The ClevelandVA

Medical Research & Education Foundation

Policies and Procedures: General Information

Mission and Purpose

Research Foundation Personnel

Source and management of funds

Oversight

Corporate Policies and Procedures

Internal Accounting Control System

Risk Management

Administrative Overhead

Personnel

Reimbursement of VAMC services

Conflict of Interest

Travel

Corporate Credit/Debit Card Use

Records Retention

Research Activities: Policies and Procedures

Research Agreements

Project Initiation

Budget Review

Research Personnel

Disbursement of Funds

Project Closeout Procedures

Transfer of equipment and/or funds (revised 3/2005)

Education and Training Activities: Policies and Procedures

Support

Project Initiation

Budget Review

Education/Training Activity Personnel

Disbursement of Funds

Project Closeout Procedures

Transfer of equipment and/or funds (revised 3/2005)

Policies and Procedures: General Information

Mission and Purpose

The Cleveland VA Medical Research and Education Foundation was established to advance the research and educational activities of staff at the Louis Stokes Cleveland Department of Veterans Affairs Medical Center. The Research Foundation’s primary mission is to administer funds on behalf of research projects approved by its Board of Directors and the VA Research and Development (R&D) Committee or educational programs approved by the Education Committee and the Board of Directors. Examples of such projects and sponsors include clinical trials, grant support from other non-profits, or state and local governmental funding.Gifts and honoraria may also be deposited with the Research Foundation, and applied to any R&D- or Education Committee-approved project. The Research Foundation does not administer VA appropriated funding.

The Research Foundation supports activities by purchasing supplies and equipment, paying salaries, supporting travel and paying for any other research and/or education activities necessary to promote and support the research and education mission of the Louis Stokes Cleveland VA. The Research Foundation makes available a portion of its discretionary income from corporate sponsors and private donors to support research in the medical center. These funds are made available as small grants on a quarterly basis to all staff within the Louis Stokes Cleveland VAMC Health Care System.

The Cleveland VA Medical Research and Education Foundation is an Equal Employment Opportunity employer in compliance with Department of Veterans Affairs guidelines and federal laws. The Research Foundation is overseen by a Board of Directors, which sets policy governing the day-to-day activities. Incorporated July 16, 1991 as a nonprofit entity (tax ID #34-1710663) under the laws of the state of Ohio, the Research Foundation shall comply with all local, state and federal laws and with the common ethical principles of academic medicine. Although the Research Foundation is a private corporation, it is subject to some forms of federal oversight as established in 38 USC 7361, 7362.

Research Foundation Personnel

Gail Burns, Executive Director

Office: (440) 526-3030, x 6723, FAX: (440) 838-6017

Email:

The Executive Director is responsible for overseeing the day-to-day management of the Research Foundation. Such duties may include, but are not limited to:

  • Reviewing contracts, agreements or collaborations between the Foundation and other entities for compliance with federal, VA and nonprofit guidelines;
  • Establishing, with appropriate professional assistance, necessary and appropriate internal accounting and management control systems;
  • Maintaining appropriate fiscal and management records of all research activities in the Foundation offices, and submitting regular reports to the Board Treasurer for review;
  • Providing assurance that all required reports and annual filings are made to funders, state, federal and VA authorities (including the Ohio Secretary of State, VA Nonprofit Program Office, the IRS Form 990, the RDIS Annual Report and reports to Regional Counsel).

Administrative and/or accounting staff may be hired by the Executive Director as needed to effectively carry out the operations of the Research Foundation. Such staff will be managed by and be responsible to the Executive Director. Accounting staff will handle the daily financial operations of the Research Foundation including, but not limited to, depositing funds, maintenance of all necessary Foundation accounts, processing of all bills, purchasing of all equipment and supplies, writing appropriate checks for signature by appropriate signer, monthly reconciliation of accounts and quarterly reporting of project financial status to investigators. Administrative staff will handle daily administrative operations of the Foundation, including, but not limited to, reviewing and revising contracts as necessary, maintenance of administrative and Board files, preparing preliminary arrangements for Board meetings and taking minutes at same.

Equal opportunity will be provided to all staff and applicants without regard to race, color, religion, disability, sex, age, or national origin.

Source and management of funds

The Research Foundation may accept funds in the form of grants, agreements, or gifts from sources such as: private nonprofit agencies, commercial organizations involved in the development of new medical materials or devices or in support of medical research and/or education; personal contributions; or from organizations to defray the costs of scientific meetings, teachings or other legitimate academic functions. The Foundation may administer government grants and contracts.

Any R & D- or Education Committee-approved project which has as principal investigator, responsible investigatoror project director a VA employee AND which is supported by non-VA funded research or education funds is required to utilize the Research Foundation as its administrative entity. All checks must be made payable to The Cleveland VA Medical Research and Education Foundation. If a donor letter does not accompany the funds, the Research Foundation will send an acknowledgement letter that confirms the intended use of the funds.

Funds related to a research project will be disbursed only after the VA R&D Committee and the Board of Directors approves the project. Funds donated in support of an education activity will be disbursed only with the approval of the Board of Directors and the Education Committee (or its designee), as detailed in Louis Stokes Cleveland VAMC policy.

Because of ethical considerations, tax implications and personal benefit concerns, The Board of Directors of The Research Foundation has formally determined that gifts of honoraria, from or on behalf of investigators, will be only be accepted as unrestricted donations and will be pooled for general support of VA research. Use of these funds will be under the control of the Board.

All funds deposited with the Research Foundation are the property of the Research Foundation and are subject to the policies and procedures established by the Board of Directors. Such policies will be consistent with applicable federal and state statutes and regulations. When legally permissible, exceptions to standard policies and procedures will be granted after review and approval of the Board, and will be granted only in extraordinary circumstances. The Board of Directors maintains the interests of the Research Foundation paramount in these deliberations, and decisions of the Board are final.

Transfer of General Post Funds

38 USC Section 4162 permits funds donated to the medical center’s General Post Funds for general VA research purposes to be transferred to the Research Foundation. Funds donated to the General Post Fund for a specific research or education project may be transferred to the Foundation with the consent of the donor. The R&D committee must approve all such transfers. The Research Foundation shall document any such transfer of funds to appropriately account for all funds received and the purpose to which such funds will be applied.

Oversight

The programs and operations of the Research Foundation are subject to the scrutiny and review of the VA Inspector General, the Comptroller General, the IRS, the Secretary of the Department of Veterans Affairs (38 U.S.C. Section 7366), and the State of Ohio. As required by statute, the Research Foundation provides an annual report to the Department of VA’s Nonprofit Corporations Program Office. This report includes the results of an annual audit and the IRS Form 990.

Corporate Policies and Procedures

Internal Accounting Control System

Accounting Principals and Procedures

Financial statements for the Research Foundation will be presented on a modified cash basis.

Internal accounting control system. The protection of assets and the reliability of financial records are the primary objectives of the Research Foundation’s internal accounting controls. An organizational chart that clearly defines the organization’s activities by function shall be established and maintained. A chart of accounts, defining the types of items chargeable to each category shall likewise be established and maintained. A system of controls over revenues and expenses shall be established and maintained.

Backup of accounting data. To protect against loss of accounting data, The Research foundation’s accounting files are copied onto a hard disk. On a weekly basis, updated files are copied to a floppy disk and maintained at an off-site location.

Audits. The Department of Veterans Affairs requires yearly audits of VA-affiliated corporations earning annual revenues in excess of $300,000.00 (VHA Handbook 1200.17). The Office of Management and Budget requires any nonprofit corporation handling government funds to be audited (OMB circular A-133). The Research Foundation will be audited annually.

Capitalization. All depreciable assets (equipment) purchased with Research Foundation funds for permanent, long-term use shall be expensed in the year purchased.

Reconciliation. The Executive Director will reconcile bank statements and general ledger on a monthly basis.

Annual Budget. The Board will be presented an expected annual budget for administrative and project-related functions for their approval. At board meetings, financial reports are presented by the Treasurer and reviewed by the Board.

Acceptance of Funds. All donations must be made payable to the Cleveland VA Medical Research and Education Foundation, not to any individual nor to the medical center. Any donation made payable to other than the Research Foundation will be returned to the donor. The Research Foundation shall acknowledge each donation in writing, including a statement regarding the purpose to which the Research Foundation will apply the donation.

Donations in support of a researcher or educational activity coordinator can be accepted only if that individual holds a VA appointment. Donations can be in support of specific research projects, specific education activities, or of a general research or education program. All unrestricted gifts, grants or bequests not restricted to an individual shall be considered available as administrative operating funds unless appropriated by the Board for a specific purpose.

The Research Foundation prefers to receive donations, restricted or unrestricted, to support an individual or program. In some cases, honoraria provided to a researcher or educational program coordinator as acknowledgement for participation in an activity may be accepted (see Honorarium Donation Form). Conditions of such acceptance for federal employees are that the employee provide evidence that s/he was on annual leave or that the activity was performed outside their official federal tour of duty, and that the activity was not directly related to his or her VA duties. The Research Foundation takes no responsibility for the federal employee’s personal tax consequences.

Check receipt. All checks received by the Foundation will be recorded in a logbook maintained by the Executive Director. The log shall include the following information: date of receipt, name of company/individual, check amount, check number, invoice number, project, date deposited. Letters to donors acknowledging receipt shall be issued on a monthly basis.

Deposit of funds. No funds will be accepted unless made payable to the Cleveland VA Medical Research and Education Foundation. All funds received are to be deposited within three (3) business days of receipt. The Research Foundation shall utilize only interest bearing Federally-insured accounts at either a bank or through a brokerage firm providing full Federal Deposit Insurance Corporation (FDIC) (or equivalent credit union) coverage of all deposits. Interest accruing from deposits is reflected in the administrative operating account.

Investment of funds. The Research Foundation may use idle funds to purchase instruments backed by the full faith and credit of the United States Government, such as Treasury bills, notes, and bank certificates of deposit. Investment in stocks, mutual funds, certain Federal agency financial instruments, or similar investment vehicles is not allowed. Investment terms shall not exceed one year, unless otherwise approved by the Board of Trustees. Interest accruing from investments is reflected in the administrative operating account.

Financial Loans. No financial loans may be made to any Director, Officer or staff member of the Research Foundation, nor to any research personnel, for any reason.

Accounts. Separate accounting shall be kept of unrestricted and restricted funds.

Separate accounting shall be maintained for each research or education activity administered through the Research Foundation. Researchers and educational activity coordinators—account holders-- will be sent financial statements at least quarterly, reporting income and expenses of each project account.

Inactive accounts. Accounts established to support research and education are the responsibility of the Board of Directors. To ensure compliance with accounting standards, account holders are expected to utilize funds for the purposes indicated by the donor, sponsor or grantor. Accounts with no activity for a continuous twelve-month period are considered inactive, and the account holder will be asked to provide a plan for the utilization of funds via a memorandum from the Executive Director. If the account holder fails to respond, or has left the medical center without providing closeout information, the Board reserves the right to contact the sponsor to return the funds, absorb the funds into the administrative operating account, or otherwise dispose of the funds in a fashion which benefits the mission of the Research Foundation.

Residual funds. Funds remaining from completed projects are generally referred to as residual funds. All expenditures from an account holder’s residual fund must be consistent with policies and procedures established by the Board of Directors. Once original project obligations have been met, and the project account closed, residual funds may be transferred within the Research Foundation to an account holder’s other active accounts or to a general residual account. If an account holder has not obtained R&D or Education Committee approval for a new project for twelve months following completion of an active project, all funds remaining in a general residual account will be considered inactive.

Disbursement of Funds. All Research Foundation checks must be co-signed by two authorized Board members. Authorized co-signers are the Board President, Vice-President, and Secretary-Treasurer.

Transfer of funds. Transfer of an active research or education project and the associated restricted funds and/or equipment, or any residual funds associated with an account holder, may be made only after approval of the Board of Directors and only to another VA-affiliated non-profit organization with the same stated purpose. Transfer of an account holder’s residual fund will be made with Board approval.

Administrative expenses. All expenditures from the administrative operating funds are limited to those that further the purpose of the Research Foundation. Such expenses include purchase of equipment, supplies, personnel, subscriptions, education, travel and business-related expenses. Support for research via the Small Grant Awards is also considered a legitimate expenditure of corporate funds.

Risk Management

The Research Foundation shall purchase and maintain the following types of policies: Directors and Officers and Professional Liability insurance; Crime, General Property and Liability Insurance to cover Research Foundation assets and property, equipment and personnel, and Professional Medical Liability Insurance to protect against claims of vicarious liability.

Administrative Overhead

Research projects supported by a for-profit sponsor are expected to incorporate in their budget an indirect fee of 20%. Exceptions to this rate are negotiable when the award is modest. Non-profit funders may impose caps on overhead, and this is acceptable. General awards, gifts made without reference to a specific project, and support for educational activities will be charged indirect fees of ten percent of the total award. Honoraria are subject to a five per cent indirect fee.

Personnel

Research Foundation personnel, whether administrative or project staff, will have “without compensation” appointments to the VAMC. To the extent possible, Research Foundation personnel will enjoy benefit and leave policies comparable to those extended VAMC employees. Specific personnel policies are outlined in the Employee Handbook, and apply to corporate and project staff equally.

Reimbursement of VAMC services

The VAMC will be reimbursed for costs incurred in supporting and conducting research or education activities administered through the Research Foundation. Specific costs incurred for clinical, diagnostic or support services provided exclusively for obtaining data on patients in a funded study will be reimbursed. Such reimbursements will be made from the appropriate project account, and may include Radiology, Laboratory, Pharmacy and specific sections of Medicine and Neurology. These costs will be reserved for payments against bills of collection from the medical center.

The VA recognizes that clinical research involving human subjects requires intensive oversight to ensure adequate protection of study participants. To support the local Facility Human Protection Program (FHPP), the Research Foundation makes funds available for training and education of lead investigators and research staff, credentialing of research staff, compliance with applicable human research protection standards, and the medical center’s AAHRPP accreditation process.

FHPP support is made available in three ways:

  1. via a 10% FHPP surcharge levied on any for-profit-sponsored research. An amount equal to 10% of direct cost of the study, or a flat fee of $1,200.00, whichever is greater, will be applied to industry- or for-profit sponsored research involving human subjects. Funds generated through this surcharge are under the control of the ACOS for Research.
  2. via an IRB review fee. Research that requires IRB review must budget $1,500.00 for initial and $500.00 for each continuing review. Funds generated through this fee are under the control of the IRB chair.
  3. via donations (outright or in-kind) from the Research Foundation to the medical center. Funds provided through this mechanism are disbursed by direction of the Board of Trustees, upon the recommendation of the ACOS/R and/or Executive Director.

Conflict of Interest

Each Research Foundation employee is subject to Federal Conflicts of Interest policy. Each employee is required to sign a “Standards of Ethical Conduct and Related Responsibilities of Employees” at commencement of their employment with the Research Foundation, and on an annual basis thereafter. Members of the Board of Directors are also required to sign annually. Copies of signed forms are kept in the Research Foundation offices.