Arbor Medical Innovations Financial Conflict of Interest Policy

Arbor Medical Innovation, LLC (“the Institution”) developed this Financial Conflict of Interest (FCOI) Policy to be compliant 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. The regulations describe actions investigators, and the organizations they are affiliated with must take to promote objectivity in PHS-funded research. These regulations apply to all Public Health Service (PHS) related research (e.g. National Institutes of Health funded grants, cooperative agreements, and research contracts). The regulations are not applicable to Phase I Small Business Innovation Research or Small Business Technology Transfer (SBIR/STTR) applications or awards.

DEFINITIONS

Financial Interest: Anything of monetary value, whether or not the value is readily ascertainable.

Significant Financial Interest (SFI): 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 appear to be related to the Investigator's institutional responsibilities performed on behalf of The Institutions:

(i) With regard to any publicly traded entity, an SFI exists if the value of any remuneration received from the entity in the twelve (12) 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.

(ii) With regard to any non-publicly traded entity, an SFI exists if the value of any remuneration received from the entity in the twelve (12) 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) exceeding $5,000.

(iii) With regard to intellectual property rights and interests (e.g., patents, copyrights), an SFI exists upon receipt of income of greater than $5,000 related to such rights and interests.

(iv) Any foreign or domestic reimbursed or sponsored travel that over the last twelve (12) months cumulatively exceeds $5,000 (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 the Investigator's institutional responsibilities.

The term SFI DOES NOT include any of the following types of financial interests; therefore, the Investigator does not disclose these types of SFI to the Institution:

(i) 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 Institutions and agreements to share in royalties related to such rights.

(ii) Any ownership interest in the Institution is held by the Investigator since the Institution is a commercial or for-profit organization and such interest is excluded from the SFI definition per the regulation.

(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 located in the United States (US), a US Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with a US Institution of higher education.

(v) Income from service on advisory committees or review panels for a federal, state, or local government agency located in the United States (US), a US Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with a US Institution of higher education.

(vi) Any foreign or domestic reimbursed or sponsored travel over the last twelve (12) months totaling $5,000 or less and travel that is reimbursed or sponsored by any of the following:

• a federal, state, or local government agency located in the United States,

• a United States Institution of higher education,

• an academic teaching hospital,

• a medical center, or

• a research institute affiliated with a United States Institution of Higher Education.

Financial conflict of interest (FCOI): an SFI that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.

Institutional responsibilities: The professional activities an investigator performs on behalf of the Institution (e.g., administration, research, or consulting). The FCOI Official, Dr. Grant H. Kruger, who has been designated by the Institution, oversees the FCOI process, including solicitation and review of disclosures of SFI and identifying FCOIs per the regulatory criteria provided in 42 CFR 50.604(f) and as stated within the policy below.

Investigator: 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 an award or proposed for such funding, which may include, for example, collaborators or consultants. The Institution’s Principal Investigator/Project Director, upon consideration of the individual's role and degree of independence in carrying out the work, will determine who is responsible for the design, conduct, or reporting of the research. 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.

Public Health Service (PHS): The Public Health Service of the US 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.

National Institute of Health (NIH): The biomedical research agency of the PHS

Senior/key personnel: 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/NIH by the Institution. This term is defined only as it relates to the public accessibility requirements described under the section labeled "PUBLIC ACCESSIBILITY OF FCOI RELATED INFORMATION".

FOREIGN FINANCIAL INTERESTS

Investigators must disclose all foreign financial interests (which includes income from seminars, lectures, or teaching engagements, income from service on advisory committees or review panels, and reimbursed or sponsored travel) received from any foreign entity, including foreign Institutions of higher education or a foreign government (which includes local, provincial, or equivalent governments of another country) when such income meets the threshold for disclosure (e.g., income in excess of $5,000).

DISCLOSURE REQUIREMENTS

At the time of application, the Principal Investigator and all other individuals who meet the definition of "Investigator" must disclose their SFIs to the Institution’s designated official. Any new Investigator who, after applying to NIH for funding or during the course of the research project, plans to participate in the project must similarly disclose their SFI(s) to the FCOI Official promptly and prior to participation in the project

Investigators who are participating in research under an NIH award must submit an updated disclosure of SFI at least annually, during the period of the award. Such disclosure must include any information that was not disclosed initially to the Institutionpursuant to this policy or in a subsequent disclosure of SFI (e.g., any financial conflict of interest identified on an NIH-funded project directly as an NIH Grantee and/or indirectly through a sub-award) that was transferred from another Institution), and must include updated information regarding any previously disclosed SFI (e.g., the updated value of a previously disclosed equity interest). Each Investigator must also submit an updated disclosure of SFI within thirty (30) days of discovering or acquiring a new SFI (e.g., through purchase, marriage, or inheritance).

Investigators must also submit an updated disclosure of reimbursed or sponsored travel within 30 days should that travel result in an SFI. The resulting disclosure must include the sponsored amounts as well as any related funds the investigator received over the previous twelve (12) months, and at a minimum, the purpose of each trip, the identity of the sponsor(s)/organizer(s), the destination(s), and the duration(s) of travel contributing to the SFI.

REVIEW OF DISCLOSURES

The designated official at the Institution will review each SFI disclosure by comparing it to each research grant application and award on which the Investigator is identified as responsible for the design, conduct, or reporting of the research. The designated official may also involve the Investigator in determining how an SFI is related to the research. The official will make the determination that the SFI constitutes an FCOI and implement a management plan if the SFI could directly have a material effect on the design, conduct, or reporting of the research, specifically:

• Could the research performed at the Institution be affected by the SFI?

• Does the SFI pertain to an external entity that could be affected by the Institution’s research?

MANAGEMENT OF AN FCOI

If an FCOI exists, the designated official will determine what management conditions and/or strategies will be put in place to manage the FCOI. Examples of conditions that might be imposed to manage a financial conflict of interest include, but are not limited to any of the following:

(i) Public disclosure of FCOI (e.g., when presenting or publishing the research, to research personnel working on the study, to the Institution's Institutional Review Board, Institutional Animal Care and Use Committee, Data Safety and Monitoring Board, etc.).

(ii) For research projects involving human subjects research, disclosure of FCOI directly to human participants in the informed consent document.

(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 FCOI.

(iv) Modification of the research plan.

(vi) Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research.

(vii) Reduction or elimination of the financial interest (e.g., sale of an equity interest);

(viii) Severance of relationships that create financial conflicts

If the designated official or committee determines that an FCOI, it will communicate its determination and the means it has developed for managing the FCOI in writing to the individual, to the relevant Principal Investigator/Project Director, and to the appropriate direct supervisor.

No expenditure on an NIH award will be permitted until the Investigator has complied with the Disclosure requirements of this policy and has agreed, in writing, to comply with any plans determined by the designated official necessary to manage the FCOI. The designated FCOI Official of the Institution will submit the FCOI report to NIH via the eRA Commons FCOI Module.

PUBLIC ACCESSIBILITY OF FCOI RELATED INFORMATION

Prior to the expenditure of any research award funds, the Institution will ensure public accessibility by written response to any requestor within five (5) business days of a request of information concerning any SFI disclosed that meets the following three criteria:

(i) The SFI was disclosed and is still held by the senior/key personnel. Senior/key personnel are the PD/PI and any other person identified as senior key personnel by the Institution in the award application, progress report, or any other report submitted to the grantee;

(ii) The Institution has determined that the SFI is related to the research funded through an award; and;

(iii) the Institution has determined that the SFI is an FCOI. The information that the Institution will make available via a publicly accessible website or in a written response to any requestor within five (5) days of request will include, at a minimum, the following:

(a) The Investigator's name.

(b) The Investigator's title and role with respect to the research project.

(c) The name of the entity in which the SFI is held.

(d) The nature of the SFI; and

(e) The approximate dollar value of the SFI in the following ranges: $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. If the Institution uses a publicly accessible website to comply with the public disclosure requirements of the sponsor’s regulations (i.e. NIH), the information posted will be updated at least annually and within sixty (60) days of receipt or identification of information concerning any additional SFI of the senior/key personnel for the funded research project that had not been previously disclosed, or upon the disclosure of an SFI of senior/key personnel new to the funded research project, if it is determined by the designated official that the SFI is related to the research and is an FCOI.

Information concerning an individual's SFI, as limited by this policy, will remain available for responses to written requests or for posting via the Institution’s publicly accessible website for at least three (3) years from the date that the information was most recently updated.

REPORTING OF FCOIs

Prior to the expenditure of any awarded research funds, the Institution’s FCOI Official will provide the sponsor with an FCOI report compliant with the sponsor’s regulations regarding any Investigator's SFI found to be an FCOI and will ensure that the Investigator has agreed to and implemented a corresponding management plan.

For any SFI that is identified as conflicting subsequent to an initial FCOI report during an ongoing awarded research project (e.g., a new SFI is identified for an Investigator who is participating in the NIH-funded research, upon the participation of an Investigator who is new to the research project, etc.), the Institution will provide to the sponsor within 60 days of identifying an FCOI, an FCOI report regarding the FCOI and ensure that the Institution has implemented a management plan and the Investigator has agreed to the relevant management plan.

For example, Figure 1 shows the NIH expectations for the report FCOI Officials must submit via their FCOI Module within eRA Commons.

Figure 1: Report required to be submitted to NIH via eRA Commons.

TRAINING REQUIREMENTS:

Each Investigator will be informed about the Institution’s FCOI Policy and be trained on the Investigator's responsibility to disclose foreign and domestic SFIs per this policy and of the FCOI regulation at 42 CFR Part 50 Subpart F. FCOI training will occur prior to an Investigator engaging in sponsored research, and at least every four (4) years as well as immediately when any of the following circumstances apply:

(i) the Institution revises this FCOI Policy, or procedures related to this policy, in any manner that affects the requirements of Investigators;

(ii) An Investigator is new to the Institution’s research under a sponsored award (training is to be completed prior to his/her participation in the research); or

(iii) the Institution finds an Investigator non-compliant with this policy or a management plan issued under this policy (training is to be completed within 30 days in the manner specified by the designated official).

In fulfillment of the FCOI training requirement of this FCOI regulation, the Institution requires its investigators to complete the NIH’s FCOI training at: http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm in accordance with the requirements and expectations of this policy. All investigators must print a certification of completion at the end of training and retain it for audit purposes.

FAILURE TO COMPLY FCOI POLICY

When an FCOI is not identified or managed in a timely manner, including failure by the Investigator to disclose a SFI that is determined by the Institution to constitute an FCOI, failure by the Institution to review or manage such an FCOI; and failure by the Investigator to comply with a management plan; The Institution will within 120 days:

(i) Complete a retrospective review of the Investigator's activities and the sponsored research project to determine whether any sponsored research, or portion thereof, conducted during the period of the noncompliance was biased in the design, conduct, or reporting of research.

(ii) Document the retrospective review consistent with the regulation at 42 CFR 50.605(a)(3)(ii)(B) or as required by the sponsor (i.e. as described in NIH's FAQ I.2. at Frequently Asked Questions (FAQs) | grants.nih.gov.)

If bias is found, the Institution shall notify the sponsor promptly and submit a mitigation report via the sponsors requested method that shall address the following:

(i) Impact of the bias on the research project, and

(ii) The Institution’s plan of action or actions taken to eliminate or mitigate the effect of the bias.

Thereafter, the Institution shall submit FCOI reports annually to the sponsor in accordance with the regulations and terms and conditions of the award agreement. Depending on the nature of the FCOI, the Institution may determine that additional interim measures are necessary with regard to the Investigator's participation in the research project between the date that the FCOI was identified and the completion of the Institution’s independent retrospective review. If bias is not found, no further action will be required.

CLINICAL RESEARCH REQUIREMENTS

If the clinical research sponsor (i.e. HHS/NIH) determines that a sponsored clinical 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 an FCOI that was not managed or reported by the Institution, the Institution 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.

SUBRECIPIENT REQUIREMENTS

A subrecipient relationship is established when federal funds flow down from or through the Institution to another individual or entity, and the subrecipient will be conducting a substantive portion of a sponsored research project and is accountable to the Institution for programmatic outcomes and compliance matters. Subrecipients, who include but are not limited to collaborators, consortium members, consultants, contractors, subcontractors, and sub-awardees, are subject to the Institutions terms and conditions, and as such, the Institution will take reasonable steps to ensure that any subrecipient Investigator compliant with the federal FCOI regulation at 42 CFR Part 50 Subpart F.

The Institution will incorporate, as part of a written agreement with the subrecipient, terms that establish whether the Institution’s FCOI Policy or that of the subrecipient's institution will apply to the subrecipient Investigator(s). (For NIH, see the NIH Grants Policy Statement Section 15.2.1 Written Agreement at 15.2 Administrative and Other Requirements at nih.gov). If the subrecipient's FCOI policy applies to the subrecipient Investigator, the subrecipient institution will certify as part of the agreement with the Institution that its policy is in compliance with the federal FCOI regulation. In this situation, the agreement shall specify the time-period for the subrecipient to report all identified FCOIs to the Institution in sufficient time to enable the Institution to provide timely FCOI reports, as necessary, to the sponsor (i.e. PHS/NIH) as required by the regulation (i.e., prior to the subrecipient's expenditure of funds and within 60 days of the subrecipient's identification of an FCOI during the period of an award). Therefore, the written agreement may establish a reporting requirement of FCOIs identified during the period of an award to be submitted to the Institution within fifty (50) days of the subrecipient's identification of an FCOI to allow the Institution to report the FCOI within the required sixty (60) day period. The institution’s assigned FCOI Officer will submit the FCOI report (subrecipient report) to the sponsor (i.e. NIH) via their requested procedure (i.e. NIH required submission via the eRA Commons FCOI Module).

If the subrecipient cannot provide the certification of compliance with the FCOI regulation, the agreement shall state that the subrecipient Investigator is subject to the Institutions FCOI Policy for disclosing SFIs that are directly related to the subrecipient's work for the Institution. Therefore, the Institution will require the submission of all subrecipient Investigator disclosures of SFIs to the Institution. The agreement will include a sufficient time-period to enable the Institution to comply in a timely manner with its review, management, and reporting obligations under the regulation. When an FCOI is identified, the Institution will develop a management plan, monitor subrecipient Investigator compliance with the plan, and submit an FCOI report (subrecipient report) to the sponsor through their requested channel for the subrecipient Investigator.

MAINTENANCE OF RECORDS

The Institution will keep all records of all Investigator disclosures of financial interests and the Institution's review of, or response to, such disclosure (whether or not a disclosure resulted in the Institution's determination of an FCOI), and all actions under the Institution's policy or retrospective review, if applicable. Records of financial disclosures and any resulting action will be maintained by the Institution for at least three (3) years from the date of submission of the final expenditures report or, where applicable, from other dates specified in 45 CFR 75.361 for different situations. The Institution will retain records for each competitive segment as provided in the regulation.

FAILURE TO COMPLY

Compliance with this policy is a condition of employment and/or participation for all applicable Investigators. Therefore, such Investigators who fails to comply with this policy are subject to discipline, including letters of reprimand, restriction on the use of funds, termination of employment, or disqualification from further participation in any sponsored research, etc., as may be deemed appropriate.

Contact Information

For any FCOI/SFI or related questions, please contact the Institutions FCOI Compliance officer at support@ami-tek.com.