K.1.3 Conflict of Interest and Conflict of Commitment

Marine Biological Laboratory
Conflict of Interest Policy Applicable to MBL Faculty & Staff
Policy No. K.1.3
Initiated by: Director of Finance
Approved by: MBL Director
Date: January 10, 1995
Revision: #9, August 7, 2019
Distribution: All MBL staff

1.0 Introduction

This policy is intended to educate those who work at the MBL (all of whom are referred to throughout this document as “MBL staff members”—see Definitions in Section 12.0) about Federal and MBL requirements on conflicts of interest and conflicts of commitment. It is one of a set of MBL policies whose purpose is to ensure that we all meet the highest ethical standards in our work and demonstrate this to Federal and other funding agencies according to their policies.

2.0 Policy Statement

It is the intent of the MBL to avoid conflicts and the appearance of conflicts between interests of the Laboratory and the personal interests of all who work at the MBL (“MBL staff members”, as defined in Section 12.0).

A conflict of interest occurs when there is a divergence between an individual’s private interests and his or her professional obligations to the MBL such that an independent observer might reasonably question whether the individual’s professional actions or decisions are determined or unduly influenced by considerations of personal gain, financial or otherwise.

A conflict of commitment occurs when a MBL staff member’s external relationships or activities have the possibility (either in actuality or in appearance) of interfering or competing with the MBL’s educational, research, or service missions, or with that individual’s ability or willingness to perform the full range of responsibilities associated with his or her position.

The complex relationships between government, industry, and research institutions, as well as the demands of commerce, necessitate the establishment of guidelines to manage potential conflicts of interest that may arise between the MBL and MBL staff members.  These guidelines have both ethical and legal bases.  While there are particular concerns with individuals supported through government-sponsored research, this policy is applicable to all MBL staff members no matter the source of funding.  Public Health Service (PHS) Investigators may have additional procedural and training requirements under federal regulations.  See addendum A.

3.0 General Standards

In recognition of the requirement for broad ethical principles, the following general standards of conduct are adopted by the MBL:

MBL staff members shall report to the MBL all Significant Financial Interests (as defined in Section 12.0) and organizational affiliations that are, or might appear to be, conflicts of interest related to their duties at the MBL.

MBL staff members shall disclose any interests or activities in which they are involved or contemplate becoming involved, directly or indirectly, that could conflict with the interests or activities of the MBL, and shall obtain approval prior to commencing, continuing, or consummating any activity or transaction that raises a potential conflict of interest. Updated disclosures should be submitted within 30 days of acquiring a new interest or involvement in a new activity that could be considered a conflict of interest or commitment.

When any MBL business transaction under consideration presents the potential for, or the appearance of, a conflict of interest for an MBL staff member, that person shall not be involved in the transaction without disclosure of the conflict of interest and acceptance of the MBL’s approach to managing it. Determination of potential conflicts shall be made by the designated Conflict of Interest (COI) Official (identified in section 5.0).  in the event that the COI Official cannot independently make a determination, the COI Official will consult with the Chief Operating Officer, the Director of Research, and a member of the University of Chicago’s legal team if necessary. If further input is needed, potential conflicts will be brought to the Compliance Committee for review and determination of next steps.

A potential for a perceived or actual conflict of interest in a MBL business transaction exists where a MBL staff member, or a close relative or member of that person’s household, stands to personally profit from an organization, in which the MBL staff member has a significant financial interest, doing business with the MBL.

A potential actual or perceived conflict exists when a MBL staff member has a significant financial interest in an organization which is in competition for MBL business and if the staff member’s position gives him/her access to proprietary or other privileged information which could benefit that organization.

Involvement in an MBL business transaction includes but is not limited to initiating, making the principal recommendation for, or approving a purchase or contract; drafting or negotiating the terms of a transaction; or authorizing payments from MBL accounts.

While waste, fraud, abuse and corruption in the affairs of the MBL do not necessarily involve conflicts of interest, as part of the general code of conduct, MBL staff members are expected to report any such instances that may come to their attention.

 4.0 Inappropriate Activities

Inappropriate activities include, but are not limited to, bribery, solicitation or acceptance of personal gifts with a value of over $250 per year, gratuities, or favors from organizations with which MBL does business.

5.0 Disclosure

Disclosure is the principal means by which an organization can track potential conflict of interest issues.  Therefore, MBL staff members, shall make disclosure to the designated COI Official of any activity that might have the appearance of conflicting with the conscientious performance of their duties to the MBL. For all MBL staff members in the Divisions of Education or Research, the Director of Research Administration and Sponsored Programs shall serve as the COI Official. For all other MBL employees, the Director of Human Resources shall serve as the COI Official.

All newly hired MBL Staff Members will be required to complete a disclosure prior to commencing activities at the MBL.

For MBL Staff Members associated with the Division of Research and select Administrative and Operational personnel, disclosures are to be submitted annually on or before August 15^th.

The Conflict of Interest disclosure filing form is attached here. 

5.1. Conflict of Interest Disclosures

MBL staff members are responsible for disclosing to the MBL, using the processes described in this policy, their Significant Financial Interests (and those of their family members) that could reasonably appear to affect the design, conduct or reporting of their research or their performance of other Institutional Responsibilities. Put another way, if a MBL staff member has a Significant Financial Interest that does or could reasonably appear to affect his or her research, teaching or other MBL activities or duties, then disclosure is required. MBL staff members may have difficulty in determining whether a financial interest could reasonably appear to affect his or her research and therefore constitute a Significant Financial Interest. Accordingly, MBL staff members should always err on the side of reporting.

As defined in this Policy, “Significant Financial Interests” can include, but are not limited to, salary or other payments for services (e.g., consulting fees or honoraria), royalties from the MBL or other organizations, equity interests in companies (e.g., stock, stock options or other ownership interests), and intellectual property rights (e.g. patents, patent applications, copyrights, licenses and royalties from such rights).

In the absence of known valuation of stock options or equity holdings, disclosure to the MBL of the existence of options or holdings is still required. The true value of that interest may not be known until a later time (e.g., when the firm goes public) but the MBL staff member should if possible, make a reasonable assessment of the future market value of the options or equity.

“Significant Financial Interests” do not include income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an institution of higher education (as defined at 20 U.S.C. 1001(a)), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education, and income from service on advisory committees or review panels for such entities. However, the performance of these activities may require disclosure to and approval by the MBL staff member’s immediate supervisor or the MBL Director for conflict of commitment purposes, e.g., when the activities are conducted during a period of residence as defined in the Statutes. Investments such as mutual funds and retirement annuities do not need to be disclosed as long as the investment decisions in underlying assets held by the mutual fund or annuity are not made by the MBL staff member.

5.2. Conflict of Commitment Disclosures

Concerning conflicts of commitment, MBL staff members are also required (i) to disclose to and receive prior approval from their direct supervisor and designated COI Official for all outside professional or commercial activities of any length of time, and (ii) to disclose to the MBL annually as part of the assurance and disclosure processes described in this policy. Any outside professional or commercial commitments that interfere or have the potential to interfere with obligations and commitments to the MBL should be disclosed. In the context of outside consulting activities, MBL staff members should disclose such arrangements to their direct supervisor in advance to assure that the arrangement does not interfere with the MBL staff member’s institutional responsibilities. Outside consulting is defined as the performance of services for which remuneration in any form is received by the MBL staff member from a person, firm or corporation other than the MBL.

5.3. Assessment and Updating of Disclosures

It is ultimately the responsibility of the MBL, not the MBL staff member, to assess the effects of any particular Significant Financial Interest (as defined in section 12.0) or outside professional or commercial commitments, and whether a Significant Financial Interest creates a Conflict of Interest, and to determine the proper management, reduction or elimination of a conflict of interest or conflict of commitment.

MBL staff members are also required to update disclosures of Significant Financial Interests and other outside professional or commercial commitments within thirty (30) days of any change in their Significant Financial Interests or outside professional or commercial commitments that could reasonably give rise to a conflict of interest or conflict of commitment.

Disclosure is a key factor in protecting one’s reputation and career from potentially embarrassing or harmful allegations of inappropriate behavior. MBL staff members are encouraged to err on the side of disclosure and to seek guidance from their direct supervisor, COI Official or the Director even if their situation is not directly covered by the disclosure procedures in this policy.

5.4. Confidentiality

The MBL will hold information concerning Significant Financial Interests disclosed under this policy in confidence to the greatest extent practicable. This means that the MBL will share the information internally only with individuals who have a specific need to know the information under this policy, other MBL policies, or applicable law. This also means that the MBL will share the information with third parties only as required by applicable law or to satisfy the MBL’s contractual obligations to sponsors of research. The MBL’s commitment to maintaining the confidentiality of disclosures shall not restrict the MBL’s ability to require disclosure of Significant Financial Interests in managing a particular conflict of interest, including public disclosure on MBL or external websites.

6.0 Areas in which Conflicts of Interest may arise

A conflict of interest may arise when a MBL staff member holds a Significant Financial Interest in a commercial enterprise. Possible examples are (1) if a MBL staff member is developing a product for a firm in which he or she has a Significant Financial Interest; (2) when a clinical investigator has an interest in a product that is being studied or tested on human subjects; (3) when a MBL staff member is asked to serve on a MBL committee that evaluates a firm or product in which the MBL staff member has a Significant Financial Interest; or (4) when a MBL staff member receives personal compensation for services which may or could be perceived to conflict with MBL duties. For example, a MBL staff member might initiate or participate in business activities that compete with, or may be perceived as competing with, the business or educational interests of the MBL; or a MBL staff member might participate in a Speakers’ Bureau whose object is to promote a company’s products.

A conflict of interest may arise from a single transaction and should be addressed, whenever possible, before that transaction is undertaken.

Among the specific issues and problems requiring particular sensitivity and attention are the following:

6.1. Research. Decisions concerning the nature and direction of scholarly research at the MBL should be governed by judgments of scholarly merit and intellectual importance. A MBL staff member’s involvement with, or interest in, outside professional or commercial applications of research should not bias judgment concerning the MBL staff member’s own scholarly research or that of other MBL staff member or students.

6.2. Publication. Free communication of the results of scholarly research is an important and long-standing policy of the MBL. Involvement in outside professional or commercial activities should not delay or inhibit the publication of scholarly research or the sharing of information derived from such research. Where appropriate, such as in situations involving commercial development, MBL staff member are expected to disclose (as described below) relevant outside consulting arrangements or affiliations in their published scholarly works. This obligation is now routinely imposed by many journals.

6.3. Education of Students. Students rely on faculty advice and guidance concerning educational matters within the MBL, such as the nature and direction of research, and temporary and career employment opportunities outside the MBL. Such advice and guidance should always be governed by a student’s best interest and should not be made to serve a MBL staff member’s interest in outside professional or commercial activities. When a MBL staff member holds equity in a company that sponsors research at the MBL, special attention should be focused on protecting the academic interests of students, research staff or post-doctorals who may be supported in whole or in part by that company.

6.4. Appointments and Promotions. Dedicated participation of MBL staff members in recommendations and decisions concerning promotions is vital to the continued strength of the MBL. A MBL staff member’s recommendations and decisions on matters of appointment and promotion should never be used to advance an actual or prospective relationship in outside professional or commercial activities (either cooperative or competitive) with candidates for appointment or promotion.

6.5. Commercial Development. MBL staff member who assume responsibility for the design, conduct or reporting of research intended for commercial development have a special obligation to avoid bias, or the appearance of bias, in the conduct of these projects. Careful scrutiny is required for clinical trials that involve materials, devices or procedures invented or discovered by MBL staff member, whether such development took place at the MBL or elsewhere; where such trials may lead to commercial development either through the MBL, the MBL staff member’s own company; or by license to a company in which the MBL staff member or the MBL has a Significant Financial Interest. Similar concerns arise when a MBL staff member consults for the company whose product is being studied.

When both the MBL and the inventing MBL staff member hold equity interests in the development of a clinical drug or device, additional considerations govern any continuing institutional involvement in the commercialization of the IP. These interests are particularly important if human subjects are involved in the testing of the drug/device because of the real and/or perceived prospect of conflicts of interest. Financial benefits to the involved parties may influence selection of subjects, may lead to failure to fully disclose risks, may overemphasize benefits, and may lead to biased reporting of clinical outcomes or other inappropriate management.

In the presence of such conflicts, under what circumstances and with what oversight might MBL staff member be permitted to continue developing their discoveries/inventions for “new use,” or for improvements in existing uses? The intention is to encourage MBL staff members to pursue inquiry consistent with traditional academic practice while recognizing that the MBL staff member and the MBL will be held to a higher standard of scrutiny. By disclosure and the subsequent development of a Management Plan, the financial conflicts may be rendered manageable. In some circumstances, the situation may be so complicated that in the interests of the MBL staff member, the institution and the public, the research is best continued outside the MBL. An extreme strategy for managing a major conflict of interest may be divestiture of the outside Significant Financial Interest by the MBL staff member, or the taking of a leave of absence from the MBL.

6.7. Human Subjects/Independent Review Board. Any possible conflict of interest relating to human subjects must be routinely disclosed to the Independent Review Board (IRB) as part of the normal obligation for submission to the IRB of any clinical study.

6.8. Office/Laboratory Space and Other Resources. A MBL staff member may make reasonable use of his/her office and office equipment for all activities permitted within the scope of their MBL employment. Incidental modest expenses associated with the use of office or office equipment for consulting conducted within the permissible consulting periods is acceptable; however, the MBL should be reimbursed for these costs. MBL facilities such as laboratories and scientific equipment, as well as MBL personnel or students, should not be used for activities outside the scope of a MBL staff member’s academic responsibilities if those activities are conducted primarily for the financial benefit of the MBL staff member or for the benefit of a company or enterprise with which the MBL staff member is associated. An MBL staff member who wishes to use MBL laboratory space for a commercial project must receive prior approval from the Director of Research or the MBL Director if necessary.

All research carried out for the benefit of an outside entity that uses MBL facilities or other resources must be conducted under a grant or contract administered by the MBL.

6.9. Hiring Family Members for MBL Employment. Under the MBL’s Employment of Family Members Policy G.1.17, faculty, other academic appointees, and staff are prohibited from making, participating in, or attempting to influence employment and salary decisions regarding relatives.

6.10. Service on Committees. MBL staff member may be asked to serve on committees or other groups to assist the MBL in its relationships with outside vendors, suppliers and contractors. It is expected that MBL staff member will report in writing to the committee chair any potential conflict of interest that arises before acceptance or after the work has begun. MBL staff member are not automatically disqualified from serving on MBL committees when potential conflicts appear. Early disclosure of outside interests is critical. The focused nature of this service makes it unnecessary for a MBL staff member to disclose to the committee chair outside activities that are unrelated to the task at hand. In most circumstances, it should be possible for the MBL staff member to continue service on the committee, but some conflicts may be so severe that they are resolvable only if the MBL staff member resigns from the committee.

6.11. Consulting. Consulting relationships with companies in the private sector are a normal, traditional and recognized part of the outside activities of MBL staff member. However, consulting relationships also have the potential to create situations in which the terms of the consulting agreement conflict with the obligations of a MBL staff member to the MBL. These may arise for example in such areas as academic freedom, ownership of IP, creation of conflicts of commitment, and the integrity of the design, conduct and reporting of research. MBL staff members must include the MBL Consulting Agreement Addendum in any consulting agreement and should review the MBL Consulting Agreement Guide and MBL’s Policy on Intellectual Property (K.1.1).  MBL staff members should discuss a potential consulting relationship with their direct supervisor, the Director of Sponsored Programs, Director of Research, or the Chief Operating Officer before entering into the relationship.

7.0 Guidelines for MBL staff members

7.1. Conflict of Commitment

A conflict of commitment occurs when a MBL staff member’s outside professional or commercial activities, whether paid or unpaid, interfere or have the potential to interfere with his or her obligations, commitments, and contributions to the MBL.  Contribution to the MBL derive not only from research and training, but also from less formal interactions with colleagues and students and from participation in the affairs of one’s department/Center and of the MBL.

To sustain the contribution that is consistent with the MBL staff member’s obligations to the MBL, the time committed by full-time employees to outside professional or commercial activities shall not exceed 20% of a MBL staff member’s effort over the course of a fiscal year.

In every case, all outside professional or commercial activities of any length of time must be disclosed to and receive prior approval from the MBL staff member’s direct supervisor. In addition, all outside professional or commercial activities must be disclosed to MBL annually as part of the assurance and disclosure processes.

When involvement in outside professional or commercial activities does not substantially impair fulfillment of obligations to the MBL, yet the time committed to outside professional or commercial activities exceeds 52 days per year, a MBL staff member should discuss, in consultation with his or her direct supervisor, an appropriate reduction in MBL responsibilities and compensation. The supervisor may recommend to the Director a reduction of effort. Arrangements for part-time status to accommodate outside professional or commercial activities should normally be of limited duration. Requests for such arrangements may sometimes be denied by the Director in order to protect the MBL’s vital interests.

When a MBL staff member’s involvement in outside professional or commercial activities does substantially impair fulfillment of obligations to the MBL, the most appropriate method for managing this conflict may be for the MBL staff member to request a leave of absence from the MBL. Except in extraordinary circumstances, a leave of absence should not exceed two years, and the frequency and duration of leaves of absence should not be such as to impair a MBL staff member’s contribution to the MBL. To protect the MBL from the adverse consequences of leaves of absence, it may be appropriate to deny some requests for leave or to require that some involvements in outside professional or commercial activities be postponed, reduced or terminated.

7.2 Institutional Conflicts of Interest, Leadership and Reputational Risk

The Director, Directors, and other senior administrative officials play a special role in administering the affairs of the MBL. It is especially important that MBL staff member serving in these administrative positions minimize (or if possible avoid) personal involvement in outside professional or commercial activities that pose potential conflicts of interest with fulfillment of their responsibilities to the MBL. Their necessary involvement in the appointment and promotion process, in decisions concerning students, and in the supervision of other staff members requires that they be especially sensitive to potential conflicts of interest and that they uphold a particularly rigorous standard for avoiding such conflicts.

7.3. Other Conflicts of Interest

7.3.1. Appointment and Promotions. To maintain the effectiveness and the integrity of the process for appointments and promotions, MBL staff member should avoid, to the greatest extent possible, involvements in outside professional or commercial activities that might give rise to conflicts of interest in recommendations, evaluations, or decisions concerning appointment or promotion of any other MBL staff. When conflicts arise with a particular appointment or promotion, the MBL staff member with a conflict should disclose the interest and avoid participation in the consideration of that case.

7.3.2.  Education.  It is necessary to ensure that the nature and direction of degree-related research conducted by students is governed by considerations of scholarly merit and intellectual importance. The efforts of students in such research must always serve the student’s best interest. A MBL staff member should avoid situations where a student’s degree-related research becomes entangled with the MBL staff member’s outside professional or commercial activities. This guideline does not preclude the temporary or part time employment of a student in outside research or consulting activities with which a MBL staff member is associated, provided that such employment serves the best interest of the student, does not substantially impede the student’s progress toward a degree or other professional experience at the MBL, and does not restrict the student’s communication with other students or researchers, or the right of the student to publish his or her work. A MBL staff member should be prepared to describe procedures that are in place to insure that workplace disagreements do not influence the student’s academic performance, evaluation or placement.

7.3.3 Consulting.  The MBL reserves the right to examine individual consulting agreements to assure that applicable MBL policies are not breached, and that the consulting services do not impinge on the integrity of the design, conduct or reporting of the research performed at the MBL. Knowledge of the specifics of the consulting relationship may be necessary to define an appropriate Management Plan.

A MBL staff member shall disclose any Significant Financial Interest he or she has in an entity that provides him or her support through a grant or contract administered by the MBL. This is of particular concern in, but not limited to, those areas involving consulting relationships with organizations sponsoring clinical studies, and in research directed to commercial development where the MBL staff member holds an equity or intellectual property interest in the organization sponsoring or benefiting from the research outcome.

Participation in the activities of an outside commercial enterprise, including a MBL staff member-owned or -managed company, and disclosure of conflicts of interest pursuant to this policy, does not excuse a MBL staff member from the normal IP requirements and procedures for disclosing discoveries and inventions that occur at the MBL. [See Policy K.1.1 Intellectual Property]

MBL staff member should reimburse the MBL for any administrative costs (e.g., phones, postage, or computer services) that outside consulting activities impose. Whenever possible, MBL staff member should arrange direct payment to third party vendors, for example by billing express mail packages to third parties.

MBL staff members should not hire staff to work in MBL buildings in the service of their outside professional or commercial activities.

7.3.4.  Other cases are likely to arise, where for example a MBL staff member on an occasional basis wishes to use unusual resources or equipment such as databases or measuring devices ordinarily not available for outside activities. Approval to do so can be granted by the Director, provided the outside activities do not interfere with the ordinary academic and research work of the MBL, and the MBL receives adequate reimbursement for the use of its resources or equipment.

7.4.  Inventions and Intellectual Property.

7.4.1 All inventions and discoveries by MBL staff members must be disclosed to the MBL in accordance with MBL policy so that IP can be appropriately assessed and protected.

7.4.2  Any MBL staff member who personally patents MBL IP without its prior disclosure and its release is not in compliance with MBL policy. While such action does not pose a financial conflict of interest per se, circumventing the MBL’s requirement for disclosure of inventions is clearly a conflict of commitment of effort, and may lead to inappropriate personal financial benefit, as well as disciplinary action.

7.4.3  When a MBL staff member seeks to market or test an invention or process using MBL facilities or personnel, he or she must first receive the MBL’s approval through the disclosure process. This approval is necessary whether the invention or process is developed within or outside the service of the MBL, or formally through a sub- award on an SBIR or STTR, or informally as a consultant on a business development application.

Approval is likely to be granted only in those extraordinary circumstances where the project is of substantial benefit to the MBL, where the MBL is fully compensated for the use of its facilities, where all relevant parties are aware of the source of funding for the outside activities, and where researchers are allowed freely to publish the findings and results of this research (except for delays strictly necessary to allow patent applications to be filed). These arrangements will not be frequently approved, since commercial or industrial facilities are normally able to undertake these activities on their own premises.

8.0 Avoidance and Management of Conflicts of Interest on Sponsored Research

The COI form must be completed and forwarded to the Director of Human Resources to initiate the review process. The Director of Human Resources will distribute or make accessible to the Director of Sponsored Programs all COI forms submitted by those MBL staff members in the Divisions of Education or Research. The COI form will be reviewed by the appropriate COI Official for purposes of distinguishing between Negative Disclosure (disclosure that reveals no financial conflict) and Positive Disclosure (disclosure that requires additional review).

Some federal funding agencies permit research to proceed despite the presence of disclosed conflicts, if the review determines that imposing restrictions or conditions would be either ineffective or inequitable, or if 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. However, the MBL is ultimately responsible for the determination of whether a research or educational project that involves a conflict should proceed.

8.1 Negative Disclosure

In those instances where the MBL staff member’s COI form clearly represents a Negative Disclosure, the Negative Disclosure Form will be filed in the Human Resources office.

8.2 Positive Disclosure

The designated COI Official will make an initial determination as to whether or not a Positive Disclosure exists. In those instances where it is concluded that the disclosure form does represent a Positive Disclosure, or if there is the slightest doubt, the COI Official will advise, in writing, the MBL staff member and staff member’s immediate and next-level supervisors. The COI Official will convene a meeting of the Chief Operating Officer, Director of Research, and a member of the University of Chicago Office of Legal Council if necessary for purposes of reviewing the Positive Disclosure.

In reviewing the Positive Disclosure, decisions will be guided by the following practices and apply them as necessary:

• Assure adherence to all relevant governmental and MBL policies.
• Consider the nature, and extent, of the financial interest in the relationship between the MBL staff member and the external sponsor.
• Obtain additional information from the MBL staff member as may be necessary in resolving conflicts.

Act within ten (10) working days so as not to unduly delay the process.

8.2.1 Actions by the MBL

In the final analysis, the COI Official and parties mentioned above will determine whether or not the Positive Disclosure constitutes a Financial Conflict of Interest (FCOI) and may take any of the following actions to manage the conflict:

• Public disclosure of significant financial interests;
• Monitoring of research by independent reviewers;
• Modification of the research plan;
• Disqualification from participation in the portion of the sponsored research that could be affected by the significant financial interests;
• Divestiture of significant financial interests as a condition to participation in the research activity;
• Severance of relationships that create actual or potential conflicts; or
• Such other actions as deemed appropriate by the COI Official
• Refer to the MBL Compliance Committee for additional review

The Compliance Committee (Section 12.0) shall be used as an additional resource as needed. The COI Official, in consultation with the Chief Operating Officer, the Director of Research, and University of Chicago Office of Legal Council will make the determination as to what potential conflicts need to be escalated to the Compliance Committee. The Compliance Committee will convey it’s determination to the MBL Director for congruence. In the event that the Compliance Committee is unable to make a determination, the decision resides with the MBL Director.

8.2.2.  Management Plan.  Final determinations, as well as steps and procedures to manage the conflict will be documented in a management plan. A management plan must include a description of the following key elements:

(a) The research affected by the FCOI, including, if applicable, the grant number;

(b) The role and principal duties of the MBL staff member who has the FCOI;

(c) The conditions or restrictions to be implemented to manage, reduce or eliminate the FCOI;

(d) A statement explaining how the management plan will protect the research from bias resulting from the FCOI;

(e) Confirmation of the MBL staff member’s agreement to abide by the management plan;

(f) A statement explaining how the management plan will be monitored to ensure compliance and who is responsible for monitoring compliance with the management plan; and

(g) Any other information as needed.

The management plan must be signed by the MBL staff member and the staff member’s supervisor and approved by the Compliance Committee. If an MBL staff member disagrees with the COI Official’s determination that an FCOI exists, the individual may appeal the determination to the MBL Director in writing within 10 business days after receiving the determination. The decision of the Director or designee is final.

In addition to the management plan, the MBL staff member will be assigned a COI Oversight Manager. The Oversight Manager will oversee compliance with the management plan and serve as a resource to the researcher whose financial and research interests intersect. The Oversight Manager will be assigned on a case by case basis by the Director of Research and/or the Chief Operating Officer.

8.2.3. Reporting to Sponsors

Prior to the expenditure of any funds under a NIH award, the MBL must report to the NIH the existence of a conflicting interest (but not the nature of the interest or the details) found by the MBL and assure the conflict has been managed, reduced or eliminated. The NSF requires notification only if the conflict cannot be managed, reduced or eliminated.  With all sponsors, if the MBL Director and the individual involved are unable to satisfactorily manage or eliminate an actual or potential conflict of interest, the MBL will immediately inform the research sponsor(s) or agency(ies), according to their applicable regulations.

8.3.  Subrecipient Requirements

MBL shall, as part of a written subrecipient agreement with a subrecipient under a PHS prime award, establish whether the Conflicts of Interest policy of MBL or that of the subrecipient will apply to the subrecipient’s investigator(s). If the subrecipient relies on its Conflicts of Interest policy, the subrecipient shall certify as part of the subrecipient agreement that its policy complies with 42 CFR Part 50 or 45 CFR Part 94, as appropriate. In either case, the subrecipient agreement will include time periods to meet the disclosure and/or Financial Conflict of Interest reporting requirements of MBL to PHS.

9.0 Distribution of these Guidelines

The MBL Human Resources Office will distribute this policy to all new MBL staff before they commence activity at the MBL, and annually to all MBL staff members.  All MBL staff members remain subject to the MBL’s Code of Conduct that is posted on the MBL web-site.

10.0 Notification of Violations

All suspected violations shall be reported, in strictest confidence, to the Human Resources Director.  Suspected violations can also be reported via the compliance hotline, at 877-534-0367 or reportlineweb.com/mbl. Please refer to the MBL’s Allegation of Misconduct policy G.1.20 for further guidance.  Violations involving the MBL Director shall be reported to the Chairman of the Board of Trustees.  The Chief Compliance Coordinator shall take such steps necessary to be appraised of such violations and their resolution and report as necessary to the Audit Committee of the Board of Trustees.

11.0 Violations

11.1. Administrative action
In instances in which the violations are not in dispute, the Human Resources Director will verify the facts with the individual who violated this policy and bring to the attention of the Compliance Committee who will make a recommendation of the appropriate remedial action(s) to the MBL Director.  If a violation involves the MBL Director, the Chairman of the Board will make a determination of the appropriate remedial action(s).

When a dispute exists, the Human Resources Director shall, in consultation with the Compliance Committee, appoint an appropriate ad hoc committee to investigate the facts and report within 120 days to the MBL Director and other appropriate individuals, including the individual alleged to have violated this policy.  The alleged violator shall then have 30 days to comment on the allegations, after which the MBL Director shall render a finding and determine appropriate remedial action(s).

11.2 Levels of severity
Administrative actions will be in proportion to the severity of the violation.  These actions, which would be in addition to any legal penalties, may include the following: (a) written reprimand; (b) reassignment; (c) demotion; (d) suspension; (e) termination/separation from MBL.

11.3. Effect of administrative action on government-sponsored research
Suspension or separation of a project director or program director or other key personnel will be reported promptly to the appropriate government awarding office.  The appropriate actions may include, or may result in, a change in Principal Investigator and a change in scope of the research project.  Other reporting to the government agencies shall be made as required by law or deemed appropriate by the MBL Director.

12.0 Definitions

Significant Financial Interest is a financial interest that meets any of the criteria for significance set forth below and is received or held:

1. by an Investigator; or
2. by an Investigator and members of his or her Family; or
3. solely by members of the Investigator’s Family, but only if the financial interest could reasonably appear to be related to the Investigator’s Institutional Responsibilities,

A financial interest is deemed to be significant if:

1. the aggregate value of Remuneration and Equity Interests in lieu of payment received from a US or foreign publicly traded entity during the 12 month period preceding the disclosure exceeds $5,000; or
2. the aggregate value of Equity Interests in a US or foreign publicly traded entity exceeds $5,000 and the entity is sponsoring any of the Investigator’s research; or
3. the aggregate value of Equity Interests in a US or foreign publicly traded entity exceeds $100,000 and the entity’s business, or any portion thereof, reasonably appears to be related to any of the Investigator’s Institutional Responsibilities; or
4. the aggregate value of Remuneration received from a US or foreign non-publicly traded entity or non-profit institution received during the 12 month period preceding the disclosure exceeds $5,000; or
5. any Equity Interest is held in a US or foreign non-publicly traded entity; or
6. the aggregate value of Remuneration received from a foreign governmental organization during the 12 month period preceding the disclosure exceeds $5,000; or
7. the aggregate value of income related to intellectual property rights and interests paid by an entity other than MBL exceeds $5,000.

Significant Financial Interest does NOT include:

1. Remuneration from MBL; (including salary and royalty payments) and
2. Remuneration paid to an Investigator’s Family by any entity what would not reasonably appear to be related to the Investigator’s Institutional Responsibilities; and
3. Remuneration from authorship of academic or scholarly works, regardless of the source; and
4. Remuneration from seminars, lectures, or teaching engagements sponsored by, or from advisory committees or review panels for, U.S. Federal, state, or local governmental agencies; U.S. institutes of higher education (e.g. Whitehead Institute and Broad Institute); U.S. research institutes affiliated with institutes of higher education, academic teaching hospitals, and medical centers; and
5. Equity Interests in or income from investment vehicles, such as mutual funds and retirement accounts, so long as the Investigator does not directly control the investment decisions for these vehicles.

Financial Conflict of Interest (FCOI)  – a significant financial interest that is related to a research program or project and could directly and significantly affect the design, conduct or reporting of that research.

Institutional responsibilities – is defined as professional responsibilities on behalf of the institution. These may include:  activities such as research, research consultation, teaching, institutional committee memberships, administrative responsibilities and service on institutional panels. 

An MBL faculty or staff member is affiliated with another organization if the MBL staff member or an immediate family member is an officer, director, employee, proprietor, partner, trustee, or otherwise is able to influence the decisions, of the other organization.

MBL staff member – For purposes of this policy, faculty or designated staff members working as either full or part-time, in administrative, scientific research, or service staff as determined by the Compliance Committee.  Also included are those individuals who, though not employees, serve as principal investigators on sponsored projects (for example adjunct scientists, course directors, Whitman Investigators with MBL Research Awards) administered by the MBL.

Family Member –a spouse, domestic partner or dependent child (children).

Subrecipient – a non-Federal entity that receives a subaward from a pass-through entity to carry out part of a Federal program; but does not include an individual that is a beneficiary of such program. A subrecipient may also be a recipient of other Federal awards directly from a Federal awarding agency.

13.0 Compliance Committee

The MBL Compliance Committee is charged with review of all Conflict of Interest issues.  The Committee is advisory to the MBL Director.  The membership of this committee includes:  Chief Operating Officer, as Chairperson, Director of Research, Director of Finance, Director of Sponsored Programs, Director of Human Resources, Director of Education, Director of Information Technology, and the Director of Facilities.  Others will be appointed on an ad hoc basis to assist in specific issues.  Committee members must declare any conflicts they have with business brought before the Committee.  Those Committee members with conflicts do not participate in discussion or vote except to provide information requested by the Committee.  The committee will meet at least quarterly to review any management plans that have been developed.

14.0 Recordkeeping

Human Resources must maintain all records related to MBL staff member’s disclosure statements and any FCOI determinations and/or management plans in a central location. These records must be kept for the longer of three years from the date of the last expenditure submitted in the case of sponsored research or as required by applicable federal law, e.g., 45 C.F.R. §§74.53(b), 92.42(b).

15.0 Policy Clarification and Updates

Policy clarification and updates are available from the office of the Chief Operating Officer or Human Resources.

Also reference:
Code of Conduct Policy, G.1.19
Trustee Conflict of Interest Policy, A.1.6

Addendums:

Addendum A: Additional Responsibilities for PHS-Funded Investigators:

A.1. Travel. As required by PHS regulations, PHS-Funded Investigators must disclose the occurrence of any reimbursed or sponsored travel related to their Institutional Responsibilities unless the travel was sponsored or reimbursed by the MBL. Disclosure does not need to include the monetary value of the travel, but it must include (1) the purpose of the trip; (2) the identity of the sponsor/organizer; (3) the destination; and (4) the duration. The MBL may investigate the monetary value in order to determine whether the travel constituted a conflict of interest with the PHS funded research. Travel sponsored or reimbursed by a federal, state, or local government agency, an institution of higher education (as defined in 20 U.S.C. 1001(a)), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education does not need to be disclosed.

A.2. Training. As required by PHS regulations, the MBL will develop a mandatory training program that specifically addresses conflict of interest compliance issues related to PHS funded research. All PHS-Funded Investigators must complete the MBL’s training program before starting their PHS-sponsored research project and at least once every four years thereafter. The MBL also will provide training to PHS-Funded Investigators immediately under these circumstances: (1) when the MBL has changed its financial conflict of interest policy in such a way that it affects disclosure requirements; (2) when a PHS-Funded Investigator is new to the MBL; or (3) when the MBL determines that a PHS-Funded Investigator is non-compliant with this policy or an applicable management plan.

Training can be completed for CITI Training: Conduct in Research here.

A.3. Public Disclosure. As required by PHS regulations, before the MBL expends funds for a research project sponsored by PHS, the MBL will provide public access to information concerning a Significant Financial Interest of a PHS-Funded Investigator if (1) the Significant Financial Interest has been disclosed to the MBL and is still held by the PHS-Funded Investigator; (2) the MBL has determined that the Significant Financial Interest is related to the PHS sponsored research; and (3) the MBL has determined that the Significant Financial Interest is a conflict of interest.

When these circumstances occur, the MBL is obligated to disclose the conflict of interest in writing within five calendar days of a written request. The disclosed information will include (1) the PHS-Funded Investigator’s name; (2) the PHS-Funded Investigator’s title and role with respect to the PHS research project; (3) the name of the entity in which the Significant Financial Interest is held (if applicable); (4) the nature of the Significant Financial Interest; and (5) the approximate dollar amount (dollar ranges may be used) of the Significant Financial Interest, or a statement that the value of the interest cannot be readily determined by reference to public prices or other measures of fair market value.

Requests for such information should be submitted via email to humanres@mbl.edu.

This information will remain available to the public for at least three years after the date on which the information was last updated.