National Institutes of Health - NIH
Amprion is proud of its scientific research partially supported by the National Institute of Neurological Disorders And Stroke of the National Institutes of Health under Award Number U44NS111672.
FINANCIAL CONFLICTS OF INTEREST POLICY
AMPRION INC
POLICY STATEMENT
Amprion is committed to protecting the integrity and objectivity of its research activities by ensuring that the design, conduct, and reporting of research will not be biased or appear to be biased by a personal financial conflict of interest. Amprion has implemented this policy to identify, manage, reduce, or eliminate financial conflicts of interest.
The procedures described in this policy were created and designed primarily to comply with the specific regulatory requirements for U.S. Public Health Service (PHS)-sponsored research but are also intended to provide a basic framework and standards for identifying, evaluating, and managing potential financial conflicts of interest relating to Amprion’s other research activities. For non-PHS research, the specific steps, timing, determinations, documentation, and notifications may be tailored as appropriate but will remain focused on maintaining Amprion’s high standards for research integrity and effectively eliminating or managing actual or potential financial conflicts of interest.
This policy and related procedures have been developed to identify, manage, mitigate, neutralize, or eliminate actual, apparent, and potential financial conflicts of interest. The policy was written to be in conformance with the Code of Federal Regulations (CFR) 42, Part 50, Subpart F, Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service (PHS) Funding Is Sought and 45 CFR Part 94, Responsible Prospective Contractors.
DEFINITIONS
Designated Official is the individual designated by Amprion to oversee the financial conflicts of interest process, including solicitation and review of disclosures of significant financial interests. Initially, the Designated Official shall be Amprion’s Chief Operating Officer.
Equity interest includes any stock, stock option, or other ownership interest, and its value may be determined through reference to public prices or other reasonable measures of fair market value.
Financial conflict of interest means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of research as determined by Amprion through the Designated Official.
Financial interest means anything of monetary value, whether or not the value is readily ascertainable.
Immediate family refers to an Investigator’s spouse and dependent children.
Investigator means the project director/principal investigator and any other person who is responsible for the design, conduct, or reporting of the research or proposed research.
PHS means the U.S. Public Health Service, an operating division of the U.S. Department of Health and Human Services (HHS), and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health.
PHS Awarding Component means the organizational unit of the PHS that funds the research that is subject to 42 CFR Part 50, Subpart F, and 45 CFR Part 94.
PHS-funded Research means research funded under PHS grants, cooperative agreements, or contracts.
Public Health Service Act, or PHS Act means the statute codified at 42 U.S.C. 201 et seq. Remuneration includes, for example, salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship).
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). For PHS-Funded Research, the term includes any such activity for which research funding is available from a PHS Awarding Component through a grant, cooperative agreement, or contract, whether authorized under the PHS Act or other statutory authority.
Significant financial interest means a financial interest consisting of one or more of the following interests of the Investigator and his/her immediate family that reasonably appear to be related to the Investigator’s Amprion project responsibilities, including:
- With regard to interests in any publicly traded entity, a financial interest consisting of any remuneration received from the entity in the 12 months preceding the disclosure and any equity interest (e.g., stock, stock option, or other ownership interest) in the entity as of the date of disclosure, in which the value when aggregated exceeds $5,000;
- With regard to interests in any non-publicly traded entity, a financial interest consisting of any remuneration received from the entity in the 12 months preceding the disclosure, in which the value when aggregated exceeds $5,000, or when the Investigator or his/her immediate family 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
- Salary, royalties, or other remuneration paid by Amprion (or a subrecipient as applicable) to the Investigator if the Investigator is currently employed or otherwise appointed by Amprion, including that paid for intellectual property rights assigned or licensed to Amprion and agreements to share in royalties related to such rights;
- Any ownership interest in Amprion (or a subrecipient as applicable) held by the Investigator (e.g., Employee Stock Ownership Plan);
- 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
- Informing Amprion Investigators of their obligations under this policy and any related regulations;
- Reviewing disclosures of significant financial interest with Amprion’s Administrator to determine whether they are related to the subject research and, if so, whether they constitute financial conflicts of interest;
- Screening and managing potential financial conflicts of interest;
- Maintaining all records relating to disclosures of financial interests, Amprion’s review of and response to such disclosures, and any related actions under this policy;
- Ensuring inclusion of any required certifications in applications for funding or contract proposals; and
- Reporting and disclosure as required under this policy and applicable
- Taking reasonable steps to ensure that Investigators for subrecipients (e.g., subgrantees, subcontractors, or collaborators) fully comply with this policy or provide Amprion with sufficient assurances to enable Amprion’s compliance with all applicable laws or regulations. To this end, the written agreement between Amprion and the subrecipient will specify whether Amprion’s or the subrecipient’s financial conflicts of interest policy will apply to the subrecipient’s Investigators and, if the subrecipient’s policy will apply, the Designated Official will:
- Obtain certification from the subrecipient that its policy complies with Amprion’s policy and the applicable regulations (absent such certification, Amprion’s policy will apply to the subrecipient’s Investigators, and
- Establish time periods for subrecipient reporting of financial conflicts of interest to Amprion that enable Amprion to report such conflicts in a timely manner, as required under its policy and the applicable
- Disclosure to research participants and the public of significant financial interests (e.g., when presenting or publishing the research);
- Monitoring of research by independent reviewers;
- Modification of the research plan;
- Disqualification of staff from participation in all or a portion of the research;
- Reduction or divestiture of a financial interest; or
- Severance of relationships that create actual or potential
- If the Investigator’s failure to comply with this policy or a financial conflicts of interest management plan has biased the design, conduct, or reporting of the PHS-funded research, Amprion shall promptly notify the PHS Awarding Component of the corrective action taken or to be taken;
- Amprion will make available to HHS all records pertinent to financial conflicts of interest and the management of those conflicts; and
- If HHS determines that a clinical PHS-funded research project 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 neither disclosed nor managed, Amprion shall require disclosure of the conflicting interest in each public presentation of the results of the research and shall request an addendum to previously published presentations, if
- Amprion revises its financial conflicts of interest policy or procedures in any manner that affects the Investigator’s obligations;
- An Investigator is new to Amprion; or
- Amprion finds that an Investigator is not in compliance with this policy or a financial conflicts of interest management