Research Administration Business Office

The MetroHealth System
Policy V-32
Objectivity in Research and Conflict of Interest Disclosure

I. POLICY

A. In partial fulfillment of its education and research objectives, The MetroHealth System encourages contracting with commercial firms and other external funding entities in the development and testing of pharmaceutical or commercial products, and to conduct research programs, projects and investigations. Commercial products include but are not limited to pharmaceuticals, procedures, protocols, processes, devices, materials and other items which may or may not be generally available in the market. These contracts, agreements and grants shall be approved and administered as specified in Policy V-7 Research Administration (Grants and Contracts).

B. This policy applies to any relationship between a profit or non-profit entity, including the federal government, and MetroHealth staff or employees (hereafter referred to as staff) where a mutual or one-directional benefit exists.

C. Benefits to industry may be, but are not limited to:

1. both research and clinical testing data,
2. device use information,
3. favorable marketing position,
4. education of potential external customers, and
5. use of specialized equipment or laboratories at MetroHealth for product development.

D. Benefits to staff are not limited to but could include some of the following:

1. free, or reduced cost equipment,
2. establishment of special funds and/or discretionary accounts,
3. laboratory and technician support,
4. salary support,
5. access to specialized techniques or equipment available in industry, and
6. travel costs.

II. PURPOSE
This policy sets forth governing principles to ensure that the design and conduct of research will not be biased by any conflicting financial interest and outlines guidelines for disclosure of outside interests by all staff at MetroHealth who engage in research -- both clinical and basic. Key principles and guidelines pertaining to the acceptance and management of contract/grants are outlined in Policy V-7 Research Administration (Grants and Contracts).

III. SCOPE
This policy applies to all staff of The MetroHealth System and other persons associated with the System, Case Western Reserve University, or other institutions who use its resources in responding to and fulfilling an external funding source's requirements for a contract/grant.

IV. GOVERNING PRINCIPLES

A. Product development, testing or use in experimentation should be guided by the highest scientific principles. The project shall be performed in a manner that assures that the intellectual integrity of The MetroHealth System, its staff and affiliated academic institutions is preserved.

B. It is essential that all research--both basic and clinical--be conducted free from any conflict of interest or financial impropriety. In order to protect the objectivity of persons who are engaged in research and to preserve the integrity of MetroHealth and its researchers, all staff must avoid any conflict of interest in their research. Conflict of interest disclosure statements must be submitted annually as outlined in Section V of this policy.

C. IRB/FDA policies and procedures need to be followed when humans and/or biological products are incorporated into the study design. Investigators are reminded that it is necessary to have an IRB - approved protocol for any investigation involving humans. IACUC policies and procedures must be followed when animals are used in conducting research.

D. The intellectual property right to developments, such as inventions and discoveries resulting from the investigation and testing, shall be specified in the contract/grant in accordance with Policy I-48 Technology Development and Transfer, whenever possible.

E. No charges beyond reasonable standard of care may be made to the patient or his/her insurance carrier for any diagnostic or therapeutic services provided under this type of agreement unless approved as part of the protocol and/or contract.

F. All contracts/agreements/grants must comply with Policy V-7 Research Administration (Grants and Contracts).

Conflict of Interest Disclosure
G. Definition of Conflict of Interest
Ownership of equity in the sponsoring organization by the investigator and/or his/her immediate family members, equity trading based on inside information known or discovered by the investigator, participation in other commercial activities of the sponsor, acceptance of sponsorship of educational activities or travel are examples of potential conflict of interest that might exist with a commercial sponsor of research. Such activities must be disclosed in accordance with the Conflict of Interest in Research Disclosure Statement. In fact, it is strongly recommended that investigators avoid any appearance of conflict of interest by maintaining a personal and professional independence from industry representatives by fostering a business/professional relationship with such representatives. One role of the review process is to assist the investigator in determining when a real or apparent conflict of interest exists.

H. Disclosure Procedure and Review

1. The Research Administration Business Office will request a disclosure statement be completed by all staff members conducting research during the first quarter of the year, but no later than April 15th. Delays in the approval of grant proposals will occur if disclosure statements are not filed.
2. If any potential conflict of interest is disclosed, the information will be forwarded to the Legal Department for review. All information will be kept confidential.

V. REPLACES
Commercial Contracts for Development and/or Testing of Pharmaceutical or Commercial Products Policy V-32.

VI. ATTACHMENT
Conflict of Interest Disclosure Form

VII. DATES
A. Initiated: October 1996
B. Reviewed/Revised: March 2000

VIII. APPROVED
Terry R. White
President and Chief Executive Officer

Melinda L. Estes, M.D.
Executive Vice President/Chief of Staff

MetroHealth Medical System
Conflict of Interest Disclosure Form

This form must be completed and filed with the Research Administration Business Office annually by September 30th. Any potential or serious conflict that arises during the interim must be disclosed to the IRB within ten (10) days of learning of it. Approval of research protocols and processing of contracts with sponsors will not be completed pending receipt of a current disclosure form.

Name: ______________________________________________________________

Title: ______________________________________________________________

Department: _________________________________________________________

Phone: ___________________ Email address: _____________________________

You should refer to MetroHealth's Policies and Conflict of Interest in Research when completing this form. Copies of these Policies and Procedures can be obtained from the Research Administration Business Office.

I DO NOT, nor do members of my immediately family (spouse, domestic partner or dependent children as defined by the Internal Revenue Service), have a financial interest in a single entity, which exceeds $10,000 income, or 5% ownership interest related to the research I am conducting.

I DO, or members of my immediate family (as described above), have a financial interest in a single entity, which exceeds $10,000 income, or 5% ownership interest to the research I am conducting.

Provide name of entity in which you or your immediate family have significant financial interest.

Name of entity ____________________________________

Please provide a written description as to why this is not a conflict of interest in the research project or a written proposal on how you plan to manage this conflict.

I certify that this is a complete and accurate disclosure of any financial interest, which would reasonably appear to be related to this sponsored project.

Signature: __________________________________ Date: ____________________

WHAT IS A RELATED FINANCIAL INTEREST? Whenever it could reasonably appear that the research to be undertaken could be affected by, or have an affect on an investigator's financial interest, the financial interest is "related" to the sponsored project. The following are financial interests "related" to the sponsored project: ¨

The investigator is conducting a project where the results could be relevant to the development, manufacturing, or improvement of the products or services of the entity in which the investigator has a financial interest.
The investigator has a financial interest in an entity which might manufacture or commercialize a drug, device, procedure or any other product used in the project or that will predictably result from the project.
The investigator receives income exceeding $10,000 from a single entity for consulting activities that would reasonably appear to be related to the research.
The investigator has a financial interest in an entity and the sponsored project will subcontract a portion of the work, or lease property, or make purchases from the entity.
The sponsored project will involve referral of patients/subjects to organizations in which the Investigator has a financial interest.

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