Consultants may be required to certify they are compliant with the PHS regulations if they provide services "under contract" for use by the Federal government and are responsible for design, conduct or reporting of research funded by PHS and are identified as key personnel in a proposal or contract.
Subgrantee, subcontractor, subrecipient relationships are established when federal funds flow down from or through an awardee institution to another individual or entity and these individuals will be conducting a substantive portion of the NIH-funded research project and is accountable to the awardee institution for programmatic outcomes and compliance matters. These investigators should complete the Subrecipient Commitment Form found on the Office of Sponsored Programs website to document that institution’s plans for training and COI disclosure.
Conflict of Interest: A conflict of interest arises in a situation in which an actual, potential or perceived conflict exists that cause undue influence over judgment associated with institutional responsibilities such as performing research, reporting research results, or mentoring students. An actual conflict of interest: involves a direct conflict between current duties and responsibilities and existing private interests; a potential conflict arises where private interests could conflict with official duties; perceived conflicts exist where it could be perceived, or appears, that private interests could improperly influence the performance of duties - whether or not this is in fact the case.
When evaluated at UMBC, acceptable conflicts of interests are those relationships, including certain financial interests that would constitute a conflict of interest, or may be perceived to constitute a conflict of interest, may be permitted if such relationships are first disclosed and approved in accordance with UMBC's policy. No individual shall perform research activities when an unapproved conflict of interest exists, and UMBC shall not enter into any agreement where an unapproved conflict of interest exists, or would be created, on the part of any individual. Only the President of UMBC can approve a conflict of interest exemption. Unacceptable conflicts of interests are those disclosed conflict of interests found by UMBC to be unmanageable; approval shall not be granted and the activity shall be prohibited.
Conflict of Interest Committee (COI Committee): UMBC's committee, with faculty representation from a broad range of research disciplines, will review the materials related to your financial interest(s) and the proposed research. The Committee will develop a recommended management plan and send it to the Vice President for Research. A written management plan will be sent to you for your review and signature.
Conflict of Interest Conditions and Actions: If UMBC accepts a PHS funded research project, the AVPR may develop and implement a plan to manage the financial conflict..
Examples of conditions or restrictions that might be imposed to manage the conflict 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 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); or
g. Severance of relationships that create financial conflicts.
Conflict of Interest Management Plan: The document created by UMBC that specifies the actions to eliminate, reduce and/or manage a COI. Management may consist of a disclosure in presentations and manuscripts, removing the conflicted individual from primary oversight of the research, or reducing or eliminating the financial interest via a structured plan. When reporting FCOIs to a PHS awarding component, UMBC will report the investigator's agreement to comply with the management plan.
Disclosure: Investigators are required to disclose SFIs at the time of application or planning to participate in PHS funded research, at least annually during the period of the award or within 30 days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new SFI.
Financial Conflict of Interest (FCOI): A type of conflict of interest related to monetary gain or influence that could directly and significantly affect an institutional interest such as performing research, reporting research results, or mentoring students.
Financial Interest: anything of monetary value received or held by an investigator or an investigator’s family, whether or not the value is readily ascertainable, including, but not limited to: salary or other payments for services (e.g., consulting fees, honoraria, or paid authorships for other than scholarly works); any equity interests (e.g., stocks, stock options, or other ownership interests); and intellectual property rights and interests (e.g., patents, trademarks, service marks, and copyrights), upon receipt of royalties or other income related to such intellectual property rights and interests.
Financial interests DO NOT include:
a) salary, royalties, or other remuneration from UMBC;
b) income from the authorship of academic or scholarly works;
c) income from seminars, lectures, or teaching engagements sponsored by or from advisory committees or review panels for U.S. Federal, state or local governmental agencies; U.S. institutions of higher education; U.S. research institutes affiliated with institutions of higher education, academic teaching hospitals, and medical centers; or
d) equity interests or income from investment vehicles, such as mutual funds and retirement accounts, so long as the Investigator does not directly control the investment decisions made in these vehicles.
Funding Agency: PHS Agencies
Investigator: An investigator has primary institutional responsibility for providing scientific and technical leadership, and administrative and financial management of an external award. He/she may be considered faculty, staff, post-doctoral fellow, or graduate student who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposes to apply for such funding. He/she may also be known in a PHS award as Senior/Key Personnel, Principal Investigator, Project Director or Project Administrator. An investigator may be other persons including collaborators, consultants, subgrantees, subcontractors, subrecipients. The UMBC Principal Investigator on a PHS award will identify who should be considered an investigator that has the responsibliliy for the design, conduct, or reporting of the research.
Institutional official: the individual at UMBC that is responsible for the solicitation and review of disclosures of significant financial interests including those of the investigator’s family related to the investigator’s institutional responsibilities. For the purposes of UMBC's policy, the Institutional Official is the Vice President for Research, or their designee.
Institutional Responsibilities: Professional responsibilities related to an individual's institutional obligations such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels (e.g. Institutional Review Boards) that may impact the design, conduct, and reporting of NIH-funded research .
Mitigation reporting: Reporting to PHS is required if a SFI is not disclosed by a researcher in a timely manner or if for any reason was not previously reviewed by UMBC. A report to PHS must be made within 60 days from that point determine whether the SFI is related to PHS-funded research and whether it is a FCOI. If it is an FCOI, the institution must implement, at least on an interim basis, a management plan.
National Institutes of Health (NIH): The PHS awarding component that provides grants or cooperative agreements for research to which the 2011 regulations apply to determine if there was bias in the design, conduct, or reporting of such research.
PHS Awarding Components: The agencies within the Department of Health and Human Services (HHS) designated as components of the U.S. Public Health Service (PHS) as may be changed from time to time include: (1) the Agency for Healthcare Research and Quality (AHRQ), (2) the Agency for Toxic Substances and Disease Registry (ATSDR), (3) the Centers for Disease Control and Prevention (CDC), (4) the Food and Drug Administration (FDA), (5) the Health Resources and Services Administration (HRSA), (6) the Indian Health Service (IHS), (7) the National Institutes of Health (NIH), and (8) the Substance Abuse and Mental Health Services Administration (SAMHSA).
Research: the systematic investigation, study, or experiment designed to contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. Funding for research is available from a PHS Awarding Component via a grant or cooperative agreement and includes examples such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, Institutional training grant, program project, or research resources award. Small Business Innovative Research (SBIR) and Small Business Technology Transfer (STTR) Phase I applications award programs are excluded from the regulations.
Reimbursed travel: Defined as any reimbursed or sponsored travel paid to an investigator by an entity, including non-profit organizations. Excluded from this requirement is travel sponsored by or reimbursed by a government agency, a U.S. institution of higher education or a research institute affiliated with such, a medical center, or an academic teaching hospital. The specific details that must be disclosed are: the name of entity sponsoring the travel and purpose, destination, and duration of the travel.
Reporting to PHS awarding components: The following must be reported: grant/contract number; name of the project director, principal investigator, or contact person (when there are multiple project directors or principal investigators); name of the investigator with the FCOI; The name of the entity with which the researcher has the FCOI; The nature of the FCOI; value of the financial interest in specific intervals: $0-4,999, $5,000-9,999, $10,000-19,999. Amounts between $20,000 and $100,000 by increments of $20,000, and 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; a description of how the SFI relates to the PHS-funded research and the basis for the institution’s determination that the SFI conflicts with the research.
Retrospective review: Required by PHS regulations if UMBC has not managed a FCOI or where a researcher has failed to comply with a management plan. UMBC must, within 120 days, complete a retrospective review of research to determine whether the research conducted during the period of noncompliance was biased in the design, conduct, or reporting of the research. If bias is identified, the UMBC must develop a mitigation report that outlines a plan of action to eliminate or mitigate the effect of the bias. The results of that determination and the mitigation report must be reported to the PHS. Documentation of the retrospective review will include the project number, project title, PI, name of Investigator with the Financial Conflict of Interest, name of the entity with which the investigator has the Financial Conflict of Interest, reason(s) for the retrospective review, detailed methodology used for the retrospective review, and findings and conclusions of the review.
Significant Financial Interests (SFI): A finanical interest related to an investigator's institutional responsibilities (or belonging to their spouse, domestic partner or dependent children) received in the past twelve (12) months that:
- if with a publicly traded entity, the aggregate value of any salary or other payments for services received during the 12 month period preceding the disclosure, and the value of any equity interest during the 12 month period preceding or as of the date of disclosure, exceeds $5,000; or
- if with a non-publicly traded entity, the aggregate value of any salary or other payments for services received during the 12 month period preceding the disclosure exceeds $5,000; or
- if with a non-publicly-traded company, is an equity interest of any value during the 12 month period preceding or as of the date of disclosure; or
- is income related to intellectual property rights and interests not reimbursed through the Institution.
- is reimbursed or sponsored travel (defined above).
Training: PHS regulations require institutions to notify investigators of the new regulations, institutional policy on financial conflicts of interest and investigator responsibilities. Among these responsibilties are investigators are required to complete training prior to engaging in PHS-funded research and every four years thereafter. Investigators may also be required to take training under other circumstances such as an investigator's failure to properly disclose SFIs or noncompliance with a management plan.
Travel Reimbursement: Payments received for travel, from a third party sponsored reimbursed or paid travel that appears related to university responsibilities and exceeds $5,000 in the previous 12-month period. Travel information includes the purpose of the trip, the identity of the sponsor/organizer, the destination, and duration. Excluded from reporting is travel reimbursement from UMBC department funds, a grant or contract to UMBC, a U.S. federal, state or government agency, or other U.S. institution of higher education; an academic teaching hospital; a medical center; or a research institute that is affiliated with a U.S. institution of higher education.