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Grundsatzerklärung zu Interessenkonflikten

HINTERGRUND

Infinite Biomedical Technologies (IBT) verpflichtet sich, die Integrität und Objektivität seiner Forschungsaktivitäten zu schützen, indem sichergestellt wird, dass die Gestaltung, Durchführung und Berichterstattung von Forschungsarbeiten nicht durch einen persönlichen finanziellen Interessenkonflikt verzerrt sind oder den Anschein erwecken, als ob sie verzerrt wären. IBT hat diese Richtlinie implementiert, um finanzielle Interessenkonflikte zu identifizieren, zu verwalten, zu reduzieren oder zu beseitigen.

Die in dieser Richtlinie beschriebenen Verfahren wurden in erster Linie entwickelt und konzipiert, um die spezifischen regulatorischen Anforderungen für vom US Public Health Service (PHS) geförderte Forschung zu erfüllen, sollen aber auch einen grundlegenden Rahmen und Standards für die Identifizierung, Bewertung und Handhabung potenzieller finanzieller Interessenkonflikte im Zusammenhang mit anderen Forschungsaktivitäten von IBT bieten. Für nicht vom PHS geförderte Forschung können die spezifischen Schritte, der Zeitplan, die Feststellungen, die Dokumentation und die Benachrichtigungen nach Bedarf angepasst werden, der Schwerpunkt liegt jedoch weiterhin auf der Einhaltung der hohen Standards von IBT für Forschungsintegrität und der effektiven Beseitigung oder Handhabung tatsächlicher oder potenzieller finanzieller Interessenkonflikte.

ZWECK

IBT has a duty to ensure that work performed under Government Awards meets the highest standard of integrity and is free of any real or perceived conflicts of interest that could harm patients, the reputation of IBT, the governmental agency providing the funding, or subrecipients. In addition, IBT must comply with government regulations when making expenditures with Government Awards.

 

This policy governs the disclosure of individual financial interests and the management and reporting of individual financial conflicts of interest in Governmental Awards.  It is intended to comply with the requirements of federal regulations,  including , but not limited to, the conflict of interest regulations of the U.S. Department of Health and Human Services Public Health Service (“the PHS FCOI Rules”) as found in 42 C.F.R. Part 50, Subpart F (titled Promoting Objectivity in Research) and 45 C.F.R. Part 94 (titled Responsible Prospective Contractors) and the Federal Acquisition Regulation FAR 52.203-16 (collectively referred to as the “Financial Conflict of Interest Rules”).

DEFINITIONEN

A. Disclosure of Significant Financial Interests means an Investigator disclosing information about a Significant Financial Interest (SFI) to IBT.

 

B. 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.

 

C. FCOI Report means an Institution’s report of a financial conflict of interest to a PHS Awarding Component.

 

D. Financial Interest means anything of monetary value, whether or not the value is readily ascertainable.

 

E. 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.

 

F. Institution means any domestic or foreign, public or private, entity or organization (excluding a Federal agency) that is applying for, or that receives, PHS research funding.

 

G. Institutional Responsibilities means an Investigator’s professional responsibilities on behalf of the Institution, and as defined by the Institution 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.

 

H. 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 (e.g., NIH), or proposed for such funding, which may include, for example, collaborators or consultants.

 

I. 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.

 

J. 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.

 

K. 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).

 

L. PHS Awarding Component means the organizational unit of the PHS that funds the research that is subject to 42 C.F.R. Part 50, Subpart F.

 

M. Public Health Service Act (PHS Act) means the statute codified at 42 U.S.C. 201 et seq.

 

N. 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). 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.

 

O. Senior/key personnel means the PD/PI and any other person identified as senior/key personnel by IBT in the grant application, progress report, or any other report submitted to the PHS by IBT.

 

P. Significant Financial Interest (SFI)

i) 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:

    1. 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;

    2. 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

    3. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.

 

ii) 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 details of this disclosure will include, at a minimum the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. The Chief Operating Officer 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 the PHS-funded research.

 

iii) The term significant financial interest does not include the following types of financial interests:

  1. 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;

  2. any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization;

  3. 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;

  4. 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

  5. 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.

 

Q. 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 42 C.F.R. Part 50, Subpart F, the term SBIR Program also includes the Small Business Technology Transfer (STTR) Program, which was established by Public Law 102-564.

 

R. Subrecipient means a consultant or subcontractor performing work under a Government Award who is not employed by IBT.

 

IV. RESPONSIBILITIES OF INSTITUTIONS REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST

 

IBT shall maintain an up-to-date, written, enforced policy on financial conflicts of interest that complies with 42 C.F.R. Part 50, Subpart F, and make such policy available to any requestor within five business days of a request.

 

 

IBT shall inform each Investigator of the Institution’s policy on financial conflicts of interest, the Investigator’s responsibilities regarding disclosure of significant financial interests, 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 renew training every four years, and immediately when (a) revision of financial conflict of interest policies or procedures in any manner that affects the requirements of Investigators; (b) an Investigator is new to IBT; or (c) an Investigator is not in compliance with its financial conflict of interest policy or management plan.

Subrecipient Requirements

 

Awardee Institutions are responsible for monitoring subrecipient’s compliance with the Financial Conflict of Interest regulation, management plans, and for reporting all identified financial conflicts of interest to the National Institute of Health (NIH).

 

IBT will take reasonable steps to ensure that any subrecipients (i.e., subcontractors or consortium members) performing work under a PHS-funded research project comply with the PHS Financial Conflict of Interest regulations by:

 

A. 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.

  1.  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 C.F.R. 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 IBT for disclosing significant financial interests that are directly related to the subrecipient’s work for IBT;

  2. 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 IBT. Such time period(s) shall be sufficient to enable IBT to provide timely FCOI reports, as necessary, to the PHS as required by the FCOI policy;

  3. Alternatively, if the subrecipient’s Investigators must comply with IBT’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 IBT. Such time period(s) shall be sufficient to enable IBT to comply timely with its review, management, and reporting obligations under the FCOI policy.

 

B. Providing FCOI reports to the PHS Awarding Component regarding all financial conflicts of interest of all subrecipient Investigators consistent with 42 C.F.R. 50, Subpart F, i.e., prior to the expenditure of funds and within sixty (60) days of any subsequently identified FCOI.

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