Effective May 24, 2018
The North American Vascular Biology Organization (“NAVBO”) respects the privacy of its members, customers, contacts, and partners. To protect online privacy, NAVBO has implemented the following policy.
Data collected by NAVBO are used to provide better service to NAVBO’s members and other users of NAVBO’s web site. It is NAVBO’s policy to collect and store only information that users voluntarily provide.
Personal data is defined in this policy and in the General Data Protection Regulation (GDPR) as any information related to an identifiable person who can be directly or indirectly identified in particular by reference to an identifier.
NAVBO is the data controller of your Personal Data. NAVBO utilizes Ungerboeck Systems International as its data processor on behalf of members for Personal Data that is processed through the website.
Notice for Visitors
NAVBO may collect certain personal data when a user visits the website. Aggregate data, such as IP addresses and the number of hits per page, may be collected. We may use information about your IP address to help diagnose problems, perform administrative tasks, analyze trends, track page usage statistics, and gather information that assists us in identifying visitor preferences. We may also use aggregate data for our business purposes such as disclosing such data to our partners and service providers, however this aggregate data does not identify you. Notwithstanding anything herein to the contrary, NAVBO may share personal data disclosed with consultants and staff for internal business purposes and as required by law if such data are subpoenaed.
Our memberships, services, and meetings are designed for those over the age of 18, and are most certainly not directed to, or to our knowledge used by, children under 13 years of age. Our memberships, services, and meetings are not targeted to, intended to be consumed by, or designed to entice individuals under the age of 18 and certainly not for those under 13 years. If you know of or have any reason to believe anyone under the age of 18 and in the very remote event that you know of or have any reason to believe anyone under the age of 13 years has provided us with any personal data, please contact us.
A cookie is a file that stores data on a user’s computer or returns it to the web server. The data in the file is information a user has entered using an online form, or generic information about the visiting user, such as IP address or browser type. A cookie can either be temporary or persistent, but ultimately the user is in control of it and how any cookie is stored through their web browser.
NAVBO requires cookies to provide functionality on certain areas of the website; the member log in portal for example. If cookies are not enabled, those areas will not function as intended and NAVBO will be unable to provide the full range of services the user might be expecting. NAVBO does not store any financial information in cookies.
Several areas of the NAVBO website (such as membership forms, meeting registration forms, abstract submission forms, and online voting) request users to provide various types of information: contact information (e.g., names and email addresses), financial information (like credit card information), and demographic information (like address and zip code). Each type of information serves a different purpose, depending on where it is requested. The types of personal data we collect are based on the services being requested by the user.
Contact information obtained from order forms may be used to provide information about educational programs and the like. Financial information that is collected is used solely to bill the user for products and/or services ordered. Financial information will in no way be used for marketing purposes, nor will it be shared with any third parties unless the third party manages the billing for NAVBO.
NAVBO uses email as a method to communicate with members and colleagues. Users may change their communication preferences and also withdraw consent to receive emails at any time.
Security Capabilities and Financial Information
Financial information may be collected online when individuals register for meetings, submit abstracts, order publications, or make payment for membership. The online forms are secured using SSL protocols. This encrypts the entered information during the transaction in order to protect the information from unauthorized access. The SSL certificates are provided by trusted and established certificate vendors.
This site contains links to other sites. NAVBO is not responsible for the privacy practices or the content of external websites. Websites maintained by third parties may collect information and use it in a way inconsistent with this privacy statement. We encourage our users to be aware when they leave NAVBO’s website, and to read the privacy statements of each website they visit. Websites maintained by third parties may also refer to NAVBO products, processes, or services; unless NAVBO has provided explicit authority, such references in no way indicate our endorsement, recommendation, or preference.
We may request information regarding various aspects of our services and programs from users through surveys. Survey participation is completely voluntary and the user has a choice whether or not to disclose any information. Information requested may include contact information and demographic information. Feedback received is used to improve our website and programs. Personal information submitted by the user in response to surveys may be used to provide information on opportunities for participation in educational activities and leadership in NAVBO, as indicated in survey forms.
Electronic comments submitted in connection with or in response to a request for input will only be published if permission is provided by the user. Participation is completely voluntary and the user has a choice whether or not to disclose any information.
Community and Public Areas
Unless clearly declared a “private” area, information posted to online forums, message boards, chat areas, news groups, and other interactive web pages is available for viewing (but not discussion) by the general public. Use of such interactive web pages is voluntary and information posted on these formats may be deleted at any time. We expect communications on such pages to be respectful of others and of NAVBO’s mission. We do not typically monitor our interactive web pages; parents should use caution when allowing children to view those pages. Please remember that any information disclosed in these areas becomes public information, and exercise caution when deciding to disclose your personal information. The email addresses of users who post such may be available to anyone who browses or uses the message area. Please use caution when posting any such information. NAVBO does not control the sending or receiving of email messages as a result of postings to our website.
Ways of Obtaining Personal Data
The ways by which NAVBO obtains personal data are defined hereby. NAVBO does not obtain any personal information about users unless they have voluntarily provided that information to NAVBO via means including but not limited to membership forms, surveys, or other on-line or hard copy forms. Members and users may choose to submit personal information by mail, phone, e-mail, or other means as deemed appropriate at that time.
The types of personal data that we collect vary based on the services offered but generally include name, address, telephone number, company name, job title, e-mail address, and other information voluntarily submitted.
While on the NAVBO website, information may be collected about your device and activity on the website. Some of the information collected may consist of, but is not limited to, search terms, browser information, computer or device type, operating system, website usage, referring/exit pages, date/time stamp, number of clicks, and ads viewed.
Use of the Information this Site Gathers and Tracks
NAVBO uses voluntarily submitted contact information to send information about meetings and membership benefits and discounts, such as voting privileges, award opportunities, funding agency requests for information, leadership opportunities, etc., as well as the NAVBO Newsletter. Contact information is also used when necessary for contractual and legitimate business purposes. The online Membership Directory is provided for informational purposes, and members may elect to be excluded from the directory either at the time of application or by contacting NAVBO and asking to be removed, as described below. (The Directory is only accessible to current members and requires a login.)
On occasion, NAVBO may rent its membership and meeting registration mailing lists for use by third parties to promote meetings, publications, or products of interest. These rented lists are mailing addresses only and do not include email addresses, phone numbers, or any other information collected by NAVBO. Members have the option to be removed from these mailing lists by contacting NAVBO.
We may also disclose personal data to third parties in the following circumstances:
– If you request or authorize (when required by the law, we will inform you in advance of the third parties to which we may provide your data and the purpose for doing so, and we will obtain your prior consent for such use);
– The information is provided, to comply with the law (for example, to comply with a search warrant, subpoena or other legal process), to protect our rights, property or safety, or the rights, property or safety of our employees or others, or to investigate fraud,
– To address emergencies;
– To address disputes, claims, or to persons holding a legal or beneficial interest;
– If we are involved in a merger, acquisition, financing due diligence, reorganization, bankruptcy, receivership, sale of company assets, or transition of service to another provider, in which case your personal data and other information may be transferred to a successor or affiliate as part of that transaction along with other assets.
Data Subject Rights
Subject to applicable law, you have the following rights in relation to your personal data:
Right of access: If you ask us, we will confirm whether we are processing your personal data and, if so, provide you with a copy of that personal data (along with certain other details). If you require additional copies, we may need to charge a reasonable fee.
Right to rectification: If your personal data is inaccurate or incomplete, you are entitled to have it rectified or completed. If we have shared your personal data with others, we will tell them about the rectification where possible. If you ask us, where possible and lawful to do so, we will also tell you with whom we shared your personal data so that you can contact them directly.
Right to erasure: You may ask us to delete or remove your personal data and we will do so in some circumstances, such as where we no longer need it (we may not delete your data when other interests outweigh your right to deletion). If we have shared your data with others, we will tell them about the erasure where possible. If you ask us, where possible and lawful to do so, we will also tell you with whom we shared your personal data so that you can contact them directly.
Right to restrict processing: You may ask us to restrict or ‘block’ the processing of your personal data in certain circumstances, such as where you contest the accuracy of that personal data or object to us processing it. We will tell you before we lift any restriction on processing. If we have shared your personal data with others, we will tell them about the restriction where possible. If you ask us, where possible and lawful to do so, we will also tell you with whom we shared your personal data so that you can contact them directly.
Right to data portability: Effective 25 May 2018, you have the right to obtain your personal data from us that you consented to give us or that is necessary to perform a contract with you. We will give you your personal data in a structured, commonly used and machine-readable format. You may reuse it elsewhere.
Right to object: You may ask us at any time to stop processing your personal data, and we will do so:
• If we are relying on a legitimate interest to process your personal data — unless we demonstrate compelling legitimate grounds for the processing; or
• If we are processing your personal data for direct marketing.
Rights in relation to automated decision-making and profiling: You have the right to be free from decisions based solely on automated processing of your personal data, including profiling, that affect you, unless such processing is necessary for entering into, or the performance of, a contract between you and us or you provide your explicit consent to such processing.
Right to withdraw consent: If we rely on your consent to process your personal data, you have the right to withdraw that consent at any time. This will not affect the lawfulness of processing based on your prior consent.
Right to lodge a complaint with the data protection authority: If you have a concern about our privacy practices, including the way we have handled your personal data, you can report it to the data protection authority that is authorized to hear those concerns.
You may exercise your rights by contacting us as indicated under “Communication Preferences” section below.
Changes to This Statement
Users can change their communication preferences at any time by logging into the the member portal on the website. This includes consenting to, or removing consent from, all of our communication areas. Alternatively, users can communicate their wishes to NAVBO via the following:
2. By sending mail or fax to:
North American Vascular Biology Organization
18501 Kingshill Road
Germantown, MD 20874
Fax: (301) 540-6903
3. By calling the following telephone number: (301) 760-7745
STATEMENT OF COMMITMENT TO DIVERSITY, EQUITY AND INCLUSION
The North American Vascular Biology Organization (NAVBO) acknowledges and affirms the importance of creating a diverse, equitable, and inclusive environment in which all members are respected and empowered. NAVBO recognizes that each person’s unique experiences, perspectives, and viewpoints add value to the NAVBO’s ability to create and deliver the best possible service to our membership.
We define diversity as creating an organizational environment that esteems individuals, their personal experiences, their scientific training, and the intersectionality of race, ethnicity, nationality, gender, sexual orientation, physical abilities, intellectual abilities, age, socioeconomic status, political beliefs, religious beliefs, military or veteran status, and ideologies.
We define equity as understanding the myriad facets of people’s personal and scientific backgrounds and working to ensure fair access to services, opportunities, and resources.
We define inclusion as the promotion of fair, safe, supportive, healthy, and open engagement among the diverse communities included in NAVBO membership.
NAVBO will promote diversity, equity, and inclusion for all with the full understanding that our individual social, ethnic, economic, and cultural identities shape and influence our experiences and perspectives. These values will guide our policies, professional development opportunities, and the continuing education of our members.
CONFLICT OF INTEREST STATEMENT - NAVBO Leadership
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.
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.
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
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.
CONFLICT OF INTEREST STATEMENT - Investigators within PHS Funded Projects
North American Vascular Biology Organization
CONFLICT OF INTEREST
POLICY FOR PUBLIC HEALTH SERVICE (PHS)
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.
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.
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.
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.
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.