I. PURPOSE
Einsenca Inc. (“Einsenca”) is committed to protecting the integrity and objectivity of its research activities by ensuring that the design, conduct, and reporting of Research performed under U.S. Public Health Service (PHS) grants and cooperative agreements will not be biased or appear to be biased by a personal financial conflict of interest.
Einsenca has implemented this policy entitled “EINSENCA INC. FINANCIAL CONFLICT OF INTEREST POLICY” to identify, manage, reduce, or eliminate financial conflicts of interest, in compliance with the requirements of 42 CFR Part 50 Subpart F entitled “Responsibility of Applicants for Promoting Objectivity in Research.” and 45 CFR Part 94, “Responsible Prospective Contractors” which are applicable to Research funded by the U.S. PHS.
The procedures described in this policy were created and designed primarily to comply with the specific regulatory requirements for U.S. PHS-sponsored research but are also intended to provide a basic framework and standards for identifying, evaluating, and managing potential financial conflicts of interest relating to Einsenca’s other research activities. For non-PHS research, the specific steps, timing, determinations, documentation, and notifications may be tailored as appropriate but will remain focused on maintaining Einsenca’s high standards for research integrity and effectively eliminating or managing actual or potential financial conflicts of interest.
II. SCOPE
This policy requires that Einsenca’s investigators, subrecipient, subgrantees and collaborators affiliated with Einsenca Inc., supported by NIH or any other applicable grant or contract, be in compliance with 42 CFR Part 50, Subpart F for PHS grants and cooperative agreements (and 45 CFR Part 94 for contracts). Each Investigator, as defined in the policy, who will participate, or is participating, in such Research, must follow this policy and complete the required training.
Subcontractors and consultants who perform services within the definition of an Investigator must either maintain a policy that complies with the requirements of 42 CFR Part 50, Subpart F and 45 CFR Part 94 or comply with this policy.
Questions and concerns regarding this policy should be directed to the Einsenca Designated Official(s), [email protected].
III. DEFINITION
The following definitions shall apply to principal or program investigators, subrecipients, subgrantees and collaborators affiliated with Einsenca. This policy and all FCOI guidance are also available at https://einsenca.com/index.php/home/financial-conflict-of-interest-policy/ so that all interested parties, including the general public, have access to this policy.
Designated Officials are the individuals designated by Einsenca to oversee the financial conflicts of interest process, including solicitation and review of disclosures of significant financial interests.
Disclosure refers to the investigator’s disclosure of Significant Financial Interest (SFIs) to Einsenca’s Designated Official(s) who will review all “disclosure” and evaluate whether they contain any FCOI.
Equity interest includes any stock, stock option, or other ownership interest, and its value may be determined through reference to public prices or other reasonable measures of fair market value.
Financial Conflict of Interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of NIH-funded research as determined by Einsenca through the Designated Officials.
Financial interest means anything of monetary value, whether or not the value is readily ascertainable.
Immediate family refers to an Investigator’s spouse and dependent children.
Investigator refers to the PD/PI and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of NIH-funded research, including subgrantees, contractors, consortium participants, collaborators, or consultants.
Institution means any domestic or foreign, public or private, entity or organization (excluding a Federal agency) that submits a proposal, or that receives, PHS research funding. Einsenca is considered an “Institution” for purposes of this policy.
Institutional Responsibilities means an Investigator’s professional responsibilities performed on behalf of Einsenca, and as defined by Einsenca in this policy, which may include for example: activities such as research, research consultation, professional practice, committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.
Management of a FCOI refers to the action taken to address a FCOI, which can include reducing or eliminating the FCOI, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias. Einsenca management plan will include:
i. The role and principal duties of the conflicted investigator in the research project.
ii. The conditions of the management plan.
iii. How the management plan is designed to safeguard objectivity in the research project.
iv. Confirmation of the investigator’s agreement to the management plan.
v. How the management plan will be monitored to ensure investigator compliance.
vi. Other information as needed
PHS means the U.S. Public Health Service, an operating division of the U.S. Department of Health and Human Services (HHS), and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH).
PHS Awarding Component means the organizational unit of the PHS that funds the research that is subject to 42 CFR Part 50, Subpart F, and 45 CFR Part 94.
PHS-funded Research means research funded under PHS grants, cooperative agreements, or contracts.
Public Health Service Act, or PHS Act means the statute codified at 42 U.S.C. 201 et seq.
Regulation or FCOI regulation refers to 42 CFR Part 50 Subpart F, Promoting Objectivity in Research, which applies to both grants and cooperative agreements.
Remuneration includes, for example, salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship).
Report refers to the Einsenca’s report of identified FCOIs to the NIH. If a FCOI is identified, it will be put on the FCOI report through the eRA Commons FCOI module prior to expending any funds. For any interests identified as conflicting subsequent to the initial report, Einsenca will report any new disclosures to the PHS awarding component that has issued the award within 60 days.
Research means a systematic investigation, study, or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social sciences research. The term encompasses basic and applied research (e.g., a published article, book, or book chapter) and product development (e.g., a diagnostic test or drug). For PHS-Funded Research, the term includes any such activity for which research funding is available from a PHS Awarding Component through a grant, cooperative agreement, or contract, whether authorized under the PHS Act or other statutory authority, but excluding applications for Phase I support under the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs.
Senior/Key Personnel means the PD/PI and any other person identified as senior/key personnel by Einsenca in the grant application, progress report, or any other report submitted to the PHS by Einsenca.
Significant Financial Interest (SFI) means a financial interest consisting of one or more of the following interests of the Investigator and his/her immediate family that reasonably appear to be related to the Investigator’s Institutional Responsibilities, as defined by the following regulation:
i. A financial interest consisting of one or more of the following interests of the investigator (and those of the investigator’s spouse and dependent children) that reasonably appears to be related to the investigator’s institutional responsibilities
1. With regard to any publicly traded entity, a Significant Financial Interest 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 the disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any 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;
2. With regard to any non-publicly traded entity, a Significant Financial Interest 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 the investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest) or
3. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests, that exceeds $5,000 in the twelve months preceding the disclosure.
ii. Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the investigator and not reimbursed to the investigator so that the exact monetary value may not be readily available), related to their Institutional Responsibilities, that exceeds $5,000 in the twelve months preceding the disclosure; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a federal, state, or local government agency located in the United States, a United States institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with a United States institute of higher education.
At minimum to be disclosed are as follows: the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. Einsenca Designated Official(s) will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research.
iii. The term Significant Financial Interest does not include the following types of financial interest:
1. Salary, royalties, or other remuneration paid by Einsenca to the investigator if the investigator is currently employed or otherwise appointed by Einsenca, including intellectual property rights assigned to Einsenca and agreements to share in royalties related to such rights;
2. Any ownership interest in Einsenca (or a subrecipient as applicable) held by the Investigator (e.g., Employee Stock Ownership Plan);
3. Income from investment vehicles, such as mutual funds and retirement accounts, as long as the investigator does not directly control the investment decisions made in these vehicles;
4. Income from the seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency located in the United States, a United States institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with a United States Institution of higher education;
5. Or income from service on advisory committees or review panels for a federal, state, or local government agency located in the United States, a United States institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with a United States institution of higher education.
IV. RESPONSIBILITIES OF EINSENCA DESIGNATED OFFICIAL
The Designated Official or his/her designee shall be responsible for the following:
i. Informing Einsenca Investigators of their obligations under this policy and any related regulations;
ii. Reviewing disclosures of significant financial interest with Einsenca Administrator to determine whether they are related to the subject research and, if so, whether they constitute financial conflicts of interest;
iii. Screening and managing potential financial conflicts of interest; iv. Maintaining all records relating to disclosures of financial interests, Einsenca review of and response to such disclosures, and any related actions under this policy;
v. Ensuring inclusion of any required certifications in applications for funding or contract proposals; and
vi. Reporting and disclosure as required under this policy and applicable regulations.
For PHS-funded research involving subrecipients (e.g., subgrantees, subcontractors, or collaborators), the Designated Official shall also have the following responsibility:
i. Taking reasonable steps to ensure that Investigators for subrecipients (e.g., subgrantees, subcontractors, or collaborators) fully comply with this policy or provide Einsenca with sufficient assurances to enable Einsenca compliance with all applicable laws or regulations. To this end, the written agreement between Einsenca and the subrecipient will specify whether Einsenca or the subrecipient’s financial conflicts of interest policy will apply to the subrecipient’s Investigators and, if the subrecipient’s policy will apply, the Designated Official will:
ii. Obtain certification from the subrecipient that its policy complies with Einsenca policy and the applicable regulations (absent such certification, Einsenca policy will apply to the subrecipient’s Investigators, and
iii. Establish time periods for subrecipient reporting of financial conflicts of interest to Einsenca that enable Einsenca to report such conflicts in a timely manner, as required under its policy and the applicable regulations.
If Einsenca policy will apply to the subrecipient Investigators, Einsenca will be responsible for meeting the requirements of this policy and the reporting obligations reflected in the applicable regulations.
V. REQUIREMENTS
Training Requirement
Each Investigator must complete training prior to engaging in PHS funded research. Acceptable forms of training include, but are not limited to, the NIH Office of Extramural Research FCOI online tutorial (located at: https://grants.nih.gov/grants/policy/coi/fcoi-training.htm) or other training courses approved by Einsenca.
Investigators must complete training at least every four years and must immediately complete training under the following circumstances:
i. Einsenca’s FCOI policy changes in a manner that affects the requirements of Investigators;
ii. An Investigator is new to Einsenca; or,
iii. Einsenca determines that an Investigator is not in compliance with Einsenca’s FCOI policy or management plan.
Disclosure Requirements
Each Investigator who is planning to participate in PHS funded Research is required to disclose to Einsenca any significant financial interests, including any significant financial interests of their spouse or dependent children, no later than the time of application for PHS funded Research.
Each Investigator who is participating in the PHS-funded Research is required to submit an updated disclosure of significant financial interests (including any significant financial interests of their spouse or dependent children): (1) at least annually, in accordance with the specific time period prescribed by Einsenca, during the period of the award; and, (2) within thirty (30) days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new significant
financial interest.
If an Investigator does not have any significant financial interests to report, the Investigator must still complete the Disclosure Form both initially and annually. Each Investigator must do so by completing the Disclosure Form provided by Einsenca to the Einsenca Designated Official(s). The Einsenca Designated Official(s) shall solicit and review all required Disclosure Forms and determine whether any reported significant financial interest is a FCOI.
Einsenca shall ensure applicable staff comply with these disclosure obligations. Failure to comply with these disclosure obligations may result in disciplinary action by Einsenca.
VI. PROCEDURES
Determination and Management of Financial Conflicts of Interest
Upon receipt of a completed significant financial interest Disclosure, the Designated Official(s) shall determine whether an Investigator’s significant financial interest is related to the subject research and, if so, whether the interest constitutes a financial conflict of interest under this policy and any applicable regulations. The Investigator may be required to submit additional
information as part of the process. A disclosed interest may be related to the subject research either because the interest could be affected by the research or because it is in an entity whose financial interest could be affected by the research. A financial conflict of interest exists if the
significant financial interest could directly and significantly affect the design, conduct, or reporting of the research.
If Einsenca determines that a financial conflict of interest exists, a FCOI management plan will be implemented and monitored on an ongoing basis. The management plan will include appropriate steps to manage, reduce, or eliminate the conflict. The following are examples of conditions or restrictions that might be imposed:
i. Disclosure to research participants or the public of significant financial interests (e.g., when presenting or publishing the research, to research personnel working on the study, to the Institution Review Board(s), Institutional Animal Care and Use Committee(s),etc.);
ii. Monitoring of research by independent reviewers;
iii. Modification of the research plan;
iv. Disqualification of staff from participation in all or a portion of the research;
v. Reduction or divestiture of a financial interest; or
vi. Severance of relationships that create actual or potential conflicts.
vii. In addition to the conditions or restrictions described above, Einsenca may require the management of conflicting financial interests in other ways as it deems appropriate.
Reporting of FCOI
FCOI reports are submitted to the NIH via the eRA Commons FCOI Module.
Initial FCOI Report: Prior to the Einsenca’s expenditure of any funds under a PHS-funded research project, Einsenca shall provide to the PHS Awarding Component an FCOI report regarding any Investigator’s significant financial interest found by Einsenca to be conflicting and ensure that Einsenca has implemented a management plan in accordance with this policy. In cases in which Einsenca identifies a financial conflict of interest and eliminates it prior to the
expenditure of PHS-awarded funds, Einsenca shall not submit an FCOI report to the PHS Awarding Component.
Subsequent FCOI Reports: For any significant financial interest that Einsenca identifies as conflicting subsequent to Einsenca’s initial FCOI report during an ongoing PHS-funded research project (e.g., upon the participation of an Investigator who is new to the research project), Einsenca shall provide to the PHS Awarding Component, within sixty (60) days, an FCOI report regarding the financial conflict of interest. Additionally, Einsenca will ensure that it has implemented a management plan in accordance with this policy and, if required, complete a retrospective review and a mitigation report according to this policy.
Contents of a FCOI Report: Any FCOI report required under this policy shall include sufficient information to enable the PHS Awarding Component to understand the nature and extent of the financial conflict, and to assess the appropriateness of Einsenca’s management plan. Elements of the FCOI report shall include, but are not necessarily limited to the following:
i. Project/Contract number;
ii. PD/PI or Contact PD/PI if a multiple PD/PI model is used;
iii. Name of the Investigator with the financial conflict of interest;
iv. Name of the entity with which the Investigator has a financial conflict of interest;
v. Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium);
vi. Value of the financial interest (dollar ranges are permissible: $0–$4,999; $5,000–$9,999; $10,000–$19,999; amounts between $20,000–$100,000 by increments of $20,000; 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;
vii. A description of how the financial interest relates to the PHS-funded research and the basis
for Einsenca’s determination that the financial interest conflicts with such research; and
viii. A description of the key elements of Einsenca’s management plan, including:
ix. Role and principal duties of the conflicted Investigator in the research project;
x. Conditions of the management plan;
xi. How the management plan is designed to safeguard objectivity in the research project;
xii. Confirmation of the Investigator’s agreement to the management plan;
xiii. How the management plan will be monitored to ensure Investigator compliance; and
xiv.Other information as needed.
Annual FCOI Report: For any FCOI previously reported by Einsenca with regard to an ongoing PHS-funded research project, Einsenca shall provide to the PHS Awarding Component an annual FCOI report that addresses the status of the financial conflict of interest and any changes to the management plan for the duration of the PHS-funded research project. The annual FCOI report shall specify whether the financial conflict is still being managed or explain why the financial conflict of interest no longer exists. Einsenca shall provide annual FCOI
reports to the PHS Awarding Component for the duration of the project period (including extensions with or without funds) in the time and manner specified by the PHS Awarding Component.
In addition to the types of financial conflicts of interest as defined in this policy that must be reported pursuant to this section, Einsenca may require the reporting of other financial conflicts of interest, as Einsenca deems appropriate.
Public Accessibility
Prior to Einsenca’s expenditure of any funds under a PHS funded Research project, Einsenca shall ensure public accessibility by posting to a publicly accessible website, or written response to any requestor within five (5) business days of a request, of information concerning any significant financial interest disclosed to Einsenca that is: (a) held by Senior/Key Personnel performing services for the Research, (b) related to the PHS funded research, and (c) determined by Einsenca to be a FCOI.
The information regarding the FCOI that Einsenca makes available via a publicly accessible website or written response to any requestor within five business days of a request, shall include:
i. Project number;
ii. Name of the Investigator with the FCOI, title, and role with respect to the Research project;
iii. Name of the entity with which the Investigator has a FCOI;
iv. Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium);
v. Value of the financial interest (dollar ranges are permissible: $0–$4,999; $5,000–$9,999; $10,000– $19,999; amounts between $20,000–$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000), or a statement that the interest is one whose value cannot readily be determined through reference to public prices or other reasonable measures of fair market value;
If Einsenca posts the above FCOI information via a publicly accessible web site, this information must be updated at least annually as well as within sixty (60) days of either: (a) Einsenca’s receipt or identification of information concerning any additional significant financial interest of the Senior/Key Personnel for the PHS funded Research project that was not previously disclosed; or, (b) upon disclosure of any significant financial interest of Senior/Key Personnel new to the PHS funded Research project, if Einsenca determines that the significant financial interest is related to the PHS funded Research and is a FCOI. The website shall note that the
information is current as of the date shown and is subject to the required updates. Any significant financial interest posted to the website shall remain available for at least three years from the date that the information was most recently updated by Einsenca.
If Einsenca responds to written requests to provide the above FCOI information, Einsenca will 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 Einsenca’s identification of a new FCOI, which should be requested subsequently by the requestor. All disclosures or information obtained in reviewing a potential FCOI is kept confidential, except where disclosure is required by federal regulations.
Retrospective Reviews
Whenever Einsenca identifies a significant financial interest that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed by Einsenca during an ongoing PHS-funded research project (e.g., was not timely reviewed or reported by a subrecipient), the Einsenca Designated Official shall, within sixty (60) days, review the significant financial interest; determine whether it is related to PHS-funded research; determine whether a FCOI exists; and, if so, implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage such FCOI going
forward.
Whenever a FCOI is not identified or managed in a timely manner, including:
i. Failure by the Investigator to disclose a significant financial interest that is determined by Einsenca to constitute a FCOI;
ii. Failure by Einsenca to review or manage such a FCOI; or
iii. Failure by the Investigator to comply with a FCOI management plan;
Einsenca shall, within one hundred twenty (120) days of its determination of noncompliance, complete a retrospective review of the Investigator’s activities and the PHS-funded Research to determine whether any PHS-funded Research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such Research.
Einsenca is required to document the retrospective review which shall include all of the following key elements:
i. Project number;
ii. Project title;
iii. PD/PI or contact PD/PI if a multiple PD/PI model is used;
iv. Name of the Investigator with the FCOI;
v. Name of the entity with which the Investigator has a financial conflict of interest
vi. Reason(s) for the retrospective review;
vii. Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed, etc.);
viii. Findings of the review; and
ix. Conclusions of the review.
Based on the results of the retrospective review, Einsenca will update any previously submitted FCOI report(s), specifying the actions that will be taken to manage the FCOI going forward. If bias is found, Einsenca will notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. If the FCOI was previously reported to the PHS Awarding Component, the mitigation report will be submitted as a “Revised FCOI Report.” The mitigation report must include, at a minimum, the key elements documented in the
retrospective review above and a description of the impact of the bias on the Research project, and Einsenca’s plan of action or actions taken 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, Einsenca will submit FCOI reports annually. Depending on the nature of the FCOI, Einsenca may determine that additional interim measures are necessary with
regard to the Investigator’s participation in the PHS funded Research project between the date that the FCOI or the Investigator’s noncompliance is determined and the completion of Einsenca’s retrospective review.
Whenever Einsenca implements a management plan, Einsenca will monitor Investigator
compliance with the management plan on an ongoing basis until the completion of the PHS funded Research project.
Enforcement
If an Investigator knowingly fails to comply with this policy (e.g., fails to identify an actual or potential financial conflict of interest), Einsenca may take appropriate disciplinary action, which may include, without limitation, termination of the Investigator’s participation in the research.
If the failure of an Investigator to comply with this policy or a FCOI management plan appears to have biased the design, conduct, or reporting of the PHS funded Research, Einsenca shall promptly notify the PHS Awarding Component of the corrective action taken or to be taken by Einsenca. The PHS Awarding Component will consider the situation and, as necessary, take appropriate action, or refer the matter to Einsenca for further action, which may include directions to Einsenca on how to maintain appropriate objectivity in the PHS funded Research
project.
The PHS Awarding Component and/or HHS may inquire at any time before, during, or after award into any Investigator disclosure of financial interests and Einsenca’s review of, and response to, such disclosure, regardless of whether or not the disclosure resulted in Einsenca’s determination of a FCOI. Einsenca is required to submit, or permit on site review of, all records pertinent to compliance with this policy. To the extent permitted by law, HHS will maintain the confidentiality of all records of financial interests. On the basis of its review of records or other
information that may be available, the PHS Awarding Component may decide that a particular financial conflict of interest will bias the objectivity of the PHS-funded research to such an extent that further corrective action is needed or that Einsenca has not managed the FCOI in accordance with this policy. The PHS Awarding Component may determine that issuance of specific award conditions under 45 CFR 75.207, or suspension of funding or other enforcement action under 45 CFR 75.371, is necessary until the matter is resolved.
In any case in which the HHS determines that a PHS-funded project of clinical research 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 Einsenca as required by the regulation, Einsenca shall require the Investigator(s) involved to disclose the FCOI in each public presentation of the results of the research and to request an addendum to previously published presentations.
VII. MISCELLANEOUS
Retention of Records
The records of all financial disclosures and all actions taken by Einsenca will be maintained in a significant financial interest binder or binders, for at least three years from the date of the final expenditure report submitted to the PHS Awarding Component under an award or, where applicable, from other dates specified in 45 CFR 75.361, and throughout the completion of any litigation, claim, negotiation, audit or other action involving the records, whichever date is later.
Confidentiality
Einsenca will, to the extent possible, protect the confidentiality of disclosures. In every instance, Einsenca will endeavor to balance the privacy interests of individuals with its responsibility and obligation to identify and manage conflicts of interest. Disclosures will be available to Einsenca staff only on a need-to-know basis and will not be disclosed outside of Einsenca unless necessary to comply with contractual, legal, or regulatory requirements.