Endorsed by the Faculty and Recommended for Adoption by the Board of Trustees, March 20, 2003
Worcester Polytechnic Institute promulgates this Conflict of Interest policy to assure its constituents of its continued commitment to the integrity of its students, faculty, staff, and associates in the conduct of research and other activities.
Universities have long recognized the importance of maintaining policies on conflict of interest. In 1964, the American Association of University Professors and the American Council on Education issued a joint statement On Preventing Conflicts of Interest in Government-Sponsored Research at Universities. This was followed in 1978 when the Association of American Universities, the ACE, and the National Association of State Universities and Land-Grant Colleges published Principles to Govern College and University Compensation: Policies for Faculty Engaged in Sponsored Research. In 1985, the AAU issued a report entitled University Policies on Conflict of Interest and Delay of Publication. Additional statements and reports have been published by the Association of American Medical Colleges, Guidelines for Dealing with Faculty Conflicts of Commitment and Conflicts of Interest in Research (1990), the AAU, Framework Document for Managing Financial Conflicts of Interest (1993), and the Association of Academic Health Centers.
Both the National Science Foundation (NSF) and the Public Health Service (PHS) require principal investigators and co-principal investigators "to certify that they have read and understood the institution's conflict of interest policy," that they have made all required financial disclosures, and that "they will comply with any conditions or restrictions imposed by the institution to manage, reduce, or eliminate actual or potential conflicts of interest." Moreover, the University's representative must certify that the University "has implemented and is enforcing a written policy on conflicts of interest," that all financial disclosures required by the conflict of interest policy were made, and that actual or potential conflicts of interests, if any, were, or prior to expenditure of funds under the award, will be satisfactorily managed, reduced or eliminated in accordance with the institution's conflict of interest policy, or disclosed to PHS or NSF.
In its Notice No. 117 dated June 30, 1994 and updated in its Notice No. 118 dated July 13, 1995 on the subject of Investigator Financial Disclosure Policy, the National Science Foundation requires that all grantee institutions employing more than fifty persons have in effect on October 1, 1995 a written and enforced conflict of interest policy. In addition, the Department of Health and Human Services published its final rule on "Objectivity in Research" on July 11, 1995 in the Federal Register (60 Fed. Reg. 35820) to coincide in effective date and requirements with NSF's Financial Disclosure Policy. As the NSF Notice states:
"The National Science Foundation encourages the increased involvement of academic researchers and educators with industry and private entrepreneurial ventures. But NSF recognizes that such interactions carry with them an increased risk of conflict of interests."
The Public Health Service (PHS) wishes to assure the public that its support to researchers will follow standards and procedures
"to ensure that the design, conduct, or reporting of research funded under ...[its] grants, cooperative agreements or contracts will not be biased by any conflicting financial interest of those investigators responsible for the research."
On August 25, 2011, the U.S. Department of Health and Human Services issued its final rule in the Federal Register that amends the Public Health Service (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94). An Institution applying for or receiving NIH funding from a grant or cooperative agreement must be in compliance with all of the revised regulatory requirements no later than 365 days after publication of the regulation in the Federal Register, i.e., August 24, 2012, and immediately upon making the Institution’s Financial Conflict of Interest policy publicly accessible as described in 42 CFR part 50.604(a). Accordingly, a new Appendix E has been added to the WPI Faculty Conflict of Interest Policy in order to implement the new regulation.
Funding sources and personal gain represent two aspects about which investigators must be ever mindful, because without clear guidelines there is a possibility for conflict of interest issues to arise. Donors, for example, providing grants to conduct research may sometimes possess a vested or proprietary interest in the research results. Professors themselves may hold equity positions or policy making authority in an enterprise from which they would benefit personally by research sponsored by the enterprise, a government, or other private agency, and that is conducted using university facilities, equipment, or personnel.
In addition, there are large numbers of other types of funded and unfunded interactions between WPI faculty members and government, industry and other non-University organizations through research, projects and consulting.
With the increased national emphasis on technology transfer and economic competitiveness, it is particularly timely for Worcester Polytechnic Institute to articulate a new conflict of interest policy to protect the integrity of the University, its faculty, and the research process, to encourage the free flow of knowledge and ideas, and to ensure that public and institutional resources are used appropriately.
WPI’s conflict of interest policy now requires annual disclosure by all faculty and other personnel associated with the university (listed in Appendix D).
Disclosure Rationale and Procedure
For all University personnel to maintain public trust, disclosure of all conflicts and potential conflicts of interest is appropriate practice. Based upon the traditions of university life there are two pillars on which to construct a conflict of interest policy.
One pillar of the academy is peer review. Some matters of peer review are handled confidentially; for example, senior faculty routinely review junior colleagues for appointment, re-appointment, promotion, and tenure. Other peer reviews are more open. Faculty committees review courses to be included in the college curriculum, and pass on degree requirements and other issues of academic policy. Peer review is essential, then, for a conflict of interest policy. Another pillar of the academy is disclosure of discoveries and other scholarly accomplishments. Indeed, peer review cannot occur without prior disclosure. When faculty publish their research, they are disclosing their findings to peers not only within the University, but to all scholars throughout the world. Disclosure is also essential for a conflict of interest policy. Indeed, NSF's Investigator Financial Disclosure Policy requires "a) limited and targeted financial disclosure, b) designation of a person(s) to review the disclosures and resolve actual or potential problems revealed, c) enforcement mechanisms, and d) arrangements for informing NSF of conflict issues that are not resolved to the satisfaction of the institution."
In addition, NSF and PHS require that an institution’s policy provide for disclosure prior to submitting a proposal, and that all actual or potential conflicts be satisfactorily managed, reduced, or eliminated prior to the time funds from an award are expended, or disclosed to NSF or PHS. In addition, both NSF and PHS require that, during the period of any award, the University obtain updated financial disclosures from investigators either on an annual basis or as investigators obtain new reportable financial interests.
How and to whom should the significant financial interest(s) of a faculty member and/or investigator be disclosed?
On or before October 1 annually or within sixty (60) days of appointment, each faculty member and other individuals identified in Appendix D shall complete and submit a Conflict of Interest Disclosure Form to his/her Department Head.
WPI policy requires Principal Investigators to complete a Proposal Coordination Form (see Appendix A) at the time the Principal Investigator submits the proposal for review and authorization by the Office of Sponsored Programs. This form includes check boxes in which the respondent shall indicate whether or not a conflict of interest exists or is likely to exist in connection with the proposal being submitted. Co-investigators and any other individuals who are expected to participate in the design, conduct, and/or reporting of the research also must complete a Conflict of Interest Disclosure Form (see Conflict of Interest Disclosure for NSF and PHS Submissions, Appendix B) concurrent with submission of the Proposal Coordination Form by the Principal Investigator, unless they have done so as a required annual disclosure. Principal Investigators will have filed the Annual Conflict of Interest Disclosure Form, Appendix C, as required.
Investigators submitting a human subjects protocol for Institutional Review Board (IRB) review must file or have on file a Conflict of Interest Disclosure Form, Appendix B, at that time.
Any Disclosure Statements, whether submitted in satisfaction of the NSF or PHS proposal submission requirement or in fulfillment of the WPI annual disclosure requirement or IRB disclosure requirement, must be updated when a new reportable Significant Financial Interest or potential conflict of interest exists.
Annual Review Process
All faculty members and other individuals, identified in Appendix D, who have not, within the last year, completed the Conflict of Interest Disclosure Form for funded research associated with an NSF or PHS submission (Appendix B) must file the Annual Conflict of Interest Disclosure Statement contained in Appendix C with his/her Department Head annually by October 1 and as any significant changes occur. Department Heads will file their Annual Disclosure Statements with the Vice Provost for Research. The individual shall, to the best of his/her knowledge, include in his/her Disclosure Statement the same information for his/her family, as defined by this Policy. Department Heads and members of the Cabinet will file with the Vice Provost for Research. The Vice Provost for Research will file his/her Annual Conflict of Interest Disclosure Form with the Provost.
Upon receipt of each annual or updated Disclosure Statement, the Department Head or his/her designee will make a review for adequacy, requesting additional information from the individual who completed the form, as necessary. If the answers to the four questions on Part I of the Disclosure Statement are “no,” then no further review is required. The Disclosure Statement should be transmitted to the Office of Sponsored Programs, the central repository for all Disclosure Statements. No additional action will be required of the faculty member or other submitter unless a significant change occurs prior to the next annual due date. If the answer to any of the four questions on Part I of the Annual Conflict of Interest Disclosure Form is “yes”, the Department Head will determine if a real or apparent conflict appears to be significant. If so, the Department Head will forward the disclosure to the Vice Provost for Research with a copy to the Office of Sponsored Programs. The Vice Provost for Research will gather further information and supporting documentation from the individual and will bring the Disclosure Statement to the attention of the Conflict Management Committee for resolution. All such documentation and subsequent discussions will be confidential. The individual will have an opportunity to meet with the Conflict Management Committee to explain the financial documentation and to discuss options for management of the conflict. Should the findings indicate significant potential conflict of interest, the Conflict Management Committee will consult with the faculty member or other submitter to devise a plan to effectively eliminate, reduce, or otherwise manage the conflict. If the Committee cannot come to an agreement with the individual and concludes that a significant conflict of interest to WPI’s interests appears to remain, the Committee will refer the matter to the Office of the Provost and so inform the individual.
Review Process for NSF and PHS Proposals
Should a disclosure associated with any NSF or PHS submission indicate a potential or actual conflict of interest, the Director of Sponsored Programs will advise the Vice Provost for Research. The Vice Provost for Research will gather further information and supporting documentation from the investigator and take the matter to the Conflict Management Committee for resolution. All such documentation and subsequent discussions will be confidential. The investigator will have an opportunity to meet with the Conflict Management Committee to explain the financial documentation and to discuss possible conditions or restrictions. Should the findings indicate significant financial interest, the Conflict Management Committee will impose conditions or restrictions to effectively manage, reduce, or eliminate the conflicts. The Conflict Management Committee will use as guidelines this policy statement and, as appropriate, Appendix E for PHS submissions, including the definitions of significant financial interest and conditions or restrictions found in the section of Definitions.
If the Conflict Management Committee 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 Conflict Management Committee may recommend to the Vice Provost for Research that the research be permitted to go forward without imposing such conditions or restrictions. In such cases, the conflict of interest of the investigator(s) will be disclosed to the government agency as required.
Appeal Process for NSF and PHS Proposals
Should the faculty member or other individual (as defined in Appendix D) not agree with the Conflict Management Committee's conditions or restrictions, he/she can appeal in writing to the Provost within ten (10) days after receipt of notification from the Vice Provost for Research, spelling out why such conditions and restrictions are inappropriate. The Provost will then consult with the Conflict Management Committee; it is possible that a modification of the conditions and restrictions will be agreeable to all parties. However, the decision of the Provost is final. Human Subject Protocols Disclosures associated with the submissions of protocols for IRB review will be reviewed following the same process as for NSF and PHS proposals. Protocols will not be approved until all conflicts are resolved.
(Note that several different and/or additional definitions are contained in Appendix E to this policy relating to the PHS regulations)
CONFLICT OF INTEREST
A conflict of interest may take various forms but arises when an individual is or may be in a position to influence University business, research, or other decisions in ways that could lead to any form of personal gain for the individual or his/her family, or give improper advantage to others. A real or perceived conflict of interest may also arise when someone engages in an action or decision that compromises the integrity of teaching, research, advising, or scholarship.
The family of a faculty member means spouse, minor children, and other persons financially dependent upon the faculty member.
The term investigator means the principal investigator, co-principal investigators, and any other person at the institution who is responsible for the design, conduct, or reporting of research or educational activities. Relationships which can give rise to conflicts of interest
RELATIONSHIPS WHICH CAN GIVE RISE TO CONFLICTS OF INTEREST
Relationships as used in this policy include relationships with others which can give rise to real or perceived conflicts of interest. These include, among others, personal relationships created by kinship, friendship, or professional contacts, and financial relationships created by contracts, shared property rights, or state or Federal law. Though a domestic partnership may create a real or perceived conflict of interest, this policy is not meant to force disclosure of one’s sexual orientation. By policy, WPI does not discriminate on the basis of sexual orientation.
SIGNIFICANT FINANCIAL INTEREST
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) when related to the subject matter of the individual’s research and/or scholarly activities, including teaching and advising. The term does not include:
salary, royalties or other remuneration from the University;
income from service on advisory committees or review panels for public or nonprofit entities;
financial interests in business enterprises or entities if the value of such interests does not exceed $10,000 or does not represent more than a 5% ownership interest for any one enterprise or entity when aggregated for the investigator and the investigator's family;
royalties or other payments that, when aggregated for the investigator, and the investigator's family, are not expected to exceed $10,000 during the next twelve-month period;
income from self-authored textbooks, software, etc. that are used for your teaching purposes; or
project fees solicited from sponsors of MQP’s and IQP’s that are returned to Faculty professional development accounts.
A significant financial interest becomes a conflict of interest if it could result in personal gain, advantage to others to the detriment of WPI, or influence the outcomes of research.
CONDITIONS OR RESTRICTIONS
Examples of conditions or restrictions that might be imposed to manage, reduce or eliminate actual or potential conflicts of interest include:
public disclosure of significant financial interests;
monitoring of funded research by independent reviewers;
modification of the funded research plan;
disqualification from participation in the portion of the NSF-or PHS-funded research that would be affected by the significant financial interests;
divestiture of significant financial interests; or
severance of relationships that create actual or potential conflicts.
INSTITUTIONAL REVIEW BOARD (IRB)
Any boards established or contracted to review protocols for human subjects research whether federally funded or not.
CONFLICT MANAGEMENT COMMITTEE
Conflict Management Committee membership shall consist of a faculty member selected annually by the Committee on Governance (COG) to chair the committee, the Chair of the Committee on Graduate Studies and Research, an additional member selected by CGSR, the Vice Provost for Research, and the Director of Sponsored Programs. COG shall also annually appoint an alternate to the Committee to serve in the event of the recusal or absence of one of the other appointed faculty members. In the event that more than one alternate is needed, COG shall appoint additional alternates as necessary. Recusal shall be required when it appears that a member of the Conflict Management Committee will be unable to fairly judge a potential conflict raised by a disclosure statement. All such potential conflicts of interest of committee members must be disclosed to the committee in advance of the proceedings, and the committee will vote to determine whether recusal is required. To prevent the appearance of bias in judgment, the committee shall follow the practices that the Committee on Tenure and Academic Freedom uses to determine whether tenure committee members are able to fairly judge candidates for tenure.
To comply with this policy regarding the submission of an annual Disclosure Statement, each Faculty Member must complete the Disclosure form and any updates on or before October 1 of each year and forward it to his/her department head.
In addition, to comply with this policy regarding authorization for the submission of a proposal for funded research to the NSF and/or PHS, a principal investigator will
- in accordance with the Explanation and Instructions, complete and sign the front side of the Proposal Coordination Form and require any co-investigators and/or other key personnel to complete and submit a Conflict of Interest Disclosure Form for funded research, Appendix B, (unless already submitted).
- ask his/her department head to review and complete the Proposal Coordination Form and any accompanying Conflict of Interest Disclosure Forms and sign them.
- submit the Proposal Coordination Form and accompanying Conflict of Interest Disclosure Form together with the NSF or PHS proposal to the Office of Sponsored Programs when requesting submission authorization.
(Revised January 30, 2003)