Policy and Procedure

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Revised July 31, 1998

RESEARCH POLICY SERIES
POLICY AND PROCEDURE STATEMENT ON
CONFLICT OF INTEREST IN FEDERALLY SPONSORED PROGRAMS
AT
MISSISSIPPI STATE UNIVERSITY

PURPOSE

The Mississippi State University Policy and Procedures on Conflict of Interest in a Federally Sponsored Program have been prepared in accordance with current federal regulations. All grant applicants to the National Science Foundation (NSF) and National Institutes of Health (NIH) are required to adopt, and enforce, written policies regarding conflicts of interest. This policy is designed to comply solely with the National Science Foundation’s Investigator Disclosure Policy, 60 F.R. 132, pp. 35810-823 (July 11, 1995) and the U.S. Department of Health and Human Services’ Objectivity in Research Rules, Subpart F - Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding Is Sought, 42 C.F.R. Part 50, Subpart F. These new requirements include adopting a Financial Disclosure Statement (attached) which must be completed by appropriate investigator(s) and forwarded for review through the designated University channels.

Issuance of this policy is required by federal regulations. The federal regulations also set forth certain specific threshold limitations regarding personal interests related to research performed under federal programs. Although state law is more restrictive than the federal regulations in the area of threshold limitations regarding what personal interests are allowed in relationship to research performed by state employees, the mechanical process required by the federal regulations and set forth in this policy is not inconsistent with state law. Thus, issuance of this policy and adherence to the mechanical process for identifying and processing potential conflicts of interest will meet the requirements of the federal regulations. However, reliance should not be placed on the federal threshold limitations set forth in the policy when determining whether personal interests do or do not comply with the more restrictive state law prohibitions regarding conflicts of interest.

REVIEW

This policy and procedure will be reviewed as needed by the University Research Ethics Review Officer and the Conflict of Interest Review Committee with recommendations for revisions presented jointly to the Vice President for Research and the Vice President of Agriculture, Forestry and Veterinary Medicine.

BACKGROUND

Effective interaction between universities and industry is essential to ensure the rapid application of scientific discoveries to the needs of the nation and to maintain the international competitiveness of domestic industry. Nonetheless, prudent stewardship of public funds includes protecting sponsored research or scholarly activities from being compromised by the conflicting financial interests of any investigator responsible for the design, conduct, or reporting of a sponsored project.

The value of the results of sponsored research to the health and the economy of the nation must not be compromised by a financial interest that will, or may be reasonably expected to, bias the design, conduct or reporting of the research or scholarly activity. This policy seeks to maintain a reasonable balance between these competing interests, give the University the ability to identify and manage those financial interests that may bias the research or scholarly activity, and minimize reporting and other burdens on the investigators.

POLICY

In accordance with federal regulations, the University has a responsibility to manage, reduce, or eliminate any conflicts of interest that would reasonably appear to be affected by a financial interest of an investigator. Thus, the University requires that investigators disclose any significant financial interest that may present an actual or potential conflict of interest in relationship with an NSF or NIH sponsored project.

This policy applies to all NSF or NIH sponsored project activities and is in addition to any other policies, requirements or laws pertaining to ethical standards of university employees. This policy is designed to conform to federal regulations. All conflicts of interest must be managed, reduced, or eliminated prior to the expenditure of funds on the project.

At no time will the University accept a sponsored agreement if the award is in any way contingent upon the condition that specific research results be obtained.

DEFINITIONS

The terms used in this policy statement are defined as follows:

1. University - Mississippi State University

2. Conflict of Interest - Situations in which financial or other personal considerations may compromise, or have the appearance of compromising, an investigator's professional judgment in designing, conducting and/or reporting of research. (For example, conflict occurs when an investigator's professional decisions may be influenced by considerations of financial gain for themselves or their immediate family or give improper advantage to an associated entity).

3. Associated Entity - Any trust, organization, or enterprise (other than the University) over which the investigator, or any member of the immediate family, exercises more than five percent (5%) ownership interest for any one enterprise entity when aggregated for investigator and investigator's spouse and children.

4. Financial Interest - Anything of monetary value to the investigator or immediate family, including, but not limited to:

1. Salary, royalties, or other remuneration from the University;

2. Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities;

3. Income from service on advisory committees or review panels for public or nonprofit entities;

4. An equity interest that when aggregated for the investigator and the investigator's spouse and dependent children, meets both of the following tests: does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not constitute more than a five percent (5%) ownership interest in any single entity; or

5. Salary, royalties or other payments that when aggregated for the investigator and the investigator's spouse and dependent children over the next twelve months, are not expected to exceed $10,000.

1. The MSU Internal Approval Sheet requires a signature by the Principal Investigator (PI) and Co-PI if there is no significant financial interest. If there is a significant financial interest, the disclosure form must be completed.

2. Each investigator is required to disclose the following significant financial interests:

1. Any significant financial interest of the investigator that would reasonably appear to be directly and significantly affected by the research or scholarly activities funded, or proposed for funding, by an external sponsor; or

2. Any significant financial interest of the investigator in an entity whose financial interest would reasonably appear to be affected by the research or scholarly activities funded, or proposed for funding, by an external sponsor.

3. If the investigator is an employee of a subgrantee or subcontractor, the Office of Sponsored Programs is responsible for receiving appropriate assurances from their employers that they have complied with current federal regulations concerning conflicts of interest or if the subcontractor or subgrantee is not required to have a conflict of interest policy assurance that the subgrantee or contractor abides by the University policy.

4. Regardless of the above minimum requirements, a faculty or staff member, in his or her own best interest, may choose to disclose any other financial or related interest that could present an actual conflict of interest or be perceived to present a conflict of interest. Disclosure is a key factor in protecting one's reputation and career from potentially embarrassing or harmful allegations of misconduct.

5. If there is a significant financial interest, each investigator shall attach all required supporting documentation. The completed Financial Disclosure Form must be submitted with the proposal and Internal Approval Sheet (IAS) using normal University procedures. Supporting documentation that identifies the business enterprise or entity involved and the nature and amount of the interest should be submitted in a sealed enveloped marked "confidential" and accompany the Financial Disclosure Form and the IAS.

It should be noted that it is the responsibility of those faculty/staff members of Mississippi State University, either full- or part-time, who will be serving as principal investigator or co-principal investigator on a sponsored project covered by this policy, to initiate the disclosure process at the time of proposal submission or at the time a significant financial interest develops in a sponsored project.

6. All significant financial interests must be disclosed at the time a proposal is submitted. All financial disclosures must be updated by investigators during the period of the award, on an annual basis and as new reportable significant financial interests are obtained. Any "negative" statement must also be included in a proposal submission.

7. If a conflict of interest is found or disclosed after an award has been made, interim action to manage the conflict will be recommended by the CIRC within 30 days from the time that the conflict of interest is identified.

8. The University Research Ethics Review Officer shall conduct an initial review of all financial disclosures to determine whether a potential for a conflict of interest exists. A conflict of interest exists when the review reasonably determines that a significant financial interest could directly and significantly affect the design, conduct, or reporting of the proposed sponsored project. If the initial determination is made that there may be a potential for conflict of interest covered by this policy, then the Disclosure packet will be referred to the University Conflict of Interest Review Committee (CIRC).

9. Prior to consideration by the University, the investigator, in cooperation with the department, college or unit, shall develop and present to the CIRC a Conflict of Interest Resolution Plan that details proposed steps that will be taken to manage, reduce, or eliminate any actual or potential conflict of interest presented by a significant financial interest. At a minimum, the Resolution Plan shall address such issues as:

1. Public disclosure of significant financial interests;

2. Review of research protocol by independent reviewers; and

3. Monitoring of research by independent reviewers.

Where the CIRC deems it appropriate, the CIRC shall review the Resolution Plan and approve it, but may add conditions or restrictions, including, but not limited to, the following:

1. Modification of the research plan;

2. Disqualification from participation in all or a portion of the research funded;

3. Divestiture of significant financial interests; or

4. Severance of relationships that create actual or potential conflicts of interest.

10. If the CIRC determines that imposing the above referenced conditions or restrictions would be inequitable, or that the potential negative impacts that may arise from a significant financial interest are outweighed by interests of scientific progress, technology transfer, or the public health and welfare, then the CIRC may recommend that, to the extent permitted by federal regulations and state law, the research go forward. In these cases, the appropriate Vice President shall either approve or disapprove the CIRC recommendation.

11. The approved Resolution Plan shall be incorporated into a Memorandum of Understanding between the CIRC and the investigator that details the conditions or restrictions imposed upon the investigator in the conduct of the project or in the relationship with the business enterprise or entity. The Memorandum of Understanding shall be signed by the investigator, the Department Head, the Dean or Director, the University Research Ethics Review Officer, and after recommendations of the CIRC, will be signed by the Chairperson of the CIRC and approved or disapproved by the appropriate Vice President. Actual or potential conflicts of interests will be satisfactorily managed, reduced, or eliminated in accordance with these guidelines prior to expenditures of awarded funds, or they must be disclosed to the sponsoring agency for action.

12. Records of investigator financial disclosures and of actions taken to manage conflicts of interest, shall be retained by the Office of Sponsored Programs for 3 years after the latter of the termination or completion of the award to which they relate, or the resolution of any government action involving those records.

13. Collaborating investigators from other institutions must either comply with this policy or provide a certification that their institutions are in compliance with federal policies regarding investigator significant financial interest disclosure and that their portion of the project is in compliance with their institutional policies.

Agencies have varying requirements regarding the reporting of conflicts of interest to the sponsoring agency. Depending upon those requirements, the University is required to report:

1. any instance of conflict of interest, or

2. any instance of conflict of interest not managed or resolved by the University, or

3. in any case, if the failure of an investigator to comply with the policy has biased the design, conduct or reporting of research, the University must notify the appropriate sponsor officer.

The sponsoring agency may determine that it is appropriate to suspend funding until the conflict is managed.

If the study is to evaluate the safety or effectiveness of a drug, medical device, or treatment and the study has been designed, conducted, or reported by an investigator with a significant financial interest that was not disclosed or managed as required by the University, the investigator(s) involved must disclose the significant financial interest in each public presentation of the results of the research.

VIOLATIONS OF POLICY

1. Any violations of this policy may result in sanctions being imposed upon the violating individual(s). In addition, adverse employment actions may be taken. It should also be noted that if the failure of an investigator to comply with the policy of the University has directly biased the design, conduct or reporting of the externally funded research, or educational activity, the University must promptly notify the external agency of the corrective action taken. Such notification will be the responsibility of the Research Ethics Review Officer who shall be the Director of Sponsored Programs unless otherwise jointly appointed by the Vice President for Research and the Vice President of Agriculture, Forestry and Veterinary Medicine. The Research Ethics Review Officer shall brief the appropriate Vice President prior to notifying the external agency.

2. Whenever an investigator has violated this policy or the terms of the Memorandum of Understanding, the CIRC shall document the violation and forward a report to the investigator’s immediate supervisor with a copy to the investigator, the Vice President for Research, and the Vice President of the division within which the investigator is employed at the university.

3. If the investigator is dissatisfied with the conclusion of the CIRC, that individual may, within five (5) working days after being informed of the CIRC finding, appeal in writing directly to the appropriate Vice President. The Vice President will confer with the investigator, as well as the CIRC, to the extent necessary and respond in writing to the investigator with a decision usually within ten (10) working days. A copy of the determination will be forwarded to the investigator’s immediate supervisor and the appropriate Vice President.

CIRC SANCTIONS

Examples of conditions or restrictions that might be imposed by the CIRC to manage or eliminate conflicts of interest include, but are not limited to:

1. public disclosure of significant financial interests;

2. monitoring of research by independent reviewers;

3. modification of the research plan;

4. disqualification from participation in all or a portion of the research;

5. divestiture of significant financial interests; or

6. severance of relationships that create actual or potential conflicts of interest.

SPONSOR REQUIREMENTS

Some sponsors, particularly governmental agencies, may have requirements that differ from this policy with regard to the timing and/or frequency of disclosures and other provisions as well. When differences occur, the sponsor's requirements to the degree that they are more stringent, shall prevail.

OP 70.09

12/15/98

Attachment A
Financial Disclosure Form (PDF)

For information about this policy, contact the reviewing department.