COI Policy

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YALE UNIVERSITY POLICY ON

CONFLICT OF INTEREST

TABLE OF CONTENTS

I. PRINCIPLES

A. Conflict of Interest

B. Fundamental Principles

C. Conflicts of Interest in Human Subjects Research

D. Start-up Companies

E. High Value Significant Financial Interests

II. PROCEDURE

A. Disclosure

B. Review by the Provost’s Committee on Conflict of Interest

C. Guidelines for Determining Conflict of Interest on Research Awards

D. Management of Significant Financial Interests that Pose a Conflict of

Interest

E. Significant Financial Interest

APPENDIX A – Conflict of Interest Procedures Applicable to Public Health Services

Funding

APPENDIX B - Conflict of Interest Procedures Applicable to National Science Foundation

Funding

APPENDIX C – Policy Applicable to Faculty with Relationships with Start-Up Companies

APPENDIX D – Policy and Procedure on Conflict of Commitment

APPENDIX E – Policy on Interactions between Clinical Personnel of the Yale Medical

Group and Industry

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I. PRINCIPLES

Yale University believes that a great university should reach out to the world. Accordingly, the

University encourages its faculty to seek and participate in sponsored research, to consult widely,

and to engage in other activities that may benefit not only the participants but also the University

itself, and the larger public. In many cases, non-faculty employees also consult or engage in

other outside activities. While Yale recognizes the benefit of such activities, it is also committed

to ensuring that they are conducted properly and consistently, in accordance with the principles

of openness, trust, and free inquiry that are fundamental to the autonomy and well-being of a

university and with the responsible management of the University’s business.

The number of faculty, staff and students engaged in sponsored research, in consulting, or in

other interactions with external organizations is substantial. The interests and commitments of

the various parties engaged in such activities or affected by them – the individual, the University

community, industry, the government, and the public – are complex and not necessarily

coincident; occasionally, these interests may conflict with and threaten to compromise the

University’s core missions and the atmosphere of free inquiry that Yale considers vital. It is

sometimes difficult to draw the line between the responsibilities of a faculty or staff member to

Yale and to external organizations. Under these conditions the possibility of perceived or real

conflict of interest or conflict of commitment is significantly heightened.

In pursuit of its own mission Yale University has formulated the following policy to identify and

address actual conflicts of interest and conflicts of commitment. The fundamental premise of this

policy is that each member of the Yale community has an obligation to act in the best interest of

the University and in furtherance of the University’s mission, and must not let outside activities

or significant outside financial interests interfere with those obligations. This policy is intended

to increase the awareness of faculty, staff and students to the potential for conflicts of interest,

and to establish procedures whereby such conflicts may be avoided or properly managed.

A. Conflict of Interest

A conflict of interest exists when an individual has a significant financial interest (SFI) that

could directly and significantly affect his or her University activities. Generally, this will be

when the external interest provides an incentive to affect the individual’s conduct of his or her

University activities and when the individual has the opportunity to affect the University

decision or other activity (for example, because he or she is the decision-maker or the principal

investigator for a research project). Conflicts of interest can arise naturally from an individual’s

engagement with the world outside the University, and the mere existence of a conflict of interest

does not necessarily imply wrongdoing on anyone’s part. When conflicts of interest do arise,

however, they must be recognized, disclosed and either properly managed or eliminated.

Conflicts of interest may exist with respect to University financial decisions in which the

For the policy on Conflict of Commitment, refer to Appendix D.

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individual is involved, for example, regarding investments, loans, purchases or sales of goods or

services, and financial accounting decisions. They may also exist with respect to the conduct of

research, the care of patients, the protection of human research subjects, and the treatment of

students and faculty colleagues. Conflicts may also exist with respect to matters with both

financial and non-financial implications, such as decisions about the use of University equipment

and facilities and the negotiation of research agreements and license agreements.

B. Fundamental Principles

The following principles are among those that underlie the University’s policy on conflicts of

interest:

1. External activities must not compromise an individual’s ability to perform all the

activities expected of him or her as a Yale employee.

2. An individual may not receive remuneration for the conduct of his or her research or

clinical activity at Yale or other Yale activity except through University channels (such

as salary).

3. An individual may not conduct research or clinical activity at Yale or carry on other Yale

business under circumstances in which there exists an unmanaged conflict of interest.

4. Yale researchers, including students and postdoctoral appointees, may not be precluded

from publishing their work by agreements with external sponsors or on account of the

interest of an external organization in which a faculty mentor or supervisor has a financial

interest.

5. Graduate students may not be held to non-disclosure of any aspect of their work in their

meetings with individuals at Yale (including members of their dissertation advisory

committees).

6. Yale facilities, equipment, and personnel may be used only for Yale activities and

purposes, except when the University specifically authorizes other uses.

7. An individual may not participate directly in the negotiation of research agreements,

license agreements, equipment purchases or other arrangements between the University

and an organization in which the individual has a significant financial interest (See

University Institutional Standards of Conduct).

8. Authors must fully disclose related significant financial interests and outside activities

when submitting for publication (including articles, abstracts, manuscripts submitted for

publication), in presentations at professional meetings, and in applications for funding.

(See University Guidance on Authorship in Scholarly and Scientific Publications)

9. In all scientific and scholarly publications and all manuscripts submitted for publication,

authors must acknowledge the sources of support for all activities leading to and

facilitating preparation of the publication or manuscript.

10. Participation by any individual responsible for the design, conduct or reporting of

research involving human subjects and holding a related significant financial interest that

may be affected by the research must receive especially rigorous review and must not

compromise the objectivity of the research or the well-being of research subjects. (See

Section on Human Subjects research below).

11. Research that is proposed to be sponsored by a privately held entity in which the faculty

member who would conduct such research has an equity interest or Board seat or other

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significant financial interest must be reviewed and approved in advance by the Provost’s

Committee on Conflict of Interest (COIC). (See Section on Start-up Companies below).

C. Conflicts of Interest in Human Subjects Research

Conflicts of interest related to research involving human subjects pose special concerns. The

University and its researchers have ethical obligations to honor the rights and protect the safety

of persons who participate in research conducted at the University. SFIs held by those

conducting the research may compromise the fulfillment of those ethical obligations and the

well-being of the research subjects, as well as the integrity of the related research. Accordingly

any person with an unmanaged conflict of interest is prohibited from participating in the conduct

of such research. In addition, research involving human subjects where there is a financial

conflict of interest may only go forward if the design and circumstances of the human subjects

research are such that they serve to protect both the human subjects and the objectivity of the

data obtained. For example, research that includes multiple independent sites, or where the

intervention or choice of device is blinded to the investigators, has an independent data and

safety monitoring board, or has other such protective elements, may be allowed to proceed with

an appropriate conflict of interest management plan. In order to address these special concerns,

when human subjects are involved in the research, conflict of interest review will be coordinated

with the appropriate Yale Institutional Review Board (See Policy on Disclosure of Interests in

Human Research).

D. Start-up Companies

Individual relationships with “startup” ventures - relatively newly formed, privately held, for-

profit companies that often may be based on intellectual property developed by the individual at

Yale or elsewhere - present opportunities for development and commercialization of inventions

but may also create conflicts of interest and commitment. In particular, while close involvement

of the individual is often critical to the further development of the technology, multiple

relationships of the individual with the start-up venture magnify the concern regarding the

individual’s commitment to their University responsibilities.

Generally, use of Yale space by a startup is not permitted, except a startup may use Yale

equipment or laboratories subject to a written agreement with the University, and with strict

limitations as to time and extent and only after review and approval by the Provost’s Office. For

faculty members, the Faculty Handbook and other relevant policies govern the relationships.

Policy guidelines specific to faculty relationships with such ventures appear as Appendix C to

this general policy statement.

E. High Value Significant Financial Interests

Income and other financial interests that are large compared to the individual’s institutional

salary pose a special challenge. They can create a perception that calls into question the

individual’s commitment and obligation to Yale. Some may find it difficult to believe that such

high value interests do not compromise the individual’s objectivity. And, indeed, high value

financial interests do have the potential for greater bias, and are also inherently more difficult to

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manage. The Provost’s Committee on Conflict of Interest must therefore pay special attention to

high value SFIs, and carefully consider the greater likelihood of conflict they represent.

In order to provide sufficient information to the COIC to enable it to determine whether actual

undue bias exists and to recommend appropriate management schemes for relevant conflicts of

interest, the Provost’s Committee will likely solicit additional detailed information from

disclosers whose significant financial interests exceed $100,000 in the past twelve months and

that are related to their institutional responsibilities. Such supplemental questions might request

more specificity on the total dollars received, the time that such financial interests demand, a

detailed explanation of the relationship of the financial interest to an individual’s research or, if

the individual is in an academic leadership role, whether and how, the financial interests are

related to the purpose of the unit for which the individual has administrative or academic

responsibility. In addition, the details of the financial interests will be provided to the Dean of

the relevant school and the cognizant Provost or appropriate Vice President.

II. PROCEDURE

A. Disclosure

The responsibility for addressing conflict of interest rests, in the first instance, with the

individual. An essential step is for the individual involved to make full disclosure of relevant

information to the Conflict of Interest Office. As described in greater detail below, certain

individuals are required to make regular, annual disclosures, with updates as needed; others need

only disclose on an ad hoc basis. When a disclosure is required, it will be reviewed by the

Provost’s Committee on Conflict of Interest (the “Committee”), which will determine what

should be done to avoid or manage any conflict of interest appropriately. For certain senior

administrators, the Office of the Vice President and General Counsel will conduct the review.

The confidentiality of the disclosures will be respected as far as possible. In particular, the

information on the forms will not be shared except with authorized individuals in the conduct of

their official University responsibilities, and, for faculty with clinical responsibilities at the Yale

New Haven Hospital or the Veterans Administration Connecticut Healthcare System, with

appropriate officials at those locations; and where required contractually or by law in connection

with sponsored funding, with the research sponsors or through public disclosure.

1. Required initial and annual disclosures

All faculty members with University appointments of greater than 50% time; all faculty who

hold administrative positions; all faculty and staff who serve as members of a research reviewing

committee (e.g., IRB, IACUC, BSC, COIC, ESCRO, Radiation Safety); and all faculty, staff and

students who are responsible for the design, conduct or reporting of research are required to

submit an annual external interest disclosure form describing their external activities and

financial interests. The disclosures must be in writing, on the forms approved by the Provost, and

must be submitted to the Conflict of Interest Office.

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Whenever an application for funding of any research project is submitted, each individual

responsible for the design, conduct or reporting of the research is required to have an up-to-date

disclosure on file with the Conflict of Interest Office.

Any individual carrying out research or other activities supported by the federal Public Health

Service (PHS) or supported by another sponsor that mandates compliance with the PHS

regulations, must refer to and comply with Appendix A. Any individual carrying out research or

other activities supported by the National Science Foundation (NSF) or other sponsor that

mandates the NSF policy, must refer to and comply with Appendix B. Any individual that is not

carrying out research or other activities supported by PHS or NSF must comply with the

procedures as prescribed below in this general procedure.

All faculty, irrespective of funding support, that have relationships with startup companies must

also comply with Appendix C. All faculty and full time non-faculty employees must also

comply with the Policy and Procedure on Conflict of Commitment contained in Appendix D. All

clinical personnel of the Yale Medical Group must also comply with Appendix E.

2. Material change from annual disclosure

Whenever SFIs or internal responsibilities change materially from those described in the annual

disclosure, the disclosure should be resubmitted as soon as possible, but no later than 30 days

after the individual’s knowledge of such events.

3. Other required annual disclosures

Certain senior, non-faculty administrators designated by the President are also required to submit

disclosures of outside activities and financial interests and thereafter annually submit disclosures

of outside activities and financial interest for as long as the individual continues to be designated

by the President as being required to submit such disclosures. These disclosures must be

prepared on the Conflict of Interest Disclosure Form for Senior Administrators and submitted to

the Office of the Vice President and General Counsel. The form will be provided to those

administrators who are designated to submit them.

4. Ad hoc disclosures by those not required to file annual disclosures

Postdoctoral appointees, non-faculty employees other than designated senior administrators and

students are not required to submit annual disclosure forms unless they are identified as being

responsible for the design, conduct, or reporting of research. If there is any possibility of a

conflict of interest with respect to an individual’s non-research activities, the individual should

consult with his or her supervisor, a senior administrator in the department, the Dean of the

School, or the Office of the Vice President and General Counsel. The Yale Personnel Policies

and Practices Manual sets forth the University’s general expectations about staff and the

avoidance of conflicts in performance of their duties in its Section 505.

B. Review by the Provost’s Committee on Conflict of Interest

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The Provost’s Committee on Conflict of Interest reviews disclosures submitted to the Conflict of

Interest Office to determine whether the Discloser’s SFI(s) present(s) a conflict of interest with

the Discloser’s University responsibilities, and if so, by what means the conflict should be

managed, reduced or eliminated. A conflict exists when a SFI could directly and significantly

impact the individual’s ability to carry out their University responsibilities without undue bias.

The Committee consists of one or more members of the Provost’s staff, one or more members of

Yale’s Institutional Review Board and one or more faculty members selected by the Provost,

together with additional individuals selected by the Provost. The Committee may delegate

review of routine matters to one of its members or supporting staff. If necessary, the Committee

may discuss disclosure-related matters with the individual involved and may also consult with

others who may have relevant information. A Discloser is entitled to meet with the Provost’s

Committee if he or she wishes.

The Committee will review any SFIs in the context of the individual’s overall Yale

responsibilities, i.e., academic, clinical or administrative (commonly referred to as an “Activities

Review”) and with respect to each research award on which the Discloser is identified as

responsible for the design, conduct, or reporting of the research to determine if a SFI is related to

the award and whether the SFI creates a conflict of interest related to that research award

(commonly referred to as “Transactional Review”).

C. Guidelines for Determining Conflict of Interest on Research Awards

The Committee will determine whether a Discloser’s SFI is related to the funded or proposed

research and, if so, whether the SFI is a financial conflict of interest (FCOI). A Discloser’s SFI is

related to funded or proposed research when the Committee reasonably determines that the SFI:

could be affected by the research; or is in an entity whose financial interest could be affected by

the research. The Committee may consult with the Investigator in the determination of whether a

SFI is related to the research.

A financial conflict of interest exists when the Committee reasonably determines that the SFI

could directly and significantly affect the design, conduct, or reporting of the research.

Among the factors that should be taken into consideration in the determination of an FCOI

include the role of the Discloser and the opportunity to bias the results, the nature of the research

being proposed, whether the work is funded by an entity in which the Investigator holds a SFI,

and consideration of the value of the SFI in relation to the size and value of the entity. The

factors that should be considered include:

1. Whether the research is of a basic or fundamental nature directed at understanding basic

scientific processes; or

2. Whether the degree of replication and verification of research results is such that immediate

commercialization or clinical application is not likely; or

3. Whether the goal of the research is to evaluate an invention linked to the SFI (such as where

the SFI is a patent, or an interest in a company that has licensed the invention); or

4. Where the research involves human subjects whether there are double blind conditions or the

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involvement of a data and safety monitoring board; or

5. Where the SFI is in a privately held company, whether the researcher’s SFI could result in

the researcher having influence over company decisions, or whether the research could have

a significant impact on the company’s business or financial outlook (excluding Phase I

SBIRs and STTRs); or

6. The magnitude of the SFIs (e.g., the amount of consulting, or the percentage or value of

equity); or

7. Where the SFI is in the sponsor of the research, and the sponsor is a licensee of the

Discloser’s technology, the amount of commercialization payments received by the faculty

member from that technology, both currently or in the future; or

8. The number and nature of relationships a Discloser has with an entity. Multiple

entanglements can create a relationship with an outside entity that is stronger than the sum of

the parts; or

9. Whether the goal of the research is to validate or invalidate a particular approach or

methodology that could affect the value of the SFI; or

10. Whether other scientific groups are independently pursuing similar questions; or

11. Whether sufficient external review of the research conducted and the reporting of research

results exist to mitigate undue bias; or

12. Whether the goal of the project is a comparative evaluation of a technology in which the

Discloser has a SFI; or

13. Whether the project involves a subaward to an entity in which the Discloser has a SFI.

D. Management of Significant Financial Interests that Pose a Conflict of

Interest

If a conflict of interest exists, the Committee will determine by what means – such as the

individual’s recusal from decisions affecting the conflicting entity, abstention from the external

activity, modification of the activity, and/or monitoring of the activity by a subcommittee -- the

conflict should be avoided or managed in order to mitigate undue bias. In making those

determinations, the Provost’s Committee will be guided by the principles discussed in this Policy

and in the Faculty Handbook, and may be informed by the deliberations of the relevant

Institutional Review Board (IRB), as appropriate. The Committee will also take into

consideration whether the Discloser’s ongoing role is necessary to continue advancing the

research, based upon the factors such as the uniqueness of his or her expertise and qualifications.

Examples of conditions that might be imposed to manage a financial conflict of interest include,

but are not limited to:

•

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

research);

•

For research projects involving human subjects research, disclosure of financial conflicts

of interest directly to human participants;

•

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;

•

Modification of the research plan;

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•

Change of personnel or personnel responsibilities, or disqualification of personnel from

participation in all or a portion of the research;

•

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

•

Severance of relationships that create financial conflicts;

•

For research projects involving human subjects research, use of a data and safety

monitoring board;

•

Double-blind conditions;

•

Provisions to conduct the work simultaneously at multiple sites;

•

Written disclosure of the conflict to all individuals working on the research project; and

•

Annual reports on the research progress to the Committee.

If the Committee determines that a conflict exists, it will communicate this determination and the

means it has identified for eliminating or managing the conflict, in writing, to the individual, to

the relevant Principal Investigator in the case of sponsored research, and to the appropriate Dean

and Department Chair where conflicts of interest arise with respect to teaching, clinical, or

administrative responsibilities. In the case of clinical responsibilities, the Committee may also

inform Yale New Haven Hospital, Veterans Administration Connecticut Healthcare System or

the Yale Medical Group. The Committee will also communicate with the Office of Grant and

Contract Administration the fact that the disclosure has been reviewed and its summary

determination, but not the substance of the disclosure.

The Committee will keep a record of the

disclosure and other relevant information for at least three years.

If the Committee prescribes

monitoring of the activity, it will describe what monitoring shall be performed and what records

are to be kept.

If the individual is not satisfied with the decision of the Committee, he or she may request in

writing to the Committee that the matter be referred to the Provost for a decision. A written

statement of the findings and recommendations of the Committee shall accompany any matter

referred to the Provost, with copies to the individual, and the appropriate Dean and Department

Chair. The Provost will notify the individual, the Committee, and the Dean and Department

Chair of his or her decision after receiving the Committee’s report.

The Provost’s decision will be final, and any failure by the individual to adhere to the decision

will be cause for disciplinary action, including, in severe cases, termination.

E. Significant Financial Interest

Any individual carrying out research or other activities supported by the federal Public Health

Service (PHS) or supported by another sponsor that mandates compliance with the PHS

regulations, must refer to Appendix A for the definition of SFI and for specific procedures

For certain federal grants and contracts, the University will be required to certify that financial conflicts

of interest have been addressed.

Records of disclosures by investigators involved in certain federally-sponsored research that are used as

the basis for the University’s certification that it has addressed any financial conflicts of interest with

respect to the funded research must be kept for at least three years beyond the termination or completion

of the sponsored award.

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applicable to PHS funding. Any individual carrying out research or other activities supported by

the National Science Foundation (NSF) or other sponsor that mandates the NSF policy, must

refer to Appendix B for the definition of SFI and for specific procedures applicable to NSF

funding.

1. Significant financial interest means:

A financial interest consisting of one or more of the following interests of the Discloser

(including those of the Discloser’s spouse and dependent children) that reasonably appear to be

related to his or her institutional responsibilities (including teaching, administration, research or

clinical care):

(i) With regard to any publicly traded entity, a significant financial interest exists

when the value of any remuneration received from the entity in the twelve months

preceding the disclosure, when aggregated, exceeds $10,000. For purposes of this

definition, remuneration includes salary, and any payment for services not otherwise

identified as salary (e.g., consulting fees, honoraria, etc.); or

When the value of any equity interest in the entity as of the date of disclosure exceeds

$10,000 or represents more than a 5% ownership interest in the entity; 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 $10,000, or when the Discloser

holds any equity interest (e.g., stock, stock option, or other ownership interest).

(iii) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt

of income greater than $10,000 related to such rights and interests.

(iv) With respect to the Discloser only, a significant financial interest exists if the

Discloser is a member of the Board of Directors or serves as a fiduciary officer

of any entity.

2. Intellectual Property Rights Assigned to Yale

Income from intellectual property rights assigned to Yale and agreements to share in royalties

related to such rights: Yale does not treat these particular interests in and of themselves as

“significant.” However, depending upon certain circumstances, Yale may take intellectual

property rights into consideration as a factor in determining whether or not a financial conflict of

interest exists. Also, because Yale’s Institutional Review Boards (IRBs) may consider

intellectual property rights in their review of human research protocols and for purposes related

to the protection of research participants, intellectual property interests should be disclosed.

3. Other Activities/Financial Interests

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The following activities/financial interests are not considered significant and do not have to be

disclosed:

(i) Salary or other remuneration paid by Yale to the Discloser if the Discloser is

currently employed by Yale;

(ii) Financial interests or activities not related to one’s academic or professional work at

Yale;

(iii) Reimbursed or sponsored travel expenses;

(iv) Income from investment vehicles, such as mutual funds and retirement accounts, as

long as the Discloser does not directly control the investment decisions made in these

vehicles;

(v) Income from lectures, seminars or teaching engagements sponsored by public or non–

profit entities, including other academic institutions;

(vi) Income for service on advisory committees (including scientific advisory committees)

or review panels for public or non–profit entities, including professional associations;

(vii) Income for book royalties, editorial activities (e.g., journal editorships or editing

compilations of scholarly papers) or authorship activities (e.g., advances) from

publishing companies (for profit or non–profit). Remuneration for editorial or

authorship activities received from or funded by entities not primarily engaged in

the publishing business (including providers/producers of continuing medical

education (CME), medical communications and other commercial enterprises such

as pharmaceutical or medical device companies) must be disclosed; or

(viii) Compensated activities and income derived from Government or non-profit research

entities such as the Veterans Administration Connecticut Healthcare System, the

Howard Hughes Medical Institute, or the Pierce Foundation.

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APPENDIX A

YALE UNIVERSITY

CONFLICT OF INTEREST PROCEDURES APPLICABLE TO PUBLIC HEALTH

SERVICE FUNDING

The federal Public Health Service (PHS) has adopted regulations (42 CFR Part 50 and 45 CFR

Part 94) on Promoting Objectivity in Research. These regulations describe the actions an

individual and the institution must take in order to promote objectivity in research. The

regulations apply to all grants, cooperative agreements, and research contracts (but not Phase 1

Small Business Innovation Research or Small Business Technology Transfer program grants)

funded by the PHS. The regulations require that applicants for PHS funding (e.g., funding from

the National Institutes of Health, the Food and Drug Administration, the Centers for Disease

Control, et al.), prior to application for PHS funds, disclose to the institution any significant

financial interests related to their institutional responsibilities.

Definitions

Solely for those applying for or receiving funds from the PHS, Institutional responsibilities

means an Investigator’s professional activities on behalf of the Institution (e.g., teaching,

administration, research or clinical care). Specifically, these include:

•

Externally sponsored research or scholarly activities (includes activities such as

proposing, conducting, and analyzing research and disseminating results);

•

Departmental/University research (includes participation in study sections, peer review of

manuscripts, or effort on non-sponsored research);

•

Instruction/University Supported Academic activities (including preparation for and

presentations of formal and informal courses to students/trainee groups, mentoring

students and trainees, and participation in resident training);

•

Clinical service activities such as performing services for the Yale Medical Group and

affiliated hospitals;

•

Administrative activities including serving as Department Chair, Program Director, or

service on institutional committees, participation in department activities or faculty

advisory boards, etc.; or

•

Special Service activities on behalf of the University including institutional community

service.

Institutional responsibilities do not include:

•

Volunteer individual community or public service unrelated to one’s responsibilities on

behalf of the University; or

•

Other activities over and above or separate from responsibilities in the primary position.

Investigator means the project director or principal Investigator and any other person, regardless

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of title or position, who is responsible for the design, conduct, or reporting of research funded by

the PHS, or proposed for such funding, which may include, for example, collaborators or

consultants. The Principal Investigator (Project Director), upon consideration of the individual’s

role and degree of independence in carrying out the work, will determine who is responsible for

the design, conduct, or reporting of the research.

The definition of Significant Financial Interest set forth herein replaces II[E] of the general

policy and procedure.

Significant Financial Interest means:

(1) A financial interest consisting of one or more of the following interests of the Investigator

(and those of the Investigator’s spouse and dependent children) that reasonably appear to be

related to the Investigator’s institutional responsibilities (e.g., consulting and other outside

compensated professional work including service on Scientific Advisory Boards or similar

boards directly related to one’s University research or scholarship; or service in external

professional organizations and societies related to one’s work):

(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) With regard to intellectual property rights and interests (e.g., patents,

copyrights), a significant financial interest exists upon receipt of income of

greater than $5,000 related to such rights and interests;

(iv) With respect to the Investigator only (but not the Investigator’s spouse or

dependent children), a significant financial interest exists if the Investigator is a

member of the Board of Directors or serves as a fiduciary officer of any entity.

(2) Any reimbursed or sponsored travel (i.e., that which is reimbursed to or paid on behalf of

the Investigator, the Investigator’s spouse or dependent children), related to the Investigator’s

responsibilities, if the cost or value received from a single entity exceeds $5,000 for the

preceding twelve (12) months. 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. The details of this

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disclosure will include, at a minimum, the purpose of the trip, the identity of the

sponsor/organizer, the destination, and the duration.

(3) The term significant financial interest does not include the following types of financial

interests:

(i) 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;

(ii) Income from investment vehicles, such as mutual funds and retirement accounts, as

long as the Investigator does not directly control the investment decisions made in

these vehicles;

(iii) Income from seminars, lectures, or teaching engagements sponsored by a federal,

state, or local government agency, 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

(iv) 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.

Disclosure

Prior to the submission of an application for funding from a PHS agency, the Principal

Investigator and all other Investigators must have disclosed to the Conflict of Interest Office an

up-to-date listing of their Significant Financial Interests [SFI] (and those of their spouse and

dependent children), as defined above. Any new Investigator, who, subsequent to the

submission of an application for funding from a PHS agency, or during the course of the research

project, plans to participate in the project, must similarly disclose their SFI to the Conflict of

Interest Office promptly and prior to participation in the project.

Each Investigator who is participating in the PHS-funded research must submit an updated

disclosure of SFI at least annually, during the period of the award. Such disclosure must include

any information that was not disclosed initially to Yale, pursuant to this Policy, or in a

subsequent disclosure of SFI (e.g., any financial conflict of interest [FCOI] identified on a PHS-

funded project that was transferred from another Institution), and must include updated

information regarding any previously disclosed SFI (e.g., the updated value of a previously

disclosed equity interest).

Each Investigator who is participating in the PHS-funded research must submit an updated

disclosure of SFI within thirty (30) days of discovering or acquiring (e.g., through purchase,

marriage, or inheritance) a new SFI.

Review by the Provost’s Committee on Conflict of Interest

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The Provost’s Committee on Conflict of Interest will conduct reviews of disclosures submitted to

the Conflict of Interest Office. The Committee will review any SFI that has been identified in a

disclosure; these interests will be compared to each PHS research award on which the

Investigator is identified as responsible for the design, conduct, or reporting of the research to

determine if a SFI is related to the award and, if so, whether the SFI creates a Financial Conflict

of Interest (FCOI) related to that research award.

Guidelines for Determining “Relatedness” and Financial Conflict of Interest

The Committee will determine whether an Investigator’s SFI is related to the PHS-funded

research and, if so, whether the SFI is a financial conflict of interest. An Investigator’s SFI is

related to PHS-funded research when the Committee reasonably determines that the SFI: could

be affected by the PHS-funded research; or is in an entity whose financial interest could be

affected by the research. The Committee may involve the Investigator in the determination of

whether a SFI is related to the PHS-funded research.

A financial conflict of interest exists when the Committee reasonably determines that the SFI

could directly and significantly affect the design, conduct, or reporting of the PHS-funded

research.

In determining if an Investigator’s SFI is related to PHS-funded research, and if so, whether the

relationship creates a FCOI, the Committee considers the role of the Investigator and the

opportunity (if any), to bias the results, the nature of the research being proposed, and the value

of the SFI in relation to the size and value of the entity. In addition, the Committee may also

consider the following factors:

1. Whether the research is of a basic or fundamental nature directed at understanding basic

scientific processes; or

2. Whether the degree of replication and verification of research results is such that immediate

commercialization or clinical application is not likely; or

3. Whether the goal of the research is to evaluate an invention linked to the SFI (such as where

the SFI is a patent, or an interest in a company that has licensed the invention); or

4. Where the research involves human subjects, whether there are double blind conditions or the

involvement of a data and safety monitoring board; or

5. Where the SFI is in a privately held company, whether the researcher’s SFI could result in

the researcher having influence over company decisions, or whether the research could have

a significant impact on the company’s business or financial outlook (excluding Phase I

SBIRs and STTRs); or

6. The magnitude of the SFIs (e.g., the amount of consulting, or the percentage or value of

equity); or

7. Where the SFI is in the sponsor of the research, and the sponsor is a licensee of the

Investigator’s technology, the amount of commercialization payments received by the faculty

member from that technology, both currently or in the future; or

8. The number and nature of relationships an Investigator has with an entity. Multiple

entanglements can create a relationship with an outside entity that is stronger than the sum of

the parts; or

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9. Whether the goal of the research is to validate or invalidate a particular approach or

methodology that could affect the value of the SFI; or

10. Whether other scientific groups are independently pursuing similar questions; or

11. Whether sufficient external review of the research conducted and the reporting of research

results exist to mitigate undue bias; or

12. Whether the goal of the project is a comparative evaluation of a technology in which an

Investigator has a SFI; or

13. Whether the project involves a subaward to an entity in which the Discloser has a SFI.

Management of Significant Financial Interests that Pose Financial Conflict(s) of Interest

If a conflict of interest exists, the Committee will determine by what means – such as the

individual’s recusal from decisions affecting the conflicting entity, abstention from the external

activity, modification of the activity, and/or monitoring of the activity by a subcommittee – the

conflict should be avoided or managed in order to mitigate undue bias. In making those

determinations, the Provost’s Committee will be guided by the principles discussed in this Policy

and in the Faculty Handbook, and may be informed by the deliberations of the relevant

Institutional Review Board (IRB), as appropriate. The Committee will also take into

consideration whether the Investigator’s ongoing role is necessary to continue advancing the

research, based upon the factors such as the uniqueness of his or her expertise and qualifications.

Examples of conditions that might be imposed to manage a financial conflict of interest include,

but are not limited to:

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

research);

b) For research projects involving human subjects research, disclosure of financial conflicts

of interest directly to human participants;

c) Appointment of an independent monitor capable of taking measures to protect the design,

conduct, and reporting of the research against bias resulting from the financial conflict of

interest;

d) Modification of the research plan;

e) Change of personnel or personnel responsibilities, or disqualification of personnel from

participation in all or a portion of the research;

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

g) Severance of relationships that create financial conflicts;

h) For research projects involving human subjects research, use of a data and safety

monitoring board;

i) Double-blind conditions;

j) Provisions to conduct the work simultaneously at multiple sites;

k) Written disclosure of the conflict to all individuals working on the research project; and

l) Annual reports on the research progress to the Committee.

If the Committee determines that a conflict exists, it will communicate its determination and the

means it has identified for eliminating or managing the conflict, in writing, to the individual, to

the relevant Principal Investigator (Project Director), and the appropriate dean or department

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chair. The Conflict of Interest Office will keep a record of the disclosure and other relevant

information for at least three years. If the Provost’s Committee prescribes monitoring of the

activity, it will describe what monitoring shall be performed and what records are to be kept.

If the individual is not satisfied with the decision of the Committee, he or she may request that

the matter be referred to the Provost for a decision. A written statement of the findings and

recommendations of the Committee shall accompany any matter referred to the Provost, with

copies to the individual, and the appropriate Dean or Department Chair. The Provost will notify

the individual, the Committee, and the Dean or Department Chair of his or her decision after

receiving the Committee’s report.

The Provost’s decision will be final, and any failure by the individual to adhere to the decision

may be cause for disciplinary action, including, in severe cases, termination.

No expenditures on PHS awards will be permitted until the Investigator has complied with the

Disclosure requirements of this Policy and has agreed, in writing, to comply with any plans

determined by the Committee necessary to manage the Conflict of Interest. The Conflict of

Interest Office will communicate with the PHS Awarding Component to notify it of the existence

and the nature of a Financial Conflict of Interest and whether the conflict has been managed,

reduced, or eliminated.

The Conflict of Interest Office will keep a record of Investigator disclosures of financial interests

and the Committee’s review of, and response to, such disclosure and all actions under this policy.

Such records will be maintained and kept for three years from the date the final expenditures

report is submitted for grants, for three years from the date of final payment for contracts, or,

where applicable, for time periods as otherwise specified in relevant PHS Regulations.

Public Accessibility to Information Related to Financial Conflicts of Interest

Prior to the expenditure of any funds under a PHS-funded research project, Yale will ensure

public accessibility, via a publicly accessible Web site or by written response to any requestor

within five business days of a request, of information concerning any SFI disclosed that meets

the following three criteria:

(i) The Significant Financial Interest was disclosed and is still held by the senior/key

personnel. Senior/key personnel are the PD/PI and any other person identified as

senior key personnel by the University in the grant application, progress report or any

other report submitted to the PHS by the University;

(ii) Yale has determined that the Significant Financial Interest is related to the PHS-

funded research; and

(iii) Yale has determined that the Significant Financial Interest is a Financial Conflict of

Interest.

The information that Yale will make available via a publicly accessible Web site or in a written

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Effective August 24, 2012 (Rev 11-29-12)

response to any requestor within five days of request will include, at a minimum, the following:

(i) The Investigator’s name;

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

(iii) The name of the entity in which the Significant Financial Interest is held;

(iv) The nature of the Significant Financial Interest; and

(v) The approximate dollar value of the Significant Financial Interest in the following

ranges: $0-$4,999; $5,000-9,999; $10,000 - $19,999; amounts between $20,000-

$100,000 by increments of $20,000; 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.

If Yale uses a publicly accessible Web site to comply with the public disclosure requirements of

the PHS regulations, the information posted will be updated at least annually, and within sixty

days of receipt or identification of information concerning any additional SFI of the senior/key

personnel for the PHS-funded research project that had not been previously disclosed, or upon

the disclosure of a SFI of senior/key personnel new to the PHS-funded research project, if it is

determined by the Committee that the SFI is related to the PHS-funded research and is a

Financial Conflict of Interest.

If Yale responds to written requests for the purposes of public accessibility, it will ascertain from

the Investigator that the information provided is current as of the date of the correspondence, and

will note in its written response that the information is subject to updates, on at least an annual

basis and within 60 days of the Yale’s identification of a new financial conflict of interest, which

should be requested subsequently by the requestor.

Information concerning the SFI’s of an individual, as limited by this Policy, will remain

available, for responses to written requests or for posting via Yale’s publicly accessible Web site

for at least three years from the date that the information was most recently updated.

Reporting of Financial Conflicts of Interest

Prior to the expenditure of any funds under a PHS-funded research project, Yale will provide to

the PHS Awarding Component an FCOI report compliant with PHS regulations regarding any

Investigator’s SFI found to be conflicting and will ensure that the Investigator has agreed to and

implemented the corresponding management plan. While the award is ongoing (including any

extensions with or without funds), Yale will provide to the PHS Awarding Component an annual

FCOI report that addresses the status of the FCOI and any changes in the management plan.

For any SFI that is identified as conflicting subsequent to an 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), Yale will provide to the PHS Awarding Component, within sixty days,

an FCOI report regarding the financial conflict of interest and ensure that Yale has implemented

a management plan and the Investigator has agreed to the relevant management plan.

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Effective August 24, 2012 (Rev 11-29-12)

Training Requirements

Each Investigator must complete training on The Yale Conflict of Interest Policy Applicable to

Public Health Service Funding. For PHS Investigators, Yale has imbedded training on conflict of

interest into its annual disclosure form. Each Investigator must complete the disclosure form

prior to engaging in research related to any PHS-funded grant, and immediately (as defined

below) when any of the following circumstances apply:

1) Yale revises this Policy, or procedures related to this Policy, in any manner that affects the

requirements of Investigators (training will be completed in the manner and within the time

frame specified in communications announcing such changes) ;

2) An Investigator is new to Yale (training must be completed through completion of the

disclosure form within 30 days of joining Yale); or

3) Yale finds that an Investigator is not in compliance with this Appendix to Yale’s Conflict of

Interest Policy or a management plan issued under this Appendix (training must be

completed within 30 days in the manner specified by the COIC).

Subrecipient Requirements

Yale shall as part of a written subrecipient agreement with a subrecipient under a PHS prime

award, establish whether the financial conflicts of interest policy of Yale or that of the

subrecipient will apply to the subrecipient’s investigator(s). If the subrecipient relies on its

conflicts of interest policy, the subrecipient shall certify as part of the subrecipient agreement,

that its policy complies with 42 CFR Part 50 and 45 CFR Part 94, as appropriate. In either case,

the subrecipient agreement will include time periods to meet the disclosure and/or Financial

Conflict of Interest reporting requirements of Yale to PHS.

Failure to Comply with Yale’s Conflict of Interest Policy Applicable to Public Health

Service Funding

Whenever an FOIC is not identified or managed in a timely manner, including, for example,

because the underlying Significant Financial Interest is not disclosed timely by an Investigator

or, because an FCOI was not timely reviewed or reported by a sub-recipient or by Yale); or

because an investigator failed to comply with a management plan; then Yale will complete a

retrospective review to determine whether any PHS-funded research, or portion thereof,

conducted during the period of noncompliance was biased in the design, conduct, or reporting of

such research. The Provost will appoint one or more individuals to determine if the research was

biased. If bias is found, Yale will develop and implement a plan to mitigate the bias. Yale will

notify the PHS Awarding Component promptly and will submit a mitigation report to the PHS

Awarding Component within 120 days of the determination of noncompliance.

No expenditures of funds on PHS awards will be permitted unless the Investigator has complied

with the Disclosure requirements of this Appendix and has agreed, in writing, to comply with

any Committee-approved FCOI management plan.

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Effective August 24, 2012 (Rev 11-29-12)

In any case in which the Department of Health and Human Services determines that a PHS-

funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a

drug, medical device, or treatment has been designed, conducted or reported by an Investigator

with a financial conflict of interest that was not managed or reported by the Institution as

required by the PHS regulations, Yale will require the Investigator involved to disclose the

financial conflict of interest in each public presentation of the research and to request an

addendum to previously published presentations.

Any failure by an individual to adhere to this Policy may be cause for disciplinary action,

including, in severe cases, termination.

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APPENDIX B

YALE UNIVERSITY

CONFLICT of INTEREST PROCEDURES APPLICABLE TO NATIONAL SCIENCE

FOUNDATION FUNDING (NSF)

The National Science Foundation (NSF) requires each grantee institution employing more than

fifty persons to maintain an appropriate written and enforced policy on conflict of interest and

that all conflicts of interest for each award be managed, reduced or eliminated prior to the

expenditure of the award funds. Therefore, for every NSF application for funding, each

Investigator must disclose to the Conflict of Interest Office all significant financial interests of

the Investigator (including those of the investigator’s spouse and dependent children):

(i) That would reasonably appear to be affected by the research or educational

activities funded or proposed for funding by NSF; or

(ii) In entities whose financial interests would reasonably appear to be affected by

such activities.

Definitions

The term “Investigator” means the principal investigator, co-principal investigators, and any

other person at the institution who is responsible for the design, conduct, or reporting of research

or educational activities funded or proposed for funding by NSF.

For those applying for or receiving funds from the NSF, the definition of Significant Financial

Interest described herein replaces II[E] of the general policy and procedure. The term

“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). With respect to the Investigator only (and not the

investigator’s spouse and dependent children), a significant financial interest exists if the

Investigator is a member of the Board of Directors of any entity, or serves as a fiduciary officer

of such an entity.

The term does not include:

(i) Salary, royalties or other remuneration from the applicant institution;

(ii) Any ownership interests in the institution, if the institution is an applicant under

the Small Business Innovation Research Program or Small Business Technology

Transfer Program;

(iii) Income from seminars, lectures, or teaching engagements sponsored by public or

non-profit entities;

(iv) Income from service on advisory committees or review panels for public or

nonprofit entities;

(v) An equity interest that, when aggregated for the investigator and the investigator’s

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spouse and dependent children, meets both of the following tests: does not exceed

$10,000 in value as determined through reference to public prices or other

reasonable measures of fair market value, and does not represent more than a 5%

ownership interest in any single entity; or

(vi) Salary, royalties or other payments that, when aggregated for the investigator and

the investigator’s spouse and dependent children, are not expected to exceed

$10,000 during the twelve month period.

Disclosure

All Investigators must have a current financial disclosure on file with the University’s Conflict of

Interest Office at the time the proposal is submitted to NSF. Financial disclosures must be

updated during the period of the award, either on an annual basis, or as new reportable

significant financial interests are obtained.

Review by the Provost’s Committee on Conflict of Interest

The Provost’s Committee on Conflict of Interest (the Committee) will review financial

disclosures, determine whether a conflict of interest exists, and determine what conditions or

restrictions, if any, should be imposed to manage, reduce or eliminate such conflict of interest. A

conflict of interest exists when the Committee reasonably determines that a significant financial

interest could directly and significantly affect the design, conduct, or reporting of NSF-funded

research or educational activities

Guidelines for Determining Conflict of Interest

The Committee will determine whether an Investigator’s SFI is related to the NSF-funded

research and, if so, whether the SFI is a financial conflict of interest. An Investigator’s SFI is

related to NSF-funded research when the Committee reasonably determines that the SFI: could

be affected by the NSF-funded research; or is in an entity whose financial interest could be

affected by the research. The Committee may involve the Investigator in the determination of

whether a SFI is related to the NSF-funded research or educational activity.

A financial conflict of interest exists when the Committee reasonably determines that the SFI

could directly and significantly affect the design, conduct, or reporting of the NSF-funded

research or educational activity.

Factors that may be taken into consideration in this determination include the role of the

Investigator and the opportunity to bias the results, the nature of the research being proposed,

and consideration of the value of the SFI in relation to the size and value of the entity. Other

factors that might be considered include:

Institutions must maintain records of all financial disclosures made by investigators involved in NSF

sponsored research and of all actions taken to resolve conflicts of interest for at least three years beyond

the termination or completion of the sponsored award to which they relate, or until the resolution of any

NSF action involving those records, whichever is longer.

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