Financial Conflict Of Interest Policy

INTRODUCTION 

This policy governing financial conflict of interest for Voxel Healthcare LLC (the “Company”) applies to all HHS-sponsored Investigators of the Company. The Company Official is responsible for ensuring implementation of this policy and may suspend all relevant activities until the financial conflict of interest is resolved or other action deemed appropriate by the Company official is implemented.  Violation of any part of these policies may also constitute cause for disciplinary or other administrative action pursuant to Company policy.  

DEFINITIONS 

Clinical Trial means any HHS-sponsored research study that involves interaction with human subjects and the concurrent investigative use of drugs, biologics, devices or medical or other clinical procedures, such as surgery.  

Family means any member of the Investigator’s immediate family, specifically, any dependent children and spouse. 

Financial Interest means anything of monetary value received or held by an Investigator or an Investigator’s Family, whether or not the value is readily ascertainable, including, but not limited to: salary or other payments for services (e.g., consulting fees, honoraria, or paid authorships for other than scholarly works); any equity interests (e.g., stocks, stock options, or other ownership interests); and intellectual property rights and interests (e.g., patents, trademarks, service marks, and copyrights), upon receipt of royalties or other income related to such intellectual property rights and interests. 

Financial Interest does NOT include:  

  1. salary, royalties, or other remuneration from the Company; 
  1. income from the authorship of academic or scholarly works; 
  1. income from seminars, lectures, or teaching engagements sponsored by or from advisory committees or review panels for U.S. Federal, state or local governmental agencies; U.S. institutions of higher education; research institutes affiliated with institutions of higher education, academic teaching hospitals, and medical centers; or 
  1. equity interests or income from investment vehicles, such as mutual funds and retirement accounts, so long as the Investigator does not directly control the investment decisions made in these vehicles. 

For Investigators, Financial Interest also includes any reimbursed or sponsored travel above $5,000 undertaken by the Investigator and related to his/her company responsibilities.  This includes travel that is paid on behalf of the Investigator as well as travel that is reimbursed, even if the exact monetary value is not readily available.  It excludes travel reimbursed or sponsored by U.S. Federal, state or local governmental agencies, U.S. institutions of higher education, research institutes affiliated with institutions of higher education, academic teaching hospitals, and medical centers. 

Significant Financial Interest means a Financial Interest that reasonably appears to be related to the Investigator’s Company Responsibilities, and: 

  1. if with a publicly traded entity, the aggregate value of any salary or other payments for services received during the 12-month period preceding the disclosure, and the value of any equity interest during the 12-month period preceding or as of the date of disclosure, exceeds $5,000; or 
  1. if with a non-publicly traded entity, the aggregate value of any salary or other payments for services received during the 12-month period preceding the disclosure exceeds $5,000; or 
  1. if with a non-publicly-traded company, is an equity interest of any value during the 12-month period preceding or as of the date of disclosure; or 
  1. is income exceeding $5,000 related to intellectual property rights and interests not reimbursed through the Company, or 
  1. is reimbursed or sponsored travel in excess of $5,000 related to their Company responsibilities. 

 Financial Conflict of Interest means a Significant Financial Interest (or, where the Company official requires disclosure of other Financial Interests, a Financial Interest) that the Company reasonably determines could directly and significantly affect the design, conduct or reporting of HHS-sponsored research. 

Company official means the individual within the Company that is responsible for the solicitation and review of disclosures of significant financial interests including those of the Investigator’s Family related to the Investigator’s Company responsibilities.  For the purposes of this policy, the Company Official is designated as Jaime Stern. 

Company responsibilities means the Investigator’s professional responsibilities associated with his or her Company appointment or position, such as research, teaching, clinical activities, administration, and Company, internal and external professional committee service.   

Investigator means the Principal Investigator (PI) / Program Director (PD) or any individual who is responsible for the design, conduct, or reporting of HHS sponsored research, or proposals for such funding.  This definition is not limited to those titled or budgeted as principal investigator or co-investigator on a particular proposal, and may include postdoctoral associates, senior scientists, or graduate students.  The definition may also include collaborators or consultants as appropriate.  For clarity, any of the following are considered an investigator: the project director/principal investigator or any other employee, collaborator, consultant, or other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the NIH, or reporting of research funded by the NIH.

Health and Human Services or HHS means the Public Health Service of the U.S. Department of Health and Human Services, and any components of the HHS to which the authority of the HHS may be delegated. The components of the HHS include, but are not limited to, the Administration for Children and Families, Administration on Aging, Agency for Healthcare Research and Quality, Agency for Toxic Substances and Disease Registry, Centers for Disease Control and Prevention, Federal Occupational Health, Food and Drug Administration, Health Resources and Services Administration, Indian Health Service, National Institutes of Health, and Substance Abuse and Mental Health Services Administration. 

Research means a systematic investigation, study, or experiment designed to 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). 

CONFLICT OF INTEREST: 

This policy is predicated on the expectation that Investigators should conduct their affairs so as to avoid or minimize conflicts of interest, and so that any and all Investigators must respond appropriately when conflicts of interest arise. To that end, this policy informs Investigators about situations that generate conflicts of interest related to research, provides mechanisms for Investigators and the Company to manage those conflicts of interest that arise, and describes situations that are prohibited.  Every Investigator has an obligation to become familiar with, and abide by, the provisions of this policy. If a situation raising questions of conflict of interest arises, an Investigator should discuss the situation with the Company official.   

1) DISCLOSURE OF FINANCIAL INTERESTS 

All Investigators are required to disclose their outside financial interests as defined above to the Company on an annual and on an ad hoc basis, as described below.  The Company official is responsible for the distribution, receipt, processing, review and retention of disclosure forms.   

a) Annual Disclosures 

All Investigators must disclose their Significant Financial Interests (SFI) that are related to the investigator’s company responsibilities to the Company, through the Company Official, on an annual basis.  All forms should be submitted to the Company official or designee by May 31st of each year.   

b) Ad hoc Disclosures 

In addition to annual disclosure, certain situations require ad hoc disclosure.  All Investigators must disclose their Significant Financial Interests to the Company, through the Company Official, within 30 days of their initial appointment or employment.   

Prior to entering into HHS-sponsored projects or applications for HHS-sponsored projects, where the Investigator has a Significant Financial Interest, the Investigator must affirm the currency of the annual disclosure or submit to the Company Official an ad hoc updated disclosure of his or her Significant Financial Interests with the outside entity.  The Company will not submit a research proposal unless the Investigator(s) have submitted such ad hoc disclosures.   

In addition, all Investigators must submit to the Company official an ad hoc disclosure of any Significant Financial Interest they acquire or discover during the course of the year within thirty (30) days of discovering or acquiring the Significant Financial Interest.   

c) Travel 

Investigators must also disclose reimbursed or sponsored travel related to their company responsibilities, as defined above in the definition of Financial Interest and Significant Financial Interest.  Such disclosures must include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, the duration, and, if known, the monetary value.  The Company Official will determine if additional information is needed (e.g., the monetary value if not already disclosed) to determine whether the travel constitutes a Financial Conflict of Interest with the Investigator’s research.   

2) REVIEW AND DECISION OF THE COMPANY OFFICIAL 

Voxel Healthcare’s company official or a designee will solicit and review disclosures of SFIs of the Investigator (and those of the Investigator’s spouse and dependent children) related to the Investigator’s company responsibilities for determination of FCOI.

i. An SFI is related to PHS-funded research if the company official reasonably determines that the SFI is related to the PHS/NIH-funded research and is an FCOI. An SFI is related to the research if the SFI:

1. Could be affected by the PHS/NIH-funded research; or

2. Is in an entity whose financial interest could be affected by the research.

ii. An Investigator may be involved in making the determination of whether the SFI is related to PHS/NIH-funded research.

iii. An FCOI exists when the company official reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS-funded research.

In the case an SFI is determined to be an FCOI, the company will manage the FCOI at its discretion. This may include full public disclosure of the FCOI (e.g., in presentations, publications, to research personnel working on the study, etc.), appointment of an independent monitor, modification of the research plan, removal of the Investigator from the PHS- funded research, etc. See NIH’s FAQ F.1. for more strategies that may be imposed to manage an FCOI.

3) REPORTING TO HHS 

The Company official will report financial conflicts of interest or non-compliance to HHS in accordance with HHS regulations.  If the funding for the Research is made available from a prime HHS-awardee, such reports shall be made to the prime awardee prior to the expenditure of any funds and within 60 days of any subsequently identified financial conflict of interest such that the prime awardee may fulfill their reporting obligations to the HHS. 

4) INVESTIGATOR NON-COMPLIANCE 

a) Disciplinary Action 

In the event of an Investigator’s failure to comply with this Policy, the Company official may suspend all relevant activities or take other disciplinary action until the matter is resolved or other action deemed appropriate by the Company official is implemented.   

A Company Official’s decision to impose sanctions on an Investigator because of failure to comply with this Policy, or failure to comply with the decision of the Company official, will be described in a written explanation of the decision to the investigator and the Company, and where applicable, an independent ethics review body selected by the Company official, and will notify the individual of the right to appeal the decision.  The Company will promptly notify the HHS Awarding Component of the action taken or to be taken.  If the funding for the research is made available from a prime HHS awardee, such notification shall be made promptly to the prime awardee for reporting to HHS.  

b) Retrospective Review 

In addition, if the Company Official determines that a Significant Financial Interest was not disclosed timely or not previously reviewed or when an 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 the company to constitute an FCOI.

ii.Failure by the company to review or manage an FCOI.

iii.Failure by the Investigator to comply with the FCOI management plan.

The Company Official will complete a retrospective review within sixty (60) days the disclosures of SFIs, determine whether the SFI is related to the Investigator’s NIH-funded research; determine whether an FCOI exists; and if so, implement, at least on an interim basis, a management plan that specifies the actions that have been, and will be taken to manage the FCOI going forward. In all cases where a Financial Conflict of Interest is identified retrospectively after any publication or public presentation is made, an addendum shall be required to be made disclosing the Financial Conflict of Interest to the earlier publication or public presentation, as well as being added to all future publications or public presentations.

Documentation of the retrospective review shall include the project number, project title, PI, name of Investigator with the Financial Conflict of Interest, name of the entity with which the Investigator has the Financial Conflict of Interest, reason(s) for the retrospective review, detailed methodology used for the retrospective review, and findings and conclusions of the review.   

The Company official will update any previously submitted report to the HHS or the prime HHS-awardee relating to the research, specifying the actions that will be taken to manage the Financial Conflict of Interest going forward. This retrospective review will be completed in the manner and within the time frame established in HHS regulations. If bias is found, the Company will promptly notify the HHS Awarding Component and submit a mitigation report in accordance with the HHS regulations.  The mitigation report will identify elements documented in the retrospective review, a description of the impact of the bias on the research project and the plan of action to eliminate or mitigate the effect of the bias. 

5) TRAINING 

a. All Investigators who plan to participate in or are participating in PHS-funded research must be informed of Voxel Healthcare’s FCOI policy, the Federal regulation 42 CFR Part 50 Subpart F, and the Investigator’s responsibility to disclose significant financial interests.

b. Investigators must be trained:

i. Prior to engaging in PHS-funded research.

ii. Every four years, thereafter.

iii. Immediately, if:

• Voxel Healthcare’s FCOI policy is revised.

• Investigator is new to the company.

• Investigator does not comply with the FCOI policy or management plan.

c. Training constitutes Investigators certifying they have read and reviewed:

i. Voxel Healthcare’s Financial Conflict of Interest Policy

ii. NIH’s “FCOI Training” on Regulation 42 CFR Part 50 Subpart F at FCOI Training | grants.nih.gov.

d. The FCOI Policy has been implemented in the following ways:

i. Each Investigator has been provided a written copy;

ii. The FCOI Policy has been added to the company website  

6) RECORD RETENTION 

The Company Official will retain all FCOI-related records relating to all Investigator disclosures of financial interests and the company’s review of and response to such disclosures (regardless of whether a disclosure resulted in the Institution’s determination of an FCOI) and all actions under the Institution’s policy or retrospective review, if applicable, for a period of three years from the date the final expenditure report is submitted to the HHS or to the prime HHS awardee, unless records will also need to be retained from other dates specified in 45 CFR 75.361 for different situations.

7) CONFIDENTIALITY 

To the extent permitted by law, all disclosure forms, conflict management plans, and related information will be confidential.  However, the Company may be required to make such information available to the HHS Awarding Component and/or HHS, to a requestor of information concerning financial conflict of interest related to HHS funding or to the primary entity who made the funding available to the Company, if requested or required. If the Company is requested to provide disclosure forms, conflict management plans, and related information to an outside entity, the Investigator will be informed of this disclosure.  

8) SUBRECIPIENTS 

a. When applicable, Voxel Healthcare will comply with all subrecipient requirements according to 42 CFR 50.604(c) and NIH Grants Policy Statement 15.2.1.

b. Voxel Healthcare will establish, via a written agreement, whether the subrecipient will follow Voxel Healthcare’s FCOI policy or the FCOI policy of the subrecipient. In the case of the latter:

i. Voxel Healthcare will obtain a certification from the subrecipient that its FCOI policy complies with 42 CFR Part 50 Subpart F.

ii. Voxel Healthcare will include in the written subrecipient agreement a requirement for the subrecipient to report identified FCOIs for its Investigators in a time frame that allows the company to report identified FCOIs to the NIH as required by 42 CFR Part 50.605(b)(1) and (2) (i.e., prior to the expenditure of subrecipient funds under a new award or within a certain period of time of identifying an FCOI during the period of award (e.g., 50 days) to allow the institution to report the FCOI to the NIH prior to the 60-day reporting period.

iii. Alternatively, Voxel Healthcare will include in the written subrecipient agreement a requirement to solicit and review subrecipient Investigator disclosures that enable the company to identify, manage, and report identified FCOIs to the NIH.

9) PUBLIC ACCESSIBILITY 

Prior to the expenditure of funds, the Company will publish on a publicly-accessible website or respond to any requestor within five business days of the request, information concerning any Significant Financial Interest that meets the following criteria: 

  1. The Significant Financial Interest was disclosed and is still held by the senior and key personnel; 
  2. A determination has been made that the Significant Financial Interest is related to the HHS-funded research; and 
  3. A determination has been made that the Significant Financial Interest is a Financial Conflict of Interest. 

The information to be made available shall be consistent with the requirements of the HHS regulation.   

10) REGULATORY AUTHORITY 

This policy implements the requirements of 42 CFR 50 Subpart F and 45 CFR 94; where there are substantive differences between this policy and the requirements, the requirements shall take precedence.