Handbook on Reporting Conflict of Interest and Commitment

  • In order to disseminate knowledge and expertise in research and teaching outside the institution, Johns Hopkins University faculty members engage in a variety of outside activities and the institution supports and encourages these activities. It is important to recognize, however, that the financial interests and time commitment that may be associated with providing advisory services, and engaging in entrepreneurship, inventorship, and related activity have the potential to conflict with one’s primary obligations to Johns Hopkins and to impact academic integrity and objectivity. Permitted outside activities will vary depending on the individual’s employment or appointment status, relationship to research, and other factors. All disclosures of outside activities must be submitted through JHU eDisclose.

  • A conflict of interest may arise when a financial interest is related to one’s research and may affect or appear to affect the objectivity of the research, the safety and welfare of human research subjects, or the interests of students and trainees. A conflict of interest also may arise if a financial interest has the potential to affect one’s responsibilities other than research, such as teaching or administrative duties.

    A disclosed financial interest is considered related to one’s research if the research could impact the value of the company in which the financial interest is held (or from which it derives) or the value of its products or those of its competitors. If the financial interest is related to one’s research and it has the potential to impact the objectivity of the research, the safety of human research subjects, or the rights and interests of students or trainees,there is a conflict of interest.

    Review for conflict of interest with research follows the JHU Policy on Financial Interests and Financial Conflicts of Interest with Research, which complies with PHS regulations on objectivity in research. The goal of each review is to determine whether a disclosed financial interest relates to an individual’s research, regardless of research sponsor, and, if so, whether it creates a conflict of interest with the research.

    Disclosures are reviewed for:

    • potential of disclosed intereststo directly and significantly affectthe design, conduct, or reporting ofresearch funded by a PHS Awarding Component or other sponsor (“financial conflict of interest” or “FCOI”); and
    • risks to the rights and safety of human research subjects; and
    • impact on the integrity ofresearch data; and
    • risks to the rights and obligations ofstudents and trainees participating in research; and
    • impact on the availability of research results to the scientific community for use in the public interest; and
    • appearance of a conflict of interest.
  • The questions posed below, when answered “yes”, are examples of potential conflicts of interest:

    • Does your external activity involve the uncompensated use of facilities or resources belonging to Johns Hopkins University by or on behalf of another organization?
    • Does your external activity involve the transfer of your intellectual or tangible property rights including patent ownership or licensing to an organization other than the University?
    • Does your external arrangement or agreement restrict the public disclosure of the existence of the external arrangement?
    • Does the external activity restrict your right to publicly disclose information developed by you through your involvement in the activity?
    • Does your involvement in the external activity appear to influence either the conduct of the University’s business or the conduct of research within the University?
    • Is your research and/or academic work sponsored by a company for which you consult or have a paid position?
    • Is your research and/or academic work sponsored by a company for which you (or your spouse or your children) hold any ownership interest (stock, not including stock owned through a mutual fund) or from which you are entitled to receive royalties from a licensing agreement?
    • Is your research and/or academic work sponsored by a company for which you serve on its scientific advisory board or board of directors?
    • Are you (or your spouse or child) in a position to influence University decision making regarding purchasing products or services from an organization that you (1) hold an equity interest (not mutual funds) in the organization, (2) hold a position in the organization or on its governing board, and/or (3) serve as a paid or unpaid consultant to the organization?
    • Is your spouse/child involved in one of your sponsored projects, either directly or through a subcontract?
    • Does your external activity involve use of the name of the Johns Hopkins University or any of its schools or divisions by another organization?

    This list is not exhaustive. There may be other instances when an external activity could pose a potential conflict and would need to be reported. Contact our office for guidance if you are unsure if an activity needs to be reported.

  • Familial relationships may also give rise to potential conflicts of interest. A familial conflict can occur when a faculty member hires a spouse, domestic partner, child, or other relative to work on his or her projects. A familial conflict can also occur when the faculty member’s spouse, domestic partner, child, or other relative has a financial interest related to the faculty member’s research or institutional responsibilities. Such arrangements must be reported. Faculty members are prohibited from supervising relatives or determining salary or remuneration for relatives.

  • The Conflict of Interest Committee reviews all reports of outside activities to determine whether a potential conflict of interest exists. If the Committee finds a potential conflict exists, the Committee informs the faculty member in writing of required conditions to manage the conflict. Common management conditions required by the Committee could include:

    • Disclose relationship with external entity in relevant publications and presentations
    • Limit of a faculty member’s role in the research study (e.g. Exclusion from consenting participants, data analysis, etc)
    • Appoint an independent oversight committee for the study
    • Require that the PI places equity in escrow account
    • Transfer supervision of a spouse to another individual

    If the Committee finds that the conflict cannot be managed, the Committee can prohibit the proposed external activity.

    Changes in previously disclosed relationships with outside entities may require that the Conflict of Interest Committee re‐review both the disclosure and any conditions in place to manage the conflict. For example, a consulting relationship with a company disclosed in eDisclose could pose a conflict if the faculty member subsequently receives a grant from the company to do research. In these situations, faculty should provide information about this additional relationship to the company in eDisclose.

  • The primary duty of full‐time faculty members is to the University. Faculty members engage with industry, government, and professional associations to further their knowledge, research, and other professional activity. At the same time, faculty must not let outside commitments interfere with their obligations to fulfill their University responsibilities. Faculty members are expected to act in the best interests of the University and in furtherance of the University’s mission at all times. A Conflict of Commitment may occur when faculty members’ time and attention devoted to external activities interferes with their ability to fulfill their obligations to the School. The existence of a potential conflict does not indicate that the activity is prohibited; most conflicts of commitment can be managed. Disclosures on outside commitments are reviewed for compliance with institutional policies and standards, including:

    • Time commitment
    • Conflict of commitment with Johns Hopkins duties
    • Use of the Johns Hopkins name by orin connection with an outside activity
    • Use of Johns Hopkins facilities and resources
    • Academic freedom
    • Regulated activity, such as provision of clinical care outside the institution

    Faculty members who receive their full‐time salary are allowed to consult or engage in entrepreneurial activity one day (ten hours) per week. Faculty members who receive less than full‐time salaries are allowed to consult beyond the one‐day per week limit when classes are notin session. The total number of days per year that faculty on part‐time appointments may consult may be determined by the formula [52 x F] + [(1‐F) x 6 x 52], where F is the fraction of full‐time equivalent salary that the Academic Staff member receives. Faculty who wish to pursue outside activities that exceed these limits must receive approval from the Dean of the appropriate School.

    Faculty members may not hold a substantive appointment at another academic institution without approval of the Dean ofthe appropriate School. Significant management roles (e.g., officer in company or positions that involve supervision of the work of others and/or day‐to‐day responsibility for operating decisions) usually are demanding in terms of both time and energy. Accordingly, Faculty members who wish to accept significant managerial responsibilities in a company or another organization must negotiate an appropriate reduction in University responsibilities and compensation with the Dean of the appropriate School.

  • The following individuals need to disclose:

    • Full‐time or salaried part‐time JHU faculty member (tenured and tenure track faculty and members of the research staff including professors, scholars, scientists, and engineers with research titles) are required to disclose outside activities and financial interests whether or not they participate in research.
    • Non‐salaried part‐time faculty must disclose outside activities and financial interests if they are related to their Johns Hopkins Institutional Responsibilities and if they participate in research at JHU.
    • Other individuals involved in research at Johns Hopkins who are Investigators must disclose outside activities and financial interests if they are related to their Johns Hopkins Institutional Responsibilities.
      • Institutional Responsibilities are those responsibilities and roles assigned to an individual in the course of their appointment or employment with the institution. These may include, among other things, research, teaching, clinical care/practice, and administrative responsibilities.
      • Investigator is the project director or principal investigator and any other person responsible for the design, conduct, or reporting of research, including collaborators and consultants, and all study team members on IRB applications.
    • JHU staff members must disclose financial interests if they are related their Institutional Responsibilities.
    • All Academic Staff must report the outside activities of their immediate family members if the activity relates to the Institutional Responsibilities of the Academic Staff member. The immediate family of an Academic Staff member includes her or his spouse, domestic partner, and/or dependent children.
    • Subrecipient investigators on PHS‐funded research must disclose occurrences of reimbursed or sponsored travel that are related to subrecipient’s work for JHU, regardless of the relationship of the travel to PHS funding, when the amount of travel during the 12 months preceding the disclosure reaches or exceeds $5,000 in the aggregate for a particular entity. (Note: This aggregate value includes travel for spouses, domestic partners and dependent children unless the travel occurs in the course of their employment by the entity.)This does not include travel that is reimbursed or sponsored by a U.S. federal,state, or local government agency, teaching hospital, medical center, U.S. institution of higher education, or related research institute. Exceptions also include travel reimbursements to Johns Hopkins, travel payments made by Johns Hopkins, or travel charged to a Johns Hopkins account.
    • Prior to undertaking an outside commitment
    • Prior to submission of an application for PHS‐funded research on which you are an investigator
    • Within 30 days of acquiring or discovering a financial interest related to your institutional responsibilities
    • Whenever a disclosed interest or activity changes(e.g.,the amount or type of remuneration, type of service, or time commitment) or ends
    • If you do not participate in any reportable outside activities, you are only required to certify on an annual basis that you have not participated in any outside activities. When it is time for your annual certification, you will receive an email reminder.

    In addition, all full‐time and salaried part‐time faculty are required to complete an Annual Certification. See the eDisclose reporting instructions for easy-to-follow steps to submit your Annual Certification.

    Late disclosure and failure to disclose may have serious consequences. Under federal conflict of interest regulation, if there is a failure to disclose, belated disclosure, or belated review of financial interests that the institution determines create financial conflicts of interest with PHS‐supported research, the
    institution must undertake a retrospective review of the completed research for bias. In addition, failure to comply with policies on conflict of interest and commitment may lead to review under professional misconduct procedures.

    Individuals must disclose the outside activities and financial interest listed below if they are related to your “institutional responsibilities.” Institutional responsibilities may include, among other things, research, teaching, clinical care/practice, and administrative responsibilities. Disclosure is required so the School can review outside interests and activities for conflict of interest and conflict of commitment.

    Activities – whether or not compensated:
    • Service on advisory committees or boards and review panels, except when provided to a U.S. state, federal or local government agency, teaching hospital, medical center or institution of higher education or related research institute
    • Publishing/editing/authoring, if remuneration is anticipated.
    • Board of Directors
    • Founder
    • Officer
    • Manager
    • Speaking, teaching and lecturing, except when provided to a U.S. state, federal or local government agency, teaching hospital, medical center or institution of higher education or related research institute
    Financial Interests:
    • Inventor oflicensed technology
    • Receipt of income from licenses, whether equity, royalty, or other
    • Entitlement to equity and/or royalty
    • Equity ownership (except mutual funds)

    You must disclose any of the above outside activities or financial interests of your spouse, domestic partner and/or minor dependents if they relate to your institutional responsibilities.

    If you are an investigator on PHS‐funded research, you must disclose occurrences of reimbursed or sponsored travel related to your institutional responsibilities when the amount of travel during the 12 months preceding the disclosure reaches or exceeds $5,000 in the aggregate for a particular entity. (Note: This aggregate value includes travel for spouses, domestic partners and dependent children unless the travel occurs in the course of their employment by the entity.) This does not include travel that is reimbursed or sponsored by a U.S. federal,state, or local government agency, teaching hospital, medical center,U.S. institution of higher education, or related research institute. Exceptions also include travel reimbursements to Johns Hopkins, travel payments made by Johns Hopkins, or travel charged to a Johns Hopkins account.

    The following do not need to be disclosed:
    • The exceptions listed above
    • Activities that are governed by an institutional agreement or contract between Johns Hopkins and a third party
    • Payments from Johns Hopkins (e.g., salary, salary supplement, reimbursements), other than payments derived from institutional licenses of intellectual property
    • Confidentiality agreements with no services or remuneration
    • Participation in local community activities (including, but not limited to, religious institutions, schools, clubs, and local charities outside the biomedical field), unless(i) you conduct research that relates to the organization, or(ii)the organization has a relationship with Johns Hopkins or seeks to do business with Johns Hopkins and you have any role in that relationship or business.
  • Faculty are responsible for ensuring that private agreements are in compliance with all University policies. All commitments to provide consulting or other services to outside entities must be governed by a written agreement that is established in advance, includes a detailed outline of the services to be provided, and specifies the associated compensation. You may wish to consult your own legal advisor before signing a private agreement or contract with an outside organization.

    Below are some general guidelines to follow when entering into private agreements:
    • Outside agreements should not interfere with your institutional responsibilities at the University.
    • Private agreements should be entered into by you as an individual and the company; you are not allowed to enter into private agreements as a representative of the University.
    • JHU is not a party in private agreements and will,therefore, have no liability under them. Consequently, JHU, or a representative thereof, will not sign any private agreements.
    • You cannot use any JHU facilities, resources or funds in the fulfillment of your responsibilities under the agreement.
    • You are not allowed to engage any JHU employees, including students, trainees, and postdoctoral fellows to provide services under the Agreement.
    • The outside entity is not allowed to use the name of JHU in any documents or marketing materials.
    • You should not disclose, or be asked to disclose, any confidential information that is proprietary to JHU, including providing early or exclusive accessto JHUresearch or disclosing inventions.
    • You should make sure that the outside entity will only have rights to any intellectual property that is developed by you alone orin collaboration with others as a sole and direct result of the performance of services under the Agreement. The entity shall have no rights under the Agreement to any intellectual property that is developed as a result of a program financed in whole orin part by funds provided by or under the control of JHU.
    • Do not participate in any activity that could constitute endorsement, promotion, or marketing of any product, technology or service.
    • Your role should be limited to providing expert advice. You should not participate in, direct or conduct research for or on behalf of an outside entity.
    • You should disclose your relationship to the outside entity in all publications and presentations of research supported by the outside entity. Disclosure is especially important in journal articles.
    • “The Johns Hopkins University Uniform Provisions” should be added to the Agreement. (See Forms & Worksheets).
    • If you want to make sure that your agreement is in compliance with JHU policies, you can email the agreement to cemerson@jhu.edu for review.
  • Conflicts of interest can arise in tech transfer when a faculty member is conducting research involving a product for which the faculty member is a licensed inventor. Faculty should report conflicts arising out of tech transfer activities at the time the research activities are proposed and provide relevant updates
    in eDisclose as they arise.

  • Conflicts of interest in human subjects research deserve special scrutiny because of the potential for such conflicts to affect the rights and welfare of human subjects. Faculty conducting human subjects research must indicate a potential conflict of interest on the IRB application and must report this
    through eDisclose. The COI Committee will review the report and make management recommendations to the IRB and the PI. A common management condition includes disclosure of the arrangement in the in the consent form.

    The IRB can decide whether to a) accept the Conflict of Interest Committee recommendations, b) accept the recommendations with additional management measures prescribed by the IRB, or c) conclude that the human subjects research cannot proceed.

  • In accordance with 42 CFR 50 Subpart F, the School must report to NIH those conflicts that are determined to be financial conflicts of interest (FCOI) related to Public Health Service (PHS) funded research. If the COI committee determines that a financial interest could directly and significantly affect the design, conduct or reporting of PHS supported research, the School will report this FCOI to the NIH. However, this does NOT mean that the research cannot be done but, instead, that a management plan for avoiding biased research must be in place. Federal regulations also require that the school respond to requests from any member of the public for information regarding FCOIs reported to NIH that are associated with PHS‐funded research.

    Grant and contract submission requires disclosure of potential conflicts related to the research to the Office of Research Administration (ORA) and in eDisclose. The Conflict of Interest Committee considers these disclosures for review and management.

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