**BUFFALO INSTITUTE FOR MEDICAL RESEARCH, INC.**

# 3495 BAILEY AVENUE

**BUFFALO, NEW YORK 14215**

## Policies and Procedures Guidebook

### [CONTENTS]{.underline}

-   **POLICY
    STATEMENT............................................................\...1**

-   **CONTRACT
    SERVICES/CONSULTANTS....................................14**

-   **CONFLICT OF INTEREST
    POLICY...........................................18**

-   **PURCHASING
    POLICY.........................................................\....24**

-   **TRAVEL
    POLICY....................................................................30**

-   **EMPLOYMENT
    POLICY..........................................................33**

-   **CREDENTIALING OF RESEARCH STUDY NURSES AND**

> **RESEARCH
> ASSOCIATES.........................................................39**

-   **EMPLOYMENT REQUEST MEMORANDUM...............................50**

-   **VERIFICATION OF NON-BIMR EMPLOYMENT...........................52**

-   **HONORARIA AND SPEAKERS
    FEES...........................................53**

-   **SUPPORT FOR MEETINGS AND CONFERENCES.........................54**

**BUFFALO INSTITUTE FOR MEDICAL RESEARCH, INC.**

**3495 BAILEY AVENUE**

**BUFFALO, NEW YORK 14215**

**POLICY STATEMENT**

1.  **Purpose of the Corporation**

The Buffalo Institute for Medical Research, Inc., (BIMR) is a
not-for-profit research corporation that was established to facilitate
the conduct of approved medical research at the VA Western New York
Healthcare System (VA WNYHS) in response to legislation enacted by
Congress (Public Law 104-262). This legislation authorizes the formation
of non-profit research corporations at Veterans Administration Medical
Centers. BIMR will administer all phases of research and related
educational activities supported by its holdings. BIMR is affiliated
with, but legally distinct from the VA WNYHS. Although BIMR is a private
corporation, it is subject to certain forms of federal oversight as
stated in 38 U.S.C. Sections 7361, 7362.

2.  **Funds Management**

BIMR was established to further medical science by supporting research
and related educational activities as defined in the Corporate By-Laws.
Support of these activities may be facilitated through the receipt and
distribution of funds originating from non-Department of Veterans
Affairs sources. Funds held by BIMR become assets of the corporation.
Sources of such funds may include, but are not limited to, federal or
private non-profit agencies, charitable foundations, professional
societies, commercial organizations such as pharmaceutical companies,
and personal contributions originating from individuals or groups. Funds
received by BIMR in support of research and related educational
activities can be accepted only if the responsible investigator holds an
appointment at the VA WNYHS. Additionally, the project and related
funding must be approved by the Research and Development Committee and
all appropriate Subcommittees. All checks must be made payable to
Buffalo Institute for Medical Research, Inc.

Funds received for federal grants cannot be commingled with non-federal
funds and must be deposited into an account separate from other BIMR
funds. Interest earned from federal funds must be returned to the
federal government. BIMR is permitted to retain \$100 per year of the
earned interest to cover administrative expenses.

Funds received by the Corporation to support research and related
educational activities shall be subject to an administrative assessment
of not less than 10% as established by the Board of Directors. The
overhead rate for industry-sponsored clinical studies is 20%, which
includes a 10% Facility Human Protection Program fee. Expenses incurred
to support corporate obligations such as accounting, banking and legal
fees, supplies and salaries for administrative personnel such as the
Executive Director, Administrative Assistant and/or Secretary will be
provided for by interest income generated from Corporation holdings and
from indirect costs associated with designated grants.

Accounts must maintain a minimum level of fiscal activity to remain in
an active status. Such activity will be evidenced by: maintaining a
minimum unobligated balance of \$100. Research accounts that do not meet
these criteria will be closed out and the remaining funds transferred to
an active account of an investigator with similar research designated by
the holder of the inactive account or to the administrative account to
support general research. The Investigator on the account will be
notified of the impending action thirty (30) days in advance.

Legislation as stated in 38 U.S.C. Section 4162 allows funds donated to
the VA General Post Funds (GPF) for general VA research purposes to be
transferred to BIMR. Funds donated to the GPF for a specific research
project may be transferred to BIMR with the consent of the donor. BIMR
shall document any such transfer of funds and the purpose to which funds
will be applied.

3.  **Intergovernmental Personnel Act**

BIMR meets Intergovernmental Personnel Act (IPA) mobility program
requirements and is eligible to participate in the IPA program. IPA
regulations amended in 1978 provide for the certification of "a
nonprofit organization which has as one of its principal functions the
offering of professional advisory, research, education, or development
services, or related services, to governments or universities concerned
with public management". BIMR is certified by VA Headquarters as fully
meeting this requirement. Employees placed on IPA appointments must
document that they have worked for the government agency or corporation
a minimum of 90 days prior to the establishment of the IPA appointment.

4.  **Standards of Ethical Conduct**

Each BIMR employee, member of the Board of Directors and VA-salaried
employee involved in corporation activities is subject to federal laws
and regulations regarding conflict of interest in the performance of
official functions. Persons involved in BIMR activities as described
above must sign VA form *Standards of Ethical Conduct and Related
Responsibilities* of Employee certifying that they are in full
compliance with regulations pertaining to conflict of interest. As part
of the VA non-profit corporation annual report requirements as stated in
RCS 10-0889, the executive director of each corporation is required to
certify that staff are fully compliant with conflict of interest
regulations. Members of the Board of Directors and corporation employees
with decision making authority must comply with the BIMR Conflict of
Interest Policy, complete a Disclosure Questionnaire and annually sign
an Affirmation of Compliance(attached)

5.  **Corporation Activities**

# [Project Approval]{.underline}

All research projects and related funding administered by BIMR must be
reviewed and approved by the VA Research and Development Committee and
all appropriate subcommittees. The sponsor of the approved research
project is formally notified in writing of R&D approval. Funds received
by BIMR can only be accepted if the responsible investigator holds a
valid appointment at the VA WNYHS. Funds can only be expended in support
of a research project after the approval process is completed.

# [Corporation Personnel]{.underline}

BIMR may employ full-time, part-time, and intermittent employees. Equal
employment opportunity will be provided to all Corporation employees
without regard to race, color, religion, disability, sex, age or
national origin. Prior to hiring, duties and responsibilities of each
position, along with the proposed salary, will be established by the
responsible investigator and the BIMR Executive Director. The
investigator is responsible for hiring and managing all personnel
assigned to their research activities. BIMR will pay research personnel
from the appropriate BIMR account following approval by the responsible
investigator.

BIMR may employ VA-salaried employees (VA/NPC) to perform work for the
Corporation. No VA employee, including BIMR officers, may work for pay
from the Corporation on their government time. Salary earned as a VA/NPC
BIMR employee must be for hours worked outside of the VA tour of duty.
All BIMR-salaried employees are required to submit a time card to a
corporation official bearing the signature of the employee and his/her
supervisor. VA/NPC-salaried employees are required to submit a BIMR time
card that includes their VA tour of duty. This is to decrease the
possibility of an employee making recording errors, ensuring no apparent
overlapping of BIMR time with the VA tour of duty. A BIMR official will
review all BIMR timecards for irregularities prior to payment to
minimize the potential risk of unlawful supplementation of pay.

Each Corporation employee, including VA/NPC staff, will be issued a
valid VA Without Compensation (WOC) appointment.

# [Consultants]{.underline}

A consultant is an individual who has been contracted to complete a
particular task relative to an approved research activity. Fees to
consultants, including travel and per diem costs, may be paid following
completion of the work assignment or at such time as specific sections
of the contract are completed. No cash advances will be provided to
consultants. A written justification including a description of the
scope of work to be performed, deadlines for completion of work,
qualifications of the consultant and an estimate of the cost must be
submitted to a BIMR official prior to commitment. The justification
should include the Social Security Number and address of the consultant.

To receive payment upon completion of the work, the consultant submits a
bill to the responsible investigator verifying that the contract work is
completed. The responsible investigator will sign and date the bill and
submit to the Executive Director for payment.

An IRS Form 1099 will be filed at the end of the calendar year for each
consultant who is paid \$600 or more annually. The IRS 20-Factor Test
will be utilized to determine whether workers are employees or
independent contractors.

# [Honorarium]{.underline}

There are restrictions that apply to VA-salaried employees engaged in
outside speaking, teaching and writing activities. Generally, if the
activity is directly related to the employee's official VA duties,
compensation for that activity cannot be accepted. In lieu of accepting
an honorarium, an investigator may request that a donation be made to
the corporation. Donations must be made payable to the Buffalo Institute
for Medical Research, Inc. and will be deposited to the investigator's
unrestricted account.. VA employees engaged in non-work related
speaking, teaching or writing activities must be on their own time
(Annual Leave) during the conduct of such activities.

# [Research Study Participant Payments]{.underline}

A responsible investigator may request payment to human subjects for
their participation in an approved research study. Such payments require
the prior approval of the R&D Committee and appropriate subcommittees. A
written request for payment must be submitted by the investigator to the
BIMR Executive Director or designee including the subject's name,
current mailing address and his/her Social Security Number. The request
must also include documentation that the subject attended the required
number of clinic visits and indicating the total number of visits and
signed by the investigator or designee. An IRS Form 1099 will be filed
with the IRS for each subject receiving \$600 or more in a calendar
year. A copy the Form 1099 will be sent to each appropriate participant
at the address indicated by the investigator.

# [Equipment]{.underline} 

BIMR may purchase, own and dispose of equipment in support of approved
research activities. Equipment purchased with BIMR funds becomes the
property of the corporation and is registered in the BIMR *Equipment
Inventory Database* folder noting its date of purchase, model and/or
serial number, location and assignment. A physical inventory of all
corporation-owned equipment will be completed annually. Purchase
requests must be submitted to an appropriate BIMR official using a
corporation *Purchase Order Form*. The BIMR Administrative Assistant
will complete the purchase, using the BIMR purchase card. A purchase
order \# will be assigned to each transaction. Alternatively, if
equipment is purchased directly with personal funds, the cost can be
reimbursed to the investigator following the procedure outlined below.

Capital equipment remains the property of the corporation. The Board of
Directors determines the disposition of all BIMR equipment including the
transfer of equipment to another non-profit organization. All equipment
belonging to the corporation must be maintained using corporation funds.
Maintenance costs will be paid out of the responsible investigator's
research account.

BIMR may donate equipment to the VA WNYHS. The responsible investigator
will forward a written request to the Executive Director identifying the
equipment to be donated along with its model and/or serial number. The
Executive Director will prepare an *Equipment Donation Memorandum* to
the VA Property Manager, Acquisition & Material Management Service
through the Chief, Voluntary Service for signature by the BIMR
President. The Chief, Voluntary Service will forward an acknowledgement
letter approving acceptance of each donation made to the VA Medical
Center. Pertinent correspondence will be maintained in the BIMR
*Equipment Inventory Database* folder.

# [Subscriptions, Memberships and Continued Education]{.underline}

Expenditures for continued education, including scientific books, CD
ROM's, professional journal subscriptions, conference and registration
fees which are specifically related to a research activity may be
requested by submitting the appropriate forms to a BIMR official.
Payments will be made and posted to the appropriate research or
administrative account by the BIMR Administrative Assistant. Corporation
funds cannot be used to pay for professional license fees, society
membership fees, and professional association dues for VA-paid
employees. Such payments are prohibited by Federal Ethics Standards and
can be construed as a "gift" and subject to gift regulations.

# [Reimbursements]{.underline}

BIMR staff, including directors, officers and responsible investigators,
may request reimbursement for purchase of items in support of approved
research or corporation activities. An itemized *Request for
Reimbursement of Expenses* *Form* must be completed with original
receipts and/or credit card billing attached and submitted to a BIMR
official for review. The BIMR Executive Director and BIMR Administrative
Assistant will review all requests for reimbursement prior to payment.
Reimbursements made to VA/NPC-salaried employees require regular
evaluation of payment documentation to minimize possible irregularities.

# [Transfer of Investigator]{.underline}

Transfer of Corporation funds and/or Corporation-owned equipment may
only be made to another non-profit organization. If an investigator
transfers out of the VA WNYHS and wishes to relocate an approved
research project to a new location, a written notification requesting
such a move, and attestation that all outstanding financial obligations
have been met, must be submitted to the BIMR Board of Directors.
Additionally, a supporting letter must be received from the new
non-profit organization accepting responsibility for the research
project and related funds and/or equipment, along with appropriate
documentation certifying their non-profit status. The BIMR Board of
Directors has sole authority to approve such a transfer. Following
approval by the Board, the investigator is responsible for the cost and
risk of shipping of equipment to the new location. If the Investigator
cannot transfer the project and funds to an appropriate non-profit
corporation, such funds may be transferred to an active BIMR
unrestricted account of an investigator with similar general research
interests, as designated by the departing investigator.

[Completed Project Funds]{.underline}

Research funds remaining in an investigator's BIMR account may be used
to support the general research activities of that investigator after
the research project for which the funds were originally received is
completed, provided the investigator has an active research project in
PROMISE to which expenditures can be posted for purposes of completing
the RDIS Report. Alternatively, if the investigator does not have an
active research project in PROMISE, the balance of funds in the
closed-out account may be transferred to an active investigator with a
BIMR account with similar stated research purpose. Otherwise, or in the
event an investigator should leave the VA WNYHS or die, all remaining
research funds in that investigator's account (s) will be transferred to
an unrestricted account and used at the discretion of the Board of
Directors. Use of remaining funds for a general research purpose is
predicated on the basis that all requirements specified by the sponsor
at the time funds are initially received have first been fulfilled.
Completed project funds may only be used for scientific and
professionally related expenditures and must further the conduct of
VA-approved research projects.

[Travel]{.underline}

BIMR may support domestic and foreign travel to scientific meetings,
seminars and conferences if such travel enhances the investigator's
capacity to pursue approved research activities. Fees to consultants,
including travel and per diem costs may be paid following completion of
assigned tasks. There will be no provision for cash advances to support
travel or consultant expenses, although registration fees for meetings
and conferences may be paid in advance of travel. The traveler will be
reimbursed for reasonable travel expenses following submission and
review of appropriate documentation upon completion of approved travel.

6.  **Accounting Principles and Procedures**

## If the corporation receives total revenues of between \$10,000 and \$300,000 annually, an independent audit must be performed once every three years. If total revenues exceed \$300,000 annually, an independent audit must be performed every year.

Financial statements of the corporation will be prepared annually by
Toski, Schaefer & Co., P.C. using the "accrual basis" in order to
conform to the American Institute of CPA's Generally Accepted Accounting
Principles. However, the underlying books and record keeping may be kept
on a "cash basis" accounting system. The commercial accounting program,
*Quicken 2007 for Windows* is used to maintain the corporation's
financial records. Separate accounting shall be maintained for
restricted and unrestricted funds to ensure segregation.

Separate research (liability) accounts shall be established for each
approved research project or activity facilitated through the
corporation. Each liability account will be subject to an administrative
overhead fee of not less than 10% as established by the Board of
Directors. Under certain conditions, the overhead rate may be adjusted
or waived at the discretion of the Board of Directors.

Approved reimbursements will be made to the Medical Care appropriation
through the Medical Center Business Manager For services provided in
support of specific research projects by departments of the Medical
Center. Such reimbursements will be posted to the appropriate
investigator's account.

Principal investigators are responsible for the distribution of funds
from their research accounts. All requests for expenditures must be made
and approved by the responsible investigator or designee. For each
authorized transaction, a journal entry is made to the appropriate
research account as designated by the responsible investigator.
Supporting documentation for each transaction is filed and attached to
the journal entry.

Funds received by the corporation are deposited into federally insured
interest-bearing accounts in the name of the Buffalo Institute for
Medical Research, Inc. For the purpose of investment, the purchase of
U.S. Treasury bills is permitted (38 U.S.C. Section 7362).

**7. Internal Controls**

Internal accounting control systems provide safeguards to protect
corporate assets and to ensure the reliability of corporate financial
records. To achieve maximum internal control, accounting functions
should be separated as staffing levels permit, so that no one person in
the organization performs all aspects of funds management, which may
include broad activities such as expenses and revenue. Total segregation
of accounting responsibilities may be difficult in smaller organizations
with only limited staff; however, concentrating all duties to one
individual may increase the risk that an error or irregularity may occur
and may not be detected in a timely manner.

[Acceptance and Deposit of Funds]{.underline}

All donations must be made payable to the Buffalo Institute for Medical
Research, Inc.

Donations made payable to an individual shall be returned to the donor.
Each donation received by BIMR will be acknowledged in writing.
Donations in support of approved research can only be accepted if the
responsible investigator holds a valid appointment with the VA WNYHS,
which may include a VA WOC appointment. Donations can be accepted for
specific approved research projects or for an investigator's general
research activity.

Separate accounting shall be maintained for unrestricted and restricted
funds:

> [Unrestricted funds]{.underline} shall be maintained in an
> administrative operating account and will be utilized for all
> expenditures that support the administrative activities of the
> corporation. This may include, but is not limited to expenditures for
> equipment, supplies, personnel, education and travel. Unrestricted
> funds for specific investigators will be maintained with funds
> remaining after the completion of a specific project. These funds may
> be spent in support of the investigator's general research efforts and
> research-related education in compliance with all applicable rules of
> the BIMR.
>
> [Restricted accounts]{.underline} shall be established for each
> approved research project and shall be controlled by the responsible
> investigator. Requests for expenditures from restricted accounts must
> be approved by the responsible investigator or his/her designee.

[Administrative Overhead Fee]{.underline}

Each approved research project shall include an administrative overhead
fee or an indirect cost rate. The overhead fee level will be determined
by the Board of Directors, but shall not be less than 20% of the total
estimated project cost. The administrative overhead fee may be adjusted
or waived at the discretion of the Board of Directors. Overhead fees
shall be deposited to the unrestricted fund account to be utilized in
support of all administrative activities.

The following **internal controls** will be utilized in managing the
financial activities of the corporation:

> [General Management]{.underline}

-   Bank signature cards are kept up to date and current. Original bank
    signature cards for the President, Executive Director, and Secretary
    are on file with HSBC and copies are maintained by BIMR.

-   Bank records are periodically checked to verify proper authorization
    of signers on signature cards.

-   Check signing policy requires two signatures on checks of \$5,000 or
    more.

-   An independent audit firm (Toski, Schaefer & Co., P.C.) annually
    evaluates the corporation's internal control systems.

> [Disbursements]{.underline}

-   Responsible Investigators may purchase goods and services by direct
    purchase or by purchase order. Direct purchases are reimbursed by
    submitting a completed *Request for Reimbursement of Expenses Form*
    along with attached expense receipts, which may include original
    store receipts or credit card statements.

-   Prior to issuing checks for payment, the responsible investigator
    must authorize such payment by signing and dating appropriate
    documentation, such as a BIMR *Purchase Order Form*, a vendor
    invoice or BIMR *Request for Reimbursement of Expenses Form*. All
    documentation is submitted to the Executive Director for review
    before payment is made.

-   The Executive Director, or designee is responsible for all journal
    entries. S/he writes checks for payments and records each payment
    into the general ledger and into the *Quicken* accounting program, a
    computer-based accounting software package. The Executive Director
    or designee records the account number from which payment is made,
    the check number and the date payment is made on supporting
    documentation. All checks, along with supporting documentation, are
    forwarded to the President for review and signature.

-   The President is generally responsible to sign all checks. However,
    in the absence of the President, the Secretary and Executive
    Director are authorized to sign checks.

-   The BIMR Administrative Assistant mails out checks for payment and
    files copies of supporting documentation into the appropriate
    current year investigator account folder.

-   Voided checks are properly defaced and maintained under the control
    of the Executive Director or designee and secured under lock and
    key.

-   A quarterly balance statement is prepared for each research account
    and forwarded to the responsible investigator shortly after each
    quarter is completed.

> [Payroll]{.underline}

-   PayChex payroll company provides complete payroll services for BIMR.

-   BIMR employees are paid biweekly by submitting a completed BIMR
    *Time Sheet* signed by their supervisor. *Time Sheets* reflect that
    VA-salaried employees performing Corporation work are doing so only
    during non-VA duty hours. The BIMR Administrative Assistant reviews
    each *Time Sheet* for completeness and enters information onto a
    PayChex *Payroll Form* which is then Fax'd to the payroll company
    for processing.

-   The Executive Director or designee enters each BIMR payroll into the
    general ledger and into the *Quicken* accounting program.

-   Direct Deposit service is provided by PayChex.

-   Payroll taxes (NYS W/H and the 941 Deposit) are computed by PayChex
    and remittance is made by the Executive Director or designee.

> [Deposits]{.underline}

-   Donor checks are recorded in the corporation *Budget Plan* *Folder*
    by the Administrative Assistant noting the name of the responsible
    investigator, BIMR account number, name of sponsor, check number,
    amount of check, check date and then initials each entry. The
    Administrative Assistant and Executive Director initial each donor
    check stub.

-   The Administrative Assistant endorses each donor check using a
    corporation stamp spelling out the full name of the organization,
    the full name of the bank and the bank account number into which
    deposits are made. Donor checks are deposited into the appropriate
    HSBC savings account after which the date of the deposit is noted in
    the *Budget Plan Folder*.

-   The Administrative Assistant records each deposit into the general
    ledger and into the *Quicken* accounting program, noting the
    appropriate investigator account.

-   A donor acknowledgement letter is sent for each donation made to the
    corporation.

> [Reconciliation]{.underline}

-   The Administrative Assistant reviews monthly bank statements and
    canceled checks and reconciles them. Any discrepancies are reported
    to the Executive Director. Each bank statement is reconciled in a
    timely manner.

> a\. [Canceled check statement]{.underline}
>
> Each canceled check entry is verified on the HSBC's *Accounts Analysis
> Form.*
>
> b\. [Savings accounts statements]{.underline}
>
> Each entry on HSBC's savings accounts monthly statement is verified by
> documenting each entry online..

-   Toski, Schaefer & Co., P.C. annually reviews all checking and
    savings account reconciliations.

8.  **Operational Guidelines Maintained On File**

[Management Reports]{.underline}

-   Approved minutes from all meetings of the Board of Directors.

-   Toski, Schaefer & Co., P.C. annually prepares an independent
    auditor's report for the Fiscal Year ending September 30 and files
    IRS Form 990 and Form CHAR-497 following appropriate federal and
    state guidelines.

-   A copy of the independent auditor's report is submitted to the
    Medical Center Director and the Board of Directors.

-   End-of-Year corporation financial statements are prepared promptly
    and made available to Toski, Schaefer & Co., P.C. at the time of
    their annual audit.

-   A BIMR chart of accounts is maintained with end-of-year statements.

-   Quarterly corporation financial statements are prepared promptly at
    the end of the quarter for each liability account. A copy is
    provided to each Responsible Investigator and a copy is kept on file
    with the corporation.

-   VA NPC Annual Report (RCS 10-0889) is prepared annually and
    submitted by June 1 to the Under Secretary for Health through the
    Chief Research and Development Officer.

-   BIMR maintains an original copy of each Clinical Trial
    Agreement/CRADA in the appropriate project folder.

-   BIMR reports all funds expended for approved research projects on
    the VA RDIS Annual Report as extra-VA funding.

[Other Corporate Documentation]{.underline}

-   M-3, Part 1, Chapter 17 (VA Research Corporations Authorized By
    Title 38 United States Code {U.S.C.} Sections 7361 Through 7368)

-   VA Handbook 1200.17 *VA Research and Education Corporations
    Authorized by Title 38 United States Code (U.S.C.) Sections 7361
    through 7368 Handbook*

-   Copy of VA nonprofit authorizing statute, Title 38, Subchapter IV,
    Sections 7361-7368, Research and Education Corporations

-   Copy of Public Law 100-322, Subchapter VI, Research Corporations.

-   Corporate By-Laws (Revised December 14, 1998)

-   BIMR has an established Fiscal Year ending September 30 (Corporate
    By-Laws, Section 8.09)

-   Listing of Directors and Officers with VA or non-VA titles.

-   Certification of Incorporation of Buffalo Institute for Medical
    Research, Inc. under Section 402 of the Not-For-Profit Corporation
    Law, New York State (April 13, 1990)

-   Certificate of Incorporation of Buffalo Institute for Medical
    Research, Inc. under Section 805 of the Not-For-Profit Corporation
    Law, New York State (July 29, 1999 re-certification)

-   ST-119 Exempt Organization Certificate, State of New York Department
    of Taxation and Finance (January 9, 1992)

-   Registration Certificate, Charities Bureau of the New York State
    Department of Law (January 31 1992)

-   Internal Revenue Service Exemption from Federal Income Tax ruling
    (October 31, 1991)

-   Internal Revenue Service Employer Identification Number assigned
    (16-1385680) (January 1, 1991)

-   United States Office of Personnel Management IPA Eligibility
    certification (June 30, 1994)

-   VA Headquarters global IPA re-certification statement (September 15,
    1998)

-   Office of Human Research Protections (OHRP) Federalwide Assurance
    Identifier: FWA 00004417 (Expiration Date 3/5/07)

-   Signed and dated copies of VA form *Standards of Ethical Conduct and
    Related Responsibilities of Employees* and Affirmation of Compliance
    with Conflict of Interest Policy are on file for each corporation
    director, officer and administrative employee.

-   BIMR maintains the following insurance coverage:

> Directors, Officers and Trustees Liability Policy, Executive Risk
> Indemnity, Inc.
>
> Commercial Crime Policy, Travelers Casualty and Surety Company of
> America
>
> Business Owners Policy, Travelers Insurance Company
>
> New York State Disability Benefits Policy, INA Life Insurance Co. of
> New York
>
> Workers' Compensation Insurance Policy, The State Insurance Fund

-   Current copies of all BIMR operating policies and procedures.

Timothy Murphy, M.D.

President

Buffalo Institute for Medical Research, Inc. Revised: March 29, 2007

**BUFFALO INSTITUTE FOR MEDICAL RESEARCH, INC.**

**3495 BAILEY AVENUE**

**BUFFALO, NEW YORK 14215**

**AGREEMENT FOR CONTRACT SERVICE(S)**

This agreement is made by and between
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

(Contractor) and the Buffalo Institute for Medical Research, Inc.
(BIMR).

BIMR agrees to retain Contractor to complete the service(s) described in
this Agreement and the Contractor agrees to accept engagement by BIMR to
perform such service(s). In such capacity, Contractor will be
responsible for planning and performing the service(s) in a timely and
efficient manner. The parties agree that Contractor is an independent
entity and this Agreement does not appoint Contractor as an employee or
agent of BIMR.

BIMR will not be authorized to control the manner, means or method by
which Contractor performs the service(s). However, BIMR will be
authorized to:

a.  Provide direction to Contractor regarding the particular service(s)
    to be performed, the results to be achieved and the period of time
    in which service(s) are to be completed.

b.  Inform the Contractor as to where and when the service(s) are to be
    performed.

c.  Supervise and evaluate the performance of the Contractor for the
    purpose of determining that the service(s) described in this
    Agreement have been satisfactorily completed.

Description of proposed service(s) to be provided by Contractor: See
**Attachment A**.

Cost of proposed service(s): \$\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Contractor Information:

Contractor Name:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Address:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

*Street*

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

*City* *State* *Zip Code*

TIN/SS#: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**AGREEMENT FOR CONTRACT SERVICE(S)**

I certify that the Contractor named in this agreement is qualified to
perform the service(s) as stated in **Attachment A**.

Principal Investigator:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Date: \_\_\_\_\_\_\_\_\_\_\_

BIMR Account #: \_\_\_\_\_\_\_\_\_\_.

Reviewed by:

Buffalo Institute for Medical Research, Inc.

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Date: \_\_\_\_\_\_\_\_\_\_\_

Nancy Evans

Executive Director

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Date: \_\_\_\_\_\_\_\_\_\_\_

Timothy Murphy, M.D.

President

**Statement of Understanding**: I have received a copy of the Agreement
for Contract Service(s) and I agree with the terms and conditions
contained herein.

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Contractor's Signature

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Date

Revised: March 29, 2007

# 

# ATTACHMENT A

Please provide the following:

-Description of Service(s)

> -Schedule for submission of Progress and/or Summary Reports as
> prepared by Contractor

# 

# 

# 

# 

# BUFFALO INSTITUTE FOR MEDICAL RESEARCH, INC.

**3495 BAILEY AVENUE**

**BUFFALO, NEW YORK 14215**

# PAYMENT REQUEST FOR CONTRACT SERVICE(S)

Please remit payment in the amount of \$\_\_\_\_\_\_\_\_\_\_\_\_\_for
Contract Service(s) performed as authorized in the attached *Agreement
for Contract Service(s)*. (Please provide copies of Progress and/or
Summary Reports prepared by the Contractor during the performance of
services)

Payment is to made payable to:

Name:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Address:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

*Street*

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

*City* *State* *Zip Code*

TIN/Social Security #: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Charge payment to BIMR Account #: \_\_\_\_\_\_\_\_\_\_\_\_

I certify that the contract service(s) as stated in the *Agreement for
Contract Service(s)* have been satisfactorily completed according to
scope of the contract agreement.

**Signature required:**

Principal Investigator:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Date:
\_\_\_\_\_\_\_\_\_\_\_\_

**Approved by:**

Buffalo Institute for Medical Research, Inc.

Executive Director:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Date: \_\_\_\_\_\_\_\_\_\_\_\_

President:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Date: \_\_\_\_\_\_\_\_\_\_\_\_

Revised: March 29, 2007

# BUFFALO INSTITUTE FOR MEDICAL RESEARCH, INC.

**3495 BAILEY AVENUE**

**BUFFALO, NEW YORK 14215**

**CONFLICT OF INTEREST POLICY**

**I. Application of Policy**

This policy is intended to supplement, but not replace, federal and
state laws governing conflicts of interest applicable to nonprofit
corporations (NPCs). It applies to board members and staff with
significant decision-making authority. Persons covered under this
policy, as well as their relatives and associates, are hereinafter
referred to as \"interested parties.\"

**II. Conflict of Interest**

A conflict of interest may exist when the interests or concerns of an
interested party may be seen as competing with the interests or concerns
of BIMR. There are a variety of situations that raise conflict of
interest concerns including, but not limited to, the following:

**A. Financial Interests** - A conflict may exist where an interested
party directly or indirectly benefits or profits as a result of a
decision, policy or transaction made by BIMR. Examples include
situations where:

-   BIMR contracts to purchase or lease goods, services, or properties
    from an interested party.

-   BIMR offers employment or compensation to an interested party or an
    entity with which the interested party has a direct or indirect
    financial interest, other than a person who is already employed by
    BIMR

-   An interested party is provided with a gift, gratuity, or favor of a
    substantial nature from a person or entity that does business or
    seeks to do business with BIMR.

-   An interested party is gratuitously provided use of the facilities,
    property, or services of BIMR

-   BIMR adopts a policy that financially benefits an interested party.

A financial interest is not necessarily a conflict of interest. A
financial conflict of interest exists only when the board decides a
person with a financial interest has a conflict of interest.

**B. Other Interests** - A conflict also may exist where an interested
party obtains a non-financial benefit or advantage that he/she would not
have obtained absent his/her relationship with BIMR. Examples include
where:

-   An interested party seeks to obtain preferential treatment by BIMR
    or recognition for himself/herself or another interested party.

-   An interested party seeks to make use of confidential information
    obtained from BIMR for his/her own benefit (not necessarily
    financial) or for the benefit of another interested party.

-   An interested party seeks to take advantage of an opportunity or
    enables another interested person or other organization to take
    advantage of an opportunity that he/she has reason to believe would
    be of interest to BIMR.

-   BIMR adopts a policy that provides a significant non-financial
    benefit to an interested party.

A conflict of interest exists only when the Board of Directors decides
there is a conflict.

**III. Disclosure of Potential Conflicts of Interest**

An interested party is under a continuing obligation to disclose any
potential conflict of interest as soon as it is known or reasonably
should be known.

An interested party shall complete the Questionnaire attached as
Appendix A to fully and completely disclose the material facts about any
potential conflicts of interest. The disclosure statement and
Affirmation of Compliance (Appendix B) shall be submitted upon his/her
association with *NPC*, and shall be reviewed annually thereafter. An
additional disclosure statement shall be filed whenever a potential
conflict arises.

Disclosure statements will be submitted as follows. For board members,
the disclosure statements shall be provided to the Chair of the Board.
The Chair\'s disclosure statement shall be provided to the Secretary of
the Board or its equivalent. Copies also shall be provided to the
Executive Director of BIMR.

In the case of staff with significant decision-making authority, the
disclosure statements shall be provided to the Executive Director of
BIMR. In the case of the Executive Director, the disclosure statement
shall be provided to the Chair of the Board.

In all cases, the recipient is the designated reviewing official
responsible for bringing potential conflicts to the attention of the
appropriate authorities. The Secretary of the Board of Directors shall
file copies of all disclosure statements with the official corporate
records of BIMR.

**IV. Procedures for Review of Potential Conflicts**

Whenever there is reason to believe that a potential conflict of
interest exists between BIMR and a Board member, the Executive Director
or other interested party, the Board of Directors shall determine the
appropriate response. This shall include, but not necessarily be limited
to, invoking the procedures described below with respect to a specific
proposed action, policy or transaction. The designated reviewing
official has a responsibility to bring a potential conflict of interest
to the attention of the board promptly for action at the next regular
meeting of the board or during a special meeting called specifically to
review the potential conflict of interest.

Where the potential conflict involves an employee of BIMR other than the
Executive Director, the Executive Director shall be responsible for
reviewing the matter and may take appropriate action as necessary to
protect the interests of BIMR. The Executive Director shall report to
the Chair the results of any review and the action taken. The Chair
shall determine whether any further board review or action is required.

**V. Procedures for Addressing Conflicts of Interest**

Where a potential conflict exists between the interests of BIMR and an
interested party with respect to a specific proposed action, policy or
transaction, the Board of Directors shall consider the matter during a
meeting of the board. BIMR shall refrain from acting until such time as
the proposed action, policy or transaction has been approved by the
disinterested members of the Board of Directors of BIMR. The following
procedures shall apply:

An interested party who has a potential conflict of interest with
respect to a proposed action, policy or transaction of the corporation
shall not participate in any way in, or be present during, the
deliberations and decision-making vote of BIMR with respect to such
action, policy or transaction. However, the interested party shall have
an opportunity to provide factual information about the proposed
conflict and/or action, policy or transaction. Also, the board may
request that the interested party be available to answer questions.

-   The disinterested members of the Board of Directors may approve the
    proposed action, policy or transaction upon finding that it is in
    the best interests of BIMR. The board shall consider whether the
    terms of the proposed action, transaction or policy are fair and
    reasonable to BIMR and whether it would be possible, with reasonable
    effort, to find a more advantageous arrangement with a party or
    entity that is not an interested party.

-   Approval by the disinterested members of the Board of Directors
    shall be by vote of a majority of directors in attendance at a
    meeting at which a quorum is present. An interested party shall not
    be counted for purposes of determining whether a quorum is present,
    nor for purposes of determining what constitutes a majority vote of
    directors in attendance.

-   The minutes of the meeting shall reflect that the conflict
    disclosure was made to the board, the vote taken and, where
    applicable, the abstention from voting and participation by the
    interested party. Whenever possible, the minutes should frame the
    decision of the board in such a way that it provides guidance for
    consideration of future conflict of interest situations.

**VI. Documentation**

The minutes of the governing board and all committees with board
deligated powers shall contain:

a\. The names of the persons who disclosed or otherwise were found to
have a financial interest in connection with an actual or possible
conflict of interest, the nature of the financial interest, any action
taken to determine whether a conflict of interest was present, and the
governing board\'s or committee\'s decision as to whether a conflict of
interest in fact existed.

b\. The names of the persons who were present for discussion and votes
relating to the transaction or arrangement, the content of the
discussion, including any alternatives to the proposed transaction or
arrangement, and a record of any votes taken in connection with the
proceedings.

**VII. Violations of Conflict of Interest Policy**

If the Board of Directors has reason to believe that an interested party
has failed to disclose a potential conflict of interest, it shall inform
the person of the basis for such belief and allow the person an
opportunity to explain the alleged failure to disclose.

If the board decides that the interested party has in fact failed to
disclose a possible conflict of interest, the board shall take such
disciplinary and corrective action as the board shall determine.

APPENDIX A

**BUFFALO INSTITUTE FOR MEDICAL RESEARCH, INC.**

**3495 BAILEY AVENUE**

**BUFFALO, NEW YORK 14215**

**NEW YORK 14215**

**Conflict of Interest**

**Disclosure Questionnaire**

Please complete the questionnaire below, indicating any potential
conflicts of interest. If you answer \"yes\" to any of the questions,
please provide a written description of the details of the specific
action, policy or transaction in the space allowed. Attach additional
sheets as needed.

**Financial Interests** - A conflict may exist where an interested
party, directly or indirectly benefits or profits as a result of a
decision, policy or transaction made by BIMR.

During the past 12 months (for each yes response, please describe on a
separate page.):

Top of Form

![](media/image1.png){width="0.3020833333333333in"
height="0.22916666666666666in"}

+---+---------------------------------------------------------+----+---+
| 1 | Has *NPC* proposed to contract or contracted to         | ![ | Y |
| \ | purchase or lease goods, services, or property from you | ]( | e |
| . | or from any of your relatives or associates?            | me | s |
|   |                                                         | di |   |
|   |                                                         | a/ | N |
|   |                                                         | im | o |
|   |                                                         | ag |   |
|   |                                                         | e2 |   |
|   |                                                         | .w |   |
|   |                                                         | mf |   |
|   |                                                         | )\ |   |
|   |                                                         | !  |   |
|   |                                                         | [] |   |
|   |                                                         | (m |   |
|   |                                                         | ed |   |
|   |                                                         | ia |   |
|   |                                                         | /i |   |
|   |                                                         | ma |   |
|   |                                                         | ge |   |
|   |                                                         | 3. |   |
|   |                                                         | wm |   |
|   |                                                         | f) |   |
+---+---------------------------------------------------------+----+---+
| 2 | Has *NPC* offered employment to you (not applicable to  | ![ | Y |
| \ | existing staff) or to any of your relatives or          | ]( | e |
| . | associates?                                             | me | s |
|   |                                                         | di |   |
|   |                                                         | a/ | N |
|   |                                                         | im | o |
|   |                                                         | ag |   |
|   |                                                         | e4 |   |
|   |                                                         | .w |   |
|   |                                                         | mf |   |
|   |                                                         | )\ |   |
|   |                                                         | !  |   |
|   |                                                         | [] |   |
|   |                                                         | (m |   |
|   |                                                         | ed |   |
|   |                                                         | ia |   |
|   |                                                         | /i |   |
|   |                                                         | ma |   |
|   |                                                         | ge |   |
|   |                                                         | 5. |   |
|   |                                                         | wm |   |
|   |                                                         | f) |   |
+---+---------------------------------------------------------+----+---+
| 3 | Have you, or any of your relatives or associates, been  | ![ | Y |
| \ | provided with a gift, gratuity or favor of a            | ]( | e |
| . | substantial nature from a person or entity that does    | me | s |
|   | business or seeks to do business with *NPC*?            | di |   |
|   |                                                         | a/ | N |
|   |                                                         | im | o |
|   |                                                         | ag |   |
|   |                                                         | e6 |   |
|   |                                                         | .w |   |
|   |                                                         | mf |   |
|   |                                                         | )\ |   |
|   |                                                         | !  |   |
|   |                                                         | [] |   |
|   |                                                         | (m |   |
|   |                                                         | ed |   |
|   |                                                         | ia |   |
|   |                                                         | /i |   |
|   |                                                         | ma |   |
|   |                                                         | ge |   |
|   |                                                         | 7. |   |
|   |                                                         | wm |   |
|   |                                                         | f) |   |
+---+---------------------------------------------------------+----+---+
| 4 | Have you or any of your relatives or associates been    | ![ | Y |
| \ | gratuitously provided use of the facilities, property,  | ]( | e |
| . | or services of *NPC*?                                   | me | s |
|   |                                                         | di |   |
|   |                                                         | a/ | N |
|   |                                                         | im | o |
|   |                                                         | ag |   |
|   |                                                         | e8 |   |
|   |                                                         | .w |   |
|   |                                                         | mf |   |
|   |                                                         | )\ |   |
|   |                                                         | !  |   |
|   |                                                         | [] |   |
|   |                                                         | (m |   |
|   |                                                         | ed |   |
|   |                                                         | ia |   |
|   |                                                         | /i |   |
|   |                                                         | ma |   |
|   |                                                         | ge |   |
|   |                                                         | 9. |   |
|   |                                                         | wm |   |
|   |                                                         | f) |   |
+---+---------------------------------------------------------+----+---+
| 5 | Have you, a relative or an associate in a position to   | !  | Y |
| \ | benefit financially from an action, policy or           | [] | e |
| . | transaction made by *NPC*?                              | (m | s |
|   |                                                         | ed |   |
|   |                                                         | ia | N |
|   |                                                         | /i | o |
|   |                                                         | ma |   |
|   |                                                         | ge |   |
|   |                                                         | 10 |   |
|   |                                                         | .w |   |
|   |                                                         | mf |   |
|   |                                                         | )\ |   |
|   |                                                         | ![ |   |
|   |                                                         | ]( |   |
|   |                                                         | me |   |
|   |                                                         | di |   |
|   |                                                         | a/ |   |
|   |                                                         | im |   |
|   |                                                         | ag |   |
|   |                                                         | e1 |   |
|   |                                                         | 1. |   |
|   |                                                         | wm |   |
|   |                                                         | f) |   |
+---+---------------------------------------------------------+----+---+

Bottom of Form

**Other Interests** - A conflict may also exist where an interested
party obtains a non-financial benefit or-advantage that he/she would not
have obtained absent his/her relationship with *NPC*, or where his/her
duty or responsibility owed to BIMR conflicts with a duty or
responsibility owed to some other organization.

Please indicate if at anytime during the past twelve months (for each
yes response, please describe on a separate page.):

Top of Form

![](media/image1.png){width="0.3020833333333333in"
height="0.22916666666666666in"}

+---+---------------------------------------------------------+----+---+
| 1 | Did you obtain preferential treatment, promotion,       | !  | Y |
| \ | recognition or a non-salaried appointment as a          | [] | e |
| . | consequence of your association with *NPC* for yourself | (m | s |
|   | or for any of your relatives or associates?             | ed |   |
|   |                                                         | ia | N |
|   |                                                         | /i | o |
|   |                                                         | ma |   |
|   |                                                         | ge |   |
|   |                                                         | 12 |   |
|   |                                                         | .w |   |
|   |                                                         | mf |   |
|   |                                                         | )\ |   |
|   |                                                         | ![ |   |
|   |                                                         | ]( |   |
|   |                                                         | me |   |
|   |                                                         | di |   |
|   |                                                         | a/ |   |
|   |                                                         | im |   |
|   |                                                         | ag |   |
|   |                                                         | e1 |   |
|   |                                                         | 3. |   |
|   |                                                         | wm |   |
|   |                                                         | f) |   |
+---+---------------------------------------------------------+----+---+
| 2 | Did you make use of confidential information obtained   | ![ | Y |
| \ | from *NPC* for your own benefit or for the benefit of a | ]( | e |
| . | relative, associate, or other organization?             | me | s |
|   |                                                         | di |   |
|   |                                                         | a/ | N |
|   |                                                         | im | o |
|   |                                                         | ag |   |
|   |                                                         | e1 |   |
|   |                                                         | 4. |   |
|   |                                                         | wm |   |
|   |                                                         | f) |   |
|   |                                                         |    |   |
|   |                                                         | ![ |   |
|   |                                                         | ]( |   |
|   |                                                         | me |   |
|   |                                                         | di |   |
|   |                                                         | a/ |   |
|   |                                                         | im |   |
|   |                                                         | ag |   |
|   |                                                         | e1 |   |
|   |                                                         | 5. |   |
|   |                                                         | wm |   |
|   |                                                         | f) |   |
+---+---------------------------------------------------------+----+---+
| 3 | Did you take advantage of an opportunity or enable a    | !  | Y |
| \ | relative, associate or other organization to take       | [] | e |
| . | advantage of an opportunity that you had reason to      | (m | s |
|   | believe would be of interest to *NPC*?                  | ed |   |
|   |                                                         | ia | N |
|   |                                                         | /i | o |
|   |                                                         | ma |   |
|   |                                                         | ge |   |
|   |                                                         | 16 |   |
|   |                                                         | .w |   |
|   |                                                         | mf |   |
|   |                                                         | )\ |   |
|   |                                                         | ![ |   |
|   |                                                         | ]( |   |
|   |                                                         | me |   |
|   |                                                         | di |   |
|   |                                                         | a/ |   |
|   |                                                         | im |   |
|   |                                                         | ag |   |
|   |                                                         | e1 |   |
|   |                                                         | 7. |   |
|   |                                                         | wm |   |
|   |                                                         | f) |   |
+---+---------------------------------------------------------+----+---+
| 4 | Have you, a relative or an associate in a position to   | !  | Y |
| \ | benefit in a nonfinancial way from an action, policy or | [] | e |
| . | transaction made by *NPC*?                              | (m | s |
|   |                                                         | ed |   |
|   |                                                         | ia | N |
|   |                                                         | /i | o |
|   |                                                         | ma |   |
|   |                                                         | ge |   |
|   |                                                         | 18 |   |
|   |                                                         | .w |   |
|   |                                                         | mf |   |
|   |                                                         | )\ |   |
|   |                                                         | ![ |   |
|   |                                                         | ]( |   |
|   |                                                         | me |   |
|   |                                                         | di |   |
|   |                                                         | a/ |   |
|   |                                                         | im |   |
|   |                                                         | ag |   |
|   |                                                         | e1 |   |
|   |                                                         | 9. |   |
|   |                                                         | wm |   |
|   |                                                         | f) |   |
+---+---------------------------------------------------------+----+---+

Bottom of Form

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\
Name                                      
Signature                                 Date

APPENDIX B

**BUFFALO INSTITUTE FOR MEDICAL RESEARCH, INC.**

**3495 BAILEY AVENUE**

**BUFFALO, NEW YORK 14215**

**Conflict of Interest**

**Affirmation of Compliance**

I have received and carefully read the Conflict of Interest Policy for
board members and staff with significant decision making authority of
BIMR and have considered not only the literal expression of the policy,
but also its intent. By signing this affirmation of compliance, I hereby
affirm that I understand and agree to comply with the Conflict of
Interest Policy. I further understand that BIMR is a nonprofit
organization and that in order to maintain its federal tax exemption it
must engage primarily in activities that accomplish one or more of its
tax-exempt purposes without personal inurement (other than by salary) by
board members or staff.

Except as otherwise indicated in the Disclosure Questionnaire and
attachments below, I hereby state that I do not have any conflict of
interest, financial or otherwise that may be seen as competing with the
interests of BIMR, nor does any relative or associate have such a
potential conflict of interest. Nor shall I, any relative or associate
benefit from any action, policy or transaction made by BIMR in a manner
that has not been previously disclosed.

If any situation should arise in the future that I think may involve me
in a conflict of interest, I will promptly and fully disclose in writing
the circumstances to the Chair of the Board of Directors of BIMR or to
the Executive Director, as applicable.

I further certify that the information set forth in the Disclosure
Statement and attachments, if any, is true and correct to the best of my
knowledge, information and belief.

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\
Name (Please print)

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_       
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\
Signature                                                           Date

**Annual Review and Reaffirmation**

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\
Signature                                                           Date

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\
Signature                                                           Date

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\
Signature                                                           Date

**BUFFALO INSTITUTE FOR MEDICAL RESEARCH, INC.**

**3495 BAILEY AVENUE**

**BUFFALO, NEW YORK 14215**

**PURCHASING POLICY**

**PROCEDURES FOR**

**FEDERALLY SPONSORED AWARDS**

The procedures outlined in this policy statement provide assurance that
all federal requirements regulating the purchase of goods and services
have been followed during the conduct of all procurement transactions.

**1. Open Competition**

Procurement negotiations must be conducted in such a way as to provide
for open and free competition among potential vendors relative to the
goals of federally sponsored awards. BIMR will make every reasonable
effort to ensure the inclusion of small businesses, minority and
women-owned businesses as potential vendors, whenever possible.

**2. Tax Exempt Status**

The Buffalo Institute for Medical Research, Inc. is a non-profit
organization and is therefore, exempt from sales tax on goods and
services purchased in New York State. Individuals using BIMR funds
should request exemption from sales tax within New York State by
presenting Form ST-119-1 (**Exempt Organization Certification**) to
vendors. Exempt Organization Certification forms are available from the
BIMR Administrative Assistant, Building 20.

**3. Contract Solicitation Guidelines**

The Responsible Investigator (or designee) will submit a completed
Purchase Order form to the Vice President or Budget Clerk clearly
describing contract specifications. All solicitations must be written in
such a way that a description of specific requirements of the goods or
services needed is clearly presented. Solicitations must not contain
language which would restrict competition from vendors; for example,
when the phrase \"brand name or equal\" is used to define expected
performance.

**[\$0 to \$4,999:]{.underline}** Purchases may be encumbered without
formal price quotations or bids. However, evidence of cost or price
analysis must be documented with every procurement action. This may be
accomplished in several ways, which may include a comparison of price
quotations and discounts along with an evaluation to determine that the
procurement is reasonable and meets the provisions of the federal award.
Costs must be reasonable and vendors reliable. BIMR encourages a
competitive atmosphere for all goods and services under \$4,999.

**[\$5,000 to \$19,999:]{.underline}** Verbal or written quotations must
be solicited from at least three (3) reliable sources. A written
justification must be provided if the resulting purchase order is not
submitted to the lowest bidder.

**[\$20,000 and over:]{.underline}** Written quotations must be
solicited from at least three (3) reliable sources. A written
justification must be provided if the resulting purchase order is not
submitted to the lowest bidder.

**[\$25,000 and over:]{.underline}** Requirements are the same as for
**\$20,000 and over** but with the additional provision that for federal
sponsors, a federal debarment certificate is required along with written
quotations.

**4. Supplies and Materials**

**[\$0 to \$4,999:]{.underline}** The Responsible Investigator (or
designee) will submit a completed Purchase Order form to the Vice
President or Budget Clerk clearly describing the goods needed with all
appropriate technical requirements accurately stated. The Purchase Order
form should include complete vendor information including address,
telephone and FAX number with the name of the vendor contact person, if
available. A Purchase Order number will be assigned to the request and
the order will be forwarded to the vendor. Upon receipt of the invoice
citing the appropriate Purchase Order number, the Responsible
Investigator\'s BIMR account will be encumbered for the cost of goods or
services as indicated on the invoice. Purchases may be encumbered
without formal price quotations or bids. However, evidence of cost or
price analysis must be documented with every procurement action. This
may be accomplished in several ways, which may include a comparison of
price quotations and discounts along with an evaluation to determine
that the procurement is reasonable and meets the provisions of the
federal award. Costs must be reasonable and vendors reliable. BIMR
encourages a competitive atmosphere for all goods and services under
\$4,999.

**[\$5,000 and \$19,999:]{.underline}** Verbal or written quotations
must be solicited from at least three (3) reliable sources. A written
justification must be provided if the resulting purchase order is not
submitted to the lowest bidder. Upon receipt of the quotations and the
identification of a vendor, a Purchase Order is issued following the
procedures as outlined in the **\$0 to \$4,999 Section** above.

**[\$20,000 and over:]{.underline}** Written quotations must be
solicited from at least three (3) reliable sources.

A written justification must be provided if the resulting purchase order
is not submitted to the lowest bidder. Upon receipt of the quotations
and the identification of a vendor, a Purchase Order is issued following
the procedures as outlined in the **\$0 to \$4,999 Section** above.

**5. Sole Source Requirements**

a\. Sole source indicates that a particular manufacturer is the
exclusive source from which needed materials or services can be
obtained. As a result, competition requirements, where total purchases
exceed \$4,999 can not be met. In such cases, the Responsible
Investigator will be required to submit a written justification
describing the goods or services needed and a statement explaining why
no other manufacturer is acceptable. This statement must provide
evidence that an analysis of various goods of an equal or like nature
has been conducted and that only the specified manufacturer should be
considered for the purchase.

b\. Maintenance agreements made directly with the manufacturers or their
local authorized representatives are exempt from Sole Source
requirements.

**6. Equipment**

a\. Equipment is tangible, nonexpendable personal property charged
directly to the federal award and having a useful life of more than one
(1) year with an acquisition cost of \$5,000 or more per unit.
Procurement procedures as outlined in **Section 4 (Supplies and
Materials)** shall be used for the purchase of equipment.

b\. [Property Management Procedures:]{.underline}

1\. Equipment records shall contain the following information for each
equipment item purchased from federally sponsored awards:

-   description of equipment item.

-   manufacturer\'s identification number such as model number and
    serial number.

-   federal award number identifying the federally sponsored award from
    which the equipment was purchased.

-   acquisition date.

-   location of equipment.

> 2\. Adequate safe guards shall be implemented by the Responsible
> Investigator to minimize the potential for loss, damage or theft of
> federally-purchased equipment
>
> 3\. A record of physical inventory shall be conducted once every two
> years and a record of such inventory shall be maintained by BIMR.

**7. Conflict of Interest**

No officer, employee or agent of the BIMR shall have any interest,
financial or otherwise in the selection of a firm for an award. No
officer, employee or agent shall engage in any business or professional
activity, which is in substantial conflict with the proper discharge of
his/her foundation duties.

**8. Resource Conservation and Recovery Act (Pub. L. 94-580 codified at
42 U.S.C.6962)**

Under this act, whenever possible, consideration will be given to the
procurement of products containing recycled materials.

Timothy Murphy, M.D.

President

Buffalo Institute for Medical Research, Inc.

Revised: March 31, 20

**BUFFALO INSTITUTE FOR MEDICAL RESEARCH, INC.**

**3495 BAILEY AVENUE**

# BUFFALO, NEW YORK 14215

## PURCHASING POLICY

## PROCEDURES FOR NON-FEDERALLY SPONSORED AWARDS

1\. Responsible Investigators maintaining an account with the Buffalo
Institute for Medical Research, Inc. (BIMR) may purchase supplies,
equipment or other materials to support approved research activities by
submitting a completed BIMR **Purchase Order** form **(Attachment A)**
to the BIMR Executive Director or BIMR Administrative Assistant. BIMR is
a non-profit organization and is therefore exempt from sales tax on
goods and services purchased in New York State. Individuals using BIMR
funds should request exemption from sales tax within New York State by
presenting Form ST-119.1, **Exempt Organization Certification** to
vendors. Purchase Order forms and Exempt Organization Certification
forms may be obtained from the BIMR Administrative Assistant in Room
106, Building 20 or on the VA research web site.

2\. **[Purchasing Procedures]{.underline}**

-   Complete a BIMR Purchase Order form by filling in all required
    information concerning item(s) to be purchased and the vendor,
    including complete address, telephone and FAX number, if available.

-   Responsible Investigator (or designee) must sign completed purchase
    Order form and submit it to the BIMR Administrative Assistant.
    Purchase Orders submitted without an appropriate signature will be
    returned to the Responsible Investigator.

-   A purchase order number will be assigned to the request and a copy
    returned to the requester.

-   Upon receipt of the purchased goods, the packing slip should be
    forwarded to the BIMR Administrative Assistant to be filed with the
    original Purchase Order form.

3.  An alternate method of obtaining materials is by direct purchase.
    Responsible Investigators may wish to expedite the purchase of
    desired goods directly by using their own personal funds. Direct
    purchases will be reimbursed from the Investigator\'s BIMR account
    upon submission of a completed **Request for Reimbursement of
    Expenses** form **(Attachment B)** and original receipts or credit
    card statements within 60 days of purchase. The Responsible
    Investigator (or designee) must sign the completed Request for
    Reimbursement of Expenses form and submit it to the BIMR
    Administrative Assistant for processing. New York State and local
    sales and use tax exemption certificates are available upon request
    from the BIMR Administrative Assistant.

4\. **[Purchase of Equipment]{.underline}**

Equipment may be purchased by the BIMR from vendors recommended by the
Responsible Investigator through the submission of a completed Purchase
Order form or by direct purchase. In either case a full justification of
the equipment should be provided. Upon receipt of the equipment, the
Executive Director or Administrative Assistant should be promptly
notified. Equipment will be tagged with the BIMR label and recorded on
an inventory database with such information as the serial number and
current room location. Equipment purchased by the corporation becomes
the property of the corporation. Upon termination of the Responsible
Investigator from the VA, the corporation retains the right to dispose
of the equipment in one of the following ways:

-   transfer equipment to another research investigator

-   transfer equipment to another not-for-profit organization

-   donate equipment to VA

All corporation equipment will be formally inspected by the VA
Engineering Service and properly tagged for approval to be located at
the VA Medical Center. An inventory of all BIMR-owned equipment will be
performed annually.

Timothy Murphy, M.D.

President

Revised: March 29, 2007

Attachments

**BUFFALO INSTITUTE FOR MEDICAL RESEARCH, INC.**

#  3495 BAILEY AVENUE

**BUFFALO, NEW YORK 14215**

**DATE:**

**FROM:**

**SUBJ: Request for Reimbursement of Expenses**

**TO:** Executive Director

1\. I am requesting a check in the amount of \$\_\_\_\_\_\_\_\_\_\_\_\_
for reimbursement of the following approved expense (please provide a
brief description of items purchased with appropriate justification):

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

2\. Please attach documentation to verify payment of direct purchase.
This may include an original paid store receipt, canceled check or
credit card slip. **Please note, requests submitted more than 60 days
after direct purchase will not be approved.**

3\. Please make the check payable
to:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Investigator Signature

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**FOR OFFICE WORK ONLY:** (Revised: March 29, 2007)

**Check \#**\_\_\_\_\_\_\_\_\_\_\_\_ **Account #\_\_\_\_\_\_\_\_\_
Amount :** \_\_\_\_\_\_\_\_\_\_\_\_\_\_

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**Executive Director Date:** \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**BUFFALO INSTITUTE FOR MEDICAL RESEARCH, INC.**

**3495 BAILEY AVENUE**

#  BUFFALO, NEW YORK 14215

## TRAVEL POLICY

1.  BIMR travel support is limited to purposes that are research
    related.

2.  **VA Employees** must complete the following **before** travel takes
    place:

-   If *VA Travel Orders* are to be issued, attach a completed copy to
    this request.

-   If *VA Travel Orders* are not being issued, please attach a copy of
    completed *VA Form SF-71* requesting Authorized Absence (AA) signed
    by the Medical Center Director. Please note, VA employee travelers
    will be granted one day of approved AA for each 1/10 VA appointment
    per annum.

-   *VA Form 10-0101B* (*VA Acceptance of Donations***)** must be
    completed. Estimate the amount of funding requested. Supporting
    documents such as program or meeting brochures, invitation letters
    and abstracts to be presented should be attached to this form.
    Please provide a clear explanation of how this travel request is
    related to your research activities.

-   *Statement of Clinical Impact* form signed by your Service
    Chief/Care Line Manager.

-   Completed travel forms will be reviewed by the BIMR Executive
    Director for accuracy and appropriateness. The original *VA Form
    10-0101B* (along with attachments) is forwarded to the Medical
    Center Director for signature and then returned to the BIMR
    Executive Director. A copy of the signed *VA Form 10-0101B* will be
    provided to the traveler.

3.  **Non-VA Employees** should refer to **Guidelines for Travel
    Reimbursement** (Section 4, below).

4\. **Guidelines for Travel Reimbursement**

All travelers must complete a BIMR *Travel Reimbursement Form* and
submit it to the BIMR Administrative Assistant within five working days
following the completion of travel. BIMR will refund all reasonable
expenses incurred during approved travel if sufficient funds are
available. Air travel cost should not exceed current full-coach fare.
Should first class air travel be necessary, a written justification must
be submitted with the completed *Travel Reimbursement Form*. Original
receipts for hotel expenses, registration fees, rental cars, ground
transportation, parking fees and the original passenger coupon from
airline tickets or E-ticket must be attached to the *Travel
Reimbursement Form*. Please note, VA per diem rates for the specific
city of destination will be used to determine meal allowances. Current
VA per diem rates are available online at:

[www.policyworks.gov/org/main/mt/homepage/mtt/perdiem/travel.htm](http://www.policyworks.gov/org/main/mt/homepage/mtt/perdiem/travel.htm).

The column marked **M&IE rate (b)** lists the allowable daily rate for
meals. Reimbursement for lodging will not be based on VA locality rates
but will require the submission of the original hotel receipt.

The completed *Travel Reimbursement Form* along with attached receipts
will be reviewed by the BIMR Executive Director for accuracy and
appropriateness. A reimbursement check will then be issued directly to
either the VA employee or non-VA employee traveler.

Timothy Murphy, M.D.

President

Revised: March 29, 2007

**BUFFALO INSTITUTE FOR MEDICAL RESEARCH, INC.**

**3495 BAILEY AVENUE**

**BUFFALO, NY 14215**

# Travel Reimbursement Form

**Date:**

**To:** Nancy Evans, Executive Director (151)

**From:**

1.  Reimbursement is requested for the following travel (Note: VA-paid
    Travelers must have an approved *VA* *Travel Request Form
    10-0101B*):

    -   Title
        \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

    -   Dates of
        Travel\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

    -   Destination
        (City)\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

    -   Purpose of
        Travel\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

2.  Itemized Expenses:

    -   Airfare \$\_\_\_\_\_\_\_\_\_\_\_

    -   Personal Auto (No. of miles x current mileage rate)
        \$\_\_\_\_\_\_\_\_\_\_\_

    -   Lodging \$\_\_\_\_\_\_\_\_\_\_\_

    -   Meals (Use VA per diem rate for City) \$\_\_\_\_\_\_\_\_\_\_\_

    -   Ground Transportation \$\_\_\_\_\_\_\_\_\_\_\_

    -   Airport Parking \$\_\_\_\_\_\_\_\_\_\_\_

    -   Registration Fees \$\_\_\_\_\_\_\_\_\_\_\_

    -   Other (Please Specify) \$\_\_\_\_\_\_\_\_\_\_\_

    -   TOTAL...................................................
        \$\_\_\_\_\_\_\_\_\_\_\_

**Note:** Please attach original receipts for hotel expenses,
registration fees, rental cars, ground transportation, parking fees and
the original coupon from airline tickets or E-ticket. Original receipts
are not required for meals. Meal allowances are based on the current VA
per diem rate for the destination (City). VA per diem rates are
available online at
[www.policyworks.gov/org/main/mt/homepage/mtt/perdiem/travel.htm](http://www.policyworks.gov/org/main/mt/homepage/mtt/perdiem/travel.htm).
The column marked **M&IE rate (b)** lists allowable daily rates for
meals.

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Signature of Requester

Approve Disapprove Check #\_\_\_\_\_\_\_\_\_\_ Acct.#\_\_\_\_\_\_\_\_

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Timothy Murphy, M.D.

President

Buffalo Institute for Medical Research, Inc.

**BUFFALO INSTITUTE FOR MEDICAL RESEARCH, INC.**

**3495 BAILEY AVENUE**

**BUFFALO, NEW YORK 14215**

**EMPLOYMENT POLICY**

This Memorandum establishes employment policy of the Buffalo Institute
for Medical Research, Inc. (BIMR). The guidelines herein may be changed
or modified by the Corporation at any time, as specific circumstances
may require. Nothing herein, should be construed as a contract of
employment, expressed or implied, or a requirement that specific
procedure be followed in the administration of personnel issues.

The Buffalo Institute for Medical Research, Inc. may employ full‑time,
part‑time and intermittent employees. Employment is understood to be "at
will" and is terminable "at will" by BIMR or employee with or without
cause. The length of employment will be indefinite with no time
commitments made. The hiring, termination, assignment of duties and
responsibilities of positions and determination of salaries will be the
responsibility of the Research Investigator and a BIMR Officer. Research
Investigators wishing to initiate a request to employ an individual will
need to complete an **Employment Request Memorandum**. This form is
available in the Research Office, Room 129, Building 20. The BIMR
Executive Director and President must approve the completed Employment
Request Memorandum before any commitment can be made to proposed
employees. All BIMR employees will be issued a VA Without Compensation
(WOC) appointment to facilitate their working on VA-approved research
activities.

**1. Employment Request Procedures**

The Research Investigator will submit the completed Employment Request
Memorandum to the President, through the Executive Director, BIMR. The
Employment Request Memorandum will contain the following information:

-   Name of applicant

-   Proposed start date

-   Position title

-   Position description (duties and responsibilities)

-   Qualifications of applicant

-   Tour of duty (full‑time, part‑time or intermittent). If part-time
    employment is requested, indicate the number of hours per week.

-   Weekly work schedule

-   Proposed annual salary/hourly wage

A formal commitment may only be made to the proposed employee upon
approval of the Employment Request Memorandum. The applicant will sign
and date the Employment Request Memorandum following notification of
approval of appointment.

The Research Investigator is responsible for initiating the WOC
appointment for each BIMR-salaried employee. All BIMR employees,
including VA-salaried employees who work for the Corporation during
their non-VA duty hours, must have a valid VA WOC appointment.
VA-salaried employees who perform work for BIMR must document that such
Corporation work is outside the scope of their VA duties and
responsibilities. Further, such work must not be performed during
Government duty time and the work must not be related to VA duties.

**2. Special Employment Considerations Relating to Human Studies
Research**

BIMR employees who have direct interactions with human subjects, or who
collect and analyze identifiable data, including laboratory data or
clinical samples, must be properly credentialed prior to engaging in
such activities. As part of the credentialing process, the Research
Investigator is responsible for authorizing the duties and
responsibilities of such staff by submitting a completed a **Scope of
Work** for Research Study Nurses or a **Functional Statement** for
Research Associates for approval at the time of hire (**See Attachment
A**). The Research Investigator will be responsible for assuring the
Research Study Nurse and/or Research Associate obtains timely
credentialing and demonstrates proficiency in study-specific skills
before engaging in any human subjects research activity.

BIMR employees involved in human subjects research are responsible for:

-   Adhering to the Scope of Practice/Functional Statement outlining
    clinical privileges that have been approved for them.

-   Being knowledgeable and adhering to all applicable statutes,
    regulations and policies related to human subjects research.

-   Completing mandatory annual training as mandated by the VA Office of
    Research and Development and VA regulations. Documentation for such
    training will be obtained from the Medical Research Office.

-   Engaging only in approved human subjects research activities.

**3. Annual Performance Evaluations**

The intent of the BIMR performance review is to appraise each employee's
performance for the entire rating period starting October 1 and ending
September 30. The Research Investigator is responsible for reviewing the
performance of each BIMR employee under his/her supervision by
completing a narrative description of the employee's actual performance
for the rating period ending September 30. The narrative description
should minimally describe the employee's performance, productivity,
timeliness and any noteworthy accomplishments. Following the narrative
description, the Research Investigator will provide a Summary Rating of
the employee's performance using a five-tiered rating system:

-   Outstanding

-   Excellent

-   Fully Successful

-   Minimally Satisfactory

-   Unsatisfactory

The completed annual performance evaluation, which will serve as the
final Rating of Record must bear the dated signature of both the
supervisor and the employee. The supervisor will provide each employee
under his or her supervision with a copy of the annual performance
evaluation. The original performance evaluation will be submitted to the
Executive Director and maintained in the employee's BIMR personnel
folder.

**4. Additional Employment Information**

Employees of BIMR are paid on a biweekly basis by direct deposit. Each
pay period is a two‑week period beginning on Sunday and ending on
Saturday. Deposits are madeon the Friday following the end of the pay
period

[Tour Of Duty]{.underline}

The employee\'s BIMR tour of duty, as indicated in the Employment
Request Memorandum, shall be established by the Research Investigator.
Changes in tours of duty must be requested in writing and approved by a
BIMR Officer prior to implementation. Full‑time shall mean 40 hours per
week. All employees are expected to be on duty during the full period of
their tours of duty unless approval for leave has been granted. A BIMR
**Time and Attendance Sheet** (available in the Research Office) will be
used to track employee time for payroll purposes. The time sheet will
encompass a two‑week period of time, equivalent to one pay period.
Completed and signed time sheets will be submitted to the BIMR Executive
Director or Administrative Assistant on the first Monday following the
end of the pay period. Employees shall be responsible for the timely
submission of completed time sheets.

[Fringe Benefits]{.underline}

Fringe benefits include Workers Compensation and Disability coverage
Unemployment Compensation and Social Security coverage. Health
insurance, pension benefits and life insurance are not currently
available. (See Sections 7 and 8 for detailed information concerning
Worker\'s Compensation and New York Disability coverage).

## [Holidays\*\*]{.underline}

Full-time BIMR employees receive the following paid holidays:

-   New Year\'s Day ‑ January l

-   Martin Luther King's Birthday - 3^rd^ Monday in January

-   President's Day -- 3^rd^ Monday in February

-   Memorial Day ‑ Last Monday in May

-   Independence Day ‑ July 4

-   Labor Day ‑ 1st Monday in September

-   Columbus Day -- 2^nd^ Monday in October

-   Veterans Day ‑ November 11

-   Thanksgiving Day -- 4^th^ Thursday in November

-   Christmas Day ‑ December 25

\*\*Please Note: Part‑time BIMR employees receive only those holidays
falling on their designated workdays.

[Leave System]{.underline}

-   [Annual Leave (A/L):]{.underline} Full‑time BIMR employees earn
    annual leave based on years of service. Employees with less than 3
    years of service earn 4 hours of A/L per pay period (13 days per
    year). Employees with between 3 and 15 years of service earn 6 hours
    of A/L a pay period (20 days per year). After 15 years, employees
    earn 8 hours of A/L a pay period (26 days per year). Part‑time BIMR
    employees earn A/L prorated according to the number of hours worked.
    Full time physicians earn 1 day of A/L per pay period. Part time
    physicians earn 1hr for each 10 hours in pay status in a pay period.
    Employees must obtain their supervisors\' approval before using
    Annual Leave. Annual Leave should be used during the calendar year
    in which it is earned.

-   The maximum vacation accrual balances allowed are:

1.  full time registered nurses - 685 hours

2.  part time registered nurses-240 hours

3.  full time physicians -- (86 days)

4.  part time physicians -- 240 hours

5.  non-professionals-240 hours

Lump sum payment for unused accrued A/L up to the hour maximum may be
provided to BIMR employees upon their separation from BIMR if employees
have at least two years of continuous employment at the time of
separation.

-   [Sick Leave (S/L):]{.underline} Full‑time BIMR employees earn 4
    hours of S/L a pay period (13 days per year). Part‑time BIMR
    employees earn S/L prorated according to the number of hours worked.
    Employees are never paid for unused sick leave benefits.
    Intermittent employees do not earn S/L.

**5. Outside Employment**

BIMR employees may not work in any other job, private or professional,
during the hours they are employed by the BIMR. Should any employee have
outside employment either at the time they are initially hired or during
the course of employment by the BIMR, a **Verification of Outside
Employment Form** (available in the Research Office) will be completed
and submitted to the Executive Director, Room 129, Building 20.

**6. Terminations and Layoff**

The employment relationship is based on mutual consent of the employee
and the BIMR. Accordingly, either the employee or the BIMR may terminate
the employment relationship \"at will\" at any time. It is expected that
whoever terminates the employment agreement, will give appropriate
notice, if at all possible. However, notice is not mandatory on either
party. Severance is not paid to terminating BIMR employees.
Additionally, separating employees are not eligible to be paid for
accumulated sick leave or compensatory time. Upon termination for any
reason, employees should contact the Executive Director to determine any
possible accrued vacation pay, unemployment insurance procedures and
disposition of final pay deposit.

**7. Worker\'s Compensation Insurance**

All BIMR employees are protected in the event of job‑related injuries
and illness under New York State Worker\'s Compensation coverage, an
employer‑paid benefit. Worker\'s Compensation provides income
replacement, as well as payments for medical expenses, for an on‑the-job
bodily injury or illness. Should you become injured during your approved
tour of duty, immediately inform your supervisor of the injury
indicating when, where and how you were injured. Obtain first aid or
other necessary medical treatment. The BIMR Executive Director should be
notified of the injury as soon as possible; any delay in reporting
accident may ultimately delay the disbursement of possible benefits.

**8. New York State Disability Insurance**

All BIMR employees are provided coverage for New York State Disability.
Disability Benefits are temporary cash benefits payable to the employee
who is disabled by an off‑the-job injury or illness. New York State
Disability coverage supplements Worker\'s Compensation by providing
weekly cash benefits to replace, in part, wages lost because of injuries
or illness that do not arise out of or in the course of employment. New
York State Disability does not provide payment for medical expenses. The
BIMR Executive Director should be consulted for assistance in filing a
claim.

**9. Equal Employment Opportunity**

The Buffalo Institute for Medical Research, Inc. is committed to equal
employment opportunities. It is the policy of BIMR that applicants for
employment or current employees shall not be discriminated against
because of race, sex, color, age, national origin, ancestry, marital
status, sexual orientation, physical or mental handicap or medical
condition.

Equal employment assures that all selection methods shall be solely
based on job-related criteria and the individual merit of the applicant.
If any employee believes that he/she has been subjected to a
discriminatory act based on race, sexual orientation, physical or mental
handicap, or medical condition, please contact a BIMR Officer for
assistance and further information.

**10. Harassment**

It is the intent of the Buffalo Institute for Medical Research, Inc. to
provide all of its employees with a working environment free from
discriminatory harassment or intimidation of any kind. Harassment,
including but not limited to slurs, epithets, threats (including both
verbal and physical), derogatory comments and unwelcome jokes or teasing
are unacceptable in the workplace. Harassment, particularly that
prohibited by law, such as racial or sexual harassment, is unacceptable
under any circumstances. The BIMR is committed to providing all
employees a comfortable workplace in which fellow employees and
supervisors foster respect for one another and are dedicated to open
communication for the resolution of problems that may arise.

The BIMR is committed to provide a workplace free of sexual harassment
and prohibits such activity by any employee or supervisor. Sexual
harassment may include unwelcome sexual advances, requests for sexual
favors and verbal or physical conduct of a sexual nature such as
drawings, pictures, jokes, teasing, uninvited touching or other sexually
related comments.

Any BIMR employee, who believes that he/she has been the victim of any
form of harassment, should immediately inform a BIMR Officer. All
complaints will be promptly addressed in the strictest confidence.
Reported incidents will be investigated discreetly, recognizing the
serious impact of such claims. BIMR employees found to be in violation
of this policy will be subject to disciplinary action.

**11. Drug-Free Workplace**

It is the policy of the Buffalo Institute for Medical Research, Inc. to
provide a drug-free environment for all of its employees engaged in
authorized activities. Each employee is expected to perform assigned
duties and responsibilities free from the influence of drugs, alcohol or
other controlled substances. Use of such agents may impair an
employee\'s ability to perform to the best of their ability assigned
tasks. Additionally, use of such agents may severely impair an
employee\'s judgment and performance such that they may become a safety
hazard not only to themselves, but also to co-workers. BIMR wishes to
maintain a safe work environment for all employees. The unlawful
manufacture, distribution, dispensing, possession or use of alcohol or
any controlled substance within the workplace is strictly prohibited by
the Drug-Free Workplace Act of 1988 (34 CFR Part 85). BIMR employees
found to be in violation of this policy will be subject to disciplinary
action up to and including termination.

As a condition of employment, all employees will be required to comply
with the following regulations:

-   BIMR employees are prohibited from the unlawful manufacture,
    distribution, dispensing, possession or use of alcohol or any
    controlled substance in the workplace. A controlled substance is
    defined by Schedules I-V of the Controlled Substance Act, 21 U.S.C.
    812.

-   BIMR employees must notify an Officer of the Corporation within
    five (5) days after conviction of any criminal drug statute
    violation. BIMR must then notify the government agency to which it
    is under contract within ten (10) days after receiving notification
    from the employee of such a conviction.

-   Any employee convicted of a criminal drug statute will be required
    to satisfactorily participate in a drug abuse assistance or
    rehabilitation program approved for such purposes by a Federal,
    State, or local health, law enforcement, or other appropriate
    agency.

**12.** BIMR employees must sign and date the attached **Statement of
Understanding** form and return to the Executive Director located in
Room 129, Building 20.

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Timothy Murphy, M.D.

President

Buffalo Institute for Medical Research, Inc.

Revised: March 29, 2007

# Statement of Understanding

I have received a copy of the BIMR **Employment Policy** and have read
and understand the terms and conditions of employment, including the
BIMR **Drug-Free Workplace Policy** statement contained in Section 11 of
this document. I am aware of the consequences of noncompliance.

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
\_\_\_\_\_\_\_\_\_\_\_\_

Employee\'s Signature Date

Attachment A

Credentialing for Research Study Nurses, for Research Associates who
Interact with Human Research Participants, or who Interact with Clinical
Material or Individually Identifiable Data

VA Western New York Healthcare System

**[Purpose:]{.underline}** To implement a credentialing process for
Research Study Nurses, for other Research Associates who have direct
clinical interactions with human subjects enrolled in approved research
protocols, and for those who collect or analyze identifiable data,
including laboratory data or clinical samples. The VA responsible
investigator or principal investigator is responsible for authorizing
the duties and responsibilities of such staff by completing a document
referred to as either a *Scope of Work* for nurses (**Attachment B**) or
a *Functional Statement* for research associates (**Attachment C**).

**[Policy:]{.underline}** Research Study Nurses and Research Associates
who interact with research participants at a clinical level must be
properly credentialed prior to engaging in such research activities.
Principal Investigators must complete a *Scope of Work* for Research
Study Nurses or a *Functional Statement* for Research Associates. All
licensed staff will be credentialed by the Human Resources Department
through VetPro.

Research Associates who only collect and/or analyze individually
identifiable data and who do not otherwise interact with human subjects
will have their credentials reviewed by Medical Research Service. This
policy applies to all Research Study Nurses and Research Associates
regardless of the source of compensation, whether VA or non-VA, or type
of appointment, VA or WOC. Staff who are already credentialed for
providing healthcare services at the VA WNYHS, must prepare an amended
*Scope of Work* or *Functional Statement* describing research-specific
duties and responsibilities.

**[Definitions:]{.underline}**

a.  [Research Study Nurse]{.underline}: Nursing Staff who are
    professionally accountable to perform a variety of human subjects
    research activities involving interaction with human subjects. Such
    activities shall be performed under the supervision of a Principal
    Investigator. A Research Study Nurse shall minimally hold a
    professional degree in nursing (such as an NP or RN) and may hold
    other advanced medical certifications.

b.  [Human Research Associate]{.underline}: Staff who perform a variety
    of human subjects research activities ranging from interaction with
    human subjects to the collection and analysis of individually
    identifiable data, including lab data or lab samples. Such
    activities are performed under the supervision of a Principal
    Investigator. Research Associates may hold a non-professional degree
    (such as a BA/BS in any one of the science disciplines).

c.  [Scope of Work]{.underline}: A document detailing the duties and
    responsibilities of a Research Study Nurse engaged in human studies
    research. The document outlines a variety of medical procedures,
    nursing care skills and knowledge required to carry out the plan of
    research described in the study protocol.

d.  [Functional Statement]{.underline}: A document detailing the duties,
    responsibilities and knowledge of a Research Associate (staff not
    utilizing specific medical certifications) engaged in human studies
    research.

#### **[Procedures:]{.underline}** Prior to a Research Study Nurse or a Research Associate engaging in a research protocol involving human subjects, the credentialing process must be completed. Each BIMR employee is required to obtain a VA WOC appointment. The directions for completing that application can be obtained in the Medical Research Office, room 129, Building 20. 

#### **[Required documents include:]{.underline}**

1.  List of Competencies specific to research activities described in
    *Scope of Work/Functional Statement*

2.  Dated copy of CV or resume

3.  Documentation of VA Employee Orientation

4.  WOC Nursing Orientation (for Research Study Nurses)

5.  Copy of current Professional License (if applicable)

6.  Certificates of completion of education requirements as mandated by
    VA Office of Research and Development and VA regulations.

7.  Attestation from Principal Investigator that the Nurse/Research
    Associate is qualified for the specific study and is familiar with
    the relevant sections of the IRB SOP, Investigator's Manual and
    Clinical Research Center SOP, if applicable.

8.  Signed VA form *Standards of Ethical Conduct and Related
    Responsibilities* of Employee

Competencies will be developed and certified annually by the Principal
Investigator. Competencies should be specific to the research activities
the Principal Investigator has authorized. The following are examples of
minimum Competency requirements for:

[Research Study Nurse]{.underline}

1.  CPR and/or BLS or ACLS certification

2.  VA mandatory annual reviews

3.  Infection Control

4.  Blood Borne Pathogens

5.  Adverse Drug Reaction reporting

6.  Venipuncture

7.  Initiates IV and IV therapy

8.  Current professional licens

> 9\. Certificates of completion of education requirements as mandated
> by VA Office of Research and Development and VA regulations.
>
> 10\. Human Consent process
>
> 11\. Informed Consent (CM 11-074)
>
> 12\. Good Clinical Practices
>
> 13\. Research Pharmacy orientation (randomization, blinding and code
> break)
>
> 14\. Signed VA form *Standards of Ethical Conduct and Related
> Responsibilities* of Employee

##### Research Associate

1.  VA mandatory annual reviews

2.  Infection Control

3.  Blood Borne Pathogens

4.  Venipuncture (if applicable)

5.  Copy of current professional license (if applicable)

6.  Adverse Drug Reaction reporting (if applicable)

> 7\. Certificates of completion of education requirements as mandated
> by VA Office of Research and Development and VA regulations.
>
> 8\. Human Consent process (if applicable)

9.  Informed Consent (CM 11-074) (if applicable)

10. Research Pharmacy orientation (randomization, blinding and code
    break) (if applicable)

11. Signed VA form *Standards of Ethical Conduct and Related
    Responsibilities* of Employee

**[Responsibilities:]{.underline}** The Principal Investigator will be
responsible for ensuring the Research Study Nurse and/or Research
Associate obtains timely credentialing and demonstrates proficiency in
study-specific skills before engaging in any human subjects research
activities.

Revised: March 29, 2007

## Attachment B

**VA Western New York Healthcare System**

## Buffalo, New York

## Scope of Work

Name of Employee:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Title of
Employee:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Name of Principal
Investigator:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

# [Responsibilities]{.underline}

The Research Study Nurse is responsible to adhere to established medical
center policies and procedures regarding the delivery of health care, to
demonstrate leadership in providing and improving nursing care, and to
provide nursing care in accordance with an approved research protocol
under the supervision of the Principal Investigator.

# [Minimum Qualifications]{.underline}

The incumbent must be a graduate of a National League for Nursing (NLN)
accredited or State-approved School of Nursing and hold a current RN
license. Possess physical and mental capabilities to satisfactorily
perform assigned duties. Completion of approximately three years of
successful nursing practice; or, a Baccalaureate degree in nursing from
an NLN-accredited program and approximately two years of successful
nursing practice; or, a Master's degree in nursing from an
NLN-accredited program and approximately one year of successful nursing
practice; or, Doctoral degree in nursing or a Doctoral degree in a field
related to nursing and a Baccalaureate or Master's degree in nursing
from an NLN-accredited program.

# [Procedures]{.underline}

The Research Study Nurse will be authorized to perform the following
duties and responsibilities on a regular basis in connection with an
approved research protocol under supervision of the Principal
Investigator. The supervisor must complete, sign and date the *Scope of
Work* document.

The incumbent possesses the necessary knowledge and skills to perform
the following mandatory functions:

**[FUNCTION]{.underline}** **[PERFORMANCE STANDARDS]{.underline}**

Practice: -Applies the nursing process to systems or processes at the
unit/team/work group level to improve care. Demonstrates leadership by
involving others in improving care.

Quality of Care: -Initiates/participates in quality improvement
activities that result in improved outcomes.

Performance: -Evaluates practice of self and others using professional
standards, relevant status and regulations.

Collegiality: -Educates colleagues and/or students and serves as a
preceptor and/or a mentor.

-Seeks out colleagues for mutual information exchange.

-Interacts in a professional manner utilizing effective communication
skills

> -Resolves conflicts and assists others in coping with stressful
> situations.
>
> -Serves as a resource person and accurately interprets and
> communicates medical center policies and procedures

Collaboration: -Uses group process to identify, analyze and resolve care
problems.

Ethics: -Supports and enhances client self-determination. Serves as a
resource for clients and staff in addressing ethical issues.

Comprehensive knowledge of: -The requirements of the research protocol
including the inclusion/exclusion criteria.

-The disease process under investigation and the effects of any proposed
medical intervention on the research subject.

> -VA Privacy policy.
>
> -Human research ethical principles as outlined in the Common Rule (45
> CFR 46), the Belmont Report, and the Declaration of Helsinki with
> emphasis on the Informed Consent process.
>
> -Regulations promulgated by various federal agencies concerning human
> subjects research (FDA, ORO, VA Headquarters, HHS and OHRP).
>
> -The *VA WNYHS Standard Operating Procedure for Human Studies
> Research*.
>
> -VISTA/CPRS computer system.

Research: -Uses a body of research to validate and/or change work group
practice.

> -Transmits data collection and other related material

to appropriate individuals in a timely manner.

-Delivers nursing care related to approved research

protocol.

-Prepares reports and papers as required.

-Assists in the interpretation of research findings.

-Assists in data collection in a timely and accurate

manner.

Education/Career Development: -Completes all mandatory training programs
as required.

-Acquires knowledge and skills to maintain expertise in area of
practice. Participates in educational activities to improve clinical
knowledge and enhance role performance.

Resource Utilization: -Identifies and assesses resource utilization and
safety issues, taking appropriate action.

> -Reports unsafe work conditions, unsafe work practices

or any occupational illness or injury which is sustained on duty.

-Adheres to all VA safety and health regulations.

-Uses proper protective equipment as required.

The incumbent is authorized to perform the following duties and
procedures on a regular basis as indicated by the Principal Investigator
initialing either the **YES or NO** column:

**[PROCEDURES]{.underline}:** **YES** **or NO**

1.  Screens patients to determine study eligibility criteria

by reviewing patient medical information or by

interviewing subjects. \_\_\_\_ \_\_\_\_

2\. Develops recruitment methods to be utilized in the study. \_\_\_\_
\_\_\_\_

3.  Performs venipuncture or places and maintains peripheral

IV catheters to obtain blood specimens required by the

study protocol. \_\_\_\_ \_\_\_\_

4.  Initiates submission of regulatory documents to study \_\_\_\_
    \_\_\_\_

Sponsor, VA WNYHS Human Studies Subcommittee and

Research and Development Committee. \_\_\_\_ \_\_\_\_

5\. Prepares study initiation activities. \_\_\_\_ \_\_\_\_

6.  Provides education and instruction relative to study medication

use, administration, storage, side effects to study subjects

as necessary.

\_\_\_\_ \_\_\_\_

i.  7\. Notifies IRB and Sponsor(if applicable) of any serious or

unexpected adverse drug reactions. \_\_\_\_ \_\_\_\_

8\. Provides education regarding study activities to patients, patient's

relatives and medical center staff as necessary. \_\_\_\_ \_\_\_\_

9\. Maintains complete and accurate data collection in case

report forms and source documents. \_\_\_\_ \_\_\_\_

**[PROCEDURES]{.underline}:** **YES** **or** **NO**

10\. Scheduling research subjects visits, documenting progress

notes, initiating orders, consults etc as required. \_\_\_\_ \_\_\_\_

11\. Accesses patient medical information while maintaining

patient confidentiality. \_\_\_\_ \_\_\_\_

12\. Obtains informed consent from research subjects and

is knowledgeable in the informed consent process. \_\_\_\_ \_\_\_\_

13\. Initiates intravenous therapy (IV) and administers IV

solutions and medications. \_\_\_\_ \_\_\_\_

14\. Collects or handles individually identifiable data or

various types of human specimens. \_\_\_\_ \_\_\_\_

The incumbent is authorized to perform the following duties and
procedures not otherwise stated in this *Scope of Work*:

a.\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

b.\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

c.\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**[Principal Investigator Statement:]{.underline}**

This *Scope of Work* document will be revised to reflect new duties and
responsibilities of the Research Study Nurse as necessary.

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Principal Investigator Date

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Research Study Nurse Date

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

ACOS/R&D Date

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Medical Center Director Date

## Attachment C

**VA Western New York Healthcare System**

## Buffalo, New York

## Functional Statement

Name of Employee:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Title of
Employee:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Name of Principal
Investigator:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

# [Responsibilities]{.underline}

The Research Associate is responsible for adhering to established
medical center policies and procedures regarding all research activities
as authorized by the Principal Investigator, including if applicable,
the delivery of health care, in accordance with an approved research
protocol.

# [Minimum Qualifications]{.underline}

The incumbent must be qualified by appropriate experience, training or
education to perform the research-related activities approved by the
Principal Investigator. The incumbent must possess appropriate physical
and mental capabilities to satisfactorily perform assigned duties.

# [Procedures]{.underline}

The Research Associate will be authorized to perform the following
duties and responsibilities on a regular basis in connection with an
approved research protocol under supervision of the Principal
Investigator. The supervisor must complete, sign and date the
*Functional Statement* document.

The incumbent possesses the necessary knowledge and skills to perform
the following mandatory functions:

**[FUNCTION]{.underline}** **[PERFORMANCE STANDARDS]{.underline}**

Works effectively with others: -Interacts in a professional manner
utilizing effective communication skills

> -May serve as a resource person and accurately interprets and
> communicates medical center policies and procedures

Collaborates with other health care -Effectively facilitates
interdisciplinary communication

Professionals: and decision-making among members of the health team as
it relates to the approved research protocol (Comprehensive knowledge of
these performance standards are specific to staff interacting with human
subjects).

Comprehensive knowledge of: -The requirements of the research protocol
including the inclusion/exclusion criteria.

-The disease process under investigation and the effects of any proposed
medical intervention on the research subject.

> -Human research ethical principles as outlined in the Common Rule (45
> CFR 46), the Belmont Report, and Declaration of Helsinki with emphasis
> on the Informed Consent process.
>
> -Regulations promulgated by various federal agencies concerning human
> subjects research (FDA, ORO, VA Headquarters, HHS and OHRP).
>
> -The *VA WNYHS Standard Operating Procedure for Human Studies
> Research*.
>
> -VISTA/CPRS computer system.
>
> (Comprehensive knowledge of these performance standards are specific
> to staff interacting with human subjects)

Under supervisory guidance -Assists in data collection in a timely and
accurate

participates in the approved manner.

scientific investigation: -Transmits data collection and other related
material

to appropriate individuals in a timely manner.

-Prepares reports and papers as required.

-May assist in the interpretation of research findings.

Participates in staff development: -Completes all mandatory training
programs as required by VA regulations and the VA Office of Research and
Development

-Reads professional journals and literature as it relates to the
approved research under investigation.

Follows established medical center -Reports unsafe work conditions,
unsafe work practices

safety practices: or any occupational illness or injury which is
sustained on duty.

-Adheres to all VA safety and health regulations.

-Uses proper protective equipment as required.

The incumbent is authorized to perform the following duties and
procedures on a regular basis as indicated by the Principal Investigator
initialing either the **YES or NO** column:

**[PROCEDURES]{.underline}:** **YES** **or NO**

1\. Screens patients to determine study eligibility criteria

by reviewing patient medical information or by

interviewing subjects. \_\_\_\_ \_\_\_\_

2\. Develops recruitment methods to be utilized in the study. \_\_\_\_
\_\_\_\_

3\. Initiates submission of regulatory documents to study

Sponsor, VA WNYHS Human Studies Subcommittee and

Research and Development Committee. \_\_\_\_ \_\_\_\_

5\. Prepares study initiation activities. \_\_\_\_ \_\_\_\_

6\. Provides education and instruction of study medication

use, administration, storage, side effects to study subjects

as necessary. \_\_\_\_ \_\_\_\_

7\. Notifies study site of any serious or unexpected adverse

drug reactions. \_\_\_\_ \_\_\_\_

8\. Provides education regarding study activities to patients, patient's

relatives and medical center staff as necessary. \_\_\_\_ \_\_\_\_

9\. Maintains complete and accurate data collection in case

report forms and source documents. \_\_\_\_ \_\_\_\_

10\. Scheduling research subjects visits, documenting progress

notes, initiating orders, consults etc as required. \_\_\_\_ \_\_\_\_

11\. Accesses patient medical information while maintaining

patient confidentiality. \_\_\_\_ \_\_\_\_

12\. Obtains informed consent from research subjects and

is knowledgeable in the informed consent process. \_\_\_\_ \_\_\_\_

13\. Collects or handles individually identifiable data or

various types of human specimens. \_\_\_\_ \_\_\_\_

14\. Performs venipuncture to obtain specific specimens required

by the study protocol, if qualified to do so. \_\_\_\_ \_\_\_\_

The incumbent is authorized to perform the following duties and
procedures not otherwise stated in this *Functional Statement*:

a.\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

b.\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

c.\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

d.\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**[Principal Investigator Statement:]{.underline}**

This *Functional Statement* document will be revised to reflect new
duties and responsibilities of the Research Coordinator as necessary.

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Principal Investigator Date

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Research Associate Date

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Executive Director Date

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

ACOS/R&D Date

**BUFFALO INSTITUTE FOR MEDICAL RESEARCH, INC.**

**3495 BAILEY AVENUE**

**BUFFALO, NEW YORK 14215**

**EMPLOYMENT REQUEST MEMORANDUM**

**DATE:**

**FROM:**

**SUBJ:** Employment Request

**TO:** Timothy Murphy, M.D.

**THRU:** Nancy Evans

1\. This is to request the employment of (Applicant\'s
Name)\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ as a (Position
Title)\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
effective (Start Date) \_\_\_\_\_\_\_.

A proposed salary of \$\_\_\_\_\_\_\_\_\_\_\_\_\_(Hourly) is requested.

2.  The appointment will be (please circle): **PART TIME** (Indicate
    Hours/Week:\_\_\_\_\_\_\_)

**FULL TIME** (40 Hours/Week)

**INTERMITTENT**

3\. Please indicate the tour of duty you wish to have assigned by
circling the days of the week the applicant will be scheduled to work.
In the bracket after each circled day, please indicate the number of
hours to be worked for that day.

Sunday ( ) Monday ( ) Tuesday ( ) Wednesday ( ) Thursday ( ) Friday ( )

Saturday ( )

( ) Intermittent

4\. Use **ATTACHMENT A** to provide a brief narrative listing the
proposed duties and responsibilities of the position and the
applicant\'s qualifications.

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Investigator Signature

**APPROVE/DISAPPROVE APPROVE/DISAPPROVE**

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

NANCY EVANS TIMOTHY MURPHY, M.D.

Executive Director President

Revised: March 29, 2007

**ATTACHMENT A**

**EMPLOYMENT REQUEST MEMORANDUM**

**DUTIES AND RESPONSIBILITIES:**

**APPLICANT\'S QUALIFICATIONS:**

(Please include applicant\'s resume and letters of recommendation if
available)

I have read and agree to the conditions of employment as described in
this Employment Request Memorandum. Further, I understand that
employment at the Buffalo Institute for Medical Research, Inc. (BIMR) is
\"at will\" and is terminable \"at will\" by the BIMR or employee with
or without cause. Any oral or written statements or promises to the
contrary are not binding upon the BIMR.

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Applicant Signature Date

**BUFFALO INSTITUTE FOR MEDICAL RESEARCH, INC.**

**3495 BAILEY AVENUE**

**BUFFALO, NEW YORK 14215**

**DATE:**

**FROM:**

**SUBJ:** Verification of Non-BIMR Employment

**TO:** Executive Director

1\. We are requesting your cooperation in providing information
concerning employment you may have outside of your regular BIMR
appointment. Please provide this information using the following format:

**[Name of Employer]{.underline} [Work Schedule]{.underline}** (ie: 8:00
AM to 4:30 PM, M-F)

2\. Please forward completed information to the Research Office, Room
129, Building 20.

.

**BUFFALO INSTITUTE FOR MEDICAL RESEARCH, INC.**

### 3495 BAILEY AVENUE

# BUFFALO, NEW YORK 14215

## Honoraria /Speaker Fee Donation Form

The Buffalo Institute for Medical Research, Inc. (BIMR) accepts
donations of honoraria and speaker fees for VA-salaried staff only if
the individual earning the funds certifies that he or she has not
violated federal ethics regulations contained in 5 CFR Part 2635,
including the provisions regarding outside teaching, writing and
speaking activities as contained in 5 CFR Section 2635.807 (See
Attachment). Generally, such activities **can not** be related to the
employee's official VA duties. While engaging in such activities that
may result in donation of honoraria and/or speaker fees, the VA employee
involved (whether full or part time) must either be on Annual Leave
(A/L) or outside of his/her regularly scheduled VA tour of duty.

# [Instructions:]{.underline}

You must certify by checking the appropriate boxes listed below
(**Sections 1 and 2 or Section 3**) that you are in compliance with the
requirements of 5 CFR Section 2635.807 in order for BIMR to accept your
donation. If you need assistance determining whether a presentation is
related to your official VA duties or otherwise is in compliance with
applicable federal ethics regulations, please consult with Regional
Counsel.

**Section 1:** \_\_\_I certify that the topic of my presentation is
unrelated to my official duties.

**and**

**Section 2:** \_\_\_I certify that I was on A/L or on off-duty status
at the time I made the presentation.

**Exception:**

**Section 3:** \_\_\_I certify that the donation comprises compensation
for teaching a course requiring multiple presentations during a program
of education or training sponsored and funded by the federal government
or by an institution of higher education, an elementary school or an
secondary school as defined by applicable federal statutes or by a State
or local government, which is not offered by an educational institution
described above.

I am directing payment of the attached honorarium/speaker fee in the
amount of \$\_\_\_\_\_\_\_\_\_\_\_\_\_\_for my presentation at (name the
facility at which the presentation was made)
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

on (date)\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ as a charitable donation to
BIMR. I understand that BIMR will provide me with an acknowledgement of
this donation.

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Investigator Signature Date

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

BIMR Official Date

Version Date: May 1, 2002

**BUFFALO INSTITUTE FOR MEDICAL RESEARCH, INC.**

**3495 BAILEY AVENUE**

**BUFFALO, NEW YORK 14215**

**SUPPORT FOR MEETINGS AND CONFERENCES**

The Buffalo Institute for Medical Research, Inc. (BIMR) recognizes that
meetings, conferences, workshops, seminars, grand rounds, town halls,
symposia, and other similar meetings are all accepted activities
associated with conducting research and related education activities.
Additionally, certain events, such as retreats and non-profit board
meetings as well as fundraising, public relations and employee morale
events, are necessary for the conduct of business. Finally, such events
must further BIMR's tax-exempt purpose. Incidental to the business
purpose of such meetings, it may be appropriate to serve meals or
refreshments.

IRS regulations, OMB Circular A-122, federal ethics standards and the
statute authorizing the establishment of VA non-profit corporations
influence the extent to which expenditures related to such events are
appropriate for support. Therefore, in order to be considered for BIMR
support by direct payment or reimbursement, the following guidelines
have been established.

The following criteria must be met to be eligible for BIMR support:

1.  A meeting or conference must have a documented research, research
    related education or BIMR business purpose. BIMR will not support
    "entertainment" expenses such as purely social activities,
    ceremonial occasions or those that provide amusement.

-   **Research meeting:** A request for BIMR support must include an
    explicit statement about the research rationale for the event 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 event to an
    approved research project.

-   **Research related educational event:** Supporting documentation
    should include an explicit statement of how the research related
    education/training activity will further the VA's research mission,
    along with the agenda, program or topic of discussion, and a roster
    of attendees.

-   **Other BIMR business events:** A request must include an explicit
    statement of how the event will further BIMR's ability to facilitate
    research and related education activities. Appropriate events
    include, but are not limited to, retreats and Board of Directors
    meetings, annual membership and investigator meetings as well as
    fundraising, public relations and employee morale events.
    Documentation should include the agenda, program or topic of
    discussion and a roster of attendees.

### BIMR will not support refreshments or meals for regularly-scheduled weekly,monthly or otherwise regularly scheduled VA committee meetings, VA staff meetings, or student/mentorship meetings when attendance is required as part of the individual's VA duties and responsibilities. Support for irregularly scheduled meetings will be considered on a case-by case basis.

The Board of Directors, or the Board's designee (Executive
Director/Treasurer) may approve exceptions to the above criteria for a
specific single event or for a type of recurring event.

All requests for BIMR support will be reviewed and approved by the
Executive Director/Treasurer. Should there be a disagreement concerning
the appropriateness of a request, or should a request exceed reasonable
standards established by the Board of Directors, the request will be
referred to the full Board for review.

Meeting organizers must complete the attached form, *Request for
Reimbursement of Expenses for Meetings and Conferences* to receive
reimbursement of expenses associated with a meeting or conference.
Meeting organizers are encouraged, but not required, to obtain
pre-approval of BIMR for scheduled events. Events lacking pre-approval
may be denied support or may only receive partial support following
review by the Executive Director/Treasurer.

Timothy Murphy, M.D.

President

Revised Date: March 29, 2007

**BUFFALO INSTITUTE FOR MEDICAL RESEARCH, INC.**

#  3495 BAILEY AVENUE

**BUFFALO, NEW YORK 14215**

**DATE:**

**FROM:**

**SUBJ:** Request for Reimbursement of Expenses for Meetings and
Conferences

**TO:** Executive Director/Treasurer

1.  I am requesting reimbursement in the amount of
    \$\_\_\_\_\_\_\_\_\_\_\_\_ for expenses associated with the
    following meeting/conference.

2.  Please document the purpose of the event by completing the following
    questions:

    -   **Who** participated (Please attach roster of attendees if
        available):

    -   **What** the event was (Please attach agenda or event program if
        available):

    -   **Date and Location** of the event:

    -   **Why** the event occurred:

    -   **How much** the event cost:

3.  Attach documentation to verify payment of direct purchase. This may
    include an original paid vendor receipt, canceled check or credit
    card slip. **\*\*\*Please note, requests submitted** **more than 60
    days** **after the meeting/conference date will not be
    approved\*\*\***

4.  Please make the check payable
    to:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Investigator Signature

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**FOR OFFICE WORK ONLY:** (Version Date December 1, 2003)

**Check \#**\_\_\_\_\_\_\_ **BIMR Account #:\_\_\_\_\_\_\_\_\_ Amount
:** \_\_\_\_\_\_\_\_

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**Executive Director/Treasurer Date:** \_\_\_\_\_\_\_\_\_\_\_