Introduction

Effective interaction between universities and industry is essential to bring about the rapid application of scientific discoveries to the needs of the nation and to maintain the international competitiveness of domestic industry. However, as a 1993 document from the Association of American Universities points out, "a degree of conflict may be inevitable whenever academic research addresses problems of the real world. What is important is that such conflicts be managed so that the purpose and mission of academic institutions are not compromised, so that the investment of the public and students is protected, and so that public confidence in the integrity of scholarly activities is maintained. Coherent conflict-of-interest policies can not only help guide relationships between industry and academia, but also help ensure the protection of the mission of the university."

The National Science Foundation and the U.S. Public Health Service have issued regulations requiring institutions that apply for funding for research and educational activities to assume responsibility for ensuring that the financial interests of the employees of the institution do not compromise the objectivity with which such research or activity is designed, conducted, or reported. Other federal government agencies are expected to issue similar regulations. To meet the requirements of those regulations, Texas Woman's University (TWU) has adopted this policy, effective October 1, 1995, and which shall continue in effect until rescinded or modified by appropriate University authority. Through this policy, Texas Woman's University requires that each investigator disclose all significant financial interests that would reasonably appear to be directly and significantly affected by proposed external funding.

This policy applies to proposals made to and sponsored projects supported wholly or in part by the U.S. Public Health Service, the National Science Foundation, and other U.S. government agencies that announce regulations on conlict of interest (or objectivity in research).

Definition of terms

In this document the term "investigator" means the principal investigator (project director), co-principal investigators, and any other person who is responsible for the design, conduct, or reporting of a research, educational, or service activity funded or proposed for funding by the U.S. Public Health Service (PHS) or the National Science Foundation (NSF). Usually, this person is a faculty member. It is understood, however, that other full-time employees of the institution may not have faculty rank but would be involved in sponsored projects; this conflict of interest policy also applies to such persons.

The term "research and sponsored projects" means a systematic investigation designed to develop or contribute to generalizable and applicable knowledge, including research in the behavioral and social sciences. For the purposes of this policy, this term encompasses basic and applied research, product development, and educational activities. In short, the term "research and sponsored projects" includes any such activity for which funding is available from a federal agency through a grant, cooperative agreement, contract, or other financial assistance award.

The term "significant financial interest" means anything of monetary value, including, but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights).

The term does not include

1. salary, royalties or other remuneration from TWU;
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 represent more than a five percent 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.

Policy statement

It is the policy of Texas Woman's University that no proposed, awarded, or ongoing research project at TWU shall be biased by any significant financial interest of any investigator responsible for the design, conduct, or reporting of that research project. The purpose of this policy is to promote objectivity in research at TWU.

TWU shall maintain an appropriate written, enforced policy on objectivity in research that complies with the federal regulations. The University shall inform each investigator of the University policy, the investigator's reporting responsibilities, and the federal regulations that bring about the policy. If TWU carries out the PHS- or NSF-funded research through subgrantees, contractors, or collaborators, TWU must take reasonable steps to ensure that subrecipients comply with these regulations, either by complying with TWU's policy or by providing assurances to TWU that the subrecipient(s) also has policies that comply with these federal regulations.

The TWU President, through this document, designates the Associate Dean for Research (henceforth referred to as the Designated Official) as the TWU administrator who shall solicit and review financial disclosure statements from each investigator who is planning to participate in PHS- or NSF-funded research. The Designated Official shall establish and oversee procedures to effect the intent of this policy in accordance with the provisions specified in this document. The Designated Official may, at his or her discretion, ask ad hoc reviewers and advisors to review the financial disclosures required by this policy.

This policy requires that, by the time an application is submitted to PHS or NSF, each investigator who is planning to participate in the PHS- or NSF-funded research has submitted to the Designated Official a statement indicating whether he or she has (or whether his/her spouse and dependent children have) any known Significant Financial Interests: (1) that would reasonably appear to be affected by the research for which funding is sought; and (2) in entities whose financial interests would reasonably appear to be affected by the research. If an award is received for this proposed research, then the investigator(s) must update all financial disclosures during the period of the award, on an annual basis.

This policy contains guidelines for the Designated Official to follow in identifying conflicting interests and taking such actions as necessary to ensure that such conflicting interests will be managed, reduced, or eliminated.

TWU will maintain records of all financial disclosures and all actions taken by the institution with respect to each conflicting interest for at least three years beyond the termination or completion of the grant to which they relate, or until the resolution of any action involving these records, whichever is longer.

TWU certifies, that in each application for funding to the Public Health Service or the National Science Foundation, that (1) there is in effect at this institution a written and enforced administrative process to identify and manage, reduce or eliminate conflicting interests with respect to all research and educational projects for which funding is sought; (2) prior to the institution's expenditure of any funds under the award, the institution will report to the sponsor the existence of a conflicting interest (but not the nature of the interest or other details) found by the institution and assure that the interest has been managed, reduced or eliminated in accordance with federal regulations; and, for any interest that the institution identifies as conflicting subsequent to the institution's initial report under the award, the report will be made and the conflicting interest managed, reduced, or eliminated, at least on an interim basis, within sixty days of that identification; (3) the institution agrees to make information available, upon request, to the Public Health Service or the National Science Foundation regarding all conflicting interests identified by the institution and how those interests have been managed, reduced, or eliminated to protect the research from bias; and (4) the institution will otherwise comply with regulations given in the published regulations.

Further, the University will keep appropriate federal agency officials informed if TWU finds that it is unable to manage satisfactorily a conflict of interest.

If there are no Significant Financial Interests to be disclosed, this is so noted in the proposal file. If there are Significant Financial Interests disclosed, the Designated Official will then commence initial review of the Investigator Disclosure Form.

Responsibilities of the Designated Official

The Designated Official shall:

• create an appropriate Investigator Financial Disclosure Form (Disclosure Form) and shall update or revise that form as required;
• ensure that the requirements of this policy are communicated to investigators;
• receive and review, with or without committee assistance, Disclosure Forms to determine whether the investigator has significant financial interests that could affect the design, conduct, or reporting of the research activities proposed for funding or funded by external agencies;
• take appropriate action to manage, reduce, or eliminate actual and potential conflicts of interest;
• certify, prior to the issuance of an award, to the awarding component of a federal agency the existence of significant financial interests and the plans of the institution for managing such interests;
• notify the awarding component of the federal agency of the identification and management, reduction, or elimination of any significant financial interests that originates or becomes known to TWU after an award has been made and within sixty days of its report to the Designated Official;
• maintain confidentially, to the extent permitted by law, all disclosures and records of actions taken to manage significant financial interests for at least three years beyond the termination or completion of the award or until resolution of any action by a federal agency involving the records, whichever is longer, and make these records available for audit by authorized agencies.

At TWU the Designated Official, at the establishment of this policy, is the Associate Dean for Research. Although it is expected that the person holding this position will remain the Designated Official for purposes of this policy, the President may name another person to carry out these responsibilities if circumstances dictate.

Responsibilities of TWU Investigators

Each TWU Principal Investigator must identify on a Significant Financial Interest (Disclosure) form those financial interests which would reasonably appear to be directly and significantly affected by proposed research, educational activities, or sponsored projects. A disclosure form covering significant financial interests of the investigator's immediate family must be submitted as well. The completed form, identifying the business enterprise or entity involved and the nature and amount of the interest, should be submitted, along with supporting documentation, in an envelope marked CONFIDENTIAL to the University's Designated Official.

The University expects that financial conflicts-of-interest will not be an issue in most cases of proposals to external sponsors. It is important that faculty and administrative staff recognize that the goal of this disclosure policy is to capture as efficiently as possible only that information pertinent to University conflict-of-interest concerns. Most information that is disclosed will not require any review past the initial stage. The information obtained will provide an opportunity for discussion, review, and appropriate management.

The information that must be disclosed

There is a possibility that a financial conflict of interest may exist whenever a faculty member's affiliation with an external sponsor meets or may meet any one of the following criteria:

1. The faculty member is an officer, director, partner, trustee, employee, advisory board member, or agent of an external organization or corporation either funding a sponsored project or providing goods and services under a sponsored project on which the faculty member is participating in any capacity.
2. The faculty member is the actual or beneficial owner of more than five percent (5%) of the voting stock or controlling interest of such organization or corporation, and
3. The faculty member has dealings with such organization or corporation from which he or she derives income of more than $10,000 per year, exclusive of dividends and interest.
4. The faculty member's immediate family meet any of the criteria stated in 1-3 above.

Each faculty member participating or proposing to participate in a sponsored project covered by this policy must disclose whether or not he or she has external affiliations that may constitute a conflict falling with the criteria stated above. Such a disclosure shall be made in writing according to the procedures outlined below.

Initial review

The Designated Official shall conduct an initial review of all financial disclosures. If this initial review determines that there is no conflict of interest, a note to that effect is signed and dated by the Designated Official and placed in the proposal file in the Office of Research & Grants Administration.

If, on the other hand, the initial determination is made that there may be a potential for conflict of interest covered by this policy, then a Disclosure Packet will be prepared by the Designated Official and referred to an ad hoc Conflict of Interest Review Committee. Committee members are appointed by the Vice President for Academic Affairs. The committee shall contain, at a minimum, four members--including representatives from the TWU faculty representing a cross section of academic disciplines. The Associate Dean for Research may serve as an ex officio member of the committee. The Vice President for Academic Affairs may appoint an additional administrator to the committee, particularly if such an appointment would provide balance of expertise.

Prior to the consideration of the Disclosure Packet by the Conflict of Interest Committee, the Investigator shall develop and present to the committee 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.

A conflict of interest exists when the Conflict of Interest Committee, using the guidelines stated in this policy, reasonably determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of the proposed sponsored project. The committee shall then recommend to the Vice President for Academic Affairs the conditions or restrictions, if any, which should be imposed by the institution to manage actual or potential conflicts of interest arising from disclosed Significant Financial Interests.

Subsequent review

The Vice President for Academic Affairs shall consider the recommendations made by the Conflict of Interest Review Committee and decide whether to concur with those recommendations, modify them, or request additional review. This decision will be conveyed to the Principal Investigator (and Co-Investigators) and the Associate Dean for Research (ffice of Research & Grants Administration), i.e., whether the University perceives that a Conflict of Interest exists between the Investigator's Significant Financial Interests and the proposed research or sponsored project, and, the actions that will be taken.

Enforcement mechanisms

If the Designated Official and others the Official has asked to help review the disclosure information determine that a conflict of interest exists, i.e., that a significant financial interest could directly and significantly affect the design, conduct, or reporting of PHS- or NSF-funded research or educational activities then conditions or restrictions might be imposed on the investigator(s) to manage, reduce, or eliminate such conflicts of interest. Examples of conditions or restrictions that might be imposed 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 the portion of the research that would be affected by the significant financial interests;
5. Divestiture of significant financial interests; or
6. Severance of relationships that create conflicts.

If the reviewer(s) determines that imposing conditions or restrictions would be either ineffective or inequitable, and 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 reviewer(s) may allow the research to go forward without imposing such conditions or restrictions.

The Designated Official is responsible for notifying the sponsoring agency, prior to expenditure of any funds, of the University decision in this matter.

Opportunities for appeal

If any questions remain as to the resolution of the conflicts of interest and the University decision as stated by the Vice President for Academic Affairs, the investigator(s) may appeal to the President for further consideration. The President may decide to let the decision stand or to convene a new ad hoc Conflict of Interest Committee to review the appeal.

REVIEWED AND APPROVED:

Dr. Leslie M. Thompson
Associate Vice President for Research and Dean of the Graduate School
10-16-95

Dr. Beverley Byers-Pevitts
Vice President for Academic Affairs
10-23-95

Dr. Carol Surles
President
10-30-95