ViVita Technologies, Inc. (“ViVita”) is committed to conducting research with the highest scientific and ethical standards. It is critical that the design, conduct, and reporting of research be free from bias due to any financial conflict of interest (FCOI) of the Investigators. ViVita has established a FCOI policy in accordance with the Public Health Service (PHS) and National Institutes of Health (NIH) (42 CFR 50, Subpart F — Promoting Objectivity in Research) containing standards and procedures to identify, manage, reduce, or eliminate FCOI.
DEFINITIONS
Financial conflict of interest (FCOI)—A significant financial interest that could directly and significantly affect the design, conduct, or reporting of research.
Investigator—Any person (regardless of title or position) who is responsible for the design, conduct, or reporting of research (both PHS and non-PHS sponsored). This includes the project director/principal investigator, employees, collaborators, consultants, and/or subrecipient employees.
Significant Financial Interests (SFIs)--
Subrecipient—A non-Federal entity that receives a subaward from a pass-through entity to carry out part of a Federal program; but does not include an individual that is a beneficiary of such program. A subrecipient may also be a recipient of other Federal awards directly from a Federal awarding agency. The term includes consortium participants.
TRAINING REQUIREMENTS
In compliance with 42 CFR 50.604(b)
Every ViVita Investigator must complete FCOI training, comprised of:
Investigators are required to complete FCOI training:
DISCLOSURE, REVIEW, AND MONITORING REQUIREMENTS
In compliance with 42 CFR 50.603, 42 CFR 50.604(e)(1)-(3), 42 CFR 50.604(d), 42 CFR 50.604(f), 42 CFR 50.605(a)(1), 42 CFR 50.605(a)(2), 42 CFR 50.605(a)(3) and (i) – (iii), 42 CFR 50.604 (g), and
42 CFR 50.605(a)(4)
Every ViVita Investigator is required to disclose their Significant Financial Interests (SFIs) (and those of their spouse and dependent children) that reasonably appear related to the Investigator’s institutional responsibilities that meet of exceed the regulator definition of SFI:
A designated Institutional FCOI official will solicit and review SFI disclosures of the Investigator (and those of their spouse and dependent children) that reasonably appear related to the Investigator’s institutional responsibilities for determination of FCOI. Guidelines consistent with the regulation (42 CFR 50.604(f)) will be provided to the designated Institutional FCOI official to determine whether an Investigator’s SFI is related to PHS/NIH-funded research and, if so related, whether the SFI is an FCOI.
NOTE: An SFI is related to PHS/NIH-funded research when ViVita, through its designated Institutional FCOI official, reasonably determines that the SFI:
The Investigator may be involved in making the determination of whether the SFI is related to the PHS/NIH-funded research. A FCOI exists when ViVita, through its designated Institutional FCOI official, reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS/NIH-funded research. Management of FCOI will occur in accordance with NIH’s FAQ F.1 ; imposed conditions or restrictions might include:
Prior to expenditure of funds, the designated Institutional FCOI official is required to:
If an Investigator is newly participating in the research project or an existing Investigator discloses a new SFI, the designated Institutional FCOI official will have sixty (60) days to review disclosures of SFIs, determine whether the SFI is related to PHS/NIH-funded research, determine whether an 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.
If ViVita identifies an SFI that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed during an ongoing PHS/NIH-funded research project (e.g., was not timely reviewed or reported by a subrecipient), the designated Institutional FCOI official shall within sixty (60) days review disclosures of SFIs, determine whether the SFI is related to PHS/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 such FCOI going forward.
ViVita will take such actions as necessary to manage FCOIs, including any financial conflicts of a subrecipient Investigator, if applicable, and monitor Investigator compliance with management plans until completion of the project.
REPORTING REQUIREMENTS TO NIH
In compliance with 42 CFR 50.604(h), 42 CFR 50.605(b), 42 CFR 50.605(a)(3)(iii), and 42 CFR 50.606(a)
Initial, annual (i.e., ongoing), and revised FCOI reports, including all required information defined in the regulation and/or NIH’s FAQ H.5, will be submitted to the NIH via the eRA Commons FCOI Module for the Institution and its subrecipients, if applicable, as required by the regulation and as stated below:
If bias has been found with the design, conduct, or reporting of PHS/NIH-funded research:
If an Investigator fails to comply with the FCOI policy or a FCOI management plan appears to have biased the design, conduct, or reporting of the PHS/NIH-funded research:
MAINTENANCE OF RECORDS
In compliance with 42 CFR 50.604(i)
ViVita will maintain all FCOI-related records relating to all Investigator disclosures of financial interests and the Institution’s review of, and response, to such disclosures (whether or not a disclosure resulted in the Institution’s determination of a financial conflict of interest) and all actions under the Institution’s policy or retrospective review, if applicable,:
ENFORCEMENT MECHANISMS AND REMEDIES AND NONCOMPLIANCE
In compliance with 42 CFR 50.604(j), 42 CFR 50.605(a)(3), 42 CFR 50.605(a)(3)(ii)(B), and 42 CFR 50.606(c)
If an Investigator does not comply with the FCOI policy, they will be subject to sanctions and administrative actions, including cessation of work related to PHS-funded research, suspension, or dismissal, depending on the severity of the noncompliance and efforts to restore compliance. The CEO will determine any sanctions or administrative actions imposed on an Investigator and will document such actions, along with the underlying noncompliance and necessary corrective actions, in writing for the Investigator. Investigators will have the right to appeal any sanctions or administrative actions. Written appeals will be reviewed by the CEO within 5 days of reception. The CEO will inform the PHS-funding agency of any Investigator noncompliance and corrective actions taken.
If an Investigator does not timely disclose a SFI or FCOI, ViVita does not review or manage a FCOI in a timely manner, or an Investigator does not comply with the FCOI management plan, a retrospective review will be conducted and documented within 120 days of the date on which the noncompliance was identified. The content of the retrospective review (see FAQs in Section I) will include:
In any case in which the Department of Health and Human Services determines that a PHS-funded research project at ViVita involving 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 an FCOI that was not managed or reported by ViVita as required by the regulation, ViVita shall require the Investigator involved to:
SUBRECIPIENT REQUIREMENTS
In compliance with 42 CFR 50.604(c), NIH Grants Policy Statement 15.2.1, and 42 CFR 50.604(c)(1)(i)-(iii)
Any subrecipients that engage in activities related to PHS-funded research performed by ViVita will be required to:
PUBLIC ACCESSIBILITY REQUIREMENTS
In compliance with 42 CFR 50.604(a), NIH GPS 4.1.10, and 42 CFR 50.605(a)(5)(i)-(iv)
The designated Institutional FCOI official will ensure that the up-to-date FCOI policy is posted in a publicly accessible section of the ViVita website. Information concerning identified FCOIs held by senior/key personnel (as defined by 42 CFR 50.605(a)(5)(i)-(iv)) will be made publicly accessible prior to the expenditure of funds. This information will contain the following minimum elements as defined by the regulation:
The information will be posted in a publicly accessible section of the ViVita website or made available within five (5) business days of a written request. Information posted to the website will be updated at least annually. Information for newly identified FCOI will be updated on the website within sixty (60) days of the identification. Responses to written requests will contain up-to-date information. Information will remain available for three (3) years from the date the information was most recently updated.
DEFINITIONS
Financial conflict of interest (FCOI)—A significant financial interest that could directly and significantly affect the design, conduct, or reporting of research.
Investigator—Any person (regardless of title or position) who is responsible for the design, conduct, or reporting of research (both PHS and non-PHS sponsored). This includes the project director/principal investigator, employees, collaborators, consultants, and/or subrecipient employees.
Significant Financial Interests (SFIs)--
- 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:
- With regard to any publicly traded entity, a SFI exists if the value of any remuneration received from the entity in the twelve (12) 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
- With regard to any non-publicly traded entity, a SFI exists if the value of any remuneration received from the entity in the twelve (12) 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
- Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
- 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; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a federal, state, or local government agency, an 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 an Institution of higher education. Disclosure, which will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. In accordance with the FCOI policy, the designated Institutional FCOI official 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.
- The term significant financial interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by ViVIta to the Investigator if the Investigator is currently employed or otherwise appointed by ViVita, including intellectual property rights assigned to ViVita and agreements to share in royalties related to such rights; any ownership interest in ViVIta held by the Investigator; 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; income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an 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 an Institution of higher education; or income from service on advisory committees or review panels for a federal, state, or local government agency, an 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 an Institution of higher education.
Subrecipient—A non-Federal entity that receives a subaward from a pass-through entity to carry out part of a Federal program; but does not include an individual that is a beneficiary of such program. A subrecipient may also be a recipient of other Federal awards directly from a Federal awarding agency. The term includes consortium participants.
TRAINING REQUIREMENTS
In compliance with 42 CFR 50.604(b)
Every ViVita Investigator must complete FCOI training, comprised of:
- Review of ViVita’s FCOI policy (which includes the Investigator’s disclosure responsibilities)
- Review of Federal regulation: NIH’s Frequently Asked Questions (FAQs) L.1
- Completion of NIH’s FCOI Training tutorial
- Upon completion of the training, a certificate of completion must be submitted electronically via email to the FCOI Institutional officer. The Investigator should retain a copy for their records.
Investigators are required to complete FCOI training:
- Prior to engaging in any research
- At least every four (4) years
- Immediately, if:
- an Investigator is new to ViVita
- ViVita revises the FCOI policy
- an Investigator is not in compliance with FCOI policy or management plan
DISCLOSURE, REVIEW, AND MONITORING REQUIREMENTS
In compliance with 42 CFR 50.603, 42 CFR 50.604(e)(1)-(3), 42 CFR 50.604(d), 42 CFR 50.604(f), 42 CFR 50.605(a)(1), 42 CFR 50.605(a)(2), 42 CFR 50.605(a)(3) and (i) – (iii), 42 CFR 50.604 (g), and
42 CFR 50.605(a)(4)
Every ViVita Investigator is required to disclose their Significant Financial Interests (SFIs) (and those of their spouse and dependent children) that reasonably appear related to the Investigator’s institutional responsibilities that meet of exceed the regulator definition of SFI:
- No later than at the time of application for PHS/NIH-funded research (see FAQ D.35)
- At least annually during the period of the award
- Within thirty (30) days of discovering or acquiring a new SFI (i.e., through marriage, inheritance, or purchase)
A designated Institutional FCOI official will solicit and review SFI disclosures of the Investigator (and those of their spouse and dependent children) that reasonably appear related to the Investigator’s institutional responsibilities for determination of FCOI. Guidelines consistent with the regulation (42 CFR 50.604(f)) will be provided to the designated Institutional FCOI official to determine whether an Investigator’s SFI is related to PHS/NIH-funded research and, if so related, whether the SFI is an FCOI.
NOTE: An SFI is related to PHS/NIH-funded research when ViVita, through its designated Institutional FCOI official, reasonably determines that the SFI:
- Could be affected by the PHS/NIH-funded research; or
- Is in an entity whose financial interest could be affected by the research
The Investigator may be involved in making the determination of whether the SFI is related to the PHS/NIH-funded research. A FCOI exists when ViVita, through its designated Institutional FCOI official, reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS/NIH-funded research. Management of FCOI will occur in accordance with NIH’s FAQ F.1 ; imposed conditions or restrictions might include:
- Full public disclosure
- Appointment of an independent monitor
- Modification of the research plan
Prior to expenditure of funds, the designated Institutional FCOI official is required to:
- Review all Investigator SFI disclosures
- Determine if any SFIs relate to PHS/NIH-funded research
- Determine if an FCOI exists (e.g., the SFI that could directly and significantly affect the design, conduct, or reporting of the NIH-funded research)
- Develop and implement a management plan to manage the FCOI(s)
If an Investigator is newly participating in the research project or an existing Investigator discloses a new SFI, the designated Institutional FCOI official will have sixty (60) days to review disclosures of SFIs, determine whether the SFI is related to PHS/NIH-funded research, determine whether an 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.
If ViVita identifies an SFI that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed during an ongoing PHS/NIH-funded research project (e.g., was not timely reviewed or reported by a subrecipient), the designated Institutional FCOI official shall within sixty (60) days review disclosures of SFIs, determine whether the SFI is related to PHS/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 such FCOI going forward.
ViVita will take such actions as necessary to manage FCOIs, including any financial conflicts of a subrecipient Investigator, if applicable, and monitor Investigator compliance with management plans until completion of the project.
REPORTING REQUIREMENTS TO NIH
In compliance with 42 CFR 50.604(h), 42 CFR 50.605(b), 42 CFR 50.605(a)(3)(iii), and 42 CFR 50.606(a)
Initial, annual (i.e., ongoing), and revised FCOI reports, including all required information defined in the regulation and/or NIH’s FAQ H.5, will be submitted to the NIH via the eRA Commons FCOI Module for the Institution and its subrecipients, if applicable, as required by the regulation and as stated below:
- Prior to the expenditure of funds
- Within sixty (60) days of identification for an Investigator who is newly participating in the project
- Within sixty (60) days for new, or newly identified, FCOIs for existing Investigators
- At least annually (at the same time as when ViVita is required to submit the annual progress report, multi-year progress report, if applicable, or at time of extension). The annual report will provide the status of the FCOI and any changes to the management plan, if applicable, until the completion of the project.
- After a retrospective review to update a previously submitted report, if new information is discovered following completion of the review.
If bias has been found with the design, conduct, or reporting of PHS/NIH-funded research:
- The NIH will be promptly notified
- A Mitigation Report to explain what action(s) have been or will be taken to mitigate the effects of the bias in accordance with the regulation will be submitted. As required by the regulation, the following reporting elements will be included:
- Name of the investigator with the FCOI
- Name of the entity with which the investigator has an FCOI
- Nature of the SFI
- Value of the financial interest
- Description of how the financial interest relates to the NIH-funded research and why the Institution determined that the financial interest conflicts with such research
- Description of the key elements of the institution’s management plan, including other required information
If an Investigator fails to comply with the FCOI policy or a FCOI management plan appears to have biased the design, conduct, or reporting of the PHS/NIH-funded research:
- The NIH will be promptly notified
- Corrective action will be taken
MAINTENANCE OF RECORDS
In compliance with 42 CFR 50.604(i)
ViVita will maintain all FCOI-related records relating to all Investigator disclosures of financial interests and the Institution’s review of, and response, to such disclosures (whether or not a disclosure resulted in the Institution’s determination of a financial conflict of interest) and all actions under the Institution’s policy or retrospective review, if applicable,:
- For at least three (3) years from the date the final expenditures report is submitted to the PHS (NIH).
- Or, where applicable, from other dates specified in 45 CFR 75.361 for different situations.
ENFORCEMENT MECHANISMS AND REMEDIES AND NONCOMPLIANCE
In compliance with 42 CFR 50.604(j), 42 CFR 50.605(a)(3), 42 CFR 50.605(a)(3)(ii)(B), and 42 CFR 50.606(c)
If an Investigator does not comply with the FCOI policy, they will be subject to sanctions and administrative actions, including cessation of work related to PHS-funded research, suspension, or dismissal, depending on the severity of the noncompliance and efforts to restore compliance. The CEO will determine any sanctions or administrative actions imposed on an Investigator and will document such actions, along with the underlying noncompliance and necessary corrective actions, in writing for the Investigator. Investigators will have the right to appeal any sanctions or administrative actions. Written appeals will be reviewed by the CEO within 5 days of reception. The CEO will inform the PHS-funding agency of any Investigator noncompliance and corrective actions taken.
If an Investigator does not timely disclose a SFI or FCOI, ViVita does not review or manage a FCOI in a timely manner, or an Investigator does not comply with the FCOI management plan, a retrospective review will be conducted and documented within 120 days of the date on which the noncompliance was identified. The content of the retrospective review (see FAQs in Section I) will include:
- Project Number
- Project Title
- PD/PI or contact PD/PI if multiple PD/PI model is used;
- Name of the Investigator with the FCOI;
- Name of the entity with which the Investigator has an FCOI;
- Reasons for the retrospective review;
- Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documentation reviewed);
- Findings of the review; and
- Conclusions of the review
In any case in which the Department of Health and Human Services determines that a PHS-funded research project at ViVita involving 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 an FCOI that was not managed or reported by ViVita as required by the regulation, ViVita shall require the Investigator involved to:
- Disclose the FCOI in each public presentation of the results of the research
- To request an addendum to previously published presentations
SUBRECIPIENT REQUIREMENTS
In compliance with 42 CFR 50.604(c), NIH Grants Policy Statement 15.2.1, and 42 CFR 50.604(c)(1)(i)-(iii)
Any subrecipients that engage in activities related to PHS-funded research performed by ViVita will be required to:
- Complete a written agreement declaring whether the subrecipient will follow the FCOI policy of ViVita or the FCOI policy of the subrecipient
- If applicable, obtain a certification from the subrecipient that its FCOI policy complies with the regulation
- If applicable, include in the written subrecipient agreement a requirement for the subrecipient to report identified FCOIs for its Investigators in a time frame that allows ViVita to report identified FCOIs to the NIH as required by the regulation
- Alternatively, if applicable, include in the written agreement a requirement to solicit and review subrecipient Investigator disclosures that enable ViVita to identify, manage and report identified FCOIs to the NIH
PUBLIC ACCESSIBILITY REQUIREMENTS
In compliance with 42 CFR 50.604(a), NIH GPS 4.1.10, and 42 CFR 50.605(a)(5)(i)-(iv)
The designated Institutional FCOI official will ensure that the up-to-date FCOI policy is posted in a publicly accessible section of the ViVita website. Information concerning identified FCOIs held by senior/key personnel (as defined by 42 CFR 50.605(a)(5)(i)-(iv)) will be made publicly accessible prior to the expenditure of funds. This information will contain the following minimum elements as defined by the regulation:
- Investigator's name
- Investigator's title and role with respect to the research project
- Name of the entity in which the significant financial interest is held
- Nature of the significant financial interest
- Approximate dollar value of the significant 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
The information will be posted in a publicly accessible section of the ViVita website or made available within five (5) business days of a written request. Information posted to the website will be updated at least annually. Information for newly identified FCOI will be updated on the website within sixty (60) days of the identification. Responses to written requests will contain up-to-date information. Information will remain available for three (3) years from the date the information was most recently updated.
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ViVita Technologies, Inc. 2018
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