews disclosures of financial conflict of interest related to research and makes recommendations regarding management of conflicts of interest.
6. Disclosure of Financial Interests
   Investigators and VBRI are under a continuing obligation to disclose any potential conflict of interest as soon as it is known or reasonably should be known.
   1. A Financial Conflict of Interest Disclosure is required from all Investigators for applicable funded projects at the time of application submission. Disclosures will be reviewed for actual, potential, or apparent COI to determine if outside activities or interest may conflict with the investigator’s responsibilities to the research project.
   2. An updated disclosure of SFI is required at least annually during the period of the award.
   3. Within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new SFI, submission of an updated disclosure is required.
   4. Within thirty days of an Investigator newly participating in the project, submission of a disclosure form is required.

7. Management, Reduction or Elimination of Conflicts of Interest

   Under certain circumstances, the R&D Committee may conclude that a conflict or potential conflict could directly affect the design, conduct, or reporting of the project, and the project will be placed on hold from any activity, until the R&D Committee can recommend a management plan acceptable to the VANJHCS Director, VBRI Executive Director, the PI and (if applicable) the sponsor. VBRI will report to any applicable funding agency the existence of a conflicting interest (but not the nature of the interest or other details) that is found. VBRI will also assure the funding agency that the interest has been managed, reduced or eliminated.

8. FCOI Compliance Failures

If an Investigator fails to comply with the VBRI Financial Conflict of Interest policy or the management plan, VBRI will, in collaboration with the R&D Committee, and within 120 days:

1. Complete a retrospective review of the Investigator’s activities and the research project to determine any bias in the design, conduct or reporting of research;
2. Document the retrospective review consistent with regulation; and
3. Document VBRI’s determination as to whether any funded research, or portion thereof, conducted during the period of time of the Investigator’s non-compliance with VBRI’s Financial Conflict of Interest policy or a Financial Conflict of Interest management plan, was biased or might appear to be biased in the design, conduct, or reporting of such research. The VBRI Executive Director will submit such evaluation request to the R&D Committee for further action as necessary.

1. • If bias is found, the Institution shall notify the sponsor promptly and submit a mitigation report that shall address the impact of the bias on the research project, and VBRI’s plan of action or actions taken to eliminate or mitigate the effect of the bias. Thereafter, VBRI will submit FCOI reports annually, in accordance with the regulation.
   • FOR NIH FUNDED CLINCIAL RESEARCH PROJECTS whose purpose is to evaluate the safety or effectiveness of a drug, medical device or treatment, that has been designed, conducted or reported by an Investigator with a Financial Conflict of Interest that was not managed or reported by VBRI, VBRI shall require the Investigator involved to disclose the Financial Conflict of Interest in each public presentation of the results of the research and to request an addendum to previously published presentations.
2. Investigator Training
   • Each Investigator must complete training prior to engaging in research related to any funded VBRI administered research or contract governed by federal conflict of interest regulation and immediately following the circumstances identified below.
     1. Institutional FCOI policies change in a manner that affects Investigator requirement
     2. An Investigator is new to an Institution
     3. An Institution finds an Investigator noncompliant with Institution’s FCOI policy or management plan.
   • VBRI will accept documentation of the completion of NIH’s FCOI training to fulfill investigators’ training requirement. VBRI requires that investigator who completed NIH training to forward the training certification as proof of completion to VBRI.
   • VBRI incorporates as part of a written agreement language regarding whether the FCOI policy of the VBRI or that of the subrecipient will apply to subrecipient investigators. This includes time periods to meet SFI disclosure, if applicable, and FCOI reporting requirements.
   • Subrecipient Institutions who rely on their FCOI policy must report identified FCOIs to VBRI in sufficient time to allow VBRI to report the FCOI to the PHS Awarding Component to meet FCOI reporting obligations.
3. VBRI will make required information on identified FCOIs held by Investigators available to requestors within five calendar days of receipt date of a written request.

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General Guidance

The Executive Director, President, or designee and the Treasurer of the Board are the only officials authorized to commit the expenditure of VBRI funds.

If it is unclear whether any item or service should be paid by VBRI, the Executive Director will determine the appropriateness of the request. Disagreement can be appealed to the Board of Directors.

Purchases considered to provide personal benefit are not allowed. Please note that some of the IRS rules in this area are not intuitive. VBRI will try to provide guidance, but final authority for payment rests with the Executive Director or President. Please review this section for guidance or discuss the proposed purchase with VBRI before ordering.

Purchases that may give the appearance of a conflict of interest are not allowed.

The following requirements apply for all purchases:
1. Sufficient funds must be available in the requester’s account to cover costs.
2. A research rationale must be provided for each research-related purchase, or for education activities the expense must be within the scope of the proposal as approved by the EC.
3. Professional licensure payments are not allowed. Costs of CME credits cannot be paid.

Payment or Reimbursement Details

1. Investigators may give signature authority to designated individuals on their VBRI accounts. The authorization may include dollar limits on the purchasing authority. VBRI will periodically review the signature authority on investigators’ accounts.
2. All Check Request and Travel Reimbursements must be accompanied with original receipts. Photocopies or facsimiles are not acceptable.
3. All requests for payment or reimbursement should be made in a timely manner. NOTE: VBRI reserves the right to deny payment for invoices held for more than 90 days.
4. VBRI is exempt from state sales tax. If sales tax is charged, VBRI is not allowed to pay unless extenuating circumstances persist.

Specific Guidelines

1. It is recommended that purchases greater than $25,000 be submitted for competitive bid. Competitive bids are required for purchases of $100,000 or more.
2. Subscriptions must indicate a business, not a residential, address for delivery, or a credible explanation be provided.
3. Certain memberships and dues may be paid/reimbursed through VBRI. For research oriented memberships, the organization must have a research focus demonstrated by provision of a research journal(s) and/or scientific meetings. Payment of such memberships and dues is predicated on the membership providing a journal or other subscription that would be at a much higher cost to non-members possibly in excess of the total membership if purchased separately. In some cases, organization journals are not available to non-members. Alternatively, a relevant research membership may provide access to the annual research meeting at a significantly reduced membership rate to justify membership as the prudent business decision.Unless the membership/subscription is obviously beneficial to the approved education projects, prior approval of the Education Committee is required for educational memberships/subscriptions without research relevance. Educational subscriptions must show a benefit to VA or VBRI employees or to VA patients

   If the subscription rate or annual meeting costs are not sufficiently reduced, VBRI may not be able to pay for these expenses.

4. No expenditures will be authorized for donations to organizations engaging in general charitable or other philanthropic activities unrelated to research conducted at the VANJHCS.

Individual Expenditures Exceeding $25,000

An investigator’s request for expenditure of funds for amounts greater than $50,000 during any 30-day period shall require 60 days’ prior notification and VBRI approval.

Exceptions may be granted in an emergency by the concurrence of the Executive Director and the Treasurer.

Funds for payroll costs (including properly executed personnel agreements) are excluded from this policy.

Furthermore, an approved transfer of funds for continuing research projects or educational activities in excess of $25,000 from VBRI to another 501(c)(3) organization may require a longer period of time to complete. Depending on the specific situation, transfers may be made on a quarterly basis.

Purchasing Procedures

Orders may be placed by either Principal Investigators, or an authorized designee.

Appropriate forms, i.e., Purchase Requisition forms, Purchase Order numbers, and Signature Authority can be obtained from the VBRI Administrative office.

A VBRI purchase order (PO) is required for all purchases made using VBRI vendor accounts. VBRI maintains accounts with many vendors. A list of current vendors is available from the accounting office and on the VBRI website.

The VBRI accounting office will establish and approve new vendor accounts in advance of the purchase. Please contact the accounting staff with the vendor information. You will be contacted once an account has been set up with the new vendor.

An authorized signer on the VBRI account must sign the PO. The signed PO serves as authorization for payment by VBRI upon receipt of the invoice from the vendor. Fax the completed, signed order request to the VBRI office at 973-677-7683, and provide the original form to the VBRI office as soon as possible.

Receipt of incoming packages must be verified, inspected for damage, defects or errors and identified by the information available on the packing slip included in the order. The packing slip must be endorsed and sent to the VBRI accounting office. Please note discrepancies or damaged items on the packing slip. This process will serve as documentation to verify discrepancies between items ordered and items shipped.

If a packing slip is not provided, a Packing Slip Replacement form must be completed.

VBRI will issue payment for the order upon receipt of the vendor invoice matching the authorized PO and packing slip or Packing Slip Replacement form.

Purchase Reimbursements

A completed, signed Check Request Form should be submitted to VBRI to initiate payment to a vendor in cases when a purchase order is not appropriate. All Check Request Forms must be accompanied with original receipts.

Credit Card Procedures

Business credit cards are to be used for Veterans Bio-Medical Research Institute business purchases only and are not for personal use. Use of the card for charges other than official, research or education related business is a direct violation of this contract and is misuse of a VBRI- issued card.

It is the sole responsibility of the business credit card holder to provide the office of VBRI with any and all receipts pertaining to card use in a timely manner. Any receipts not received can result in the card holder having to reimburse VBRI for the amount of the item for which the receipt pertains.

Users must ensure project accounts have the necessary funds available in order to cover any purchase made using this card. Any purchases over $2,500 require advance approval by the Executive Director or Board President.

Any finance charges and/or late fees arise due to negligence on the card holder’s part, are the responsibility of the card holder.

Unallowable expenses include, but are not limited to the following:

1. Video purchases/rental not related to research/education
2. Clothing, boots, shoes, accessories not related to research/education
3. Alcohol, tobacco and firearms
4. Personal prescriptions
5. Tires, automotive repairs and maintenance for personal vehicle
6. Gasoline charges for personal vehicle
7. Personal gifts
8. Department store charges for personal items
9. Cell phone accessories not business-related
10. Household products, goods and decorations not related to research/education

VBRI business credit cards are institutional property and must be used with good judgment. Card holders agree to accept responsibility for safekeeping of the credit card and that theft or loss of the card, or fraudulent charges, will be reported to the VBRI office immediately.

Use of VBRI business credit cards can be revoked at any time if card holders do not comply with VBRI credit card policy.

Supplies

Laboratory supplies (including animals) and research office supplies may be purchased with research rationale provided.

Supplies purchased for an educational activity must be within the scope of the activity as approved by the Education Committee.

Laboratory Animals

The Animal Research Facility (ARF) supervisor or the Veterinary Medical Officer (VMO) must approve in advance any animal orders that are to be delivered to the VA. Approval must be obtained before the order is placed with the vendor. This policy is to assure that only animals for which there is an Animal Care Committee approved protocol are ordered; that an acceptable vendor is used; that space and caging are available; and that, should an expected order not arrive, it can be immediately investigated.

To obtain approval, you may send an email message to the VMO or ARF supervisor. An approval response will be sent back to you. You may also contact the VMO or ARF supervisor by phone for approval. However, leaving a voice mail message is not sufficient. An email message and response will provide confirmation that the order is approved.

The request must include the following information:

1. Principal Investigator
2. Protocol number (IACUC number)
3. Species of Animal
4. Strain
5. Quantity
6. Age or Weight
7. Sex
8. Vendor
9. Source of Funds (VBRI)
10. Any special housing or care instructions
11. Date of Arrival
12. Contact person/phone number
13. VBRI purchase order number

Please contact the ARF Supervisor if you have any questions about this policy.

Radioactive Materials

The preferable method for purchasing radioactive substances is to order through the VANJHCS.

In those cases where VBRI is used, the following should be done:

1. The radioactive material must be under the site license. Check with the Radiation Safety Officer (RSO) prior to ordering any material to verify.
2. Clearly note on every order that delivery should be to the RSO.
3. The investigator name should appear as user so the RSO will know where to send the supplies after the material is checked.
4. The RSO must be notified by telephone whenever radioactive material is ordered. Notification must include the PI’s name, isotope, quantity, and expected delivery date.
5. Please inform the RSO that this order is for VBRI and supply the RSO with a VBRI purchase order number.

Electronic Devices

VBRI funds may be used to purchase desktop and notebook computers for use in or support of VA-approved research. Purchase in support of an educational activity must be within the scope of the proposal as approved by the Education Committee for all education activities.

All computers purchased must be shipped to the VBRI Office c/o the investigator. Once received the equipment must be tagged by IRM with the appropriate VA form completed as above before it is released for use.

Computers purchased with VBRI funds may in turn be donated to the VA for use unless this is specifically forbidden by the sponsor. Forms for this donation would indicate “equipment put in VA use” on the VBRI website. Specifically, this can not apply for items purchased with Federal Funds.

VBRI funds may not be used for the purchase of cell phone equipment unless specifically approved by the Board of Directors. In general it is not allowed.

Other specialty devices or electronic items such as digital cameras may have a valid research rationale, but due to the potential personal use should be pre-approved before purchase and with written justification.

Policy on Portable Computing Devices

VBRI funds may be used to purchase portable computing devices (such as laptops, netbooks, notebooks and electronic pads) for use in support of VA-approved research and/or education. To purchase a portable computing device, a specific rationale that explains the business need must be provided. Purchase in support of an educational activity must be within the scope of a project as approved by the Education Committee for all education activities.

VBRI-purchased computing devices must either be 1) encrypted and managed on a VA Equipment Inventory List (EIL), in compliance with VA Handbook 6500, or 2) managed through VBRI policy and may not be used to store VA data or linked to the VA network.

VA-managed devices: VA requirements for information security outlined in VA Handbook 6500 apply to non-VA purchased and non-VA owned IT equipment used for VA research purposes if the equipment will be used to store VA-sensitive information or may connect to a VA network. Portable computing devices, such as laptop computers, used to store VA sensitive information or that may be connected to a VA network, must be encrypted in compliance with VA Handbook 6500.

VBRI-managed devices: VBRI-purchased portable computing devices will be managed only on the VBRI inventory list and do not require VA encryption if the following requirements are maintained:

1. The device will not store VA data
2. The device will not be connected physically to the VA network. The device may be connected via Citrix Access Gateway (CAG) Virtual Private Network (VPN) connection to the VA network remotely, with appropriate authorizations.
3. The device will not connect directly to a VA computer/equipment.

Portable devices purchased by VBRI are the property of VBRI. They do not become the property of the investigator for whose use it is purchased. Funding for requests for purchase of portable computing devices to support research or education activities must be derived from available grant or other funds held in VBRI and must be an allowable charge on active grants. All users must submit a signed certification of the appropriate use of portable computing devices indicating understanding of relevant VBRI and VA policies and procedures and commitment to comply.

VBRI will track, inventory and manage portable devices and they will be subject to regular physical inventory and content review.

When an individual no longer requires the use of a VBRI-owned device or leaves the facility, the device must be returned to VBRI. Obsolete and non-functioning equipment also must be returned to VBRI.

Certification by User of Requirements for Portable Computing Device

User Name:______________________________ Date: ________________________
Description of Equipment/Device: _________________________________________

All users of VBRI-purchased portable computing devices must complete and sign this certification indicating understanding of relevant VBRI and VA policies and procedures.

1. I agree to use the equipment/device for VA-related research or education purposes only. Examples of this could include: Non-business hour VA work locally or during travel by connecting device to VA network via CAG VPN Travel to research-related or educational meetings requiring the need to access presentations or other materials while connected to VA through CAG VPN or using VA-approved and encrypted USB drive
2. I will ensure that the equipment/device will not contain any VA sensitive data, will not connect physically to the VA network on VA grounds, and will not connect directly to VA computers/equipment.
3. I understand the equipment/device is subject to recall by VBRI on 24 hour notice for inspection and content review.
4. I understand the equipment/device will remain the property of VBRI.
5. I understand I am responsible for all activities related to the use of this device and personally liable for any misuse or unapproved use.
6. I have reviewed VA Handbook 6500 on VA Data Security, and VBRI’s policy and certification on Portable Computing Devices and I agree to the terms within.

Donation of Animal Purchases and Expendable Supplies to VA New Jersey Health Care System

The mission of VBRI, established under Public Law 100-322 dated May 20, 1988, is to facilitate research carried out as a part of the Veterans Health Administration for the medical care and treatment of veterans and includes biomedical research, mental illness research, prosthetic and other rehabilitative research, and health-care services research. To this end, VBRI utilizes the facilities and the review and reporting mechanisms of the VANJHCS to comply with the law.

Research and development activities supported by funds administered by VBRI may involve the use of animal subjects. The VANJHCS Animal Care and Use Committee established in accordance with Federal law reviews all such studies. Only studies approved by this committee and its parent VANJHCS R&D Committee are conducted. The animal research program and facilities are accredited by the American Association for the Advancement of Laboratory Animal Care (AAALAC); a current Assurance is on file with the NIH Office for Laboratory Animal Welfare; the program is appropriately registered with the US Department of Agriculture.

Within the requirements of the law, and in order to eliminate duplication of registration, review and reporting activities, it is VBRI policy that any animals purchased by VBRI for the purposes of research are immediately upon receipt donated to, and become the property of, VANJHCS.

Within this framework VBRI also utilizes VANJHCS resources for such activities as handling and removal of medical and laboratory waste, including radioactive materials and other hazardous or controlled materials. In order to ensure conformance with requirements of the law and to eliminate duplication of activities, it is VBRI policy that all expendable supplies purchased by VBRI that are to be used in VA research laboratories for VA-approved research and educational activities are immediately upon receipt donated to, and become the property of, VANJHCS.

SUBJECT PAYMENTS

Subject payments and reimbursements to patients and volunteers for their participation in a study must be issued in accordance with the IRB and the R&D Committee approvals for the project.

For all such participation payment or reimbursements, appropriate language must be in the human subjects consent form or Health Insurance Portability and Accountability Act (HIPAA) addendum to notify the participant that the individual’s Protected Health Information (PHI) will be released to VBRI in order to process such payments. If the study will require release of PHI to VBRI in order to pay for diagnostic tests not available at VANJHCS and obtained from outside vendors for the participant, the consent form should also include this information.

Subject participation payments are taxable income. Individuals receiving payments of $600 or more in a given calendar year will be sent an IRS 1099-MISC form. VBRI therefore requires the Social Security Number and permanent mailing address of each individual to whom subject payments are made.

NOTE: The $600 threshold does not include reimbursement of costs (e.g., travel) to study participants.

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Support for Meetings and Conferences

Meetings, conferences, workshops, seminars, grand rounds, town halls, symposia, and other similar meetings are all accepted features of conducting research and education. Additionally, certain events, such as retreats and board meetings as well as fundraising and public relations, are necessary for the conduct of business. Meals and refreshments may be considered for support only if they are incidental to the business purpose of such meetings.

Various laws and regulations, the federal ethics standards and the statute that authorizes VBRI control the extent to which expenditures related to such events are appropriate for VBRI support. Consequently, in order for such costs to be considered for direct payment or reimbursement by VBRI, the following policy has been established.

1. In order to be eligible for VBRI support, a meeting must have a documented research, education or VBRI business purpose. VBRI will not support “entertainment” expenses such as social activities, parties, ceremonial occasions or those that provide amusement.
   1. For a research related meeting: A request for VBRI support must include an explicit statement about the research rationale for the event; that is, its research related purpose and how it will further VA research. Accompanying documentation should include the program, agenda or topic of discussion, and a roster of attendees. When appropriate, the request should tie the meeting to an approved research project.
   2. For an educational program not related to research: The education activity itself must first be approved by the VA New Jersey Health Care System Education Council (EC). Documentation should include an explicit statement of the purpose and how the program will further the VA’s education and training mission. See VBRI website at http://www.VBRI.org for the education approval request form to submit for Education Committee review.
   3. For other VBRI business events: A request must include an explicit statement of how the meeting will further VBRI’s ability to facilitate research and education. Appropriate events include, but are not limited to, retreats, board meetings, annual membership meetings and investigator meetings, as well as fundraising and public relations events. Documentation should include the purpose, agenda, program or topic of discussion, and a roster of attendees.
2. The types of meetings that may be eligible for VBRI support are too numerous to list and the characteristics of appropriate meetings may vary. However, factors that VBRI will consider when evaluating a meeting for support include:
   1. Whether at least one speaker makes a research presentation or presents educational instruction.
   2. Whether there is a non-VA and or non-VANJHCS speaker and/or non-VA or non-VANJHCS personnel are among the expected attendees.
   3. The frequency of similar meetings that may involve the same personnel. Irregularly scheduled meetings may be eligible for support; monthly meetings will not.
   4. Whether the meeting involves at least one individual who is being recruited to conduct research or education at the PSHCS.
   5. Whether the meeting lasts more than two hours or extends through a normal mealtime. Regardless of the type of meeting, the documentation required in #1 above is a prerequisite for VBRI support.
3. Requests for VBRI support will be reviewed and approved by the individual designated by the board, generally the Executive Director or the Executive Director’s designee. VBRI will provide direct payment for reasonable meeting costs, or reimbursement based on submission of original receipts. In the event of disagreement, the request may be referred to a designated member of the Board of Trustees or to the full Board as appropriate.
4. VBRI encourages meeting organizers to obtain pre-approval of VBRI support for meetings. Such approval is not mandatory, but events lacking pre-approval may be denied support or may receive only partial support. For meetings of significant size or cost, prior discussion and authorization by VBRI management is highly recommended.

Additional Factors for Meetings and Conferences

1. Actual, reasonable costs will qualify for reimbursement.
2. Credit card statements or receipts are not acceptable. An itemized receipt will be necessary for reimbursement.
3. VBRI does not pay for alcoholic beverages.
4. Refreshments may be paid as part of a non-routine research or education meeting if incidental to the meeting. VBRI will not pay for refreshments for regular staff meetings.
5. Lunch and/or dinner expenses for a meeting with only VA staff cannot be reimbursed.
6. Please note that luncheon or dinner meetings with invited speakers may be an appropriate expense for reimbursement through VBRI. However, such an event should be reviewed prior to the event to make sure it is eligible for reimbursement.

Guest Lecturer Information

When investigators are providing honoraria, speaker fees, or travel reimbursement to invited guest lecturers, the following apply:

1. Check Request must include the Social Security or Tax Identification Number and the address of the guest lecturer.
2. Sufficient credentials should be provided to show the expertise of the speaker as the basis for providing an honorarium. For example, part or all of the speaker’s CV.
3. If the speaker is a VA employee, the decision tree following and on the VBRI web site should be filled out and provided to VBRI before honorarium can be paid.
4. If the invited speaker is a non-resident alien VBRI must be advised in advance in order to determine if an honorarium can be provided. VBRI will also need to withhold taxes on such a payment.
5. VBRI must file IRS 1099 Misc forms for speaker fees and honoraria payments totaling $600 or more in a single tax year.
6. The payment of travel expenses associated with this category follows the same policy as for general travel by investigators (see TRAVEL).

Back to Accounting Policies

VBRI may support expenses for the domestic or foreign travel of authorized individuals to bona fide scientific meetings or for other research or research-related educational purposes. The travel support will be consistent with VBRI policies and the stipulations of any relevant funding source(s).

The Education Committee must approve travel related to educational or training activities.

If the travel reimbursement is for a visiting fellow or scholar, the visa status of the individual must allow such reimbursement. All travel for foreign fellows or scientists should be pre-approved through VBRI.

Please see the Executive Director regarding per diem rates for domestic and International travel. VBRI will use the Federal Rate available on the VBRI website.

Note: Original itemized receipts are required for reimbursement. Credit card receipts or statements are not acceptable.

Meeting registrations can be pre-paid through VBRI directly to the meeting organizer. Alternatively, the registration cost will be reimbursed after the meeting along with other travel expenses.

Travelers should purchase their own economy class tickets, pay for their costs, and seek reimbursement after the travel is completed. Cash advances and pre-paid airfare are generally not provided to investigators. Cash advances and pre-paid airfare may be available to employees.

The request should be submitted on the Travel Reimbursement Form.

If another organization is providing partial reimbursement for a trip, sufficient information must be provided to VBRI to show that we are reimbursing appropriately. For example, the VA travel documents showing which items have been reimbursed and the amount.

Documentation of the meeting dates, location, and topic or theme must be provided. A program guide or brochure (a copy of the cover is sufficient if all the information is stated on it); invitation letter; or other written documentation that includes the dates, location and purpose must be submitted with the reimbursement request.

Full reimbursement of reasonable hotel expenses with appropriate documentation will be made.

The per diem reimbursement (meal and incidental expenses) will be at the federal per diem rate. These rates are posted on our website. Travel days will be reimbursed at 100% of the federal rate for full days (place of origin departure before 8:30 am / arrival after 5:00 pm) and 75% of the federal rate for partial days.

If a member hosts a special dinner meeting with research collaborators, these costs may be paid separately with a clear research rationale. However, such events should be discussed with the Executive Director or designee to ensure that reimbursement will not be problematic. Note: the cost of the meal for the member should be deducted because the per diem provided would include that cost.

Individual items $25 or greater in cost must be accompanied by receipts. Items costing less than $25 need only be itemized. Transportation reimbursement may be up to full reimbursement for reasonable costs of air, rail, bus or taxi and parking.

If the traveler chooses to take an indirect route, interrupt the business travel or utilize a mode of travel that requires additional accommodations en route, any resulting expense will be borne by the traveler.

The cost of a rental automobile may be allowable under certain circumstances. For example, if rooms are unavailable at the conference hotel, a shuttle service is not available, or cab fare is prohibitively expensive. However, car rental is allowable only as an exception. Specialty vehicles such as convertibles and SUV’s are not allowable

Please Note:

1. Ground transport is generally limited to travel between the home or place of business and the airport; the airport and meeting site, and the return.
2. Mileage expenses for private automobile use will be at published government rates.
3. Generally, only coach airfare will be reimbursed. Exceptions may be made under special circumstances. Such exceptions should be reviewed with VBRI prior to making travel arrangements.
4. VBRI recognizes the particular requirements of persons with disabilities and will make every effort to accommodate those needs. Please contact the VBRI administrative office for further information.

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Research Grant Submission Process

Generally, VBRI will need to review all grants prior to submissions and receive the completed grants submission form. For projects that require services or subcontracts with other organizations, please submit the materials to VBRI no less than three (3) weeks or 15 business days prior to submission deadline. Shorter times may be acceptable if no other organizations are involved.

For investigator-initiated projects with corporate sponsors, a formal agreement is usually required by the sponsor prior to release of funding. These agreements will be reviewed and negotiated by VBRI. All such agreements must be signed by VBRI. Investigators cannot enter into agreements with sponsors that bind VBRI or VANJHCS in any way. Since negotiating agreements with corporate sponsors may be a lengthy process, please advise VBRI as soon as possible.

Clinical Studies

For clinical studies sponsored by pharmaceutical companies, the investigator should advise VBRI as soon as the determination to participate is made. Sponsor contact information including name, email, and phone number will be needed. VBRI will work with Regional Counsel to process the Clinical Research and Development Agreements.

VBRI will also assist with budget review and finalization including any requirement for human subject review costs or the Facility Human Protections Program fees.

Clinical studies that are investigator-initiated will follow the grants process.

The investigator should ensure that all regulatory and compliance issues are addressed, including possible requirements for an FDA Investigational New Drug application.

Post Award

For all research studies, projects cannot be signed, initiated, or have any funds expended prior to VA R&D Committee approval. R&D Committee approval will not be given until committee and all subcommittee reviews and approvals have been received. This may take up to eight (8) weeks or more if Human Subjects Committee approval is required.

In order to avoid a significant delay in study start up, the approval process should begin as soon as notification is received by PI and/or VBRI that a grant or project will be funded.

For pharmaceutical studies, generally the research agreement is negotiated at the same time that the project is being reviewed for IRB approval, so that the project will not be delayed. If any other subcommittee approvals are required, they will need to be completed prior to R&D Committee approval.

The following are the relevant committees for approval of research projects as applicable:

• R&D Committee
• IRB Subcommittee
• Safety Biohazard Committee
• Institutional Animal Care and Use Committee (IACUC)

Once a study has received all required approvals and funding has been received, an VBRI account will be opened. The account number will reflect the VBRI number assigned and promise number issued by R&D after R&D Committee approval.

Funds may be expended from the project account according to the study budget and all relevant guidelines of the sponsor and VBRI policy. Financial reports will be provided monthly to investigators for each project or separate fund.

For all studies utilizing VANJHCS clinical resources that are considered over and above the standard care required for normal patient care, the VANJHCS must be reimbursed. The completed clinical impact form should accurately reflect the resources used, whether for standard care or research only. VBRI will review projects at least annually to verify that bills of collection have been received for these services. If not, staff will follow up with the appropriate services.

When required VBRI will send all required financial reports to sponsors. The principal investigator will be responsible for any scientific progress reports.

Study Closeout

A study should not be closed in VBRI prematurely and generally not until it is removed from the R&D list of approved projects. For grants requiring final reports to sponsor, the fund will not be closed until submission of the final report and its acceptance by the grantor. Study completion occurs when all study research activities have been completed, the study is closed with the relevant VANJHCS research committees, and the grant has been closed out with the sponsor.

Most granting agencies will require return of all unencumbered or unexpended grant funds. However, requests for no cost extensions are usually allowed if appropriate scientific rationale is provided. This allows an extension of the grant period and continued use of the project funds.

If residual funds remain after completion of the project, all expenses have been paid, and there is no requirement by the sponsor to return unexpended funds, these monies may be transferred to a general research account (“0”) to be used by the project Investigator for general research and education expenditures for a 12 month “bridge” period. After the 12^th month following post-study closure, the unused residual funds will be automatically transferred into the VBRI general support fund to benefit VA research and education at VANJNCS. VBRI Principal Investigators and associated VA staff can make requests to the VBRI Board for use of general support funds to cover the costs of research or education activities of importance to VANJHCS. For VA approved research projects all expenditures must be consistent with VBRI policies.

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Consultant and Professional Services

In order to distinguish it from work performed as an employee, professional services must be based on self-directed work towards an objective determined by the VBRI member. Such services will be arranged by contractual agreement with VBRI.

In order to retain an independent contractor, certain IRS criteria must be met to distinguish an employee relationship from a contractor relationship. A member considering arranging an agreement for a consultant or other professional services should review the criteria with VBRI staff. For your information, the 20 point test that the IRS has promulgated to distinguish an employee from an independent contractor is available at http://www.VBRI.org.

If the consultant or independent contractor is a non-resident alien, payment may be prohibited or subject to tax withholding based on INS or IRS rules.

Acquisition and payment for any service to be provided by technical, consultative or professional individuals or groups in support of member research programs or educational activities must be authorized by VBRI administration in advance of receipt of such services. The Executive Director’s signed approval of the standard professional services agreement will provide authorization. Investigators may not commit the Institute to pay for such services without approval.

Member or their designees will certify such services have been received before reimbursement or payment to the vendor by VBRI is initiated.

Additional details of the VBRI policy and the template for a professional services agreement can be found below. The template is available on the web site http://www.VBRI.org.

Contractual Services Detail Information

In order to obtain the written purchase agreement for individual professional/technical contractual services, a request to VBRI administration should be submitted in writing and should contain sufficient information for review and processing. The following list highlights the details needed to complete a service or contractor agreement. A template service agreement follows this list. The agreement form or an equivalent one covering all the pertinent information should be completed before services are initiated.

1. Contractor’s name, address and phone number.
2. Contractor’s social security number.
3. Contractor’s State of New Jersey UBI or other relevant licenses.
4. Description of contractor’s qualifications (a CV or resume may be used where appropriate).
5. Period of the agreement.
6. Cost basis and rate of pay (cost reimbursement basis or fixed fee), for example: $___ per hour x ___ hours = $___ total cost, or 1 job @ $___.
7. A “not to exceed” amount, if other than the total cost above. This is particularly important if estimates are involved.
8. Description of work to be performed. This should be specific and should include end results or product desired; where work is to be performed; any technical requirements; a description of what measures will be used to determine the degree of completion by the contractor. A statement indicating that “the contractor’s work will be self-directed to meet the goals and objectives as set by the Principal Investigator” should be included.
9. Justification of the use of the contractor, including (a) a certification by the member that such services are not available through existing R&D Cores, and (b) how this work is related to the principal investigator’s VA-approved R&D program, citing specific studies by title and RDIS number where possible.
10. Delivery and invoice/payment schedule. The requesting member must certify invoices before payment will be made.
11. VBRI will need to ensure funds are available before entering into a contractual agreement.

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The Veterans Bio-Medical Research Institute (VBRI) collaborates with the U.S. Department of Veterans Affairs (VA), Department of Defense (DoD), National Institutes of Health (NIH), and the National Association of Veterans’ Research and Education Foundations (NAVREF) to improve Veterans’ health by supporting medical research and education programs for Veterans in New Jersey.

Alzheimer’s disease is the most common form of dementia and is characterized by progressive impairment of memory and other cognitive functions. Veterans may be at increased risk for Alzheimer’s disease because of both the demographics of the Veteran population, who are, on average, older than the general population, and also experience risks related to combat injury such as traumatic brain injury and posttraumatic stress disorder. The aggregate cost of care for Alzheimer’s disease patients is already massive and increasing rapidly. Thus, there is a critical need for continued investment in research to develop breakthrough discoveries that will improve clinical outcomes and decrease the cost burden of Alzheimer’s disease in our Veteran population. There is strong evidence that inflammation in the brain is a critical component of Alzheimer’s disease. Therefore, new drugs that decrease inflammation and modulate the immune system could be effective in treating Alzheimer’s disease.

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Late onset Parkinson’s disease (PD) is a very common neurodegenerative disease affecting millions of people and it is over-represented in the U.S. Veteran population. It is an incurable, debilitating and progressive disease most commonly characterized by tremors, stiffness, rigidity, and imbalance. PD is caused by the progressive loss of dopamine producing neurons located deep in the brain but why these neurons die in the first place remains incompletely understood. Over the past decade several predisposing risk factors have been identified (e.g. mutations, toxin exposures, and traumatic brain injury). Research conducted at VBRI, aims to determine the mechanism of PD than can be exploited to develop diagnostic tools, treatments, and preventative strategies for our Veterans.

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