Forms, Policies and Procedures

 

Here you will find a repository of forms, policies and procedures related to research at the University of Delaware. This repository draws on sources throughout campus to provide quick and easy access to these resources in a variety of formats, such as html, MSWord and Adobe PDF. We encourage you to explore and use the tools provided to narrow your search by word, resource type or category in order to learn more about the content that governs research at UD.

Forms, Policies and Procedures (2 Policies Entries)
Policy: Conflict of Interest, Intellectual Property
Intellectual Property Protection, Ownership and Commercialization
Policy

Intellectual Property Protection, Ownership and Commercialization

  1. PURPOSES
    1. to provide a mechanism for placing in the public realm the fruits of research, while safeguarding the interests of the University, the inventor(s), and the sponsor;
    2. to provide procedures to evaluate the significance of inventions, discoveries, research materials, and works, and the opportunities by which such creative advances may be brought to the point of commercial viability;
    3. to provide adequate legal protection for intellectual property including patent, trademark, and copyright protection for inventions and works falling within the scope of this policy, through the collaboration of University faculty, staff, and students with the assigned attorney(s) and Research Office staff;
    4. to establish principles for determining the rights of the University, the inventor(s), or developer(s) or author(s), and the sponsor;
    5. to provide greater incentives for pursuing and commercializing intellectual property by University personnel;
    6. to assist the inventor(s) or developer(s) or author(s) in realizing tangible benefits from the intellectual property;
    7. to satisfy requirements of certain research grants and contracts; and
    8. to provide a basis for establishment of institutional patent, copyright, and trademark agreements with the federal government and other agencies.
  2. POLICY
    1. General policy statementThe University of Delaware strives to support its faculty, staff, and students by pursuing the commercial development of intellectual and tangible research property resulting from University research. The early transfer of such knowledge and rights is consistent with the University’s mission of creating new knowledge and facilitating its application to the benefit of the public. The University has established policies and guidelines that provide incentives for faculty, staff, and students while protecting the integrity of research (also see Legacy Policy 6-11 related to avoidance of conflicts of interest). The University provides a number of administrative and legal services to inventors and authors to effectively and efficiently pursue intellectual property rights and technology transfer.It is policy of the University that all inventions and discoveries, together with any tangible research materials, know-how and the scientific data and other records of research including any related government protections (collectively “Intellectual Property”), which are conceived or reduced to practice or developed by University faculty, staff, or students in the course of employment at the University, or result from work directly related to professional or employment responsibilities at the University, or from work carried out on University time, or at University expense, or with the substantial use of University resources, shall be the property of the University. An invention shall constitute any discovery, machine, new and useful process, article of manufacture, composition of matter, life form, design, algorithm, software program, or concept that may have commercial value. University faculty, staff, or students employed by the University who discover or invent or develop a device, product, plant variety, method, or work while associated with the University must cooperate with the University in defining and establishing the rights to such inventions, works, materials, and data. This obligation extends to any Intellectual Property, whether or not made on University time with or without use of University facilities.When an invention is made, the inventor shall promptly provide, via the appropriate Department Chair and Dean, and the University Senior Vice Provost for Research, or his/her designee, an invention disclosure statement describing the circumstances under which the invention was conceived and reduced to practice, with particular attention to:
      1. describing the invention, including how the invention is made and used (i.e., its utility or applications), and including the results of a patent search establishing the novelty of the invention;
      2. indicating whether the invention was made under terms of a consulting or other personal agreement between the inventor(s) and client;
      3. indentifying in a business plan the anticipated business/societal value of the invention, and indicating those countries in which patent protection may be desirable;
      4. identifying the sponsor, if any, of the project or program;
      5. stating whether the invention is within the inventor’s normal activities and responsibilities with respect to his/her University employment; and
      6. indicating the extent to which equipment or physical facilities provided by the University were used in the work which led to the invention.

      To implement University Legacy Policy 6-7 on Copyright Processing and Funding, an author or developer who may wish to pursue copyright or trademark protection for a work or development would file a memorandum with the Research Office requesting review of the material and opportunities for intellectual property protection.

    2. Administrative Responsibility
      The administration of the principles and policies set forth in succeeding sections of this document is the responsibility of the Provost of the University. The Provost, however, has delegated routine administration to the Senior Vice Provost for Research, with the understanding that no departures from the stated principles and policies will be made without his/her prior concurrence.Inventions, developments, and works in which the University and the inventor(s)/developer(s) are the sole parties in interest shall be promptly evaluated for filing by the Chair(s) of the Department(s) involved and the Dean(s) of the College(s) involved, and a recommendation regarding how to proceed with patent filing (simple provisional patent application, fully developed provisional patent application, no provisional patent application) shall then be forwarded for review and appropriate action by Office of the Senior Vice Provost for Research and patent counsel for patentability or novelty for registration. Should the Dean(s) of the College(s) involved decide not to proceed with the patent filing, that decision may be appealed to the University Research Council. Following this review and evaluation, the inventions, developments, or works will then:

      1. be referred to counsel, who shall work with the full cooperation of the University inventor(s), to draft, file, and prosecute a patent application or to file a trademark or copyright application, or;
      2. be considered by the University (or the UD Technology Corporation if the Intellectual Property has been assigned to the University’s commercialization affiliate, see Section C-5, below), in collaboration with the inventor(s), for opportunities to commercialize the invention;
      3. be offered to the Federal funding agency when the University initially elected to retain title under the Bayh-Dole statue but the invention and associated patent application(s) are no longer of interest to the University;
      4. be released to the inventor if found not to be of interest to the University or any Federal agency which may have funded the research leading to the invention; or
      5. in certain cases referred to brokers or outside entities with whom the University has contracts to assess commercial potential and interest in their filing and attempting commercial development.
    3. Rights and Obligations of the University, Faculty, Staff, and StudentsThe respective rights and obligations of the University, faculty, staff, and students in various situations are as follows:
      1. University-funded researchIntellectual Property resulting from efforts conducted by faculty, staff, or students, that have been financed wholly by the University or have involved the use of University facilities, equipment, or materials, are covered by section B, above.
      2. Government-funded researchInventions or discoveries that result from efforts financed wholly or in part by Federal funds will be treated in accordance with the provisions of Public Law 96-517, “The Patent and Trademark Amendments of 1980” known as the Bayh-Dole Act. This act provides that the contractor (University of Delaware) may retain full title, right, and interest in inventions made under contract with the government, with certain exceptions for unusual circumstances. Except as specifically superseded by provisions of a specific funding agreement, inventions and discoveries covered by this section will be treated as outlined in section B, above.
      3. Research funded by grants or other contractsIntellectual Property resulting from research conducted by faculty, staff, or students, which research has been financed wholly or partially by industrial, philanthropic or other organizations, or by individuals, under contracts or written agreements are governed by the terms of such contracts or agreements, and the principal investigator is responsible for informing co- workers of their rights under such contracts or agreements before initiation of the research. Intellectual Property not required to be assigned by contractual terms may be processed or disposed of by the University as provided in section B, above.
      4. Intellectual Property resulting from research conducted wholly at the expense of the individual, without use of University facilities, equipment, or materials, and are outside the individual’s normal field of activities and employment responsibilities are the property of the individual, and the University undertakes no responsibility with respect to such Intellectual Property. In all such cases the Provost will confirm the individual’s ownership rights to the Intellectual Property to the inventor(s) or developer(s) to dispose of as the inventor(s) or developers see(s) fit. At the sole option of the inventor(s) or developer(s) and with the University’s prior assent, such Intellectual Property may be conveyed by assignment to the University.
      5. It is the policy of the University, with reference to all creative work of faculty, staff, and students, to recognize the interests of all parties involved, to provide a mechanism for the identification of commercial opportunities, to provide guidelines for making a proper and equitable distribution of benefits, and to assist the inventor(s) or developer(s) in benefiting from his or her creative efforts. It is important to realize, however, that under U.S. law the parties identified as possible joint inventors are those who have contributed to the conception of an invention and sign a declaration attesting to their role. The decision on inventorship is a legal decision and different from the guidelines used to establish co-authorship. In situations where the University pursues commercialization through the licensing or transfer of rights in the Intellectual Property to another entity, the University normally elects to do so by assigning its rights to the UD Technology Corporation, a University affiliate established to facilitate such commercialization.
    4. Roles and Responsibilities in Patent ProcurementThe patent procurement system involves technical and legal efforts over a number of years to obtain meaningful, enforeceable patents to protect valuable intellectual property developed through research programs at the University. After a University inventor files an Invention Disclosure to initiate the patenting process with the Research Office, there are four stages of patent prosecution over a 3-5 year period. The most critical decisions in this process, however, occur within the first 30 months and carry with them significant costs. This policy defines the critical elements and procedures of the process and allocates technical, legal, and financial responsibilities attendant with each element.
      1. Invention Disclosures, prepared by University research personnel, are submitted to the Research Office via the Department Chair(s) and the Dean(s) of the College(s) involved for review, approval, and action as described in Section B above. If approved, the Research Office will arrange for an appropriate U.S. provisional patent application to be prepared and filed with the USPTO through outside counsel. In the case of industry-supported research agreements, the costs associated with the preparation and filing of the provisional application will be borne by the industrial collaborator.
      2. Costs incurred for patenting inventions from research not supported by an industrial partner will be shared as follows.
          1. for the simple form of the provisional patent application, costs will be paid by the Research Office; or
          2. if the fully developed form of the provisional patent application is selected as appropriate and filed, the costs will be shared one-third by the Research Office; one-third by the department(s) of the inventor(s); and one-third by college(s) of the inventor(s).

        If the University determines it will not file, the inventor(s) shall have the right to appeal such a decision to the University Research Council.

      3. If agreed by the inventor(s), the Department Chair(s), and the Dean(s) of the College(s), the provisional patent application will be converted to a non-provisional, utility application and a global foreign application under the Patent Cooperation Treaty (“PCT”) will be filed within one year of the original filing of the provisional application. Costs associated with this industry-supported research agreements, or as follows for all others:
        1. one-third of the costs by the Research Office;
        2. one-third of the costs by the Department(s) of the inventor(s);
        3. one-third of the costs by the College(s) of the inventor(s).If the University determines it does not wish to continue, the inventor(s) shall have the right to appeal such a decision to the University Research Council. If the Dean(s) of the College(s) elect(s) not to proceed and the University does not wish to continue, the invention and associated patent application(s) shall be offered to the inventor(s) as per Paragraph II.B.4 above. If accepted by the inventor(s), they shall be fully responsible for all future costs, governmental notifications, and other obligations. No conversion to a utility application, or filing of a PCT application, will be made until the inventor(s) have developed a detailed plan and/or identified an industrial partner to further develop the invention. The University Intellectual Property Committee will be asked to assist in evaluating the intellectual property for future marketing and utilization and to identify potential industrial partners to further develop the invention.
      4. At 30 months after the original filing of the provisional application, a decision regarding in which foreign countries to pursue a patent (enter the PCT National Phase) by the inventor(s), the Department Chair(s), and the Dean(s) must be made. Costs associated with this selection of countries in which to pursue foreign patents will be borne by the industrial collaborator for industry-supported research agreements, or as follows for all others:
        1. one-third of the costs by the Research Office;
        2. one-third of the costs by the Department(s) of the inventor(s);
        3. one-third of the costs by the College(s) of the inventor(s).If the University determines it does not wish to continue, the inventor(s) shall have the right to appeal such a decision to the University Research Council. If the Dean of the College elects not to proceed and the University does not wish to continue, the invention and associated patent application(s) shall be offered to the inventor(s) per Paragraph II.B.4 above. If accepted by the inventor(s), they shall be fully responsible for all future costs, governmental notifications, and other obligations.
      5. The decision to continue prosecution of the U.S. utility patent application and any associated foreign patent applications shall be reviewed periodically among the inventor(s), the Department Chair(s) of the appropriate Department(s), the Dean(s) of the appropriate College(s), and the University. Costs associated with continued patent prosecution will be borne by the industrial collaborator for industry-supported research agreements, or as follows for all others:
          1. one-third of the costs by the Research Office;
          2. one-third of the costs by the Department(s) of the inventor(s);
          3. one-third of the costs by the College(s) of the inventor(s).

        If the University determines it does not wish to continue, the inventor(s) shall have the right to appeal such a decision to the University Research Council. If the Dean of the College elects not to proceed and the University does not wish to continue, the invention and associated patent application(s) shall be offered to the inventor(s) as per Paragraph II.B.4 above. If accepted by the inventor(s), they shall be fully responsible for all future costs, governmental notifications, and other obligations. NOTE: In the event the patent application has been licensed or is subject to other legal obligations, prosecution of such applications shall continue until expiration or release of such obligation(s).

      6. The Research Office will operate to manage the patent prosecution effort and oversee the activities of outside counsel. The Research Office shall communicate information and coordinate decisions with the inventor(s), Department Chair(s), and the Dean(s) of the appropriate College(s) involved to ensure the implementation of academic directives.
      7. If the patent(s) are successfully licensed, for the purpose of recovering patent prosecution costs, Net Revenues from the licenses will be allocated in accord with the allocation formulas of Section F, below.
      8. Appeals of any decision not to file an application or to discontinue patent prosecution of a pending patent application shall be taken to the University Research Council.
    5. Arbitration of DisputesIn the event the University and the inventor(s) or developer(s) cannot agree with respect to any of their respective rights or obligations hereunder regarding a non-patent procurement matter, such dispute shall be submitted for determination to an arbitration panel of three members chosen from the University community and having a member named by the inventor(s), or developer(s), a member named for the University by the Provost, and a chair selected by mutual agreement of these two nominees. The decision of a majority of such panel shall be final and binding upon both the inventor(s) and the University.
    6. Division of Income
      1. Income received by the University or the UD Technology Corporation from the commercialization of Intellectual Property, including but not limited to upfront technology access fees, royalties, approvals to assign rights, equity interests, compensatory damages for infringement and other direct damages awards (“Revenue”) shall be used first to reimburse the parties (the University, UD Technology Corporation and other University units as appropriate) that shared in the costs for direct assignable or foreseeable future expenses arising in connection with obtaining or litigating the Intellectual Property (“Expenses”). An additional 15 percent of the net Revenue remaining after recovery of expenses shall be retained by the University or UD Technology Corporation for management expenses to cover overhead.
      2. For the case where income is coming from all sources except litigation, the remaining balance, “Net Revenue” shall be distributed quarterly and divided one-third to the inventor(s), one-sixth to the department(s) of the inventor, one-sixth to the College(s) of the inventor(s), and one-third to the University or UD Technology Corporation.
      3. For the case where income is coming from litigation, “Net Revenue” up to $3 million dollars shall be distributed quarterly and divided one-third to the inventor, one-third to the College(s) of the inventor(s), and one-third to the University or UD Technology Corporation. Above $3 million dollars, “Net Revenue” shall be distributed quarterly and divided one-fifth to the inventor, two-fifths to the College, and two-fifths to the University or UD Technology Corporation. Punitive damages and/or treble damage awards obtained in litigation of IP matters shall be retained solely by the University.
      4. If two or more inventors or developers are entitled to share in the portion of “Net Revenue” earned by them under Section II.F(i), the inventors and developers must sign, have notarized, and present to the University an agreement stipulating how such income will be shared among themselves before the University will distribute any “Net Revenue” to such inventors and/or developers. In the absence of an agreement among the inventors providing specific guidance regarding the distribution of their shares of “Net Revenue”, the University (or UD Technology Corporation) shall distribute the inventors’ share of “Net Revenue” in equal shares to each University inventor.
      5. In the event that compensation from the Intellectual Property is in the form of restricted or unrestricted common or preferred stock, such stock will be distributed in accordance with Section II.F(i) as soon as practical after receipt by the University, or the appropriate portion of shares may be registered directly with the inventor(s) or developer(s). It shall be the sole responsibility of the inventor(s) or developer(s) to satisfy any personal tax obligations related to stock distributed to them under Section II.F(i).
      6. When Intellectual Property is created under contract with an outside agency as provided in Sections II.C-2 and II.C-3, the division of income shall be in accordance with the terms of the contract. In the event that any contract with an outside agency provides for the University to receive unrestricted funds from the Intellectual Property, such funds shall be divided as provided in Section II.F(i).
      7. In the event that Revenue is received under an agreement granting licenses for two or more patents or works, the prorating of income among the patents or works shall be determined by the University Patent Committee(see Section II.F(i), above) using the procedure of Section B as a guide. This Committee shall utilize legal, accounting, and scientific consultants as it deems necessary in making its decisions. If one or more of the inventors named in the patents or works involved disagrees with the decision of the committee, the matter shall be resolved by arbitration as provided in Section II.E.
      8. Revenues less than $100.00 received by the University or UD Technology Corporation shall be retained by the University or UD Technology Corporation and not distributed.

 

Policy Details:

OWNER: Provost

SECTION: Research, Sponsored Program, Technology Transfer and Intellectual Property Policies

RESPONSIBLE OFFICE: UD Research Office

POLICY NUMBER (Legacy): 6-06

ORIGINATION DATE: October 1, 1981

REVISION DATE(S): June 5, 1989; March 1, 1996; March 6, 2002; March 3, 2005; September 6, 2005; May 22, 2007; January 18, 2008; February 28, 2008; August 11, 2008

Policy Source Open Policy



Policy: Conflict of Interest
Conflict of Interest Policy and Procedures for Faculty and Professional Staff
Policy

Conflict of Interest Policy and Procedures for Faculty and Professional Staff

  1. SCOPE OF POLICY
    This policy addresses the University of Delaware’s (UD or University) responsibility to promote objectivity in research and education activities by 1) requiring that significant financial interests of faculty, staff and other members of the University-research community be disclosed, and 2) providing means for managing conflicts of interest (COI) should they arise.
  2. DEFINITIONS
    A potential COI occurs when there is a divergence between an individual’s private interests and his or her professional obligations, such that an independent observer might reasonably question whether the individual’s professional judgment, commitment, actions, or decisions could be influenced by considerations of personal gain, financial or otherwise. Whether a COI exists depends on the circumstances, and should be determined on a case by case basis.

    1. As used in this policy, the following terms shall have the meanings indicated:Financial Conflict of Interest (FCOI) refers to a significant financial interest (SFI) that could directly and significantly affect the design, conduct, or reporting of research.
    2. SFI refers to a financial interest, as described in Section IV of this policy that reasonably appears to be related to the employee’s institutional responsibilities. SFI does not include income, payment, or sponsorship received from: 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 affiliated with an institution of higher education.
    3. Investigator refers to the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research (may include collaborators and consultants).
    4. Remuneration includes salary and any payment not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship, etc.).
    5. Equity interest includes any stock, stock option, or other ownership interests as determined through reference to public determination or other reasonable measures of fair market.
  3. POLICY STATEMENT
    The involvement of faculty, staff and other members of the University-research community with appropriate commercial enterprises is an important part of the transfer of knowledge and is encouraged by the University to enhance teaching, research and outreach programs. Association of faculty or professional staff with commercial enterprises should be such that it benefits all the parties involved, including the University. All faculty, staff and members of the University-research community are expected to conduct their research-related duties with integrity, and to avoid association with activities that could diminish or could be perceived as diminishing the effectiveness of their commitment to the University. It is the responsibility and obligation of faculty, staff and members of the University-research community to disclose all SFIs that may affect, or appear as if they could affect, their University-related responsibilities.
  4. POLICY STANDARDS AND PROCEDURES
    1. SFIs (including those of the employee’s spouse and dependent children) must be disclosed on an annual basis.  On or before February 15, and within 30 days of any changes in their previously disclosed interests, faculty and professional staff are obligated to submit complete written disclosure to the chair, dean, unit head, or supervisor for all of the following:
      1. With regard to any publicly traded entity: any remuneration during the previous 12 months received from the entity, and the value of any equity interest in the entity that when aggregated exceeds $5,000; and/or any equity interest that represents more than 5% ownership in a single entity.
      2. With regard to any non-publicly traded entity: any remuneration during the previous 12 months received from the entity that when aggregated exceeds $5,000; and/or any equity interest.
      3. Intellectual property rights and interests (e.g., patents, author’s rights, etc.), other than those assigned to UD and shared through proper agreements (Intellectual Property Protection, Ownership, and Commercialization), upon receipt of related income that when aggregated exceeds $5,000.
      4. Any reimbursed or sponsored travel during the previous 12 months by an entity different from those listed in the definition of SFI (Section V of this policy).
      5. Any arrangements that involve a consulting agreement or other outside professional activities.
      6. Participation in, or personal sponsorship from, any entity that invests in, or provides financial support for, activities related to the employee’s University areas of responsibility.
      7. An appointment as an officer, director, or any other managerial position in a commercial enterprise; participation in the day-to-day operations, including serving on the scientific advisory board, of a commercial enterprise.

      Any situation that has the potential for, or could be perceived as, a conflict of interest (i.e., might interfere with the employee’s institutional responsibilities).

    2. Information to be disclosed about any and all SFI(s) previously identified shall include details of:
      1. the nature of the relationship;
      2. the name and address of the enterprise, the type of business, and its relationship with the University;
      3. the expected benefits to the enterprise, the University, and the faculty or professional staff member in terms of professional growth, technology transfer, and commercial feedback;
      4. basis for avoiding conflict of interest between the SFI and professional obligations to the University;
      5. With respect to a disclosed travel event:
        1. the purpose of the trip,
        2. the identity of the sponsor or organizer,
        3. the destination,
        4. the duration of the trip, and
        5. if known, the monetary value of the reimbursement or sponsorship.
    3. Disclosures of SFIs must be directed to the appropriate chair, dean, unit head, or supervisor for review, COI determination, approval, and direct management, and forwarded to the Research Office for compliance monitoring.
    4. Conflict Of Interest Management
      1. The chair, dean, unit head, or supervisor shall review the SFI disclosure to determine if any of the SFIs disclosed could generate a COI. A COI exists when an SFI is related to a specific research project and/or any other institutional responsibility of the employee, and could have a significant and direct effect on it.
      2. If, after reviewing the facts, an SFI is deemed to be a COI, the chair, dean, unit head, or supervisor shall develop and implement a management plan jointly with the faculty or staff member. Examples of conditions or restrictions that might be imposed to manage a COI include, but are not limited to:
        1. Public disclosure of the conflict (e.g., when presenting or publishing affected research);
        2. Appointment of an independent monitor capable of taking measures to protect against bias resulting from COI;
        3. Change of personnel or personnel responsibilities, and/or modification of the research plan;
        4. Reduction or elimination of a financial interest;
        5. Severance of relationships that create the conflict(s).
      3. If the situation remains unresolved following this review, the chair, dean, unit head, or supervisor may submit the matter to a Conflicts Advisory Committee appointed by the dean (or equivalent). This committee will consider the situation and recommend steps necessary to resolve the matter. The dean (or equivalent) may accept, reject, or modify the committee’s recommendations.
      4. If the faculty or staff member objects to the resolution offered by the dean (or equivalent), the matter shall be referred to the Provost (or equivalent) who shall appoint, convene, and seek advice from a university level ad hoc Conflicts Committee. The Committee, which shall include no less than five members representing the colleges and other constituencies as appropriate, shall serve as a resource in the identification and resolution of the specific conflict of interest. The Provost (or equivalent) shall make a final decision regarding the resolution of any conflicts.
      5. Management plans will be monitored for compliance during the life of the COI by the chair, dean, unit head, or supervisor with the assistance of the Research Office. Failure to disclose an SFI which is later determined to be a COI, failure by the University to review and manage such COI, or failure to comply with a management plan, would be considered a noncompliance event.
      6. If a noncompliance event is identified, then, within 120 days of such determination, the appropriate supervisor, with the assistance of the Research Office, will perform a retrospective review of the employee’s activities to determine if any bias occurred during the noncompliance time period. The retrospective review will be documented including all the following as applicable: the project number, project title, project director, name of the investigator with the SFI/COI, name of entity with which the SFI/COI exists, reason for the retrospective review, detailed methodology used for the review process, compositions of the review panel, and findings and conclusion of the review.
      7. If bias is found, the University will promptly inform the appropriate sponsor and submit a mitigation report. The mitigation report will include the key elements from the retrospective review and a description of the impact of the bias, and the University’s plan of action or actions taken to eliminate or mitigate the bias.
      8. Records of financial disclosures and all decisions and actions taken by the University will be maintained by the Research Office for three years from effort closeout.
      9. Agency Specific Requirements

        As provided by federal regulation (42 C.F.R. Part 50, Subpart F, and 45 C.F.R. Part 94), COI policy compliance for research projects funded by, or requesting funding from, any awarding component of the Public Health Service (PHS) will be monitored as follows:

        1. Prior to the expenditure of any funds under a PHS-funded research project, the disclosures of SFIs from all involved investigators will be evaluated according to this policy for determination of a potential FCOI relevant to that PHS-funded project based on the following criteria:
          1. An SFI is related to PHS-funded research if the SFI could be affected by that research.
          2. An FCOI exists when it is determined that the SFI could directly and significantly affect the design, conduct or reporting of the PHS-funded research.
        2. Whenever the University identifies an SFI not disclosed timely, or not previously reviewed, the dean (or equivalent) shall within 60 days evaluate the SFI and determine if it is an FCOI, in which case a management plan will be implemented.
        3. In an event of noncompliance (i.e., FCOI not identified or managed in a timely manner, and/or failure to comply with a management plan), the University shall, within 120 days, complete a retrospective review to determine whether bias occurred during the noncompliance period.
        4. If bias is found, the University is required to notify the PHS awarding component promptly and submit a mitigation report, including a description of the impact of the bias on the research project and the Institution’s plan of action or actions taken to eliminate or mitigate the effect of the bias.
        5. Elements to include in the retrospective review and the mitigation reports can be found in 42 C.F.R. §50.605.
        6. In any case in which HHS determines that a PHS-funded research project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been affected by a FCOI not properly managed or reported the University shall require the Investigator involved to:
          1. Disclose the FCOI in each public presentation of the results of the research, and
          2. Request an addendum to previously published presentations.
        7. As required by the regulations, SFI(s) disclosed to the University and related to PHS-funded research will be made available to the funding agency within five days of a formal request.
        8. Disclosures related to federally funded projects, records will be kept for three years from the date of submission of the financial closeout documentation.

Related Links

General Counsel Page for this Policy

 

Policy Details:

OWNER: Provost

SECTION: Research, Sponsored Program, Technology Transfer and Intellectual Property Policies

RESPONSIBLE OFFICE: UD Research Office

POLICY NUMBER: 6-11

ORIGINATION DATE: November 15, 1989

REVISION DATE(S): March 1, 1996; February 18, 2002; January 18, 2008; August 11, 2008; August 23, 2012; May 8, 2015

Policy Source Open Policy



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