Chapter 4: Collaborations

4.1 Individual Research Personnel Collaborations

4.1.1 Individual Conflict of Interest and Conflict of Commitment in Research Policy

Duke University is committed to maintaining a collaborative, productive environment for Duke faculty and staff so that they may carry out the University’s mission of advancing knowledge, including accelerating the translation of novel research ideas into practice. This includes the encouragement of outside activities and relationships with third parties that further the work and research of Duke faculty. While these relationships are inevitable in a university setting, they also give rise to the possibility of conflicts of interests and commitment.

A conflict of interest may arise when a covered individual’s relationship with an outside entity might appear to influence that individual’s judgment in performing their professional responsibilities at the University, and could or may appear to directly and significantly affect the design, conduct, or reporting of research.

A conflict of commitment may arise when a faculty member engages in external activities or assumes external commitments that might appear to compromise their ability to fulfill the responsibilities of their University obligations.

Duke University faculty have an obligation to disclose conflicts of interest and conflicts of commitment to University officials so that potential conflicts of interest or commitment can be evaluated and managed by the Duke Office of Scientific Integrity – Conflict of Interest Office (DOSI-COI). University officials may be engaged if the need for eliminating the conflict arises. The management and/or elimination of conflicts of interest and conflicts of commitment allows the University to maintain the integrity of the institution, its personnel, and the public’s interest.

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. Individuals granted Principal Investigator status and Duke employees providing material benefits to externally funded research projects. This will be indicated by being named as key personnel or receiving salary from effort on an externally funded project that had financial activity within the preceding twelve months.

I. Guiding Principles

Conflict of Interest
For an outside interest to be considered in conflict with the institutional responsibilities of a Covered Individual, the outside interest could have the real or apparent ability to directly and significantly affect either the design, conduct or reporting of funded research, or the performance of duties and responsibilities on behalf of Duke. A conflict of interest may exist in educational, purchasing and research settings. Examples of conflicts of interest include, but are not limited to, the following:

• Using University resources in activities that may lead to financial gain for the Covered Individual (or their immediate family).
• Using University resources to benefit an external entity
• Using the name of the University in promoting activities that may lead to financial gain for the Covered Individual (or their immediate family).
• Interacting with students in external as well as internal roles. e.g., seeing students as clients or patients, employing students for non-University work.
• Engaging in research in which a Covered Individual (or their immediate family) has a financial interest, including interests in a start-up company and/or interests related to licensed intellectual property.
• Having a relationship or affiliation between the Covered Individual and the source of information or materials.
• Competing with the University for clients, contracts, etc.
• Financial involvement of a Covered Individual (or their immediate family) with an outside organization, or holding a position in an outside organization.
• Having an external interest that could be implicated in internal University decisions. e.g., contracts, hiring, research, or in giving advice.
• Payments from outside entities or publicly traded stock interests greater than $5,000.
  • Note: the acceptance of gifts is governed by a separate policy.

Conflict of Commitment
Duke faculty members owe their primary professional commitment to the University, and faculty members should devote the commensurate time and mental energies to the education, research and service programs of the institution. The specific responsibilities and professional activities that constitute an appropriate primary commitment will differ across schools and departments, but they should be based on the expectations specified in the faculty member’s initial offer or reappointment letter and the awareness of the departmental chair, dean or appropriate faculty leader.

Regular rank faculty have an obligation to meet the University’s expectations for teaching, research, service, and faculty governance.

Even where obligations to the University are met, a faculty member may not engage in activities that compete with the University or that otherwise diminish or undermine the University’s mission. It is inappropriate for faculty, without prior approval from their supervisor, to divert to other entities or institutions opportunities for research, education, clinical care or financial support which otherwise might flow to the University.

For other faculty, who may hold titles such as lecturers or clinical professor, the University has the expectation that these individuals will meet the commitments commensurate with their appointments and as specified in their initial offer and/or re-appointment letter.

Regardless of title, any faculty member’s outside engagements must not detract from the performance of University duties or responsibilities nor should faculty engage in undisclosed external professional activities.

Faculty members should disclose, and have a supervisor and/or other appropriate university official review at least annually (typically during the faculty member’s annual review). The disclosures should be comprised of non-Duke activities within a faculty member’s area of professional and/or academic expertise, whether paid or unpaid, and whether for profit, not-for-profit, or non-profit. In reviewing the disclosures, supervisors should consider the faculty member’s comprehensive commitments and obligations at the University and their ability to meet commitments.

Note: At no time should any outside activity, with or without compensation, exceed the four (4) days per month standard, for full-time faculty, averaged over an annual period of service based on term of appointment. Exceptions to this policy may be granted by the dean, director or designee where conditions such as reduced effort allow for increased outside activity without creating a conflict of commitment. The University has established four days per month as the outer limit for faculty members’ outside activity, as stated in Appendix M of the Faculty Handbook.

II. Disclosure of Outside Interests

University policy and federal regulations require an annual conflict of interest disclosure form for Covered Individuals. Covered Individuals must also report any changes to outside interest as they arise or within thirty (30) days of a change, by updating their disclosure form. Covered Individuals must also update their disclosure form with any new or changed relationships at the time of submitting a proposal for an external research award, and at the time of receiving an external research award.

The information reported may be compared to information provided by companies, federal agencies or other sources. Duke reserves the right to request additional information, as deemed necessary.

When preparing their disclosure form, Covered Individuals must disclose the following interests for the reporting time period and the preceding 12 months, regardless of value unless specified (hereafter referred to as "Outside Interests"):

• Payments for services (consulting, lectures, advisory board payments, or honoraria);
• Any equity interest in privately held stock such as stocks, stock options, and other ownership interests;
• Equity interest greater than $5,000 in a publically traded entity;
• Intellectual property rights (e.g., licenses and royalties);
• Donations (monetary, unrestricted funds, in-kind designated for research)
• Relationships and activities with foreign institutions and funding agencies
• All external professional activities
• Federally funded Covered Individuals may have additional disclosure requirements such as:
  • Sponsored or reimbursed travel
  • Gifts and gratuities.
    Dislcosures should be made using appropriate mechanisms and in accordance with relevant university policies.

Individuals are not required to disclose the following:

• Ownership of a share in a mutual fund;
• Salary or other remuneration from Duke or another accredited U.S. institution of higher education;
• Salary or other remuneration from the U.S. Department of Veterans Affairs or another U.S. federal, state, or local government entity;
• A distribution from Private Diagnostic Clinic, PLLC or the Duke University Health System;
• Book Royalties

The annual disclosure process includes institutional training regarding the reporting requirements and federal regulations related to conflict of interest.

III. Disclosures regarding Conflict of commitment

Per University and sponsor requirements, faculty members must be able to demonstrate a lack of real or apparent conflicts of commitment when engaging in research. Information regarding conflicts of commitment may be requested for completion of Other Support, Current & Pending, or other sponsor forms, or no less than an annual review with a faculty member’s direct supervisor (may be as a part of the official performance review). When compiling a list of real or potential conflicts of commitment, an individual should consider the following:

• A managerial role at a startup company that has received Series A investment. Duke faculty may hold managerial roles (i.e., C-level positions, membership on the Board of Directors, or the equivalent) in a startup company only while the company is privately held and prior to receiving Series A investment. After that time, the Duke faculty member may serve only in advisory or consultant positions and may no longer hold a managerial position with the startup company. Please see Conflict of Interest Considerations for Faculty Involved with Startups.
• Relationships with individuals for whom the faculty has a supervisory role as a part of their responsibilities for Duke. Please see Guidelines for Faculty/Non-Faculty Outside Relationships.
• Outside professional activities involving a company in which the Duke faculty member has equity, intellectual property interests, a leadership role, or other significant interest must also meet the requirements of all other applicable Duke University policies, including but not limited to University-Industry Guidelines, Intellectual Property, Conflict of Interest, and SBIR-STTR.

Furthermore, individuals should be aware of the following conditions:

• Outside activities may not involve the use of University facilities, materials, services, personnel, or information without prior University approval and a written agreement between all parties.
• If a faculty member is identified (by themselves or others) with their Duke title or affiliation for purposes related to outside activities, the faculty member must take care to indicate that their comments and actions are purely personal, neither part of their Duke responsibilities nor done on Duke’s behalf. If public materials, such as advertisements, promotional material, solicitations, websites, blogs, emails and/or social media posts, are prepared it should also include noting that titles and affiliations are provided for identification purposes only and that any views expressed by the individual are theirs alone.
• Any personal contract or other agreement entered into by the faculty member for outside professional activities will not include Duke as a party, and negotiation of the terms of the contract or agreement is the responsibility of the faculty member. The faculty member should ensure the terms of any such agreement, including confidentiality and intellectual property terms, are consistent with their obligations under applicable Duke policies. Research in Duke facilities must not be conducted under such personal contracts or agreements.

IV. Evaluation and Management of Potential Conflicts of Interest and Commitment

The DOSI-COI Office is responsible for overseeing the evaluation and management of disclosed outside interests by Covered Individuals. Upon disclosure of an outside interest, DOSI-COI officials will evaluate the interest to determine whether if it is a conflict of interest. If an interest is determined to be a conflict of interest, DOSI-COI officials will determine if the conflict can be managed or not.

Upon evaluation, DOSI-COI may determine that one or more of the following actions is appropriate:

• Further consultation with central administration to help determine how to respond to and manage a given disclosure. In these instances, DOSI-COI will engage the necessary central administration office, as appropriate.
• No further action is necessary. In these instances, DOSI-COI may determine it is sufficient to document the outside interest, but take no action to manage.
• Issuing an advisory memo. These memos may be sent in situations where there is a disclosed outside interest that, at present, does not require a formal management plan.
• Develop and implement a conflict management plan to mitigate the real or apparent conflict. The plan may include, but is not limited to:
  • Disclosing the potential conflict to appropriate sources inside and/or outside the University;
  • Modifying or limiting the Covered Individual’s duties to minimize or eliminate the conflict;
  • Reducing the Covered Individual’s appointment to accommodate the outside interest or activity;
  • Securing the Covered Individual’s agreement to modify or suspend the outside interest, use of University resources, or other activities that create the potential conflict;
  • Prohibiting certain outside interests as inconsistent with the Covered Individual’s obligations to the University;
  • Initiating an oversight plan to mitigate potential bias;
  • Other actions or steps, as appropriate

In determining the appropriate actions, DOSI-COI will make decisions in order to best strengthen the institution’s commitment to the rigor and reproducibility of research conducted using University resources and personnel.

V. Dispute Resolution

Faculty members may dispute decisions made in response to the disclosure or non-disclosure of an outside interest. The recourse for such a dispute is to make a request in writing to the Conflict of Interest Committee at dosicoi@duke.edu. Once a request is received, the DOSI-COI office will issue an email notifying the individual that their case is under review.

VI. Documentation and Record Retention

DOSI-COI will maintain records relating to all outside interests disclosures and the review of, and response to such disclosures, and all actions under Duke policy or retrospective review, if applicable, for at least three years from the close of the research or date of the final expenditure report, or accordance with 45 CFR 75.361, as applicable for certain federally funded research.

Records are made available as deemed institutionally appropriate and required by federal regulations. This will in part assist University officials in responding to disclosures in an equitable manner.

If the disclosures involve externally-funded research, DOSI-COI will communicate and provide information as required with the appropriate sponsors, per their guidelines and reporting instructions.

VII. Violations

Failure to comply with this policy may lead to disciplinary action, up to and including termination of appointment in accordance with applicable disciplinary procedures. Possible violations that may lead to disciplinary action include, but are not limited to, the following:

• failure to fully disclose an outside interest;
• failure to fully comply with a required conflict management plan; and
• failure to respond to inquiries made by DOSI-COI.

Potential violations may be submitted to the DOSI-COI office by emailing dosicoi@duke.edu. In consultation with leadership, DOSI-COI may refer the potential violation to a relevant University committee or official, such as the COI Committee, Incident Response and Issue Resolution Committee (for cases involving Sponsored Research), the Research Misconduct Officer, the Chief Audit, Risk, & Compliance Officer, etc. 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, Director or appropriate designee for action, which should be consistent with University policy. If the faculty wishes to dispute any decision or action, they may notify their Dean, Director or appropriate designee for escalation to the Vice President for Research.

VIII. Exceptions

Exceptions to these policies will not be granted without the existence of compelling circumstances. Faculty members are responsible for presenting information that would substantiate a claim of compelling circumstances; and the DOSI-COI office is responsible for reviewing and processing these claims. Further review or resolution of disputes should be carried out in the manner of violation disputes.

IX. Policy Revision

The deans or department directors (or their designees) may review all action taken under this policy. As a result of these reviews, they may present any recommendations for adjustment or increased education to the University’s Executive Research Oversight Committee.

The DOSI-COI office, in conjunction with the COI committee, will review this policy.

This policy is intended to be consistent with federal and state law. Where there is a discrepancy, the applicable federal or state law or rule of the funding agency will take precedence, unless the law or rule is less restrictive than Duke’s more stringent standard.

4.1.2 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.