2.  Institutional Responsibilities and Administrative Support.  Cost centers are used to ensure that costs are charged to the correct ORI program.  A common resource is a facility, function, or piece of equipment shared commonly by several programs.  

(a) Administration of Funds.  The following entities may administer funds for ORI-approved activities, in accordance with applicable state law and Marshall University:

1.  Marshall University administers all intramural funds, all funds in the Departmental Operating Budget Fund earmarked for ORI administration, and all funds received from another state or Federal agency under an interagency agreement.

 

2.  The Marshall University Research Corporation, MURC, administers all funds that the corporation receives. 

(b) Administration of Contracts.  Contracts may be awarded for ORI purposes.  Some examples of activities to be achieved by contract include but are not limited to:  written consultative opinions, reviews, and critiques of research proposals or ongoing projects; and statistical analyses and tabulations.  The ORI shall award contracts for research purposes only when the ORI cannot provide the service and in order to accomplish its specific goals and objectives. 

1.  Contracts must be in compliance with state acquisition regulations.

2. All contract negotiations are to be handled by the contracting officer.  Only a contracting officer is empowered by state law to execute the contract.  There must be technical or scientific assistance, however, from the principal investigator or from a contracting officer’s technical representative designated by the ORI.  No contract will be written for a period exceeding 1 year (although option years may be included), and each will specifically contain the information outlined in University policy.

a.  Commercially available supplies, devices, and services can be obtained within the allowed dollar limits by local contract for use in an approved project.

b.  In the case of consultant services, Letters of Agreement may be used subject to institutional policies and controls as outlined in current MU regulations.  Any questions about applicability should be directed to the contracting officer.

(c) Administration of Inter-institutional Agreements.  The Office of Research Integrity may enter into inter-institutional agreements with other institutions to provide a portion(s) of their overall Human Research Protections Program such as IRB reviews.  Such agreements provide a means by which Marshall University may provide service or product contracts with another institution or department, which has a need for the required services.  The funding for an inter-institutional agreement is provided through a reimbursable mechanism.  The reimbursement to ORI for the service provided is accomplished by billing the other institution’s appropriated fund and then issuing the funds to ORI. 

Departmental Operating Budget Fund Procedures. 

Departmental Operating Budget Funds will be managed according to current MU financial management policies and procedures. 

Policies and Procedures.  As set forth in Funds: 

1. The Director of ORI may authorize expenditures from the balances of the institution's earmarked Departmental Operating Budget Funds for the purpose(s) for which the funds have been designated.

2. All withdrawals from the Departmental Operating Budget Funds must be approved by the Director or his designee and recorded as obligations prior to release of purchase documents or expenditures.  The approval may be indicated on the purchase document.

3. Expenditures from the Departmental Operating Budget Fund for ORI activities are limited to funds specifically earmarked by the donor for such purpose(s).

4. The Director may authorize travel from earmarked Departmental Operating Budget monies, which support an approved HRPP activity, provided the travel is essential to the conduct of the ORI.  Travel will be authorized and performed in accordance with existing state directives and travel regulations. 

5. The costs associated with the IRB-related activities of the ORI shall be shared equitably between each IRB-related institution.

Charging Industry Sponsors for IRB Review 

The revenue collected for charging for the IRB services can be utilized to defray administrative direct and indirect costs and to obtain other necessary resources and external services.  A fee for IRB review for supported protocols will provide improved services.

Monetary Fees for IRB Reviews

The IRB review charge will appear as a separate category distinct from the project budget within the contract.  The principal investigator assumes responsibility for ensuring that fees are paid.  Checks should be made to the Marshall University Research Corporation and must include the IRB protocol number.

Fees:  If the full convened or expedited protocol is industry sponsored, the ORI will be charging the sponsor a one time fee of $2,500 that will cover the initial review and all continuing IRB reviews.  The fee is the same for industry sponsored expedited reviews.  Payment is to be made to the Marshall University Research Corporation and must accompany the study application.  With approval of the Director ORI, a verification of allocated funds can accompany the application in lieu of payment. 

Waivers:  There may be extenuating circumstances where such a charge would be unwarranted (e.g., small project budgets).  Please send written requests for waiver of the IRB fee to Cynthia Winger, M.D., Director, ORI.

FOLLOW-UP RESPONSIBILITY:  Director, Office of Research Integrity

Revised  5-1-2007