Policy regarding conflict of interest in scientific activities and research

*Pending final approval

Introduction
  1. The mission of the Weizmann Institute of Science (the "Institute") is to conduct basic and applied research and to educate and train new scientists in the natural and exact sciences. The Institute’s role as a research institution is stimulated and enriched by the interaction of its faculty with other research institutions, institutions of higher learning as well as with industrial and business organizations. This requires establishing Institute rules and policies regarding the prevention and management of conflicts of commitment and interest between the Institute and its Scientists (as defined hereunder).
  2. This document sets out the Policy of the Institute governing the prevention and management of conflicts of commitment and interest between the Institute and its Scientists (as defined hereunder), as well as the promotion of objectivity in Research (as defined hereunder) by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of Research (as defined hereunder) will be free from bias resulting from Scientists' financial and other conflicts of interest. Within the foregoing, this Policy indicates situations that generate Potential Conflicting Activities (as defined hereunder) related to Research, either directly or indirectly, and provides mechanisms for Scientists and the Institute to manage those Potential Conflicting Activities that arise.
  3. This Policy applies to all Scientists, as defined hereunder, performing any task or participating in or performing any Research (as defined hereunder) at the Institute.
  4. Subject to the provisions of this Policy, the Institute’s Vice President for Technology Transfer (the "VPTT") is authorized to review cases of Potential Conflicting Activities in Research (as such terms defined hereunder) and to determine the necessary actions that should be taken in order to manage such activities.
  5. Every Scientist should become familiar with, and abide by, the provisions of this Policy and is urged to discuss any questions of Potential Conflicting Activities (as defined hereunder) with VPTT.
  6. This Policy shall be available via the Institute's publicly accessible Website.
  7. This Policy replaces all previous rules, decisions or regulations of the Institute in respect of the matters dealt with in this document, including the provision of Section 5 to Institute Rules of Intellectual Property and Conflict of Interests effective ___ __, ___.
Definitions
  1. In this Policy, the following terms shall have the following meanings:
  2. "Activity" – means any engagement, arrangement and/or activity, of any kind or nature whatsoever, which the Scientist performs and/or is involved in, either wholly or partially, formal or otherwise, in any field or matter, including any of the Scientist's Institutional Responsibilities.
  3. "Contracting Party" – means any entity which engages, or intends to engage, in any activity in the field(s) in which a Scientist is engaged, either wholly or partially, at the Institute, and with which the Institute and/or Yeda Research and Development Company Ltd. ("Yeda") intend to enter into or have already entered into any arrangements, understandings or agreements, formal or otherwise, in any field or matter.
  4. "Conflict of Interest Committee (“COIC”)" – means a committee of the Institute comprised of three members: (i) the Vice President of the Institute (the "VP"), (ii) a Scientist appointed by the VPTT (the Institute's Vice President for Technology Transfer), and (iii) a legal adviser appointed by the General Counsel of the Institute.
  5. "Conflicting Activity"- means any (i) Financial Conflict of Interest of the Scientist and/or any Relative thereof; and/or (ii) any Potential Conflicting Activity which has been determined by the VPTT as an Activity that creates, directly or indirectly, a conflict with the Institute’s interests and/or activities, and/or as an Activity that has to be Managed, in accordance with the provisions of this Policy.
  6. "Financial Interest" – means anything of monetary value, whether or not the value is readily ascertainable.
  7. "Financial Conflict of Interest (“FCOI”)" – means a Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of a Research. For the avoidance of doubt, any FCOI, shall also be deemed as a Conflicting Activity.
  8. "Institutional Responsibilities" – the Scientist’s professional responsibilities associated with his or her institutional appointment or position, such as Research, Research consulting, teaching, administration and institutional, internal and external, professional committee service.
  9. "Manage" – means taking action to address a Conflicting Activity, which can include reducing or eliminating the Conflicting Activity, to ensure, to the extent possible, that the design, conduct, and reporting of Research will be free from bias.
  10. "Potential Conflicting Activity" – means any engagement, arrangement and/or activity of any kind or nature whatsoever, which might create, directly or indirectly, a conflict with the Institute’s interests and activities, including any such activity which might create, directly or indirectly, a conflict between the Institute’s interests and activities, on the one hand, and any interest or benefit of any kind or nature whatsoever which the Scientist and/or any Relative thereof may have, gain, derive or receive, or which may be expected to be accrued, gained, derived or received by the Scientist and/or any Relative thereof due or resulting from or in connection with any such activity and/or any of the Scientist's Institutional Responsibilities, on the second hand, including any Significant Financial Interest of the Scientist and/or any Relative thereof.
  11. "Relative" – means any spouse, sibling, parent, grandparent, descendant, descendants or parent of a spouse or the spouse of any such sibling, parent, grandparent or descendant; “descendant” includes a descendant by adoption; “spouse” includes a common-law spouse.
  12. "Research" – means a systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge. This term encompasses basic and/or applied research and/or product development.
  13. "Scientist" – means any employee of the Institute, as well as any persons who are not Institute employees, regardless of title or position, who use the Institute laboratories and/or other facilities and/or resources, including students and post-docs, and all guest scientists and retired scientists (including emeritus), who perform any task or participate in or perform any Research at the Institute.
  14. "Significant Financial Interest (“SFI”)" – means:
    1. A Financial Interest consisting of one or more of the following interests of the Scientist and/or any Relative thereof that reasonably appears to be related to one or more of the Scientist's Institutional Responsibilities:
      1. With regard to any entity: (a) any Remuneration received from the entity; and/or (b) any Proprietary Interest in the entity, as of the date of disclosure.
        For the purpose of this Policy:
        The term "Remuneration" – includes salary, benefits and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship);
        The term "Proprietary Interest" – means any holding, directly or indirectly, by a Scientist and/or any Relative thereof, of any equity or other proprietary interest of any kind or nature, in any entity, corporate or otherwise (including, without limitation, any equity, shares, stock, stock option, warrants, ADRs, options, debentures, securities, convertible into equity or into options to equity and any other instruments conferring upon its holder or beneficiary any right in any such entity and any option to receive any such right or any other ownership interest) which entitles the holder thereof to exercise:

        • voting rights in the relevant entity, and/or
        • rights to appoint directors (or equivalent organs) in the relevant entity, and/or
        • rights to a share in the profits of the relevant entity, and/or
        • a right to be appointed as a director (or equivalent organ) or to an executive position in the relevant entity.
          Notwithstanding the foregoing, the holding, directly or indirectly, of equity or other proprietary interests as aforesaid which are listed for trading on a stock exchange shall not be deemed a "Proprietary Interest" if such holding constitutes less than 1% (one percent) of the issued relevant equity or other proprietary interests for the time being of the relevant entity.
      2. Any receipt of income and/or any other Remuneration in connection with any intellectual property rights and/or interests (e.g., patents, copyrights etc.).
    2. The occurrence of any reimbursed or sponsored travel (i.e., that which is fully or partly paid on behalf of the Scientist and not reimbursed to the Scientist so that the exact monetary value may not be readily available), related to his/her Institutional Responsibilities; provided, however, that this does not apply to travel that is reimbursed or sponsored by a federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.
    3. Exclusions: Notwithstanding anything to the contrary contained herein, the term Significant Financial Interest (SFI) does not include the following types of Financial Interests:
      1. Salary, royalties, or other remuneration paid by the Institute or by Yeda to the Scientist, including intellectual property rights assigned to the Institute or Yeda and agreements to share in royalties related to such rights;
      2. Income from investment vehicles, such as saving funds and retirement accounts and/or any other investment(s) which is not related to the Institute and/or Yeda and/or any affiliate or related entity thereof and/or to the Scientist's Research or to his Institutional Responsibilities (or any part thereof), all as long as the Scientist does not directly control the investment decisions made in these vehicles or such investment(s), as applicable;
      3. Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education; and/or
      4. Income from service on advisory committees or review panels for a federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.

For the avoidance of doubt, any SFI shall also be deemed as a Potential Conflicting Activity.

Prevention of conflict of interests – general
  1. A Scientist has an obligation of loyalty to the Institute, as well as the duty to dedicate the required professional expertise, time and energy to the Scientist's Activities at the Institute, including all of the Scientist's Institutional Responsibilities.
  2. Accordingly, a Scientist must refrain from any Conflicting Activity, and is expected to avoid or minimize any Potential Conflicting Activity. Without derogating from the generality of the foregoing, Scientists must comply with this Policy when conflicts of interest or Potential Conflicting Activity arise.
  3. Scientists are often approached to serve in outside bodies as consultants, on advisory committees, as board members, or in other capacities in either commercial or non-commercial entities, such as Government agencies, public organizations or academic institutions ("External Entity"). Without derogating from the provisions of Clause ‎5.1 below Scientists’ services to External Entities, shall be disclosed pursuant to this Policy, and shall reviewed and managed according to the Institute's Rules of Intellectual Property and Conflict of Interests.
  4. The VPTT is authorized to determine whether an Activity is a Potential Conflicting Activity and whether a Potential Conflicting Activity is a Conflicting Activity.
  5. The VPTT may consult with the COIC in the process of review and determination of a Potential Conflicting Activity and/or a Conflicting Activity.
  6. In the event that the VPTT is in conflict of interest in connection with the VPTT's authorities and powers herein (such as in the event that the VPTT is the Scientist for whom a decision is required hereunder), then all of the VPTT's authorities and powers herein shall be transferred to the President of the Institute (the “President”), who shall be authorized to determine, decide and approve any activity or arrangement regarding the foregoing.
  7. In the event that the President is in conflict of interest in connection with the President's authorities and powers herein (such as in the event that the President is the Scientist for whom a decision is required hereunder), then all of the VPTT's and President's authorities and powers herein shall be transferred to the a committee of the Institute comprised of the following members: (i) the VP, (ii) the VPTT, and (iii) the General Counsel of the Institute, and such committee shall be authorized to determine, decide and approve any activity or arrangement regarding the foregoing.
Disclosure of potential conflicting activity
  1. A Scientist who, whether alone or with another person or persons, whether with or without present or future or expected Remuneration or consideration of any kind, nature or description, whether prior to or during his/her Activity at the Institute engages or intends to engage in any Potential Conflicting Activity, must immediately make full written disclosure to the VPTT regarding such existing or Potential Conflicting Activity.
  2. Without derogating from the generality of the provisions of Clause ‎4.1 above, each Scientist must submit to the VPTT, an updated disclosure of SFI within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new SFI by the Scientist or his Relative.
  3. Without derogating from the generality of the aforesaid, all Scientists are required to disclose their SFI: (a) to the Research Grants and Projects Office ("RGP") at the time of grant proposal submission; (b) to the relevant Institute’s ethics committee at the time of submission of an application for ethics approval for the Research; and (c) to the Academics Affairs Office on an annual basis. Such disclosure will be forwarded to the VPTT for his/her review and decision.
  4. The details of Potential Conflicting Activity disclosure shall be in accordance with Appendix A.
Review and decision of potential conflicting activities

Prohibitions

  1. A Scientist may not engage in any Potential Conflicting Activity, which has been acquired or has begun prior to the Scientist's Activity at the Institute, unless prior written approval by the VPTT is obtained to such Potential Conflicting Activity, and solely in accordance with the conditions laid down by the VPTT for such approval, as shall be determined by the VPTT.
  2. Notwithstanding anything to the contrary herein, a Scientist who is an employee of the Institute shall not be entitled:
    • To serve in any managerial or executive capacity in any commercial entity, save during the period that such Scientist is on unpaid leave of absence and provided that the Scientist has received the prior written approval of the VPTT to serve in such capacity during such period; or
    • To serve as a director of any commercial entity unless such Scientist have received the VPTT’s prior written approval therefore.
  3. Notwithstanding anything to the contrary herein, a Scientist or his/her Relative shall not be entitled:
    • To serve as a director of any Contracting Party or any other commercial entity with which the Institute and/or Yeda has entered into an agreement or is conducting commercial negotiations regarding any Institute's invention, development, discovery, improvement, advance, system, material, compounds process, product, software, hardware, algorithm, organism, genetic materials, plant species, plant strains, design, machine, and/or all other know-how, Research results and technology of whatsoever nature, to which the Scientist is a contributor; or
    • To serve as a director (or equivalent organ) of any commercial entity to which the Scientist is providing consulting services.

Management Plan –Conflicting Activities

  1. Without derogating from the generality of the provisions of Clause ‎5.1 above (and without derogating from the power of the VPTT to lay down conditions for any approval the VPTT may grant pursuant to Clause ‎5.1.1 above), if a disclosure made by a Scientist reveals a Potential Conflicting Activity, it will be reviewed at a timely manner by the VPTT for a determination of whether it constitutes a Conflicting Activity.
  2. If the VPTT is of the view that such Potential Conflicting Activity does not create a Conflicting Activity – the VPTT will approve it.
  3. If the VPTT determines that (a) a Conflicting Activity exists and (b) such Conflicting Activity can be Managed, in a way that is intended to eliminate the conflict, the VPTT will take action to develop and implement a written management plan that shall specify the actions that have been, and will be, taken to Manage such Conflicting Activity, with the aim to eliminate the conflict ("Management Plan").
  4. The Management Plan shall specify the actions that have been, and shall be, taken to Manage such Conflicting Activity. Examples of conditions or restrictions that might be imposed to Manage a Conflicting Activity are detailed in Appendix B.
  5. If the VPTT determines that (a) a Conflicting Activity exists, and (b) such Conflicting Activity cannot be Managed, than, subject to the approval by the President and subject to any applicable law, the Scientist shall immediately be removed from all of his/her Institutional Responsibilities, Research(s) and any other Activities at the Institute which creates, directly or indirectly, the conflict of interest.
  6. The affected Scientist must formally agree to and sign the proposed Management Plan before any related Research goes forward.
  7. Whenever the Institute implements a Management Plan pursuant to this Policy, the Institute shall monitor Scientist compliance with the Management Plan on an ongoing basis.
  8. Whenever during an ongoing Research: (i) a Scientist who is new to participating in the Research project discloses a Potential Conflicting Activity, or an existing Scientist discloses a new Potential Conflicting Activity  to the Institute (“New Potential Conflicting Activity”); or (ii) the Institute identifies Potential Conflicting Activity that was not disclosed timely by a Scientist or, for whatever reason, was not previously reviewed by the VPTT during an ongoing Research project (“Existing Undisclosed Potential Conflicting Activity”), the VPTT shall, within sixty days: review the New Potential Conflicting Activity or Existing Potential Undisclosed Potential Conflicting Activity, as the case may be; determine whether a Financial Conflict of Interest or any other Conflicting Activity exists (and if such FCOI or any other Conflicting Activity can be Managed, in a way that is intended to eliminate the conflict); and, if so, implement a Management Plan in line with the guidelines set in Appendix C.
Scientist non-compliance
  1. Without derogating from the powers of President, and/or the VPTT hereunder, in the event of a Scientist’s failure to comply with this Policy, the President may suspend all Scientist's relevant Activities at the Institute or take any other action deemed appropriate pursuant to the Institute’s regulations and policies until the matter is resolved.
  2. The President’s administrative action regarding a Scientist's failure to comply with this Policy will be conveyed in writing to the Scientist.
Phs-funded research projects
  1. Research Projects that are funded by the US Public Health Service ("PHS"1) are subject to 42 CFR Part 50 Subpart F2 which aims to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under PHS grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest (“PHS Funded Research”).
  2. The provisions applicable to PHS Funded Research in addition to this Policy are detailed in Appendix D.    

 

[1]        In this Policy, the term "PHS" – means the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH).

[2]        https://ecfr.io/Title-42/Section-50.601

Record retention
  1. The VPTT will retain all disclosure forms, Management Plans, and related documents.
  2. Such retention shall be for a period of at least three years (and with respect to any funded Research project, at least three years from the date of the final financial report is submitted to the funding agencies), unless any litigation, claim, financial management review, or audit is started before the expiration of such three year period, in which case the records shall be retained until all litigation, claims or audit findings involving the records have been resolved and final action taken.
Confidentiality

To the extent permitted by law, all disclosure forms, Management Plans, and related information will be confidential. However, the Institute may be required to make such information available to the PHS, to a requestor of information concerning Financial Conflict of Interest related to PHS or other source of funding, or to the primary entity who made the funding available to the Institute, if requested or required. Subject to applicable law, if the Institute is requested to provide disclosure forms, Management Plans, and related information to an outside entity, the Scientist will be informed of this disclosure.

Appendix A

Disclosure of Potential Conflicting Activity

Disclosure shall include, at a minimum, the following details:

  1. The Scientist's name;
  2. In case of PHS Funded Research, the Scientist's title and role with respect to the Research project;
  3. The name of the entity in which the SFI is held.
  4. The nature of the SFI;
  5. The approximate USD value of the SFI within the following ranges in USD: $0-$4,999; $5,000-$9,999; $10,000-$19,999; $20,000-$100,000; amounts above $100K by increments of $50K, 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.
  6. In addition, in case of SFI in the form of any reimbursed or sponsored travel, as set out in Clause ‎2.14.2 of the Policy, such disclosure shall include, at a minimum, the following details: (i) the purpose of the trip, (ii) the identity of the sponsor/organizer, (iii) the destination, and (iv) the duration. The VPTT will determine if any further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI.
Appendix B

Management Plan

Examples of conditions or restrictions that might be imposed to Manage a Conflicting Activity include, but are not limited to:

  1. Public disclosure of the Conflicting Activity (e.g., when presenting or publishing the Research);
  2. For Research projects involving human subjects research, disclosure of the Conflicting Activity  directly to participants;
  3. Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the Research against bias resulting from the Conflicting Activity;
  4. Modification of the Research plan;
  5. Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the Research;
  6. If applicable, reduction or elimination of the FCOI (e.g., sale of a Proprietary Interest or depositing the SFI in Blind Trust). “Deposit in a Blind Trust” for the purpose hereof shall mean transfer of said SFI to a trustee or (with respect to SFI in publicly traded entities) to a public portfolio or asset management entity or an outright sale or a sale with a re-purchase option of said SFI to a bona fide third party. All such Blind Trust arrangements by the Scientist and/or his Relative(s) shall be subject to prior written approval by the VPTT.
  7. Severance of relationships that create the Conflicting Activity.
  8. If the Scientist has so requested – Subject to the approval by the President, to approve unpaid leave, for a period and on such further terms and conditions as shall be determined by the President, such period not to exceed two years.
Appendix C

Guidelines for Review and Management of New or Existing Undisclosed Potential Conflicting Activity during an Ongoing Research

  1. Management of New Potential Conflicting Activity
    Following review, depending on the nature of the New Potential Conflicting Activity, the VPTT may determine the interim measures that are necessary with regard to the Scientist's participation in the Research project between the date of disclosure and the completion of the Institute's review.
  2. Management of Existing  Undisclosed Potential Conflicting Activity
    Following review, the VPTT shall:

    1. Implement, on at least an interim basis, a Management Plan going forward;
    2. In addition, whenever a Financial Conflict of Interest is not identified or Managed in a timely manner, including failure by the Scientist to disclose SFI that is determined by the VPTT to constitute a FCOI, failure by the Institute to review or manage such FCOI, or failure by the Scientist to comply with a Management Plan, the VPTT shall, within 120 days of the determination of noncompliance, complete a retrospective review of the Scientist's Activities and the Research project to determine whether any Research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such Research.
    3. The VPTT will document the retrospective review; such documentation shall include, but not necessarily be limited to, all of the following key elements: (1) Research project number, (2) Research project title, (3) Research project Principal Investigator, (4) name of the Scientist with the FCOI, (5) name of the entity with which the Scientist has a 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) conclusion of the review.
    4. Depending on the nature of the FCOI, the VPTT may determine that additional interim measures are necessary with regard to the Scientist's participation in the Research project between the date that the FCOI or the Scientist's non-compliance is determined and the completion of the Institute's retrospective review.
Appendix D

PHS Funded Research – Additional Provisions

  1. Training
    • It is required that Scientists complete training regarding this Policy, the Institute's rules concerning Financial Conflict of Interest and the Scientists responsibilities in connection therewith, prior to submitting a Research proposal to the PHS.
    • Such training must be done prior to engaging in Research funded by PHS, and at least every four years thereafter, as well as immediately when any of the following circumstances apply: (a) the Institute revises this Policy or rules concerning Financial Conflict of Interest in any manner that affects the requirements of Scientists; (b) a Scientist is new to the Institute; or (c) the Institute finds that a Scientist is not in compliance with this Policy, the Institute's rules concerning Financial Conflict of Interest or Management Plan.
    • NIH online Financial Conflict of Interest tutorial.
    • Following completion of such training, a conflict of interest training certificate, in a PDF format, should be sent by the Scientist to RGP.
  2. Reporting
    PHS Funded Research is subject to reporting requirements as detailed in Appendix D1
  3. Public Accessibility
    The Institute will respond to any requestor of information concerning any SFI disclosed to the Institute regarding PHS Funded Research, within five business days of the request, as detailed in Appendix D2.
  4. Sub-Recipients of the Institute
    • For PHS-funded Research that is carried out through a sub-recipient, the Institute will take reasonable steps to ensure that any sub-recipient Scientist complies with 42 CFR 50 subpart F, by incorporating in the sub-contract, terms that establish whether this Policy or the sub-recipient’s own FCOI Policy will apply to its Scientists.
    • Sub-recipient institutions who rely on their FCOI Policy must report identified FCOI to the Institute in sufficient time to allow the Institute to report the FCOI to the PHS or NIH to meet its reporting obligations.
Appendix D1

PHS Funded Research - Reporting Requirements

  1. Prior to the Institute’s expenditure of any funds under a PHS Funded Research, RGP shall provide to the PHS Awarding Component a Financial Conflict of Interest Report (“FCOI Report”) regarding any Scientist’s SFI found to be conflicting and ensure that a Management Plan was implemented. In cases in which FCOI was identified and eliminated prior to the expenditure of PHS awarded funds, FCOI report is not required.
  2. For any FCOI previously reported with regard to an ongoing PHS Funded Research project, RGP 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 financial conflict is still being managed or explain why the financial conflict of interest no longer exists. RGP 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.
  3. For any SFI that is identified as conflicting subsequent to the initial FCOI Report during an ongoing PHS Funded Research project, RGP shall provide to the PHS Awarding Component, within sixty days, an FCOI Report and ensure that a Management Plan has been implemented.
  4. Where such FCOI Report involves SFI that was not disclosed timely by a Scientist or, for whatever reason, was not previously reviewed or managed, the VPTT shall 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. If bias is found, RGP shall to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component.
  5. Any FCOI Report shall include sufficient information to enable the PHS Awarding Component to understand the nature and extent of the financial conflict, and to assess the appropriateness of the Management Plan. Elements of the FCOI Report shall include, but are not necessarily limited to the following:
    • Project number;
    • Name of the Scientist with the FCOI;
    • Name of the entity with which the Scientist has a FCOI;
    • Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium); (v) Value of the 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;
    • A description of how the financial interest relates to the PHS Funded Research and the basis for the determination that the financial interest conflicts with such Research; and
    • A description of the key elements of the Management Plan, including: role and principal duties of the conflicted Scientist in the Research project; conditions of the Management Plan; how the Management Plan is designed to safeguard objectivity in the Research project; confirmation of the Scientist's agreement to the Management Plan; how the Management Plan will be monitored to ensure Scientist compliance; and other information as needed.
  6. In addition, RGP will promptly notify the PHS of Scientist incompliance with this Policy and the action taken or to be taken by the Institute in the event of Scientist non-compliance. If the funding for the Research is made available from a prime PHS awardee, such notification shall be made promptly to the prime awardee for reporting to PHS.
Appendix D2

PHS Funded Research - Public Accessibility

  1. The Institute will respond to any requestor of information concerning any SFI disclosed to the Institute regarding PHS Funded Research that meets the following criteria, within five business days of the request:
    • The SFI was disclosed and is still held by the Scientist;
    • A determination has been made that the SFI is related to the PHS Funded Research; and
    • A determination has been made that the SFI constitutes a Financial Conflict of Interest.
  2. Such information will include:
    • The Scientist's name.
    • The Scientist's title and role with respect to the Research project.
    • The name of the entity in which the SFI is held.
    • The nature of the SFI.
    • The approximate USD value of the SFI within the following ranges in USD: $0-$4,999; $5,000-$9,999; $10,000-$19,999; $20,000-$100,000; amounts above $100K by increments of $50K, 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.
  3. The information as aforesaid shall be updated at least annually.
  4. When the Institute responds to written requests it 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 60 days of its identification of a new Financial Conflict of Interest, which should be requested subsequently by the requestor.
  5. Information concerning the SFI shall remain available, for responses to written requests for at least three years from the date that the information was most recently updated.