Disclosure

Investigator’s Name: Lawrence S. Zisman
Title: NIH grant 2 R44HL102946-02
An Inhaled PDGF receptor inhibitor for the treatment of pulmonary arterial hypertension
Role: Principal Investigator
Name of entity in which the Significant Financial Interests are held: Pulmokine Inc.; private equity ownership interest.
Value: cannot be readily determined through reference to public price or other measure of fair market value.

 

Pulmokine Inc. policy for managing conflicts of financial interests.

I. INTRODUCTION

A. General Policy

The principles articulated herein are intended to provide guidance in the management of formal relationships between employees of Pulmokine Inc. (“Company”) and their external constituencies in order to ensure that the design, conduct, and reporting of sponsored research will not be biased by any conflicting financial interests. Under the Public Health Service (PHS) and National Science Foundation (NSF) final rules on Objectivity in Research (Federal Register, July 11, 1995), and the Final Rule 2011 each investigator is required to disclose a listing of his/her significant financial interests, as well as those of his/her spouse and dependent children, that would reasonably appear to be affected by the research purposed for funding by the PHS or the NSF. If, after review of these disclosures, it is determined that the reported financial interests could directly and significantly affect the design, conduct, or reporting of the research, the Company will report the existence of such conflicting interests to the sponsor and act to protect the resulting research from bias owing to the conflict of interest. This policy statement is intended to satisfy current Federal rules for disclosure with regard to projects funded by the PHS or the NSF.

B. SCOPE

This policy and the associated procedures are applicable immediately to all sponsored program activity at Pulmokine carried out by Company employees, consultants, scientists, trainees, technicians and other agents, research collaborators, or subcontractors (“Company employees/consultants/subcontractors”). The policy and the associated procedures are derived from the final rules on Objectivity in Research promulgated by the PHS and the NSF that were published in the Federal Register of July 11, 1995 and the Final Rule 2011. These procedures will be followed whenever Pulmokine or its employees submit a request for funding from any external agency, whether it is the PHS, the NSF or another Federal agency.

C. RESEARCH AND THE MISSION STATEMENT

The Mission Statement for Pulmokine states:

The Company’s Mission: To Develop Novel Therapeutics for Pulmonary Vascular Diseases and Related Disorders.

Such company research is facilitated and/or made possible through external funding from private as well as public sources. It is the Company’s responsibility to assure the integrity of all aspects of such sponsored research while, simultaneously, taking care not to discourage the development of external funding opportunities. The purpose of this document is to identify situations where potential conflicts of significant financial interest are likely to arise and to establish a process whereby such conflicts are either avoided or at least managed equitably to the satisfaction of all concerned parties.

D. MANAGING CONFLICTS OF SIGNIFICANT FINANCIAL INTEREST

This document articulates Company policy on the management or elimination of conflicts of significant financial interest between outside constituencies and the associated funded activities carried out by Company. While this policy focuses upon avoiding, or at least managing, conflicts of significant financial interest, its primary purpose is to promote compliance with the standards of Objectivity in Research.

II. DEFINITIONS

A. Institutional Responsibilities means an Investigator’s professional responsibilities on behalf of the Institution (Pulmokine Inc.) and as defined by this policy on financial conflicts of interest. These responsibilities include research and institutional committee memberships.

B. Conflict of Significant Financial Interest is considered to occur whenever a Company employee, or a family member of the Company employee, has an existing or potential financial or other material interest that impairs, or appears to impair, the Company employee’s independence and objectivity in the discharge of his/her responsibilities to and/or for the Company; or, alternatively, conflict of significant financial interest is considered to occur whenever a Company employee receives financial or other material benefit through inappropriate use of knowledge or information confidential to the Company.

C. Company Employee is any individual employed on a full- or part-time basis by Pulmokine and is receiving, or will receive, compensation for such employment. (Includes Consultants, Agents and Research Collaborators of Company).

D. Investigator is the principal investigator, co-principal investigators, or any other Company employee responsible for the design, conduct, or reporting of externally funded scientific research activities. Senior/key personnel means the PD/PI and any other person identified as senior/key personnel by the Institution in the grant application, progress report, or any other report submitted to the PHS by the Institution under 42 CFR 50.603. An Investigator as defined herein may be a Senior/Key personnel.

E. Family member includes the Company employee’s spouse and children or other adults who qualify as dependents under the Internal Revenue Code definitions.

F. Project implies any externally funded activity such as basic, applied, or developmental research, or other activity conducted by Company employees on behalf of the Company.

G. Significant Financial Interest means 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.

Investigators also must disclose the occurrence of any travel reimbursed or sponsored by an entity other than Pulmokine Inc.  (i.e., that which is paid by a non-Pulmokine Inc. entity,  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 will include the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. 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 PHS‐funded research. Initial disclosure shall include reimbursed or sponsored travel that is received in the preceding 12 months that is related to an Investigators Institutional Responsibilities.

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, 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; or income from service on advisory committees or review panels for 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.

H. Negative Finding means a determination has been made that no conflict of significant financial interest exists.

I. Positive Finding means a determination has been made that a conflict of significant financial interest does exist and, therefore, appropriate administrative action will be required as given under III.D. below.

III. POLICY STATEMENT

A. MANDATORY DISCLOSURE OF SIGNIFICANT FINANCIAL INTERESTS

In accord with relevant Federal and State regulations, the Company is required to manage, eliminate, or reduce any potential conflicts of significant financial interests that may be inherent in the personal financial interest of an investigator. Company, therefore, requires investigators to disclose to the Company, any significant financial interest, including those of his/her family members, which would reasonably appear to affect institutional responsibilities. Investigators are required to provide updated disclosure information of significant financial interests no later than at the time of grant application, , annually during the time period of an award, and within 30 days of acquiring or discovering a new significant financial interest.

B. IDENTIFICATION OF CONFLICTS OF SIGNIFICANT FINANCIAL INTEREST

In conjunction with the administrative review of applications for grants, the Chief Scientific Officer (CSO), will review each Financial Disclosure submitted and shall make the determination of whether or not a conflict of significant financial interest exists. If the CSO, determines that no conflict of significant financial interest exists, the resulting negative finding will be filed in the Company’s Legal and Human Resource files. For negative findings no further review is required. At the current time the CSO is also the CEO.

C. APPEAL OF POSITIVE FINDINGS

Investigators may appeal a resulting positive finding to the CEO for a review of the conflict of significant financial interest determination reached by the CSO. The review of an appealed positive finding must be completed prior to the expenditure of any funds under an award. In reviewing positive findings, the CEO will be guided by the following principles: 1) Assure adherence to all relevant Company policies; 2) Give full considerations to the nature and extent of the financial interests in the relationship of the investigator, and/or the investigator’s family members, with the external constituencies; 3) Give special consideration to the terms and conditions of sponsored project agreements that mitigate or complicate the given situation; and 4) Consult fully with the investigator and obtain additional information from the investigator, as deemed appropriate to the management of the apparent conflict of significant financial interest.

D. MANAGING POSITIVE FINDINGS OF SIGNIFICANT FINANCIAL INTEREST

Following the determination of a positive finding, or upon receipt of the review by the CEO, CSO, shall make a final determination involving one of the administrative actions: 1) Accepting the sponsored project award; 2) Not accepting the sponsored project award; or 3) Accepting the sponsored project award subject to suitable modifications in the award documentation or in the investigator’s, or his/her family’s, affiliation with the external constituencies involved. Reasonable modifications under option (3) above might include one or more of the following actions; 1) Requiring that public disclosure of the identified financial interests be made; 2) Requiring that the data and research results be reviewed by independent reviewers identified by the CEO and the investigator; 3) Requiring that the research plan be modified; 4) Requiring that the investigator be disqualified from participation in a portion of the research; 5) Requiring that the investigator and/or her/his family member(s) divest certain significant financial interests related to the positive finding; or 6) Requiring that the investigator and/or his/her family members(s) sever relationships that create the conflict of significant financial interest.

E. COMPLIANCE

If an investigator who is required under this policy to file a conflict of significant financial interest disclosure fails to do so or fails to disclosure a significant financial interest on the disclosure form, the investigator may be subject to company and legal procedures. If an unreported significant financial interest involves a research project administered by the Company, appropriate administrative action required by the funding agency will also be taken. Pulmokine will promptly notify the funding agency if it is determined that the company is unable to manage satisfactorily any conflict of significant financial interest. Intentional disregard for this policy, including non-adherence to the agreed upon management plan, shall constitute serious misconduct and may be the basis for further administrative or legal inquiry.

If the failure of an Investigator to comply with the Institution’s financial conflicts of interest policy or a financial conflict of interest management plan appears to have biased the design, conduct, or reporting of the PHS‐funded research, the Institution shall promptly notify the PHS Awarding Component of the corrective action taken or to be taken. The Institution will follow appropriate directions from the PHS Awarding Component on how to maintain appropriate objectivity in the PHS‐funded research project, including enforcement of applicable corrective actions prior to a PHS award or when the transfer of a PHS grant(s) involves such an Investigator.

F. TRAINING REQUIREMENTS

The Institution will Inform each Investigator of the Institution’s policy on financial conflicts of interest, the Investigator’s responsibilities regarding disclosure of significant financial interests, and of 42 CFR regulations related to financial conflicts of interest, and require each Investigator to complete training regarding the same prior to engaging in research related to any PHS‐funded grant and at least every four years, and immediately when any of the following circumstances apply:

(1)        The Institution revises its financial conflict of interest policies or procedures in any manner that affects the requirements of Investigators;

(2)        An Investigator is new to an Institution; or

(3)        An Institution finds that an Investigator is not in compliance with the Institution’s financial conflict of interest policy or management plan.

The training shall consist of reading this Financial Conflict of Interest Policy and discussing it with the Investigator’s supervisor or the Pulmokine Board as appropriate.

G. RECORD RETENTION

The Institution will retain records relating to all Investigator disclosures of financial interests and the Institutions review of, and response to, such disclosures (whether or not a disclosure resulted in the Institution’s determination of a financial conflict of interest) and all actions under the Institution’s policy or retrospective review, if applicable, for at least three years from the date of the final expenditures report is submitted to the PHS.

H. CLINICAL RESEARCH

In any case in which the HHS determines that a PHS‐funded research project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with a financial conflict of interest that was not managed or reported by the Institution as required by this regulation, the Institution 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.

I. SUBCONTRACTORS OR SUBRECIPIENTS 

If the Institution carries out the PHS‐funded research through a subrecipient (e.g., subcontractors or consortium members), the Institution (awardee Institution) shall take reasonable steps to ensure that any subrecipient Investigator complies with this policy by:

(1)        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.

(i)         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 42 CFR 50.604(c). If the subrecipient cannot provide such certification, the agreement shall state that subrecipient Investigators are subject to the financial conflicts of interest policy of the awardee Institution for disclosing significant financial interests that are directly related to the subrecipient’s work for the awardee Institution;

(ii)        Additionally, 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 the awardee Institution to provide timely FCOI reports, as necessary, to the PHS as required;

(iii)       Alternatively, if the subrecipient’s Investigators must comply with the awardee Institution’s financial conflicts of interest policy, the agreement referenced above shall specify time period(s) for the subrecipient to submit all Investigator disclosures of significant financial interests to the awardee Institution. Such time period(s) shall be sufficient to enable the awardee Institution to comply timely with its review, management, and reporting obligations under 42 CFR 50.604(c).

(2)        Providing FCOI reports to the PHS Awarding Component regarding all financial conflicts of interest of all subrecipient Investigators consistent with this subpart, i.e., prior to the expenditure of funds and within 60 days of any subsequently identified FCOI.

J. REVIEW OF SIGNIFICANT FINANCIAL INTERESTS AND MANAGEMENT PLAN

Prior to the Institution’s expenditure of any funds under a PHS‐funded research project, the designated official(s) of an Institution shall, consistent with § 50.604(f): review all Investigator disclosures of significant financial interests; determine whether any significant financial interests relate to PHS‐funded research; determine whether a financial conflict of interest 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 financial conflict of interest. Examples of conditions or restrictions that might be imposed to manage a financial conflict of interest include, but are not limited to:

(i)         Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research);

(ii)        For research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants;

(iii)       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;

(iv)       Modification of the research plan;

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

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

(vii)      Severance of relationships that create financial conflicts.

In compliance with 42 CFR 50.605(a)(4), the Institution shall implement a management plan for Investigators with a significant conflict of interest, and the  Institution shall monitor Investigator compliance with the management plan on an ongoing basis until the completion of the PHS‐funded research project.

Whenever, in the course of an ongoing PHS‐funded research project, 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 Institution, the designated official(s) of the Institution shall, within sixty days: review the disclosure of the significant financial interest; determine whether it is related to PHS‐funded research; determine whether a financial conflict of interest 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 financial conflict of interest. Depending on the nature of the significant financial interest, the 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 of disclosure and the completion of the Institution’s review.

Whenever the Institution identifies a significant financial interest that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed by the Institution during an ongoing PHS‐funded research project (e.g., was not timely reviewed or reported by a subrecipient), the designated official(s) shall, within sixty days: review the significant financial interest; determine whether it is related to PHS‐funded research; determine whether a financial conflict of interest 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 financial conflict of interest going forward;

(ii)   (A) In addition, whenever 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, the Institution shall, within 120 days of the Institution’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)       The Institution is required to 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 a financial conflict of interest;

(6)        Reason(s) for the retrospective review;

(7)        Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed);

(8)        Findings of the review; and

(9)        Conclusions of the review.

Based on the results of the retrospective review, if appropriate, the Institution shall update a 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 shall notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. The mitigation report shall 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, the 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.

K. PUBLIC ACCESSIBILITY TO IDENTIFIED FINANCIAL CONFLICTS OF INTEREST

(i)         Prior to the Institution’s expenditure of any funds under a PHS‐funded research project, the Institution shall ensure public accessibility, via posting on Pulmokine’s website or by written response to any requestor within five business days of receipt of a request, of information concerning any significant financial interest disclosed to the Institution that meets the following three criteria:

(A)       The significant financial interest was disclosed and is still held by the senior/key personnel;

(B)       The Institution determines that the significant financial interest is related to the PHS‐funded research; and

(C)       The Institution determines that the significant financial interest is a financial conflict of interest.

(ii)        The information that the Institution makes available via written response to any requestor within five business days of a request, shall 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 (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.

Information concerning the financial conflicts of interests of an Investigator that meet criteria of this section shall remain available for responses to written requests for at least three years from the date that the information was most recently updated.

Written requests should be addressed to:
Pulmokine Inc.
7 University Place, B127B
Rensselaer NY 12144

L. PROVISION OF FCOI REPORT TO THE PHS AWARDING COMPONENT

Prior to the Institution’s expenditure of any funds under a PHS‐funded research project, the Institution shall provide to the PHS Awarding Component an FCOI report regarding any Investigator’s significant financial interest found by the Institution to be conflicting and ensure that the Institution has implemented a management plan. In cases in which the Institution identifies a financial conflict of interest and eliminates it prior to the expenditure of PHS‐awarded funds, the Institution shall not submit an FCOI report to the PHS Awarding Component.

For any significant financial interest that the Institution identifies as conflicting subsequent to the Institution’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), the Institution shall provide to the PHS Awarding Component, within sixty days, an FCOI report regarding the financial conflict of interest and ensure that the Institution has implemented a management plan. Where such FCOI report involves a significant financial interest that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed or managed by the Institution (e.g., was not timely reviewed or reported by a subrecipient), the Institution also shall complete a retrospective review to determine whether any PHS‐funded research, or portion thereof, conducted prior to the identification and management of the financial conflict of interest was biased in the design, conduct, or reporting of such research. Additionally, if bias is found, the Institution shall notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component.

M. ANNUAL FCOI REPORT

For any financial conflict of interest previously reported by the Institution with regard to an ongoing PHS‐funded research project, the Institution shall provide to the PHS Awarding Component an annual FCOI report that addresses the status of the financial conflict of interest and any changes to the management plan for the duration of the PHS‐funded research project. The annual FCOI report shall specify whether the financial conflict is still being managed or explain why the financial conflict of interest no longer exists. The Institution shall provide annual FCOI reports to the PHS Awarding Component for the duration of the project period (including extensions with or without funds) in the time and manner specified by the PHS Awarding Component.

 

 

 

DISCLOSURE OF SIGNIFICANT FINANCIAL INTERESTS FORM

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Name: Department:
Title:
Grant Proposal Title:
Intended Government Funding Agency:
Name of Constituent Organization/Institution in which you claim a Significant Financial Interest:
Name:
Address
City State Zip

Describe in detail the nature of your financial interest or role in the Constituent Organization or institution with respect to the following:

1. Describe your significant financial interest in the organization (other than ______________) that is directly related to your research interest (or would be affected by your research) or directly relates to a business decision you are participating in.

“Significant Financial Interest” means anything of monetary value, including but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interest (e.g. stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights).

The term does not include:

(1) salary, royalties, or other remuneration from the applicant institution;

(2) income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities;

(3) income from service on advisory committees or review panels for public or nonprofit entities;

(4) an equity interest that when aggregated for the Investigator and the Investigator’s spouse and dependent children, meets both of the following tests: does not exceed $5,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not represent more than five percent ownership interest in any single entity;

(5) salary, royalties or other payments that when aggregated for the investigator and the investigator’s spouse and dependent children over the next twelve months, are not reasonable expected to exceed $5,000.

2. Describe your involvement or financial interest that is, or could be perceived to be, in conflict with the discharge or your duties at:

 

Screening form for Identifying Conflicts of Significant Financial Interests

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Name: ____________________ Department: ______________

(Investigator)

Title/Status: ______________________ Other Affiliate or Status: _________

(Employee, Consultant)

Grant Proposal Title: ____________________________________

Intended Government Funding Agency: ____________________________

1. Do you have a significant financial interest in a commercial organization (other than Pulmokine) that is directly related to your research interest (or would be affected by your research) or directly relates to a business decision you are participating in?

For this purpose “Significant Financial Interest” means an interest which annually exceeds $5,000 in value (such as salary, consulting fees, fees for seminars, lectures, royalties, or intellectual property rights) or an ownership interest or Stock Option(s) in the organization which exceeds 5% when aggregated with the interests of your spouse and dependent children. (Excluding any remuneration from ______________________)

2. Do you have some involvement or financial interest that is, or could be perceived to be, in conflict with the discharge of your duties at __________?  Yes  No

3. Do you have a consulting or other financial relationship with a non-governmental external sponsor/donor of your research?  Yes  No

4. Do you have a managerial role in or an opportunity for personal gain through a significant financial interest in a company in a field of your research or a company that does business with _______________?  Yes  No

5. Do you or any member of your family have any relationships, commitments, or activities that might, in your good faith judgment, present or appear to present a conflict of interest with your research activities?  Yes  No

6. Do you currently have, or will this proposal lead to the award of, external funding for research in a subject area in which you also have a significant financial interest in any external activity such as a managerial or ownership role in a company or an opportunity to receive significant financial interest?  Yes  No

If you answer yes to any of the above questions, you will be asked to disclose in further detail any Significant Financial Interest. Italicized phrases are defined in the Policy For Managing Conflicts of Significant Financial Interest at ________________________.

Affirmation: In submitting this form, I affirm that the above information is true and accurate and, further, that I accept responsibility for being familiar with the Policy for Managing Conflicts of significant Financial Interest at _____________________.

Signature: ________________________ Date: ______________

Approved: __ Disapproved __ Signature:_______________ Date: _______

 

SOURCE: NIH SAMPLE Attachment #9

Prepared by: Lawrence Zisman, CEO 31 August 2012; updated 8 August 2015

Approved by Board of Directors: 31 August 2012 and 8 August 2015