Policies and Statements

NORTH AMERICAN VASCULAR BIOLOGY ORGANIZATION CONFLICT OF INTEREST POLICY

Conflict of Interest - Representatives
The NORTH AMERICAN VASCULAR BIOLOGY ORGANIZATION, its officers, directors, and council members scrupulously shall avoid any conflict between their own respective personal, professional or business interests and the interests of the association, in any and all actions taken by them on behalf of the association in their respective capacities.

In the event that any Officer or Councilor of NAVBO shall have any direct or indirect interest in, or relationship with, any individual or organization which proposes to enter into any transaction with NAVBO, including but not limited to transactions involving:

a. the sale, purchase, lease or rental of any property or other asset;
b. employment, or rendition of services, personal or otherwise;
c. the award of any grant, contract, or subcontract;
d. the investment or deposit of any funds of NAVBO

Such person shall give notice of such interest or relationship and shall thereafter refrain from discussing or voting on the particular transaction in which he/she has an interest, or otherwise attempting to exert any influence on NAVBO, or its components to affect a decision to participate or not participate in such transaction.

General Principles
The following general principles apply to all corporate relationships. Additional specific requirements are set out in subsequent sections below.
NAVBO prohibits the endorsement of commercial products, processes, services or enterprises. Corporate membership in NAVBO shall not be deemed as an endorsement but as an acknowledgement that a corporation supports the NAVBO mission.
NAVBO will enter corporate relationships to provide meaningful mission-related benefits, but not solely or primarily for NAVBO's financial benefit.
Use of the NAVBO name in the stylized format, the blood vessel logo servicemark, other servicemarks, or other identifying marks will be permitted by a person or organization only with the express prior written consent of NAVBO.
Whenever NAVBO is involved in a corporate relationship, an appropriate statement clarifying the relationship between NAVBO and the corporation must appear in accompanying materials.

MEETINGS

Corporate Relationships
The following general principles apply to all corporate relationships as they pertain to meetings, conferences, workshops, etc.
NAVBO prohibits the endorsement of commercial products, processes, services or enterprises within the content of its scientific sessions.
NAVBO will enter corporate relationships (accept contributions for program specific functions) to provide meaningful mission-related benefits, but not solely or primarily for NAVBO's financial benefit.
Whenever NAVBO is involved in a corporate relationship, an appropriate statement clarifying the relationship between NAVBO and the corporation must appear in accompanying materials. The statement must be conspicuous and legible. Examples of acknowledgement include:

(1) This program is supported by an educational grant from Company ABC
(2) For non-scientific events, such as a reception: Company DEF is a proud sponsor of this North American Vascular Biology Organization event.
(3) Supported by XYZ Company

Speakers
For CME accredited activities, invited speakers and abstract authors and co-authors are required to complete a Financial Disclosure Form. This form will be provided by the CME provider in compliance with the ACCME rules, policies and guidelines.

For non-CME accredited activities, invited speakers and abstract authors are instructed to refrain from endorsing commercial products, processes, services or enterprises. All invited speaker and organizers are required to complete a Disclosure Form. Abstract authors who indicate on the electronic submission form that they have a financial relationship with a company are required to complete a Disclosure Form.

In the event that a presenter does have a real or perceived relationship with a for-profit entity, that relationship is noted and made available to attendees within the meeting program and/or mobile app.

STATEMENT OF DISCLOSURE

First: Directors, officers, council members, volunteers and employees shall adhere to the highest standards of honesty, good faith and fair dealing in all activities relating to the society.

Second: No director, officer, council member, volunteer, employee or any member of their respective families or households should accept gifts, gratuities or favors of any kind which could reasonably be expected to influence his or her actions affecting the society, from any person, firm or corporation doing business or seeking to do business with the society. This prohibition is not intended to preclude nominal benefits in the reasonable and ordinary course.

Third: Each director, officer, council member, other volunteer and employee should provide the society’s Council with a full and complete written disclosure of all facts of any transaction or situation that is subject to any reasonable doubt concerning the possible existence of a conflict of interest by the director, officer or employee.

Fourth: it is recognized that situations may arise in which the society may wish to contract or enter into an arrangement for goods or services under circumstances that may present a conflict of interest. Before entering into any such contract or arrangement, the terms of the contract or arrangement should be fully and completely disclosed to the society’s Council. The society will only enter into the contract or arrangement if (1) the contract or arrangement is upon terms and conditions at least as advantageous to the society as can be reasonably obtained from any other source for equivalent goods or services; and (2) the society (with any interested members abstaining) by resolution approves such contract or arrangement.

Resolution: that annually the Executive Officer shall send to all directors, officers, councilors and contracted employees a copy of this Conflict of Interest/Statement of Disclosure, together with the form, “Conflict of Interest/ Statement of Disclosure” which shall be completed and returned to the society office. The President shall cause a confidential report to be included in the records of the corporation concerning any interests of directors, officers, councilors and contracted employees, together with his/her recommendations to the Council concerning the same. The President shall administer this policy and any disputed action of the President with respect to this policy shall be resolved by the Council.

Each new director, officer, councilor, selected volunteers and contracted employees shall participate in a similar procedure immediately upon assumption of his or her responsibilities.

NORTH AMERICAN VASCULAR BIOLOGY ORGANIZATION
CONFLICT OF INTEREST
POLICY FOR PUBLIC HEALTH SERVICE (PHS)
FUNDED PROJECTS

INTRODUCTION

The purpose of this policy is to establish guidelines for recognizing, disclosing, and managing significant financial conflict of interest in relation to PHS funded research or activity. This policy operates in conjunction with other NAVBO policies governing conflicts of interest. This policy governing financial conflict of interest applies to all investigators of the North American Vascular Biology Organization (NAVBO) engaging in PHS funded research or activity. 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 Institutional policy.

DEFINITIONS

Family - means any member of the Investigator’s immediate family, specifically, any dependent children and spouse.

Financial Interest - means anything of monetary value received or held by an Investigator or an Investigator’s Family, whether or not the value is readily ascertainable, including, but not limited to: salary or other payments for services (e.g., consulting fees, honoraria, or paid authorships for other than scholarly works); any equity interests (e.g., stocks, stock options, or other ownership interests); and intellectual property rights and interests (e.g., patents, trademarks, service marks, and copyrights), upon receipt of royalties or other income related to such intellectual property rights and interests.

Financial Interest does NOT include: a)salary, royalties, or other remuneration from the Institution; b)income from the authorship of academic or scholarly works; c)income from seminars, lectures, or teaching engagements sponsored by or from advisory committees or review panels for U.S. Federal, state or local governmental agencies; U.S. institutions of higher education; research institutes affiliated with institutions of higher education, academic teaching hospitals, and medical centers; or d)equity interests or income from investment vehicles, such as mutual funds and retirement accounts, so long as the Investigator does not directly control the investment decisions made in these vehicles.

For Investigators, Financial Interest also includes any third party reimbursed or sponsored travel undertaken by the Investigator and related to his/her institutional responsibilities. This includes travel that is paid on behalf of the Investigator as well as travel that is reimbursed, even if the exact monetary value is not readily available. It excludes travel reimbursed or sponsored by U.S. Federal, state or local governmental agencies, U.S. institutions of higher education, research institutes affiliated with institutions of higher education, academic teaching hospitals, and medical centers.

Significant Financial Interest - means a Financial Interest that reasonably appears to be related to the Investigator’s Institutional Responsibilities, and:

a) if with a publicly traded entity, the aggregate value of any salary or other payments for services received during the 12-month period preceding the disclosure, and the value of any equity interest during the 12-month period preceding or as of the date of disclosure, exceeds $5,000; or

b) if with a non-publicly traded entity, the aggregate value of any salary or other payments for services received during the 12-month period preceding the disclosure exceeds $5,000; or

c) if with a non-publicly-traded company, is an equity interest of any value during the 12-month period preceding or as of the date of disclosure; or

d) is income exceeding $5,000 related to intellectual property rights and interests not reimbursed through the Institution, or

e) is third party reimbursed or sponsored travel related to their institutional responsibilities with an aggregate value per entity exceeding $5,000 during the 12-month period preceding the disclosure.

Financial Conflict of Interest - means a Significant Financial Interest (or, where the Institutional Official requires disclosure of other Financial Interests, a Financial Interest) that the Institution reasonably determines could directly and significantly affect the design, conduct or reporting of PHS-sponsored 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 as the NAVBO Executive Officer.

Institutional responsibilities - means the Investigator’s professional responsibilities associated with his or her Institutional appointment or position, such as research, teaching, clinical activities, administration, and institutional, internal and external professional committee service.

Investigator - means any individual who is responsible for the design, conduct, or reporting of PHS sponsored research, or proposals for such funding. This definition is not limited to those titled or budgeted as principal investigator or co-investigator on a particular proposal, and may include postdoctoral associates, senior scientists, or graduate students. The definition may also include collaborators or consultants as appropriate.

Public Health Service (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 of the PHS may be delegated. The components of the PHS include, but are not limited to, the Administration for Children and Families, Administration on Aging, Agency for Healthcare Research and Quality, Agency for Toxic Substances and Disease Registry, Centers for Disease Control and Prevention, Federal Occupational Health, Food and Drug Administration, Health Resources and Services Administration, Indian Health Service, National Institutes of Health, and Substance Abuse and Mental Health Services Administration.

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).

Subrecipient - means any domestic or foreign, public or private, entity or organization (excluding a Federal agency) that receives pass-through funding from NAVBO in the form of a subaward.

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. Subrecipients that receive pass-through PHS funding from NAVBO shall meet the standards of this policy or certify that the subrecipient possesses and maintains a conflict of interest policy that meets of the requirements of all applicable Federal standards.

1) DISCLOSUREOF FINANCIAL INTERESTS

All Investigators are required to disclose their outside financial interests as defined above to the Institution on an annual and on an 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, as determined by the Institution.

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.

c) Travel

Investigators must also disclose third party 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 PHS-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 PHS-sponsored research goes forward. The Institutional Official will periodically review the ongoing activity, monitor the conduct of the activity (including use of students and postdoctoral appointees), to ensure open and timely dissemination of the research results, and to otherwise oversee compliance with the management plan.

3) 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.

4) INVESTIGATOR NON-COMPLIANCE

a) Disciplinary Action

In the event of an Investigator’s failure to comply with this Policy, the Institutional Official may suspend all relevant activities or take other disciplinary action until the matter is resolved or other action deemed appropriate by the Institutional Official is implemented. An Institutional Official’s decision to impose sanctions on an Investigator because of failure to comply with this Policy, or failure to comply with the decision of the Institutional Official, will be described in a written explanation of the decision to the investigator, and, where applicable, the IRB, and will notify the individual of the right to appeal the decision. The Institution will promptly notify the PHS Funding Agency of the action taken or to be taken. If the funding for the research is made available from a prime PHS awardee, such notification shall be made promptly to the prime awardee for reporting to PHS.

b) Retrospective Review

In addition, if the Institutional Official determines that a Financial Conflict of Interest was not identified or managed in a timely manner, including but not limited to an Investigator’s failure to disclose a Significant Financial Interest that is determined to be a Financial Conflict of Interest, or failure by an Investigator to materially comply with a management plan for a Financial Conflict of Interest, a committee comprised of the NAVBO Executive Officer, NAVBO President and Secretary/Treasurer shall complete a retrospective review of the Investigator’s activities and the PHS-sponsored research project to determine whether the research conducted during the period of non-compliance was biased in the design, conduct or reporting of the research. Documentation of the retrospective review shall include the project number, project title, PI, name of Investigator with the Financial Conflict of Interest, name of the entity with which the Investigator has the Financial Conflict of Interest, reason(s) for the retrospective review, detailed methodology used for the retrospective review, and findings and conclusions of the review. The Institutional Official will update any previously submitted report to the PHS or the prime PHS-awardee relating to the research, specifying the actions that will be taken to manage the Financial Conflict of Interest going forward. This retrospective review will be completed in the manner and within the time frame established in PHS regulations. If bias is found, the institution will promptly notify the PHS Awarding Component and submit a mitigation report in accordance with the PHS regulations. The mitigation report will identify elements documented in the retrospective review, a description of the impact of the bias on the research project and the plan of action to eliminate or mitigate the effect of the bias.

5) TRAINING

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.

6) 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.

7) CONFIDENTIALITY

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 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.

8) 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.

9) 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.