The University has updated its Conflict of Interest in Research Policy #2370.005 to comply with revised regulations of the U.S. Department of Health and Human Services, Public Health Service (PHS) effective August 24, 2012. The complete updated policy may be viewed at https://policies.fiu.edu/policy/572.
The updated policy furthers the University’s emphasis on promoting objectivity in research by establishing and maintaining standards that ensure that the design, conduct, and reporting of research are free from bias due to an impermissible conflict of interest. This page provides an overview of the new requirements and processes in light of the updated policy. If you have particular questions about your sponsored project proposal or award, please contact your Pre-Award representative at 305-348-2494 .
Q&As Below Provide an Overview of Required Steps in the Conflict of Interest Process:
University employees are to continue to make those disclosures on the Division of Human Resources Report of Outside Activity/Conflict of Interest web based portal at http://hr.fiu.edu/index.php?name=conflict_of_interest (the OA/COI Electronic Portal). Individuals who are not University employees (e.g., students, subcontractors, consultants or collaborators) shall disclose using the paper form available on the OA/COI Electronic Portal. The questions on the OA/COI Electronic Portal have been updated to capture the new disclosure requirements of the PHS regulations.
Your disclosure in the OA/COI Electronic Portal is due no later than the time a proposal for a sponsored research project to a PHS agency is submitted to the Office of Research and Economic Development (ORED) for review, and must be updated annually by September 30 thereafter. Additionally, you must update your disclosure within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new Significant Financial Interest.
Outside activity/financial interest disclosures are now required from “Investigators” (defined as anyone responsible for the design, conduct or reporting of research, including collaborators, students, etc.). Thus, an “Investigator” is not limited to only FIU employees. It could include non-FIU employees such as subrecipients (i.e., collaborators, subcontractors or consultants). Disclosures from such non-FIU personnel are also required and are addressed in question #4 below.Another change is that Investigator disclosures are due, not as relates to a particular research project, but rather, as they relate to the Investigator’s Institutional responsibilities (i.e., teaching, research, research consultation, professional practice, committee membership, etc.). Research-related disclosures are no longer project-specific.
Each Investigator must report his/her Significant Financial Interests (SFIs) and those of his/her spouse and dependent children. The SFIs that must be reported are delineated in the updated policy and the OA/COI Electronic Portal questions have been revised to capture the required SFI disclosures. Therefore, as long as you answer all questions in the Research section of the OA/COI Electronic Portal (check box 1.J on the first page of the Portal), all required disclosures will be captured.
There is a new requirement that Investigators must now disclose the sponsorship of their travel if the travel relates to the Investigator’s Institutional Responsibilities. However, no travel disclosure is required if the travel is paid for by any of the following entities:
- a federal, state, or local government agency;
- an institution of higher education or a research institute affiliated with an institution of higher education;
- an academic teaching hospital;
- a medical center.
You must disclose the travel sponsorship both: (1) when you know the amount of reimbursement or payment for the travel; and also (2) when the travel is paid on your behalf but you don’t know the monetary value. The travel details which must be disclosed are:
- purpose of the trip,
- identity of the travel sponsor/organizer,
- destination and duration.
Again, the questions on the OA/COI Electronic Portal capture the travel information that is required.
- A new ORED Subawardee Commitment Form is now required for each proposed subawardee (subcontractor, consultant, collaborator) on a proposal. Among the questions to be answered by the subawardee on that Form is whether the subawardee has a policy on financial conflicts of interest that complies with applicable PHS regulations. If the answer is “yes”, no further disclosure is required from the subawardee. If the answer is “no”, then each subawardee Investigator on the proposed project must make their disclosures of outside activities/financial interests to FIU on the paper form found on the OA/COI Electronic Portal and those disclosures must be reviewed by FIU in the same manner that FIU reviews the disclosures of FIU employees.
- Yes, but only if the student qualifies as an investigator pursuant to the definition in the FIU Conflict of Interest in Research Policy #2370.005 at https://policies.fiu.edu/policy/572.The PHS financial conflict of interest regulations (and FIU policy #2370.005) requires disclosures, and University review, of certain outside activities and financial interests of investigators only. The FIU policy defines an Investigator as set forth below:An “Investigator” is the principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research or of proposed research, which may include, for example, collaborators or consultants. For purposes of this definition:
- “Conduct of research” means the supervision or management of a study’s execution. This is typically done by the principal investigator (PI) and co-investigators, but also may be performed by postdoctoral fellows and graduate students who have significant supervisory roles for junior researchers or technicians who are part of the study. For studies involving human subjects, this includes anyone who is responsible for explaining the study, risk-benefit, and/or alternatives to potential participants, is listed on the Form FDA 1572 or device agreement, and/or must complete a sponsor’s conflict of interest form.
- “Design of research” means the planning of the scientific strategy to test a research proposal.
- “Reporting of research” means the authorship of: publications to journals or otherwise, reports to the research sponsor, or presentation at conferences or scientific meetings related to the research.
If a student qualifies as an Investigator under the above definition, then the student must disclose his/her outside activities and financial interests on the Division of Human Resources webpage called Report of Outside Activity/Conflict of Interest at http://hr.fiu.edu/index.php?name=conflict_of_interest, using the paper form on that page. The disclosures will be reviewed by ORED as detailed in Policy #2370/005.
If a student does not qualify as a Investigator (for example, a student is merely collecting and/or analyzing data at the direction of the PI and is not reporting designing or reporting the research as defined above, then no outside activity/financial interest disclosure or review is required.
Please note that the NIH has provided the FAQ on this issue (at http://grants.nih.gov/grants/policy/coi/coi_faqs.htm#3172):
I am a graduate student working on research funded by the NIH. Am I subject to the requirements of the Financial Conflict of Interest regulation? (Investigator)
Yes. If you meet the definition of an “Investigator,” the PHS regulation applies to you. As stated above, the term “Investigator” is defined to encompass individuals “responsible for the design, conduct or reporting” of research funded by the NIH. Be sure to confirm with your Institutional designated official(s) whether you, as a graduate student, meet this definition.
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II. Review of Disclosures, Management and Reporting
ORED has established the following processes to ensure compliance with the updated conflict requirements:
- The electronic Proposal Routing Approval Form (ePRAF) has updated questions to ensure that persons who qualify as investigators have disclosed their outside activities/financial interests on the HR portal.
- If the proposal is being submitted to a PHS awarding component, the ePRAF questions will direct the investigators on the proposal to complete a new ORED Investigator Report of Financial Interests in Research form .
- ORED will review the information provided on the Investigator Report of Financial Interests in Research form and on the Subawardee Commitment Form (for subrecipients) and, as necessary, will provide the information to the Vice President for Research for a determination of whether a Financial Conflict of Interest (FCOI) exists on any particular research project.
- If a FCOI exists, a management plan will be developed prior to the start of a project to manage the FCOI, with the involvement of the Investigator, his/her Chair or supervisor, Dean and the Vice President for Research and the same will be reported by ORED to the PHS sponsor, as required by the regulations.
- When DOR receives an award for a PHS funded project, ORED Pre-Award will email the Investigators on the proposal to inquire if there has been any change to the outside activity/conflict of interest disclosures on the HR portal and the Investigator Report of Financial Interests in Research form since they submitted the proposal. If yes, then the Investigators must submit an updated Investigator Report of Financial Interests in Research form and Pre-Award will determine if there is a FCOI for those new disclosures.
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III. Additional Requirements
Yes, if you are submitting a proposal to a PHS awarding component.
PHS-awarding components include: Administration on Aging (AoA), Agency for Children and Families (ACF), Agency for Healthcare Research and Quality (AHRQ); Agency for Toxic Substances and Disease Registry (ATSDR); Centers for Disease Control and Prevention (CDC); Centers for Medicare & Medicaid Services (CMS), Federal Occupational Health (FOH), Food and Drug Administration (FDA); Health Resources and Services Administration (HRSA); Indian Health Service (IHS); National Institutes of Health (NIH) and Substance Abuse and Mental Health Services Administration (SAMHSA) Department of Health and Human Services (HHS).
Investigators on PHS-funded projects must now complete financial conflict of interest training before a PHS project begins and at least every 4 years thereafter or earlier, if the Investigator fails to comply with FIU’s Conflict of Interest in Research policy or with a management plan or the FIU policy requirements change.
Click here to access information about Conflict of Interest online training.
- Yes.In addition to the Conflict of Interest in Research policy, the University has conflict of interest policies unrelated to research that apply to all faculty and staff members. All employees of Florida International University are subject to the Florida Code of Ethics for Public Officers and Employees which is found in Part III, Chapter 112, Florida Statutes. The OA/COI Electronic Portal captures both research and non-research related disclosures.
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IV. List of Organizations that require compliance with PHS FCOI regulations
This list is updated on a periodic basis. Additional sponsors that are not listed here may also require adherence to the U.S. Department of Health and Human Services Public Health Service Financial Conflict of Interest regulations, as specified in their Award Terms and Conditions.
1. Public Health Service
- Administration on Aging (AoA)
- Administration for Children and Families (ACF)
- Agency for Healthcare Research & Quality (AHRQ)
- Agency for Toxic Substances & Disease Registry (ATSDR)
- Centers for Disease Control & Prevention (CDC)
- Centers for Medicare and Medicaid Services (CMS) [formerly HCFA]
- Food and Drug Administration (FDA)
- Health Resources & Services Administration (HRSA)
- Indian Health Service (IHS)
- National Institutes of Health (NIH)
- Office of Global Affairs (OGA)
- Office of the Assistant Secretary for Health (ASH)
- Office of the Assistant Secretary for Preparedness and Response (ASPR)
- Biomedical Advanced Research and Development Authority (BARDA)
- Office of Minority Health Resources Center (OMH)
- Office of Population Affairs (OPA)
- Office of Research Integrity (ORI)
- Office of Research on Women’s Health (OWH)
- Substance Abuse and Mental Health Services Administration (SAMHSA)
2. Non PHS Sponsors
- Alliance for Lupus Research (ALR)
- American Cancer Society (ACS)
- American Heart Association (AHA)
- Arthritis Foundation (AF)
- California Breast Cancer Research Program (CBCRP)
- California HIV/AIDS Research Program (CHRP)
- Juvenile Diabetes Research Foundation (JDRF)
- Lupus Foundation of America (LFA)
- Susan G. Komen for the Cure
3. FDP List of Agencies Using PHS FCOI Regulations
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