Conflict of Interest

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Conflict of Interest Disclosure Statement - Intellectual Property and Commercial Ventures

Conflict of Interest Human Subjects - UMass Medical School

These procedures are promulgated pursuant to the University of Massachusetts Conflicts Committee Guidelines for the Oversight of Individual and Institutional Financial Interests in Human Subjects Research dated December 22, 2009, as amended on May 1, 2012 (Guidelines) and were approved by the President effective as of May 1, 2012.

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Document File: 

UMass Guidelines for the Oversight of Individual and Institutional Financial Interests in Human Subjects Research

(Doc. T96 -039)

I. Introduction.

The missions of the of University of Massachusetts (UMass) and its five campuses include the important goal to advance the health and well-being of the people in the Commonwealth of Massachusetts, the nation, and the world through advances in education, research and knowledge. It has become increasing apparent that in order to fulfill its mission, UMass must engage in a variety of complex relationships with commercial entities, such as, pharmaceutical and biotechnology companies, with whom we share the critical responsibility of promoting the development of novel therapies for individuals for whom current health outcomes are inadequate.

In the course of these relationships, there are occasions in which the potential for real or apparent conflicts of interest arise that might call into question the integrity of advancements that are developed by UMass. It is the responsibility of individual investigators, other faculty, administrative leaders, and the institution itself to delineate clearly how and why it may be justified to act in a manner that may involve conflicts of interest or the appearance of conflicts of interest. Justification of conflicts of interest may only be maintained insofar as those interests are fully disclosed and do not materially damage the interests of research subjects, patients, UMass employees, UMass, or the Commonwealth of Massachusetts. The purpose of this document is to provide a framework for pursuing such interactions in keeping with overall University of Massachusetts policy and accepted best practices.

II. Association of American Medical Colleges (AAMC) and Association of American Universities (AAU) -“Protecting Subjects, Preserving Trust, Promoting Progress” (Parts 1 and 2), 2001 and 2002 and “Protecting Patients, Preserving Integrity, Advancing Health: Accelerating the Implementation of COI Policies in Human Subjects Research,” 2008.

The AAMC comprises the 137 accredited US medical schools with participation by their associated teaching hospitals through the Council of Teaching Hospitals. The AAU comprises 61 leading United States and Canadian universities that are distinguished by the breadth and quality of their programs of graduate education and research. As such, these organizations represent a widely accepted source of community standards of best practice with regard to the conduct of research within universities and academic medical centers. In 2001 and 2002, the AAMC and the AAU issued two sets of Policies and Guidelines regarding the oversight of conflicts of interest, the first dealing with individual financial interests and the second dealing with institutional interests. Each of these reports was authored by a panel of experts and leaders in academic medicine and was thoroughly researched and referenced. In February 2008 the AAMC and the AAU issued a new report that refined the two earlier reports and urged United States universities and medical schools to establish clear and consistent conflicts of interest policies. These three reports (AAMC Reports) form the impetus and basis for these Guidelines.

The UMass Policy on Conflicts of Interest Relating to Intellectual Property and Commercial Ventures (Conflicts Policy) is aligned with both of the AAMC - AAU reports, and our institutional mission and vision regarding this guidance document are based upon the following principles:

  • The welfare of research subjects is of foremost concern in Clinical Research studies. The Conflicts Committee affirms that all Pecuniary Interests in Research (as defined in the attachment to these Guidelines) with respect to Clinical Research are potentially problematic, and, therefore, require close scrutiny and rigorous review. Thus, UMass hereby establishes the presumption that an individual who holds any Pecuniary Interests in Research with respect to Clinical Research proposed to be conducted at UMass may not conduct that research. This presumption applies regardless of the source of funding. A key feature of these Guidelines, however, is that this presumption is potentially rebuttable when the investigator or institution can make a compelling argument for exemption. “Clinical Research” is defined in the Conflicts Policy as research involving human subjects.
  • The same presumption is in force when the institution holds Pecuniary Interests in Research (as defined in the 2001 AAMC report) with respect to Clinical Research. UMass may have a conflict of interest in Clinical Research whenever the financial interests of the institution (such as an equity or royalty interest), or of an institutional official acting within his or her authority on behalf of the institution, might affect– or reasonably appear to affect – institutional processes for the design, conduct, reporting, review, or oversight of the Clinical Research. Similarly, due consideration, informed by the AAMC Reports, shall be made of any substantial gifts, major institutional purchases or non-routine supply contracts with a company that sponsors Clinical Research at UMass.  Each VCR shall be responsible for developing procedures, using available databases, to identify potential institutional financial interests in accordance with the principles established in these Guidelines and the AAMC Reports. 
  • A Covered Individual with Pecuniary Interests in Research with respect to Clinical Research may rebut the presumption against allowing conduct of the Clinical Research and be permitted to conduct the Clinical Research only after a showing of compelling circumstances and approval by the Conflicts Committee, including its plan for managing or reducing the conflict. Similarly, compelling circumstances may exist to justify the conduct of Clinical Research within UMass despite an institutional conflict of interest.
  • Whether the circumstances are deemed compelling will depend in each case upon the nature of the science, the nature of the financial interest, how closely the financial interest is related to the Clinical Research, and the degree to which the financial interest may affect or be affected by the research. Special consideration may be given to protocols that are directed at orphan diseases (as defined by the U.S. Food and Drug Administration) and to protocols for compassionate use of potential therapeutics. When the interest is very direct and the potential effects substantial, the risk is greatest, and the bar must be high. However, when the individual UMass investigator holding the financial interest is uniquely qualified by virtue of expertise and experience, and the work could not otherwise be conducted safely or effectively without that individual, he or she would be permitted the opportunity to rebut the presumption against conducting the research by demonstrating these facts along with an effective management plan.
  • Transparency of reporting of real or perceived financial conflicts of interest, whether they are individual or institutional shall be disclosed (a) within the written informed consent documents, (b) within all publications (print or electronic), and (c) within all presentations of the Clinical Research outside the  University.
  • A plan for effective, disinterested monitoring of the Clinical Research should be included in any request to rebut the presumption. Examples of appropriate features of monitoring include the utilization of an external data monitor (with periodic on -site inspection of source documents and reconciliation of documents with the case report forms) and the use of external data and safety monitoring committees or boards (composed of peer reviewers who periodically examine data and reports redacted by the independent study monitor). In the case of an institutional conflict of interest, it may be deemed appropriate to use an external IRB for initial protocol review.
  • These Guidelines apply to all Clinical Research in which any Covered Individual participates or for which they assume any role or responsibility, whether or not the study is to be conducted at the University or at another venue such as another institution, a hospital or a private concern (and all such Covered Individuals are subject to the authority of the respective campus Institutional Review Board (IRB)).
  • Often a Covered Individual who has a Pecuniary Interest in Clinical Research has made prior disclosures of related financial interests for non-Clinical Research pursuant to the Policy on Faculty Consulting and Outside Activities (DOC. T96-047), the Conflicts Policy and/or the applicable Federal financial conflict of interest regulations. However, those prior disclosures or approvals do not replace or circumvent the disclosure and approval required under these Guidelines with respect to Clinical Research.
  • For Clinical Research supported by the PHS (including the NIH), if the Department of Health and Human Services determines that a PHS -funded project of clinical research, who se purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment, was designed, conducted, or reportedly an investigator with a financial conflict of interest that was not properly disclosed or managed as required under the PHS Financial Conflict of Interest Regulations, the University, through the respective office of the VCR, must require the investigator(s) to disclose the financial conflict of interest in each public presentation (such as articles, manuscripts and oral presentations, including classroom materials) of the results of the research and to request an addendum to previously published presentations.

III. Conflicts Reporting Process.

Covered Individuals shall report to the Vice Chancellor for Research (VCR) when he/she perceives that any individual or institutional conflict of interest in Clinical Research exists, may exist, or may be perceived to exist. This is in addition to reporting all financial interests to the campus Institutional Review Board (IRB).

  • Upon the VCR’s receipt of the disclosure of the Covered Individual, the VCR shall determine whether any individual Pecuniary Interests in Research exists, may exist, or may be perceived to exist. In addition, the VCR shall also consider whether there are institutional conflicts of interests that exist, may exist,r may be perceived to exist and whether any of those interests constitute Pecuniary Interests in Research.
  • With respect to specific Clinical Research to be conducted at UMass or being conducted at UMass, it is incumbent on administrative officials with direct responsibility for the Clinical Research to immediately make known to the VCR if they hold Pecuniary Interests in Research in a commercial research sponsor or an entity that owns or controls an investigational product. The VCR shall assist these officials in making a determination whether there is a conflict of interest for consideration in the case.
  • It is the responsibility of the VCR to ensure that all of these applicable individual and institutional conflicts of interests are presented for review of the Clinical Research by the campus and the Conflicts Committee.
  • If any campus review procedures apply in accordance with IV. below, the VCR shall ensure that those procedures are undertaken promptly and shall notify the Conflicts Committee of his/her receipt of the disclosure and the initiation of the campus procedures.
  • The VCR shall refer the Clinical Research case to the Conflicts Committee for review and consideration in accordance with the standard of review established in these Guidelines, after completion of the campus procedures, if any. The VCR shall present to the Conflicts Committee, in writing, the background of the case, including an explanation of the individual and institutional conflicts for consideration, the deliberations of any campus committee(s), the risk-benefit analysis conducted including what compelling circumstances and special considerations were identified and considered, and the recommendation of the campus.
  • Even in the presence of compelling circumstances, any approval will include a sufficient plan to disclose the conflict to volunteer subjects and to provide external monitoring of the protocol.
  • If the Conflicts Committee does not approve the Clinical Research, the VCR shall inform the IRB in writing and the Clinical Research may not be approved.
  • Only upon final approval by the Conflicts Committee may the enrollment of the first volunteer research subject commence.

 

IV. Campus Review Procedures

Due to the unique complexities and health and safety concerns raised by Clinical Research and the myriad of campus constituencies and administrative bodies that participate in these decisions, including the campus IRB, the campuses may, but are not obliged, to develop additional procedures, beyond those set forth herein, for assisting the VCR in the consideration of these Clinical Research cases. Such campus -specific procedures would be supplemental to those set forth herein and are not in lieu of the Conflicts Committee deliberations and determination. However, each campus may develop its procedures and submit them to the Conflicts Committee or to the President (or his/her designee) for adoption if the procedures are consistent with these Guidelines (including the principles established in the AAMC Reports) and the Conflicts Policy and are found to not unduly delay the consideration of these cases by the Conflicts Committee.

 

V. Relationship of UMass Policy to Faculty Physicians employed by UMass Memorial Health Center (UMMHC). 

Physicians and other providers employed by UMMHC who hold faculty or other positions (e.g., student, resident, fellow, or other health care provider) at the University of Massachusetts Medical School are Covered Individuals who are subject to the Conflicts Policy for all participation in Clinical Research within the UMMHC or elsewhere, including clinical or research sites operated by the University of Massachusetts Medical School or its divisions (including Commonwealth Medicine and the Massachusetts Biologic Laboratories). This element of the policy is in keeping with the statement in the 2002 AAMC - AAU policy document.

 

Pecuniary Interest in Research (Defined)

Pecuniary Interest in Research include the following interests of the Covered Individual (and spouse/domestic partner and dependent children) that is reasonably related to the Covered Individual’s Institutional Responsibilities:

With regards to Publicly-Traded Entities, any payment or value, including salary, consultant payments, honoraria, paid authorship, equity interest (stock, stock option or other ownership interest) during the prior twelve months. 

With regards to Privately Held Entities, any payment or value, including salary, consultant payments, honoraria, paid authorship, equity interest (stock, stock option or other ownership interest) during the prior twelve months. 

With regards to Intellectual Property, intellectual property rights and interests (patents, copyrights) upon receipt of income related to such rights and interests.

With regards to Travel Reimbursements, any reimbursed or sponsored travel related to the Covered Individual’s Institutional Responsibilities during the prior twelve months (with the exception of travel that is reimbursed or sponsored by a Federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.

The term “Pecuniary Interest in Research” does not include: salary, royalties, or other remuneration paid by the University to the Covered Individual if the Covered Individual is currently employed or otherwise appointed, including intellectual property rights assigned to the Institution and agreements to share royalties related to such rights; income from investment vehicles, such as mutual funds and retirement accounts; income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education; or income from service on advisory committees or review panels for a Federal, state, or local government agency, an institution of highereducation, an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education.

 

These Guidelines are issued pursuant to the Board of Trustees’ Policy on Conflicts of Interest Relating to Intellectual Property and Commercial Ventures (DOC. T96-39) (Conflicts Policy) and here approved by the

President on December 22, 2009 and amended effective as of May 1, 2012. All terms which are capitalized but not defined within these Guidelines have the meaning ascribed to those terms in the corresponding campus Conflicts

Policy.

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Release Info: 

Revised May 1, 2012

OUTLINE OF GUIDANCE PRINCIPLES FOR FACULTY

ON CONFLICTS OF INTEREST

By

Tom Chmura, Vice President for Economic Development,

Chair, University Conflicts of Interest Committee

And

Liz Rodriguez, Associate Counsel

Counsel for the University Conflicts of Interest Committee

 

BACKGROUND

  • Prior to 1996-97 when the University adopted its own conflict of interest policies and procedures, all faculty were subject to the state ethics law called 268A and the oversight of the state ethics commission for all possible conflicts of interest matters (including those related to technology commercialization).
  • Under previous arrangements, faculty were subject to the cumbersome and prohibitive constraints of 268A when developing University relationships (e.g., start-up companies, licensing of technology, sponsored industrial R&D) with companies in which they had a financial interest.

FORMATION OF UNIVERSITY POLICIES AND PROCEDURES

  • In 1996-97, the University (as permitted by the five-campus merger legislation) developed its own policies and procedures for governing financial conflicts of interests in matters specifically related to intellectual property and technology transfer.
  • The policies and procedures (including the creating of a system-wide conflicts of interest committee) were developed by a system-wide task force with the assistance of outside counsel and with the extensive review of the practices of leading universities.
  • The new University policies and procedures were approved by the Board of Trustees and successfully negotiated with collective bargaining units at each of the campuses (except for Worcester, where they were reviewed and adopted by the Scientific Council).
  • With the adoption of these new policies and procedures, the University became the primary entity in the Commonwealth to have control over conflicts of interest regarding intellectual property and commercial ventures at the University.
  • The University's Conflicts Committee reviews conflict situations on a case-by-case basis and has broad discretion to approve, deny, or approve with conditions proposed relationships.

PERSPECTIVES AND INTERESTS OF THE UNIVERSITY

  • University policy states that it is assumed that all faculty members conduct themselves according to the highest standards of ethical conduct.
  • Moreover, University policy and priorities are supportive of patenting and licensing of inventions that are based on University research, participating in industry partnerships designed to commercialize technology, and making other contributions to the economic development of the Commonwealth.
  • Such activities can enable the translation of research results into practical applications for society, the receipt of licensing income for the University and faculty, the provision of additional sources of research funding for the University, economic development benefits for the Commonwealth, and important learning experiences for students.
  • However, the involvement of faculty with private companies in which they have financial interests carries with it the potential for inappropriately diverting the University and its faculty from their primary University missions of education, research and service. Such conflicts are not necessarily prohibited, but they do need to be disclosed, reviewed, and formally considered by the University. Where permitted, they need to be managed appropriately so as to preserve the values and interests of the University and the Commonwealth, including primarily the integrity of the University research.
  • In its review of any proposed faculty arrangement with private companies that have a potential for conflict of interest, the University is concerned that the faculty maintain their primary commitment and allegiance to the University, the University's educational/research/service mission, and the University's financial interests. The Conflicts Committee has responsibility for ruling on different kinds of conflicts, and, where it allows a conflict, for developing strategies for managing the conflict to preserve the values and interests of the University.

TYPES OF CONFLICTS AND APPROACHES TO DEALING WITH THEM

  • Since its creation in 1995, the University's Conflicts Committee has considered more than 150 cases involving faculty from across the system (all campuses except Boston), and it has developed experience with a variety of conflicts and means of handling them.

CONFLICTS OF FINANCIAL INTEREST

  • As employees of the University, faculty are expected to place the financial wellbeing of the University above that of any commercial entity. According to the policy, faculty have a conflict of interest when they have a financial stake in the well-being of a company engaged in commercialization activities with the University.
  • In simple cases (e.g., faculty owns a small amount of stock or has a consulting. arrangement with a company sponsoring research at the University), the Conflicts Committee may require public disclosure of the conflict at the University, notification of the conflict in publications and presentations (e.g., research papers), use of University standard rider on intellectual property with any consulting agreement with the company, and oversight of the research by a special review committee (with regular written reports from the faculty member to the review committee).
  • Financial conflicts have been deemed much more serious by the Conflicts Committee when the faculty member assumes personal responsibility for the financial well-being of a commercial entity by taking on a role as a member of the board or as chief executive or officer of the company. In virtually all cases, the Committee has required faculty to relinquish board and executive/officer positions to resolve such conflicts, and urged adoption of a scientific consultant/advisor role instead. Only with the most early stage companies has the Conflicts Committee permitted board or management positions, and then only with strict time limitations.

CONFLICT OF COMMITMENT

  • Each campus is responsible for its own conflict of commitment policy, but such issues are often entangled with conflict of financial interest cases. All campus policies require that faculty give their primary commitment and allegiance to the University, not to a commercial entity in which they have a financial take. The amount of time a faculty needs to spend on certain commercial ventures could result in a serious conflict of commitment.
  • Frequently, the Conflicts Committee has urged a campus to establish special review mechanisms (e.g., department heads, deans) that would oversee both the conflicts of financial interest and commitment. In extreme cases, the Committee has urged a faculty to consider an unpaid leave of absence (e.g., during the startup period of a new company) as an appropriate means of managing this conflict.

RESEARCH INTEGRITY

  • Faculty are required to maintain the highest level of scientific integrity in the conduct of their research and to adhere to generally accepted academic standards regarding dissemination of research findings. A faculty member's financial interests in a commercial entity should never be allowed or appear to allow influence over the integrity of University research.
  • In cases where this issue has arisen, the Conflicts Committee has typically required full public disclosure of the faculty's financial interest in any research (including in presentations and publications), appointed an independent oversight committee for the research program, and required independent review of research results before publication.
  • In more serious cases where the level of financial interest is especially high, the Committee has also required the appointment of independent principal investigators or co-principal investigators on research grants from commercial entities in which a faculty has a financial interest.
  • The Committee may also seek assurance that any federal agency sponsoring research in a faculty's laboratory is aware of and comfortable with the commercialization arrangements.

HUMAN SUBJECTS  RESEARCH

  • In no area of research do concerns about research integrity loom greater than in the field of human subjects research. Thereby, practically any financial interest relating to human subjects research requires full review by the Conflicts Committee.
  • The University's guidelines in this area adhere to the standards established by the AAMC and the AAU. There is a presumption against allowing a personal financial interest to exist in the context of a human subjects study. Further, there is a presumption against conducting human subjects research on technology developed at the University.
  • These individual and institutional conflicts are ordinarily disallowed. Upon a showing of compelling circumstances and after a thorough assessment of therisks, it is possible to overcome the presumption against proceeding with the study. In those rare cases, there must be proper disclosure of the financial interest to the subjects and meaningful external monitoring of the study.

EDUCATIONAL MISSION

  • Faculty have a responsibility to provide their students and advisees witheducationally appropriate experiences. The educational process must not be compromised by the commercial goals of a commercial entity in which a faculty member has an interest.
  • In cases where this issue has arisen, the Conflicts Committee has generally insisted that no students who are students or advisees of a faculty member involved with a commercial entity have any link to that commercial entity or work on research supported by funding from the commercial entity.
  • On the other hand, students who are not the responsibility of a faculty with the commercial entity may find useful educational and/or employment opportunities with such companies.

ASSISTANCE FOR FACULTY

  • In sum, the Conflicts Committee seeks to help faculty in developing and approving arrangements that effectively commercialize University technology and put it into public use, while adequately protecting the University's institutional interests and appropriately managing the personal conflict of interest issues in each case.
  • Faculty with questions about the Conflicts Policy and workings of the Committee should contact their Vice Chancellor for Research or equivalent chief research officer.

10/22/2010

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UMass Policy for Compliance with NSF and Other Federal Agency's Financial Disclosure Regulations

Revised 4/6/2012

Under the Federal financial disclosure regulations, a conflict of interest exists when it can be reasonably determined that an investigator's personal financial concerns could directly and significantly influence the design, conduct, or reporting of government funded research activities. Faculty and staff of the University of Massachusetts Amherst (the University) have an obligation to maintain the objectivity of their research, avoiding any conflict of interest. This Conflict of Interest in Research and Scholarly Activity Policy has been developed by the University of Massachusetts Amherst and complies with specific NSF requirements laid out in NSF’s Grant Policy Manual.  Every investigator participating in NSF funded research must comply with this requirement. University employees are reminded that, in addition to the provisions of this policy, activities of University employees are subject to the requirements of the University of Massachusetts Policy on Conflicts of Interest Relating to Intellectual Property and Commercial Ventures.

DEFINITIONS:

As used in this Policy:

Investigator means the principal investigator and any other person who is responsible for the design, conduct, or reporting of research funded by NSF , or proposed for such funding. For purposes of the requirements of this subpart relating to financial interests, “Investigator” includes the Investigator's spouse and dependent children.

Research means a systematic investigation designed to develop or contribute to generalizable knowledge relating broadly to science and engineering , including behavioral and social-sciences research. The term encompasses basic and applied research and product development. As used in this Policy, the term includes any such activity for which research funding is available from an NSF Awarding Component through a grant or cooperative research agreement.

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 the applicant institution;

(2) Any ownership interests in the institution, if the institution is an applicant under the SBIR Program;

(3) Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities;

(4) Income from service on advisory committees or review panels for public or nonprofit entities;

(5) 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

(6) 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.

Small Business Innovation Research (SBIR) Program is the extramural research program for small business that is established by the Awarding Components of the NSF  and certain other Federal agencies under Pub. L. 97-219, the Small Business Innovation

Development Act, as amended. For the purposes of 42 CFR Part 50 Subpart F the term SBIR

Program includes the Small Business Technology Transfer (STTR) Program, which was established by Pub. L. 102-564.

PROCEDURES:

Each investigator covered by this policy will annually report all "significant financial interests" held by themselves, their spouse and dependent children. Disclosures will be made by completing the DISCLOSURE OF SIGNIFICANT FINANCIAL INTEREST FORM at the end of this document, and sent to the Department Head/Chair, the Dean and the Vice Chancellor for Research and Engagement on an annual basis and when new significant financial interests are acquired. A disclosure form must be completed prior to the submission of an application for NSF grant or cooperative research agreement.  Care should be given in every proposal to disclose any relationship where the Investigator(s) have a financial interest that would be of interest to the sponsor, since every Federal agency requires honesty and transparency in the proposal process.

Positive disclosures will be reviewed by the Department Head/Chair and Vice Chancellor for Research and Engagement (or designee). Ad hoc reviewers may be consulted on a case-by-case basis. In those cases where, in consultation with a faculty member involved, the Vice Chancellor for Research and Engagement (or designee) determines that a real or apparent conflict exists, one of the following actions will be taken: l) Accept the sponsored project; 2) Not accept the sponsored project; 3) Accept the sponsored project subject to certain conditions, e.g.,

(i) public disclosure of significant financial interests;

(ii) monitoring of research by independent reviewers;

(iii) modification of the research plan;

(iv) disqualification from participation in all or a portion of the research funded by the PHS;

(v) divestiture of significant financial interests; or

(vi) severance of relationships that create actual or potential conflicts.

Appeal of the decision may be made to the Provost, who will consult with the Investigator and the review committee before making a final determination, within thirty days of the appeal, as to the action to be taken. In all cases, resolution of the actual or apparent conflict of interest will be achieved before the University implements a sponsored project.

Prior to the University's expenditure of any funds under the award, the University will report to the Awarding Component 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 the NSF requirements. For any interest that the University 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.

The Institution agrees to make information available, upon request, to the NSF regarding all conflicting interests identified by the Institution and how those interests have been managed, reduced, or eliminated to protect the research from bias.

COMPLIANCE:

Failure to comply with the above Policy will subject the Investigator to the University's Scholarly Misconduct Policy . University employees are reminded that if the failure of an Investigator to comply with the conflict of interest policy of the University has biased the design, conduct, or reporting of the NSF-funded research, the University will promptly notify the NSF Awarding Component of the corrective action taken or to be taken. The NSF awarding Component will consider the situation and, as necessary, take appropriate action, or refer the matter to the University for further action, which may include directions to the Institution on how to maintain appropriate objectivity in the funded project.

RECORDS:

The University will maintain the Disclosure Form and other records of all financial disclosures and all actions taken by the Institution with respect to each conflicting interest for at least three years from the date of submission of the final expenditures report or, where applicable, from other dates specified in 45 CFR 74.53(b) for different situations. Records will be maintained in the Office of the Vice Chancellor for Research and Engagement. All disclosures and related documentation are considered confidential, and only those persons involved in the implementation of this policy will have access to such records.

NOTIFICATION TO FEDERAL AGENCIES:

As required by NSF, the University will report the existence of a conflict of interest which is unable to be resolved within the University to the NSF Office of the General Counsel.

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Policy on Conflicts of Interest Relating to Intellectual Property and Commercial Ventures Amherst & Boston

DOC. T96-039
Passed by the BoT
4/2/97 (UMA, UMB)


Table of Contents

I. Definitions
II. Purpose of Policy 
III. Administration of Policy
IV. Policy 
V. Public Statements 
VI. Appeals 
VII. Enforcement   
VIII. Periodic Review of Policy  

Under most circumstances, conflicts of interest involving individuals associated with the University are addressed by Chapter 268A of the Massachusetts General Laws, which governs the conduct of public officials and employees. However, pursuant to Massachusetts General Laws Ch. 75 - 14A, in the area of intellectual property and technology transfer this policy is controlling. In matters not addressed by this policy, the provisions of Chapter 268A apply.

I. Definitions

As used in this Policy, the following words shall have the following meanings:
 
A. Chair - The Chairperson of the Conflicts Committee, as described in detail below.
B. Clinical Research- Research involving human subjects.
C. Company- Any corporation, partnership, association, or other legal entity, excluding entities controlled by the United States government, the Commonwealth of Massachusetts, and the University. A Company shall include all affiliates and other associated entities.
D. Conflict of Interest- (i) An actual or potential conflict between the personal interests of a Covered Individual and the interests of the University or the public or (ii) the reasonable appearance of such a conflict to the public. As explained below, the University recognizes that the existence of a conflict of interest is not improper, but could lead to improper behavior. This Policy seeks to manage conflicts of interest to minimize both the appearance of improper behavior and the harm that could result from actual improper behavior. The University does not require disclosure and review of every Conflict of Interest, but only those involving a Financial Interest and certain identified activities, as described below.
E. Conflicts Committee- A five-campus committee that reviews and manages conflicts of interest, as further described in Article II.
F. Covered Individual- Any individual associated with the University, including without limitation faculty, staff, and students, but excluding members of the CVIP and Vice Chancellors for Research. Anyone who is not a Covered Individual remains subject to the more restrictive provisions of Mass. Gen. Laws Ch. 268A.
G. CVIP- The University Office of Commercial Ventures and Intellectual Property.
H. Director - The Executive Director of the CVIP.
I. Equity- All ownership interests in a Company and all rights to obtain ownership interests in a Company, including without limitation common or preferred stock, warrants, options, and partnership units, and also including compensation arrangements based on equity performance (e.g., phantom stock). "Equity" does not include ownership interests that are held through publicly-traded mutual funds.
J. Financial Interest - A Significant Financial Interest or Substantial Financial Interest, both as defined below.
K. Non-Equity Compensation - All compensation other than Equity that is provided by a Company or contractually promised by a Company, including without limitation salary, gifts, royalties, consulting fees, honoraria, goods, services, and travel expenses. "Non-Equity Compensation" does not include compensation that is provided by the University pursuant to (i) its Intellectual Property Policy or by another educational or research institution pursuant to a similar policy or (ii) University-approved research funding.
L. Significant Financial Interest- Has either of the following meanings.

1. Clinical Research- In relation to Clinical Research that is performed or directed by a Covered Individual, "Significant Financial Interest" means (i) any Equity in a Company that is directly owned by, or is under the control of, a Covered Individual or a member of his or her immediate family or (ii) Non-Equity Compensation from a Company in an aggregate amount greater than $1,000 within the prior twelve-month period that is directly or indirectly received by or contractually promised to a Covered Individual or a member of his or her immediate family.
2. Non-Clinical Research - In relation to research other than Clinical Research that is performed or directed by a Covered Individual, "Significant Financial Interest" means either (i) Equity that represents more than one percent (1%) of the total equity in a Company or has a total current value of more than $10,000 that is directly owned by, or is under the control of, such Covered Individual or a member of his or her immediate family or (ii) Non-Equity Compensation in an aggregate amount greater than $10,000 within the prior twelve-month period that is received by or contractually promised to a Covered Individual or a member of his or her immediate family.

M. Substantial Financial Interest - Has either of the following meanings.

1. Clinical Research- In relation to Clinical Research that is performed or directed by a Covered Individual, "Substantial Financial Interest" has the same meaning as "Significant Financial Interest."
2. Non-Clinical Research - In relation to research other than Clinical Research that is performed or directed by a Covered Individual, "Substantial Interest" means either (i) Equity that represents more than five percent (5%) of the total equity in a Company or has a total current value of more than $100,000 that is directly owned by, or is under the control of, such Covered Individual or a member of his or her immediate family or (ii) Non-Equity Compensation in an aggregate amount greater than $100,000 within the prior twelve-month period that is received by or contractually promised to a Covered Individual or a member of his or her immediate family.

N. Vice Chancellor for Research - The Vice Chancellor for Research at each campus, or where no such position exists, the Provost (or their designees).

 

II. Purpose of Policy

The University recognizes that interactions between University researchers and commercial entities has many beneficial effects for the University and its faculty, staff, and students, as well as companies. For example, such interactions are an especially effective means of facilitating the commercial development of University intellectual property, which benefits the public with new goods and services and stimulates economic development. The University also recognizes that its faculty, staff, and students are unlikely to undertake the significant burdens associated with such activities without additional economic incentives. These economic incentives may raise conflicts between the personal financial interests of the University researcher and the interests of the University, the Commonwealth, the academic community, and the general public. In some cases, these conflicts of interest may reasonably appear to be likely to affect the judgment of a University researcher. The University has determined that a strict prohibition of these research conflicts of interest, with disciplinary sanctions for violation, does not serve the public interest because potentially beneficial interactions with industry are lost. The University recognizes that research conflicts of interest will inevitably arise in a modern research university and that the mere existence of such conflicts, in the absence of wrongful behavior, is not improper. Therefore, this Policy seeks to manage research conflicts of interest to minimize both the appearance of an effect on the judgment of our researchers and the potential harm that could result from any conflict of interest that actually impaired their judgment. The University reserves the ability to prohibit the existence of conflicts of interest that present unmanageable risks or which would require excessive resources to manage.


III. Administration of Policy


A. Philosophy and Role of Conflicts Committee
The University assumes that its faculty and staff act with the highest level of personal responsibility, integrity and commitment to the University. Nevertheless, complex situations can arise involving Conflicts of Interest whose management requires specialized knowledge and a multi-disciplinary, problem-solving approach. Therefore, this Policy establishes a five-campus Conflicts Committee that will administer this Policy, review conflicts disclosures, and dispose of conflicts involving Financial Interests in a fair, objective, and confidential manner, utilizing the knowledge and judgment of Committee members and other resources the Committee desires to access. Over time, decisions made by the Committee may become precedents that will be used for guidance by the Committee to assure continued principled decisionmaking. Some decisions may periodically be communicated (in a non-identified fashion) to faculty and staff in the form of advisories or guidelines. It is anticipated, for example, that promptly after its formation the Committee will establish and distribute advisories regarding typical Conflict of Interest situations with their appropriate resolution.
The Committee has no authority with regard to Conflicts of Interest that do not involve a Significant Financial Interest or Substantial Financial Interest. All Conflicts of Interest outside the authority of the Committee are left entirely to campus-based procedures (if any).
B. Composition of Conflicts Committee
The University will establish a thirteen-member, University-wide Committee consisting of one member of the faculty at each campus appointed under procedures established by the campus; the Vice Chancellor for Research or his or her designee at each campus; the President or his or her designee; and two non-voting members who the President may appoint from outside the University. The President shall annually select the Chair of the Committee from among the voting members. The faculty members of the Committee shall serve three year terms and may not serve more than two consecutive terms. The Director or his or her designee and the General Counsel or his or her designee may attend all meetings of the Committee.
C. Actions by Conflicts Committee
The Committee shall hold regular meetings on a monthly basis unless there are no matters for the Committee to consider or a quorum will not be achieved. The Committee shall establish procedures for special meetings. The Vice Chancellor for Research shall collect disclosures on each campus, and the Chair shall be responsible for collecting disclosure forms from the Vice Chancellors of Research, distributing forms in advance of meetings, scheduling meetings, and setting the agenda. Members may participate in meetings using voice or video-conferencing technology, provided that all members shall receive advance notice of all meetings. The Director and the General Counsel shall be informed of the date, time and place of all meetings in the same fashion as Committee members and shall be furnished with all information provided to Committee members. Decisions of the Committee will be made by a majority of the voting members in as expeditious a manner as possible and will be recorded in written minutes. These minutes shall not include any identifying information about the individuals or companies that are the subject of Committee deliberations, but shall describe situations and their resolution in available to the campus community. At the request of any Covered Individual, the Vice Chancellor for Research shall furnish that Covered Individual with complete information regarding the status of his or her disclosed Conflict of Interest.
D. Recusal Procedures
A Committee member shall recuse himself or herself from voting on any specific case in which that member has an actual bias or the reasonable appearance of bias. A Committee member shall recuse himself or herself from voting on or discussing, and shall exit the meeting during consideration of, any specific case in which that member has an actual conflict of interest or the reasonable appearance of conflict of interest. These recusal procedures shall not apply to votes on, or consideration of, the consent agenda as a whole. For the purposes of these Rules, the term "bias" means circumstances under which a Committee member would experience (or would reasonably appear to experience) impaired objectivity with respect to a case, and the term "conflict of interest" means circumstances in which the Committee member (or a member of his or her immediate family) has a financial interest that would be affected by (or would reasonably appear to be affected by) the disposition of a case. An example of bias is where a Committee member has a personal relationship with, or a strong opinion about an individual, either positive or negative, that could reasonably appear to impair the objectivity of the member in a case involving that individual. An example of conflict of interest is where a Committee member has a lucrative consulting relationship with a company that is the subject of a case before the Committee. Although a recusal decision will ordinarily be made by the Committee member, the Chair may require recusal of a member under two circumstances. First, any Committee member may be challenged for bias or conflict of interest by a faculty member whose case is before the Committee. This challenge shall take the form of a confidential written explanation that the faculty member transmits to the Chair. If the Chair concurs with the challenge, the Chair may require recusal of the Committee member. Second, if the Chair has actual knowledge or a reasonable belief, based on competent information, that the Committee member has an actual bias or that a conflict of interest exists, the Chair may require recusal of the member. If the Chair requires recusal of a Committee member for any reason, or if the Chair does not require recusal of a challenged Committee member, the Chair shall include within the file a confidential written record of the basis for the decision, which shall be available for consideration on appeal.
E. Confidentiality of Disclosures
Many of the matters brought to the Committee for review and action will include information of a personal and private nature concerning the financial interests of Covered Individuals, proprietary business information, and other information of a highly confidential nature. Accordingly, the Committee will meet in closed session; all members and observers must maintain all disclosed information in strict confidence; and the Committee will take all precautions and actions necessary to preserve the confidentiality of such information. In addition, at the request of a faculty member, the Vice Chancellor for Research shall have discretion to limit disclosure of identities to University counsel and the Committee Chair, rather than the whole Committee, to satisfy the preferences of that faculty member. Information disclosed under this Policy may be further disclosed outside the University if required by applicable law, but only after the General Counsel approves such disclosure and the affected Covered Individual is notified that the information will be released.


IV. Policy


A. Authority of Conflicts Committee

The Conflicts Committee shall have general authority to review and dispose of Conflicts of Interest involving Significant and Substantial Financial Interests together with the activities described in Section IV.B. The Committee will have broad discretion in resolving Conflicts of Interest. The Committee shall have authority to add to the list of activities in Section IV.B. as the Committee identifies additional activities that raise serious concerns. The Committee shall annually review the dollar amounts indicated in Sections I.K. and I.L. of the Policy, and shall have authority to adjust those amounts to account for inflation and other economic factors. The Committee shall have authority to interpret the Policy. The Committee shall give notice of its interpretative statements through its written minutes and periodic advisories.


B. Disclosure of Conflicts of Interest
All Covered Individuals must disclose a Significant or Substantial Financial Interest to the Vice Chancellor for Research or his or her designee in situations designated by this Policy in which the Financial Interest may present a Conflict of Interest involving the use of students, technology transfer activities, or the outcome of research that is performed or directed by that Covered Individual with significant use of University funds, facilities, or equipment. In addition, some federal agencies and non- profit organizations may require disclosure of a Financial Interest under certain circumstances. The CVIP will prepare appropriate disclosure forms and make them available on campus.


The following situations require disclosure at the time noted in each paragraph:
1. Company-Sponsored Research Proposals- If a Covered Individual intends to perform or direct Company-sponsored research at the University, and if the Covered Individual has a Financial Interest in that Company, or has received a Financial Interest from that Company, then the Financial Interest should be disclosed to the Vice Chancellor for Research and approved in accordance with this Policy before the Covered Individual submits to the University a proposal relating to such research.
2. Company-Sponsored Research - If a Covered Individual performs or directs Company-sponsored research at the University, and if the Covered Individual intends to receive or actually receives a Financial Interest in that Company or from that Company at any time (i) during the conduct of the research or (ii) within one year after cessation of the research, then the Financial Interest must be disclosed to the Vice Chancellor for Research and approved in accordance with this Policy before it is received, if possible, or immediately after it is received, if prior disclosure is impossible.
3. Government and Non-Profit Institution Grant Applications - In general, if a Covered Individual intends to submit an application for research funding from a U.S. Government agency or a non-profit institution, then the Covered Individual must comply with any disclosure and approval procedures required by the agency or institution in connection with such application. For example, in order to comply with Public Health Service and National Science Foundation requirements, the University requires that a Covered Individual first disclose to the Vice Chancellor for Research and obtain approval of (i) certain of his or her Financial Interests that would reasonably appear to be affected by the proposed research and (ii) certain of his or her Financial Interests in any Company whose financial interests would reasonably appear to be affected by the proposed research.
4. Government and Non-Profit Institution-Funded Research- If a Covered Individual performs or directs research that is funded directly or indirectly by a U.S. Government agency or a non-profit institution, the Covered Individual must comply with any disclosure and approval procedures required by the agency or institution in connection with such funding. For example, in order to comply with Public Health Service and National Science Foundation requirements, the University requires that if a Covered Individual intends to receive or actually receives (i) a Financial Interest that would reasonably appear to be affected by the proposed research or (ii) a Financial Interest in any Company whose financial interests would reasonably appear to be affected by the proposed research, then the Financial Interest must be disclosed to the Vice Chancellor for Research and approved in accordance with this Policy before it is received, if possible, or immediately after it is received, if prior disclosure is impossible.
5. Licensing to Certain Companies- If a Company intends to obtain a license to University-owned intellectual property, directly or indirectly, and if the Covered Individual who developed, discovered, or created that intellectual property or who is involved in negotiating the license (i) becomes aware of such intention and (ii) has a Financial Interest in that Company, the Financial Interest must be immediately disclosed to the Vice Chancellor for Research, who shall notify the CVIP. If the Director or a member of the CVIP staff or the Vice Chancellor for Research has such a Financial Interest, it must be disclosed to the President or his or her designee.
6. Involvement of Students- If a faculty member intends to receive or actually receives a Financial Interest in a Company, and if the faculty member supervises or otherwise has control over students who will be involved in work for the Company outside of the University, then the faculty member must disclose the Financial Interest and planned student involvement to the Vice Chancellor for Research and receive approval in accordance with this Policy before the assistance of students in such work commences.
7. Changes to a Financial Interest - All Covered Individuals must disclose material changes in previously disclosed Financial Interests. A Significant Financial Interest that becomes a Substantial Financial Interest is always considered a material change.
No disclosure is required under this Policy unless the Conflict of Interest is within one of the above categories. The Conflicts Committee has authority to add to this list. In such event, the Committee will issue an official advisory to provide notice of the change, and shall update the Conflict of Interest Disclosure Form to reflect the change.


C. Management of Conflicts
Covered Individuals are generally prohibited from having a Conflict of Interest that is disclosable under Section IV.B. unless the University has reviewed and allowed both the activity and the Financial Interest. There are two different procedures for review and allowance of these Conflicts of Interest, as set forth below. If a Conflict of Interest involves a Substantial Financial Interest, it necessitates rigorous review that may result in prohibition or allowance accompanied by conditions. On the other hand, if a Conflict of Interest involves a Significant Financial Interest and not a Substantial Financial Interest, then the Conflict of Interest ordinarily requires a less rigorous review process and ordinarily will be allowed.
1. Interim Decisions.The University understands that transactions sometimes arise quickly and unexpectedly, such that the usual conflicts review process could cause delays that might jeopardize the transaction. Under these unusual circumstances, at the request of a Covered Individual, the Conflicts Committee or its Chair, in consultation with the Vice Chancellor for Research, may give an interim decision or otherwise impose measures that it finds necessary or desirable to preserve the existing situation until a formal review is completed. Such measures may allow a Conflict of Interest to exist, with or without conditions, while a formal review is pending. The interim decision may also prohibit the existence of the Conflict of Interest until reviewed by the Committee. As necessary, the Committee may also hold a special meeting to review a disclosure before the next regularly scheduled meeting.
2. Expedited Review of Conflicts: Consent Agenda - If a disclosure involves a Significant Financial Interest but not a Substantial Financial Interest, the Conflict of Interest will ordinarily receive expedited review and allowance. Under this expedited procedure, the Vice Chancellor for Research will review the disclosures submitted by Covered Individuals at his or her campus and either grant preliminary allowance or recommend review by the full Committee. If the Vice Chancellor for Research recommends review by the full Committee, the Vice Chancellor for Research shall give written reasons for that recommendation, which shall become part of the record and shall be made available to the Covered Individual. All Conflicts of Interest that are granted preliminary allowance will be placed on a list that is provided to the full Committee. The Chair or any Committee member may select disclosures on the list for review by the full Committee on the regular agenda; all disclosures not selected will be finally allowed in a single vote at the conclusion of the meeting. If a disclosure is selected for full review, the Chair shall give written reasons for that selection, which shall become part of the record and shall be made available to the Covered Individual. The Committee may establish conditions to manage certain categories of these Conflicts of Interest under special or unusual circumstances.
3. Full Review of Conflicts: Regular Agenda - If a disclosure involves a Substantial Financial Interest, the Vice Chancellor for Research will forward the disclosure to the Chair for inclusion on a Committee meeting agenda. The Chair will also include on the meeting agenda any disclosures involving a Significant Financial Interest that have been selected by the Vice Chancellor for Research as appropriate for full review. The Conflicts Committee will regularly review and dispose of all such Conflicts of Interest as described in detail below, as expeditiously as possible.
a. Review of Conflicts- The Conflicts Committee will formally review all conflicts disclosures that (i) involve a Substantial Financial Interest, (ii) involve a Significant Financial Interest and are recommended for full review by the Vice Chancellor for Research, or (iii) are selected by the Chair from the list of disclosures involving a Significant Financial Interest. In the case of a disclosure involving a Substantial Financial Interest, the Conflicts Committee will ordinarily permit such a Conflict of Interest to exist only under certain conditions, which are intended to minimize any harm that could result from the Conflict of Interest.
b. Disposition of Conflicts- After completing the formal review, the Conflicts Committee may decide upon one or more of the following dispositions:
(1) allow a Conflict of Interest because the circumstances require no action;
(2) allow a Conflict of Interest with conditions, such as
•    public disclosure of the Financial Interest in publications describing the research results;
•    independent monitoring of the research;
•    modification of the research plan;
•    imposition of a holding period on the stock or other security in the case of a Financial Interest consisting of Equity, which will minimize the appearance of influence on the outcome of the research;
(3) prohibit a Conflict of Interest with compliance steps to remove the conflict, such as
•    divestiture of the Financial Interest in
•    disqualification of the Covered Individual from the research; or
(4) postpone consideration of the matter pending further information or investigation.
4. Time Periods for Decisions.At the request of a Covered Individual, and under circumstances in which an urgent decision is required, the Chair shall render an interim decision (which may result in prohibition) within thirty days after receiving a complete and accurate disclosure of the Conflict of Interest. This decision will remain in effect until the Conflicts Committee renders a decision. In all other cases, the Conflicts Committee will ordinarily render a decision not later than ninety days after receiving a complete and accurate disclosure of the Conflict of Interest. The Conflicts Committee will use every effort to render a decision earlier than this ninety-day deadline. In appropriate circumstances, the Committee may hold a special meeting to make a decision prior to the next regularly scheduled meeting. The University strongly recommends that Covered Individuals begin the conflicts approval process at the first step of any transaction so that the review process will be completed before the transaction is completed. This will ensure that transactions will not be delayed while the conflicts review process occurs.

V. Public Statements

A number of problems may be posed when statements are made by scientists about research before the research has been publicized in scholarly journals or symposia, when the scientist has a Financial Interest in a Company that stands to benefit from the research. In order to avoid any such occurrences at the University, all Covered Individuals who perform or direct research for a Company in which they have a Financial Interest must refrain from making public statements about the results of any research relating to that disclosure prior to (i) publication of the results in a recognized scholarly journal or (ii) presentation of the results at a recognized scholarly meeting. The Vice Chancellor for Research may make exceptions to this rule in appropriate cases. This restriction applies whether or not the University allows an activity that presents a Conflict of Interest to continue after review.

VI. Appeals

Any Covered Individual may appeal an initial decision of the Committee by requesting a rehearing of the matter. The rehearing shall occur at the next regularly scheduled meeting of the Conflicts Committee. At the rehearing, the Covered Individual may personally appear before the Committee and shall have the right to be accompanied by counsel or a union representative. The Committee shall establish written procedures for the conduct of rehearings. The Committee shall issue a reconsidered decision promptly after the conclusion of the rehearing.
If a Covered Individual who is a faculty member continues to disagree with the reconsidered decision of the Committee, the faculty member may request an advisory opinion from an ad hoc faculty committee composed of three members appointed by the Chancellor for that campus and three members appointed by the Faculty Senate. The faculty member and the Vice Chancellor for Research (on behalf of the Conflicts Committee) will each present their views to the ad hoc committee. The committee will adopt an opinion by vote of a majority of its members. In the event of a deadlock, the committee may adopt two opinions. The committee will transmit its written opinion to the faculty member and the Vice Chancellor for Research (who shall relay the decision to the Conflicts Committee). The Conflicts Committee shall consider the opinion of the ad hoc committee at its next regularly scheduled meeting, and may either reaffirm or change its decision.
Any Covered Individual may make a final appeal to the President. The President shall review the documentary record of the decision and, at the discretion of the President, may meet with the Covered Individual and members of the Committee. In the case of a faculty appellant who has requested an advisory opinion from an ad hoc faculty committee, the President shall consider that opinion and shall provide a written rationale in the event of disagreement. The decision of the President shall be final.
If a Covered Individual disagrees with this final decision, the Covered Individual may exercise his or her individual legal rights to challenge the decision on the grounds that (i) due process was not followed or (ii) the decision is arbitrary and capricious, but no Covered Individual may challenge the decision on substantive grounds. Any such challenge shall be brought in a court of law located in the Commonwealth of Massachusetts. This acknowledgment by the University that a Faculty Member has the right to pursue a legal claim is not an admission by the University that any Faculty Member actually has any actionable legal claim. Rather, the University seeks to preserve the legal rights of a Faculty Member outside of the collective bargaining process after internal appeals are exhausted.

VII. Enforcement

If a Covered Individual fails to disclose a disclosable Conflict of Interest, or otherwise violates the Policy, the Committee may refer the matter to the appropriate University official or committee for disciplinary action or other appropriate action.
If a Covered Individual discloses a Conflict of Interest but refuses to accept a decision of the Committee, the Covered Individual may voluntarily eliminate the Conflict of Interest by removing the Financial Interest or ceasing the activity affected by the Financial Interest. For example, a Covered Individual could choose to retain a lucrative consulting agreement and refuse a sponsored research agreement with the same company. In this situation, no enforcement is necessary because there is no violation of the Policy.
In contrast, if a Covered Individual does not eliminate the Conflict of Interest and either proceeds with a prohibited Conflict of Interest or refuses to agree with the conditions imposed by the Committee for allowance, the Covered Individual has violated the Policy and enforcement actions are appropriate.

VIII. Periodic Review of Policy

At least every three years following adoption of this Policy, the Conflicts Committee will conduct an evaluation of this Policy and, if necessary, formulate amendments for consideration by the President and Trustees of the University. The Conflicts Committee will solicit comments from the Faculty Senate before formulating any amendments.


(Amherst/Boston Version, 2/3/97)-105. - (UMA & UMB)

 

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