K&A Wireless, LLC
CONFLICT OF INTEREST POLICY
As an employee of K&A Wireless, LLC, you are expected to act at all times in the Company’s best interest and to exercise sound judgment unclouded by personal interest or divided loyalties. As a recipient of Federal funding, K&A must adhere to Federal regulations that require all institutions applying for or receiving research funding from a federal agency to maintain a conflict of interest policy. The goal of this policy is to promote objectivity in research by establishing standards to ensure there is no reasonable expectation that the design, conduct, or reporting of research funded under federal grants will be biased by any conflicting financial interest of an Investigator (see definition below).
This policy governing financial conflict of interest applies to all Public Health Service (PHS)-sponsored Investigators of the Institution. The Institutional Official is responsible for ensuring implementation of this policy and may suspend all relevant activities until the financial conflict of interest is resolved or other action deemed appropriate by the Institutional official is implemented. Violation of any part of these policies may also constitute cause for disciplinary, or other administrative, action pursuant to the K&A personnel policy manual.
Investigator means the project director or Principal Investigator (PD/PI) and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research to, and funded by, NSF, NIH, NIOSH, or any other government agency, or proposed for such funding, which may include, for example, collaborators or consultants.
Investigator’s 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, professional practice institutional committee memberships, and service on panels.
Family means any member of the Investigator’s immediate family, specifically, any dependent children and spouse.
Significant Financial Interest (SFI) means:
(1) A financial interesting consisting of one or more of the following interests of the Investigator (and those of the Investigator’s family) that reasonably appears to be related to the Investigator’s institutional responsibilities:
(i) 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 $5000. 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, etc.); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measure of fair market value;
(ii) 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 $5000, or when the Investigator (or the Investigator’s family) holds any equity interest (e.g., stock, stock option, or other ownership interest); or (iii) Intellectual property rights and interest (e.g., patents, copyrights), upon receipt of income related to such rights and interest.
(2) 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 excluded sources provided in regulation.
Financial Interest does NOT include:
a) Salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution;
b) Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights;
c) Any ownership interest in the Institution held by the Investigator;
d) 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;
e) 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
f) Income from service on advisory committees or review panels for a federal, state or local government agency, 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.
Financial Conflict of Interest (FCOI) means an SFI that could directly and significantly affect the design, conduct, or reporting of government agency funded research.
Institutional official means the individual within the Institution that is responsible for the solicitation and review of disclosures of significant financial interests including those of the Investigator’s Family related to the Investigator’s institutional responsibilities. For the purposes of this policy, the Institutional Official is designated by the President-CEO of the company to oversee all policies. Any significant action must be approved and authorized by the President-CEO of the Company.
Institutional responsibilities means the Investigator’s professional responsibilities associated with his or her Institutional appointment or position, including but not limited to, research, clinical activities, administration, and institutional, internal and external professional committee service.
Research means a systematic investigation, study, or experiment designed to 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).
CONFLICT OF INTEREST:
This policy is predicated on the expectation that Investigators should conduct their affairs so as to avoid or minimize conflicts of interest, and must respond appropriately when conflicts of interest arise. To that end, this policy informs Investigators about situations that generate conflicts of interest related to research, provides mechanisms for Investigators and the Institution to manage those conflicts of interest that arise, and describes situations that are prohibited.
Every Investigator has an obligation to become familiar with, and abide by, the provisions of this policy. If a situation raising questions of conflict of interest arises, an Investigator should discuss the situation with the Institutional official.
1) DISCLOSURE OF FINANCIAL INTERESTS
All Investigators must disclose their Significant Financial Interests utilizing the provided form and attaching all required supported documentation on an annual and ad hoc basis, as described below. The Institutional official is responsible for the distribution, receipt, processing, review and retention of disclosure forms.
a) Annual Disclosures
All Investigators must disclose their Significant Financial Interests that are related to the investigator’s institutional responsibilities to the Institution, through the Institutional Official, on an annual basis. All forms should be submitted to the Institutional official by 24 August of each calendar year.
b) Ad hoc Disclosures
In addition to annual disclosure, certain situations require ad hoc disclosure. All Investigators must disclose their Significant Financial Interests to the Institution, through the Institutional Official, within 30 days of their initial appointment or employment.
Prior to entering into PHS-sponsored projects or applications for PHS-sponsored projects, where the Investigator has a Significant Financial Interest, the Investigator must affirm the currency of the annual disclosure or submit to the Institutional Official an ad hoc updated disclosure of his or her Significant Financial Interests with the outside entity. The Institution will not submit a research proposal unless the Investigator(s) have submitted such ad hoc disclosures.
In addition, all Investigators must submit to the Institutional official an ad hoc disclosure of any Significant Financial Interest they acquire or discover during the course of the year within thirty (30) days of discovering or acquiring the Significant Financial Interest.
Investigators must also disclose reimbursed or sponsored travel related to their institutional responsibilities, as defined above in the definition of Financial Interest and Significant Financial Interest. Such disclosures must include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, the duration, and, if known, the monetary value. The Institutional Official will determine if additional information is needed (e.g., the monetary value if not already disclosed) to determine whether the travel constitutes a Financial Conflict of Interest with the Investigator’s research.
2) REVIEW AND DECISION OF THE INSTITUTIONAL OFFICIAL
If the disclosure form reveals a Significant Financial Interest, it will be reviewed promptly by the Institutional Official or designee for a determination of whether it constitutes a Financial Conflict of Interest. If a Financial Conflict of Interest exists, the Institutional Official will take action to manage the financial conflict of interest including the reduction or elimination of the conflict, as appropriate.
A Financial Conflict of Interest will exist when the Institutional Official or designee determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of sponsored research. If the Institutional Official determines that there is a Financial Conflict of Interest that can be managed, he or she must develop and implement a written management plan. The affected Investigator must formally agree to the proposed management strategies and sign the written management plan before any related sponsored research goes forward.
The Institutional Official will periodically review the ongoing activity, monitor the conduct of the activity (including use of students and other University personnel), to ensure open and timely dissemination of the research results, and to otherwise oversee compliance with the management plan.
3) CLINICAL TRIALS
Review of Significant Financial Interests Related to Clinical Trials
Clinical trials involve particularly sensitive issues if the Investigator has a Financial Interest related to the clinical trial.
a) K&A Wireless, LLC is extremely sensitive to any Financial Conflict of Interest involving clinical trials whose purpose is to evaluate the safety or effectiveness of a medical device, the impact of the medical device on treatment or a recommended treatment.
b) In the event of non-compliance with reporting and/or management of a financial conflict of interest involving a clinical trial, as required by this Policy, the investigator must disclose the financial conflicts of interest in each public presentation of the results of the affected sponsored research and request an addendum to previously published presentations.
4) REPORTING TO PHS
The institutional official will report financial conflicts of interest or non-compliance to PHS in accordance with PHS regulations. If the funding for the Research is made available from a prime PHS-awardee, such reports shall be made to the prime awardee prior to the expenditure of any funds and within 60 days of any subsequently identified financial conflict of interest such that the prime awardee may fulfill their reporting obligations to the PHS.
5) INVESTIGATOR NON-COMPLIANCE
When a Financial Conflict of Interest is not identified or managed in a timely manner, including, for example, because the underlying SFI is not disclosed timely by an Investigator, or, because a FCOI was not timely reviewed or reported by K&A Wireless, LLC; or because an Investigator failed to comply with a management plan; then K&A Wireless, LLC will within 90 days:
Complete a retrospective review of the Investigator’s activities and the research project to determine any bias in the design, conduct or reporting of research; Document the retrospective review consistent with the regulation; Document K&A Wireless, LLC’s determination as to whether any research, or portion thereof, conducted during the period of time of the Investigator’s non-compliance with this Policy or a FCOI management plan, was biased in the design, conduct, or reporting of such research; and Notify the PHS Grantee in writing.
If bias is found, K&A Wireless, LLC shall notify the PHS Grantee promptly and submit a mitigation report to the PHS Grantee that shall address the following:
Impact of the bias on the research project and K&A Wireless, LLC’s plan of action or actions taken to eliminate or mitigate the effect of the bias. Thereafter, K&A Wireless, LLC shall submit FCOI reports annually to the PHS Grantee, in accordance with the regulation and terms and conditions of the agreement. Depending on the nature of the FCOI, K&A Wireless, LLC 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 is identified and the completion of K&A Wireless, LLC’s independent retrospective review. In addition, K&A Wireless, LLC will document the disciplinary action, if required, taken against the individuals, or investigators for non-compliance to this policy.
Each Investigator must complete training on this Policy, the investigator’s responsibilities regarding disclosure and the PHS regulations prior to engaging in research funded by PHS, and at least every four years thereafter. They must also complete training within a reasonable period of time as determined by the Institutional Official in the event that this Policy is substantively amended in a manner that affects the requirements of Investigators, if the Investigator is new to the institution, or if it is determined that the Investigator has not complied with this policy or with a management plan related to their activities.
7) RECORD RETENTION
The Institutional Official will retain all disclosure forms, conflict management plans, and related documents for a period of three years from the date the final expenditure report is submitted to the PHS or to the prime PHS awardee, unless any litigation, claim, financial management review, or audit is started before the expiration of the three year period, the records shall be retained until all litigation, claims or audit findings involving the records have been resolved and final action taken.
To the extent permitted by law, all disclosure forms, conflict management plans, and related information will be confidential. However, the Institution may be required to make such information available to the PHS Awarding Component and/or Health and Human Services (HHS), to a requestor of information concerning financial conflict of interest related to PHS funding or to the primary entity who made the funding available to the Institution, if requested or required. If the Institution is requested to provide disclosure forms, conflict management plans, and related information to an outside entity, the Investigator will be informed of this disclosure.
9) PUBLIC ACCESSIBILITY
Prior to the expenditure of funds, the Institution will publish on a publicly-accessible website or respond to any requestor within five business days of the request, information concerning any Significant Financial Interest that meets the following criteria:
a) The Significant Financial Interest was disclosed and is still held by the senior and key personnel;
b) A determination has been made that the Significant Financial Interest is related to the PHS-funded research; and
c) A determination has been made that the Significant Financial Interest is a Financial Conflict of Interest. The information to be made available shall be consistent with the requirements of the PHS regulation.
10) REGULATORY AUTHORITY
This policy implements the requirements of 42 CFR 50 Subpart F and 45 CFR 94; where there are substantive differences between this policy and the requirements, the requirements shall take precedence.