Delve is dedicated to maintaining public trust in the integrity of our research-related activities. The identification and responsible management of financial conflicts of interest (FCOI) are crucial both for safeguarding research objectivity and for compliance with federal regulations and Delve policies.
FCOI is defined as a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research. *50.603
A. Purpose and Scope
This policy complies with regulations regarding financial conflicts of interest and allows Delve to identify and manage any such conflicts its designated project staff may be subject to. It applies to all staff members and outside contractors working on designated projects that are PHS funded, including any projects funded by the National Institutes of Health and NCI.
This policy complies with the federal regulation Title 42 Code of Federal Regulations (CFR), Part 50, Subpart F, Promoting Objectivity in Research
This policy shall be posted publicly on the Delve website, www.Delve.com. *50.604(a)
B. Training - *50.604(b)
All staff members, including outside contractors, assigned to work on designated projects shall be trained on this policy prior to beginning work on the designated project.
A refresher training for all staff actively working on a designated project shall be held every four (4) years, and within two weeks of any change to this policy that affects disclosure requirements.
Any staff member working on designated projects found not to be in compliance with this policy, or a conflict management plan established under this policy, shall be trained within two weeks.
Upon completion of training, all staff shall acknowledge training via Delve’s eLearning module and will be maintained by Delve’s human resources department
C. Subcontractor - *50.604(c)
If the Delve carries out the PHS-funded research through a subrecipient (e.g., subcontractors or consortium members), Delve will take reasonable steps to ensure that any subrecipient Investigator complies with 42 CFR, Part 50, Subpart F by:
(1) Incorporating as part of a written agreement with the subrecipient terms that establish whether the financial conflicts of interest policy of the awardee Institution or that of the subrecipient will apply to the subrecipient's Investigators.
(i) If the subrecipient's Investigators must comply with the subrecipient's financial conflicts of interest policy, the subrecipient shall certify as part of the agreement referenced above that its policy complies with 42 CFR, Part 50, Subpart F. If the subrecipient cannot provide such certification, the agreement shall state that subrecipient Investigators are subject to the financial conflicts of interest policy of Delve for disclosing significant financial interests that are directly related to the subrecipient's work for the Delve;
(ii) Additionally, if the subrecipient's Investigators must comply with the subrecipient's financial conflicts of interest policy, the agreement referenced above shall specify time period(s) for the subrecipient to report all identified financial conflicts of interest to Delve. Such time period(s) shall be sufficient to enable the awardee Institution to provide timely FCOI reports, as necessary, to the PHS as required by 42 CFR, Part 50, Subpart F;
(iii) Alternatively, if the subrecipient's Investigators must comply with Delve’s financial conflicts of interest policy, the agreement referenced above shall specify time period(s) for the subrecipient to submit all Investigator disclosures of significant financial interests to the awardee Institution. Such time period(s) shall be sufficient to enable Delve to comply timely with its review, management, and reporting obligations under 42 CFR, Part 50, Subpart F.
(2) Providing FCOI reports to the PHS Awarding Component regarding all financial conflicts of interest of all subrecipient Investigators consistent with 42 CFR, Part 50, Subpart F, i.e., prior to the expenditure of funds and within 60 days of any subsequently identified FCOI. (refer to section J of this policy for reporting details)
D. Responsibilities - *50.604(d)
It is the responsibility of Delve’s CFO or their designee to solicit initial and annual disclosures.
It is the responsibility of the individual staff member or contractor working on designated projects to make disclosures related to the acquisition or discovery of new Significant Financial Interests without prompting.
It is the responsibility of the individual staff member or contractor working on designated projects to make disclosures related to Significant Financial Interests of their spouses or dependent children, without prompting.
E. Initial and Annual Disclosures - *50.604(e)
1. All staff members and outside subcontractors, working on designated projects must disclose all Significant Financial Interests reasonably related to their responsibilities at Delve.
‘Significant Financial Interest’ (SFI) is defined as the following: *50.603
- With regard to any publicly traded entity, a Significant Financial Interest (SFI) exists if the value of any remuneration received from the entity, in the 12 (twelve) months preceding the disclosure, and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. Included are payments and equity interests;
- 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 12 (twelve) months preceding the disclosure, when aggregated, exceeds $5,000, or when the staff member or contractor (or the staff member or contractor’s spouse or dependent children) holds any equity interest; or
- Intellectual property rights and interests, upon receipt of income related to such rights and interest.
Significant Financial Interests do not include the following:
- Income from seminars, lectures, teaching, service on advisory or review panels for US government agencies, US institutions of higher education, US academic teaching hospitals, US medical centers, or US research institutes affiliated with an institution of higher learning;
- Income from investment vehicles such as mutual funds and retirement accounts, as long as the staff member, or contractor, does not directly control the investment decisions made in these vehicles; or
- Income from, or equity interest, in Delve, or any of its branches or subsidiaries.
2. Initial disclosures shall be made by each staff member or contractor within one week of training on the policy (see next section), and in any case prior to beginning work on any Public Health Service (PHS)-funded research.
3. Annual disclosures will be made by each staff member, or contractor during the first quarter of the year. *50.604 (e.2)
4. Subsequent disclosures shall be made (a) by any staff member, or contractor, within 30 (thirty) days of discovering or acquiring a new Significant Financial Interest. *50.604 (e.3).; and (b)
5. If a staff member or contractor is unsure if an SFI is reasonably related to their responsibilities, they should contact Delve’s CFO for guidance.
6. Disclosure shall be made via an email from the employee to the Company’s Chief Financial Officer – copying the company’s HR department.
F. Review and Conflict Management - *50.604 (f)(g) and 50.605(a)
All disclosures of Significant Financial Interests shall be reviewed by Delve’s CFO prior to expenditures of PHS funds 50.605(a). Delve’s CFO shall determine whether a FCOI exists, and if so, Delve’s CFO shall reasonably determine whether the SFI: *50.604 (f)
- could be affected by the PHS-funded research; or is in an entity whose financial interest could be affected by the research;
- is related to a designated project that is funded by the Public Health Service (PHS), including the National Institutes of Health;
- creates a Financial Conflict of Interest (FCOI), defined as an SFI that could directly and significantly affect the design, conduct, or reporting of the project
If Delve’s CFO determines that an FCOI exists, Delve’s CFO or their designee shall develop a Conflict Management Plan that shall specify the actions that have been, and shall be, taken to manage such FCOI. *50.604(g) and 50.605(a).
Examples of conditions or restrictions that might be imposed to manage an FCOI include, but are not limited to: *50.605(a)
- Public disclosure of FCOIs (e.g., when presenting or publishing the research);
- For research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants;
- Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the FCOI;
- Modification of the research plan;
- Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;
- Reduction or elimination of the financial interest (e.g., sale of an equity interest);
- Severance of relationships that create financial conflicts.
The relevant staff member or outside contractor shall agree, in writing to abide by the terms of the management plan.
Delve’s CFO or their designee shall monitor compliance with the management plan until completion of the project.
G. Records Retention - *50.604(i)
All disclosures, FCOI Reports, management plans, retrospective reviews, mitigation reports, and other records generated under this policy shall be retained for a minimum of 6 (six) years. In the case of PHS-funded research, records will be kept for at least 3 (three) years from the date the final expenditures report or the applicable quarterly or annual financial report is submitted to the relevant agency.
H. Enforcement and Sanctions - *50.604(j)
Delve’s CFO or their designee is responsible for ensuring that disclosures are made in a timely manner, and following up with any staff members or outside contractors who do not make disclosures by the indicated deadline.
If a staff member is found not to have disclosed a Significant Financial Interest, either as part of their initial disclosure or subsequently, Delve’s CFO shall consider the nature of the failure to disclose to determine an appropriate sanction.
The determination of sanctions shall take into account, but not necessarily be bound by, the following guidelines:
- Unintentional or careless violations shall generally result in retraining on this policy, and may result in a verbal or written warning. Repeated or particularly flagrant violations may result in stronger sanctions.
- Intentional violations regarding Significant Financial Interests, not found to constitute Financial Conflicts of Interest, shall generally result in a verbal warning or a written warning, as well as, retraining on this policy. Repeated or particularly flagrant violations may result in stronger sanctions.
- Intentional violations regarding Significant Financial Interests found to constitute Financial Conflicts of Interest shall result in a written warning, as well as, retraining on this policy. Depending on the nature of the interest and the conflict, stronger sanctions including suspension without pay or termination may also be imposed.
If an outside contractor is found not to have disclosed a Significant Financial Interest, either as part of their initial disclosure or subsequently, Delve’s CFO shall consider the nature of the failure to disclose, and the recourse available under the agreement with the outside contractor to determine an appropriate remedy.
I. Certification - *50.604(k)
Delve will certify in each application for funding that Delve
1. Has in effect at that Institution an up-to-date, written, and enforced administrative process to identify and manage financial conflicts of interest with respect to all research projects for which funding is sought or received from the PHS;
2. Shall promote and enforce Investigator compliance with the requirements of 42 CFR, Part 50, Subpart F, including those pertaining to disclosure of significant financial interests;
3. Shall manage financial conflicts of interest and provide initial and ongoing FCOI reports to the PHS Awarding Component consistent with 42 CFR, Part 50, Subpart F
4. Agrees to make information available, promptly upon request, to the HHS relating to any Investigator disclosure of financial interests and the Institution's review of, and response to, such disclosure, whether or not the disclosure resulted in the Institution's determination of a financial conflict of interest; and
5. Shall fully comply with the requirements of 42 CFR, Part 50, Subpart F
J. Reporting - *50.604(h) and 50.605(b)
1. Prior to expenditure of any funds under a PHS-funded research project, Delve shall provide to the contact designated in the relevant contract or grant document an FCOI Report identifying any Financial Conflicts of Interest relating to the PHS-funded research.
The FCOI Report shall include the following: *50.605 (b3)
- the Project number and title;
- the PD/PI, or Contact PD/PI if a multiple PD/PI model is used;
- the name of the staff member, or outside contractor, with the FCOI;
- the name of the entity with which the staff member or outside contractor has an FCOI;
- the nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium);
- the 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;
- a description of how the financial interest relates to the PHS-funded research, and the basis for Delve’s determination that the financial interest conflicts with such research;
- a description of the key elements of the Institution’s management plan, including the role and principal duties of the conflicted Investigator in the research project; conditions of the management plan; how the management plan is designed to safeguard objectivity in the research project; confirmation of the Investigator’s agreement to the management plan; how the management plan will be monitored to ensure Investigator compliance; and other information as needed; and
- any other information the Delve’s CFO deems necessary to enable the relevant government agency to understand the nature and extent of the financial conflict, and to assess the appropriateness of the management plan.
2. For any FCOI relating to PHS-funded research that is identified subsequent to the initial FCOI report, Delve shall provide to the contact designated in the relevant contract or grant document an FCOI Report identifying any FCOI, as described above, within 60 (sixty) days.
3. If any FCOI is identified concerning key personnel, as defined in the relevant contract or grant document, a public disclosure of the following information shall be posted on the Delve website at the same location as this policy is posted: *50.605 (a.1)
- the staff member or outside contractor’s name;
- the staff member or outside contractor’s title and role with respect to the research project;
- the name of the entity in which the Significant Financial Interest is held;
- the nature of the Significant Financial Interest; and
- the 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.
4. The public disclosure per 50.605 (a.1) shall be posted prior to the expenditure of funds, shall be updated at least annually during the course of the PHS-funded project, as well as, within 60 (sixty) days of the identification of any new FCOI, and shall remain available for 3 (three) years following the most recent update.
K. Review of Improperly-Handled Financial Conflicts of Interest/Remedies – *50.606
The following procedures shall be carried out whenever an FCOI is not identified or managed in a timely manner, including failure by the staff member or outside contractor to disclose a Significant Financial Interest that is determined by the Institution to constitute an FCOI; failure by Delve to review or manage such an FCOI; or failure by the staff member or outside contractor to comply with an FCOI management plan:
- Delve’s CEO shall appoint a review panel consisting of 3 (three) senior employees not reporting to the Delve’s CFO.
- Within 120 days of the determination of noncompliance, the review panel shall complete a retrospective review of the staff member or outside contractors’ activities, and the PHS-funded research project 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.
- The review panel shall document the retrospective review in a record including at least the following key elements:
- Project number and title;
- PD/PI or contact PD/PI if a multiple PD/PI model is used;
- Name of the staff member or outside contractor with the FCOI;
- Name of the entity with which the staff member or outside contractor has an FCOI;
- Reason(s) for the retrospective review;
- Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed);
- Findings of the review; and
- Conclusions of the review.
Based on the results of the retrospective review, if appropriate, Delve’s CEO shall update the previously submitted FCOI Report, specifying the actions that will be taken to manage the FCOI going forward
If bias is found, Delve’s CEO is required to promptly notify the contact designated in the relevant contract, or grant document, and submit a mitigation report to that contact. The mitigation report must include, at a minimum, the key elements documented in the retrospective review above, a description of the impact of the bias on the research project, and Delve’ plan of action(s) 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).
Depending on the nature of the FCOI, Delve’s CEO may determine that additional interim measures are necessary with regard to the staff member or outside contractor’s participation in the PHS-funded research project between the date that the FCOI, the staff member, or outside contractor’s noncompliance is determined, and the completion of Delve’s retrospective review.