Policy for the Review of Financial Conflict of Interest Disclosures by

Personnel Engaged in Research and Other Sponsored Programs

Research and other sponsored activities conducted at Maine Medical Center (MMC) by its staff and affiliates are governed by the concepts of Academic Freedom and Responsibility as well as by codes of integrity and ethical conduct, such as the Belmont Report and the Common Rule. MMC ensures, to the maximum extent possible, that the results of research are free from individual researcher bias, such that all research is in compliance with all applicable regulations, therefore maintaining the integrity and ethical framework of our investigative activities. A key aspect of research is to protect the public’s investment and trust.

Policy Summary:

This policy applies to all Senior or Key Personnel (hereafter known as “Investigator”) who are responsible for designing, conducting or reporting research projects or sponsored programs conducted at, or in affiliation with, MMC.

The final rule for Financial Conflict of Interest (FCOI) from Public Health Services (PHS) became effective August 24, 2011. As of August 25, 2012, all Investigators at MMC who are submitting research projects for potential PHS funding are required to follow the new requirements. MMC has adopted these requirements for disclosure for all PHS or non-PHS funded projects.

Definitions:

  1. “Dependent(s)” (child, spouse and/or domestic partner) is defined as any person who receives more than one-half of his/her annualsupport from an Investigator.
  1. “Entity” is defined as an institution, organization, or business.
  1. “Financial Conflict of Interest (FCOI)” exists when an Investigator’s Significant Financial Interest(s) (SFI, see below) could affect, or reasonably appear to affect, the Investigator’s research or sponsored program.
  1. “Financial Interest” is defined as anything of monetary value, whether or not the value is readily ascertainable (e.g. equity, stocks, honorariums, travel reimbursement, etc.).
  1. “Family Members” is defined as the Investigator’s spouse or domestic partner (as defined by MMC policies) and their dependent children.
  1. “Investigator” means Senior or Key personnel as well as any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research or other sponsored programs.
  1. “Institutional Official (IO)” has institutional authority to legally bind the institution in grants administration matters and is responsible for the institution complying with the FCOI regulations.
  1. “Manage” means taking action to address an FCOI, which can include reducing or eliminating the FCOI, to ensure, to the extent possible, that the design, conduct and reporting of the research will be free from bias.
  1. “Outside Entity” is any company ororganization outside MMC.
  1. “Prime Awardee” is the institution who was awarded a grant.
  1. “PHS” means the Public Health Service of the Department of Health and Human Services and any components of the PHS, including the National Institutes of Health (NIH).
  1. “Principal Investigator” is the lead/contact Investigator on a research project or sponsored program and serves as the contact person on grant activities.
  1. “Research” means a systematic investigation designed to develop or contribute togeneralizable knowledge. The term encompasses basic and applied research (such as clinical) and product development.
  1. “SBIR Program” refers to the Small Business Innovation Research Program, an extramuralresearch program for small business established under federal law.
  1. “Significant FinancialInterest (SFI)” is a financial interest that exceeds a financial threshold amount as specified herein.
  1. “Sponsored Research” refers to research activities undertaken by Investigators within MMC that are supported by external funds.
  1. “Sponsored Programs” refers to projects or activities, other than research, undertaken by faculty or staff within MMC that are supported by external funds.
  1. “STTR Program” refers to the Small Business Technology Transfer program, an extramuralresearch program for small business established under federal law.
  1. “Sub-recipient” is an institution/or individual who is contracted by the prime awardee to carry out research activities (e.g., subcontractors orconsortium members).

Mandatory Investigator Training:

Investigators are required to participate in FCOI training every four years by completing either the NIH Financial Conflict of Interest Training Tutorial or MMC’s Collaborative Institutional Training Initiative (CITI) Program. This requirement must have been fulfilled prior to the expenditure of any newly funded projects, including non-competing continuation awards.

Access the FCOI Web-Based tutorial by clicking on

Access the CITI program portal by clicking on

When Financial Interest Reporting Should Be Made:

A financial interest form must be submitted to MMC’s Office of Research Compliance:

  • Each time a new proposal for financial support is submitted;
  • Each time human subjectproposals are submitted to MMC’s Institutional Review Board (IRB), both initially and for continuing review;
  • Within 30 days of becoming aware of a new FCOI;
  • Or at least annually.

How are Financial Disclosures Made?

Investigators will complete a Financial Interest Form online at

If the Investigator has a financial interest then an additional form - the Financial Interest Disclosure Form- must also be completed.

What Must be Disclosed?

  • Any remuneration from a for-profit entity that exceeds$5,000;
  • The value of equity interest (e.g. stock, stock option) or other ownership interest that exceeds $5,000 from publicly traded entities;
  • Any (>$0) equity interest held by the Investigator and/or Family Members from non-publicly traded entities;
  • Intellectual property rights and interests (e.g., royalty income, patents, copyrights) of the Investigator
  • Any funds provided or paid to the Investigator by an outside entity as reimbursement for travel or paid authorship. Exceptions are travel funds provided by institutions of higher education and their affiliates, or federal, state, and local governments
  • Exclusions:
  • Compensation or funding from MMC (unless otherwise listed above);
  • Income from seminars, lectures or other educational activities sponsored by not-for-profit entities;
  • Income from service on advisory committees or review panels for a federal, state or local government agency, an institute of higher education, an academic teaching hospital, a medical center or a research institute that is affiliated with an institute of higher education;
  • Any financial interest arising solely by means ofinvestment in a mutual, pension or other institutional investment fund wherein the Investigator does not manage the assets;
  • Any ownership interests in the Institution, if the Institution is an applicant under the SBIR/STTR programs

Research Conflict of Interest Committee (RCOIC) Membership:

The RCOIC is comprised of the Director(s)of Research Administration, Office of Research Compliance, Clinical Ethics, Research Finances as well as MMC’s Technology Transfer consultant and the IRB Chair. The Institutional Official will appoint members to the Committee and will reassess its composition annually based on attendance, performance, and needed areas of expertise.

Review Process:

The following describes the process for determining if management of an SFI is necessary.

  • Investigator’s submitted Financial Interest Form will be reviewed by the Office of Research Compliance.
  • The review will determine if the financial interest meets the threshold for an SFI.
  • Next steps:
  • If it is determined that an SFI is not present, this will be recorded in the Financial Interest Database and reported quarterly to the RCOIC.
  • If it is determined that an SFI is present and human subjects are involved, the form will be submitted to the IRB for further review and management.
  • If it is determined that an SFI is present and no human subjects are involved, the form will be submitted to the RCOIC.

1) When no human subjects are involved,the RCOIC conducts the SFI review:

  • Instances where the SFI does not constitute a conflict of interest such that there is no potential for the SFI to influence the design, conduct and/or reporting of a research study, then an FCOI is not declared, no action is taken, and this outcome is noted in the Financial Interest Database.
  • When, in the judgment of the RCOIC Chair, an SFI represents a significant FCOI, the Chair and the Committee will work with the Investigator to prepare a management plan of the FCOI for review by the Institutional Official (IO).
  • In instances where the SFI only requires a modest plan to eliminate or manage the potential conflict, the Chair may elect to conduct an expedited review and approval instead of engaging the full committee. These actions and all SFIs will be reported on a quarterly basis to the RCOIC.
  • The RCOIC will send comments and dispositions to the IO.
  • The IOwill agree or disagree that the management is appropriate.
  • If the IO disagrees with the management plan, his comments will be brought back to the Committee until consensus is met.
  • Once we have consensus, the management plan will be communicated to the Investigator and entered into the Financial Interest Database.

2) When human subjects are involved, the IRB conducts the SFI review:

In situations where research involves human subjects, the protection of those subjects must be of paramount concern. For a research protocol involving human subjects, each Investigator must submit to the IRB a Financial Interest Disclosure Form.

  • In instances where the IRB Chair determines the SFI does not constitute a conflict of interestsuch that there is no potential for the SFI to influence the design, conduct and/or reporting of a research study, then an FCOI is not declared, no action is taken and this outcome is noted as such in the Financial Interest Database.
  • When, in the judgment of the IRB Chair and the RCOIC Chair, an SFI represents a significant FCOI, theywill work with the Investigator to prepare a management plan of the FCOI for review by the RCOIC. In instances where the SFI only requires a modest plan to eliminate or manage the potential conflict, the IRB Chair may allow expedited review of the plan.
  • In instances where the management plan needs full IRB review and approval, the RCOIC will send a provisional management plan to the Boardfor their review and final determination.
  • The plan approved by the IRB will be communicated to the RCOIC.

Decision and Management Considerations:

Factors to be considered in the development of an FCOI management plan include:

  • The potential for risk to human subjects;
  • The nature and significance of the conflict;
  • The potential for having a serious adverse impact on the conduct of the science or on the reputation of the Investigator and/or MMC; and
  • The level of difficulty involved in managing the conflict relative to the benefit of conducting the research.

Management strategies include:

  • Public disclosures of SFI;
  • Monitoring of research by independent reviewers;
  • Disqualification of the Investigator from participation in all or a portion of the research funded by the agency;
  • Divestiture by the Investigator of SFI related to the FCOI;
  • Severance of relationships that create actual or potential conflicts;
  • Transfer of the research to another Investigator.

In cases where a significant FCOI cannot be effectively managed by the means above, the research will not be conducted at MMC.

An approved plan for management and/or elimination of the FCOI must be in place before the research begins. IRB approval will not be granted until the conflict of interest oversight or a management plan has been established and approved by the IRB. MMC may prohibit research that involves a conflict of interest even if the IRB approves the research. Such a decision will be made in consultation with the IO, the Senior Vice President for Medical and Academic Affairs, and legal counsel.

Federal grant applications may be submitted while MMC is considering a possible FCOI with the understanding that the research will not be conducted unless the FCOI is managed or eliminated.

Once a management plan is in place for a specific FCOI, it will be reviewed annually. In addition, the Investigator will inform MMC’s Office of Research Compliance of any changes related to the FCOI.

Retrospective Reviews:

Whenever an SFI is not disclosed or an identified FCOI is not managed in a timely manner by the Investigator, the RCOIC shall complete a retrospective review of the Investigator’s activities and the research project within 120 days of determination of noncompliance. The RCOIC willdetermine whether any research, or portion thereof, was biased with regard toits design, conduct, or reportingduring the time of noncompliance.

If a retrospective review has found an FCOI that was not disclosed or that bias has occurred in the conduct of the research as a result of the undisclosed SFI or improperly managed FCOI:

  • The Investigator is required at a minimum to:
  • Disclose the FCOI in each public presentation of the results of the research;
  • Submit an addendum to previously published presentations.
  • The IO at a minimum is required to:
  • Notify the funding agency and, if required, submit a mitigation report to the PHS Awarding Component.

PHS Funded Sub-recipient Agreements:

  • MMCInvestigators who are sub-recipients on grants awarded to other institutions will follow the requirements of prime awardeesregarding disclosing, managing and reporting FCOIs;
  • When MMC is the prime organization, sub-recipients from other organizations are required to certify in writing that they are following their own institution’s policy for disclosing SFIs and managing FCOIs;
  • Sub-recipient’s FCOI(s) and management plan(s) will be submitted to MMC’s Office of Research Compliance;
  • Sub-recipient agreements will incorporate terms that establish whether the FCOI policy of the prime awardee Investigator will apply to the sub-recipient Investigators and will include a time period to meet disclosure and/or FCOI reporting requirements; and
  • As prime awardee, MMC will be required to report to the funding agency any FCOI disclosed by the sub-recipient Investigator.

Transparency/Public Accessibility for PHS Funded Research and Sponsored Programs:

MMC will ensure that required information concerning FCOIs is accessible and maintained on a public website at

PHS Reporting Responsibilities:

  • MMC will certify to PHS funding agencies that it has a written and enforced administrative process to identify, manage or eliminate FCOIs.
  • Failure of the Investigator to disclose an SFI can result in disciplinary action by MMC. Allowing an FCOI to influence an Investigator’s judgment with regard to research activities may constitute scientific misconduct and may result in disciplinary action under MMC’s Policy on Reporting Misconduct of Science.
  • At any time, a funding agency may inquire into MMC’s procedures and actions regarding FCOIs
  • Additionally, a funding agency may suspend funding untilmatters involving FCOI are resolved.

Other Requirements Specific to PHS Funded Research Activities:

  • Prior to spending any awarded PHS funds, MMCwillreport the existence of any FCOI to this agency.
  • In these cases, MMC will ensure the FCOI has been managed, reduced, or eliminated in accordance with 42 CFR Part 50. Part 94.
  • If a new FCOI is disclosed,an amendment to the FCOI report will be filed and the FCOI managed or eliminated within sixty (60) days of the disclosure.
  • All MMC reportsto PHS agency will include the following information:
  • Grant or Contract number;
  • Principal Investigator (PI) or contact PI of the awarded grant or contract;
  • Name of the Investigator (if different from the PI)with the FCOI;
  • Description of which method was used to protect the involved PHS-funded research from bias (e.g., managed or eliminated);
  • Name of the entitywith which the Investigator has an FCOI;
  • Nature of the FCOI (e.g. equity, consulting fees, travel reimbursement, honorarium);
  • Value of financial interest: ($0 – 4,999); ($5K – 9,999); ($10K – 19,999); Amounts between $20K – 100K by increments of $20K, amounts above $100K by increments of $50K, or a statement that a value cannot be readily determined;
  • A description of the basis for determining that the Investigator’s financial interest conflicts with the research;
  • Key elementsof the FCOI management plan, including any monitoring requirements.
  • MMC must report annually to NIH:
  • Status of reported FCOI;
  • Changes to the management plan
  • If MMC conducts a retrospective review, it must contain the following information:
  • Grant or contract number;
  • Project title;
  • Principal Investigator (PI) or contact PI of the awarded grant or contract;
  • Name of the Investigator (if different from the PI) with the FCOI;
  • Name of the entity with which the Investigator has an FCOI;
  • Reason(s) for the retrospective review;
  • Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed, etc.);
  • Findings of the review; and
  • Conclusions of the review and recommended actions.
  • If the retrospective review determines that bias in the conduct of the research has occurred, RCOIC will file a Mitigation Report to the funding agency.
  • The Mitigation Report must include:
  • The report of theretrospective review;
  • A description of the impact of the bias on the research project (i.e. impact on the research project, extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable) and;
  • The Institution’s plan of action to eliminate or mitigate the effect of the bias.

Internal Committee Report:

The RCOIC Chair shall submit a quarterly report to the VPR detailing the actions taken by the Committee during that quarter.

Record Retention:

Records of all financial interest forms, disclosures and any actions taken by MMC with respect to FCOI will be retained in the Office of Research Compliance as follows:

  • For grants or cooperative agreements – at least three years from the submission date of the final expenditures report or, where applicable, from other dates specified in 45 C.F.R. 74.53(b) and 92.42(b) for different situations; and
  • For research contracts – for three years after final payment to MMC or sub-recipient, or where applicable, for the other time periods specified in 48 CFR part 4, subpart 4.7.

Other Considerations:

Students/Trainees:An important part of the training of graduate students and postdoctoral fellows is research mentoring. MMC and the staff who oversee student research must ensure that the educational interests of these trainees are not compromised by FCOIs. Care must be taken to ensure that the source of research funding does not cause a change in the training experience. Students and fellows should not be placed in a situation where the financial interests of MMC or the mentor will influence the direction of the research project. Furthermore, agreements with sponsors should not compromise therights of students to publicly present and publish dissertations and manuscriptsreporting their research.