The National Institutes of Health (NIH) has adopted regulations (42 CFR Part 50 Subpart F) on Promoting Objectivity in Research. These regulations describe the actions an individual and an organization must take in order to promote objectivity in NIH-funded research. The regulations apply to all National Institutes of Health (NIH) grants, cooperative agreements, research contracts (but not Phase 1 Small Business Innovation Research or Small Business Technology Transfer program grants), and subawards where the originating sponsor is NIH. 

Guidance: This guidance is provided to assist members of our grant team with disclosure of relationships (financial and other) to manage potential or perceived conflicts of interest relating to Public Health Service (e.g., NIH) grants and cooperative agreements.

Purpose: The purpose of this guidance is to manage potential financial conflict of interest or the appearance of financial conflict of interests (FCOI) with the intention of promoting the objectivity of Public Health Service (NIH).  This disclosure provides support for conducted research by the project investigators and protects them from potential financial conflicts of interests. 

Subrecipients Responsibilities: The awardee Institution is responsible for ensuring any subrecipient’s compliance with the regulation and reporting identified financial conflicts of interests for subrecipient Investigators to the NIH.  Awardee institutions must incorporate as part of a written agreement with a subrecipient terms that establish whether the Financial Conflict of Interest policy of the awardee Institution or that of the subrecipient will apply to subrecipient Investigators and include time periods to meet disclosure and/or Financial Conflict of Interest reporting requirements. 

Subrecipient Institutions who rely on their Financial Conflict of Interest policy must report identified financial conflicts of interests to the awardee Institution in sufficient time to allow the awardee Institution to report the Financial Conflict of Interest to the NIH to meet its reporting obligations. 

Subrecipient institutions that must comply with the awardee Institution’s policy must submit all Investigator disclosures of Significant Financial Interests to the awardee in sufficient time to allow the awardee to review, manage and report identified FCOIs to the NIH.

Awardee Institutions are responsible for monitoring subrecipient’s compliance with the Financial Conflict of Interest regulation, management plans, and for reporting all identified financial conflicts of interest to the NIH. 

DEFINITIONS

Financial conflict of interest (FCOI): a significant financial interest that could directly and significantly affect the design, conduct, or reporting of NIH-funded research.  A financial conflict of interest exists when the institution's designated official(s) reasonably determines that an investigator's significant financial interest (SFI) could directly and significantly affect the design, conduct, or reporting of the NIH-funded research. The institution is required to review each Investigator SFI disclosure to determine if a SFI:

1. is related to the NIH-supported research (i.e., could the SFI be affected by the research or is the SFI in an entity whose financial interest could be affected by the research)
   and
2. could directly and significantly affect the design, conduct, or reporting of the NIH-funded research.

SFI:  Significant Financial Interest (see SFI section below for full detail).

NIH: National Institutes of Health (NIH).

HHS: the Department of Health and Human Services

Institutional Responsibilities: an Investigator’s professional activities on behalf of the NMSUF Program (e.g., administration, research or consulting).

Principal Investigator/Investigator: the project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by award, or proposed for such funding, which may include, for example, collaborators or consultants. NMSUF’s Principal Investigator/Project Director, upon consideration of the individual’s role and degree of independence in carrying out the work, will determine who is responsible for the design, conduct, or reporting of the research.

OBLIGATIONS OF PARTICIPANTS REGARDING FCOIs:

It is the obligation of all participants to understand and comply with the policies of their individual Institution and its Institutional Review Board (IRB) and National Health Institutes guidelines.

• All Study research personnel should be in full compliance with all relevant DHHS, NIH, FDA and IRB DOI policies as well as all individual institutional DOI policies.
• Under the DHHS “final rule” (see Subpart F http://grants.nih.gov/grants/policy/coi/FCOI_final_rule.pdf) a FCOI for the purposes of the grant project consists of any qualifying (see below) financial affiliation or equity holding in a private entity where that entity could reasonably be interpreted to be affected by the results of the grant project.
• Any such FCOI that is reported to the individual’s Institution must also be reported to the grant project PI’s.
• The participant’s individual Institution then determines whether a declared FCOI requires management and the steps to be taken to mitigate the appearance of a FCOI. The management plan should also be reported to signing official of the grant project that in turn may take additional steps to manage the FCOI.
• Regardless of the individual’s Institutional requirements, each participant must also disclose any FCOI that satisfies the criteria for a significant financial interest as specified the grant project.

Who Should Complete a FCOI Disclosure Form (SFI): All individuals who are participating in the conduct of the grant project in any capacity (e.g., Principal Investigators, Co-Investigators, Study Coordinators, study staff, consultants, etc.) should complete a FCOI Disclosure Form. 

Study Duration to Which Guidance Applies: This guidance applies for the duration of the grant project activity, the preceding 12 months prior to completing the Disclosure Form, and until all major primary outcome publications are completed.

Examples of Interest that Should be Disclosed: All activities that would qualify as a duality according to the individual’s Institution requirements should be reported to the Institution and also to the grant project signing official. In addition, regardless of the Institution’s requirements, all relationships with commercial entities whose products/services are being used/tested or are in direct competition with those being used/tested should be disclosed to signing official of the grant project.

• Ownership of stock, equity, or other financial interest in a company/entity which has products that might be used in or benefit from or be harmed by the results of the grant project.
• Employment, office or directorship in any company/entity involved or potentially involved with the grant project.
• Personal compensation from any company/entity involved or potentially involved with the grant project.
• Consulting/advisory arrangements with any company/entity involved or potentially involved with the grant project, including service on:
  • Data and Safety Monitoring Boards
  • External Evaluation Committees
  • Advisory Boards
• Involvement with grants, contracts, research, training or other support (restricted or unrestricted) from any company/entity involved or potentially involved with the grant project.
• Travel grants to attend educational symposia provided by any company/entity involved or potentially involved with the grant project. This includes serving in one of the aforementioned consulting/advisory arrangements.
• Intellectual property rights (i.e. copyright, patent, trademark) related to the activities of the grant project.
• Relationship with a company/entity that may affect academic advancement or status, such as sponsorship of an endowed chair or establishment of a fund for use by the grant project investigator.

All of the above applies to companies/entities being studied as well as those in direct competition with the companies/entities being studied as defined above.

FCOI DISCLOSURE PROCEDURE:

Prior to the submission of an application to the NIH for funding, the Principal Investigator and all other individuals who meet the definition of “Investigator” (including consultants and collaborators) must have disclosed to NMSUF’s Financial Conflict of Interest Committee (FCOIC)/designated official an up-to-date listing of their Significant Financial Interests [SFIs] (and those of their spouse and dependent children), as defined above. Any new Investigator, who, subsequent to the submission of an application to the NIH for funding from the NIH, or during the course of the research project, plans to participate in the project, must similarly disclose their SFI to the FCOIC/designated official promptly and prior to participation in the project. 

Each Investigator who is participating in research under an award that originates from NIH must submit an updated disclosure of SFI at least annually, during the period of the award. Such disclosure must include any information that was not disclosed initially to NMSUF pursuant to this Policy, or in a subsequent disclosure of SFI (e.g., any financial conflict of interest identified on a NIH- funded project directly as a NIH and/or indirectly through a subaward) that was transferred from another Institution), and must include updated information regarding any previously disclosed SFI (e.g., the updated value of a previously disclosed equity interest).

Each Investigator who is participating in research under an award that originates from NIH must submit an updated disclosure of SFI (including reimbursed travel) within thirty (30) days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new SFI.

• FCOI Disclosure Forms will be completed when first engaged in the grant project and will be updated on an annual basis. New SFIs will be reported as soon as they are identified by submitting a new SFI form to the signing officer. 
• The New Mexico Start-Up Factory is responsible for reviewing the disclosures before expending funds under a new award since the institution is responsible for reporting identified FCOIs to the NIH "prior to the expenditure of funds" under a new award.
• The New Mexico Start-Up Factory is required to review a subsequently disclosed SFI within 60 days of disclosure so they can develop a management plan and report an identified FCOI to NIH within 60 days of its identification. 

• Individuals meeting the qualifications for completion of a FCOI Disclosure Form should specify their level of interest in combination with the levels of interest of their spouse and children as follows:
  • No financial interest or equity.
  • Financial interest in any publicly traded entity with a value > $5,000 including the value of equity interest.
  • Financial interest > $5,000 in a commercial entity that is NOT publicly traded OR ANY equity interest in such an entity.

                   For example:

• If an individual and/or the individual’s and/or dependent children own stock in a publicly traded company, and the individual and/or the spouse and/or dependent children have received payments from the company (e.g. as a consultant), and the total value of the income received and equity interest exceeds $5000, then this would be declared as a duality of interest under (B).
• If an individual owns equity in a company that is not publicly traded that is worth $50, regardless of any other financial interest (e.g. income) then this would be declared under (C).
• If an individual secures a $6,000 speaking fee from Pharmaceutical Company Y, whether publicly traded or not, the speaking fee is greater than $5,000 and therefore would be declared as (B or C).
• FCOI forms for all participants in the grant project should be maintained by the grant project signing official. See Records retention section below. 

REVIEW BY NEW MEXICO START-UP FACTORY’S FCOIC/DESIGNATED OFFICIAL

The FCOIC/designated official will conduct reviews of SFI disclosures. The COIC/designated official will review any SFI that has been disclosed  in a disclosure; these financial interests will be reviewed to determine if any SFI is related to the pending NIH-funded project or any NIH-funded project to determine if the SFI is related to the research and compared to each research award funded by the NIH on which the Investigator is identified as responsible for the design, conduct, or reporting of the research to determine if the SFI is related to the award and, if so, whether the SFI creates a Financial Conflict of Interest (FCOI) related to that NIH award.

FCOI REVIEW PROCEDURE:

• FCOI forms may be reviewed by the NIH and a committee appointed by the Administrative Committee of the grant project. A review group independent of the Executive Committee may review the executive committee the grant project members’ FCOI forms.
• FCOIs that are relevant should be reported prior to each steering committee meeting of the grant project.
• Change in FCOI status should be reported as soon as identified.

SIGNIFICANT FINANCIAL INTEREST (SFI): The Specific Regulatory Definition

Significant Financial Interest means: 

(1) 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) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests with the threshold of $5,000.

(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel with the threshold of $5,000 (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 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 Institution's FCOI policy will specify the details of this disclosure, which will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. In accordance with the Institution's FCOI policy, the institutional official(s) will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the NIH-funded research. 

(3) The term significant financial interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights; any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization; 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; 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:

• If an up-to-date financial disclosure is on file at the Institution at the time an application is submitted to the NIH, a new financial disclosure is not required unless an Investigator needs to report a change to the SFI data from what was previously disclosed to the Institution.  This was highlighted in the Preamble to the final rule which states that Investigators who have not previously disclosed their SFIs to the Institution's designated official(s) must do so no later than the time of application.  Institutions may establish a process prior to the submission of an application for Investigators to verify the currency of their SFI data and provide the ability to make changes, when needed, to ensure that an up-to-date financial disclosure is on file at the time of application to promote compliance with the regulation.
• 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. See NIH Guide Notices NOT-OD-18-160 and NOT-OD-22-210for more information. 

Small Business Innovation Research (SBIR) Program means the extramural research program for small businesses that is established by the Awarding Components of the Public Health Service and certain other Federal agencies under Public Law 97–219, the Small Business Innovation Development Act, as amended. For purposes of this subpart, the term SBIR Program also includes the Small Business Technology Transfer (STTR) Program, which was established by Public Law 102–564.  

Reference:  https://www.ecfr.gov/current/title-42/chapter-I/subchapter-D/part-50#p-50.603(Significant%20financial%20interest)

MANAGEMENT OF SIGNIFICANT FINANCIAL INTERESTS THAT POSE FINANCIAL CONFLICT(S) OF INTEREST

If a conflict of interest exists, the FCOIC/designated official will determine by what means

– such as the individual’s recusal from decisions affecting the conflicting entity, abstention from the external activity, modification of the activity, and/or monitoring of the activity by a subcommittee – the conflict should be avoided or managed in order to mitigate undue bias. In making those determinations, the FCOIC/designated official will be guided by the principles discussed in this Policy the FCOIC/ designated official will also take into consideration whether the Investigator’s ongoing role is necessary to continue advancing the research, based upon the factors such as the uniqueness of his or her expertise and qualifications.

Examples of conditions that might be imposed to manage a financial conflict of interest include, but are not limited to:

1. Public disclosure of financial conflicts of interests (e.g., when presenting or publishing the research; to staff members working on the project; to the Institution’s Institutional Review Board(s), Institutional Animal Care and Use Committee(s), etc; 
2. For research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants; 
3. Disclosure of all publications, presentations, speaking events relevant to the study of the project including IRB, IACUC, etc.
4. Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the Financial Conflict of Interest;  
5. Modification of the research plan;
6. Change of personnel or personnel responsibilities, or disqualifications of personnel from participation in all or a portion of the research; 
7. Reduction or elimination of the financial interest (e.g., sale of an equity interest); or
8. Severance of relationships that create financial conflicts
9. Double-blind conditions;
10. Provisions to conduct the work simultaneously at multiple sites;
11. Written disclosure of the conflict to all individuals working on the research project;

If the FCOIC/designated official determines that a conflict exists, it will communicate its determination and the means it has identified for eliminating or managing the conflict, in writing, to the individual, to the relevant Principal Investigator/Project Director, and the appropriate direct supervisor. The FCOIC/designated official will keep a record of the disclosure and other relevant information for at least three years. If the FCOIC/designated official prescribes monitoring of the activity, it will describe what monitoring shall be performed and what records are to be kept.

No expenditures on an award supported by the NIH will be permitted until the Investigator has complied with the Disclosure requirements of this Policy and has agreed, in writing, to comply with any plans determined by the FCOIC/designated official necessary to manage the Conflict of Interest. The FCOIC/designated official will communicate, in writing, with the NIH Grantee to notify it of the existence and the nature of a Financial Conflict of Interest and whether the conflict has been managed, reduced, or eliminated.

The FCOIC/designated official will keep a record of Investigator disclosures of financial interests and the FCOIC/designated official’s review of, and response to, such disclosure and all actions under this policy. Such records will be maintained and kept for at least three years from the date the final expenditures report is submitted and in accordance with the terms and conditions of the award and relevant Regulations at 45 CFR 75.361.

PUBLIC ACCESSIBILITY TO INFORMATION RELATED TO FINANCIAL CONFLICTS OF INTEREST

Prior to the expenditure of any funds under an award funded by the NIH, NMSUF will ensure public accessibility, via a publicly accessible website or by written response to any requestor within five business days of a request of information concerning any SFI disclosed that meets the following three criteria:

• The Significant Financial Interest was disclosed and is still held by the senior/key personnel. Senior/key personnel are the PD/PI and any other person identified as senior key personnel by NMSUF in the award application to the NIH, progress report or any other report submitted to the NIH Grantee;
  
  
• NMSUF has determined that the Significant Financial Interest is related to the research funded through an award;and 
  
  
• NMSUF has determined that the Significant Financial Interest is a financial conflict of

The information that NMSUF will make available via a publicly accessible Website or in a written response to any requestor within five days of request will include, at a minimum, the following:

• The Investigator’s name;
• The Investigator’s title and role with respect to the research project;
• The name of the entity in which the Significant Financial Interest is held;
• The nature of the Significant Financial Interest; and
• The approximate dollar value of the Significant Financial Interest in the following ranges: $0-$4,999; $5,000-9,999; $10,000 - $19,999; amounts between $20,000-$100,000 by increments of $20,000; amountsabove

$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.

If NMSUF uses a publicly accessible Website to comply with the public disclosure requirements of the NIH regulations, the information posted will be updated at least annually, and within sixty days of receipt or identification of information concerning any additional Significant Financial Interest of the senior/key personnel for the NIH-funded research project that had not been previously disclosed, or upon the disclosure of a Significant Financial Interest of senior/key personnel new to the NIH-funded research project, if it is determined by the COIC/designated official that the Significant Financial Interest is related to the research and is a financial conflict of interest.

If NMSUF responds to written requests for the purposes of public accessibility, it will ascertain from the Investigator that the information provided is current as of the date of the correspondence, and will note in its written response that the information is subject to updates, on at least an annual basis and within 60 days of the NMSUF’s identification of a new financial conflict of interest, which should be requested subsequently by the requestor.

Information concerning the Significant Financial Interests of an individual, as limited by this Policy, will remain available, for responses to written requests or for posting via NMSUF’s publicly accessible Website for at least three years from the date that the information was most recently updated.

REPORTING OF FINANCIAL CONFLICTS OF INTEREST

Prior to the expenditure of any funds under an NIH award, NMSUF will provide to the NIH Grantee a FCOI report compliant with NIH regulations regarding any Investigator’s Significant Financial Interest found to be conflicting and will ensure that the Investigator has agreed to and implemented the corresponding management plan. NMSUF cannot incur expenditures until it has received notification to do so from the NIH Grantee.

While the award is ongoing (including any extensions with or without funds), NMSUF will provide to the NIH Grantee an annual FCOI report that addresses the status of the FCOI and any changes in the management plan.

For any Significant Financial Interest that is identified as conflicting subsequent to an initial FCOI report during an ongoing NIH-funded research project (e.g., upon the participation of an Investigator who is new to the research project), NMSUF will provide to the NIH Grantee, within sixty (60) days, an FCOI report regarding the financial conflict of interest and ensure that NMSUF has implemented a management plan and the Investigator has agreed to the relevant management plan.

RECORDS RETENTION 

NMSUF policies must be followed regarding maintenance of records as long as they are in compliance with the NIH regulation. Under the regulation, NMSUF is required to keep all records of all Investigator disclosures of financial interests and the Institution’s review of, or response to, such disclosure (whether or not a disclosure resulted in a determination of a Financial Conflict of Interest), and all actions under the Institution’s policy or retrospective review, if applicable, as follows:

• Records of financial disclosures and any resulting action must be maintained by the Institution for at least three years from the date of submission of the final expenditures report or, where applicable, from other dates specified in 45 C.F.R. 75.361 (see FAQ A.11) for different situations. 

NMSUF retains records for each competitive segment as provided in the regulation. 

TRAINING REQUIREMENTS

Each Investigator must complete training on The regulation, the New Mexico Start-up Factory’s FCOI policy, and of the Investigator's disclosure requirements per the Conflict of Interest Policy applicable to a prime recipient or subaward prior to engaging in research related to any NIH-funded award and at least every four years, and immediately (as defined below) when any of the following circumstances apply:

• NMSUF revises this Policy, or procedures related to this Policy, in any manner that affects the requirements of Investigators (training is to be completed within the timeframe specified in communications announcing such changes);
• An Investigator is new to NMSUF research under an award issued by the NIH (training is to be completed prior to his/her participation in the research); or
• NMSUF finds that an Investigator is not in compliance with this Policy or a management plan issued under this Policy (training is to be completed within 30 days in the manner specified by the COIC/designated official).

In fulfillment of the training requirement on the regulation, NMSUF requires its investigators to complete the National Institutes of Health’s Financial Conflict of Interest tutorial located at: http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm in accordance with the requirements and expectations of this Policy. All investigators must print a certification of completion at the end of training and retain it for audit purposes.

CLINICAL RESEARCH

If the NIH Grantee determines that one of its funded clinical research projects 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 a Financial Conflict of Interest that was not managed or reported by NMSUF shall require the Investigator involved to disclose the Financial Conflict of Interest in each public presentation of the results of the research and to request an addendum to previously published presentations.

FAILURE TO COMPLY WITH NMSUF’S FCOI POLICY APPLICABLE TO AN NIH GRANT AWARD

When a Financial Conflict of Interest is not identified or managed in a timely manner, including:

• Failure by the Investigator to disclose a Significant Financial Interest that is determined by the Institution to constitute a Financial Conflict of Interest;
• Failure by the Institution to review or manage such a Financial Conflict of Interest; or 
• Failure by the Investigator to comply with a Financial Conflict of Interest management plan;

NMSUF shall, within 120 days of determination of noncompliance, complete a “retrospective review” of the Investigator’s activities and the NIH-funded research project to determine whether any NIH-funded research, or portion thereof, conducted during the time period of the noncompliance was biased in the design, conduct, or reporting of such research. 

NMSUF shall document the retrospective review which must include at least 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 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, etc.);
8. Findings of the review; and
9. Conclusions of the review.

If bias is found, NMSUF must notify NIH promptly and submit a mitigation report.  If the FCOI was previously reported to the NIH, the mitigation report is submitted as a “Revised FCOI Report.” (see FAQ H.2.).  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 (i.e., 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, NMSUF will submit FCOI reports annually as prescribed by the regulation. 

FAILURE TO COMPLY WITH THIS POLICY

No expenditures of funds on an award supported by the NIH will be permitted unless the Investigator has complied with the Disclosure requirements of this Policy and has agreed, in writing, to comply with any COIC/designated official approved FCOI management plan.

Any failure by an individual to adhere to this Policy may be cause for disciplinary action, including, in severe cases, termination.