ROWAN UNIVERSITY POLICY 

Title: Managing Conflicts of Interest
Subject: Research
Policy No: Res:2015: 02
Applies: University-Wide
Issuing Authority: President
Responsible Officer: Vice President for Research
Adopted: 11/09/2015
Last Revision: 05/3/

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2024
Last Reviewed: 05/3/

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2024

I.    PURPOSE

The purpose of this policy is to ensure the integrity of the University's research, protecting the rights and welfare of human subjects, maintaining the intellectual freedom of faculty, students, postdoctoral appointees and other trainees, and safeguarding the freedom to publish, communicate and discuss research results.

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1. Disclosure of Interests and Conflicts
   1. Upon the submission of applications to sponsors for funded research (whose sponsor is not DHHS, DHHS agency, or the National Science Foundation), or prior to the commencement of unsponsored research, or prior to the execution of a licensing agreement with a publicly-traded company in which the investigator has an equity interest or other association that is a conflict, investigators must identify if a conflict exists, the nature of the conflict, any significant financial interests related to the conflict, and any conflicts of commitment.
   2. Upon the submission of applications to sponsors for funds, or prior to the commencement of unsponsored research, or prior to the execution of a licensing agreement with a publicly-traded company in which the investigator has either an equity interest that exceeds $5,000 or a greater than one percent (1%) ownership interest, whichever is less, or prior to the execution of a licensing agreement with a non-publicly traded company in which the investigator has an equity interest of any amount, all investigators must complete and submit to the Rowan University Office of Research Compliance or Office of Sponsored Programs the Conflict of Interest (COI) and Significant Financial Interest (SFI) form, (hereinafter "Disclosure Form"), and include any such interests related to their Institutional responsibilities described in Section IV.K above for themselves and/or members of their immediate family. If the investigator has no such interest, the investigator must check the box indicating that no such interest exists.
   3. Investigators that will significantly contribute to a research project and be responsible for and authority granted to approve aspects of the research by the Principal Investigator are key personnel and named on the project must complete a Disclosure Form. If one or more such investigators had not been named at the time of proposal submission, a Disclosure Form or Forms must be completed subsequently by such investigator(s) and submitted to the Office of Research Compliance as soon as such investigators are assigned to the project.
   4. In the event the research involves human subjects, all investigators must also attach the completed Disclosure Form to the protocol submitted for IRB review.
   5. All Disclosure Forms must be completed in full and in detail, with sufficient information to determine if the interests meet the definition of "significant interest," and must be signed by the investigator and the investigator's Chair or Vice President. If the investigator is a Chair, the form must be signed by the Dean. Sponsored or unsponsored research for which there are disclosed interests from any investigator on the research project may not commence until the disclosures are reviewed to determine whether the disclosure(s) poses a real or perceived COI and, if needed, a plan developed to manage any and all disclosures determined to represent a COI.
   6. On an annual basis during the duration of the research, or within 30 days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) new interests with respect to potential conflict of interest which otherwise changes since the original disclosure, each investigator shall be responsible for completing a new Disclosure Form and submitting it to the Rowan University Office of Research Compliance or Office of Sponsored Programs and, when human subjects are involved, to the Rowan University IRB. The Rowan University Director of Research Compliance or Senior Associate Dean for Research shall review annual and revised Disclosure Forms as in Section VI.A.2.b-e, below.
   7. For projects involving contracts, subcontracts or collaborations with outside institutions or groups, Rowan University Office of Research Compliance will take steps to ensure that any subrecipient Investigator complies with the Public Health Service, pursuant to 42 CFR Part 50, Subpart F by incorporating as part of a written agreement with the subrecipient terms that establish whether the financial conflicts of interest policy of the awardee Institution or that of the subrecipient will apply to the subrecipient's Investigators. If the subrecipient's Investigators must comply with the subrecipient's financial conflicts of interest policy, the subrecipient shall certify as part of the agreement referenced above that its policy complies with this subpart. If the subrecipient cannot provide such certification, the agreement shall state that subrecipient Investigators are subject to the financial conflicts of interest policy of Rowan University for disclosing significant financial interests that are directly related to the subrecipient's work for Rowan University. If the subrecipient's Investigators must comply with the subrecipient's financial conflicts of interest policy, the agreement referenced above shall specify time period(s) for the subrecipient to report all identified financial conflicts of interest to the awardee Institution. Such time period(s) shall be sufficient to enable Rowan University to provide timely COI reports, as necessary, to PHS as required by this subpart. If the outside entity is an agency of the State of New Jersey, its policy must meet the requirements of New Jersey Law, Conflicts of Interest Law, N.J.S.A. 52:13D-19.1, and of the Public Health Service pursuant to 42 CFR Part 50, Subpart F. In the event the outside entity has no investigator conflict-of-interest policy, the written agreement referenced above shall specify time period(s) for the subrecipient to submit all Investigator disclosures of significant financial interests to Rowan University. Such time period(s) shall be sufficient to enable Rowan University to comply timely with its review, management, and reporting obligations under this subpart.
2. Processing of Disclosure Forms
   1. All completed original and updated Disclosure Forms must be submitted by the investigator to the Rowan University Office of Research Compliance or Senior Associate Dean for Research and, when human subjects are involved, to the IRB.
   2. The Rowan University Office of Research Compliance or Senior Associate Research Deans shall review the Disclosure Form and determine which interests, if any, are significant interests as defined in Section IV.O.
   3. Disclosure Forms that reveal no significant interests shall remain on file in the Rowan University Office of Research Compliance or Office of Sponsored Programs.
   4. Whenever significant interests are disclosed, either on initial Disclosure Forms or on annual or revised Disclosure Forms, the Rowan University Office of Research Compliance or RowanSOM Senior Associate Dean for Research shall forward the Disclosure Form to the COIC with notice to the investigator, the investigator's Chair, if any, and, when human subjects are involved, to the IRB.
   5. If an Investigator who is new to participating in the research project discloses a significant financial interest or an existing Investigator discloses a new significant financial interest to the Rowan University Office of Research Compliance or Senior Associate Dean for Research, the COIC shall, within sixty days: review the disclosure of the significant financial interest; determine whether it is related to the research; determine whether a financial conflict of interest exists; and, if so, implement a management plan to manage the conflict of interest. Depending on the nature of the significant financial interest, the Rowan University Office of Research Compliance or Senior Associate Dean for Research may determine that interim measures are necessary with regard to the Investigator's participation in the research project between the date of disclosure and the completion of the COIC's review. 
3. Assessment of Significant Interests by the COIC
   1. Whether the significant interests disclosed are relevant to the proposed research and whether they constitute or appear to constitute a conflict of interest. A conflict of interest shall be deemed to exist when the COIC reasonably decides that the significant interest could directly and significantly affect the objectivity of the research through the design, conduct or reporting of the research or training activities, or have the appearance of doing so. Not all significant interests constitute or appear to constitute a conflict of interest.
   2. Which conditions or restrictions, if any, should be imposed upon the investigator prior to the expenditure of any funds under the Funding Agreement or the initiation of unsponsored research or training activities in order to manage, reduce or eliminate such conflicts of interest or appearances of conflicts of interest. The COIC or COIC designated member reviewer may impose conditions or restrictions to manage, reduce or eliminate conflicts of interest including but not limited to:
      1. public disclosure of significant interests
      2. monitoring plan with independent reviewers, such as data safety monitoring board, routine on-site study review, and/or consent process with independent subject advocate/representative
      3. audits of the informed consent and subject enrollment process
      4. modification of the conduct of the research plan or educational activity
      5. disqualification of those with significant interests from participation in all or a portion of the research or training activity
      6. reduction or divestiture of significant interests 
      7. severance of relationships that create conflicts of interest or the appearance of such conflicts.
   3. Whether significant interests constitute a conflict or appearance of conflict and cannot be managed, reduced or eliminated. In these cases, the research cannot proceed.
   4. Ask the investigator to appear before it to provide additional information to assist in the Committee's deliberations. In the event the Committee determines that the investigator has a conflict of interest or an appearance of such conflict, the investigator must present compelling circumstances that the research can go forward as proposed, or with modifications imposed by the Committee.
   5. Consult with individuals such as other faculty, scientists, financial experts, patents and licensing experts, IRB representatives, the pertinent Dean or other University officials, and others from inside or outside the University.
   6. When no conflicts of interest exist or appear to exist, the Committee will inform in writing the investigator, the investigator's Chair, Director of Research Compliance, and the Senior Associate Research Dean that the research can proceed as proposed. If the research involves human subjects, the Committee will also notify the Rowan University IRB.
   7. When conflicts exist or appear to exist, the Committee may decide that the research may not proceed, or may impose measures to reduce, manage or eliminate the conflicts, such as those described in Section VI.A.3.b.(2) as a condition of the research going forward.
   8. When conflicts exist or appear to exist and the Committee decides that the research can proceed as proposed or with measures to reduce, manage or eliminate the conflict or the appearance of a conflict, the Committee shall require the following disclosures:
      1. those investigator interests which constitute conflicts of interest in human research subjects be included in the consent forms associated with the research, and
      2. those investigator interests which constitute conflicts of interest be disclosed to research sponsors, journal editors, co-investigators, other relevant IRBs, and in oral presentations of the research.
   9. The COIC will report its decision, including an explanation of its decision and a description of conditions or restrictions, if any, in writing to the investigator(s), the investigator, the investigator's Chair, Director of Research Compliance, and the Senior Associate Research Dean. If the research involves human subjects, the Committee will also notify the The Rowan University IRB. In the case of PHS funded research, the Office of Research Compliance will notify the PHS funding agency within 60 days of the existence of the conflict of interest prior to any expenditure of any funds under the Funding Agreement in an Initial FCOI Report which will include the following elements:
      1. Role and principal duties of the conflicted Investigator in the research project;
      2. Conditions of the management plan;
      3. How the management plan is designed to safeguard objectivity in the research project;
      4. Confirmation of the Investigator's agreement to the management plan;
      5. How the management plan will be monitored to ensure Investigator compliance; and
      6. Other information as needed.
      7. Following an Initial Report, the Institution will submit an Annual Report to the PHS Funding Agency to provide the information on the status of the financial conflict of interest and any changes to the management plan.
      8. The name of the entity with which the investigator has a COI;
      9. The nature of the COI e.g., equity, consulting fees, travel reimbursement, honoraria, etc.;
      10. The value of the financial interest in increments of $5000, $10,000, $20,000 or $50,000 or a statement to the effect that the value cannot be readily determined; 
      11.  A description of how the financial interest relates to the funded research and the basis for the institution's determination that the financial interest conflicts with such research;
      12. Key elements of the Institution's management plan, including:
   10. If the COIC's decision is that the research cannot proceed, the investigator(s), the investigator, the investigator's Chair, Director of Research Compliance, Vice President for Research, and the Senior Associate Research Dean will be notified of this decision. The funding agency or sponsor will be notified of the existence of the conflict of interest prior to any expenditure of any funds under the Funding Agreement and in the case of a PHS award, with an Initial Report as described above.
   11. If the final decision includes conditions or restrictions to manage, reduce or eliminate a conflict of interest, the investigator shall document his or her compliance with such conditions or restrictions in writing to the investigator, the investigator's Chair, Director of Research Compliance, COIC, and the Senior Associate Research Dean, and, in cases where human subjects are involved, the Rowan University IRB, prior to the expenditure of any funds under the Funding Agreement or the commencement of unsponsored research.
   12. If the final decision is that a conflict of interest exists but can go forward under conditions specified, the Office of Research Compliance shall note this interest in an initial report to the PHS funding agency or sponsor of the identification of the conflict of interest prior to the expenditure of any funds under the Funding Agreement. If the final decision includes conditions or restrictions to manage, reduce or eliminate the conflict, the Office of Research Compliance shall provide within the initial report to the funding agency or sponsor details of how the conflict of interest has been eliminated or acceptably managed or reduced.
   13. Whenever an Investigator discloses a significant financial interest that was not previously disclosed or, for whatever reason, was not previously reviewed by the COIC during an ongoing research project (or was not timely reviewed or reported by a subrecipient), the COIC shall, within sixty days: review the significant financial interest; determine whether it is related to the research; determine whether a financial conflict of interest exists; and, if so implement a management plan that shall specify the actions that have been, and will be, taken to manage such financial conflict of interest going forward.
   14. For any interest that the COIC identifies as a conflict of interest subsequent to the COIC's initial report under the Funding Agreement, and after the expenditure of funds, the Institution will conduct a retrospective review of these cases of non-compliance to determine the impact of the bias on the research project. In instances where bias of the research has been found to exist, the Rowan University Vice President for Research or Senior Associate Dean for Research will file a report to sponsor indicating what was found and what actions the Institution has taken, or will take, to eliminate or mitigate the effect of the bias within 120 days of that identification. In case of PHS-funded research, the Office of Research Compliance will document the retrospective review to the agency. Such documentation shall include, but not necessarily be limited to, all of the following key elements:
       1. Project number
       2. Project title
       3. PD/PI or contact PD/PI if a multiple PD/PI model is used
       4. Name of the Investigator with the COI
       5. Name of the entity with which the Investigator has a financial conflict of interest
       6. Reason(s) for the retrospective review
       7. Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed)
       8. Findings of the review; an
       9. Conclusions of the review
   15. Based on the results of the retrospective review, if appropriate, the Office of Research Compliance shall update the previously submitted FCOI report, specifying the actions that will be taken to manage the financial conflict of interest going forward. If bias is found, the Institution is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. The mitigation report must include, at a minimum, the key elements documented in the retrospective review above and 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 (e.g., impact on the research project; extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable). Thereafter, the Institution will submit FCOI reports annually, as specified elsewhere in this subpart. Depending on the nature of the financial conflict of interest, an Institution may determine that additional interim measures are necessary with regard to the Investigator's participation in the PHS-funded research project between the date that the financial conflict of interest or the Investigator's noncompliance is determined and the completion of the Institution's retrospective review.
   16. Compliance with the conditions for managing the conflict of interest will be monitored annually. If the investigator fails to comply with the management plan and it is determined by the COIC that this noncompliance has biased the design, conduct, or reporting of the research, this shall be promptly reported to the investigator, the investigator's Chair, Director of Research Compliance, the Senior Associate Research Dean and the funding agency or sponsor along with a corrective action plan taken or to be taken to maintain appropriate objectivity of the research.
   17. It is the responsibility of each member of the COIC to divulge potential conflicts of interest. In the event that any member of the COIC has any real or apparent personal or professional conflicts of interest or bias with respect to the disclosure being considered, that member shall be recused. Such conflicts include, but are not limited to, involvement with the research in question, competition with the investigator, and a previous or ongoing close professional or academic relationship with the investigator, the sponsor, or competitor of the sponsor.
   18. The COIC will review all Disclosure Forms forwarded by the Rowan University Office of Research Compliance.