Compliance & Trust

1. Introduction

The purpose of this policy is to reasonably ensure that research funded by the National Institutes of Health (NIH) is designed, conducted, and reported objectively and without bias resulting from Investigator financial conflicts of interest (FCOI). The 2011 revised regulations are 42 CFR Part 50 Subpart F, “Promoting Objectivity in Research” and 45 CFR Part 94, “Responsible Prospective Contractors”, which set requirements for promoting objectivity in Public Health Service (PHS)-funded research for grants, cooperative agreements, and research contracts, respectively.

This policy is intended to implement the regulatory requirements for PHS/NIH grants and cooperative agreements per the regulation at 42 CFR Part 50 Subpart F and NIH guidance.

Microstructure Imaging, Inc. (MICSI) adopts this policy for all Investigators engaged in PHS/NIH-funded research. It establishes processes to identify, disclose, and manage Investigator financial conflicts of interest to protect research integrity, ensure the safety of human and animal subjects, and maintain public trust in PHS/NIH-supported research.

2. Applicability

This policy applies to grants and cooperative agreements issued by the NIH. The regulations and this policy do not apply to SBIR or STTR Phase I applications or awards.

This policy applies to individuals who meet the regulatory definition of “Investigator” who are planning to participate in or who participate in PHS/NIH-funded research.

3. Definitions

For the purpose of these policies and procedures, the following definitions apply:

Financial Conflict Of Interest (FCOI): A significant financial interest that is related to the PHS/NIH-funded research (i.e., the SFI could be affected by the research or the SFI is in an entity whose financial interest could be affected by the research) and could directly and significantly affect the design, conduct, or reporting of PHS-funded research.

Financial Interest: Anything of monetary value, whether or not its value is readily ascertainable.

Institutional Responsibilities: The professional activities or responsibilities an Investigator performs on behalf of MICSI, including research, publication and communication of research, clinical or regulatory activities, software or product development, grant administration, and service on advisory panels or review boards.

Designated Official (DO): The individual appointed by MICSI to solicit and review disclosures of Investigator significant financial interests, determine whether the SFI is related to the research and whether it constitutes an FCOI in accordance with 42 CFR 50.604(f) and as stated in Section 6. The DO will also develop management plans to manage identified FCOIs. Unless otherwise designated in writing, MICSI’s Chief Executive Officer serves as the DO. If the Chief Executive Officer has a disclosed SFI requiring review, MICSI will appoint an independent alternate DO or qualified external reviewer for that disclosure.

Institution: Any public or private organization, domestic or foreign (excluding a federal agency) that is applying for or receives PHS/NIH research funding.

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 research funded by PHS/NIH or proposed for such funding, which may include collaborators or consultants. The Institution determines who is responsible for the design, conduct, or reporting of PHS/NIH-funded research based on the individual’s role and degree of independence in carrying out the work.

Manage: Taking action to address a financial conflict of interest, which can include reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.

Research: A systematic investigation, study, or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health. The term encompasses basic and applied research and product development, including development of medical imaging software, MRI or PET image-processing methods, quantitative imaging biomarkers, diagnostic tests, or medical devices.

PHS-Funded Research: Any activity supported by a Public Health Service (PHS) Awarding Component through a grant, cooperative agreement, or contract, whether funded under the PHS Act or other statutory authority.

PHS: The Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH).

NIH: The biomedical research agency within the Public Health Service (PHS) that funds and conducts research to improve health and advance scientific knowledge.

Senior/Key Personnel: The PD/PI and any other individual identified as senior/key personnel by the Institution in a grant application, progress report, or any other report submitted to PHS/NIH. For this policy, the term applies specifically to the public accessibility requirement described in Section 9.

4. Significant Financial Interest (SFI) Disclosure Requirements

A Significant Financial Interest (SFI) means a domestic or foreign (non-U.S.) financial interest consisting of one or more of the following interests of the Investigator, and those of the Investigator’s spouse, domestic partner, and dependent children, that reasonably appears to be related to the Investigator’s institutional responsibilities performed on behalf of MICSI:

• Publicly traded entity: An SFI exists if the total of remuneration received from the entity in the previous 12 months and the value of any equity interest in the entity on the disclosure date exceeds $5,000. Remuneration includes salary and payments for services, such as consulting fees, honoraria, or paid authorship.
• Non-publicly traded entity: An SFI exists if the aggregated value of remuneration received from the entity in the 12 months preceding the disclosure exceeds $5,000, or if the Investigator, spouse, domestic partner, or dependent children hold any equity interest in the entity.
• Intellectual property: An SFI exists if receipt of income related to intellectual property rights or interests, such as patents or copyrights, exceeds $5,000 during the 12 months preceding the disclosure.
• Sponsored or reimbursed travel: Investigators must disclose any reimbursed or sponsored travel related to their institutional responsibilities with a value exceeding $5,000. Such travel includes trips paid on behalf of the Investigator rather than reimbursed directly, where the exact cost may not be known. The disclosure must cover the previous 12 months and include, at minimum, the purpose, sponsor or organizer, destination, and duration of each trip.

The 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; an academic teaching hospital; a medical center; or a research institute affiliated with a United States Institution of Higher Education.

The term “significant financial interest” does not include the following types of financial interests; therefore, Investigators are not required to disclose the following:

• Salary, royalties, or other remuneration paid by MICSI to the Investigator if the Investigator is currently employed or otherwise appointed by MICSI, including intellectual property rights assigned to MICSI and any agreements to share royalties related to those rights.
• Any ownership interest in MICSI held by the Investigator, since MICSI is a commercial or for-profit organization. This exclusion applies only if the applicant or recipient, including a subrecipient, is a for-profit or commercial institution.
• Income from investment vehicles such as mutual funds and retirement accounts, provided the Investigator does not directly control the investment decisions for those vehicles.
• Income from seminars, lectures, or teaching engagements sponsored by a U.S. federal, state, or local government agency, a U.S. institution of higher education, an academic teaching hospital, a medical center, or a research institute affiliated with a U.S. institution of higher education.
• Income from service on advisory committees or review panels for a U.S. federal, state, or local government agency, a U.S. institution of higher education, an academic teaching hospital, a medical center, or a research institute affiliated with a U.S. institution of higher education.

Foreign Financial Interests: Investigators must disclose all financial interests originating outside the United States, including income from seminars, lectures, teaching engagements, service on advisory committees or review panels, and reimbursed or sponsored travel received from any foreign entity. This includes foreign institutions of higher education and foreign governments, including local or provincial governments. Disclosure is required when the aggregated amount of such income meets the threshold for disclosure (e.g., income in excess of $5,000).

Investigators will disclose their SFIs that are related to their institutional responsibilities as defined in this policy. The disclosure will not be limited to an Investigator’s research responsibilities or their funded research, as this is too narrow in scope and not consistent with the 2011 regulation. Investigator SFI disclosures will be retained by MICSI as part of its record maintenance requirements.

Investigators are required to disclose SFIs at the following times:

• At the time of application: The PI and all other individuals who meet the definition of Investigator must disclose their SFIs to the DO. Any new Investigator who joins the project after the NIH application has been submitted or during the course of the research must also disclose SFIs promptly and before participating in the project.
• Annual disclosure: Each Investigator participating in research under an NIH award must submit an updated SFI disclosure at least annually as prescribed by MICSI, on or before July 1st, during the award period. The annual disclosure must include any new information not previously disclosed and updated details for any previously disclosed SFI.
• Ad hoc basis during the award: Each Investigator participating in PHS/NIH-funded research must submit an updated SFI disclosure within 30 days of discovering or acquiring a new SFI, including through purchase, marriage, domestic partnership, inheritance, or another change in circumstances. Updated disclosure of reimbursed or sponsored travel must also be submitted within 30 days of each occurrence.

5. Review of SFI Disclosures

The DO is responsible for reviewing all SFI disclosures. Each SFI will be evaluated in relation to every PHS/NIH research application or award on which the Investigator is responsible for the design, conduct, or reporting of research, to determine whether the SFI is related to the funded research and, if so, whether it constitutes an FCOI.

• Prior to the issuance of a new award or before any expenditure of awarded funds: The DO will review the Investigator’s SFIs before NIH issues a new award, including during the Just-in-Time stage where applicable. If an FCOI is identified, an FCOI report will be submitted to NIH via the eRA Commons FCOI Module prior to any expenditure of funds.
• Annual SFI disclosure: As part of the annual disclosure process, Investigators must provide updated information on any previously disclosed SFIs. The DO will review these updates to determine whether changes to an existing management plan are needed.
• Ad hoc basis during award period: If a new Investigator joins a project or an existing Investigator acquires or discovers a new SFI during the project, the DO will, within 60 days, review the disclosure, determine whether the SFI is related to the PHS/NIH-funded research, determine whether an FCOI exists, and, if so, implement at least an interim management plan.

An FCOI report will be submitted to NIH within 60 days of identifying the FCOI.

6. Relatedness of SFIs to PHS/NIH-Funded Research and FCOI

The DO is responsible for assessing the relatedness of SFIs to NIH-funded research and determining when they constitute an FCOI. An SFI is considered related when the DO reasonably determines that the SFI could be affected by the PHS/NIH-funded research, or the SFI is in an entity whose financial interests could be affected by the PHS/NIH-funded research. The DO may consult with the Investigator when assessing whether an SFI is related to the research.

An FCOI exists when the DO reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS/NIH-funded research, with “significantly” meaning that the financial interest would have a material effect on the research.

7. Management of SFIs that Pose an FCOI

When an FCOI is identified, the DO will determine and implement management strategies to ensure the research is conducted objectively. Examples of management conditions include, but are not limited to:

• Public disclosure of the FCOI, for example in publications or presentations, to study personnel, to the IRB, IACUC, or Data Safety Monitoring Board.
• For human subjects research, disclosure of the FCOI to participants in the informed consent document.
• Appointment of an independent monitor to protect against bias in the design, conduct, and reporting of the research.
• Modification of the research plan.
• Change of personnel roles or removal from portions of the research.
• Reduction or elimination of the financial interest, such as divesting equity.
• Severance of relationships that create financial conflicts.

The DO will communicate the determination and management plan in writing to the Investigator, the PD/PI, and the appropriate supervisor or responsible MICSI officer. No expenditures on an NIH award may occur until the Investigator has met all disclosure requirements and agreed in writing to comply with the management plan.

8. Monitoring Investigator Compliance

MICSI and its DO will monitor Investigator compliance with the management plan for the duration of the NIH award. As part of this monitoring process, the DO may request and review documentation demonstrating compliance with required FCOI disclosures, including publications, presentation materials, abstracts, posters, and written communications to study personnel. Investigators must provide copies of such materials, including relevant emails or other written disclosures, to the DO for recordkeeping.

9. Public Accessibility of the FCOI Policy and FCOIs Held by Senior/Key Personnel

FCOI Policy: A copy of this FCOI policy is available on https://www.micsi.com/compliance-trust/ as required by Section 4.1.10 Financial Conflict of Interest of the NIH Grants Policy Statement.

Identified FCOIs held by Senior/Key Personnel: Before any funds are spent under an NIH award, MICSI will ensure public accessibility by providing a written response within five business days to requests for information about any SFI that meets all three of the following criteria:

• The SFI was disclosed and is still held by Senior/Key Personnel, meaning the PD/PI and any other individual identified by MICSI as senior/key personnel in the application, progress report, or other NIH submission.
• MICSI has determined that the SFI is related to the NIH-funded research.
• MICSI has determined that the SFI constitutes an FCOI.

When applicable, MICSI will make available at least the Investigator’s name, Investigator’s title and role with respect to the research project, name of the entity in which the SFI is held, nature of the SFI, and approximate dollar value of the SFI in the regulatory ranges. The written response will note 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 60 days of MICSI’s identification of a new FCOI.

If MICSI uses a publicly accessible website to meet this requirement, the information will be updated at least annually and within 60 days of receiving or identifying an additional SFI of Senior/Key Personnel related to the NIH-funded research, or upon disclosure of an SFI by Senior/Key Personnel joining the project that is determined to be related and an FCOI. Information on SFIs subject to public accessibility will remain available for at least three years from the most recent update.

10. Reporting Identified Financial Conflicts of Interest

Prior to spending any funds under an NIH-funded award, MICSI will submit an identified FCOI report to NIH, in accordance with NIH regulations, for any Investigator’s SFI determined to be an FCOI. MICSI will also ensure that the Investigator has agreed to and begun implementing the associated management plan.

MICSI will designate an institutional official to act as the FCOI Signing Official (FCOI SO) in the eRA Commons FCOI Module. The FCOI SO is authorized to submit FCOI reports to NIH. FCOI reports are submitted only when an award is active and an FCOI has been identified.

• Initial FCOI Reports: Submitted before any funds are spent or within 60 days of identifying an FCOI during an ongoing award.
• Annual FCOI Reports: Submitted for the duration of an award, including extensions with or without funds, at the same time as the Research Performance Progress Report (RPPR) or multi-year progress report.
• Revision or Mitigation FCOI Reports: Submitted after completing a retrospective review if new information about the FCOI is discovered, or if the review finds that bias has occurred.

11. Training Requirements for Investigators

Each Investigator will be informed of MICSI’s FCOI Policy and trained on their responsibility to disclose foreign and domestic SFIs under this policy and the FCOI regulation at 42 CFR Part 50 Subpart F. Training must be completed before an Investigator engages in PHS/NIH-funded research, at least once every four years, and promptly when MICSI revises this policy in a way that affects Investigator requirements, an Investigator is new to MICSI research under an NIH award, or MICSI determines that an Investigator has not complied with this policy or with a management plan issued under it.

To meet the NIH training requirement, MICSI requires Investigators to complete the NIH FCOI Training and retain the Completion Certificate for audit purposes. The certificate should be shared with the DO. MICSI also requires Investigators to review the NIH Virtual Seminar presentation on FCOI compliance.

12. Noncompliance With FCOI Policy and Corrective Actions

Whenever MICSI identifies an SFI that was not disclosed timely by an Investigator or was not previously reviewed during an ongoing PHS/NIH-funded research project, including because it was not timely reviewed or reported by a subrecipient, the DO will within 60 days review the SFI, determine whether it is related to NIH-funded research, determine whether an FCOI exists, and, if so, implement at least an interim management plan. MICSI will also submit an FCOI report to NIH via the eRA Commons FCOI Module.

Whenever an FCOI is not identified or managed in a timely manner, including failure by the Investigator to disclose an SFI that is later determined to constitute an FCOI, failure by MICSI to review or manage an FCOI, or failure by the Investigator to comply with an established management plan, MICSI will, within 120 days of determining noncompliance, complete and document a retrospective review of the Investigator’s activities and the NIH-funded research to determine whether the research, or any part of it, was biased in the design, conduct, or reporting.

If bias is found, MICSI will promptly notify NIH and submit a mitigation report. The report will include the impact of the bias on the research project and the plan of action or corrective steps taken to eliminate or mitigate the effect of the bias. MICSI may determine that additional interim measures are necessary with regard to the Investigator’s participation in the NIH-funded research project while the retrospective review is pending.

13. Clinical Research Requirements

If HHS determines that a PHS-funded clinical research project evaluating the safety or effectiveness of medical imaging software, MRI or PET image-processing methods, quantitative imaging biomarkers, diagnostic tests, or medical devices was designed, conducted, or reported by an Investigator with an unmanaged or unreported FCOI, MICSI will require the Investigator to disclose the conflict in every public presentation of the research results and to request an addendum to previously published presentations.

14. Subrecipient Requirements

A subrecipient relationship exists when federal funds flow from or through MICSI to another individual or entity that will carry out a substantive portion of a PHS-funded research project and is accountable to MICSI for programmatic outcomes and compliance.

Subrecipients, including collaborators, consortium members, consultants, contractors, subcontractors, and subawardees, are subject to MICSI’s terms and conditions. MICSI will take reasonable steps to ensure that all subrecipient Investigators comply with the federal FCOI regulations at 42 CFR Part 50 Subpart F. MICSI will include in each written agreement with a subrecipient terms specifying whether MICSI’s FCOI Policy or the subrecipient’s own FCOI policy will apply to subrecipient Investigators.

• If the subrecipient’s FCOI policy applies: The subrecipient institution must certify in the agreement that its policy complies with federal FCOI regulations. The agreement will specify the timeframe for the subrecipient to report identified FCOIs to MICSI in time for MICSI to meet NIH reporting deadlines, typically within 50-55 days of identification.
• If the subrecipient cannot certify compliance: The agreement will specify that MICSI’s FCOI Policy applies. Subrecipient Investigators must disclose SFIs directly related to the subrecipient’s work for MICSI, and MICSI will review, manage, monitor, and report any resulting FCOIs as required.

15. Maintenance of Records

MICSI will maintain all records of Investigator financial interest disclosures and MICSI’s review of, and response to, such disclosures, whether or not a disclosure resulted in a determination of an FCOI, and all actions under this policy or retrospective review, if applicable, for at least three years from the date the final expenditures report is submitted to PHS/NIH or, where applicable, from other dates specified in 2 CFR 200.334. Copies of Investigator management plans will be retained as part of MICSI’s records and not submitted to NIH except as required or requested, consistent with NIH guidance.

16. Enforcement Actions for Investigator Noncompliance and Remedies for Noncompliance

Compliance with this policy is a condition of employment, appointment, contract, and/or participation for all applicable Investigators. Investigators who fail to comply may be subject to disciplinary action, which can include termination of employment or contract, formal warning letter or official notice of disciplinary action, restrictions on the use of research funds, and/or disqualification from further participation in any PHS/NIH-funded research, as deemed appropriate.

The PHS/NIH Awarding Component and/or HHS may inquire at any time before, during, or after award into any Investigator disclosure of financial interests and MICSI’s review, including any retrospective review, and response to such disclosure. MICSI will submit, or permit on-site review of, all records pertinent to compliance with the regulation and this policy. The PHS/NIH Awarding Component may determine that imposition of specific award conditions under 2 CFR 200.208, or suspension of funding or other enforcement action under 2 CFR 200.339, is necessary until the matter is resolved.

17. Useful FCOI and NIH Resources

• NIH email address for FCOI-related inquiries: fc************@******ih.gov
• FCOI Regulation 42 CFR Part 50 Subpart F – Promoting Objectivity in Research: eCFR 42 CFR Part 50 Subpart F
• NIH Financial Conflict of Interest website: NIH FCOI policy page
• NIH FCOI Training: NIH FCOI Training
• NIH FCOI Frequently Asked Questions: NIH FCOI FAQs
• NIH Grants Policy Statement Section 4.1.10 Financial Conflict of Interest: NIH GPS Section 4.1.10

18. Point Of Contact

If you have a question related to the FCOI Policy of MICSI, or would like to request information related to an identified FCOI, contact us using the information below:

Contact:
Research Compliance
Microstructure Imaging, Inc.
in**@***si.com