ROWAN UNIVERSITY POLICY
Title: Managing Conflicts of Interest
Policy No: Res:2015: 02
Issuing Authority: President
Responsible Officer: Vice President for Research
Last Revision: 06/24/2021
Last Reviewed: 06/24/2021
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.
At the direction of the President, the Vice President for Research shall implement these procedures at Rowan University. The Vice President for Research and RowanSOM Dean Healthcare Units and other University Officers shall ensure compliance with this procedure.
This procedure shall apply to all Rowan University and faculty, non-faculty employees, students and other individuals who, in the course of their association with Rowan University:
- Apply for or receive funds for any research, service, or training purpose, by grant or subgrant, or by contract or subcontract, or by cooperative agreement (individually and collectively referred to herein as "Funding Agreement(s)")
Funded sponsors include but are not limited to Federal, State, and Local governments, non-profit institutions, industry and for-profit entities or businesses, or any individual, organization, or foundation that has funding available or will provide funding for sponsored projects conducted by or on behalf of Rowan University.
- New Jersey Conflict of Interest Law (N.J.S.A. 52:13D-12, seq.): Establishes specific standards of conduct for State employees and officers. This policy supplements State law.
- Department of Health and Human Services. 45 CFR: Title 42, Chapter I, Subchapter D, Part 50, Subpart F: Promoting Objectivity in Research
- National Science Foundation. Proposal and Award Policies & Procedures Guide and Code of Federal Regulations: Title 2, Subtitle A, Chapter II, Part 200, Subpart B, 200.112.
- Rowan University recognizes the importance and potential benefits of transferring to the private sector knowledge developed through University research and scholarship. It also recognizes the risks inherent when researchers have financial or other personal interests in their research or training activities, and the need to avoid arrangements that might compromise, or seem to compromise, the intellectual principles, independence and responsibility to the public that underlie the ethical conduct of research. Therefore, while welcoming industry sponsorship, collaboration and licensing of its technology, the University recognizes the need for having procedures in place for identifying and managing actual or perceived conflicts of interest that may arise in research to ensure the integrity, objectivity and freedom of inquiry of its investigators, and the safety and welfare of its human research subjects.
- Of critical importance is 76 Fed. Reg. 53,256: On Aug. 25, 2011, the Department of Health and Human Services (HHS) published its final rule on financial conflicts of interest (FCOI). The regulations are a significant update on initial rules published in 1995, and they demand greater transparency and accountability for research institutions that receive Public Health Service (PHS) funds from the National Institutes of Health (NIH). Though this rule has many similarities with regulations promulgated in 1995, the new modifications have greater impact on the conflict of interest for institutions that receive HHS funds.
- Thus, procedures described below are intended to implement the National Science Foundation and HHS final rule published in August 2011 for applicants for promoting Objectivity in Research for which PHS funding is sought (42 CFR Part 50, Subpart F) and Responsible Prospective Contractors (45 CFR part 94) and to provide the provide the reasonable expectation that the design, conduct, and reporting of the research will be free from bias resulting from Investigator financial conflicts of interest.
- Thus, procedures described below are not intended for sponsored research whose sponsor is not DHHS, DHHS agency, or the National Science Foundation, but upon identification of a conflict by an investigator, reporting of any significant financial interest that is a conflict can follow the procedures below.
- Relationship Between the Conflict-of-Interest Committee (COIC) and the Institutional Review Board (IRB)
- In cases of human subjects research, the COIC will inform the Rowan University IRB of record of its decision and reasons. The Rowan University IRB may either accept the decisions of the COIC, or impose additional requirements or restrictions, and shall convey its final decision in writing to the investigator, the investigator's Chair, the Vice President for Research, and the respective College and School Dean.
- Where the proposed research involves human subjects and the investigator's interests are beneath the threshold of a significant interest, the IRB may request a review and recommendation from the COIC, both as to whether or not to permit that individual to conduct the proposed research and, if the research is permitted, under what terms and conditions.
- Publication and Other Communications of Research Results
- Contracts with research sponsors may not include provisions that prevent the investigator from independently accessing, examining, analyzing and interpreting the research data, or that restrict publication or other public communications of the methods, data and results of the research. Sponsors may be given up to thirty (30) days in which to review a manuscript, presentation or abstract that originates from the sponsored research prior to submission for publication or otherwise publicly communicated. Such review shall be limited to protection of confidential information furnished by the sponsor to the investigator, if any, or for the purpose of protection of patent or other intellectual property rights covered under the contract. The sponsor does not have the right to approve or consent to the publication or other communication of the research results.
- In the event that the proposed publication or other communication contains patentable subject matter or confidential information, the University will, upon written request from the sponsor within the thirty (30)-day review period, delay the publication or other communication for a maximum of an additional sixty (60) days to allow the sponsor to file a patent application, or to modify the proposed publication or communication to delete sponsor-provided confidential information and/or to present the results in a manner that will not compromise such confidential information.
- Publications should conform to the Uniform Requirements for Manuscripts Submitted to Biomedical Journals with regard to conflicts of interest.
- In the case of multi-site clinical trials, the contract should state: how the results will be published; how authorship will be decided; how each investigator will have access to all data from all sites (and not simply to summary tables) in order to be able to analyze the full data independently if there is no multi-site publication within one year of the termination of the study; and that such one-year delay in publication or presentation of data results by the investigator can be waived if the investigator has a good faith belief that publication or presentation should not be delayed for reasons of public health, safety or public welfare.
- Protection of Students, Postdoctoral appointees and Other Trainee
Contracts with research sponsors may not include restrictions on the activities of students, postdoctoral appointees or other trainees, and may not include non-disclosure provisions regarding such individuals beyond those specified above (Sections VI.B.1 and 2). Exceptions must be approved by the COIC and must be fully disclosed to all students, postdoctoral appointees and other trainees prior to their involvement in the research. However students, postdoctoral appointees and other trainees may not, under any circumstances, be permitted to participate in research if such participation would prevent them from meeting pertinent University degree requirements, such as completion and public defense of a thesis or dissertation.
- Investigator conflict of interest training
- The Office of the Rowan University Vice President for Research or Senior Associate Deans for Research will create training content and be responsible for the implementation of a University-wide web-based training module.
- Each investigator must complete the COI training prior to engaging in sponsored or unsponsored research and at least every four years, or immediately if the University's conflict of interest policy changes in a manner that affects investigator requirements, an investigator is new to the University, or the University finds an investigator noncompliant with the University's COI policy.
- Enforcement and sanctions
- Non-compliance with any provision of these procedures shall be subject to sanctions up to and including dismissal or termination for cause. Non-compliance shall be reported by any knowledgeable individual to the COIC, and the Rowan University IRB if human subjects are involved. The COIC, and the Rowan University IRB if human subjects are involved, shall investigate the allegation, reach a conclusion and recommend sanctions or dismissal of the charges to the Research Deans who shall have the final decision. Recommendations will also involve the notification of the sponsor and/or journal editors if non-compliance may have resulted in compromise of the integrity of the research and/or resulting publications or other communications.
- Appeal of the committee's decision may be made to the President of Rowan University. After the President or representative of the President has made a final decision, the committee will inform the Investigator.
- Standards set by governmental agencies will be monitored and considered in the University's routine review of this policy.
- Reports and record keeping
The Rowan University Vice President for Research or Senior Associate Deans for Research shall maintain records of all disclosures of financial and other personal interests, COIC determinations and recommendations, final decisions, actions taken to resolve conflicts of interest and the outcomes thereof for at least three (3) years from the date of submission of the final expenditure report of the project, or from the conclusion of unsponsored research, or until the resolution of any governmental or legal actions involving these records, whichever is longer.
- Conduct of Research
- Compelling Circumstances are facts that convince the Conflict-of-Interest Committee (see definition below) that an individual with a conflict of interest which is relevant to the proposed research project should be permitted to conduct the proposed research under requirements established by the Committee. These facts may include, but are not limited to: the nature of the research, the magnitude of the financial or other personal interest, the degree to which these interests are related to the research, the extent to which these interests could be affected by the research and in the case of human subjects research, the degree of risk to the human research subjects.
- Conflict of Interest is a divergence between an investigator's financial or other personal interests and the obligation to abide by principles of the ethical conduct of research, especially the obligation to protect the rights and welfare of human subjects, such that considerations of personal gain, financial or otherwise, may influence or create the perception of influencing that investigator and compromise the objectivity or appropriate design, conduct or reporting of the research.
- Conflict-of-Interest Committee (COIC) is a Rowan University committee whose role is to review disclosures of significant interests (see definition below) and determine if these constitute a conflict of interest and, if so, to decide how such conflicts will be managed, reduced or eliminated.
- The committee is appointed on an Ad hoc basis by the Vice President for Research or Senior Associate Research Deans. Representation will include the Senior Associate Dean for Research, Sponsored Programs Directors, Chief Research Compliance Officer, a member of the Rowan Privacy Compliance Office, General Counsel or Technology and Commercialization and will include faculty members and others, when necessary. The committee may have additional ad hoc members in order to appropriately assess the presence of a conflict based on individual disclosures.
- Conflict of Interest Training is required of all "investigators" (defined below) prior to engaging in sponsored or unsponsored research and every four years thereafter, and immediately under designated circumstances.
- Financial Conflict of Interest (FCOI) Report means an Institution's report of a financial conflict of interest to a PHS Awarding Component.
- Financially Interested Company means a commercial entity with financial interests that would reasonably appear to be affected by the conduct or outcome of the research, or any entity acting as the agent of or with an equity interest in such an entity. This term includes companies that sponsor the research, are competitors of the sponsor, are the manufacturers or licensees of an investigational product, or the investment industry (individual stockbrokers and analysts, investment bankers, venture capital firms and investment firms).
- Human Subjects Research includes all "research" performed with "human subjects" as these terms are defined in the federal Common Rule (45 C.F.R. Part 46 and 21 C.F.R. Part 56), regardless of the source of research funding or whether the research is otherwise subject to federal regulation.
- Immediate Family means spouse (by marriage or civil union), domestic partner, children, parents, or siblings who reside in the same household.
- Institutional responsibilities mean an Investigator's professional responsibilities on behalf of the Institution including: activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.
- Institutional Review Board (IRB) is a committee established in accord with federal Common Rule at 45 C.F.R. Part 46 and FDA regulations at 21 CFR Part 50 and 56 with the authority to approve, require modifications in, or disapprove all University research activities involving human subjects.
- Interest is a financial or other personal involvement of the investigator, or his or her immediate family that are related to the individual's Institutional responsibilities. Financial interest means anything of monetary value, whether or not the value is readily ascertainable. Interests include, but are not limited to: income; honoraria or other payment for services; equity such as stock, stock options or other ownership rights (except interests of any amount in publicly traded, diversified mutual funds, pension funds, or other institutional investment funds over which the faculty member does not exercise control); patents and copyrights; contracts, licensing and other agreements; royalties (including those royalties distributed by the University); employment; reimbursed travel or sponsored travel; and services, relationships or positions, even if uncompensated.
- Excluded from the disclosure requirement are income from seminars, lectures, or teaching engagements, reimbursed travel or sponsored travel, and service on advisory or review panels sponsored by a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.
- Investigator means the Principal Investigator, co-principal investigator, co-investigators and any other University personnel (including faculty, non-faculty employees, residents, postdoctoral trainees and students) who, in the course of their association with the University are or will be responsible for the design, conduct, and/or reporting of either research or training activities, funded or proposed for funding by any sponsor, or of unsponsored research or training activities. As used herein, the term "investigator" also covers collaborators, grantors or contractors.
- Manage means taking action to address a real or apparent financial conflict of interest, which can include reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.
- Research means a systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. The term encompasses basic and applied research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug). For the purposes of this policy, research shall include training activities.
- Significant Interest means:
- A financial or other personal interests of the investigator, his or her spouse, domestic partner, children, parent or siblings that reasonably appears to be related to the Investigator's institutional responsibilities:
- Service as an officer, director or in any other fiduciary role for a financially interested company, whether or not remuneration is received for such service;
- Intellectual property rights (e.g., pending patent applications, patents, licenses, material transfer agreements, copyrights and royalties of any amount from such rights, including those royalties distributed by the University);
- With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes compensation, royalties, consulting fees, honoraria, gifts or other emoluments, bonuses, enrollment incentives or milestone payments, and "in kind" compensation or entitlement to same made directly or indirectly to the investigator by a financially interested company (or entitlement to the same), whether for consulting, lecturing, travel (including reimbursed travel or sponsored travel), service on an advisory board, or for any purpose not directly related to the reasonable costs of conducting the research (as specified in the research agreement between the sponsor and the University), as determined through reference to public prices or other reasonable measures of fair market value, either in the year prior to the grant application or initiation of unsponsored research and submission of the accompanying Disclosure Form, or in the twelve months following the grant application or initiation of unsponsored research;
- Greater than 1% of the ownership of stock, assets or profits of a company which has, or seeks to have an agreement with the University, where the agreement is for the development of scientific or technological discoveries or innovations in which the University has or will have a property right;
- Equity interests, including stock options, of any amount in a non-publicly traded financially interested company (or entitlement to the same);
- Equity interests (or entitlement to the same) that in aggregate exceed $5,000 in a publicly-traded financially interested company;
- Investigators must disclose the occurrence of any reimbursed or sponsored travel ( i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their institutional responsibilities; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of Higher Education. This disclosure must include the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.
- The term "significant interest" does NOT include:
- Salary or other remuneration from the University unrelated to the investigator's Institutional responsibilities;
- Reimbursement and/or income from seminars, lectures, or teaching engagements sponsored by, reimbursed travel or sponsored travel, and service on advisory or review panels for federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education;
- Interests of any amount in publicly-traded, diversified mutual funds, pension funds, or other institutional investment funds over which the faculty member does not exercise control; A significant interest does not necessarily constitute a conflict of interest or the appearance of a conflict of interest as defined above.
Conduct of Research
- Disclosure of Interests and Conflicts
- 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.
- 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 Investigator Financial and Other Personal Interests Disclosure Form, (hereinafter "Disclosure Form", EXHIBIT), 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.
- Each investigator 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.
- In the event the research involves human subjects, all investigators must also attach the completed Disclosure Form to the protocol submitted for IRB review.
- 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.
- 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.
- 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.
- Processing of Disclosure Forms
- 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.
- The Rowan University Office of Research Compliance and Senior Associate Research Deans shall review the Disclosure Form and determine which interests, if any, are significant interests as defined in Section IV.O.
- Disclosure Forms that reveal no significant interests shall remain on file in the Rowan University Office of Research Compliance or Office of Sponsored Programs.
- 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.
- 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.
- Assessment of Significant Interests by the COIC
- 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.
- The COIC will review all Disclosure Forms forwarded by the Rowan University Office of Research Compliance or Senior Associate Dean for Research and make the following determinations:
- 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.
- 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 may impose conditions or restrictions to manage, reduce or eliminate conflicts of interest including but not limited to:
- public disclosure of significant interests
- 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
- audits of the informed consent and subject enrollment process
- modification of the conduct of the research plan or educational activity
- disqualification of those with significant interests from participation in all or a portion of the research or training activity
- reduction or divestiture of significant interests
- severance of relationships that create conflicts of interest or the appearance of such conflicts.
- Whether significant interests constitute a conflict or appearance of conflict and cannot be managed, reduced or eliminated. In these cases, the research cannot proceed.
- In making these determinations, the COIC may:
- 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.
- 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.
- COIC Decisions:
- 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.
- 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.
- 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:
- those investigator interests which constitute conflicts of interest in human research subjects be included in the consent forms associated with the research, and
- 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.
- Outcome of the COIC's decisions:
- 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:
- the name of the entity with which the investigator has a COI;
- the nature of the COI e.g., equity, consulting fees, travel reimbursement, honoraria, etc.;
- 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;
- 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;
- key elements of the Institution's management plan, including:
- Role and principal duties of the conflicted Investigator in the research project;
- conditions of the management plan;
- How the management plan is designed to safeguard objectivity in the research project;
- Confirmation of the Investigator's agreement to the management plan;
- How the management plan will be monitored to ensure Investigator compliance; and
- Other information as needed.
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.
- 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.
- 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.
- 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.
- 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.
- 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:
- Project number
- Project title
- PD/PI or contact PD/PI if a multiple PD/PI model is used
- Name of the Investigator with the COI
- Name of the entity with which the Investigator has a financial conflict of interest
- Reason(s) for the retrospective review
- Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed)
- Findings of the review; an
- Conclusions of the review
- 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.
- 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.