Disclosure FAQs

Disclosure FAQs

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  • What policy requires disclosures?

    The University of Miami (UM) Conflict of Interest, Conflict of Commitment, Foreign Influence, and Institutional Conflict of Interest Policy addresses conflicts of interest and foreign engagements in order to support our commitment to transparency.

     

  • How are disclosures submitted to UM?

    To facilitate compliance with the new policy, the University is introducing upgrades to its university-wide system, UDisclose, that enables the quick and thorough review and management of conflicts throughout the institution. The NEW UDisclose System, a robust, university-wide system enabling review and management of conflicts throughout the institution.

  • Why does UM require the disclosure process?

    Entrepreneurial and consulting partnerships with outside entities are important to the clinical, research, and educational missions of the University of Miami (UM). Importantly, these relationships must be undertaken with a clear understanding of potential conflicts of interest that might endanger patient safety, data integrity, the integrity of our educational/training programs, and/or our reputation.

    The UDisclose System streamlines UM’s disclosure process. Most users will disclose interests on an annual basis, and update new/changes to disclosures in the UDisclose System within thirty (30) days.

  • Who needs to disclose their outside interests to UM?

    All Covered Persons must complete the disclosure process on at least an annual basis.

    Covered Persons includes but is not limited to University Officials, all faculty and other academic appointees, visiting scholars, graduate students, foreign students, postdoctoral associates, volunteers, UHealth and Miller School of Medicine faculty and clinicians, and individuals responsible for the design, conduct, or reporting of Scholarly Activities.

    Questions about the disclosure requirement should be directed to Disclosures & Scholarly Activities Management (DSAM) via the UDisclose System help line at 305-243-0877.

  • If I do not have outside relationships or activities to disclose, do I need to complete the disclosure process?

    Yes. If you are considered to be a Covered Person, you must complete the disclosure process in the UDisclose System, even if you have not engaged in any outside activities or hold any interests.

  • What needs to be disclosed to UM?

    Within the UDisclose System, a Covered Person should include in their Disclosure Profile:

    • Financial interests/activities with external entities (including fiduciary responsibilities)
    • Financial interests of spouse and dependent children, that are related to UM responsibilities or with entities that do, or propose to do, business with UM
    • Royalties, Innovations or Intellectual Property Rights
    • Holding an IND/IDE
    • Receipt of other support from any non-UM entity for research and/or scholarship
    • Receipt of any gifts from an entity, organization, or individual

     

  • Are there special requirements for UHealth and Miller School employees?

    Yes, a separate UHealth section of the policy:

    • Applies to all UMMG faculty, UHealth clinical providers, Miller School deans, and assistant/associate deans, regardless of faculty status.
    • Articulates permitted and restricted activities
    • Describes process for engaging in permitted activities
    • Addresses gifts/contributions and clinical activities
    • All UMMG Faculty and UHealth Clinical Providers must submit all proposed consulting agreements (fee-for-service arrangements) to their Chair/Chief and UHealth Compliance (“UHC”) for review.

  • Are there special requirements for UM community members involved in teaching research, etc.?

    Yes, there is a separate Scholarly Activities section of the policy.

    “Scholarly Activities” embrace inquiry, research, and creative professional performance, create and/or advance existing knowledge, and broaden the intellectual advancement in areas related to a Covered Person’s discipline and the University community. Examples include, but are not limited to teaching, performing research, conducting clinical studies, participation in University service and administration, shaping public policy, editing journals, consulting, and writing or performing.

    The Scholarly Activities section of the policy articulates that a conflict of interest (COI) means an actual or potential interest that could directly and substantially, affect, or be affected by, the design, conduct, or reporting of scholarly and/or educational activities, and:

    • Covered Persons who are Investigators also must disclose obligational interests
    • If required by a sponsor, disclosures must be submitted prior to proposal submission.
    • Project-specific disclosures are not required (but may be asked to submit)
    • Requires review and approval of “C”-suite positions/fiduciary duties at subcontracting/awardee entities before engaging in or conducting scholarly activities.
    • Unless approval is granted by the OVPRS, UM must review disclosures prior to release of funds or clearance of a project
    • Human subject researchers must disclose any relationship to study (e.g., consulting for sponsor/drug manufacturer) irrespective of receipt of compensation.
    • Addresses IND/IDE reporting requirements
    • Articulates enforcement and sanctions specific to scholarly activities

  • Are there special requirements for Public Health Service (PHS)- or Department of Energy (DOE)- funded Covered Persons?

    Covered Persons who are funded by the DOE, PHS agencies, or funded by entities whose policies require that the University abide by PHS regulation in order to accept their funding, must also disclose additional details about the occurrence of any reimbursed travel or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their Institutional Responsibilities.

    This disclosure requirement does not apply to travel that is reimbursed or sponsored by a U.S. federal, state, or local government agency, a US institution of higher education as defined in 20 U.S.C. 1001(a), a US academic teaching hospital, a US medical center, or a US research institute that is affiliated with a US Institution of higher education.

  • What happens if an interest or relationship is not entered in a timely fashion? 

    If related to sponsored research, an interest or relationship that was not disclosed within 30 days could require UM to conduct a retrospective review to determine whether bias had been introduced into the Investigator’s work since the time the interest should have been disclosed.

  • Are there entities/payors that are excluded from the UM disclosure requirements?

    Yes. The term “financial interest” does not include the following types of interests:

    • salary,  or other remuneration paid by the University to the Covered Person if the Covered Person is currently employed or otherwise appointed by the University;
    • income from investment vehicles, such as mutual funds and retirement accounts, as long as the Covered Person does not directly control the investment decisions made in these vehicles; and
    • income from seminars, lectures, service on advisory committees or review panels for, or sponsored by a United States Federal, state, or local government agency, an Institution of higher education as defined at 20 USC 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.

  • What if I don't know the exact amount of compensation or duration of OPA?

    Enter information to the best of your ability at the time of entry. You can update your certification as many times as you wish; any information you enter is saved and will be available for editing.

  • I am on sabbatical or on leave. Do I need to disclose?

    Yes. UM is committed to maintaining the integrity of our community of scholars and to re- enforcing the public trust in the academy. With that in mind, Covered Persons are required to complete the disclosure process at least annually.

  • Why do I have to disclose unexercised stock options?

    Unexercised stock options are classified as compensation due to their potential/future value.

  • How long do i have to disclose a newly acquired OPA (or FOI)

    You must disclose a new interest or relationship within 30 days of acquisition. Also, if any of your disclosures change, you must update the change within 30 days. If not disclosed in a timely manner, your interest and work may have to undergo a comprehensive retrospective review to determine if bias has occurred.

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