Investigator Conflicts Of Interest
The purpose of the Center’s Conflict of Interest Policy is to affirm the Center’s commitment to promoting the highest level of integrity and objectivity in research, to protect the Center’s business interests, and to comply with applicable laws and regulations. The Center staff, trustees, and others acting on the Center’s behalf are expected to comply with the applicable procedures set forth pursuant to this Policy Statement, which describe the circumstances or actions that may give rise to actual or potential conflicts of interest and establish standards for disclosure and management of conflicts of interest.
Approved by Board of Trustees: April 27, 2012
INVESTIGATOR CONFLICT OF INTEREST PROCEDURES
Conflict of Interest – Any interest, relationship or responsibility that influences, has the potential to influence, or would appear to an independent observer to influence an individual’s ability to exercise objectivity in research.
Designated Officials – The Center individuals responsible for (1) reviewing all Significant Financial Interest disclosures by Investigators and Subrecipient Investigators, as applicable; (2) determining whether any Financial or other Conflict of Interest exists; and (3) preparing Management Plans for identified Financial Conflicts of Interest and monitoring Investigator compliance with Management Plans; (4) submitting Financial Conflict of Interest and other reports to Public Health Service (PHS) awarding component(s) or other Funders, as applicable.
Entity – Any domestic or foreign, public or private, organization (excluding a federal agency) from which an Investigator (or their spouse or dependent children) receives remuneration or has an ownership or equity interest.
Family Member – Family Member means the spouse/domestic partner and dependent children of an Investigator.
Financial Conflict of Interest (FCOI) – A Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of research.
FCOI Report – The Center’s report of an FCOI to the PHS awarding component.
Funder – An entity or organization that funds research, including the PHS and any awarding component of the PHS such as the NIH (collectively “PHS”). If the Funder is other than the PHS, the procedures in Section III shall be followed unless the non-PHS Funder has its own FCOI requirements applicable to Investigators. In addition, procedures with respect to reporting, Subrecipients and public accessibility of Conflict of Interest information are governed by such Funder’s requirements rather than PHS requirements.
Institutional Responsibilities – An Investigator’s professional responsibilities on behalf of the Center, including but not limited to research, research consultation, teaching, professional practice, clinical activities, purchasing, institutional committee membership, and service on advisory or review panels or boards.
Investigator – The project director (PD) or principal investigator (PI) and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of funded research, which may include, for example, Subrecipients, collaborators or consultants. As used herein, “Investigator” includes Senior/Key Personnel.
Management Plan – The Center’s documented plan that specifies the actions that have been and will be taken to manage an FCOI.
Mitigation Report – Reports prepared for and submitted to the PHS awarding component after bias is found in the course of a Retrospective Review of an FCOI.
PD/PI – Project director or principal Investigator of a funded research project; the PD/PI is included in the definitions of Senior/Key personnel and Investigators.
Retrospective Review – Documented process of determining whether any funded research, or portion thereof, was biased in the design, conduct or reporting of such research. A Retrospective Review is conducted whenever an FCOI is not identified or managed in a timely manner.
Senior/Key Personnel – The PD/PI and any other person identified as senior/key personnel by the Center in a grant application, progress report, or any other report submitted to a Funder by the Center.
Significant Financial Interest (SFI) –
(1) A financial interest consisting of one or more of the following interests of an Investigator or Investigator’s Family Member (i.e., spouse/domestic partner or dependent child) that reasonably appears to be related to the Investigator’s Institutional Responsibilities:
a. With regard to any publicly traded Entity, an SFI exists if the value of any remuneration received from the Entity in the twelve months preceding the disclosure and the value of any equity interest in the Entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;
b. With regard to any non-publicly traded Entity, an SFI exists if the value of any remuneration received from the Entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator or Family Member holds any equity interest (e.g., stock, stock option, or other ownership interest);
c. Intellectual property rights and interests (e.g., patents, copyrights, royalties), upon receipt of income related to such rights and interests;
(2) Reimbursed or sponsored travel related to an Investigator’s Institutional Responsibilities where the aggregate value of such reimbursed or sponsored travel received from a single outside organization exceeds $5,000 in the twelve months preceding the disclosure. (Sponsored travel is travel that is paid on behalf of the Investigator and not reimbursed to the Investigator.) Reimbursed or sponsored travel does not include travel expenses reimbursed by or sponsored by a U.S. federal, state, or local government agency, an accredited, domestic institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.
The term Significant Financial Interest does not include the following types of financial interests:
- Salary, royalties or other remuneration from the Center to the Investigator if the Investigator is currently employed or otherwise appointed by the Center, including intellectual property rights assigned to the Center and agreements to share in royalties related to such rights;
- Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator (or Family Member, as applicable) does not directly control the investment decisions made in these vehicles.
- Income from seminars, lectures or teaching engagements sponsored by a U.S. federal, state, or local government agency, an accredited, domestic institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education;
- Income from services on advisory committees or review panels for a U.S. federal, state, or local government agency, an accredited, domestic institution of higher education an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.
- Project number;
- Project title;
- PD/PI or contact PD/PI if a multiple PD/PI model is used;
- Name of the Investigator with the FCOI;
- Name of the Entity with which the Investigator has a financial conflict of interest;
- 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 Retrospective Review; and
- Conclusions of the Retrospective Review
Subrecipient – A Subrecipient relationship is established when PHS funds flow down from or through the Center to another individual or entity, and the Subrecipient will be conducting a substantive proportion of the funded research and is accountable to the Center for programmatic outcomes and compliance matters. A Subrecipient may be a subgrantee, collaborator, consultant, subcontractor or consortium member.
II. Objectivity in Research
Investigators shall carry out their Institutional Responsibilities with the utmost integrity and objectivity, and ensure that the design, conduct, and reporting of research will be free from bias resulting from Conflicts of Interest.
III. Financial Conflicts of Interest
These Financial Conflict of Interest Procedures are based on the HHS regulations provided at 42 CFR Part 50 and 45 CFR Part 94.
a. Disclosure of Significant Financial Interests
Investigators shall submit disclosures of SFIs to the Office of Sponsored Research for review by the Designated Officials.
When disclosing an SFI of reimbursed or sponsored travel, Investigators shall disclose the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration of the travel. The Designated Officials shall determine if further information is needed, in order to determine whether the travel constitutes an FCOI. Disclosure forms will guide Investigators through the necessary elements of disclosure of all types of SFIs.
i. Annual Disclosure
Investigators are required to complete an annual disclosure of SFIs. A current annual disclosure must be on file prior to submission of an application for funded research.
Ongoing annual disclosures shall include any information that was not disclosed in a previous annual disclosure or in a subsequent disclosure of SFIs. Annual disclosures shall include updated information regarding any previously disclosed SFI (e.g., the updated value of a previously disclosed equity interest).
Investigators who are new to the Center must complete an annual disclosure upon hiring and prior to engaging in any research activities.
ii. Updating Disclosure within 30 Days of New SFI
Each Investigator is required to submit an updated disclosure of SFIs within 30 days of discovering or acquiring a new SFI (e.g., through purchase, marriage, or inheritance).
iii. Project-Specific Disclosure
Each Investigator is required to submit a project-specific disclosure form prior to application for funded research. The project-specific disclosure confirms that the Investigator has submitted an up-to-date annual disclosure and allows the Investigator to provide his/her opinion as to whether any SFI disclosed on the annual disclosure or any updated disclosure could reasonably affect or be affected by the proposed research.
b. Review by Designated Officials of Significant Financial Interest Disclosures
The Designated Officials shall review SFI disclosures to determine whether an Investigator’s SFI is related to funded research and, if so related, whether the SFI is an FCOI.
An Investigator’s SFI is related to funded research when the Center, through its Designated Officials, reasonably determines that the SFI could be affected by the funded research or is in an Entity whose financial interest could be affected by the research. The Investigator may be involved in this determination.
An FCOI exists when the Center, through its Designated Officials, reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the funded research.
i. Review of Disclosures Prior to Expenditure of Funds
Prior to the Center’s expenditure of any funds under a funded research project, the Designated Officials shall review all Investigator and applicable Subrecipient disclosures to determine (1) whether any SFIs relate to funded research, (2) determine whether a FCOI exists, and if so, (3) develop and implement a Management Plan that shall specify the actions that have been or will be taken to manage the FCOI.
If an FCOI exists and the Funder is the PHS, the Center shall provide to the PHS awarding component an FCOI Report prior to the expenditure of funds, in accordance with Section III.d.i.(a), and ensure that a Management Plan has been implemented. Thereafter, the Center will submit FCOI Reports to the PHS awarding component annually, as specified in Section III.d.i.(c). In cases in which the Center identifies an FCOI and eliminates it prior to the expenditure of funds, the Center shall not submit an FCOI Report to the PHS awarding component.
ii. Review of Disclosures Related to Ongoing Research
Whenever, in the course of an ongoing funded research project, an Investigator who is new to participating in the research project discloses an SFI or an existing Investigator discloses a new SFI, the Designated Officials shall, within 60 days, review the disclosure of the SFI to determine whether it is related to the funded research and whether a FCOI exists. If a FCOI exists, the Designated Officials shall implement, on at least an interim basis, a Management Plan that shall specify the actions that have been and will be taken to manage the FCOI. Depending on the nature of the SFI, the Center may determine that additional interim measures are necessary with regard to the Investigator’s participation in the funded research project between the date of disclosure and the completion of the Designated Officials’ review.
If an FCOI exists and the Funder is the PHS, the Center must submit an FCOI Report to the PHS awarding component accordance with Section III.d.i.(a) within the same 60-day period provided for review and ensure that a Management Plan has been implemented. Thereafter, the Center will submit FCOI Reports annually, as specified in Section III.d.i.(c).
iii. Review of Failure to Disclose or Failure to Review and Retrospective Review
Whenever the Center identifies an SFI that was not timely disclosed by an Investigator or, for whatever reason, was not previously reviewed during an ongoing funded research project (e.g., was not timely reviewed or reported by a Subrecipient), the Designated Officials shall follow the procedures outlined in subsection b(ii), above.
In addition, whenever an FCOI is not identified or managed in a timely manner (including failure by the Investigator to disclose an SFI that is determined to constitute a FCOI, failure by the Center to review or manage such FCOI, or failure by the Investigator to comply with an FCOI Management Plan), the Center shall, within 120 days of the determination of noncompliance, complete a Retrospective Review of the Investigator’s activities and the funded research project to determine whether any research, or portion thereof, conducted during the time period of noncompliance was biased by the FCOI.
The Designated Officials shall conduct and document the Retrospective Review, which must include at least the following key elements:
Based on the results of the Retrospective Review, the Center shall update the previously submitted FCOI Report, as appropriate, specifying the actions that will be taken to manage the FCOI going forward.
If bias is found and the Funder is the PHS, the Center shall notify the PHS awarding component promptly and submit a Mitigation Report, as described in Section III.d.ii. Any reports to non-PHS Funders shall be made in accordance with such Funder’s policy or instructions.
Depending on the nature of the FCOI, the Designated Officials may determine that additional interim measures are necessary with regard to the Investigator’s participation in the funded research project between the date of determination of the FCOI or Investigator noncompliance and the completion of the Retrospective Review.
c. Management of Financial Conflicts of Interest
When the Designated Officials identify an FCOI, they shall develop and implement a Management Plan that specifies the actions that have been and will be taken to manage the FCOI. This Management Plan must include the following:
Examples of conditions or restrictions that might be imposed to manage a FCOI include, but are not limited to:
The Center shall monitor Investigator compliance with the Management Plan on an ongoing basis until completion of the funded research project.
d. Reports to Funder
The reports referred to in this Section apply to instances when the Funder is the PHS. Any Conflict of Interest reports to non-PHS Funders shall be made in accordance with such Funder’s policy or instructions.
In cases where the FCOI is eliminated prior to the expenditure of PHS-awarded funds, no FCOI Report will be submitted to the PHS awarding component.
i. FCOI Reports
(a) Required Information
All FCOI Reports must include sufficient information to enable the PHS awarding component to understand the nature and extent of the FCOI and to assess the Page 7 of 12
Investigator Conflict of Interest Policy Statement and Procedures
appropriateness of the Center’s Management Plan. The FCOI Report must include the following:
(b) Method and Timing of Submitting FCOI Reports
If the PHS awarding component is NIH, the Center shall submit FCOI Reports though the electronic Research Administration (eRA) Commons FCOI Module. Submissions of FCOI Reports to other PHS awarding components shall be done in the manner specified by the awarding component. FCOI Reports shall also be submitted to the Executive Committee of the Board of Trustees (Executive Committee).
FCOI Reports must be submitted prior to the Center’s expenditure of any funds under a PHS-funded research project. Additionally, the Center must submit an FCOI Report within 60 days after its determination that an FCOI exists for an Investigator who is newly participating in a project or for an existing Investigator who disclosed a new SFI during the period of award.
Whenever an Investigator does not disclose timely a previously existing FCOI or the Center fails to timely review a previously existing SFI during an ongoing PHS-funded project, the Designated Officials shall, within 60 days, review the SFI as provided in Section III.b.iii. If an FCOI exists, the FCOI Report must be submitted within the same 60-day period provided for review.
(c) Annual FCOI Reports
For any FCOIs previously reported to the PHS awarding component with regard to an ongoing PHS-funded research project, the Center shall provide an annual FCOI Report that addresses the status of the FCOI and any changes to the Management Plan for the duration of the PHS-funded research project. Annual FCOI Reports shall specify whether the FCOI is still being managed or explain why it no longer exists.
Annual FCOI Reports must be submitted to the PHS awarding component for the duration of the research project period (including extensions with or without funds) at the same time as when the Center is required to submit the annual progress report, multi-year progress report (if applicable), or at the time of the extension.
ii. Mitigation Reports
If bias is found in the course of a Retrospective Review conducted under Section III.b.iii, the Center shall notify the PHS awarding component promptly and submit a Mitigation Report to the PHS awarding component. The Mitigation Report must include the key elements documented in a Retrospective Review, the impact of the bias on the research project, and the Center’s plan to eliminate or mitigate the effect of the bias (e.g., 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). Thereafter, the Center will submit FCOI Reports annually as described in Section III.d.i.(c).
The Center must take reasonable steps to ensure that all Subrecipients that receive PHS funds from or through the Center comply with FCOI regulations promulgated by HHS. Subrecipients who rely on the Subrecipient’s own FCOI policy must certify as part of the written agreement with the Center that the Subrecipient’s policy complies with 42 CFR Part 50 or Part 94, as applicable. If the Subrecipient cannot provide such certification, the written agreement shall state that Subrecipient Investigators are subject to the Center’s FCOI Policy and Procedures for disclosing SFIs that are directly related to the Subrecipient’s work for the Center. The written agreement will include time periods to meet SFI disclosure or FCOI reporting requirements, as applicable, and will set forth requirements to make any FCOI information publicly available pursuant to Section III.j of these procedures. Subrecipients that rely on their own FCOI policy must report identified FCOIs to the Center in sufficient time to allow the Center to report the FCOI to the PHS pursuant to its reporting obligations. Subrecipients that are subject to the Center’s FCOI policy must submit all Subrecipient Investigator disclosures of SFIs to the Center in sufficient time to allow the Center’s Designated Officials to review, manage and report identified FCOIs to the PHS.
f. Training Requirements
Each Investigator shall complete Conflict of Interest training prior to engaging in research and at least every four (4) years thereafter. In addition, Investigators must complete training immediately (i.e., within 30 days unless a shorter period is set by the Designated Officials) when any of the following circumstances apply:
The training will describe Investigator and Subrecipient responsibilities for disclosure of SFIs and the Center’s Conflict of Interest Policy and Procedures. The Designated Officials will provide Investigators with information regarding how to complete the required training and will maintain records of such training.
g. Violations of Procedures
i. PHS Remedies
When the failure of an Investigator to comply with these Policies and Procedures or a Management Plan appears to have biased the design, conduct or reporting of PHSfunded research, the Center shall promptly notify the PHS awarding component of the corrective action taken or to be taken. The PHS awarding component will consider the situation and, as necessary, take appropriate action, or refer the matter to the Center for further action, which may include directions to the Center on how to maintain appropriate objectivity in the research project.
The PHS awarding component and/or HHS may inquire at any time before, during, or after award of funds into any Investigator disclosure of financial interests and the Center’s review (including any Retrospective Review) of, and response to, such disclosure, regardless of whether the disclosure resulted in the Center’s determination of a FCOI. The Center must submit, or permit on-site review of, all records pertinent to compliance with these procedures. On the basis of its review of records or other information that may be available, the PHS awarding component may decide that a particular FCOI will bias the objectivity of the PHS-funded research to such an extent that further corrective action is needed, or that the Center has not managed the FCOI in accordance with these procedures. The PHS awarding component may determine that imposition of special award conditions, or suspension of funding or other enforcement action, is necessary until the matter is resolved.
If HHS determines that an PHS-funded clinical research project whose purpose is to evaluate the safety or effectiveness of a drug, medical device or treatment has been designed, conducted or reported by an Investigator with a FCOI that was not managed or reported by the Center, the Center shall require the Investigator involved to disclose the FCOI in each public presentation of the results of the research and to request an addendum to previously published presentations.
ii. Internal Remedies
In addition to any reports to or remedies required by the Funder, violations of these procedures by an Investigator will be reported to the Center’s Leadership Team for appropriate action. The Leadership Team may seek the guidance of the Executive Committee concerning the handling of any FCOI or violation of these procedures, and will report any decision to the Executive Committee.
All records relating to SFI disclosures and the Center’s review of, or response to such disclosures (whether or not a disclosure was designated to be an FCOI) and all action taken under these FCOI procedures will be maintained for at least three (3) years from the date of the final expenditures report, or as otherwise required by law, whichever is longer. The Office of Sponsored Research shall maintain these records.
i. Designated Officials
The Chief Operating Officer shall appoint Designated Official(s) to solicit and review disclosures of SFIs from Investigators.
j. Public Accessibility
i. Policy Statement and Procedures on Website
The Center’s Investigator Conflict of Interest Policy and Procedures shall be made available via the Center’s publicly accessible Web site.
ii. Public Availability of Certain Significant Financial Interests
Prior to the Center’s expenditure of funds for PHS-funded research, the Center shall ensure public accessibility of information concerning any SFI disclosed to the Center that meets the following criteria:
The following information shall be made available via a publicly accessible web site or written response to any requestor within five (5) business days (postmarked or dated, if replying by electronic means) of receipt of a request:
If the Center uses a publicly-accessible website for purposes of this subsection, it shall note on the website that the information provided is current as of the date listed and is subject to updates, on at least an annual basis and within 60 days of the Center’s identification of a new FCOI. If the Center responds in writing, it shall note in its written response that the information provided is current as of the date of the correspondence and is subject to updates, on at least an annual basis and within sixty (60) days of the Center’s identification of a new FCOI, which should be requested by the requestor. Information concerning any SFIs that is required to be publicly available shall be available for at least three years from the date that the information was most recently updated.
IV. Modification/Amendment of Policy Statement and Procedures
The Investigator Conflict of Interest Policy Statement may be modified or amended at any time by the Center’s Board of Trustees. The Investigator Conflict of Interest Procedures may be modified or amended at any time by the Center Operations Team.
Procedures Last Updated: March 13, 2014