Financial Conflict of Interest Policy

This financial conflict of interest (FCOI) policy is derived from 42 CFR Part 50, Subpart F – Promoting Objectivity in Research: https://www.ecfr.gov/current/title-42/chapter-I/subchapter-D/part-50#sp42.1.50.f, and adapted for organizational use with some sections taken verbatim to maintain regulatory adherence.

This FCOI policy adheres to the regulations that require institutions receiving Public Health Service (PHS) research funding to establish policies that identify, disclose, review, manage, and report investigator FCOIs to ensure research remains objective and free from bias. This policy applies to all Investigators who are responsible for the design, conduct, or reporting of National Institutes of Health (NIH)-funded research at Somatolynk. It also applies to “Investigators” who participate as employees, subcontractors, or collaborators on NIH-funded projects.

A. Definitions and Delineations of Understanding.

Investigator means the project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding, which may include, for example, collaborators or consultants.
PD/PI means a project director or principal Investigator of a PHS-funded research project; the PD/PI is included in the definitions of senior/key personnel and Investigator under this subpart.
PHS means 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).
PHS Awarding Component means the organizational unit of the PHS that funds the research (e.g. National Institutes on Aging per National Institute on Aging).
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). As used in this subpart, the term includes any such activity for which research funding is available from a PHS Awarding Component through a grant or cooperative agreement, whether authorized under the PHS Act or other statutory authority, such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award.
Senior/key personnel means the PD/PI and any other person identified as senior/key personnel by the Institution in the grant application, progress report, or any other report submitted to the PHS by the Institution under this subpart.
Financial interest means anything of monetary value, whether or not the value is readily ascertainable
Financial conflict of interest (FCOI) means a significant financial interest (SFI) that could directly and significantly affect the design, conduct, or reporting of PHS-funded research. A FCOI exists when the institution's designated official(s) reasonably determines that an investigator's SFI could directly and significantly affect the design, conduct, or reporting of the NIH-funded research. The institution is required to review each Investigator SFI disclosure to determine if an SFI:
1. is related to the NIH-supported research (i.e., could the SFI be affected by the research or is the SFI in an entity whose financial interest could be affected by the research), and
2. could directly and significantly affect the design, conduct, or reporting of the NIH-funded research.

9. Significant financial interest (SFI) is delineated in the following:

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 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 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 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
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. The Institution's FCOI policy will specify the details of this 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 Institution's FCOI policy, the institutional official(s) will determine if further information is needed, including a determination or disclosure of monetary value, to determine whether the travel constitutes an FCOI with the PHS-funded research.
Investigators must disclose all ﬁnancial interests originating outside the United States (Foreign Financial Interests), 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 exceeds $5,000.
The term significant financial interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights; any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization; 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.

10. Small Business Innovation Research (SBIR) Program means the extramural research program for small businesses that is established by the Awarding Components of the Public Health Service and certain other Federal agencies under Public Law 97-219, the Small Business Innovation Development Act, as amended. For purposes of this subpart, the term SBIR Program also includes the Small Business Technology Transfer (STTR) Program, which was established by Public Law 102-564.

C. Training.

All investigators at Somatolynk will be informed of the Institution's FCOI policy, the Investigator's responsibilities regarding disclosure of SFIs, and of these regulations, and require each Investigator to complete training regarding the same prior to engaging in research related to any PHS-funded grant and at least every three years, and immediately when any of the following circumstances apply:
- When Somatolynk revises its FCOI policies or procedures in any manner that affects the requirements of Investigators;
- An Investigator is new to Somatolynk; or
- Somatolynk finds that an Investigator is not in compliance with its FCOI policy or management plan.

2. All investigators at Somatolynk will complete the NIH FCOI tutorial to provide educational training on what constitutes FCOI. The course is accessible at: https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html

Upon completion of the training, a certificate of completion must be turned into the DO. Investigators should also retain a copy of their records. This training is required prior to engaging in research relating to any NIH-funded grant or as deemed necessary by Somatolynk due to changes in the FCOI policy, non-compliance of the Investigator/Key Personnel or new to the Company.

3. Training for non-Somatolynk investigator’s that are participating in NIH-funded projects and meet the criteria of investigator, inclusive of subcontractors, consultants, and/or consortiums are defaulted to the respective subrecipient FCOI training policy, with coverage of FCOI regulations and responsibilities of the subrecipient institution addressed below in section C subpart b). If a subrecipient investigator, inclusive of their affiliated institution, lacks a training process by which to inform the investigator of requirements for NIH-funded research, such individuals will be required to adhere to Somatolynk’s training as addressed above.

D. Procedures and Responsibilities.

Each Somatolynk Investigator is responsible for reviewing this FCOI policy. The Investigator's responsibilities regarding disclosure of SFIs, and of these regulations, and require each Investigator to complete training regarding the same prior to engaging in research related to any PHS-funded grant and at least every three years, and immediately when any of the following circumstances apply:

Somatolynk revises its FCOI policies or procedures in any manner that affects the requirements of Investigators;
An Investigator is new to Somatolynk; or
Somatolynk finds that an Investigator is not in compliance with the Institution's FCOI policy or management plan.

If Somatolynk carries out the PHS-funded research through a subrecipient (e.g., subcontractors or consortium members), Somatolynk will take reasonable steps to ensure that any subrecipient Investigator complies with this subpart by:
1. Incorporating as part of a written agreement with the subrecipient terms that establish whether the FCOI policy of Somatolynk or that of the subrecipient will apply to the subrecipient's Investigators.
2. The subrecipient shall certify as part of the agreement mentioned above that its policy complies with this subpart. If the subrecipient cannot provide such certification, the agreement shall state that subrecipient Investigators are subject to the FCOI of Somatolynk for disclosing SFIs that are directly related to the subrecipient's work for the NIH-funded work.
3. A subrecipient policy must confirm and certify that each Investigator of a subrecipient participating in the specifically identified PHS/NIH-funded research must submit an updated SFI disclosure within 30 days of discovering or acquiring a new SFI (e.g., through purchase, marriage, or inheritance). Updated disclosure of reimbursed or sponsored travel must also be submitted within 30 days of each occurrence.
4. Somatolynk will provide FCOI reports to the PHS Awarding Component regarding all FCOIs of all subrecipient Investigators consistent with this subpart, i.e., prior to the expenditure of funds and within 60 days of any subsequently identified FCOI.

The designated official (DO) for Somatolynk is the company CEO. Responsibilities of Somatolynk, via DO, are to:
1. provide guidelines through the FCOI policy to determine whether an Investigator's significant financial interest is related to PHS-funded research and, if so related, whether the SFI is a FCOI.
2. obtain updated disclosure(s) of SFIs at least annually, in accordance with the specific period prescribed Somatolynk, during the period of the award.
3. review all Investigator SFI disclosures;
4. determine if any SFIs relate to PHS-funded research;
5. determine if an FCOI exists (SFI that could directly and significantly affect the design, conduct, or reporting of the NIH-funded research; and develop and implement management plans, as needed to manage FCOIs (4s CFR 50.605(a)(1)).
6. Take such actions as necessary to manage identified FCOIs, including any financial conflicts of a subrecipient Investigator pursuant to paragraph (b) of this section.
7. Maintain 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 FCOI) and all actions under Somatolynk’s policy or retrospective review, if applicable, for at least three years from the date the final expenditures report is submitted to the PHS or, where applicable, from other dates specified in 2 CFR 200.334 for different situations.
8. Provide initial and ongoing FCOI reports to the PHS as required pursuant to § 50.605(b).
9. Establish adequate enforcement mechanisms and provide for employee sanctions or other administrative actions to ensure Investigator compliance as appropriate
10. Certify, in each application for funding that Somatolynk will:
  1. Provide an up-to-date, written, and enforced administrative process to identify and manage FCOIs with respect to all research projects for which funding is sought or received from the PHS;
  2. Promote and enforce Investigator compliance with this subpart's requirements including those pertaining to disclosure of significant financial interests;
  3. Manage financial conflicts of interest and provide initial and ongoing FCOI reports to the PHS Awarding Component consistent with this subpart;
  4. 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 FCOI; and
  5. Fully comply with the requirements of this subpart.

Submission and Review of SFI-DF. Every individual having a SFI requiring disclosure under this policy shall prepare a fully completed SFI-DF that shall be submitted to the DO. An initial review of the SFI-DF will be conducted by the DO to determine whether a potential for conflict of interest exists. The DO will utilize the FCOI disclosure form to consider if a potential FCOI exists. This form compares the focus, contractual involvements, and research goals of the research project against the SFI-DF provided by the researcher. If it is determined that there is a potential conflict of interest, then steps will be taken to determine what measures are needed to address the SFI identified in the DF. A management plan may be required to outline the terms, conditions and restrictions, if any, to ensure compliance with this policy.

All management plans are required to be signed by the Investigator and the DO. The DO will communicate the determination and the management plan in writing to the Investigator, the PI/PD, and the appropriate supervisor. Compliance of the management plan shall be monitored by the DO and implemented within 60 days of identified FCOI. A management plan may require one or more of the following actions (but not limited to these actions) to be taken to manage, reduce or eliminate any actual or potential conflict of interest:

Public disclosure of significant financial interests;
Review of research protocols;
For human subjects research, disclosure of the FCOI to participants in the informed consent document;
Monitoring of research;
Modification of research plan;
Disqualification from participation in all or a portion of the research funded;
Divesture of significant financial interests;
Severance of relationships that create actual or potential conflicts.

Monitoring Plan Compliance with the management plan will be performed for the duration of the NIH award or until the FCOI no longer exists. Monitoring includes verifying that required public disclosures of FCOIs are made in publications, presentations, and other communications.

6. Violations of FCOI Policy. Investigators are expected to comply fully and promptly with this policy. Whenever a person has violated this policy, including failure to make a required disclosure of financial interests or failure to comply with a requirement of the management plan, the DO shall make recommendations regarding the impositions of sanctions or disciplinary proceedings against the violating individual. The DO will review the employee or Investigator the specific behaviors and consequences that are determined relevant based upon review, and any other administrative actions to assure Investigator compliance, including but not limited to supervised research activities. The DO will conduct retrospective reviews within 120 days of the Institution determining noncompliance for SFIs not disclosed in a timely manner or previously reviewed or whenever an FCOI is not identified or managed in a timely manner and to document the reviews consistent with the regulation.

7. If the failure of an Investigator to comply with Somatolynk’s FCOI policy or a FCOI management plan appears to have biased the design, conduct, or reporting of the PHS-funded research, Somatolynk shall promptly notify the PHS Awarding Component of the corrective action taken or to be taken. The PHS Awarding Component will consider the situation and, as necessary, take appropriate action, or refer the matter to the DO for further action, which may include directions to Somatolynk on how to maintain appropriate objectivity in the PHS-funded research project. PHS may, for example, require Institutions employing such an Investigator to enforce any applicable corrective actions prior to a PHS award or when the transfer of a PHS grant(s) involves such an Investigator.

8. 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 Somatolynk as required by this subpart, Somatolynk shall require the Investigator involved to disclose the FCOI in each public presentation of the results of the research and to request an addendum to previously published presentations.

E. FCOI Reports.

Reporting process defines the reporting steps to send initial, annual (i.e., ongoing) and revised FCOI reports, including reporting elements required by the regulation to the NIH for the Institution and its subrecipients, if applicable, as required by the regulation (42 CFR 50.604(h) and 42 CFR 50.605(b)):
1. prior to the expenditure of funds;
2. within 60 days of identification for an Investigator who is newly participating in the project;
3. within 60 days for new, or newly identified, FCOIs for existing Investigators;
4. at least annually (at the same time as when the Institution is required to submit the annual progress report, multi-year progress report, if applicable, or at time of extension) to provide the status of the FCOI and any changes to the management plan, if applicable, until the completion of the project; and
5. following a retrospective review to update a previously submitted report, if appropriate (42 CFR 50.605(a)(3)(III)).

2. Initial (Original) FCOI Reports. Prior to the expenditure of funds: If an FCOI is identiﬁed at the time a new NIH award is issued, the FCOI SO will submit an “Original” FCOI report (2011 FCOI) through the eRA Commons FCOI Module before any funds are spent. The report must include all information required under 42 CFR 50.605(b)(3) or as outlined in NIH FAQ H.5 https://grants.nih.gov/faqs#/ within 60 days during the award: If an FCOI is identiﬁed during the award period (e.g., a new SFI is disclosed or a new Investigator joins the project), the Institution must submit an Original FCOI report within 60 days of identifying the FCOI.

FCOI reports should 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 the Institution's management plan. Elements of the FCOI report shall include, but are not necessarily limited to the following: Project number;

PD/PI or Contact PD/PI if a multiple PD/PI model is used;
Name of the Investigator with the FCOI;
Name of the entity with which the Investigator has a FCOI;
Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium);
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 the Institution's determination that the financial interest conflicts with such research; and
A description of the key elements of the Institution's management plan, including:
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.

3. Annual FCOI Reports: For the duration of an award, including any extensions with or without funds, the Institution must submit an annual FCOI report to NIH. This report will indicate whether each previously reported FCOI is still being managed or no longer exists and describe any changes to the management plan, if applicable.

The annual report must be submitted at the same time as the Research Performance Progress Report (RPPR) or multi-year progress report, and at the time of any grant extension, following NIH guidance (see NIH FAQ H.2: https://grants.nih.gov/faqs#/

Annual FCOI reports are not required at grant closeout.

Annual Reporting and After-Acquired Significant Financial Interests – All Investigators shall provide annual SFI-DFs or more frequently if required by the management plan or acquired interests. Any Investigator who acquires a new or increased SFI shall promptly submit a new SFI-DF within 30 days of discovering or acquiring the new SFI. It is the Principal Investigator’s responsibility to ensure that any newly acquired Investigator on a research project submits the required SFI-DF to the DO. The DO must report to NIH any FCOIs within 10 days of notification of new SFIs identified by the PI on either notification report, or annual report, and immediately upon review and determination of any bias found with the design, conduct, or reporting of NIH-funded research and to include the requirement to submit a Mitigation Report in accordance with the regulation, and including the following NIH FCOI reporting items:

The name of the Investigator with the FCOI;
The name of the entity with which the Investigator has an FCOI;
The nature of the Significant Financial Interest (SFI);
The value of 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; and
Description of the key elements of the Company’s management plan, including other required information;

4. Revision (or Mitigation) FCOI Reports. After completing a retrospective review, Somatolynk’ DO will submit a Revision report to NIH if new information about the FCOI is discovered, or a Mitigation report if the review ﬁnds that bias has occurred.

5. For any SFI that Somatolynk identifies as conflicting subsequent to the Institution'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), the Institution shall provide to the PHS Awarding Component, within sixty days, an FCOI report regarding the FCOI and ensure that Somatolynk has implemented a management plan, where such FCOI report involves a SFI that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed or managed by the Institution (e.g., was not timely reviewed or reported by a subrecipient), Somatolynk also is required to complete a retrospective review to determine whether any PHS-funded research, or portion thereof, conducted prior to the identification and management of the FCOI was biased in the design, conduct, or reporting of such research. Additionally, if bias is found, the Institution is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component.

F. Record Keeping.

Pursuant to this FCOI policy, all NIH-funded projects must maintain copies of the certifications and documentation specified in §§ 50.304 and 50.306 for three years pursuant to the retention and custodial requirements for records at 2 CFR 200.334.
Records of Investigator SFI-DFs, and of actions taken to manage actual or potential conflicts of interest, shall be retained for three (3) years from the date the final expenditure report is submitted to the NIH, and from other dates specified in 45 CRF 75.361, where applicable (42 CFR 50.604(I)).

G. Public Accessibility.

Somatolynk will maintain an up-to-date, written, enforced policy on FCOIs and make such policy available via a publicly accessible Web site: https://www.somatolynk.com/ and/or within 5-days of written request. The DO will ensure that any updated versions of this policy are provided for updated posting immediately upon implementation. In addition, if FCOI determined to exist for any Investigator or Senior Key Personnel will be posted to this same webpage in compliance with regulation, including the date of posting and:

the minimum elements as provided in the regulation;
posting within 5 days of a written request;
annual updates, unless written requests are made which should continue to be available;
any updates within 60 days of newly identified FCOI; and
remain available for three years from the date the information was most recently updated.

Useful FCOI AND NIH Resources.

NIH e-mail address for FCOI-related inquiries:

FCOICompliance@mail.nih.gov

FCOI Regulation 42 CFR Part 50 Subpart F-Promoting Objectivity in Research:
https://www.ecfr.gov/current/title-42/chapter-I/subchapter-D/part-50/subpart-F

FCOI Training:
https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html

FCOI Frequently Asked Questions (FAQs):
https://grants.nih.gov/faqs#/financial-conflict-of-interest.htm?anchor=52884