The Johns Hopkins University: University Policies
The Johns Hopkins University

The Johns Hopkins University and
The Johns Hopkins Health System Corporation
Policy on Institutional Conflict of Interest

Principle and Purpose

The Johns Hopkins University and The Johns Hopkins Health System Corporation (together, "Johns Hopkins," the "Institution," or the "Institutions") are committed to the highest standards of conduct in research, teaching, clinical care, professional practice, business transactions, and other activities that support their core missions. Relationships with the commercial sector play an important role in supporting the Institutions' missions, and institutional financial interests arise in the normal course of Institutional operations. However, these financial interests should not compromise the Institutions' standards or integrity or unduly influence decisions in any activity at Johns Hopkins. Potential conflicts of interest between the Institutions' primary objectives and its financial interests must be identified and properly managed with policies and procedures that support integrity and advance the Institution's missions. The purpose of this policy is to set forth the standards and procedures for reporting and review of potential Institutional conflicts of interest ("ICOIs")1.

Scope of the Policy

This ICOI policy outlines standards of conduct and general procedures for all Johns Hopkins divisions. It applies to The Johns Hopkins University, including all its divisions, institutes, centers, and units, and to The Johns Hopkins Health System Corporation and all its constituent entities.

Institutional financial interests may be created by gifts, payments, royalty income, equity, and other benefits from or interests in for-profit organizations. Institutional financial interests also are created by financial and fiduciary interests of Institutional Officials.

Institutional Officials should recognize that any investment in an entity with which the Institution does business may and will give rise to review for ICOI. Institutional Officials are strongly advised to avoid investing in or otherwise engaging in personal financial or fiduciary relationships with for-profit entities that sponsor research at or have significant business relationships with the University where the official is likely to have involvement in or direct supervisory authority over decisions relating to such entities. All financial interests of Institutional Officials must be reported and will be reviewed in accordance with this policy. Institutional Officials may not participate in decisions relating to entities in which they have an interest as defined in this Policy, except as provided for pursuant to review under the Policy

This policy applies to all institutional activities, including research activities; educational activities; clinical care; professional practice; business activities; purchasing; and technology transfer.

General Standards and Requirements

Each division of the University and the Health System should develop, publish, and implement procedures for dealing with ICOIs. In the alternative, a division may adopt this Institution-wide policy or the policy of another division as its own procedures. A divisional policy may not conflict with this policy. Divisional ICOI procedures must be based on the principle that no area of Institutional activity should be subject to undue influence from the Institution's outside financial interests. The procedures must incorporate the highest ethical standards for the conduct of the activities covered by this policy. They must satisfy key requirements of this policy. They also must set forth the process for reviewing and making determinations in cases involving ICOIs. They should identify review criteria, including those outlined in this policy (See Review Criteria, below). Divisions that conduct or oversee human subject research must adopt especially rigorous standards that support protection of subjects' safety and welfare, including close scrutiny of ICOIs and stringent review and management.

Reporting Requirements

Outlined below are reporting requirements for specific categories of financial and fiduciary interests. These are not prohibited arrangements. Rather, they trigger reporting requirements to allow for the review and management of potential institutional conflicts.

For purposes of this policy, there are two kinds of Institutional financial interests.

  • First, in the conduct of its business, the Institution itself may receive gifts, payments, royalty income, and equity, and it may develop business relationships with for- profit organizations. In some cases, these financial interests have the potential to influence or appear to influence actions, recommendations, and/or decisions made by faculty, staff, or others acting on behalf of the Institution, thus generating ICOIs.

  • Second, certain Institutional Officials, by virtue of their Institutional responsibilities, may influence decisions or be perceived as able to influence decisions. The individual interests of these high-level officials — whether arising independently or through Institutionally-promoted activities — may create ICOIs. Therefore, major financial interests of these Institutional Officials are classified as ICOIs.
  • This policy mandates that both of these types of financial interests, above certain thresholds that are defined below, be reported, in order to ensure that ICOIs are identified and addressed.

    Reporting of the Institutions' Financial Interests

    The following financial interests of the Institutions must be reported to a single, secure database:

  • Equity and ownership interests worth more than $100,0002 in any publicly-traded, for-profit organization, except for equity held in the University's or Health System's endowment (see "Institutional Investment Assets, Including Endowment," below);

  • Equity and ownership interests of any amount in any for-profit organization that is not publicly traded;3.

  • Gifts of $1 million or more from any for-profit organization or philanthropic unit associated with a for- profit organization (see "Philanthropy," below); and

  • Payments, including royalty payments, resulting from technology transfer, licensing, and business activities such as Institutional consulting or service agreements that, for each arrangement, exceed $100,000 per year. Clinical care income and tuition income are not included as institutional interests. Such a financial interest itself, e.g. sponsored project income, does not ipso facto create a conflict. Rather, the purpose of these procedures is to identify activities, such as research, that may be affected by financial interests other than support for the research itself.

  • The senior staff member responsible for the arrangement (e.g., technology license, gift, Institutional consulting agreement) must make the report to the database at the time the arrangement is proposed. The database will require sufficient detail (e.g., number of shares or percentage of ownership; amount of gift; magnitude and timing of payments, royalty, and consulting fees) for a thorough initial review of potential ICOIs; however, additional information may be requested for ICOI review of a given case.

    Reporting of Institutional Officials' Financial Interests

    For purposes of this policy, Institutional Officials4 include:

  • University President
  • University Provost and Vice/Associate/Assistant
  • Provosts
  • University Vice Presidents
  • Deans and Vice/Associate/Assistant Deans
  • Institute and Center Directors and other senior administrators, as determined by the University
  • Health System President
  • Health System Vice Presidents and Directors

  • Divisional procedures may define additional categories, within their divisions, of Institutional Officials whose personal interests have the potential to generate ICOIs. For example, divisional procedures may include Department Directors/Chairs as Institutional Officials.

    The following financial interests of Institutional Officials must be reported to a single, secure database:

  • Equity and/or ownership interests in publicly-traded for-profit organizations of an amount exceeding $25,000 in the value of its stock. Not included are a) equity or ownership interests in mutual funds for which the individual has no control over the investment decisions of the fund, and b) equity or stock holdings for which the Institutional Official has no role or influence over trading decisions. For example, if an Institutional Official attests in writing that his equity investments are managed under contract with a professional asset manager (who is not a member of his immediate family) and that he does not participate in (e.g., direct, recommend, influence, or control) the purchase or sale of specific stocks, the requirement to disclose holdings of publicly traded stock subject to such an arrangement will be waived.

  • Equity (including stock, options, warrants, and the like), ownership, or founders' interests in non-publicly traded companies;

  • Any fiduciary role, such as service on the board of directors of a for-profit organization.

  • Income, including royalty, equity, consulting fees, or other payments from for-profit organizations that, in the aggregate, exceeds $25,000 per year from each organization.

    Divisional procedures may establish a more stringent reporting standard for their Institutional Officials.

    Institutional Officials must submit a report annually and must update their reports within a reasonable time after they learn that their financial interests have changed. In the annual report, Institutional Officials will be required to certify that they are in compliance with all applicable conflict of interest policies. This requirement does not affect reporting and other obligations as applicable under each division's policy on individual conflict of interest or reporting in connection with separate policies, such as those addressing intermediate sanctions.

    Review Procedures

    Each division or entity shall appoint an ICOI committee to consider ICOIs that arise within the division. This may be the same committee that reviews individual conflicts of interest, the same committee with additional members, or a separate committee.5 The University President also shall appoint a central committee to consider ICOIs involving institutional officials who are not within a division and institutional financial interests that do not arise within a division.

    The division will develop a procedure to check the database for ICOIs when an Institution is considering entering into any of the following transactions.6

  • sponsored research;
  • research involving testing or evaluation of a product or service, whether or not the manufacturer or vendor is sponsoring the research;
  • purchase or procurement of products or services7;
  • license of Institutional technology;
  • contracting for Institutional consulting services or business partnerships; or
  • gifts of $1 million or more from any for-profit organization or philanthropic unit associated with a for-profit organization.

  • The ICOI committee will review the reports of the activities described above to determine whether they are Institutional Financial Interests that may generate potential conflicts of interest. To ensure efficiency, algorithms will be developed to allow for preliminary review and triage of potential ICOIs. The algorithms will identify specified categories of ICOIs for which review, documentation, and management can be implemented by staff without the need for committee review.

    Detailed disclosure and review procedures are outlined on the attached chart.

    Review Criteria

    Reviews must consider whether the financial or fiduciary interests disclosed in accordance with this policy have the potential to appear to affect any of the following:

  • safety of human research subjects;
  • safety of patients;
  • integrity of research;
  • appropriate allocation of resources;
  • objectivity and independence of educational activities, including undergraduate, graduate, post-graduate, and continuing education;
  • independence of clinical care or other professional practice judgment;
  • objectivity in business and contracting decisions
  • The same standards will apply to the review of the financial interests of the Institution and all Institutional Officials.

    Making Recommendations

    The ICOI review of a specific case may result in one of three types of recommendations: 1) the arrangement does not represent a significant actual, potential, or perceived ICOI that needs to be managed; 2) the arrangement can be managed including required changes; or 3) the arrangement is not manageable and either the activity may not proceed or the financial interest must be eliminated (or reduced). In type 3 recommendations, it is expected that the ICOI committee will usually recommend that the elimination (or reduction) of the financial interest would be preferable to prohibiting the proposed research, clinical, or educational activity. In all cases reviewed, the ICOI committee must retain documentation of its review and determination.

  • No ICOI: In cases resulting in a finding that there is no significant actual, potential, or perceived ICOI, the ICOI committee must communicate its decision to the appropriate individual responsible for the activity and any Institutional Official whose interest was at issue.

  • Manageable ICOI: In cases that the ICOI committee considers manageable, it will recommend one or more management measures. These may include, but are not limited to, 1) effective recusal from decision-making regarding the proposed arrangement by the financially interested Institutional Official and disclosure of the recusal to the appropriate individuals to implement the recusal; 2) reduction in the magnitude of the financial interest (generally to below the thresholds outlined above); 3) disclosure of the financial interest in relevant publications, presentations, human subject consent forms, clinical procedure or other consent forms, educational material, etc., 4) oversight by a disinterested senior individual or committee, and/or 5) other measures as deemed appropriate.

  • ICOIs in Human Subject Research and Clinical Care: For arrangements involving ICOIs with human subject research and clinical care, there must be particularly close scrutiny. Primary consideration will be given to the potential impact of the ICOI on the safety and welfare of human research subjects and patients. In addition, the potential impact on the integrity of research data that could affect future clinical use will be considered carefully.

  • Unmanageable ICOI: In cases the ICOI committee considers not manageable, it will report its recommendation to the appropriate recipient of the recommendation with written justification. In cases judged to involve an unmanageable ICOI, it is expected that the ICOI committee should usually recommend the elimination (or reduction) of the financial interest rather than prohibition of the proposed research, clinical, professional, or educational activity. The ICOI committee and the Institution should generally give precedence to activities that carry out Institutional missions over conflicting financial interests.

  • Making and Reporting Decisions

    On receiving a recommendation regarding an ICOI case, the individual identified in the accompanying chart as receiving the recommendation will make a decision to accept, reject, or revise the recommendation. An aggrieved party may appeal the decision to the JHU President or the JHHS President, as appropriate. All final decisions made by recipients of ICOI committee recommendations must be reported to the ICOI committee that submitted the recommendation.

    Philanthropy and Endowments


    Gifts, pledges, and solicitation of gifts to the Institutions (or any of their constituent entities or units) are important to their missions. However, no charitable donation is allowed to be contingent upon the outcome of any research or business transaction conducted at or by the Institutions. The Institutions hereby affirm that they will not solicit or accept gifts that in any way limit the ability of their investigators to conduct and/or report the results of research in accordance with the highest scientific, medical, professional, and ethical standards. Nor will the Institutions solicit or accept gifts (including gifts to support research) that are contingent upon any particular business or purchasing decision(s).

    In some cases, the Institutions may enter into arrangements involving the donation of all or a portion of capital equipment, with the expectation the equipment will be used for research or patient care. Such arrangements are appropriate, provided they do not limit the professional independence of faculty and staff.

    Institutional Investment Assets, Including Endowment

    The Institutions' endowment includes assets received from philanthropy, investment, and other sources. University endowment assets are managed by the University's Chief Investment Officer. The Johns Hopkins Hospital Endowment Fund assets are managed by the Endowment which contracts with outside investment managers to make investment decisions on behalf of the Endowment.

    The Institutions hereby affirm that the Office of the Chief Investment Officer, and its outside investment contractors and the Hospital Endowment managers and its outside investment contractors are forbidden from communicating with Institutional Officials or Institutional researchers concerning the conduct and interpretation of ongoing or planned research performed at the Institutions for the purpose of influencing investment decisions. Maintaining this robust "firewall" is essential for ensuring that the core activities of the Institutions are not affected, or perceived to be affected, by the Institutions' interest in maximizing the value of the endowments.

    If an individual becomes aware of a situation in which there appears to be a conflict of interest involving philanthropic gifts, solicitation of gifts, or management of the endowments, the individual must notify the ICOI committee of the division in which the related research or other activity is proposed or underway. The divisional ICOI Committee will review the arrangements and make a recommendation to the appropriate official.

    Regulations and Guidance

    There is currently no general federal or state regulation of ICOIs (although a subset of ICOIs also may constitute arrangements requiring review for compliance with federal anti-kickback laws, intermediate sanction rules, or other federal regulations). The Department of Health and Human Services (DHHS) has issued guidance on ICOI in human subject research.8 The Association of American Universities (AAU) offers guidance9 on ICOIs, and the Association of American Medical Colleges (AAMC) issued recommendations for addressing ICOIs in human subject research.10 Many of the principles and procedures contained in this policy are based on these documents.


    Fiduciary Role
    A fiduciary role refers to a legal and/or ethical obligation on the part of a covered party to act in the best interests (i.e., the financial and operational success) of another. Examples of fiduciary roles include, but are not limited to:

  • Membership on a board of directors
  • Management role in a company or partnership.

  • Financially Interested Company
    Financially interested company means a commercial entity whose financial interests would reasonably appear to be affected by the conduct or outcome of research, clinical, purchasing, or other activity conducted at or under the auspices of the Institution. Examples include, but are not limited to, companies that hold patent rights for discoveries, drugs or devices being studied in research protocols or companies that provide financial or in-kind support for research projects. This term includes companies that compete with the sponsor of the research or the manufacturer of the investigational product, if the covered party knows that the financial interests of such a company would reasonably appear to be affected by the research. This term also includes any entity acting as the agent of a financially interested company (e.g., a contract research organization).

    Human Subject Research
    Human subjects research includes all research meeting the definition of "research" performed with "human subjects" as defined in the Federal Common Rule (45 C.F.R. Part 46 and 21 CFR Part 56), regardless of the source of research funding or whether the research is otherwise subject to federal regulation. In the event that the Common Rule definitions of "human subject" or "research" are modified through rulemaking, any such revisions shall apply for the purposes of this policy.

    Institution means The Johns Hopkins University (JHU), The Johns Hopkins Health System (JHHS) Corporation, and all their divisions, units, and constituent entities.

    Institutional Conflict of Interest
    An Institutional Conflict of Interest (ICOI) is a situation in which a primary mission or objective of the Institution is or may be perceived as in conflict with or unduly affected by an Institutional Financial Interest, as defined in this Policy. An ICOI is not inherently unethical or dangerous; however, it may introduce risks (e.g., to research integrity or business practices) that must be identified, reviewed, and managed or eliminated.

    Institutional Official
    For purposes of this policy, Institutional Officials11 include:

  • University President
  • University Provost and Vice/Associate/Assistant Provosts
  • University Vice Presidents
  • Deans and Vice/Associate/Assistant Deans
  • Institute and Center Directors and other senior
    administrators, as determined by the University
  • Health System President
  • Health System Vice Presidents and Directors

  • Divisions may designate those in additional roles as Institutional Officials.

    Research/Conducting Research
    "Research" shall mean any organized program of scientific inquiry. "Conducting Research" includes designing research, directing or serving as an investigator, performing laboratory experiments, having a role in soliciting consent from research subjects or making decisions related to eligibility of patients to participate in research, analyzing or reporting research data, or submitting manuscripts or abstracts concerning the research for publication. Examples include, but are not limited to, projects for which outside support is requested and projects for which approval of an IRB is required. For purposes of this policy, the determination of what constitutes research and what constitutes the conduct of research shall be made by the appropriate ICOI committee.


    1 Terms whose first use in this policy is italicized are defined at the end of the policy.

    2 The value of $100,000 in publicly traded stock is set as a reporting threshold, as recommended by the AAMC Recommendations; see page 6 of Protecting Subjects, Preserving Trust, Promoting Progress II: Principles and Recommendations for Oversight of an Institution's Financial Interests in Human Subjects Research, available at

    3 For equity acquired by the Institution as the result of a technology license, the equity is placed in escrow until the stock is publicly traded. When public trading is initiated, as a matter of standard procedure, the Treasurer s Office will arrange for release of the stock from the escrow account. The Treasurer s Office will manage the stock into liquidation. This standard practice is intended to reduce or eliminate the Institution s financial interest in licensees of University technology and potential ICOIs with activity involving licensees of University technology.

    4 Trustees of the Institutions are covered under separate conflict of interest policies and are not subject to this policy.

    5 It is anticipated that the School of Medicine and the Health System will establish a joint ICOI committee. That committee must include at least one senior official of the Health System.

    6 It is recommended that the ICOI committees outlined in this policy include faculty members and others with sufficient expertise to evaluate the risks of potential ICOIs. The committees may include as a member an individual from outside Johns Hopkins.

    7 Purchases or procurements involving the following will be reviewed: new vendor; sole source vendor request; purchases of capital equipment or supplies of over $XXXX (TBD). Routine purchases and those under $XXXX (TBD) involving competitive bidding will not be reviewed.

    8 Department of Health and Human Services Final Guidance Document — Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection, available at

    9 AAU Report on Individual and Institutional Conflict of Interest, available at

    10 Protecting Subjects, Preserving Trust, Promoting Progress II: Principles and Recommendations for Oversight of an Institution's Financial Interests in Human Subjects Research, available at

    11 Trustees of the Institutions are covered under separate conflict of interest policies and are not subject to this policy.

    [December 2010]


    © 2007 The Johns Hopkins University. Baltimore, Maryland. All rights reserved.
    Last updated 23Oct07 by