Financial Conflict of Interest (FCOI) Policy for Investigators Participating in Funded Research

Definitions

• Investigator – Principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research proposed for funding by the NIH, including collaborators or consultants.
• Institutional Responsibilities – an Investigator’s professional responsibilities on behalf of the Institution, which may include research, teaching, consultation, professional practice, institutional committee memberships, and service on panels such as IRBs or Data Safety Monitoring Boards.
• Remuneration – salary, consulting fees, honoraria, paid authorship (excludes income from seminars, lectures, or teaching engagements sponsored by federal, state or local government agencies, institutions of higher education, academic teaching hospitals, medical centers, or research institutes affiliated with institutions of higher education.
• Equity Interest ‐ stock, stock options, or other ownership interest (excludes income from investment vehicles such as mutual funds and retirement accounts as long as investigator does not control investment decisions made in these vehicles.)
• Intellectual Property Rights and Interests – patents and copyrights (excludes IP rights assigned to the Institution and agreements to share royalties related to such rights.)
• Significant Financial Interests (SFI) – include financial interests related to an Investigator’s institutional responsibilities, aggregated for the investigator and those of his/her spouse and dependent children:
  • SFI in publicly traded entities – the value of remuneration in the 12 months preceding disclosure and the value of any equity interest as of the date of disclosure that, when aggregated, exceeds $5,000 (For NIH/PHS & DOE) or $10,000 (For NSF & NASA).
  • SFI in non‐publicly traded entities ‐ the value of remuneration in the 12 months preceding disclosure exceeding $5,000 (For NIH/PHS & DOE) or $10,000 (For NSF & NASA); or ANY equity interest or intellectual property rights and interests, upon receipt of income related to such rights and interests.
  • Reimbursed or sponsored travel ‐ travel paid on behalf of the investigator and not reimbursed directly to investigator so that the exact monetary value may not be readily available. This does not include travel on sponsored projects if charged to a grant account or payment for travel for seminars, lectures, teaching, or service on advisory or review panels for government agencies or U.S. based institutions of higher education (IHE) or U.S. based facilities affiliated with IHEs.  Note: ANY reimbursed or sponsored travel paid by a foreign entity, including a university, must be disclosed.
• Financial Conflict of Interest (FCOI) – A significant financial interest that could directly and significantly affect the design, conduct, or reporting of the research.

All Significant Financial Interests that meet the above thresholds must be disclosed. UA will then determine if the SFI represents a Financial Conflict of Interest with the research project submitted for funding.

NOTE: Most federal agencies ADDITIONALLY require disclosures of foreign affiliations, even if there is no funding/remuneration involved.  Generally, such information should be disclosed on the Current and Pending Support or analogous document.

Investigators must disclose all Significant Financial Interests (SFI), as defined in the regulations, agency policy, or sponsor policy, whether or not they are related to their funded research. The Institution is responsible for determining if the SFI relates to the funded research and if it represents a Financial Conflict of Interest (FCOI).

Investigator Disclosure Requirements:  Investigators are required to submit a Proposal‐Specific Significant Financial Interest Disclosure Form to their immediate supervisor with every new proposal submitted for PHS, NSF, DOE, or NASA funding (or other sponsor as required per the sponsor policy). “Investigator” includes all individuals who will be involved in the design, conduct, or reporting of the research, regardless of title or position.

1.        Investigators on existing NIH awards must submit the Proposal‐Specific Significant Financial Interest Disclosure Form to their immediate supervisor with the submission of the next annual progress report to NIH.
2.        The Principal Investigator on an NIH proposal must identify all individuals who meet the definition of Investigator and insure that they submit the disclosure form to their immediate supervisor.
3.        Disclosure forms must be updated and submitted within 30 days of acquiring any new significant financial interest, and annually at the time of the submission of the annual progress report for the NIH‐funded award.
4.        If it is determined that a financial conflict of interest exists between the proposal/award and one of the disclosed SFIs, the conflicted Investigator must agree to a management plan to reduce or eliminate the conflict. For new awards, the management plan must be submitted to the ORA when the Principal Investigator receives the request for Just‐In‐Time information. For existing awards, the management plan must be submitted within 30 days of the identification of the conflict.

Department Chair / Supervisor Responsibilities: Review and certify all disclosure forms and determine if a conflict of interest exists with the proposal.

1.       Certify to the Office of Research Administration that all investigators on the proposal have submitted a disclosure form (The responsible Grant Coordinator will request this certification via email before the proposal is submitted).
2.       Forward all disclosure forms to the ORA within 15 days of institution receiving a Just‐In‐Time request.
3.       For all identified conflicts of interest, work with the investigator to develop a conflict management plan. Forward to ORA all management plans within 15 days of institution receiving a Just‐In‐Time request. All conflict management plans will be reviewed and approved by the ORA. Plans must either reduce or eliminate the conflict. Plans must be in place prior to expenditure of any grant funds.

Conflict of Interest Training Requirements:

1. All Investigators on existing NIH awards that were awarded prior to August 24, 2012, must complete the on‐line Financial Conflict of Interest course available on The University of Akron’s CITI site by September 30, 2012. This training must be renewed every 4 years.
2. Investigators on new awards received after August 24, 2012, must complete the on‐line Financial Conflict of Interest course prior to engaging in research related to the NIH‐funded grant, and at least every 4 years.
3. The CITI Training can be accessed at http://www.citiprogram.org
   1. Affiliate with “The University of Akron”
   2. Select “Financial Conflict of Interest” from the curriculum list
   3. Complete all three required modules and take the related quizzes
   4. The Office of Research Administration will receive notification of your completion and will file the reports in the award file.

The University must certify in each application for funding that we:

1.       have an up‐to‐date written, and enforced administrative process to identify and manage FCOIs related to all PHS funded research;
2.       will promote and enforce investigator compliance and training;
3.       shall manage FCOIs and provide initial and ongoing reports to PHS;
4.       will make information available to PHS upon request relating to any investigator disclosure of SFI, whether or not it resulted in determination of an FCOI;
5.       will make information concerning FCOIs held by investigators available within 5 business days of receipt of a written request; and
6.       will insure that all subrecipient institutions and investigators are in compliance with the PHS regulations.

 The Responsibilities of the Office of Research Administration are to:

1.        act in good faith to assist the University in implementing this policy;
2.        convey to the V.P. for Research the concerns they, or others, have with this policy;.      
3.        review all disclosure forms and conflict management plans and forward to the V.P. for Research with comments on any case which still appears to present a conflict. Such comments should include actions recommended by the director to manage or remediate the conflict(s).
4.        submit all financial conflicts on the Commons prior to the expenditure of any funds on the award and within 60 days of the disclosure of any new conflict of interest.
5.        make available information on FCOI held by NIH investigators to any requestor within 5 business days of receipt of a written request.
6.        insure that all subrecipient institutions either have a agency or sponsor-specific compliant conflict of interest policy or agree to abide by UA’s policy.
7.        Require subrecipients to provide investigator financial interest disclosures and management plans to UA in sufficient time for UA to meet its reporting requirements.

 Record Retention and Reporting Requirements for Funded Proposals

1.         All disclosure forms will be kept in the award file for 3 years from the filing of the final expenditure report.
2.        For all identified conflicts of interest, records of the institution’s review of, and actions taken to manage the conflict (management plans) will be kept for 3 years from the filing of the final expenditure report.
3.        For each identified FCOI, reports will be submitted to NIH through the eRA Commons FCOI module. The following information will be submitted:
   1.        Award ID #
   2.        PI Name
   3.        Name of individual with FCOI
   4.        Name of entity with which the FCOI exists
   5.        Nature of the FCOI
   6.         Amount of FCOI (within specified ranges)
   7.        Description of how the financial interest relates to the NIH‐funded research and the basis for the determination that the interest conflicts with the research
   8.        Key elements of the management plan
   9.          Information concerning FCOIs held by Investigators will be made available to any requester within five business days of a written request.
   10.          All FCOIs will be updated annually and submitted to NIH through the eRA Commons when annual progress reports are submitted.

Subrecipient Monitoring

1.         Subrecipients will indicate in their Letter of Intent if they have an agency- or sponsor‐compliant COI policy
   1. Subrecipients with an NIH‐compliant policy will certify that all subrecipient investigators have submitted a significant financial interest disclosure form.
   2. Subrecipients without an NIH‐compliant policy will be required to submit to UA copies of disclosure forms for all participating investigators.
2.        When a proposal is funded the subrecipient institution will certify in the research agreement that all participating investigators have submitted disclosure statements and that all FCOI’s have been forwarded to UA. The information must be submitted with the subaward agreement and prior to the expenditure of any funds.
3.        Updated FCOI’s and any changes in management plans must be submitted to UA 10 days prior to the deadline for submission of the annual progress report, and within 10 days of any change

 Noncompliance

 Retrospective Review:

When a significant financial interest is identified that was not disclosed or managed in a timely manner, the director of the ORA will, within 60 days, review and make a determination of an FCOI and report it to the agency or sponsor. Within 120 days of the determination of noncompliance, a retrospective review of the investigator’s activities and project will be conducted to determine bias in the design, conduct or reporting of the research. The director of ORA, the V.P. for Research, and others as deemed necessary will conduct the review. If warranted, an updated FCOI report will be submitted to the agency or sponsor.

 The retrospective review will include:

·         Award #

• ·         Award title
• ·         PI of award
• ·         Name of investigator with the FCOI
• ·         Name of entity with which investigator has a conflict
• ·         Reason for retrospective review
• ·         Methodology used for review – composition of review panel, documents reviewed
• ·         Findings and conclusions

 Mitigation Report:

If bias is found through retrospective review, UA will notify the awarding component and submit a Mitigation report within 45 days which will include:

• ·         Key elements documented in the retrospective review
• ·         Description of the impact of the bias on the research project
• ·         Plan of action to eliminate or mitigate the effect of bias

Many agencies and several sponsors follow the Public Health Service (PHS) requirements, as described in Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought (Title 42 CFR Part 50 Subpart F) and Responsible Prospective Contractors (Title 45 CFR Part 94). The regulations are effective as of August 24, 2012.

• NIH – National Institutes of Health
• CDC – Centers for Disease Control and Prevention
• HRSA – Health Resources & Services Administration
• FDA – Food & Drug Administration
• SAMHSA – Substance Abuse & Mental Health Services
• IHS – Indian Health Services
• ATSDR – Agency for Toxic Substances & Disease Registry
• AHRQ - Agency for Health Care Research and Quality
• Alliance for Lupus Research
• Alpha-1 Foundation
• American Asthma Foundation
• American Cancer Society
• American Heart Association
• American Lung Association
• Arthritis Foundation
• CurePSP
• JDRF - Juvenile Diabetes Research Foundation
• Lupus Foundation of America
• Patient-Centered Outcomes Research Institute (PCORI)
• Susan G. Komen Foundation

Some Federal agencies require an SFI disclosure prior to submission of a grant.  In those cases, the key personnel must submit the appropriate SFI disclosure form PRIOR to submission of the grant.

Additionally, when the grant is awarded, the SFI Disclosure form MUST be (re)submitted:

• Within 30 days of discovering or acquiring a new SFI;
• At least annually during the award period; and
• For any new grant/sponsored award application submission, to which this policy applies.