Financial Conflict of Interest Policy
A. Persons Covered by this Policy
This policy (“Policy”) applies to all full-time, part-time, temporary, and contract employees, of Cure Network Dolby Acceleration Partners LLC (“Company”) who are planning to participate in, or are participating in, Public Health Service (“PHS”)-funded research by means of a grant or cooperative agreement, including without limitation all Investigators and Senior/Key Personnel (each as defined below).
B. Preamble
The primary goal of this policy is to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under PHS grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest and to prevent an employee's activities from adversely influencing Company operations.
It is recognized that research related conflicts of interest can arise from legitimate and appropriate activities including economic development, public-private interactions, and employee's and their family's personal business relationships.
This policy is implemented in accordance with 42 CFR Part 50 Subpart F - "Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought" and 45 CFR Part 94 "Responsible Prospective Contractors" as well as all other relevant policies of federal funding and oversight agencies.
C. Statement of General Policy
The design, conduct, and reporting of research funded under PHS grants or cooperative agreements should be free from bias resulting from Investigator financial conflicts of interest.
To provide a reasonable expectation of achieving the goal of this policy, Investigators shall complete appropriate training as required under this policy; Investigators shall disclose perceived and real financial conflicts of interest annually and provide new or updated disclosures in a timely manner; Company shall provide for the elimination or management of FCOI; and Company shall make disclosures to both the PHS and to the public as required under this policy.
Nothing in this policy shall be construed to permit, even with disclosure, any activity that is prohibited by law.
Nothing in this policy shall be construed to limit or abridge the authority of the management or Board of the Company to take such action as they deem appropriate regardless of any action or inaction by a Company employee.
D. Definitions
Contractor means an entity that provides property or services under contract for the direct benefit or use of the Federal Government.
Disclosure means an Investigator's disclosure of Significant Financial Interests to the Company.
Financial Conflict of Interest (FCOI) means a Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
FCOI Report means the Company's report of a Financial Conflict of Interest to a PHS Awarding Component.
Financial Interest means anything of monetary value, whether or not the value is readily ascertainable.
HHS means the United States Department of Health and Human Services, and any components of the Department to which the authority involved may be delegated.
Investigator means the project director (PD) or Principal Investigator (PI) and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding, which may include, for example, collaborators, subcontractors, 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.
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).
Senior/Key Personnel means the PD/PI and any other person identified as senior/key personnel by the Company in the grant application, progress report, or any other report submitted to the PHS by the Company and any other personnel considered to be essential to work performance in accordance with HHSAR subpart 352.242–70.
Significant Financial Interest means 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 responsibilities to Company:
a) 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;
b) 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 a management or governance position; or
c) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
In addition, Significant Financial Interest shall include 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) that is related to Investigator’s responsibilities to the Company; 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 for travel shall include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. The Company 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 respect to the PHS-funded research.
Notwithstanding the foregoing, the term Significant Financial Interest does not include the following types of financial interests:
(i) Salary, royalties, or other remuneration paid by the Company to the Investigator if the Investigator is currently employed or otherwise appointed by the Company, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights;
(ii) any ownership interest in the Company held by the Investigator;
(iii) 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;
(iv) 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;
(v) 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
(vi) An Investigator may choose to disclose any other financial or related interest that might present an actual, potential, or perceived conflict of interest.
E. Policy Implementation
Training Required: Investigators shall complete FCOI training provided by the Company on or before their becoming subject to this policy and then every four (4) years thereafter. Currently, for training on Federal regulations (45 CFR Subtitle A, subchapter A, part 94), the Company uses the NIH web-based training which can be accessed at:
https://grants.nih.gov/grants/policy/coi/tutorial2018/story html5.html
Investigators must save and print the FCOI Certificate as proof of completion of the training. Company shall also provide specific training on this policy and Investigator's disclosure responsibilities. Immediate training will be required if the Company revises this policy in a manner that affects the Investigator, when an Investigator is new to the Company, or as a result of a finding of noncompliance with this policy or a management plan, or other related misconduct.
Disclosure Requirement:
a) An Investigator shall disclose any situation in which the Investigator has, or may have, a real or potential Significant Financial Interest as defined and provided for herein. Research should not be undertaken where a Significant Financial Interest is present until a determination and approval has been made pursuant to this policy.
b) Investigators shall keep their supervisors informed of the Investigator's Significant Financial Interest. If a supervisor becomes aware of a conflict of interest that an employee has not disclosed, the supervisor shall discuss the situation with the employee, require that a written disclosure be made as provided in this policy, and inform the President to anticipate the receipt of a new Disclosure.
3. Disclosure Frequency:
a) A Disclosure must be made no later than the time of application for PHS-funded research.
b) Thereafter, a Disclosure must be made annually to the Company. If no Significant Financial Interest is present, a Disclosure must still be submitted that state “none.” The date such annual Disclosure is due shall be set by the Company and disseminated Company-wide.
c) In addition to the annual Disclosure, a new or updated Disclosure must be completed in a timely manner whenever a new or potential Significant Financial Interest arises or when a significant change occurs concerning an existing Disclosure.
d) In any event, Disclosure must be made within thirty (30) days of discovery or acquiring a new Significant Financial Interest.
e) Newly hired Investigators should make a Disclosure as part of their new hire employment process.
4. Review and Management:
a) The Company shall appoint and authorize a committee of appropriate composition and skills to review each Disclosure and determine if an FCOI exists. This committee shall be known as the Research Conflict of Interest Committee (“Committee”) and will serve at the pleasure of the Company. Such Committee shall comply with all applicable regulatory requirements, including all requirements for timing of its review of Disclosures.
b) If a determination is made that a FCOI exists, then the Committee shall seek input from the Investigator and recommend to the Company a suitable action plan ("Management Plan”) to eliminate or manage the FCOI consistent with the objectives of this policy. The Management Plan shall provide for its periodic review and updating at least annually. In the event that there is no reasonable way to manage a FCOI, then the Investigator may be prohibited from participating in the related research until such a time as the FCOI is eliminated.
c) Examples of conditions or restrictions that might be imposed to manage a financial conflict of interest include, but are not limited to:
(i) Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research);
(ii) For research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants;
(iii) Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the financial conflict of interest;
(iv) Modification of the research plan;
(v) Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;
(vi) Reduction or elimination of the financial interest (e.g. sale of an equity interest); or
(vii) Severance of relationships that create financial conflicts
(viii) The Company shall review the proposed Management Plan and can approve, modify and approve, or return to the Committee for additional work. Final review and determination must be completed prior to the expenditure of any PHS funds for the applicable research.
F. Violations and Sanctions
Sanctions: Violations of Company policies, including the failure to avoid a prohibited activity or disclose a Significant Financial Interest in a timely manner, will be dealt with in accordance with applicable policies and procedures that may include disciplinary actions up to and including termination of employment.
Clinical Research: 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 the Company as required by this policy, the Company 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.
G. Reporting by Company
The Company shall provide annual and revised reports of FCOI to PHS per the applicable regulations, including at the following times:
a) Prior to the expenditure of funds;
b) within sixty days of identification for an Investigator who is newly participating in the project;
c) within sixty days for new or newly identified FCOIs for existing investigators;
d) at least annually (at the same time as when the Company 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;
e) following retrospective review to update a previously submitted report, if appropriate.
2. The Company shall notify PHS of bias found in the design, conduct, or reporting of PHS-funded research including whether Investigator failure to comply with this FCOI policy or management plan appears to have caused such bias. In the event bias is found, Company will submit a mitigation report in accordance with applicable regulations. The mitigation report must include, at a minimum, a description of the impact of the bias on the research project and the Company’s plan of action or actions 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).
3. FCOI records shall be maintained for at least three (3) years from the submission of the final expenditure reports for the pertinent PHS/NIH funding or longer as required by other policy or regulation.
H. Subrecipients
Company shall require sub-recipient compliance with pertinent FCOI requirements as mandated by applicable regulations, including the following:
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 the Company to report identified FCOIs to PHS as required by the applicable regulations.
Alternatively, if applicable, include in the written agreement a requirement to solicit and review subrecipient Investigator disclosures that enable the Company to identify, manage, and report identified FCOIs to PHS.
Company shall provide applicable FCOI reports to PHS regarding all FCOIs of all subrecipient Investigators consistent with this Policy.
I. Public Accessibility Requirement
Company shall maintain, update and post this FCOI policy on the Company public website, as required by applicable regulations. In the alternative, if Company does not have any current presence on a publicly accessible website (and only in those cases), Company shall make this FCOI policy available to any requestor within five business days of a request.
Company shall implement a procedure for receiving and responding to FCOI informational requests by the public concerning identified FCOIs held by Senior/Key Personnel. The Company shall respond to any such requests for FCOI information within five (5) business days with minimum reporting elements as provided for under applicable regulations.