Conflict of interest policy

CONFLICT OF INTEREST POLICY

PURPOSE

This Conflict of Interest Policy (“Policy”) is adopted by the La Jolla Institute for Immunology, a California non-profit public benefit corporation (“LJI”) to establish the requirements and responsibilities associated with identifying and managing financial conflicts of interest to safeguard the integrity of LJI research and to comply with federal regulations. Specifically, this Policy is adopted to address and comply with the revised Code of Federal Regulations, Title 42 CFR Part 50, Subpart F, Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought and Title 45 CFR Part 94, Responsible Prospective Contractors (“FCOI Regulations”), and promotes objectivity in research by establishing standards to ensure there is no reasonable expectation that the design, conduct, or reporting of research funded under Public Health Service (“PHS”) grants, cooperative agreements, or contracts will be biased or create the appearance of bias by any conflicting financial interest of an investigator responsible for the research.
LJI recognizes that Investigators may properly have Significant Financial Interests that can create a Financial Conflict of Interest. Neither this Policy nor applicable law prohibits such Significant Financial Interests or the occurrence of a Financial Conflict of Interest situation, so long as the Significant Financial Interest is properly disclosed in accordance with this Policy, and appropriate actions are taken to manage and report the Financial Conflict of Interest.
It is recognized that a transaction involving a Financial Conflict of Interest might be subject to recision by LJI and claims for damages, if proper disclosure and approval does not occur.

GENERAL STATEMENT OF POLICY

It is the policy of LJI to address and comply with the specific federal agency requirements as defined in revised Code of Federal Regulations, Title 42 CFR Part 50, Subpart F, Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought and Title 45 CFR Part 94, Responsible Prospective Contractors (“FCOI Regulations”). The intent of this Policy is to set out the requirements for Investigators to disclose their Significant Financial Interests related to their responsibilities they perform on behalf of LJI for LJI’s determination of Financial Conflicts of Interest and the requirement for LJI to manage Financial Conflicts of Interest to promote objectivity of research, including federally funded research. These requirements maintain the public’s trust that the research at LJI, including federally funded research, is conducted without bias and with the highest scientific and ethical standards. In addition, LJI at its discretion may designate additional employees, including administrative employees, or other individuals conducting work at or for LJI as covered by this Policy.

1. DEFINITIONS

1.1 Conflict of Interest Policy Disclosure Form: Attached Appendix A. To be completed as indicated in Section 2 of this Policy.

1.2 Conflict Review Committee (“CRC”): The CRC will be made up of no less than 3 individuals appointed by the President of LJI, including the CRO and a representative from the Faculty, and shall meet to review, as needed, conflicts of interest cases identified by the CRO. If a conflict of interest case involves a member of the CRC, that member shall be recused from the case, and an alternate member shall be appointed if necessary to meet the minimum number of 4 individuals on the CRC.

1.3 Conflict Review Officer (“CRO”): The CRO shall be an LJI employee designated by the President of LJI. The CRO is responsible for the review of all Conflict of Interest Policy Disclosure Forms and other pertinent information, to review SFIs and assess whether an FCOI exists, and to forward these forms and other pertinent information to the Conflict Review Committee (CRC) for further review if necessary. The Conflict of Interest Policy Disclosure Form for the CRO will be reviewed by outside counsel or by another LJI employee designated by the President of LJI when a SFI is reported.

1.4 Conflict of Interest Policy Training Certification Form: Attached Appendix C. This form must be completed as indicated in Section 2.2 and returned to the CRO.

1.5 Financial Conflict of Interest (“FCOI”): An FCOI means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.

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

1.7 Institutional Responsibilities: An Investigator’s professional responsibilities on behalf of LJI including, but not limited to research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.

1.8 Investigators: The Principal Investigator or Project Director (PI/PD) and any other person, regardless of title or position, who is eligible to submit grant applications on behalf of LJI or who will be responsible for the design, conduct, or reporting of research funded by or proposed for funding by the PHS, which may include, for example, collaborators, consultants.

1.9 PHS AwardingComponent: The organizational unit of the PHS that funds the research that is related to the SFI.

1.10 Senior/Key Personnel: means the PD/PI and any other person identified as senior/key personnel by LJI in the grant application, progress report, or any other report submitted to the PHS by LJI in accordance with FCOI Regulations.

1.11 Significant Financial Interest (SFI): A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s Institutional Responsibilities:

(i) 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 salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;

(ii) With regard to any non-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, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or

(iii) Remuneration not received from LJI related to intellectual property rights and interests such as patents and copyrights including royalties from such rights and agreements to share royalties related to intellectual property rights and interests,

(iv) 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 and reimbursed or sponsored by any entity other than LJI or a Federal, state, or local government agency located in the United States, a United States 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 a United States Institution of higher education. The disclosure must include the following details:

- Purpose of the travel
- Identity of sponsor/organizer
- Destination of the travel
- Time duration of travel

The Institute will determine if the travel requires further investigation, including determination or disclosure of the monetary value in order to determine whether the travel constitutes a FCOI.

Investigators must disclose all foreign financial interests (which includes income from seminars, lectures, or teaching engagements, income from service on advisory committees or review panels, and reimbursed or sponsored travel) received from any foreign entity, including foreign Institutions of higher education or foreign government (which includes local, provincial, or equivalent governments of another country) when such income meets the threshold for disclosure (e.g., income in excess of $5,000).

The term significant financial interest does not include the following types of financial interests:

(i) salary, royalties, or other remuneration paid by LJI to the Investigator if the Investigator is currently employed or otherwise appointed by LJI, including intellectual property rights assigned to LJI and agreements to share in royalties related to such rights;

(ii) income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles;

(iii) income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency located in the United States, a United States 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 a United States Institution of higher education; or income from service on advisory committees or review panels for a Federal, state, or local government agency located in the United States, a United States 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 a United States Institution of higher education.

Many scientific journals have implemented policies that require authors to declare competing financial interests in relation to work published in those journals. Such requirements of third parties, including how financial interests are defined, are distinct from the requirements in this policy relating to PHS Funded Research and should not be used as guidance for the information an Investigator must disclose under this policy.

1.12 Subrecipients: An individual or entity that receives federal funds from or through LJI to another individual or entity where the subrecipient will be conducting a substantive portion of the PHS‐funded research project and who will be accountable to LJI for programmatic outcomes and compliance matters. This may also include subgrantees, consortium participants, collaborators, and/or consultants.

2. THE RESPONSIBILITIES OF INVESTIGATORS UNDER THIS POLICY

All Investigators will receive this Policy and have an obligation to become familiar with, and abide by, the provisions of this Policy which describe the Investigator’s responsibilities regarding disclosure of SFIs and the FCOI Regulations.

2.1. Disclosures: LJI requires and promotes objectivity in all scientific research conducted by Investigators and their subgrantees, contractors, and collaborators. Accordingly, each Investigator is required to design, conduct, and report all research without any adverse influence or bias from any FCOI. LJI is authorized to furnish all relevant information concerning an FCOI situation to the agency or source providing funding for the Investigator’s research as may be required.

No later than the time of application for PHS- funded research, each Investigator must disclose to LJI’s CRO the Investigator’s SFI’s (and those of the Investigator’s spouse and dependent children), including any reimbursed or sponsored travel received in the preceding twelve (12) months, at the time of hire and annually thereafter, using LJI’s Conflict of Interest Policy Disclosure Form. All Investigators are required to complete a current, accurate annual disclosure form that identifies and describes both existing and new SFIs and shall include updated information regarding any previously disclosed SFIs (e.g. the updated value of a previously disclosed equity interest). Such annual disclosure forms will include any SFIs and required information that was not disclosed initially by Investigator to LJI, or in a subsequent disclosure of SFIs (e.g., any FCOI identified on a PHS-funded project that was transferred from another Institution).

In addition, Investigators have an ongoing obligation to promptly update their Conflict of Interest Policy Disclosure Form to accurately reflect any new SFIs, including any reimbursed or sponsored travel received in the preceding twelve (12) months, or new external activities or significant changes in their existing external activities and SFIs as follows:

• At the time of application for PHS funded research

• Prior to expenditure of funds on any PHS award

• Within 30 days of discovering or acquiring a new SFI

2.2 Conflict of Interest Training. LJI requires all Investigators to complete FCOI training prior to engaging in federally funded research and at least every 4 years thereafter, or as directed by LJI, and certify on the Conflict of Interest Policy Training Certification Form that the Investigator has completed FCOI training, reviewed this Policy, and acknowledge that Investigator’s conduct is governed by this Policy. Training is required immediately when any of the following circumstances apply:

(a) this Policy changes in a manner that affects Investigators’ requirements;

(b) an Investigator is new to LJI; or

2.3 Fair Dealing. LJI strives to be regarded as carrying out its business with integrity. LJI intends to succeed in its mission through superior performance and fair dealings by LJI Investigators. Under federal and state laws, LJI is prohibited from engaging in unfair methods of competition and unfair deceptive acts and practices. Every Investigator will:

(a) not participate in or accept any plan, transaction, or arrangement involving unlawful or unethical conduct; and

(b) not partake in bribery or payments to influence judgment or improper conduct to ensure a desired outcome or action.

2.4 Compliance with Accounting and Disclosure Control Policy. As applicable to an Investigator’s activities for LJI, an Investigator must: i) maintain complete and accurate personal and professional financial records and report complete and accurate personal and professional financial information; and ii) gather, tabulate, and report all financial data in accordance with all applicable accounting, IRS, legal, and granting agency regulations.

2.5 Confidential and Proprietary Information. All confidential or proprietary information concerning LJI is the property of LJI and must be protected. Every Investigator will maintain the confidentiality of LJI’s confidential and proprietary information and will use LJI’s confidential and proprietary information only for the benefit of LJI in accordance with the purposes and policies of LJI. An Investigator will not share confidential, unpublished, or proprietary information, research results, or research products of LJI with a business in which the Investigator has or seeks to have an SFI without the written consent of LJI.

2.6 Protection and Proper Use of LJI Assets. Investigators are responsible for the proper use, conservation and protection of LJI’s assets. Assets are to be used only for the legitimate business of LJI. Assets include, but are not limited to: monetary resources, intellectual property such as patents, trademarks, copyrights, proprietary information, designs, databases, physical facilities, laboratories, laboratory notebooks, computers, networks and information related to how LJI conducts its business. An Investigator will not directly or indirectly use, lease, rent, trade or sell real property, personal property, or intellectual property belonging to LJI for the personal benefit of the Investigator.

2.7 General Conflicts of Interest. The best interests of LJI must be at the forefront of any work-related activity or decision of Investigators. An Investigator will:

(a) not serve as an officer, director, employee, committee member, agent, representative or consultant to any business other than LJI when such service may adversely affect their responsibilities to LJI;

(b) inform LJI whenever they become aware of, or is involved in, directly or indirectly, a business transaction between LJI and a business association in which they have activities, or they have an SFI;

(c) not engage in consulting or extramural activities that might impair their independence of judgment in the performance of their duties and responsibilities to LJI. All Investigators must abide by LJI’s Uniform Consulting Agreement Provisions (Appendix B) in connection with any consulting services to third parties. All such arrangements must be disclosed and approved in accordance with LJI’s Staff Guidelines, and the CRO will advise the Investigator of LJI’s position with respect any such arrangements;

(d) contact the CRO if requesting to serve as a member of the Board of Directors of outside companies;

(e) ensure that the manner of their participation in outside non-profit activities does not imply LJI’s endorsement or sponsorship, and does not affect the Investigator’s primary commitment to LJI;

(f) not enter into a sponsored research agreement or a collaboration arrangement with an outside organization or business without prior notification and approval by LJI. Any sponsored research agreement or a collaboration arrangement for work to be done at LJI must be negotiated and approved by LJI as a party to the agreement for the work and executed by an authorized signatory of LJI.

2.8 Cooperation. Each Investigator will cooperate with LJI to comply with the procedures set forth in this Policy, to minimize risks of any General Conflict of Interest and any detriment to LJI.

2.9 Non-Retaliation. LJI strictly prohibits retaliation or reprisal against any individual who makes a good faith report of a violation or suspected violation of this Policy or the FCOI Regulations. Anyone who retaliates against an individual who in good faith reports possible misconduct will be subject to appropriate disciplinary action. Any LJI employee who believes they are the subject of retaliation following a report of possible misconduct, should immediately notify LJI Human Resources Department, the CRO, or President of LJI.

3. LJI REVIEW OF SFI DISCLOSURES

3.1 CRO Review. LJI’s CRO will initially review the Conflict of Interest Policy Disclosure Form to determine (1) whether an Investigator’s SFI is related to PHS-funded research and, (2) if so related, whether the SFI is an FCOI. LJI’s CRO may request further information or clarification of the information provided in the Conflict of Interest Policy Disclosure Form. The review of SFIs and determination of whether a FCOI exists as set forth in this Section 3 must be completed promptly following disclosure of an SFI to enable any FCOIs to be reported to the PHS within the sixty (60) day deadline as required under the FCOI Regulations. Each Investigator is required to fully cooperate with any inquiry conducted by LJI concerning a potential FCOI. All inquiries and possible results thereof will be kept confidential, to the extent permitted by applicable laws, regulations, and LJI policy; but subject to reporting and disclosure processes and requirements of FCOI Regulations or LJI policies and disclosure of FCOIs as required by scientific journals, conferences or other outlets in which Investigator research will be presented.

3.2 Determination of Whether a SFI is related to PHS-funded Research. An Investigator’s SFI is related to PHS- funded research when LJI, through its designated official(s), reasonably determines that the SFI (1) could be affected by the PHS-funded research, or (2) is in an entity whose financial interest could be affected by the research. LJI may involve the Investigator in the designated official(s)’s determination of whether an SFI is related to the PHS-funded research.

3.3 Determination of Whether a SFI is an FCOI. An FCOI exists when LJI, through its designated official(s), reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS-funded research.

3.4 CRC Review. The CRO shall review all Conflict of Interest Policy Disclosure Forms, and any other reported SFIs or possible FCOIs. If the CRO, in reviewing an SFI in accordance with this Section 3.1 of this Policy, determines that an FCOI may exist or requires further review, the CRO will forward relevant information regarding the conflict to the CRC. The CRO may also provide the CRC with a recommended plan to best manage the FCOI. If an FCOI is determined by the CRC to exist, the CRC may i) concur with the CRO’s recommended plan for managing the conflict situation; ii) agree on a modification to the CRO’s recommended plan; or iii) the CRC (or its designee) may meet and confer with the affected Investigator, and design a plan appropriate for the specific situation, which plan may include requiring the Investigator to take actions which manage, reduce or eliminate the FCOI.

3.5 Management following Determination of no FCOI. Where a documented SFI or other financial interest is deemed by LJI’s designated official(s) not to constitute a current FCOI, LJI nevertheless may decide to manage the SFI and may institute a management plan for the Investigator to follow.

4. MANAGING FCOIS

4.1 New PHS Funded Award. Prior to LJI’s expenditure of any funds under a PHS-funded research project, the CRO shall, consistent with 42 CFR Part 50, Subpart F § 50.604(f) and Section 3 of this Policy: review all Investigator disclosures of SFIs; determine whether any SFIs relate to PHS-funded research; determine whether a FCOI exists; and, if so, develop and implement a management plan that shall specify the actions that have been, and shall be, taken to manage such FCOI. Examples of conditions or restrictions that might be imposed to manage an FCOI include, but are not limited to:

(a) Public disclosure of FCOIs (e.g., when presenting or publishing the research);

(b) For research projects involving human subjects research, disclosure of FCOIs directly to participants;

(c) Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the FCOI;

(d) Modification of the research plan;

(e) Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;

(f) Reduction or elimination of the SFI (e.g., sale of an equity interest); or

(g) Severance of relationships that create FCOIs.

4.2 Ongoing PHS Funded Research. Whenever, in the course of an ongoing PHS-funded research project, an Investigator who is new to participating in the research project discloses an SFI or an existing Investigator discloses a new SFI to LJI, the CRO shall, within sixty (60) days: review the disclosure of the SFI; determine whether it is related to PHS-funded research; determine whether an FCOI exists; and, if so, implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage such FCOI. Depending on the nature of the SFI, LJI may determine that additional interim measures are necessary with regard to the Investigator’s participation in the PHS-funded research project between the date of disclosure and the completion of LJI’s review.

4.3 SFI not timely disclosed or reviewed. Whenever LJI identifies an SFI that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed by LJI during an ongoing PHS-funded research project (e.g., was not timely reviewed or reported by a subrecipient), the CRO shall, within sixty (60) days: review the SFI; determine whether it is related to PHS-funded research; determine whether an FCOI exists; and, if so:

i. Implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage such FCOI of interest going forward and submit an FCOI report to the PHS Awarding Component.

ii.

(A) In addition, whenever an FCOI is not identified or managed in a timely manner including failure by the Investigator to disclose an SFI that is determined by LJI to constitute an FCOI; failure by LJI to review or manage such FCOI; or failure by the Investigator to comply with an FCOI management plan, LJI shall, within one hundred and twenty (120) days of the LJI’s determination of noncompliance, complete a retrospective review of the Investigator’s activities and the PHS-funded research project to determine whether any PHS-funded research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research.

(B) LJI will document the retrospective review; 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 FCOI;

(5) Name of the entity with which the Investigator has an FCOI;

(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; and

(9) Conclusions of the review.

(iii) Based on the results of the retrospective review, if appropriate, LJI shall update the previously submitted FCOI report, specifying the actions that will be taken to manage the FCOI going forward. If bias is found, LJI will 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 LJI’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, LJI will submit FCOI reports annually, as specified elsewhere in this Policy. Depending on the nature of the FCOI, LJI 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 FCOI or the Investigator’s noncompliance is determined and the completion of the LJI’s retrospective review.

4.4 Monitoring. Whenever LJI implements a management plan pursuant to this Policy, LJI shall monitor Investigator compliance with the management plan on an ongoing basis until the completion of the PHS-funded research project.

4.5 Non-federal award entity. With regard to a non-federal award entity, LJI may, if warranted, disclose to such entity (e.g., corporation, educational institution, nonprofit entity, private foundation, trust or individual donor) information about an identified conflict of interest before dispersing or spending any funds and/or during the duration of the award.

4.6 Record Management. LJI will maintain records relating to all Investigator disclosures of SFIs and LJI’s review of, and response to, such disclosures (whether or not a disclosure resulted in LJI’s determination of an FCOI) and all actions under LJI’s policy or retrospective review, if applicable, for at least three (3) years from the date the relevant final expenditures report is submitted to the PHS or, where applicable, from other dates specified in 45 CFR 75.361 for different situations.

4.7 Subrecipient Research. If LJI carries out research through a subrecipient (e.g. subcontractors or consortium members), LJI must take reasonable steps to ensure that any subrecipient Investigator complies with Title 42 CFR Part 50, subpart F and 45 CFR Part 94 by incorporating as part of a written agreement with the subrecipient terms that establish whether this Policy or the financial conflicts of interest policy of the subrecipient will apply to the subrecipient investigators. If the subrecipient’s policy applies, the subrecipient shall certify as part of the agreement that its policy complies with Title 42 CFR Part 50, subpart F and 45 CFR Part 94. If the subrecipient cannot provide such certification, the agreement shall state that subrecipient Investigators are subject to this Policy for disclosing SFIs that are directly related to the subrecipient’s work for LJI. The agreement shall specify time period(s) for the subrecipient to report all identified FCOI (if its policy applies) or all investigator disclosures of SFIs (if this Policy applies) to LJI. Such time period(s) shall be sufficient to enable LJI to provide timely FCOI reports, as necessary, to comply with its reporting obligations.

5. REPORTING FCOIS

Following determination of the existence of an FCOI, LJI will provide an FCOI report to the applicable PHS awarding component as follows, submitting report sto the NIH via the eRA Commons FCOI Module:

5.1 New PHS Funded Award. Prior to LJI’s expenditure of any funds under a PHS-funded research project, LJI shall provide to the PHS Awarding Component an FCOI report regarding any FCOI identified by LJI and ensure that LJI has implemented a management plan in accordance with this Policy. In addition, LJI may be required to submit an FCOI report for FCOIs identified for subrecipient investigators, if applicable under Paragraph 4.6 of this policy. In cases in which LJI identifies a FCOI and eliminates it prior to the expenditure of PHS-awarded funds, LJI shall not submit an FCOI report to the PHS Awarding Component.

5.2 Ongoing PHS Funded Research. For any FCOI that LJI identifies subsequent to LJI’s initial FCOI report during an ongoing PHS-funded research project (e.g., upon the participation of an Investigator who is new to the research project LJI shall provide to the PHS Awarding Component, within sixty (60) days, an FCOI report regarding the FCOI and ensure that the LJI has implemented a management plan in accordance with this Policy. Where such FCOI report involves an SFI that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed or managed by LJI (e.g., was not timely reviewed or reported by a subrecipient), LJI will also complete a retrospective review to determine whether any PHS-funded research, or portion thereof, conducted prior to the identification and management of the FCOI was biased in the design, conduct, or reporting of such research. Additionally, pursuant to Paragraph 4.3 of this Policy, if bias is found, LJI will notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component.

5.3 Content of FCOI report. Any FCOI report to be submitted to a PHS Awarding Component under this Policy or FCOI Regulations shall include sufficient information to enable the PHS Awarding Component to understand the nature and extent of the FCOI, and to assess the appropriateness of LJI’s management plan. Elements of the FCOI report shall include, the following:

(i) Project number;
(ii) PD/PI or Contact PD/PI if a multiple PD/PI model is used;
(iii) Name of the Investigator with the FCOI;
(iv) Name of the entity with which the Investigator has a FCOI;
(v) Nature of the SFI (e.g., equity, consulting fee, travel reimbursement, honorarium);
(vi) Value of the SFI (dollar ranges are permissible: $0-$4,999; $5,000-$9,999; $10,000-$19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000), or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value;
(vii) A description of how the SFI relates to the PHS-funded research and the basis for LJI’s determination that the SFI conflicts with such research; and
(viii) A description of the key elements of LJI’s management plan, including:

(A) Role and principal duties of the conflicted Investigator in the research project;
(B) Conditions of the management plan;
(C) How the management plan is designed to safeguard objectivity in the research project; (D) Confirmation of the Investigator’s agreement to the management plan;
(E) How the management plan will be monitored to ensure Investigator compliance; and (F) Other information as needed.

5.4 Annual Report. For any FCOI previously reported by LJI with regard to an ongoing PHS-funded research project, LJI shall provide to the PHS Awarding Component an annual FCOI report that addresses the status of the FCOI and any changes to the management plan for the duration of the PHS-funded research project. The annual FCOI report shall specify whether the FCOI is still being managed or explain why the FCOI no longer exists. LJI shall provide annual FCOI reports to the PHS Awarding Component for the duration of the project period (including extensions with or without funds) and annual FCOI report shall be submitted at the time of submission of the annual progress report, multi- year progress report, if applicable, or at the time of a project extension.

6. PUBLIC ACCESSBILITY

6.1 Accessibility to Policy and SFIs. This Policy will be made accessible through LJI’s public web site. In addition, in compliance with the FCOI Regulations, LJI will, by written response within five (5) business days of a request, make available information concerning SFIs disclosed to LJI that meets the following three criteria:

(A) The SFI was disclosed and is still held by the Senior/Key Personnel;

(B) LJI determines that the SFI is related to the PHS-funded research; and (C) LJI determines that the SFI is an FCOI

6.2 SFI Information. The information regarding SFIs that LJI makes available via written response to any requestor within five (5) business days of a request, shall include:

(A) the Investigator’s name;

(B) the Investigator’s title and role with respect to the research project;

(D) the Nature of the SFI (e.g., equity, consulting fees, travel reimbursement, honoraria);

(E) the Approximate dollar value of the SFI (dollar ranges are permissible: $0-$4,999; $5,000-$9,999; $10,000-$19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000), or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.

LJI will note in its written response that the information provided is current as of the date of the correspondence and is subject to updates, on at least an annual basis and within sixty (60) days of LJI’s identification of a new FCOI, which should be requested subsequently by the requestor.

Information concerning SFIs of an individual subject to LJI’s obligation to make publicly accessible in accordance with this Section 6 of this Policy shall remain available for responses to written requests for at least three years from the date that the information was most recently updated.

7. NON-COMPLIANCE AND RESOLVING ALLEGED VIOLATIONS OF THIS POLICY

7.1 Non-compliance. To protect LJI and continued eligibility for funding, protect patient safety and welfare, and preserve the integrity of LJI research, disciplinary action may be warranted for Investigators who do not comply with this Policy. Noncompliance with this policy and/or written recommendations of the CRC shall be reported to the President of LJI by the CRO. The President shall communicate in writing to the CRC and the Investigator involved a directive for the elimination or management of such noncompliance. The involved Investigator shall provide a written report acknowledging compliance with the directive to the CRC.

If an individual subject to this policy does not comply with a directive of the President, disciplinary action, including but not limited to one or of the following may be imposed upon the noncompliant individual, at the discretion of the President: a) research activities may be put on hold; b) clinical activities may be put on hold; c) ineligibility for internal funding; d) financial penalties may be assessed on the faculty member’s research account. Failure to comply with a directive of the President concerning this policy may also, at the determination of the President, constitute good cause shown as grounds for termination in accordance with the LJI policies and procedures.

In matters where the noncompliant party is the President or the CRO, the matter will be reported by the CRC to the Board of Directors, the Board will provide the communication to the President to eliminate or manage the noncompliant activity, and the Board will make determinations regarding any disciplinary action.

7.2 Notification of PHS Awarding Component. If the failure of an Investigator to comply with this Policy or FCOI management plan appears to have biased the design, conduct, or reporting of the PHS-funded research, LJI shall promptly notify the PHS Awarding Component of the corrective action taken or to be taken. The PHS Awarding Component will consider the situation and, as necessary, take appropriate action, or refer the matter to LJI for further action, which may include directions to LJI on how to maintain appropriate objectivity in the PHS-funded research project. PHS may, for example, require LJI to enforce any applicable corrective actions prior to a PHS award or when the transfer of a PHS grant(s) involves such an Investigator.

7.3 Clinical Research. In any case in which the Department of Health and Human Services determines that a PHS- funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with an FCOI that was not managed or reported by LJI as required by FCOI Regulations, LJI shall require the Investigator involved to disclose the FCOI in each public presentation of the results of the research and to request an addendum to previously published presentations.

REFERENCES AND RELATED POLICIES

42 CFR Part 50, Subpart F, Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought

45 CFR Part 94, Responsible Prospective Contractors

NIH Financial Conflict of Interest (http://grants.nih.gov/grants/policy/coi/)

NIH Notice No. NOT-OD-18-160 (March 30, 2018), “Financial Conflict of Interest: Investigator Disclosures of Foreign Financial Interests,” https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-160.html