Full text of Robert Killoren's message and the Pennsylvalia State University Conflict of Interest Draft Policy: (Forwarded with permission from, and thanks to Bob Killoren) I'd be happy to share the information with anyone who wants it. Of course, I've just heard that NIH and NSF have reached some agreements on final form -- so there may be a few minor changes (they look as if they are going to go with a $10k threshold, and clarify that there's a $10k/year threshold on anticipated salaries, royalties, etc. They also want to clarify that certain exclusions will not apply if receipt of the income is contingent on specific results being obtained.) I'm not on RESADM, but if you want to share that info with any of those folks that would be fine. I just don't have the time to do it all myself. I'm teaching a workshop on the subject for the NCURA Region II meeting in Alexandria on April 30, if anyone is interested in attending. I have an electronic version of an updated policy if you are interested... I'll send it below. If you want to share it with folks that's okay... (Your message to me is at the end of this message. Just so you don't copy that with the policy...) You can list it on the gopher too, if you want. Penn State's Significant Financial Interest Policy (DRAFT) These guidelines define general University policy and procedures regarding conflicts of interest in relationship to sponsored projects involving research, education, and university service. Their purpose is to protect the credibility and integrity of the University's faculty and staff so that public trust and confidence in the University's sponsored activities is ensured. In accordance with Federal regulations, the University has a responsibility to manage, reduce, or eliminate any actual or potential conflicts of interest that may be presented 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 a sponsored project. A. Background - Technology Transfer and Conflict of Interest Effective interaction between universities conducting research 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 from being compro mised by the conflicting financial interests of any investigator responsible for the design, conduct, or reporting of sponsored research. Numerous statutes and programs demonstrate Federal interest in the promotion of in teractions among Government, academia and industry. For example, the Stevenson- Wydler Technology Innovation Act of 1980 (Public Law (P.L.) 96-480) encourages tech nology transfer, particularly through industrial- academic collaborations. The Patent and Trademark Act Amendments of 1980 (P.L. 96-517) allow universities and other funding recipients to apply for patents developed with Federal funding, and expressly promote collaboration between commercial concerns and nonprofit organizations. The Economic Recovery Tax Act of 1981 (P.L. 97-34) is aimed at fostering research and development by small companies and associated university partners. The Federal Technology Transfer Act of 1986 (P.L. 99-502), which amended P.L. 96-480, and Executive Order 12592 provide similar patent and licensing authority to Federal laboratories, and encourage them to par ticipate in cooperative research and development agreements with the private sector and nonprofit organizations, including universities. These legal authorities facilitate the movement of intellectual capital between the Federal Government, academic institutions, and the private sector. This kind of cross-fer tilization is critical to the development of U.S. industry. However, these and other in ducements for collaboration have created a climate in which the stewardship of public funding for research is increasingly complex and challenging. The value of the results of sponsored research to the health and the economy of the Nation must not be compromised by any financial interest that will, or may be reasonably expected to, bias the design, conduct or reporting of the research. This policy seeks to maintain a reasonable balance between these competing interests, give the University the ability to identify and manage financial interests that may bias the research, and minimize reporting and other burdens on the investigators. B. Definitions A potential Conflict of Interest occurs when there is a divergence between an individual's private interests and his or her professional obligations to the University such that an independent observer might reasonably question whether the individual's professional actions or decisions are determined by considerations of personal gain, financial or otherwise. An actual conflict of interest depends on the situation and not on the character or actions of the individual. Investigator means the principal investigator/project director, co-principal investiga tors, and any other person at the University who is responsible for the design, conduct, or reporting of research, educational, or service activities funded, or proposed for funding, by an external sponsor. In this context, the term "Investigator" includes the investigator's spouse and dependent children. 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) * intellectual property rights (e.g., patents, copyrights and royalties from such rights). The term does not include: (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; or (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, or, constitute 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. Provided, however, that the exclusions in items (1), (4), and (5) shall not apply if the compensation or transfer of an equity interest is conditioned upon a particular outcome in a sponsored research project. C. Guidelines 1. Each Investigator is required to disclose the following Significant Financial Interests: (i) Any Significant Financial Interest of the Investigator that would reasonably appear to be directly and significantly affected by the research or educa tional activities funded, or proposed for funding, by an external sponsor; or (ii) Any Significant Financial Interest of the Investigator in an entity whose financial interest would reasonably appear to be directly and significantly af fected by the research or educational activities funded, or proposed for funding, by an external sponsor. 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. 2. Each Investigator who has Significant Financial Interest requiring disclosure shall complete a Significant Financial Interests Disclosure Form and attach all required supporting documentation. The completed Disclosure Form must be submitted with the proposal and University Clearance Data Form (CDF) to the Office of Sponsored Programs (or with the "Blue Sheet" at Hershey Medical Center to the Office of Research Affairs) 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 envelope marked confidential and accompany the Disclosure Form and the CDF. 3. As required by Federal regulation, all Significant Financial Interests must be disclosed prior to the time a proposal is submitted. All financial disclosures must be updated by Investigators during the period of the award, either on an annual basis or as new reportable Significant Financial Interests are obtained. 4. The Director of Sponsored Programs or the Director of Research Affairs at Hershey Medical Center, or official designee, shall conduct an initial review of all financial disclosures to determine whether 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 appropriate University Conflict of Interest Review Committee (CIRC). Committee members are appointed by the Senior Vice President for Research and Graduate Education for the University Park CIRC and by the Senior Vice President for Health Affairs and Dean of the Medical School for the Hershey Medical Center CIRC. The CIRC shall contain, at a minimum, four faculty members (three at Hershey Medical Center) representing a cross section of academic disciplines and a research administrator. The Committee shall determine what conditions or restrictions, if any, should be imposed by the institution to manage actual or potential conflicts of interest arising from disclosed Significant Financial Interests. 5. Prior to consideration by the CIRC, the Investigator, in cooperation with the academic unit or College, 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, add conditions or restrictions, including 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. 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, the research go forward without imposing such conditions or restrictions. In these cases, the Senior Vice President for Research or the Senior Vice President for Health Affairs, as appropriate, shall make the final decision regarding resolution. 6. The approved Resolution Plan shall be incorporated into a Memorandum of Understanding between Penn State University and the faculty member 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 Chair/Unit Head and, on behalf of the University, the Investigator's cognizant University administrator (usually a Dean/Director or, at Hershey Medical Center, the Associate Dean for Academic Affairs). Actual or potential conflicts of interests will be satisfactorily managed, reduced, or eliminated in accordance with these Guidelines prior to accepting any award, or they will be disclosed to the sponsoring agency for action. 7. Records of investigator financial disclosures and of actions taken to manage actual or potential conflicts of interest, shall be retained by the Office of Sponsored Programs (or the Office of Research Affairs at Hershey Medical Center) until 3 years after the later of the termination or completion of the award to which they relate, or the resolution of any government action involving those records. 8. Whenever an Investigator has violated this policy or the terms of the Memorandum of Understanding, the CIRC shall recommend sanctions which may include disciplinary action ranging from a public letter of reprimand to dismissal and termination of employment. If the violation results in a collateral proceeding under University policies regarding misconduct in science, then the CIRC shall defer a decision on sanctions until the misconduct in science process is completed. The CIRC's recommendations on sanctions shall be presented to the Investigator's cognizant University official who, in consultation with the Senior Vice President for Research (or the Senior Vice President for Health Affairs at Hershey Medical Center), shall enforce any disciplinary action. 9. Collaborators 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. END Forwarded by: . ********************************************************************* Charles E. Graham, PhD., xxxxxx@UNIX1.SNCC.LSU.EDU Director, Office of Sponsored Research 504-388-8692 117D David Boyd Hall, Louisiana State University FAX 388-6792 Baton Rouge, LA 70810 *********************************************************************
