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Conflict of Interest Policy

Effective: August 24, 2012
Revised: April 29, 2013

Approved by Council on Sponsored Activities June 5, 2012

Introduction

Regulatory bodies and authorities on governance encourage nonprofit organizations to adopt and regularly evaluate a written conflict of interest policy that: requires governing board members and employees, when exercising their institutional authority, to act solely in the interests of the organization; includes procedures for determining whether a financial interest or other relationship results in a conflict of interest; and prescribes a course of action in the event a conflict of interest is identified.  With regard to federally sponsored research, government agencies such as the Department of Health and Human Services' Public Health Service and the National Science Foundation prescribe specific requirements designed to assure objectivity in research.  Since at least 1977, Dartmouth College has had a conflict of interest policy.  That policy, however, has not undergone a general review for many years.  In the meantime, the Public Health Service has substantially revised its objectivity-in-research regulations.

This document reflects both a general review of Dartmouth College's conflict of interest policy and the adoption of procedures to comply with the revised Public Health Service requirements.   It is organized as follows:

I. Definitions of General Application

For purposes of this policy:

"Board of Trustees" means the Board of Trustees of Dartmouth College.

"COIC" means the subcommittee of the Council on Sponsored Activities referred to as the Conflict of Interest Committee composed of persons appointed by the Chair of the Council on Sponsored Activities.

"CPHS" means the Committee for the Protection of Human Subjects, which is the unified institutional review board for Dartmouth College and D-H.

"Dartmouth College" means all of Dartmouth College, including Amos Tuck School of Business Administration, Audrey and Theodor Geisel School of Medicine at Dartmouth and Thayer School of Engineering, and affiliated organizations controlled by Dartmouth College (e.g., Dartmouth Educational Loan Corporation).

"D-H" means Dartmouth-Hitchcock Clinic, Mary Hitchcock Memorial Hospital, and the Hitchcock Foundation.

"D-H CCO" means the Chief Clinical Officer for D-H.

"D-H Organizational Ethics Committee" means the Organizational Ethics Committee at D-H, of which the D-H CCO is a chair, and which shall make recommendations and take decisions on behalf of D-H on matters related to this policy.

"Entity" means a corporation, partnership, limited liability company, joint venture, trust, unincorporated organization, government or governmental or regulatory body, political subdivision or authority of any government, or any other body.

"Investigator" means the PD or PI and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of any Research Activity, which may include, without limitation, collaborators and consultants.

"OGC" means the Office of General Counsel of Dartmouth College.

"OSP" means the Office of Sponsored Projects of Dartmouth College.

"PD/PI" means a project director or principal investigator of a Research Activity, including without limitation a PHS-funded Research project.

"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 without limitation the National Institutes of Health.

"PHS Awarding Component" means the organizational unit of PHS that funds Research covered by this policy.

"Provost" means the Provost of Dartmouth College.

"Research" means a systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge, including behavioral and social-sciences research and including investigations involving human subjects. The term encompasses basic and applied research and product development. The term includes any such activity for which research funding is available from any Entity, including without limitation a PHS Awarding Component, through a grant or cooperative agreement, such as a research grant, career development award, center grant, individual fellowship award, institutional training grant, program project, or research resources award.

"Research Activities" means all Research or other activities administered through the OSP, the TTO, the CPHS or D-H, including without limitation any Research funded, or proposed to be funded, by any government agency or external private organization.

"TTO" means the Technology Transfer Office of Dartmouth College.

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II. General Principles and College-wide Disclosure Requirements

All decisions by members of the Board of Trustees, administrators, appointees (including faculty), and other employees, of Dartmouth College in the course of performing their professional responsibilities to Dartmouth College, as well as research fellows and students engaged in certain research projects, should be made in a manner consistent with the principles of honesty and integrity. Dartmouth College acknowledges that outside interests can be maintained in a manner consistent with these principles. A conflict of interest occurs when an individual's outside interests, financial or otherwise, might reasonably lead an independent observer to question whether the individual's actions or decisions in connection with his or her Dartmouth College-related professional activities are influenced by considerations of such outside interests. Not all outside interests constitute conflicts of interest and not all conflicts of interest are necessarily impermissible. The purpose of this Conflict of Interest Policy is to provide mechanisms whereby conflicts of interest can be identified and appropriate steps can be taken to address them.

In the event that a trustee, administrator, appointee (including a faculty member), or other employee, of Dartmouth College, or any research fellow or student Investigator, has an outside interest, financial or otherwise, that might lead an independent observer reasonably to question whether such person's actions or decisions in connection with his or her Dartmouth College-related professional activities are influenced by considerations of such outside interest, such person shall, as soon as he or she has knowledge of the relevant circumstances, take the following actions:

  1. Disclosure. Disclose fully in writing the precise nature of his or her interest to his or her Dean, Department Chairperson, supervisor, or other independent responsible authority and follow such person's guidance regarding additional steps to be taken and, in the case of interests relating to a transaction, make the foregoing disclosure to those at Dartmouth College involved with the transaction; and
  2. Non-Participation in Consideration of Actions or Decisions. Refrain from participation (including acting individually or as a member of a committee or other group) in Dartmouth College's consideration of the proposed action or decision unless expressly permitted to do so by a responsible authority of Dartmouth College.

For the avoidance of doubt, it is noted that the performance of Research Activities by an Investigator does not constitute an "action" or "decision" governed by this Section II; such matters are governed by Section IV and Appendix A of this policy.

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III. Additional Required Disclosures of Trustees and Certain Administrators

The following persons shall also disclose in writing to the OGC on an annual basis on disclosure forms provided by that office information regarding certain financial transactions between Dartmouth College and such persons, or certain members of such persons' families, or certain Entities in which such persons have an interest:

  1. The trustees (including the President);
  2. The Provost, the Vice, Assistant and Associate Provosts, the Vice Presidents, the Dean of Dartmouth College, the Deans of the Faculty of Arts and Sciences and the Professional Schools, and their respective principal financial officers;
  3. Department chairs;
  4. Administrators in the Purchasing Department, and senior administrators in the offices of the Deans and Vice Presidents; and
  5. Such other employees as the General Counsel shall designate as being employees who, because of their respective duties and responsibilities, should disclose transactions with Dartmouth College to the OGC.

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IV. Additional Required Disclosures of Investigators Engaged in Research Activities

Dartmouth College and D-H have an obligation under federal law and institutional policy, as well as an ethical duty, to assure that the design, conduct and reporting of Research will not be biased by any conflicting interests of an Investigator. In addition, the rights and welfare of human subjects and the integrity of Research involving human subjects should not be subordinated to or compromised by the personal interests or relationships of Investigators. Dartmouth College and D-H recognize, however, that academic engagement and relationships with industry are vital to advancing their missions of creating new knowledge and improving the general welfare of society at large. Academic relationships with industry are acknowledged as necessary to facilitate the transformation of knowledge into the development of socially beneficial products. Faculty expertise is often a crucial contribution to making the transformation process both effective and efficient.

To ensure institutional compliance with these fundamental principles and the requirements of applicable law, Dartmouth College and D-H adopt the procedures set forth at Appendix A governing Investigator disclosure and the management of outside interests. For the avoidance of doubt, the provisions of Appendix A will apply to Investigators at D-H either by virtue of a dual appointment at D-H and Dartmouth College or due to their involvement in Research Activities. With regard to Research Activities involving human subjects, these procedures represent one component of coordinated institutional efforts to protect the rights and welfare of Research participants. The Provost (in consultation with the Counsel on Sponsored Activities, as appropriate) and the D-H Organizational Ethics Committee, as they shall agree from time to time, are authorized to modify the Appendix A procedures as appropriate to carry out the purposes of this policy and the missions of the institutions.

Research and other activities that do not fall within the definition of "Research Activity" are governed by Section II of this policy and not this Section IV or Appendix A. In addition, a transaction which might relate to a Research Activity, such as the leasing of equipment owned by an Investigator to Dartmouth College for use in a Research Activity, is governed by Section II of this policy and not this Section IV or Appendix A.

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V. Compliance

All persons subject to this policy, including all Dartmouth College trustees, administrators, appointees (including faculty), and other employees, of Dartmouth College, as well as research fellows, and student Investigators, are required to comply fully with it. Violations of this policy, including failure to file or knowingly filing incomplete, erroneous, or misleading disclosure forms and failure to comply with prescribed monitoring procedures, will be reported to the appropriate senior officer and, in the case of Investigators, also to the Provost or his or her designee and, if applicable, the D-H Organizational Ethics Committee or its designee. Matters under this policy concerning a trustee or the President shall be referred to the Chairman of the Board of Trustees for appropriate action. Matters under this policy concerning the Provost shall be referred to the President for appropriate action. Matters under this policy concerning any Dean shall be referred to the Provost for appropriate action. Matters under this policy concerning all others shall be referred to the Provost or his or her designee and, if applicable, the D-H Organizational Ethics Committee, or its designee, for appropriate action.

In the event of non-compliance by an Investigator who is subject to the provisions of Section IV and Appendix A, the Provost or his or her designee and the D-H Organizational Ethics Committee or its designee, as applicable, will work with the Dean of the appropriate faculty in accordance with the regular guidelines and procedures of Dartmouth College or D-H regarding possible sanctions to be imposed on an Investigator.

Potential sanctions include, but are not limited to:

  1. Formal admonition,
  2. A letter from the Investigator's appropriate academic Dean, or where the Investigator is a Dean, from the Provost, to the person's permanent personnel file,
  3. Ineligibility for (i) grants, (ii) CPHS or other institutional review board approval, or (iii) supervision of graduate students,
  4. Non-renewal of appointment, or
  5. Dismissal.

Subject to any applicable requirements of the protocols referred to below, for Dartmouth College the final decision regarding sanctions will be made as follows: (i) with respect to a trustee or the President, by the Board of Trustees, (ii) with respect to the Provost, by the President and (iii) with respect to all others, by the Provost or his or her designee, as appropriate. Subject to any applicable requirements of the protocols referred to below, the D-H Organizational Ethics Committee will make the final decision in the case of D-H. In all cases, imposition of sanctions will occur in accordance with the protocols established pursuant to other applicable Dartmouth College or D-H policies, including without limitation protocols established by the Dartmouth College Committee on Academic Freedom and Responsibility.In addition, Dartmouth College shall follow federal regulations regarding the notification of any sponsoring agency or regulatory authority in the event an Investigator has failed to comply with this policy.

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Appendix

Procedures Applicable to Investigators Engaged in Research Activities

A. Applicable Definitions

For purposes of this Appendix A, the following definitions shall apply in addition to the Definitions of General Application set forth in Section II above:

"COIC" means the subcommittee of the Council on Sponsored Activities referred to as the Conflict of Interest Committee composed of persons appointed by the Chair of the Council on Sponsored Activities.

"CPHS" means the Committee for the Protection of Human Subjects, which is the unified institutional review board for Dartmouth College and D-H.

"Dartmouth College" means all of Dartmouth College, including Amos Tuck School of Business Administration, Audrey and Theodor Geisel School of Medicine at Dartmouth and Thayer School of Engineering, and affiliated organizations controlled by Dartmouth College (e.g., Dartmouth Educational Loan Corporation).

"D-H" means Dartmouth-Hitchcock Clinic, Mary Hitchcock Memorial Hospital, and the Hitchcock Foundation.

"D-H CCO" means the Chief Clinical Officer for D-H.

"D-H Organizational Ethics Committee" means the Organizational Ethics Committee at D-H, of which the D-H CCO is a chair, and which shall make recommendations and take decisions on behalf of D-H on matters related to this policy

"Entity" means a corporation, partnership, limited liability company, joint venture, trust, unincorporated organization, government or governmental or regulatory body, political subdivision or authority of any government, or any other body.

"Entity Interests" has the meaning set forth in the definition of "Financial Interest."

"Financial Conflict of Interest" ("FCOI") means a Significant Financial Interest that could directly and significantly affect, or could directly and significantly be affected by, the design, conduct, or reporting of a Research Activity, including without limitation PHS-funded Research.

"Financial Interest" means any direct or indirect interest of monetary value, whether or not the value is readily ascertainable, including but not limited to:

  1. Salary or any other payments for services not otherwise identified as salary (e.g., consulting fees, honoraria or paid authorship), royalties, license fees or other income related to IP Interests, or dividends, interest or other distributions in respect of property (other than IP Interests), received from any person or Entity ("Remuneration");
  2. Equity interests (e.g. stocks, stock options or other ownership interests) or debt interests in an Entity ("Entity Interests"); and
  3. Intellectual property rights, ownership or otherwise(e.g., disclosed inventions, patent and copyright applications and issued patents and copyrights or rights with respect to any of the foregoing, such as income-sharing rights under institutional policies or licensee interests) ("IP Interests").

For purposes of this definition, (i) a "direct" interest is one that is held in the name of the disclosing party or his or her nominee and (ii) an "indirect" interest is one held through (A) with regard to a corporation, ownership of more than thirty-five percent (35%) of the total combined voting power of the corporation, (B) with regard to a partnership, ownership of more than thirty-five percent (35%) of the interest in the profits of the partnership and (C) with respect to an estate or trust, ownership of more than thirty-five percent (35%) of the beneficial interests of the estate or trust.1

"Institution of Higher Education" means an institution of higher education as defined at 20 U.S.C. 1001(a).

"Institutional Official" means the person appointed by the Provost (or his or her designee) to serve in such position.

"Institutional Responsibilities" means an Investigator's professional responsibilities on behalf of Dartmouth College or D-H, as applicable, including without limitation Research, academic administration, teaching, professional practice, provision of consulting services to third parties who have engaged Dartmouth College or D-H, as applicable, as a consultant2 , institutional committee memberships, and service on panels such as institutional review boards or data and safety monitoring boards.

"Investigator" means the PD or PI and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of any Research Activity, which may include, without limitation, collaborators and consultants.

"IP Interests" has the meaning set forth in the definition of "Financial Interest."

"Management Plan" means conditions or restrictions to be observed in connection with the conduct of a Research Activity in order to manage, reduce or eliminate an FCOI or an NFCOI.

"Non-Financial Conflict of Interest" ("NFCOI") means an interest other than a Financial Interest that could directly and significantly affect, or could directly and significantly be affected by, the design, conduct, or reporting of a Research Activity, including without limitation PHS-funded Research.

"PD/PI" means a project director or principal investigator of a Research Activity, including without limitation a PHS-funded Research project.

"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 without limitation the National Institutes of Health.

"PHS Awarding Component" means the organizational unit of PHS that funds Research covered by this policy.

"PHS Compliant Research" means any Research Activity funded in whole or in part by an Entity specifically requiring compliance with 42 CFR 50, subpart F (Promoting Objectivity in Research) or 45 CFR 94 (Responsible Prospective Contractors) as a condition of providing funds for such Research Activity, including without limitation Research Activity funded by the PHS.

"Provost" means the Provost of Dartmouth College.

"Research" means a systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge including behavioral and social-sciences research and including investigations involving human subjects. The term encompasses basic and applied research and product development. The term includes any such activity for which research funding is available from any Entity, including without limitation a PHS Awarding Component, through a grant or cooperative agreement, such as a research grant, career development award, center grant, individual fellowship award, institutional training grant, program project, or research resources award.

"Research Activities" means all Research or other activities administered through the OSP, the TTO, the CPHS or D-H, including without limitation any Research funded, or proposed to be funded, by any government agency or external private organization.

"Remuneration" has the meaning set forth in the definition of "Financial Interest."

"Significant Financial Interest" means a Financial Interest consisting of one or more of the following interests of an Investigator or those of the Investigator's spouse or domestic partner or dependent children that (i) in the case PHS Compliant Research, reasonably appears to be related to the Investigator's Institutional Responsibilities and (ii) in the case of non-PHS Compliant Research, reasonably appears to affect or be affected by the Research Activity as to which disclosure is made pursuant to this Appendix A:

  1. With regard to any publicly-traded Entity, a Significant Financial Interest exists if the value of any Remuneration received from the Entity by one or more of the Investigator and the Investigator's spouse or domestic partner and dependent children in the twelve (12) months preceding disclosure pursuant to this Appendix A, or which is anticipated to be received from the Entity by one or more of such persons in the twelve (12) months subsequent to disclosure pursuant to this Appendix A, and the value of any Entity Interests in the Entity received by one or more of the Investigator and the Investigator's spouse or domestic partner and dependent children as of the relevant disclosure date, when aggregated, exceeds $5,000;
  2. With regard to any non-publicly traded Entity, a Significant Financial Interest exists if the value of any Remuneration received from the Entity by one or more of the Investigator and the Investigator's spouse or domestic partner and dependent children in the twelve (12) months preceding disclosure pursuant to this Appendix A, or which is anticipated to be received from the Entity by one or more of such persons in the twelve (12) months subsequent to disclosure pursuant to this Appendix A, when aggregated, exceeds $5,000, or when the Investigator or the Investigator's spouse or domestic partner or dependent children holds any Entity Interest;
  3. With regard to any individual person, a Significant Financial Interest exists if the value of any Remuneration received from such person by one or more of the Investigator and the Investigator's spouse or domestic partner and dependent children in the twelve (12) months preceding disclosure pursuant to this Appendix A, or which is anticipated to be received from such person by one or more of the Investigator's spouse or domestic partner and dependent children in the twelve (12) months subsequent to disclosure pursuant to this Appendix A, when aggregated, exceeds $5,000; or
  4. IP Interests of any of the Investigator, the Investigator's spouse or domestic partner or the Investigator's dependent children;

provided, that the term "Significant Financial Interest" does not include:

  1. Remuneration, other than royalties, license fees or similar payments, paid by Dartmouth College or D-H to the Investigator if such person is employed or otherwise appointed by Dartmouth College or D-H at the time of submitting a disclosure form pursuant to this Appendix A;
  2. Income from investment vehicles, such as mutual funds and retirement accounts, received by an Investigator or those of an Investigator's spouse or domestic partner and dependent children as long as any of such persons cannot directly control the investment decisions made in these vehicles;
  3. Income received by the Investigator (or any of the Investigator's spouse or domestic partner and dependent children) 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;
  4. Income received by the Investigator (or any of the Investigator's spouse or domestic partner or dependent children) 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; or
  5. Copyrights in books, primary literature (such as journal articles or similar), and/or presentations, provided that income received or anticipated to be received in connection with such copyrights shall continue to be a Significant Financial Interest in accordance with the terms of provisions 1 through 3 of this definition.

For purposes of this definition, "value" shall mean (i) with respect to any Entity Interest that is publicly traded, reference to public prices and (ii) with respect to any Entity Interest that is not publicly traded or to any other Financial Interest that is not paid in cash, any reasonable measure of fair market value.

"Travel Payments" means any reimbursed or sponsored travel expenses exceeding $5,000 in the aggregate from a single Entity in the twelve (12) months preceding disclosure pursuant to this Appendix A, or which is anticipated to exceed $5,000 in the aggregate from a single Entity over the twelve (12) months subsequent to disclosure pursuant to this Appendix A, including without limitation expenses for transportation, food, lodging and entertainment received or obtained in connection with such travel. The term "Travel Payments" does not include any travel expenses that are 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.   For purposes of this definition, "sponsored travel expenses" means that which is paid on behalf of the Investigator (or any of the Investigator's spouse or domestic partner or dependent children) and not reimbursed to the such person.

"TTO" means the Technology Transfer Office of Dartmouth College.

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B. Required Investigator Disclosure

Provisions of General Applicability. Investigators engaged, or planning to engage, in Research Activities must disclose all Significant Financial Interests to the Institutional Official using institution-provided disclosure forms. Investigators must also disclose any other interest, financial or otherwise, that might reasonably lead an independent observer to question whether such Investigator's actions or decisions in connection with his or her Research Activities are influenced by considerations of such interest.3 Any disclosure of such other interest should provide sufficient detail to permit an accurate and objective evaluation of whether an independent observer might reasonably be led to question whether such Investigator's actions or decisions in connection with his or her Research Activities are influenced by considerations of such interest. See "Timing of Disclosures" below.

Disclosure of Travel Payments by Investigators Engaged in PHS Compliant Research. Investigators engaged, or planning to engage, in PHS Compliant Research must disclose any Travel Payments in connection with trips taken by the Investigator (or any of the Investigator's spouse or domestic partner or dependent children) related to the Investigator's Institutional Responsibilities. Such disclosure must include the purpose of the trip, the identity of the sponsor/organizer of the trip and the destination and duration of the trip.  Investigators must provide additional information, including a determination or disclosure of monetary value, regarding any such Travel Payments as requested by the Institutional Official. See "Timing of Disclosures" below.

Timing of Disclosures. Investigators engaged in Research Activities must submit an institution-prescribed disclosure form to the Institutional Official on or prior to the date specified by the Institutional Official.  Investigators planning to engage in Research Activities must submit to the Institutional Official an institution-prescribed disclosure form on or prior to the date specified by the Institutional Official, which shall be no later than the time of filing of any application for funding of such Research Activity.   All Investigators must update their disclosure forms at least annually during the period of the award as prescribed by the Institutional Official. In addition, all Investigators must update their most recently filed disclosure form within thirty (30) days of (i) acquiring (e.g., through purchase, marriage or inheritance) a Significant Financial Interest and, with respect to Investigators engaged in PHS Compliant Research, the event for which Travel Payments were or are expected to be sponsored or reimbursed or (ii) discovering a Significant Financial Interest that was improperly omitted from a prior disclosure form.

Additional Disclosures Required for Human Subjects Research. Investigators planning to engage in Research Activities involving human subjects must submit an institution-prescribed form to the CPHS at the time of the initial CPHS review of such Research Activity; such submission shall be in addition to any submission required by the preceding subsection. Investigators engaged in Research Activities involving human subjects must update their most recently filed disclosure form at the time of any subsequent CPHS review of such Research Activity; such update shall be in addition to any submission required by the preceding subsection.

Additional Responsibilities of PDs and PIs. It shall be the responsibility of PDs and PIs to ensure that all Investigators involved in their Research Activities are aware of the foregoing disclosure requirements.

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C. Review of Disclosures; Determination of Conflicts of Interest; Appeal Process

The Institutional Official shall review all disclosure forms submitted by Investigators.   If the Institutional Official determines, after reviewing any disclosure form and other available information, that an Investigator (i) has a Significant Financial Interest, (ii) has received Travel Payments having such characteristics as the COIC shall establish from time to time to require COIC review or (iii) has disclosed any other interest as described in the second sentence of the paragraph entitled "Provisions of General Applicability", in Section B above, the Institutional Official shall refer the matter to the COIC. With respect to PHS Compliant Research, the COIC or its designee first shall determine whether such Significant Financial Interest, Travel Payment or such other disclosed interest is related to any Research Activities included in the PHS Compliant Research of the disclosing Investigator. In making such determination, the COIC may solicit from the Investigator additional information regarding the relevant facts and circumstances. In the case of (i) PHS Compliant Research as to which the COIC has determined that a Significant Financial Interest, Travel Payment or other disclosed interest is related to one or more Research Activities included therein and (ii) non-PHS Compliant Research, as to which disclosure has been made under this Appendix A, the COIC shall make one of the following determinations:

  1. No Financial Conflict of Interest and no Non-Financial Conflict of Interest exist and, if the Research Activity in question is a proposed Research Activity, such Research Activity shall be accepted as proposed, and if an ongoing Research Activity, no Management Plan need be implemented;
  2. A Financial Conflict of Interest or a Non-Financial Conflict of Interest exists and, if the Research Activity in question is a proposed Research Activity, either (i) such proposed Research Activity shall not be accepted, or (ii) the proposed Research Activity may be accepted provided a Management Plan (the principal elements of which shall initially be designated by the COIC) is implemented with respect to such Research Activity; or
  3. A Financial Conflict of Interest or a Non-Financial Conflict of Interest exists and, if the Research Activity in question is an ongoing Research Activity, a Management Plan (the principal elements of which shall initially be prepared by the COIC) must be implemented with respect to such Research Activity.

Examples of possible conditions or restrictions that might be included in a Management Plan include, but are not limited to:

  1. Public disclosure of the Financial Conflict of Interest or the Non-Financial Conflict of Interest (e.g., when presenting or publishing the Research);
  2. For Research projects involving human subjects Research, disclosure of the Financial Conflict of Interest or the Non-Financial Conflict of Interest 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 Financial Conflict of Interest or the Non-Financial Conflict of Interest;
  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. Reduction or elimination of the Financial Conflict of Interest (e.g., sale of an Entity Interest or placement of such Entity Interest in a blind trust) or the Non-Financial Conflict of Interest; or
  7. Severance of relationships that create the Financial Conflict of Interest or the Non-Financial Conflict of Interest.

If the Research Activity as to which the COIC has determined that an FCOI or an NFCOI exists involves human subjects, the Institutional Official shall submit to the CPHS for review and approval the elements of a Management Plan recommended by the COIC or notify the CPHS that the COIC does not recommend that a Management Plan be implemented. The CPHS shall review the COIC's recommendations regarding the Management Plan and shall accept or modify the elements of such Management Plan, or of a COIC recommendation not to implement a Management Plan, as the CPHS deems appropriate in connection with of its approval of the proposed Research Activity.

With respect to Research Activities that do not involve human subjects, the COIC will inform the Investigator of its determination regarding the existence of any FCOI or NFCOI within ten (10) business days thereof. If the Investigator is dissatisfied with the determination, the Investigator may, within ten (10) business days of such determination, appeal to the Provost (or his or her designee). Such person will consult with the Investigator and the COIC, as appropriate. After such review, the Provost will make the final decision.

With respect to Research Activities that involve human subjects, the CPHS will inform the Investigator of its determination (as modified by the CPHS) in accordance with usual CPHS business practices. If the Investigator is dissatisfied with the determination, the Investigator may, within ten (10) business days of such determination, appeal to the Provost (or his or her designee). Such person will consult with the Investigator, the COIC and the CPHS Chairs, as appropriate. After such review, the Provost will make the final decision.

Depending on the nature of a disclosed Significant Financial Interest, the COIC or the CPHS may determine that interim measures are necessary with regard to the Investigator's participation in the Research Activity between the date of disclosure and the completion of the review of such disclosure.

The procedures in this Section C shall also apply to Significant Financial Interests, Travel Payments and any other interest that might lead an independent observer to reasonably question whether an Investigator's actions or decisions in connection with his or her Research Activities are influenced by considerations of such interest, in each case of which Dartmouth College or D-H becomes aware and that has not been disclosed by an Investigator to the Institutional Official.

Whenever a Financial Conflict of Interest or a Non-Financial Conflict of Interest is not identified or managed in a timely manner, Dartmouth College shall conduct such reviews as are required by applicable law or as it otherwise deems necessary or appropriate in the circumstances, including conducting a retrospective review of the Investigator's activities and the Research Activity 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 or affected the rights or welfare of any human subjects participating in the Research Activity.   In addition to the foregoing, Dartmouth College and, if applicable, D-H, shall conduct such reviews or investigations and take such actions as are required by applicable law or as it otherwise deems necessary or appropriate in the circumstances.

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D. External Reporting Requirements

Dartmouth College, will report Financial Conflicts of Interests and Non-Financial Conflicts of Interest to government agencies when required by law. In addition, with respect to FCOIs relating to PHS Compliant Research, Dartmouth College will disclose such FCOIs to members of the public who request such disclosure as required by applicable law. The Institutional Official will notify the Investigator of any such request and the proposed response to such request and afford the Investigator an opportunity to comment on such request within a time period that will allow a timely response (i.e., within five (5) business days of the request) to be issued; however, Dartmouth College will have the final authority regarding the content of such response.

Whenever a Financial Conflict of Interest or a Non-Financial Conflict of Interest is not identified or managed in a timely manner, Dartmouth College shall file such reports and take such actions as required by applicable law or as it otherwise deems necessary or appropriate in the circumstances.

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E. Training Requirements for Investigators Engaged in PHS Compliant Research

Investigators engaged, or planning to engage, in PHS Compliant Research are required to complete Dartmouth College-sponsored training regarding this policy and applicable regulations as prescribed by the Institutional Official.

Investigators who are engaged in PHS Compliant Research are required to repeat such training every four (4) years provided that they continue to be engaged, or are planning to engage, in such Research Activities. In addition, such Investigators must repeat such training (i) within the time period specified by the Institutional Official following any revision of this policy that affects the requirements applicable to Investigators or (ii) within the time period specified by the Institutional Official if Dartmouth College or D-H, as applicable, finds that an Investigator is not in compliance with this policy or any applicable Management Plan.

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F. Regulations

Several governmental regulations and policies apply to Investigators engaged in Research Activities. They include, but are not limited to: 42 CFR 50, subpart F – Promoting Objectivity in Research for Which PHS Funding is Sought; 45 CFR 74—Uniform Administrative Requirements for Awards and Subawards to Institutions of Higher Education, Hospitals, Other Nonprofit Organizations, and Commercial Organizations; and 21 CFR 54 – Food and Drug Administration – Financial Disclosure by Clinical Investigators.

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G. Subrecipients, Subcontractors or Collaborators

If Dartmouth College or D-H carries out any Research Activity through subrecipients, subcontractors or collaborators, it shall require such subrecipients, subcontractors or collaborators to agree either to comply with Section IV and Appendix A of this policy or provide assurances that its own policy conforms to Section IV and Appendix A of this policy.

[1] By way of example, if the disclosing party has shares of stock in a corporation that are registered in his or her name or are registered in the name of a broker on his or her behalf, such shares are held directly by him or her. If the disclosing party holds shares of Corporation A that constitutes more than forty percent (40%) of the combined voting power of Corporation A and Corporation A owns one hundred shares of Corporation B, then the disclosing party is deemed to own forty (40) shares of Corporation B. If Corporation A receives a dividend of $10,000 from Corporation B, then the disclosing party is deemed to have received a $4,000 dividend.

[2] These services refer to consulting services where Dartmouth College or D-H has been engaged by a third party to provide such services and the Investigator is providing such services on behalf of Dartmouth College or D-H pursuant to that arrangement. It does not cover consulting services rendered to third parties by Faculty Members or other Dartmouth College or D-H employees or appointees in their individual capacities. Compensation received for consulting services received by such persons in their individual capacities constitutes "Remuneration" and, if applicable thresholds are met, constitutes "Significant Financial Interests," and may constitute other interests that are subject to disclosure pursuant to this policy.

[3] Although not specifically required by applicable regulations, in the case of Investigators engaged or planning to engage in non-PHS Compliant Research, consideration should be given as to whether any Travel Payments should be disclosed.

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End Notes

1By way of example, if the disclosing party has shares of stock in a corporation that are registered in his or her name or are registered in the name of a broker on his or her behalf, such shares are held directly by him or her. If the disclosing party holds shares of Corporation A that constitutes more than forty percent (40%) of the combined voting power of Corporation A and Corporation A owns one hundred shares of Corporation B, then the disclosing party is deemed to own forty (40) shares of Corporation B. If Corporation A receives a dividend of $10,000 from Corporation B, then the disclosing party is deemed to have received a $4,000 dividend. Return to text

2These services refer to consulting services where Dartmouth College or D-H has been engaged by a third party to provide such services and the Investigator is providing such services on behalf of Dartmouth College or D-H pursuant to that arrangement. It does not cover consulting services rendered to third parties by Faculty Members or other Dartmouth College or D-H employees or appointees in their individual capacities. Compensation received for consulting services received by such persons in their individual capacities constitutes "Remuneration" and, if applicable thresholds are met, constitutes "Significant Financial Interests," and may constitute other interests that are subject to disclosure pursuant to this policy. Return to text

3Although not specifically required by applicable regulations, in the case of Investigators engaged or planning to engage in non-PHS Compliant Research, consideration should be given as to whether any Travel Payments should be disclosed. Return to text

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Last Updated: 4/29/13