Chapter 4: Collaborations

4.1 Individual Research Personnel Collaborations

4.1.1 Duke University Financial Conflict of Interest in Research Policy

I. Purpose

The purpose of this policy is to promote the scientific integrity and objectivity of research conducted at Duke University (“Duke”, the “University” or “Institution”). This policy outlines Duke’s approach to identifying outside financial interests of Duke personnel that are relevant to their Duke work, evaluating and determining whether these outside financial interests create financial conflicts of interest (FCOIs) related to research conducted through the auspices of Duke, and developing strategies to manage or otherwise mitigate such conflicts.

This policy is meant to serve as a distinct, but complementary policy to both the Duke University Outside Activity and Conflict of Commitment Policy and Policy on Dual Interest and Outside Activity for Faculty and Staff of Duke University, Duke University Health System, DUMAC, Inc., and the Related Wholly Owned Subsidiaries, Support Corporations and Controlled Affiliates.

II. Applicability

Individuals to whom this policy applies are referred to as "Covered Individuals." Covered Individuals include:

1. Regular-rank tenure and non-tenure track faculty members.
2. Any other individual, regardless of title or position, who is responsible for the design, conduct, or reporting of research at Duke, which includes, but may not be limited to, a principal investigator, project director, co-investigator and other key personnel. The principal investigator/project director is responsible for making the determination of any other individuals who meet this definition.
3. Individuals participating in research subject to expanded Conflict of Interest (COI) disclosure and review requirements under sponsor or institutional policy. These individuals will be notified when they are identified as falling within this scope.

III. Principles

The University is committed to advancing knowledge and accelerating the translation of novel research into practice, while preserving the public’s trust in Duke’s highest scientific and ethical standards for conducting research. The University recognizes that Covered Individuals have opportunities to provide their expertise outside of Duke and that these opportunities can foster collaborations and promote scientific advancement. However, such opportunities may result in individual financial benefits or other gains for Covered Individuals (“financial interests”), that when present, have the potential to affect, or appear to affect, the objectivity and integrity of Duke research.

This policy requires Covered Individuals to disclose outside financial interests that are related to their institutional responsibilities and establishes how these will be evaluated by institutionally designated officials (“Designated Officials”), including the Duke Office of Scientific Integrity – Conflict of Interest Office (“DOSI-COI”) and the Conflict of Interest Committee (“COIC”), with input, as needed, from school and/or unit leadership. Disclosure is integral to identifying and managing real or perceived conflicts of interest in research. The existence of a conflict, whether perceived or actual, neither implies wrongdoing nor automatically necessitates the divestiture of the financial interest. Designated Officials will strive to work with the Covered Individual to implement management so that any related Duke research can continue in a way that minimizes the possibility of bias and preserves the objectivity of the research.

The scope of this policy is specific to outside financial interests and identified financial conflicts of interest (as defined below). Covered Individuals are responsible for familiarizing themselves with the complementary policies noted in the “Purpose” section above, as these policies outline requirements beyond those contained herein (e.g., disclosure of outside activities relying on an individual’s academic, professional, or scientific expertise that are uncompensated).

IV. Definitions

Financial Conflict of Interest (FCOI): A significant financial interest (“SFI”) that could directly and significantly affect the design, conduct, or reporting of research.

Financial Interest: Anything of monetary value, whether or not the value is readily ascertainable.

Institutional Responsibilities: A Covered Individual’s professional responsibilities which they perform at Duke (e.g., their Duke work). This may include activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards under the auspices of the University.

Intellectual Property: Any new invention or discovery that may include devices, processes, systems, compositions of matter, methods, life forms, computer software, copyrighted works, mask works, tools, data, know-how, certain defined trade and service marks, tangible materials, and all domestic and foreign legal rights to the same.

Investigator: Duke personnel who are responsible for the design, conduct, or reporting of sponsored research. This includes the project director or principal investigator, any regular rank faculty, and all senior/key personnel on a sponsored research project. Additional individuals may be considered an Investigator under this policy based on their project responsibilities.
Manage: Taking action(s), via a management plan issued by DOSI-COI, to address a real or apparent FCOI by implementing strategies to ensure that the design, conduct, and reporting of research will be free from bias.

Research: A scholarly work or systematic investigation to develop or contribute to general or specific knowledge. For purposes of this Policy, research includes all basic, applied, clinical, translational, and demonstration research in all academic and scholarly fields. Research fields include, but are not limited to, the arts, the physical sciences, humanities, applied sciences, social and medical sciences, the professions and research involving human participants and animal subjects.

Significant Financial Interest (SFI): A financial interest of a Covered Individual, and those of the Covered Individual’s spouse and dependent children, that reasonably appears to be relateds to their institutional responsibilities and meets the following criteria:

• $5,000 or more in remuneration or equity in a publicly traded entity, in the aggregate
• Any ownership interest or equity in a non-publicly traded entity
• Any receipt of income related to intellectual property (IP) rights and interests, regardless of the source* (e.g., through Duke or another institution)
• An agreement with an entity, including one negotiated through Duke, that entitles the individual to future income/royalties related to IP rights*

The term SFI does not include:

• Income from seminars, lectures, or teaching engagements sponsored by a U.S. federal, state, or local government agency, or U.S. institutions of higher education, academic teaching hospitals, medical centers, or research institutes affiliated with U.S. institutions of higher education
• Income from service on advisory committees or review panels for a U.S. federal, state, or local government agency, U.S. institutions of higher education, academic teaching hospitals, medical centers, or research institutes affiliated with U.S. institutions of higher education

*The COIC has previously determined that income related to IP rights and interests, as well as entitlement to future income/royalties related to IP rights through Duke, shall be considered an SFI even if this exceeds a sponsor’s de minimis requirements.

V. Responsibilities

It is the responsibility of Covered Individuals to disclose outside financial interests as described by this policy.

It is the Institution’s responsibility, via its Designated Officials, to solicit and review disclosures of Covered Individuals. Designated Officials include DOSI-COI and the COIC and may include school and/or unit leadership as appropriate.

• DOSI-COI is an administrative support unit of the Office for Research & Innovation (OR&I), charged with managing the administration of this policy, completing primary reviews of completed disclosure forms, and providing support to the COIC.
• The COIC is charged with protecting the integrity of Duke research from bias related to outside interests of Covered Personnel. The COIC consists of faculty members with a wide array of experience in the design, conduct, and reporting of research. Members are appointed by the Vice President for Research and Innovation (VPRI) or their designee. The COIC is conducted in accordance with its charter under the governance of the VPRI.

Designated Officials will determine whether a disclosed outside financial interest is an SFI, according to standards established by the COIC that adhere to applicable federal, sponsor, or regulatory agencies. Upon identifying an SFI, Designated Officials will determine the SFI’s relatedness to Duke research, whether an FCOI exists, appropriate management strategies, and whether sponsor reporting is required. Designated Officials will be responsible for issuing management plans and monitoring adherence, as well as completing any necessary sponsor reporting.

VI. Disclosure of Financial Interests

All Covered Individuals must submit an annual disclosure using Duke’s interactive online disclosure form distributed by DOSI-COI. Covered Individuals must disclose outside financial interests that existed in the preceding 12 months or are anticipated in the next 12 months. Failure to submit a disclosure form is considered a violation of this policy; please refer to the Violation section below for details.

In addition to the annual disclosure requirement, Covered Individuals must update their disclosure form within 30 calendar days of any changes to existing outside financial interests, or discovering, acquiring, or otherwise establishing any new outside financial interest (e.g., through purchase, marriage, or inheritance).

Covered Individuals performing externally sponsored research are also required to disclose outside financial interests at the time of proposal and at the time of award. This disclosure is done through event-based electronic attestation at the time of proposal and award, and through the interactive online disclosure form. Awards will not be released until Designated Officials have determined that either no FCOIs exist, or any FCOIs are appropriately managed and reported as per sponsor requirements.

VII. Disclosure Requirements

Covered Individuals must disclose the following outside financial interests, regardless of value, that appear to be related to their institutional responsibilities:

• Payments for services or outside appointments (e.g., salary, consulting fees, editorial/advisory board payments, paid authorship, speaking engagements, or other honoraria)
• Ownership interest in a private or public entity (stocks, stock options, warrants, or other ownership interests)
• Being an inventor of optioned, licensed, or otherwise commercially held technology, as well as the receipt of royalty payments (including receipt of income related to intellectual property rights and interests through Duke)
• Gifts or other benefits received as part of or because of an outside service or appointment (e.g., donations or in-kind support designated for research)
• Book royalties/publishing agreements

Covered individuals must disclose the above for themselves, as well as those held by their spouse and dependent children.

Covered Individuals who conduct research through the auspices of Duke that is sponsored by U.S. federal agencies and/or organizations that have adopted the COI policy of a U.S. federal agency must disclose travel for which the individual is either reimbursed or paid for on the individual’s behalf. Travel reporting is conducted separately, using DOSI-COI’s Sponsored Travel application.

The following are NOT required to be disclosed:

• Salary or other compensation from Duke University (including percentages of effort from sponsored research managed through Duke)
• Salary or other remuneration from the U.S. Department of Veterans Affairs (VA) when the Covered Official has a joint appointment with the VA and Duke (e.g., an MOU or IPA)
• Payments from Duke Health Integrated Practice (DHIP), or the Duke University Health System
• Ownership of a share in a mutual fund or other investment vehicles where there is no direct control of investment decisions
• Income from seminars, lectures, or teaching engagements sponsored by U.S. federal, state, or local government agency, or U.S. institutions of higher education, academic teaching hospitals, medical centers, or research institutes affiliated with an institution of higher education*
• Income from service on advisory committees or review panels for a U.S. Federal, state, or local government agency, U.S. institutions of higher education, academic teaching hospitals, medical centers, or research institutes affiliated with a U.S. institution of higher education*
• Travel paid for by Duke, U.S. federal, U.S. state, or U.S. local government agencies, other U.S. institutions of higher education, academic teaching hospitals, medical centers, or research institutes affiliated with an institution of higher education located within the U.S. Note that travel paid by any foreign entities must be disclosed.

When in doubt, a Covered Individual should err on the side of disclosure.

Based on information disclosed by Covered Individuals in their online disclosure form, advisory memos will be system-generated and issued upon form completion for any outside financial interests that meet the threshold for SFI. The purpose of the advisory memo is to ensure that Covered Individuals are aware of their SFI(s), and accompanying responsibilities should they conduct research at Duke that may be related to the SFI. The advisory memo is educational in nature and provides real-time guidance to Covered Individuals upon disclosure. DOSI-COI will contact Covered Individuals directly upon review of their disclosure form should additional information and potential management be needed.

VIII. Disclosure Review and Identification of Potential FCOIs

Designated Officials will review disclosures to determine whether an SFI is present. If an SFI is identified and the Covered Individual is engaged in sponsored research at Duke, Designated Officials will assess whether there is apparent relatedness of the SFI to the Covered Individual’s Duke research. Generally, a financial interest is related to research when the financial interest could be affected by the research or is in an entity whose financial interests could be affected by the research. Designated Officials may involve the Covered Individual in the relatedness determination. If an SFI is determined to be related to the Covered Individual’s Duke research, an FCOI may exist.

An FCOI exists when it can be reasonably determined that the identified SFI could directly and significantly affect the design, conduct, or reporting of the related Duke research. Designated Officials will consider precedent and make the determination as to whether an FCOI exists.
Potential bias due to the presence of an FCOI can affect various aspects of research, including, but not limited to, data collection, data analysis, interpretation of findings, selection of materials, or choice of statistical analysis. The following elements are illustrative of what is considered when making an FCOI determination:

• The magnitude of the financial interest
• The extent to which the research could impact the value of the financial interest
• The nature of the research
• Possible ways that bias might manifest or even be perceived
• The degree of risk to human subjects, if applicable
• The impacts on the progress of students/trainees, if applicable

Covered Individuals will be consulted throughout the disclosure review process if additional information is needed and to ensure that potential conflict management strategies will effectively mitigate bias and allow critical research to move forward.

IX. Management Plans for Identified FCOIs

Upon determining the existence of an FCOI, Designated Officials, in consultation with the Covered Individual as needed, will develop a management plan to reduce or eliminate the potential for bias. Covered Individuals will receive a copy of the management plan that requires their signature. The management plan will detail the conditions or restrictions with which the Covered Individual must comply in their conduct of the research.

Management plans are issued for all identified FCOIs and may be issued for SFIs that are related to Duke research but not determined to be an FCOI.

Examples of management elements include, but are not limited to:

• Public disclosure of the financial interest (e.g., when presenting or publishing the research results)
• For research projects involving human subjects, disclosure of the financial interest to the IRB and directly to participants and potential participants
• Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias
• Modification of the research plan
• Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research
• Reduction or elimination of the financial interest (e.g., sale of equity)

Designated Officials will monitor Covered Individuals’ compliance with issued management plans.

X. Appeals

Covered Individuals have the right to appeal all or part of an issued management plan within 14 calendar days of receipt of the plan. A written request of appeal must be submitted to dosicoi@duke.edu. Once a request is received, DOSI-COI will respond within 2 business days that acknowledges the request with a copy to the Chair of the COIC.

The Chair of the COIC will review the appeal and may request clarification or additional information. If the Chair determines that COIC re-review is warranted, the case will be re-reviewed by the COIC during its next regularly scheduled monthly meeting. If the Chair determines that COIC re-review is not warranted or the COIC determines that the management plan as originally issued shall stand, the Covered Individual will be notified and advised that they have the right to appeal to the VPRI.

If the Covered Individual chooses to appeal to the VPRI, DOSI-COI will submit the appeal to VPRI@duke.edu with a copy to the Covered Individual and the Chair of the COIC. The VPRI and/or their designee(s) will consider the COIC’s review and determination as well as the terms of the management plan and may request additional information. Unless there are extenuating circumstances, the ultimate decision of the VPRI will be rendered within 30 calendar days of receipt of the receipt of the appeal.

XI. Reporting to Sponsors

Certain sponsors require the University, through its Designated Officials, to report the existence and subsequent management of FCOIs relevant to their funded projects that are ongoing at Duke. Reports shall include sufficient information to enable the sponsor to understand the nature and extent of the financial conflict, and to assess the appropriateness of the management plan. Designated Officials will create and submit reports according to sponsor expectations and law, as applicable, with input from the Covered Individual as appropriate.

XII. Recordkeeping

A Covered Individual’s disclosures of financial interests and the University’s review of, and response to, such disclosures shall be retained as required by governmental and sponsors’ requirements. If a record is subject to more than one record retention requirement, the longer retention requirement shall apply.

XIII. Training Requirements

Covered Individuals will complete training regarding this policy and applicable federal regulations upon hire and prior to engaging in sponsored research. Covered Individuals will complete training annually thereafter at the time of submitting the annual disclosure form. Revisions to this policy, as well as instances of non-compliance, may necessitate additional training.

XIV. Violations

Failure to comply with this policy may lead to disciplinary action, up to and including termination of appointment and/or employment in accordance with applicable disciplinary procedures. Failure to comply with this policy includes, but is not limited to:

• Not submitting or updating a truthful and timely disclosure form
• Failing to fulfill training requirements
• Failing to cooperate with or otherwise respond to requests for additional information from Designated Officials or a sponsor
• Failing to comply with the elements of a management plan

Potential violations of this policy may be submitted to dosicoi@duke.edu. Designated Officials may refer the potential violation to other relevant University committees or officials. These committees or officials will conduct an assessment of the potential violations, per their operating procedures, taking into consideration any mitigating circumstances.

The results of the assessment may be submitted to the Dean, Chair, Director, or other appropriate designee for action, consistent with University policies. Additionally, the violation may be reported to research sponsors in accordance with sponsor policies. If the Covered Individual wishes to dispute any decision or action, they may submit an appeal in line with the process outlined above.

XV. Public Accessibility

Requests for information about FCOIs from the public will be provided as required and in accordance with federal regulations.

XVI. Policy Approval

Revisions to this policy will be reviewed by the Research Policy Advisory Committee (RPAC) and considered in accordance with Duke processes regarding research policies.

Questions concerning the interpretation or applicability of this policy should be directed to DOSI-COI and the Chair of the COIC by contacting dosicoi@duke.edu.

4.1.2 Outside Activity Disclosure and Conflict of Commitment Management Requirements for Covered Individuals Engaging in Research

I. Purpose

This document appends Duke's Dual Interest and Outside Activity Policy for Faculty and Staff of Duke University, Duke University Health System, DUMAC and the Related Wholly Owned Subsidiaries, Support Corporations and Controlled Affiliates.

This is the research-specific policy requiring Covered Individuals to disclose outside activities, obtain prior approval before engaging in higher-risk activities, comply with sponsor disclosure obligations, and refrain from prohibited activities in alignment with requirements for federally-funded institutions.

II. Applicability

Faculty and staff engaged in research and sponsor-funded activities (“Covered Individuals”) with federal agencies, governmental entities, and other 3rd parties including industry and foundations that require pre-approval, disclosure and/or institutional attestation.

Covered Individuals include:

1. Regular-rank tenure and non-tenure track faculty members.
2. Any other individual, regardless of title or position, who is responsible for the design, conduct, or reporting of research at Duke, which includes, but may not be limited to, a principal investigator, project director, co-investigator and other key personnel. The principal investigator/project director is responsible for making the determination of any other individuals who meet this definition.
3. Individuals participating in research subject to expanded Conflict of Interest (COI) disclosure and review requirements under sponsor or institutional policy. These individuals will be notified when they are identified as falling within this scope.

The University understands and values that opportunities available to Covered Individuals outside the University can be beneficial for cross-collaboration, professional development, and ultimately scientific advancement. The University strives to balance these opportunities with the expectation that Covered Individuals owe their primary professional commitment and duty to the University. Accordingly, engaging in professional activities outside of Duke must be done in accordance with this policy, other applicable University policies, and sponsor requirements; and after securing appropriate institutional approvals addressed in this policy.

III. Required Procedures

While Outside Activities may occur in the normal course of faculty responsibilities, appropriate disclosure and review enables the institution to manage internal and external requirements. Duke’s responsibilities include certifying to its researchers’ outside and foreign activities at proposal submission and prior approval for certain higher-risk outside activities and commitments.

Disclosure
Covered Individuals must disclose Outside Activities so that the University and school/unit leadership can evaluate and manage potential conflicts, as described below. Disclosures should occur no less than annually, through the Outside Interest form. As stated in the Individual Conflict of Interest in Research Policy, Covered Individuals must also report any changes to outside interests, including Outside Activities, as they arise or within thirty (30) days of a change (unless the activity requires prior approval), by updating their disclosure form.

Review and Approval
For Covered Individuals who have active or pending federally-funded research projects, in addition to disclosure, certain activities require approval by school leadership prior to beginning the activity. Depending on the nature of the activity, a secondary level of review/approval may be required.

Mandatory Prior Approval
The following activities require approval prior to beginning the activity:

1. Serving as lead (or “contact” or “overall”) PI on applications and awards based at other institutions, unless the Covered Individual has received appropriate institutional approvals for the activities.
2. Performing research activities within the specific subject area of Covered Individual’s current and ongoing University research activities on behalf of an external entity where there is no agreement in place between Duke and the external entity. Research activities include participating in the design, conduct, or reporting of research. Individuals should note that anticipated co-authorship is an indicator that the Outside Activity would be considered research.
3. Titled and/or compensated appointments/affiliations with institutions of higher education, academic medical centers, government employment (US or foreign), and/or research institutes.
4. Outside activities and engagement with foreign entities, subject to the below specifications. Approval is required regardless of whether this is done during summer months (for faculty with nine-month appointments) or other non-contracted Duke time. This does not include activities conducted under agreements where Duke is a party (e.g., a subcontract).
   1. Entering into a contract, grant, memorandum of understanding, or other agreement with foreign entities that involve research-related activities or other professional activities of the Covered Individual requires prior approval regardless of the foreign country involved
   2. Informal activities that do not involve a contract, grant, memorandum of understanding, or other agreement with a foreign entity (e.g., serving on a dissertation or thesis committee, advising or mentoring students, etc.) only requires prior approval if the activity involves a “foreign country of concern” (per Public Law 117-167, The CHIPS and Science Act, Section 10612 Aug 9. 2022; People’s Republic of China, the Russian Federation, the Islamic Republic of Iran, the Democratic People’s Republic of North Korea, or any other country determined to be a country of concern by the Department of State). This list is subject to change based on federal government updates

Prohibited Activities
Engaging in the following activities represents a violation of sponsor or federal regulations and/or University policies and, therefore, Covered Individuals are prohibited from:

1. Participation in a malign foreign talent recruitment program (see myRESEARCHpath for definition)
2. Employment at an external entity involving the conduct of research or other duties similar to the Covered Individual’s responsibilities at Duke, absent prior approval from school leadership
3. Outside activities that will result in the Covered Individual spending in excess of four (4) days per month on the activity (either individually or when aggregated with other Outside Activities) absent prior approval and flexible work arrangement
4. Serving as Chief Executive Officer (CEO) or other C-suite positions (once series A funding is received) absent prior approval

Review Requirements
On an annual basis, school and/or unit leadership are responsible for ascertaining if the Outside Activity and its associated time commitment are in alignment with Duke University policies and expectations. Guidance for identifying and managing potential conflicts of commitment is on myRESEARCHpath. Additional guidance is available from DOSI, who will also perform a risk-based review of disclosures and will communicate with school and/or unit leadership to discuss any activities that may require additional review.

Conflict Management and Mitigation
Upon disclosure and review of Outside Activities, school and/or University officials may approve without further action or the school and/or University officials may recommend further action which could include conflict management, appointment reduction, and/or disengagement from sponsored research.

Violations and Disciplinary Actions
Failure to comply with this policy may lead to disciplinary action commensurate with the compliance violation, up to and including termination of appointment and/or employment in accordance with applicable disciplinary procedures. Potential violations of this policy may be submitted to DOSI (DOSICOI@duke.edu). In consultation with school leadership, DOSI may refer the potential violation to a relevant University committee or official. These committees/officials will conduct an assessment of the potential violations, per their operating procedures, taking into consideration any mitigating circumstances. The results of the assessment may be submitted to the Dean, Chair, Director, or appropriate designee for action, consistent with University policy. If the Covered Individual wishes to dispute any decision or action, they may notify their Dean, Chair, Director or appropriate designee for escalation to the Vice President for Research & Innovation. Additionally, the violation may be reported to research sponsors in accordance with sponsor policies.

IV. Other Considerations

When contemplating or engaging in Outside Activities, a Covered Individual should consider the following:

If a Covered Individual is identified (by themselves or others) with their Duke title or affiliation for purposes related to Outside Activities, the Covered Individual must take care to indicate that any comments and actions are purely personal and the Outside Activities are not part of their Duke responsibilities or performed on Duke’s behalf. If public materials, such as advertisements, promotional material, solicitations, websites, blogs, emails and/or social media posts, are prepared, the public materials must include notice that titles and affiliations are provided for identification purposes only and that any views expressed by the individual are theirs alone. Duke letterhead can only be used when acting on behalf of Duke University.

Any personal contract or other agreement entered into by the Covered Individual for Outside Activities will not include Duke as a party, and negotiation of the terms of the contract or agreement is the responsibility of the Covered Individual. The Covered Individual is responsible for ensuring that the terms of any such agreement, including confidentiality and intellectual property terms, are consistent with their Duke obligations under applicable Duke policies. Duke will provide a template addendum that outlines the Covered Individual’s responsibilities to Duke which can be included as an addendum to the outside agreements.

Outside Activities may not involve the substantive use of University facilities, materials, services, personnel, data, or information without prior University approval and a written agreement among all parties. Research using Duke facilities or resources cannot be conducted under such personal contracts or agreements.

V. Definitions

Conflict of Commitment: A situation in which an individual accepts or incurs conflicting obligations between or among multiple employers or other entities. Conflicting obligations can include, but are not limited to, (1) commitments of time/effort in excess of University or sponsor policies or commitments or (2) improperly sharing information with or withholding information from Duke University or a sponsor.

Institutional Responsibilities: A Covered Individual’s professional responsibilities which they perform at Duke (e.g., their Duke work). This may include activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards under the auspices of the University.

Outside Activities: Activities a Covered Individual engages in outside of their Institutional Responsibilities and there is no agreement between the University and external entity, but which rely on their academic, professional, or scientific expertise. Outside Activities may be compensated or uncompensated, part-time, or voluntary.

VI. Owning Office and Administrative Management

Vice President for Research and Innovation and the Duke Office for Scientific Integrity (DOSI).

DOSI will provide administrative support for implementation and interpretation of this policy. Any questions regarding the definition(s), scope, or application of this policy—including inquiries related to procedures—should be directed to DOSI@duke.edu.

VII. Related Resources

Financial Conflict of Interest in Research Policy
Policy on Dual Interest and Outside Activity for Faculty and Staff of Duke University, Duke University Health System, DUMAC, Inc., and the Related Wholly Owned Subsidiaries, Support Corporations and Controlled Affiliates
Guidelines for Faculty/Non-Faculty Outside Relationships
Implementation Guidance and FAQs

4.1.3 Institutional Conflict of Interest Policy

I. Introduction

An institutional conflict of interest ("Institutional COI") describes a situation in which the financial interests of an institution or an institutional official, acting within his or her authority on behalf of the institution, may affect or appear to affect the research, education, clinical care, business transactions, or other activities of the institution. Institutional COIs are of significant concern when financial interests create the potential for inappropriate influence over the institution’s activities. This policy is intended to protect against exposure from risks related to Institutional COIs as they may affect research performed at or under the auspices of the University.

An institution like Duke University ("Duke"), including its officials, must balance many competing pressures. It engages in relationships with a variety of sponsors that may lead to financial benefit for the institution in many forms, including gifts, business ventures, royalty payments and equity from licensing intellectual property, as well as sponsored educational and research agreements. In addition, university-industry relationships are essential for advancing scientific frontiers and enabling the commercial development of academic discoveries to the benefit of the public. Nonetheless, while generally part of legitimate educational, research, and business activities, relationships with external entities or individuals cannot be allowed to compromise, or appear to compromise, the integrity of the Duke’s primary missions, including the safety and integrity of its research, education, and clinical care.

II. Definitions

Institutional Conflict of Interest in Research: An Institutional COI in Research may occur whenever the financial interests of the institution, or of an institutional official who has authority to act on behalf of the institution, might affect—or reasonably appear to affect—institutional processes for the design, conduct, reporting, review, or oversight of research.

Covered Officials: This Institutional COI in Research Policy applies to the Board of Trustees; President; Chancellor for Health Affairs, Vice Chancellors, and the Executive Vice President for Health Affairs; the Provost and vice-provosts; other senior officers; Deans and vice-deans, associate deans and other institutional administrators; particularly insofar as the individuals have oversight of research, with special attention to human subjects research, at the University. This policy will also require review of conflicts of interest involving department chairs, division chiefs, institute and center directors, Institutional Review Board chairs, the COI and Institutional COI committee chairs, the chair of the Institutional Biosafety Committee, the chair of the Stem Cell Review Committee, and chairs of other similar committees that might be created in the future.

Officials with Oversight of Research: Covered officials with responsibility for the supervision of faculty and staff participating in research conducted at or under the auspices of the institution. Of particular importance in defining an “official with oversight of research” are supervisory roles like evaluation and management of promotion, pay raises, and the assignment of job responsibilities.

Significant Financial Interest (individual): For covered officials, “significant financial interest” is defined as being consistent with Duke University’s faculty conflict of interest policy and procedures, laid out above. Areas of consideration include: payments, honoraria, royalties (even through the institution), equity, options and warrants, board of directors and management positions, and gifts.

Significant Financial Interest (institutional):

1. Royalties: Institutional COI may be present when the institution has agreements to receive milestone payments and/or royalties from the sales of an investigational product that is the subject of the research;
2. Non-publicly traded equity: When, through its technology licensing activities or investments related to such activities, the institution has obtained an equity interest or an entitlement to equity of any value (including options or warrants) in a non-publicly traded company that is: i) the sponsor of research at the institution, or ii) the manufacturer of a product to be studied or tested at or under the auspices of the institution;
3. Publicly traded equity: When, through technology licensing activities or investments related to such activities, the institution has obtained an ownership interest or an entitlement to equity (including options or warrants) exceeding $100,000 in value (when valued in reference to current public prices, or, where applicable, using accepted valuation methods), in a publicly-traded company that is i) the sponsor of research at the institution, or ii) the manufacturer of a product to be studied or tested at or under the auspices of the institution.
4. Gifts from sponsors: When the institution has received substantial gifts (including gifts in kind) from a potential commercial sponsor of research or a company that owns or controls products being studied or tested, or an individual affiliated with these companies. The following circumstances should be evaluated:
   1. Whether a gift is of sufficient magnitude that even when held in the general endowment for the benefit of the entire institution, it might affect, or reasonably appear to affect, oversight of research at the institution;
   2. Whether a gift is held for the express benefit of the college, school, department, institute or other unit where the research is to be conducted; or
   3. Whether any institutional official who has the authority, by virtue of their position, to affect or appear to affect the conduct, review or oversight of the proposed research has been involved in solicitation of the gift.

III. Identification of Potential Institutional Conflicts of Interest

The following significant financial and fiduciary interests of the institution warrant formal review for potential Institutional COI with respect to research:

• Significant financial interests for the institution.
• Significant financial interests on the part of covered officials responsible for the oversight of research.
• Situations when an investigator, research administrator, or Duke institutional official with research oversight authority participates materially in a procurement or purchasing decision involving major institutional purchases from, or non-routine supply
• contracts with, a company that sponsors research at the institution, or whose product is being studied or tested in human subjects research at the institution.

In addition to those circumstances indicated above, other financial relationships with research sponsors may warrant formal scrutiny, depending on the circumstances. In general, the institution should assess the potential for conflict of interest and weigh the magnitude of any risk to the research’s integrity.

Although the listed circumstances are potential areas of concern, the goal of this policy is not to preclude Duke from accepting philanthropy from companies that sponsor research, or that own or control products that are being studied or tested. Rather, the policy is intended to require the institution to develop means of identifying and examining such circumstances, and of managing, through disclosure, separation of responsibilities, and as otherwise appropriate, mitigate any actual or apparent conflicts of interest that may result. All gifts should be accepted in conformance with these policies and accepted by the development office for record-keeping purposes. All faculty and staff members are accountable for adhering to the institutional gift policy.

IV. Establishment of an Institutional Conflict of Interest Committee

In order to review and manage Institutional COIs, a committee will be established that includes members who are not employed by Duke as well as senior Duke employees. A member of the General Counsel’s Office will be a non-voting participant. The Committee will be advisory to the University Board of Trustees, which holds final authority regarding questions of Institutional COIs.

V. Management of Potential Institutional Conflicts of Interest

The reasons to manage Institutional COIs include: 1) To maintain the highest possible standards in research; 2) To adhere to all applicable federal and state regulations; 3) To maintain the primacy of the university’s educational mission; 4) To protect the reputation and credibility of the University, its faculty and staff. Based on those needs, the following basic principles will be applied in the management of potential Institutional COI:

1. When Duke itself has a significant financial interest:
   1. Human Subjects Research: There is a “rebuttable presumption” that human subjects research should not be carried out at Duke when the institution has a significant financial COI. In those situations where Duke faculty have unique capabilities, or where there are unique resources at the institution, the research may be performed at Duke after the establishment of a formal institutional management plan. This plan will include establishment of an oversight board for the project made up of non-Duke individuals. Other management steps may be required (e.g. use of a non-Duke IRB, external monitoring, etc).
   2. Non-Human Subjects Research: Because research subject safety is not an issue in the case of non-human subjects research, the primary reasons to manage Institutional COI focus on protection of the integrity of the University’s research and educational missions. If a decision is made by the Institutional Conflict of Interest Committee that the potential value of a line of research exceeds the potential risks related to Institutional COI, management will usually include some form of oversight external provided from outside Duke. The level of oversight should be proportional to the risk to the institution’s reputation and/or educational mission.
2. When an individual in a supervisory administrative role has a conflict of interest:
   1. Human Subjects Research: In this situation, there is not the same “rebuttable presumption” made that the work cannot be performed, since in most cases alternative supervision can be arranged. The Institutional Conflict of Interest Committee should review the administrator’s role in relation to the research and to the researchers, the nature of the administrator’s conflict of interest, and should then formulate a plan so that an appropriately objective administrator can oversee the research for the institution.
   2. Non-Human Subjects Research: In most cases for this circumstance, an alternative administrator should be identified, and the conflicted administrator should voluntarily recuse themselves. The situation should be reviewed by the Institutional Conflict of Interest Committee to be certain no bias will introduced that could affect the research, the researchers, or any students working on the research project. If there is potential for bias or pressures, particularly in the case of a student, alternative supervision should be arranged by the Committee.

4.2 Collaborations with Industry

4.2.1 University - Industry Guidelines

Duke is committed to increasing engagement with industrial firms unique resources available only in universities with the private capital and research capabilities of industrial firms so that the research community may contribute to new knowledge, products and services for the benefit of society.
The following statements set the institutional expectations for engaging in research related activities with for-profit partners and are based upon the principles of nurturing development of new knowledge while maintaining the integrity and independence of the university, its faculty, staff and students. The interpretation and application of these statements and principles is the responsibility of the Vice President for Research & Innovation, who shall seek advisement from University leadership as needed.

I. Acceptance and Design of a Research Activity or Project

The following principles govern the acceptance and design of research activities with for-profit sponsors or funders:

• No researcher shall be required to accept specific research grants or contracts as a condition of employment at Duke University. This policy does not alter the terms of employment for researchers hired by the University to direct or contribute to identified research efforts.
• An entity providing the funding for a research project or activity shall have the privilege to define broadly the topic of the research it will fund. The individual approved by the University to be the Principal Investigator bears the ultimate responsibility for carrying out the research on behalf of the University.
• Applications for external funding must be reviewed and approved by authorized organizational representatives (AORs). Depending on the nature of the arrangement , contracts or agreements may also require review and approval from other institutional offices and adherence to the Internal Submission for External Funding Applications Policy.

II. Publication and Use of Research Results

The following principles governing the publication of research results seek to protect the academic freedom of the researcher while meeting any limitations on disclosure included in the terms and conditions of specific agreements. While terms and conditions of agreements may be dependent upon the party which initiates the research activity (investigator or sponsor), all agreements must be reviewed and approved by Institutional officials:

• A sponsor may be provided a reasonable amount of time to review proposed publication materials resulting from projects the sponsor funds, not to exceed ninety (90) days, except with approval from appropriate Institutional officials.
• Specific terms of sponsorship, data usage, and publication will be included in sponsorship and other agreements, which are subject to University review and approval. In negotiating these agreements, the University will seek terms that support research data and outputs usage for Duke’s research, education, and clinical purposes.
• The University will refrain from publication of a sponsor’s proprietary information; however, in general, the University will seek to retain the ability to publish research data sufficient to enable the validation of research outputs.

III. Freedom to Do Related Work

The University is committed to academic freedom, but also must uphold agreements and meet its obligations as an applicant organization. Therefore, the University will agree to restrict research activities only in limited circumstances if it is determined by University leadership to be in the best interest of the University, its mission and the public.

IV. Best Efforts

Since state-of-the-art research is by nature unpredictable and without guarantee of success, research within the University is conducted on a “best effort” basis. However, a good faith effort will be made to organize research projects in a manner that is sensitive to the special needs and time constraints of the sponsor.

4.3 International Collaborations

4.3.1 Export Controls

It is the policy of Duke University to fully abide by federal and state laws and regulations governing the export of goods, technology, software, and services, collectively referred to as export controls. These regulations include the Export Administration Regulations (EAR), the International Traffic in Arms Regulations (ITAR), the Office of Foreign Assets Control (OFAC) regulations, the Department of Energy’s National Nuclear Security Administration (NNSA) and Nuclear Regulatory Commission (NRC) foreign activities controls, as well as specific requirements promulgated by multiple US government agencies related to exports and international activities.

Under US export controls, goods, technology, and software are exported when they are physically moved or transmitted outside of the United States by any method. The transfer of technology or software to a foreign person, whether within the US or abroad, is deemed to be an export to the foreign person’s home country or in some cases all countries where the person has held citizenship. Services are considered exported when they are performed either for, or on behalf of, a foreign person, entity, or government.

For export control purposes, U.S. persons are defined as U.S. citizens, U.S. permanent residents (“green card holders”), and certain individuals in the United States under refugee or asylum status. All other individuals are considered foreign persons. A foreign entity is any organization not incorporated or organized to do business in the United States. U.S. person employees of foreign governments (e.g., US citizens working for a foreign Embassy) or entities which are not incorporated in the U.S. acting on behalf of their employer are also considered foreign persons.

Compliance with export controls requires determining the regulatory authority, evaluating the proposed transaction against the applicable regulations, and when necessary, obtaining the required government licenses, authorizations, or exemption documentation prior to initiating the export activity. Each regulating agency maintains lists of items, technology, software, and services that are prohibited or require government authorization prior to export. The Office of Export Controls will assist in determining what, if any, regulatory matters must be addressed prior to an export transaction.

There are three broad export control exemptions which Duke is able to utilize to facilitate the unrestricted sharing of information. These exemptions do not apply to physical items.

The following types of information are not subject to export controls:

• Information that exists in the public domain and is freely accessible to any interested party;
• Information released in a catalog course or teaching laboratory of an academic institution;
• Information that arises during, or results from, “fundamental research.”

University research results may be exempt from export control laws under the “Fundamental Research Exclusion” by ensuring the research is conducted with a clear intent to publish the results, and to do so without restriction or approval, and that the research does not have any national security restrictions, such as a restriction on the participation of foreign nationals. Additional principles are articulated in the University-Industry Guidelines, which, if applied to sponsored research, regardless of funding, would uphold the University’s exemption under the fundamental research exclusion.