The following Financial Conflict of Interest (FCOI) Policy is specific to all government sponsored grants or government funded contracts. This Policy is intended to ensure compliance with 42 CFR 50, Subpart F, "Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought”.
1.Purpose.
1.1. The purpose of this policy is to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, or reporting of funded research grants or cooperative agreements will be free from bias resulting from Investigator’s financial conflicts of interest. Such financial conflicts include those of the Investigator’s spouse and/or dependent children.
2.Scope.
2.1. This policy is applicable to each Investigator who is planning to participate in or is participating in such government funded research; provided, however, this does not apply to SBIR Program Phase I applications. If a research project involves subcontractors, subgrantees, or subawardees (collectively subrecipients), the subrecipient institution must provide written assurance that a financial conflict of interest in research policy is in effect at that institution and compliant with all applicable federal regulations. Should Public Health Service (PHS) or National Science Foundation (NSF) funds be subcontracted by Aruna Bio to a subrecipient institution without a conflict of interest in research policy, a written agreement must state that this policy shall apply to the subrecipient.
3.1. Contractor means an entity that provides property or services under contract for the direct benefit or use of the Federal Government.
3.2. Disclosure of significant financial interests means an Investigator's disclosure of significant financial interests to Aruna Bio.
3.3. Financial conflict of interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of Funded research.
3.4. FCOI report means Aruna Bio's report of a financial conflict of interest to a PHS Awarding Component.
3.5. Financial interest means anything of monetary value, whether or not the value is readily ascertainable.
3.6. 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.
3.7. Institution means any domestic or foreign, public or private, entity or organization (excluding a Federal agency) that submits a proposal, or that receives, PHS research funding. For the purposes of this policy, Aruna Bio is considered Aruna Bio.
3.8. Institutional responsibilities are an Investigator's professional responsibilities on behalf of Aruna Bio, and as defined by Aruna Bio in its policy on financial conflicts of interest, which may include for example: activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.
3.9. Investigator means the Project Manager, 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.
3.10. Key personnel shall include the PM/PD/PI and any other personnel considered to be essential to work performance in accordance with HHS requirements and who are identified as key personnel in the contract proposal and contract.
3.11. Manage means taking action to address a financial conflict of interest, which can include reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.
3.12. PM/PD/PI means a project manager or project director or principal Investigator of a Funded research project; the PM/PD/PI is included in the definitions of key personnel and Investigator under this part.
3.13. 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).
3.14. PHS Awarding Component means the organizational unit of the PHS that funds the research that is subject to this part.
3.15. Public Health Service Act or PHS Act means the statute codified at 42 U.S.C. 201 et seq.
3.16. 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 part, the term includes any such activity for which research funding is available from a PHS Awarding Component through a contract, whether authorized under the PHS Act orother statutory authority.
3.17. Significant Financial Interest (SFI) means:
1. 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:
a. Regarding 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. Regarding any non-publicly traded entity, a significantfinancial interest exists if the value of any remuneration received fromthe entity in the twelve months preceding the disclosure, when aggregated,exceeds $5,000, or when the Investigator (or the Investigator's spouse ordependent children) holds any equity interest (e.g., stock, stock option, orother ownership interest); or
c. Intellectual property rights and interests(e.g., patents, copyrights), upon receipt of income related to such rights andinterests.
2. For PHS-funded investigators, any reimbursed or sponsored travel related to an Investigator’s institutional responsibilities,including that which is paid on behalf of the investigator so that the exact monetary value may not be readily available.
3. The term significant financial interest does not include the following types of financial interests:
a. Salary, royalties, or other remuneration paid by Aruna Bio to the Investigator if the Investigator is currently employed or otherwise appointed by Aruna Bio, including intellectual property rights assigned to Aruna Bio and agreements to share in royalties related to such rights; any ownership interest in Aruna Bio 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 inthese vehicles;
b. Income from seminars, lectures, or teaching engagements sponsored by a federal, state or local agency, Aruna Bio of higher education,an academic teaching hospital, a medical center, or a research institute that is affiliated with Aruna Bio of higher education.
c. Income from service on advisory committees or review panels for a federal, state, or local government agency, Aruna Bio of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with Aruna Bio of higher education.
d. Travel by a PHS-funded Investigator that is reimbursed or sponsored by a federal, state, or local government agency, ArunaBio of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with Aruna Bio of higher education.
3.18 Small Business Innovation Research (SBIR) Programmeans the extramural research program for small businesses that is establishedby the awarding components of certain Federal agencies under Public Law 97–219,the Small Business Innovation Development Act, as amended. For purposes of thisPolicy, the term SBIR Program also includes the Small Business TechnologyTransfer (STTR) Program, which was established by Public Law 102–564.
Each year an investigator who conducts PHS sponsored research at Aruna Bio must disclose in writing all significant financial interests (SFIs) that are relevant to an investigator's institutional research responsibilities or within 30 days after he/she becomes aware of new SFI or after a financial conflict of interest has been eliminated. Investigators are required to complete the annual disclosure form even if they have no financial interest to report. Transactional disclosure by the PI is also required at the time a research proposal is submitted to Sponsored Programs in order to ensure compliance with federal disclosure and management requirements.
5. Management of FCOIs and Reporting Procedures
5.1. Investigator’s Responsibilities Investigators are responsible for:
5.1.1. Disclosing all significant financial interests Providing updates to disclosed information as needed
5.1.2. If acting as the PI/PD, providing a list of individuals who meet the definition of “Investigator”within the required disclosure timeline
5.1.3. Completing and providing Certificates of training for all required training and education including those provided by Aruna Bio and the HHS at
https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html
5.1.4. Completing the annual disclosure form even if they have no financial interests to report.
5.1.5. Ensuring that an updated FCOI in Research Disclosure is on file.
5.1.6. Require each Investigator who is participating in the Funded research to submit an updated disclosure of significant financial interests within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new significant financial interest.
5.2. Financial Conflicts of Interest
A financial conflict of interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct or reporting of research. Examples include, but are not limited to, the following:
5.2.1.Investigator (and/or an Investigator's spouse and/or dependent children) entering into a paid consultancy with an outside entity that has an interest in the investigator's Aruna Bio-based research;
5.2.2.Investigator (and/or an investigator's spouse and/or dependent children) receiving royalties or non-royalty payments related to ongoing research;
5.2.3.Investigator (and/or an investigator's spouse and/or dependent children) having an equity interest (e.g., stocks, stock options, warrants) related to ongoing research;
5.3. Review of FCOIs
Aruna Bio’s designated Administration Official (AO) conducts an initial review of all disclosures. If necessary, the AO shall obtain additional information from the investigator and other individuals to inform whether the SFI disclosed is related to a proposed or existing sponsored project or program. Should the AO formally identify cases requiring further review, the AO will refer such cases to the Board of Directors for review.
Board of Directors will review the collected information to determine whether a financial conflict of interest exists by considering the following:
5.3.1. Impact on integrity of research data;
5.3.2. Risks to rights and safety of animal and/or human research subjects;
5.3.3. Risks to the rights of students and trainees participating in research; and
5.3.4. Appearance of conflict of interest.
If a financial conflict of interest is identified, the Board of Directors will determine whether the research can be undertaken with appropriate management.
5.4. Management of FCOIs
Should a conflict be found to exist, the AO will develop and implement a management plan that shall specify the actions that have been, and shall be, taken to manage such financial conflict of interest.
5.4.1 The Management Plan will be developed collaboratively and examples of conditions or restrictions that may be employed to manage conflicts include:
• Public disclosure of significant financial interests (e.g., when presenting or publishing the research), if appropriate;
• Disclosure of significant financial interests directly to subjects involved in human research;
• Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of research;
• Modification of research plan;
• Change of personnel or personnel responsibilities or disqualification 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 the actual or potential conflict of interest;
• If it proves impossible to reach an acceptable Management Plan, funds will be returned to the sponsor.
The draft Management Plan will be provided to the Investigator for review and comment before it is finalized. The Investigator and their supervisor must sign the approved plan as acknowledgement of their agreement to comply
5.4.2. Whenever, in the course of an ongoing Funded research project, an Investigator who is new to participating in the research project discloses a significant financial interest or an existing Investigator discloses a new significant financial interest to Aruna Bio, the Aruna Bio’s AO shall, within sixty days: review the disclosure of the significant financial interest; determine whether it is related to Funded research; determine whether a financial conflict of interest 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 financial conflict of interest. Depending on the nature of the significant financial interest, Aruna Bio may determine that additional interim measures are necessary regarding the Investigator's participation in the Funded research project between the date of disclosure and the completion of Aruna Bio’s review.
5.4.3. If Aruna Bio identifies a significant financial interest that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed by Aruna Bio during an ongoing Funded research project (e.g., was not timely reviewed or reported by a subrecipient), the AO shall, within sixty days: review the significant financial interest; determine whether it is related to Funded research; determine whether a financial conflict of interest 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 financial conflict of interest going forward;
• (A) In addition, whenever a financial conflict of interest is not identified or managed in a timely manner including failure by the Investigator to disclose a significant financial interest that is determined by Aruna Bio to constitute a financial conflict of interest; failure by Aruna Bio to review or manage such a financial conflict of interest; or failure by the Investigator to comply with a financial conflict of interest management plan, Aruna Bio shall, within 120 days of Aruna Bio’s determination of non-compliance, complete a retrospective review of the Investigator's activities and the Funded research project to determine whether any Funded research, or portion thereof, conducted during the time period of the non-compliance, was biased in the design, conduct, or reporting of such research.
• (B) Aruna Bio is required to document the retrospective review; such documentation shall include, but not necessarily be limited to, all the following key elements:
- Grant or Contract Number issued by PHS;
- Project Title;
- PM/PD/PI name (if multiple Investigators, identify the name of the Investigator with the FCOI;
- Name of the entity with which Investigator has a financial conflict of interest;
- Justification for the retrospective review and the methodology used for the review (include methodology for review process, if review panel was used, the composition of the panel,
and documents reviewed);
- Findings and conclusion of the review.
Based on the results of the retrospective review, if appropriate, Aruna Bio shall update the previously submitted FCOI report, and shall include the actions that will be taken to manage the financial conflict of interest going forward. Depending on the nature of the financial conflict of interest, Aruna Bio may determine that additional interim measures are necessary regarding the Investigator's participation in the Funded research project between the date that the financial conflict of interest or the Investigator's non-compliance is determined and the completion of Aruna Bio's retrospective review.
5.5. Subrecipients
If Aruna Bioengages a subrecipient/consortium to carry out the Funded research through asubrecipient, Aruna Bio will take reasonable steps to ensure that anysubrecipient Investigator complies by:
5.5.1.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.
• 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 this Policy. If the subrecipient cannot provide such certification, the agreement shall state that subrecipient Investigators are subject to the financial conflicts of interest policy of the awardee Institution for disclosing significant financial interests that are directly related to the subrecipient's work for Aruna Bio;
• 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 the awardee Institution. Such time period(s) shall be sufficient to enable Aruna Bio to provide timely FCOI reports, as necessary, to the PHS as required;
• Alternatively, if the subrecipient's Investigators must comply with Aruna Bio’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 Aruna Bio. Such time period(s) shall be sufficient to enable Aruna Bio to comply timely with its review, management,and reporting obligations under this Policy.
5.5.2. Providing FCOI reports to the PHS Awarding Component regarding all financial conflicts of interest of all subrecipient Investigators consistent with this Policy.
5.6. Aruna Bio - Compliance,and Monitoring Responsibilities
Compliance and monitoring FCOIs is the responsibility of Aruna Bio. The frequency of such monitoring shall be dictated by PHS agency and provisions set forth in any Management Plan that may be implemented. Responsibilities related to compliance and monitoring shall include but may not be limited to the following:
5.6.1. Maintain, update, and enforce this Policy, and make it available via a publicly accessible Web site. Aruna Bio shall make this Policy available to any requestor within five business days of a request.
5.6.2. Inform each Investigator of Aruna Bio’s policy on financial conflicts of interest, the Investigator's responsibilities regarding disclosure of significant financial interests, and of the relevant regulations, and require each Investigator to complete training regarding the same prior to engaging in research related to any Funded contract and at least every four years, and immediately when any of the following circumstances apply:
• ArunaBio revises its financial conflict of interest policies or procedures in any manner that affects the requirements of Investigators;
• AnInvestigator is new to Aruna Bio; or
• Aruna Bio finds that an Investigator is not in compliance with Aruna Bio’s financial conflict of interest policy or management plan.
5.6.3. Provide initial and ongoing FCOI reports to the PHS as required pursuant to 42 CFR 50.604(h), 42 CFR 50.605(b). Reports shall include at least the following:
5.6.4. Maintain records relating to all Investigator disclosures of financial interests and ArunaBio’s review of, and response to, such disclosures (whether a disclosure resulted in Aruna Bio's determination of a financial conflict of interest, or not), and all actions under Aruna Bio's policy or retrospective review, if applicable, for at least three years from the date of final payment or, where applicable, for the time periods specified under current regulations.
5.6.5. Enforce the Policy and reserve the right to take administrative actions to ensure Investigator compliance as appropriate.
5.6.6. Certify that for instances where this Policy applies, Aruna Bio shall:
• Have in effect 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;
• Shall promote and enforce Investigator compliance with this Policy’s requirements including those pertaining to disclosure of significant financial interests;
5.6.7. Shall manage financial conflicts of interest and provide initial and ongoing FCOI reports to the PHS Awarding Component consistent with this Policy;
• Agree to make information available, promptly upon request, to the HHS relating to any Investigator disclosure of financial interests and Aruna Bio’s review of, and response to, such disclosure, whether or not the disclosure resulted in ArunaBio’s determination of a financial conflict of interest; and
• Comply with the requirements of this Policy.
5.7. Reporting of financial conflicts of interest.
5.7.1. Aruna Bio shall provide a report of any known FSI prior to expending any funds under a Funded research project, Aruna Bio shall provide to the PHS Awarding Component an FCOI report regarding any Investigator's significant financial interest found by Aruna Bio to be conflicting and ensure that Aruna Bio has implemented a management plan in accordance with this Policy. In cases in which Aruna Bio identifies a financial conflict of interest and eliminates it prior to the expenditure of PHS-awarded funds, Aruna Bio shall not submit an FCOI report to the PHS Awarding Component.
5.7.2. For any significant financial interest that Aruna Bio identifies as conflicting subsequent to Aruna Bio’s initial FCOI report during an ongoing Funded research project (e.g., upon the participation of an Investigator who is new to the research project), Aruna Bio shall provide to the PHS Awarding Component, within sixty days, an FCOI report regarding the financial conflict of interest and ensure that Aruna Bio has implemented a management plan in accordance with this Policy.
5.7.3. Any FCOI report required shall include, but are not necessarily limited to the following:
· Project/Contract number;
· PM/PD/PI or Contact PM/PD/PI if a multiple PM/PD/PI model is used;
· Name of the Investigator with the financial conflict of interest;
· Name of the entity with which the Investigator has a financial conflict of interest;
· 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 onewhose value cannot be readily determined through reference to public prices orother reasonable measures of fair market value;
· A description of how the financial interest relates to the Funded research andthe basis for Aruna Bio’s determination that the financial interest conflicts with such research; and
· A description of the key elements of Aruna Bio’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.
5.7.4. For any financial conflict of interest previously reported by Aruna Bio regarding an ongoing Funded research project, Aruna Bio shall provide to the PHS Awarding Component an annual FCOI report that addresses the status of the financial conflict of interest and any changes to the management plan for the duration of the Funded research project. The annual FCOI report shall specify whether the financial conflict is still being managed or explain why the financial conflict of interest no longer exists. Aruna Bio shall provide annual FCOI reports to the PHS Awarding Component for the duration of the project period (including extensions with or without funds) in the time and manner specified by the PHS Awarding Component.
5.7.5. In addition to the types of financial conflicts of interest as defined in this Policy that must be reported pursuant to this section, Aruna Bio may require the reporting of other financial conflicts of interest in its policy on financial conflicts of interest, as Aruna Bio deems appropriate.
6.1 If the failure of an Investigator to comply with Aruna Bio's financial conflicts of interest policy or a financial conflict of interest management plan appears to have biased the design, conduct, or reporting of the Funded research, Aruna Bio 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 Aruna Bio for further action, which may include directions to Aruna Bio on how to maintain appropriate objectivity in the Funded research project.
6.2 The PHS Awarding Component and/or HHS may inquire at any time (before, during, or after award) into any Investigator disclosure of financial interests and Aruna Bio’s review of, and response to, such disclosure, regardless of whether or not the disclosure resulted in Aruna Bio’s determination of a financial conflict of interest. Aruna Bio is required to submit, or permit on site review of, all records pertinent to compliance with this Policy. To the extent permitted by law, HHS will maintain the confidentiality of all records of financial interests. On the basis of its review of records or other information that may be available, the PHS Awarding Component may decide that a particular financial conflict of interest will bias the objectivity of the Funded research to such an extent that further corrective action is needed or that Aruna Bio has not managed the financial conflict of interest in accordance with this part. The PHS Awarding Component may determine that issuance of a Stop Work Order by the Contracting Officer or other enforcement action is necessary until the matter is resolved.
6.3 In any case in which the HHS/PHS determines that a 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 financial conflict of interest that was not managed or reported by Aruna Bio as required by this Policy, Aruna Bio shall require the Investigator involved to disclose the financial conflict of interest in each public presentation of the results of the research and to request an addendum to previously published presentations.