Privacy Policy

Influents Innovations is strongly committed to protecting privacy.

Your privacy is critically important to us.

Influents Innovations is located at:

3800 Sports Way
Springfield, OR 97477
541-484-2123 

It is the policy of Oregon Research Behavioral Intervention Strategies, Inc, doing business as Influents Innovations (Influents Innovations) to respect your privacy regarding any information we may collect while operating our website. We respect your privacy and are committed to protecting personally identifiable information you may provide us through the Website. We have adopted this privacy policy (“Privacy Policy”) to explain what information may be collected on our Website, how we use this information, and under what circumstances we may disclose the information to third parties. This Privacy Policy applies only to information we collect through the Website and does not apply to our collection of information from other sources. 

This Privacy Policy, together with the Terms and conditions posted on our Website, set forth the general rules and policies governing your use of our Website. Depending on your activities when visiting our Website, you may be required to agree to additional terms and conditions. 

Website Visitors

Like most website operators, Influents Innovations collects non-personally identifiable information of the sort that web browsers and servers typically make available, such as the browser type, language preference, referring site, and the date and time of each visitor request. Influents Innovations’s purpose in collecting non-personally identifiable information is to better understand how Influents Innovations’s visitors use its website. From time to time, Influents Innovations may release non-personally identifiable information in the aggregate, e.g., by publishing a report on trends in the usage of its website. 

Influents Innovations also collects potentially Personally Identifiable Information (PII) like Internet Protocol (IP) addresses for logged in. Influents Innovations only discloses logged in user and commenter IP addresses under the same circumstances that it uses and discloses PII as described below. 

Gathering of Personally Identifiable Information (PII)

Certain visitors to Influents Innovations’s websites choose to interact with Influents Innovations in ways that require Influents Innovations to gather Personally Identifiable Information (PII). The amount and type of information that Influents Innovations gathers depends on the nature of the interaction. For example, we ask visitors who sign up for a blog at our ABCDuet app to provide a username and email address. 

Security

The security of your Personal Information is important to us but remember that no method of transmission over the Internet, or method of electronic storage is 100% secure. While we strive to use commercially acceptable means to protect your Personal Information, we cannot guarantee its absolute security. 

Links to External Sites

Our Service may contain links to external sites that are not operated by us. If you click on a third-party link, you will be directed to that third party’s site. We strongly advise you to review the Privacy Policy and terms and conditions of every site you visit. 

We have no control over, and assume no responsibility for the content, privacy policies or practices of any third-party sites, products or services. 

Protection of Certain Personally Identifiable Information (PII)

Influents Innovations discloses potentially Personal Information (PI) and Personally Identifiable Information (PII) only to those of its employees, contractors and affiliated organizations that (i) need to know that information in order to process it on Influents Innovations’s behalf or to provide services available at Influents Innovations’s website, and (ii) that have agreed not to disclose it to others. Some of those employees, contractors and affiliated organizations may be located outside of your home country; by using Influents Innovations’s website, you consent to the transfer of such information to them. Influents Innovations will not rent or sell PI or PII information to anyone. Other than to its employees, contractors and affiliated organizations, as described above, Influents Innovations discloses PI and PII only in response to a subpoena, court order or other governmental request, or when Influents Innovations believes in good faith that disclosure is reasonably necessary to protect the property or rights of Influents Innovations, third parties or the public at large. 

If you are a registered user of any of our apps and have supplied your email address, Influents Innovations may occasionally send you an email to tell you about new features, solicit your feedback, or just keep you up to date with what’s going on with Influents Innovations and our products. We primarily use our product associated blogs to communicate this type of information, so we expect to keep this type of email to a minimum. If you send us a request (for example via a support email or via one of our feedback mechanisms), we reserve the right to publish it in order to help us clarify or respond to your request or to help us support other users. Influents Innovations takes all measures reasonably necessary to protect against the unauthorized access, use, alteration or destruction of potentially PI or PII. 

Aggregated Statistics

Influents Innovations may collect statistics about the behavior of visitors to its website. Influents Innovations may display this information publicly or provide it to others. However, Influents Innovations does not disclose your Personally Identifiable Information. 

Cookies

To enrich and perfect your online experience, Influents Innovations uses “Cookies”, similar technologies and services provided by others to display personalized content, appropriate advertising and store your preferences on your computer.  

A cookie is a string of information that a website stores on a visitor’s computer, and that the visitor’s browser provides to the website each time the visitor returns. Influents Innovations uses cookies to help Influents Innovations identify and track visitors, their usage of http://influentsin.com/, and their website access preferences. Influents Innovations visitors who do not wish to have cookies placed on their computers should set their browsers to refuse cookies before using Influents Innovations’s websites, with the drawback that certain features of Influents Innovations’s websites may not function properly without the aid of cookies. 

By continuing to navigate our website without changing your cookie settings, you hereby acknowledge and agree to Influents Innovations’s use of cookies. 

Privacy Policy Changes

Although most changes are likely to be minor, Influents Innovations may change its Privacy Policy from time to time, and in Influents Innovations’s sole discretion. Influents Innovations encourages visitors to frequently check this page for any changes to its Privacy Policy. Your continued use of this site after any change in this Privacy Policy will constitute your acceptance of such change. 

Contact Information

If you have any questions about this Privacy Policy, please contact us via email (info@influentsin.com) or phone (541-484-2123). 

Welcome to our Privacy Policy.
Your privacy is critically important to us.

This Influents Innovations Alexa Skill Privacy Policy describes how Influents Innovations (“Influents Innovations”, “Influents”, “us”, “our” or “we”) protects your (“you”, “your”, or “the user”) privacy and your data when using any of Influents’ Alexa Skills (“our Skills”). Before using any of our Alexa Skills, please read this Influents Innovations Alexa Skill Privacy Policy and the Influents Innovations Alexa Skill Terms of Use as well as the Alexa Terms of Use and the Privacy Policies by the Amazon Digital Services LLC (with its affiliates, “Amazon”), which also govern and apply to any use by you of our Skills.

Regarding Amazon, “Alexa” means the Alexa Voice Service which includes third-party services (like our Skills), any third-party Alexa enabled hardware (such as Amazon’s “Echo” device”), and other related Software.

If you use one of our Skills, you fully agree to this Influents Innovations Alexa Skill Privacy Policy.

User Provided Information

When you use one of our Skills, you have to “talk” to Alexa. Your voice input is sent to Amazon and us, where we use it to understand what our Skill should do for you. This is necessary for our Skill to give you an appropriate answer to any of your queries posed to our Skill or to provide feedback on that voice input.

In addition, our Skills may obtain information that you provide when you download and register our Skills through the Amazon Alexa skills web site. In the context of research studies, there may be a requirement for pre-registration and in those cases appropriate consents would be requested before pre-registration. Should your registration be required to use future enhancements, please keep in mind that you may not be able to use some of the features offered by the Skills unless you register with us. Credit card information is not collected by any of our Skills at this time. Any information that you share with Amazon’s own online app store during purchase is held by Amazon and covered by Amazon’s own privacy policy(ies).

We will not normally use any information you provide to us in the Skill to contact you. Important information concerning required notices, upgrades and/or bug-fix notifications to any of our Skills, or marketing promotions will normally be distributed by means of the Amazon Alexa skills site.

If one of our Skills has a companion website, it is possible that our Skill will collect your login information. Any future enhancements to our Skills which enable to us to collect your login information will be notified to you at the time of delivery or upgrade, and you may consent to, or otherwise opt-out, of such collection at any time.

Automatically Collected Information

In addition, our Skills may automatically collect certain of your information as part of normal operation within the context of the Amazon Alexa environment, including, but not limited to, your hardware device(s) unique ID (such as the IMEI associated with your device(s)), a unique user ID, your internet protocol (IP) addresses, type of browser, browser version, your prior usage of our Skills, and information about the way you use our Skills. Our Skills may also employ “cookies”, which are files with small amounts of data, which may include an anonymous unique identifier. Cookies may be sent to your browser from one of our or Amazon’s website and stored on your computer’s hard drive. We use “cookies” to collect information. You can instruct your browser to refuse all cookies or to indicate when a cookie is being sent. However, if you do not accept cookies, you may not be able to use some portions of our Skills.

None of our Skills collects precise information about the location of your device (such as the physical location where your device is being used. Only aggregated, anonymized data that may be automatically collected by our Skills will be periodically transmitted to Amazon’s software environment and services to help us improve the Skills and the services you received from them.

We may share User Provided and Automatically Collected Information (“your information”) with third parties only in the ways that are described in this Influents Innovations Alexa Skill Privacy Policy. We will not sell this information.
We may disclose User Provided and Automatically Collected Information:
  • As required by law, such as to comply with a subpoena, court or administrative agency order, or similar legal process;
  • When we believe in good faith that disclosure is necessary to protect our rights, protect your safety or the safety of others, investigate fraud, or respond to a judicial, administrative agency, government request or investigation, or otherwise;
  • With our trusted services providers who work on our behalf, do not have an independent use of the information we disclose to them, and have agreed to adhere to the rules set forth in this privacy statement.
  • In the event of a merger, acquisition, or sale of all or a portion of the stock, business or assets of Influents Innovations (a “change in ownership”), you will be notified via the contact information you may have provided to us (if any) and/or via a prominent notice on our Web site of any such change in ownership of Influents Innovations and/or and changes to the uses of your information as a result of any such change in ownership, as well as any choices you may have regarding your information.
What are my Opt-Out Rights?

You may use the standard uninstall processes as may be available as part of your device or Amazon account.

Financial Conflict of Interest Policy

I. Statement of Philosophy Purpose of Policy

Oregon Research Behavioral Intervention Strategies Inc., dba Influents Innovations (Influents) and its employees are committed to conducting themselves and Company activities in accordance with the highest standards of integrity and ethics and in compliance with applicable state and federal laws related to conflict of interest and objectivity in research. It is the purpose of this policy to set forth the procedures for identifying significant financial interests, determining if those interests constitute a financial conflict of interest, and the procedures for reviewing and managing those conflicts. It is important to ensure that conflicts do not improperly affect Company research and other activities. To maintain objectivity in research, Influents and its employees and investigators will completely disclose, appropriately review, and robustly manage identified conflicts.

A financial conflict of interest exists when Influents, through its designated official(s), reasonably determines that the significant financial interest could directly and significantly affect the design, conduct, or reporting of all research at Influents.

Professional Interactions Encouraged

Influents actively encourages and participates in interactions with both the public and private sectors as an important component of its research activities. Influents encourages the recruitment, retention, and recognition of individuals with creative abilities who can contribute to technology transfer and interactions with private and public entities consistent with their primary commitment to Influents. Employees involved in such interactions may receive personal financial remuneration in accordance with the principles and guidelines provided in this policy.

II. Application

This policy applies to any person employed by, on the Influents Board of Directors or operating under a subaward agreement who, on behalf of Influents, is: (1) responsible for or in a position to influence the design, conduct, or reporting of research or other scholarly activity; or (2) in direct contact with suppliers or potential suppliers to Influents, or who have direct or indirect influence over purchasing decisions or contracts, or otherwise have official involvement in the purchasing or contracting process.

III. Compliance with Other Policies and Laws Applicable State and Federal Laws

Employees must comply with all applicable state and federal laws and regulations, including those related to conflict of interest and objectivity in research. These laws include, but are not

limited to: Federal Public Health Service regulations 42 CFR, part 50, subpart F; and 45 CFR, part 94.

Applicable Company Policies

This policy complements the provisions of the Scientific Misconduct Policy and the Influents Innovations Purchasing Policy.

IV. Definitions1

1 § 50.605

Conflict of Interest Committee (COIC) means the Board of Directors, the Designated Institutional Official and the Conflict of Interest Compliance Officer (COIC staff).

Conflict of Interest Compliance Officer (Compliance Officer) means the individual charged with staffing the COIC and providing administrative support for and working in concert with the Designated Institutional Official in implementing and enforcing this policy.

Designated Institutional Official (DIO) means the Human Resource Director (HRD) or the individual designated by the President who will solicit and review disclosures of significant financial interests to determine whether those interests represent a financial conflict of interest. Should a financial conflict of interest exist, the DIO and the President will work with the investigator/employee and the Compliance Officer to develop a management plan to minimize the impact of or eliminate the conflict.

Disclosure of significant financial interests means an investigator’s or an employee’s disclosure of significant financial interests to Influents.

Employee means any person employed or contracted at Influents who on behalf of the Company and/or a research project is in direct contact with suppliers or potential suppliers to Influents, or who have direct or indirect influence over purchasing decisions or contracts, or otherwise have official involvement in the purchasing or contracting process.

Financial conflict of interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of Company research and/or the negotiation of contracts and the purchase of supplies and services.

FCOI Report means Influents’ report of a financial conflict of interest to all funding agencies subject to this regulation, e.g., any component of the Public Health Service of the United States Department of Health & Human Services, including the Centers for Disease Control and Prevention and the National Institutes of Health.

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

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.

Investigator’s Institutional Responsibilities means an investigator’s or employee’s professional responsibilities on behalf of Influents, which may include: activities such as purchasing, contracting for services, research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.

Investigator means the Principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research which may include, for example, research associates, project managers, data analysts, and collaborators or consultants.

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.

Influents means Oregon Research Behavioral Intervention Strategies, dba Influents Innovations, a behavioral intervention company that routinely applies for, and receives, research funding from the Federal government.

PI means a Principal Investigator of a research project; the PI is included in the definitions of Senior/Key Personnel and Investigator in this policy.

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 policy, the term includes such activity as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award, regardless of funding source.

Senior/Key Personnel means the PI and any other person identified as senior/key personnel by Influents in the grant application, progress report, or any other report submitted to the funding agency by Influents under these regulations.

Significant Financial Interest means a financial interest consisting of one or more of the following interests of the investigator or employee (and those of the investigator’s/employee’s spouse/domestic partner and dependent children) that reasonably appears to be related to the investigator’s or employee’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 $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, 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 employee (or the investigator’s or employee’s spouse/domestic partner or dependent children) holds equity interest of any amount (e.g., stock, stock option, or other ownership interest); or

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

iv. Excluded from the definition of a significant financial interest is any income related to a phase one Small Business Innovation Research grant (SBIR). Individuals employed at Influents on phase one SBIRs are not required to disclose financial interests that may be related to their institutional responsibilities on that project.

Significant financial interest also includes occurrences of any reimbursed or sponsored travel related to an investigator’s or employee’s institutional responsibilities, the value of which is estimated to exceed $5,000. This 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 Company that is affiliated with an institution of higher education.

Significant financial interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by Influents to the investigator or employee if the individual is currently employed or otherwise appointed by Influents, including intellectual property rights assigned to Influents and agreements to share in royalties related to such rights; any ownership interest in Influents held by the individual; income from investment vehicles, such as mutual funds and retirement accounts, as long as the individual 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 Company 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 Company that is affiliated with an institution of higher education.

V. Training2

2 § 50.604 (b)

All Influents investigators must complete training prior to engaging in research related to any research grant and prior to commencing an activity involving purchases of supplies, services and/or contracting at least every four years, and immediately under these circumstances: Influents’ FCOI policy changes in a manner that affects investigator/employee requirements; an

investigator/employee is new to Influents, or; Influents finds an investigator/employee noncompliant with Influents’ FCOI policy or management plan.

VI. Disclosure3

3 § 50.604 (e)

Each investigator who is planning to participate in research or planning to assume direct or indirect responsibility for purchases of supplies, services and/or contracts must disclose to the Designated Institutional Official his or her significant financial interests (and those of their spouse/domestic partner and dependent children). Disclosure forms reflecting an investigator’s current significant financial interest must be provided prior to Influents’ expenditure of any funds under a research project and annually thereafter in order to continue in the capacity of an investigator or an employee responsible for purchasing. Updated disclosures are also required within 30 days of a change in the significant financial interests of an investigator that are related to the investigator’s institutional responsibilities. The financial interest consists of one or more of the following interests that reasonably appears to be related to the investigator’s institutional responsibilities:

  • 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;
  • 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 their spouse/domestic partner or dependent children) holds equity interest of any amount (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 interests.

Each investigator who is participating in research and/or participating in purchasing decisions is required to submit an updated disclosure of significant financial interests within thirty (30) days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new significant financial interest.

Each investigator must submit an updated disclosure of significant financial interests annually. Annual disclosures will be collected during the last quarter of the calendar year. Such disclosure shall include any information that was not disclosed initially to Influents or in a subsequent disclosure of significant financial interests, and shall include updated information regarding any previously disclosed significant financial interest (e.g., the updated value of a previously disclosed equity interest).

Investigators also must disclose the occurrence of any reimbursed or sponsored travel related to their institutional responsibilities, the value of which is estimated to exceed $5,000. 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 Company that is affiliated with an institution of higher education.

Travel to scientific meetings and to present research findings to colleagues and other interested parties is an integral part of the scientific research enterprise and affords many important opportunities for forging relationships and collaborations among researchers. Influents investigators’ travel expenses are frequently reimbursed and/or sponsored by professional societies to enable the investigator to give presentations at professional society meetings.

To minimize administrative burden, Influents investigators are required to disclose such travel only once a year. Investigators will disclose their planned or anticipated reimbursed or sponsored travel in a prospective manner (e.g., over the next twelve months) annually, at the time of the annual update of financial disclosures. No further disclosure is needed that year, assuming there are no changes to the details of the purpose of the trip, identity of the sponsor/organizer, destination, and duration. However, an investigator/employee is required to disclose a new source of travel (i.e., that was not anticipated and disclosed at the annual reporting) within thirty (30) days if the additional travel value is estimated to exceed $5,000.

The investigator will attest in writing that he/she will comply with all provisions of Influents’ Conflict of Interest Policy including the terms and conditions of a management plan, if applicable4.

4 § 50.605(b)(3)(viii)(D)

5 § 50.605(a)(10)

VII. Management5

Prior to Influents’ expenditure of any funds under a research project or the expenditure of any funds for purchasing supplies and services from an external business entity Influents’ DIO shall: review all investigator and employee disclosures of significant financial interests; determine whether any significant financial interests relate to the research or to the employee’s institutional responsibilities for purchasing/negotiating contracts; determine whether a financial conflict of interest exists; and, if so, work with the President and the investigator to develop and implement a management plan that shall specify the actions that have been, and shall be, taken to manage

such financial conflicts of interest. In cases where the conflicted investigator is not the Principal Investigator on the project, the Principal Investigator will be involved in the development and implementation of the management plan.

Examples of conditions or restrictions that might be imposed to manage a financial conflict of interest include, but are not limited to:

  • Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research);
  • For research projects involving human subjects, disclosure of financial conflicts of interest directly to participants;
  • Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the financial conflict of interest;
  • Modification of the research plan;
  • Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research or purchasing duties;
  • Reduction or elimination of the financial interest (e.g., sale of an equity interest); or
  • Severance of relationships that create financial conflicts.

The management plan will be a formal document signed by both the investigator/employee and the DIO and will include the following key elements: (a) Role and principal duties of the conflicted investigator in the research project; (b) Conditions of the management plan; (c) How the management plan is designed to safeguard objectivity in the research project; (d) Confirmation of the investigator’s agreement to the management plan; (e) How the management plan will be monitored to ensure investigator compliance; and (f) Other information as needed.

VIII. Reporting6

6 §50.605(b)(1)

Prior to the Influents’ expenditure of any funds under a research project, Influents shall provide to any funding agency requiring such a report an FCOI report regarding any investigator’s significant financial interest found by Influents to be conflicting and ensure that Influents has implemented a management plan in accordance with the regulations. In cases in which Influents identifies a financial conflict of interest and eliminates it prior to the expenditure of awarded funds, Influents shall not submit an FCOI report to the funding agency.

Any FCOI report required shall include sufficient information to enable the funding agency to understand the nature and extent of the financial conflict, and to assess the appropriateness of ORBIS’s management plan. Elements of the FCOI report shall include, but are not necessarily limited to the following:

  • Project number;
  • PI or Contact PI if a multiple 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 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;
  • A description of how the financial interest relates to the research and the basis for the institution’s determination that the financial interest conflicts with such research; and
  • A description of the key elements of Influents’ management plan, including: o 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.

For any financial conflict of interest previously reported by Influents with regard to an ongoing research project, Influents shall provide to any funding agency requiring such a report 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 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. Influents shall provide annual FCOI reports to the funding agency for the duration of the project period (including extensions with or without funds) in the time and manner specified by the funding agency.

New Personnel: For any significant financial interest that Influents identifies as conflicting subsequent to Influents initial FCOI report (e.g., upon the participation of an investigator who is new to the research project), Influents shall provide to any agency requiring such a report, within sixty (60) days, an FCOI report regarding the financial conflict of interest. Influents will implement, at least on an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage the FCOI. Depending on the nature of the significant financial interest, Influents may determine that additional interim measures are necessary with regard to the investigator’s participation in the research project and/or purchasing activities between the date that the financial conflict of interest or the investigator’s noncompliance is determined and the completion of Influents’ review.

Untimely disclosure: If Influents identifies a significant financial interest that was not disclosed timely by an investigator or, for whatever reason, was not previously reviewed or managed by Influents (e.g., was not timely reviewed or reported by a subrecipient), the DIO and President shall, within sixty (60) days: review the significant financial interest; determine whether it is related to the research; determine whether a financial conflict of interest exists; and, if so:

implement, at least on 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.

Subrecipients: Influents is responsible for ensuring any subrecipient’s compliance with the regulations and reporting identified financial conflicts of interests for subrecipient investigators to the awarding agency7. Influents must incorporate as part of a written agreement with a subrecipient, terms that establish whether the Financial Conflict of Interest policy of Influents or that of the subrecipient will apply to subrecipient investigators and include time periods to meet disclosure and/or financial conflict of interest reporting requirements. Influents is responsible for monitoring subrecipient’s compliance with the financial conflict of interest regulations, management plans, and for reporting all identified financial conflicts of interest prior to the expenditure of funds and within sixty (60) days of any subsequently identified FCOI.

7 §50.604(c) (1) – (2) 8 §50.605(a)(3)(ii)(A)

IX. Noncompliance and Retrospective Review8

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 Influents to constitute a financial conflict of interest; failure by Influents 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, Influents shall, within one hundred twenty (120) days of Influents’ determination of noncompliance, complete a retrospective review of the investigator’s activities and the research project and/or purchasing responsibilities to determine whether any research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research. Such retrospective review shall be completed by the DIO, the President and the COI Compliance Officer. The results of the review will be reported to the Conflict of Interest Committee.

Influents’ documentation of the retrospective review shall include, but not necessarily be limited to, all of the following key elements:

  • Project number;
  • Project title;
  • PI or contact PI if a multiple PI model is used;
  • Name of the investigator with the FCOI;
  • Name of the entity with which the investigator has a financial conflict of interest;
  • Reason(s) for the retrospective review;
  • Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed);
  • Findings of the review; and
  • Conclusions of the review.

Based on the results of the retrospective review, if appropriate, Influents shall update the previously submitted FCOI report, specifying the actions that will be taken to manage the financial conflict of interest going forward. If bias is found, Influents is required to notify any funding agency subject to these regulations promptly and submit a mitigation report8 to the funding agency. The mitigation report must include, at a minimum, the key elements documented in the retrospective review above and a description of the impact of the bias on the research project and Influents’ plan of action or actions taken to eliminate or mitigate the effect of the bias (e.g., impact on the research project; extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable). Thereafter, Influents will submit FCOI reports annually. Depending on the nature of the financial conflict of interest, Influents may determine that additional interim measures are necessary with regard to the investigator’s participation in the research project between the date that the financial conflict of interest or the investigator’s noncompliance is determined and the completion of Influents’ retrospective review.

8 §50.605(a)(3)(iii)

X. Remedies

Influents will establish adequate enforcement mechanisms and provide for employee sanctions or other administrative actions to ensure investigator and employee compliance as appropriate.

If the failure of an investigator to comply with Influents’ financial conflict of interest policy or a financial conflict of interest management plan appears to have biased the design, conduct, or reporting of the research, Influents shall promptly notify the funding agency of the corrective action taken or to be taken. If the funding agency is subject to these regulations (e.g., an organizational component of the Public Health Service (PHS), including the Centers for Disease Control and Prevention (CDC) or the National Institute of Health (NIH)), it will consider the situation and, as necessary, take appropriate action, or refer the matter to Influents for further action, which may include directions to Influents on how to maintain appropriate objectivity in the PHS-funded research project. The funding agency may, for example, require institutions employing such an investigator to enforce any applicable corrective actions prior to a grant award or when the transfer of a grant(s) involves such an investigator.

The funding agency may inquire at any time before, during, or after award into any investigator disclosure of financial interests and Influents’ review (including any retrospective review) of, and response to, such disclosure, regardless of whether the disclosure resulted in Influents’ determination of a financial conflict of interest. Influents is required to submit, or permit on-site review of, all records pertinent to compliance with the regulations. To the extent permitted by law, the funding agency 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 funding agency may decide that a particular financial conflict of interest will bias the objectivity of the research to such an extent that further corrective action is needed or that Influents has not managed the financial conflict of interest in accordance with the regulations. The funding agency may determine that imposition of special award conditions under 45 CFR 74.14 and

92.12, or suspension of funding or other enforcement action under 45 CFR 74.62 and 92.43, is necessary until the matter is resolved.

In any case in which the funding agency 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 Influents as required by the regulations, Influents 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.

XI. Public Accessibility9

9 §50.605(a)(5)(i-ii)

10 §50.605(a)(5)(iv)

Prior to Influents’ expenditure of any funds under a research project, Influents shall ensure public accessibility to this Policy, via a written response to any requestor within five business days of a request. In addition Influents will respond within five business days to any request for information concerning any significant financial interest disclosed to Influents that meets the following three criteria:

(1)The significant financial interest was disclosed and is still held by the senior/key personnel as defined by this policy;

(2) Influents determines that the significant financial interest is related to the research; and

(3) Influents determines that the significant financial interest is a financial conflict of interest.

The information shall include, at a minimum, the following: the investigator’s name; the investigator’s title and role with respect to Influents and/or the research project; the name of the entity in which the significant financial interest is held; the nature of the significant financial interest; and the approximate dollar value of the significant 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 one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value. Influents will note in its written response that the information provided is current as of the date of the correspondence and is subject to updates, on at least an annual basis and within sixty (60) days of Influents’ identification of a new financial conflict of interest, which should be requested subsequently by the requestor. This information shall remain available, for responses to written requests for at least three years from the date that the information was most recently updated10.

XII. Maintenance of Records11

11 §50.604(i)

Each year, within the final calendar year quarter, updated disclosure forms will be required of all

investigators who are planning to participate in research or planning to assume direct or indirect responsibility for purchases of supplies, services and/or contracts. It is the responsibility of the DIO and the Compliance Officer to maintain these forms, and to ensure that a current form is on file for all investigators at the time of a new grant submission and annual progress reports as required by Federal regulations. Financial conflicts of interest will be reported to funding agencies, as required, and a record of those reports and related management plans will also be maintained by the Designated Institutional Official and the Conflict of Interest Compliance Officer.

Influents shall maintain records relating to all investigator and employee disclosures of financial interests and Influents’ review of, and response to, such disclosures (whether or not a disclosure resulted in Influents determination of a financial conflict of interest) and all actions under Influents’ policy or retrospective review, if applicable, for at least three years from the date the final expenditures report is submitted to the funding agency or, where applicable, from other dates specified in 45 CFR 74.53(b) and 92.42 (b) for different situations.

Influents will certify, in each application for funding to which the regulations apply, that Influents (1) Has 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 ; (2) Shall promote and enforce investigator and employee compliance with the regulation’s requirements including those pertaining to disclosure of significant financial interests; (3) Shall manage financial conflicts of interest and provide initial and ongoing FCOI reports to any funding agency which requires such reports consistent with the regulations; (4) Agrees to make information available, promptly upon request, to the funding agency relating to any investigator or employee disclosure of financial interests and Influents’ review of, and response to, such disclosure, whether or not the disclosure resulted in Influents’ determination of a financial conflict of interest; and (5) Shall fully comply with the requirements of the regulations.