1. THE NAME OF THE SOCIETY
The name of the society shall be: INTERNATIONAL SOCIETY FOR VACCINES
2.1. To encourage, establish and promote the development and the use of vaccines/immunity to prevent and control infectious and non-infectious diseases in humans and animals.2.2. To develop a professional and academic society devoted to all aspects of vaccines, and to support and promote the career development of scientists in the field of vaccinology, including trainees.
3.1. To actively promote study, communication and collaboration, among individuals and organizations who seek to innovate, develop, manufacture and enhance vaccines that decrease or eliminate those diseases that are susceptible to vaccine
prophylaxis and treatment.
3.2. To examine and evaluate efficiency, safety and control issues and communicate such evaluations to those involved in the issuing of product licenses for such materials.
3.3. To encourage the development of appropriate vaccine materials and production processes on the basis of the cost-benefit relationship to the vaccinees.
3.4. To encourage and support research that seeks to determine the basis of immune protection and to use such knowledge to produce new and more efficient vaccines/immunization approaches.
3.5. To hold meetings, conferences, fairs, seminars and lectures that will promote the aims.
3.6. To publish such data and information in research papers, reviews and other media that will promote the aims.
3.6.1. To support efforts needed to establish a web site for all matters relating to vaccines and vaccination.
3.7. To examine and establish codes of practice for the production and the use of vaccines.
3.7.1. To establish the means for the professionalization and continuing education of the vaccinologists.
3.8. To honor those who have made exemplary contributions to the field.
3.9. To interact with the public and news media and present messages to the community that are consonant with the range of opinions existing in the leading workers in the field.
3.10. To generate and promote educational materials for the scientists, technicians and engineers that will continue to progress the field.
3.11. To establish standards that can be used to control the allocation of certificates of proficiency in the field.
3.12. To set up an information service to provide verbal and visual materials to those pursuing the aims of the society.
3.13. To promote the establishment of banks of materials that can support vaccine research, development, manufacture and use.
3.14. To promote those commercial activities that are both central and peripheral to those pursuing the aims of the society.
3.15. To set up task groups to tackle particular problems that stand in the way of the achievement of the aims.
3.16. To respond to initiatives from governments or their official agencies that seek to exploit vaccines or that need to be informed what vaccines can achieve in the furtherance of the aims.
3.17. To work with national and international bodies to recognize the social benefit of research and development in vaccines vis à vis therapy.
3.18. To arrange the organization, administration and finances of the Society so that it can achieve its aims.
3.19. To establish statutes in accordance with the furtherance of the aims of the Society.
3.20. To establish statutes that enable the full participation of those individuals who from time to time may have conflicts of interest.
3.21 To achieve the aims in a manner that is fair, unbiased and not subjected to pressures that are not inherent in the aims.
4.1. The Society shall consist of Ordinary, Student and Honorary Members. All such members will be or will have been actively engaged in promoting the Aims and Objectives of the Society.
4.2. The names, qualifications and professional experience of the candidates for Ordinary Membership of the Society must be sent to the Secretary on the form provided for this purpose and the record of membership fee payment sent to the Treasurer. The Secretary will review the Membership application and approve on behalf of ISV. A list of the approved Members will be updated quarterly and submitted to the Board, and available at the Annual General Meeting of the Society.
4.3. When a person has been approved as a member of the Society, the Secretary shall inform that individual and shall send the new member a copy of the Constitution.
4.4. A Student Membership is granted to students actively enrolled in a degree-awarding program in an accredited higher institution. A letter is required from a mentor, department chair or school registry to confirm the student status. The membership fee is reduced for a student member.
4.5. The Board shall have the power to terminate a membership if such a termination appears to them to be in the interests of the Society. Termination must be justified internally by the Board. An explanation of such a termination may be requested at a General Meeting.
4.6. Honorary Members of the Society shall not number more than 10% of the membership. Nominations for Honorary Membership shall be put forward by the Board and shall be circulated to Members with the Agenda for the Annual General Meeting. Members who cannot attend the meeting shall be entitled to vote by post or by e-mail. To qualify for Honorary Membership the nominee must be supported by 66 % of the Members who take part in the voting.
5. ISV Fellows
5.1. ISV may elect people with significant contribution to the science of vaccines and to ISV as ISV fellows.
5.2. ISV fellows must maintain active ISV membership status with paid membership dues, and only fellows in active status are qualified to vote for new fellows and are eligible for running as a member of the Board.
5.3. The Past-president will coordinate the election and activities of ISV fellows.
5.4. Each year, existing ISV fellows may nominate certain numbers of candidates to Past-president who will solicit supporting letters from two ISV members including at least one from an ISV fellow.
5.5. Existing fellows will vote to elect new ISV fellows by simple majority, with no more than five new fellows elected in any given year.
6. OFFICERS AND BOARD
6.1. The Honorary Officers of the Society shall be a President, a Secretary, a Treasurer, a Past President and a President-Elect.
6.2. There shall be a Board of the Society consisting of the five Officers and ten elected members (including five elected from the existing Fellows and five from the other ordinary ISV members). Non-Fellow members can also be nominated for the openings reserved for Fellows if there are less than five candidates for Fellow positions. The President shall serve as Board Chair during his or her term.
6.3 The President shall have the authority to appoint one or more Board Members as Vice Chair(s) to assist the Board Chair in managing Board activities as assigned by the Board Chair during his or her term. This role is designed to ensure continuity of the organization and to stimulate other Board Members to take on leadership roles within ISV.
6.4. The Officers shall run the regular operation of ISV activities including the Annual General Meeting of the Society. The Board sets the overall strategy of ISV and oversees the work of Officers. The term of newly elected Officers and the Board starts on January 1st of the year immediately following the election and ends on December 31st of the next year for a full two calendar years.
6.5. The Officers of the Society and the other five non-Fellow members of the Board shall be elected at the Annual General Meeting of the Society. Five Fellow members will be elected by existing ISV Fellows no later than the Annual General Meeting of the Society.
6.5.1. President and President-Elect of the current term will be the persons to run election with the support of ISV Office.
6.5.2. Nominations for a position on the Board may be made by any Member of the Board or by any two ordinary Members no later than two weeks prior to the Annual General Meeting of the Society. The final list of candidates shall be sent together with the written consent of the nominees along with nominees’ personal statement and/or bio to the Secretary no later than two weeks before the Annual General Meeting of the Society. Such nominations shall be circulated with the notice of that meeting. Only members in good standing can vote. Members unable to attend the meeting shall be entitled to vote by post or e-mail. If other nominations are not received for the filling of vacancies, the Board shall nominate one for each available vacancy.
6.6. The President shall hold office for two consecutive years and shall not be eligible for re-election to the same office for a further period of two years. The President-Elect serves for a two-year term before becoming President. The Past-President has a two-year term which commences after stepping down from the position of President.
6.7. The President may be removed from office by 25 members of the society signing a petition that there be a vote calling for the removal of the President from office. There will then be a ballot by email of all the Members and in the event that over 66% of those voting to uphold the petition, then the President will stand down and an election by email will be held to obtain a new President.
6.8. Other Officers and Board members shall hold office for two years and may be re-elected to the same or different offices in subsequent elections.
6.9. The Board may, for specific purposes, co-opt members to participate in Board Meetings but such co-opted members would not be eligible to vote on resolutions proposed in Board.
6.10. From time to time the Board may establish sub-committees to pursue specified elements of the Aims and Objectives of the Society. The Board shall have the power to appoint and remove individuals from such sub-committees and to dissolve such sub-committees when this is deemed necessary. An Officer of the Society shall be an ex-officio member of each sub-committees.
7.1. Members shall pay to the Society's account an annual membership due payable in advance due on the 1st of January. The amount of the subscription shall be set at the Annual General Meeting of the Society and shall remain in force until it is changed at another Annual General Meeting of the Society. The Board shall have the power to terminate membership if a member fails to pay the subscription after due notice has been given. Honorary Members do not pay a subscription.
7.2. For membership of the Society to become effective an electronic method for the transfer of funds or other acceptable fund transfer approach will be used for the payment of the subscription that shall be received by the Treasurer at the time of application or the annual renewal. But the Board shall have the power to relax this requirement in exceptional cases.
7.3. The funds and estates of the Society shall be derived from the annual membership due of Members, donations, grants, funds generated by running events and other endowments accepted by the Board on behalf of the Society. They shall be administered by the President and/or Treasurer acting on instructions given by the Board of the Society and shall only be used for the furtherance of the Aims and Objectives of the Society.
7.4. The accounts of the Society shall be audited by the Board before the Annual General Meeting of the Society and a report shall be made by the Treasurer to the Annual General Meeting of the Society.
7.5. In the event that the Society is dissolved for any reason, the surplus funds remaining after the satisfaction of all debts and liabilities shall not be distributed among the Members but shall be paid or transferred to some other charitable institution or institutions having objects similar to those of the Society and which shall also prohibit the distribution of its or their income among its or their Members. Such institution or institutions shall be determined by the Members of the Society at or before the time of dissolution and if effect cannot be given to this provision, the surplus funds shall be devoted to some charitable object or objects.
8.1. The Annual General Meeting of the Society (and when necessary a Special General Meeting) shall be held annually as part of the annual congress or at a place and time decided by the Board. The Secretary shall circulate the Agenda to all Members before the Meeting.
8.2. Scientific meetings and symposia relating to the objects of the Society shall be arranged from time to time by the Board. One such meeting may immediately precede or follow the Annual General Meeting and at each such Meeting the Board shall submit proposal for the dates of such Meetings to be held during the ensuing twelve months. Unauthorized reports, minutes of the proceedings of any Meeting of the Society or its officers shall not be disclosed to the press.
9. ALTERATIONS TO THE CONSTITUTION
9.1. Alterations to any provision of this Constitution of the Society shall be made only at the Annual General Meeting of the Society provided that notice of such an alteration has been given on the Agenda of the Meeting and that two-thirds or more of those voting on the alteration signify their assent. Members unable to attend the Meeting shall be encouraged to express themselves in letters which will be read out at the Meeting. Notice of any proposed alteration duly seconded shall be given to the Secretary no later than two weeks before the Meeting.
9.2. ISV is incorporated in the state of Massachusetts, USA and registered with US IRS as a 501(c)(3) organization. The Constitution of the Society cannot be altered such that the Society will cease to be a charity at law.
POLICIES of the ISV
The ISV Safety Plan and Anti-Harassment Policy
The International Society for Vaccines (ISV) is committed to global outreach and global equity to promote and provide a welcoming and safe environment for all membership and meeting participants, regardless of their sex, race, ethnicity, color, national origin, age, religion, sexual orientation, gender identity, disability, or other status. The organization has zero tolerance for harassment of any kind toward congress delegates or congress support staff. The ISV expects all congress delegates to engage in considerate and professional discourse throughout activities and events of the Society.
Reporting & Notification Steps
If an ISV congress delegate or society member believes they have been discriminated against, experienced bias, or harassment because of race, color, national origin, disability, age, sex, gender, sexual orientation, culture, or religion they are supported and encouraged to notify the ISV Society President, or the Society President-Elect, or the ISV Congress Co-Chairs. ISV Staff may also be informed to assist with reporting of allegations. Anonymous concerns may be expressed to the ISV general emails (email@example.com, firstname.lastname@example.org), and the email addresses of ISV Officers may be provided for direct communications to the complainant or person filing a complaint on behalf of another person. An ombudsman may be appointed to help the person submitting the harassment complaint.
It is not a requirement to file a complaint through the ISV Congress Chairs, Officers, Board Members or Staff, if the complainant wishes to file a complaint of discrimination with the Health and Human Services (HHS) Office for Civil Rights (OCR); information to be found here: https://www.hhs.gov/civil-rights/filing-a-complaint/index.html. Further, if the complainant seeks assistance from the Congress Chairs or ISV leadership, they are not prohibited from also filing complaints with HHS OCR.
The ISV leadership and staff convey their commitment to providing a welcoming and inclusive environment for the free exchange of ideas to all ISV members and conference delegates. Should an ISV member or meeting delegate express concerns of harassment or discrimination, the ISV leadership and staff will provide the support and procedures to address the situation as described above. Any violation of the ISV Code of Conduct will result in the ISV launching investigation and taking appropriate action against the individual(s) concerned. This may result in individual(s) not being admitted to an event, being removed from an event and/or being removed from the membership (if they are a member). The ISV reserves the right to take action as deemed necessary and appropriate.
The ISV Diversity Plan
The International Society for Vaccines (ISV) engages, supports, and sustains the professional goals of a diverse membership in all areas relevant to vaccines. As such, the ISV is fully committed to continuous growth of its inclusive membership, reach and impact. The ISV Diversity Plan focuses on the inclusion of diverse and underrepresented (UR) groups defined by gender, sexual orientation, race/ethnicity, culture, geography, country of origin, stage of career, affiliation, culture and background and also breadth of viewpoints important for the fruitful exchange of information, sharing of research for the acceleration of vaccine development.
Diversity in Life Sciences at the ISV
As a central pillar of the ISV mission, ISV leadership has proactively ensured that diversity, in its different guises, is represented throughout ISV membership, at its conferences, and within the ISV Board, Officer and Committees. The ISV has a focus to boost diversity and inclusion in vaccinology and its underpinning sciences to bring people with diverse backgrounds, experiences and viewpoints together for the sharing of ideas and acceleration of vaccine research. As an international society representing over 44 countries, headquartered in the United States, the ISV is uniquely capable of implementing strategies to broaden UR representation of US citizens and resident-alien scientists who are Black/African American, Hispanic/Latino, Native American/Alaskan Native, Native Hawaiian/Pacific Islander, Bi-cultural, also including persons with disabilities. Over the past decade, ISV has focused strategic efforts to encourage women to run for positions on the Board and as Officers, with the result that the current President and President-Elect, one of the two Co-Chairs of the Board, and 4 of the remaining 10 Board Members are female. Thus, 43% of ISV Officers, 40% of the ISV Board, and 33% of ISV Fellows are women, and 2% of ISV Fellows represent UR groups. Each year’s annual congress program is designed by ISV Congress Co-Chairs, with input from the Scientific Committee, ISV Officers and Board Members; invited speakers are selected to bring a variety of scientific expertise to the program, avoid repetition of speakers, and reflect the diversity in the audience.
ISV Committee Strategies
Early in 2022, the ISV Board formed committees to put its strategic goals into action. Specifically, the ISV Education & Mentorship, Awards & Prizes, and Global Equity & Engagement Committees provide support, mentorship, and educational resources for junior investigators to develop leadership skills and form collaborations important for career development. These activities are extended further though initiatives that expand gender and race diversity to include scientists of different countries of origin, cultures, religions, backgrounds, stages of career, and affiliation, providing platforms to share in their many experiences, form new connections, widen networks and career path opportunities, all to the benefit of scientific research and contribution. Through its diverse membership, committed leadership and extensive reach, ISV is well equipped to provide mentorship opportunities that expand beyond one-to-one connections, leading to research advancement and career progression. Face-to-face mentorship activities occurring during the ISV Annual Congress are considered critical to the success of the conference programs. Educational Breakout Sessions, Meet-the Expert Lunches, and Career Development Panels are planned to foster in-person exchange between junior and senior investigators.
ISV Awards and Prizes to support Diverse Participation
ISV Awards are a tradition at ISV Congresses, relying upon donations and grants to support the participation of junior investigators, students, postdocs, females, and scientists representing UR groups, and scientists from Low- and Middle-Income Countries (LMICs). The Bright Sparks in Vaccinology competition recognizes research and presentation skills of early-career researchers attending the ISV Congress. These exciting programs combine competition with outstanding science. A panel of judges scores abstracts and onsite presentations. This NIAID conference grant would allow continuation and broadening of successful ISV Award programs for students, postdocs, junior, UR, and female investigators at the 2023 ISV Annual Congress.
The ISV Annual Congress Information on Childcare Services and Disability Access
At the 2023 ISV Annual Congress in Lausanne, Switzerland, ISV Staff has confirmed that childcare services are available with the SwissTech Convention Center for any congress delegate requesting such assistance so they may fully participate in the congress while also attending to the needs of their family. Within communications to ISV Congress delegates and faculty, ISV administrative staff will survey the needs of attendees and provide childcare details as requested. In addition, the ISV congress registration form includes questions for delegates to provide any special dietary or disability needs to help coordinate transportation, hotel and convention center access, and meal service. The SwissTech Convention Center and accompanying SwissTech Hotel is fully accessible to persons in wheelchairs with ramps, wide hallways, automatic doors, and elevators, as well as a disabled lavatory facility at the convention center and personnel assistance as needed.
Financial Conflict of Interest (FCOI) Policy for the International Society for Vaccines (ISV, the Society)
The Department of Health and Human Services has set regulations designed to require disclosure and management of any financial conflicts of interest (FCOI) of organizations or individuals who receive funding from the National Institutes of Health. To comply, the ISV’s Financial Conflict of Interest (FCOI) serves the purpose to protect the organization’s interest when entering into financial agreements or transactions that may benefit a private interest of an ISV Officer, ISV Board Member, ISV Fellow, ISV Member, or the ISV Staff. The FCOI aims to avoid excessive benefit or perception of beneficial transactions. FCOI means a significant financial interest that could directly or significantly affect the conduct or reporting of the NIH-funded project. It does not substitute applicable federal or state conflict of interest governance that is applicable to nonprofit organizations. The ISV’s FCOI serves to establish definitions, procedures, and recordings of procedures that will offer protection against charges of impropriety involving ISV Officers, ISV Board Members, or ISV Staff.
Interested Persons, as mentioned below, include any principal member of the Society, Officer, or Director, who may have either a direct or indirect financial interest. Financial Interest, as mentioned below, is defined as any person who has a direct or indirect financial interest through business, family (spouse, partner, dependent children), or investment to the following:
- Investment interest in an entity, financial institution, business, professional firm, or individual providing goods or services with which the ISV has a transaction or financial agreement.
- Compensation arrangement with the Society or an entity or individual with which the society has a transaction or agreement.
- Compensation may include direct and indirect payment or substantial gifts or favors.
-The potential for investment interest or compensation arrangement with any entity or individual with which the Society is negotiating a transaction or agreement.
- A financial interest in Society does not necessarily mean a conflict of interest; it is the ISV Officers who may determine that a conflict of interest exists in accordance with this policy.
Should a financial conflict of interest be perceived to exist, the following procedures may occur:
- There will be a duty to disclose a connection with any actual or possible conflict of interest, and an interested person must disclose the existence of the financial conflict of interest with the opportunity to disclose all material facts to the ISV Officers.
- Any ISV Officer may recuse themselves, at any time, from involvement in any decision or discussion in which the Officer believes they may have a conflict of interest, without going through the process for determining whether a conflict of interest exists.
- Determination of whether a conflict of interest exists would follow the disclosure of the financial interest and all material facts. After any discussion with the interested person, they shall leave the Officers or Board meeting which such determination of a conflict of interest is reviewed and voted upon. The remaining Officers or Board Members shall determine if a conflict of interest exists.
To address a conflict of interest, the following procedures may occur:
- An interested person may make a presentation at the ISV Officers or ISV Board or Committee Meeting then leave the meeting for discussion and vote by other Members on whether the transaction or agreement involved a potential conflict of interest.
- The ISV President or ISV Vice-Chair of the Board shall, if appropriate, appoint a disinterested person to investigate options to the proposed transaction or agreement.
After investigation, the ISV Officers or Board shall determine whether the ISV can obtain a solution with reasonable efforts that avoids or does not give rise to a conflict of interest.
- If a more advantageous transaction or agreement is not reasonably possible under the circumstances to avoid a conflict of interest, then the ISV Officers or Board shall determine, by a majority vote of disinterested Members, whether the transaction or agreement is in the best interest of the Society, for its own benefit, and whether it is fair and reasonable. In conformity with the above determination, it shall make its decision as to whether to enter into the transaction or agreement.
- If there is violation of the ISV Financial Conflict of Interest Policy, the following actions may occur:
- If an ISV Officer or Board Member has reason to believe that another Member has failed to disclose an actual or possible financial conflict of interest, then the interested Member shall be informed of the basis for the violation of the FCOI. The Member will be offered the opportunity to explain the alleged failure to disclose the interest.
- After hearing the Member’s response to the information, further investigation may be warranted and the ISV Officers or Board may determine that the Member has failed to disclose an actual or possible conflict of interest, then it shall take appropriate disciplinary and correction action.
- The Minutes of the ISV Officers meeting or ISV Board meeting will contain the names of the persons who disclosed or were found to have a financial interest in connection with an actual or possible conflict of interest, with the nature of the financial interest. Any action taken to determine whether a conflict of interest was present will be recorded in the minutes with the ISV Officers or ISV Board’s determination as to whether a conflict of interest, in fact, existed. The names of those present in the discussion, investigation, and votes taken in connection with the proceedings will be recorded in the minutes.
- A staff member, ISV Officer or ISV Board Member who receives compensation, directly or indirectly, from the ISV for services is precluded from voting on matters pertaining to that member’s compensation.
- A voting member of any ISV Committee, whose jurisdiction includes compensation matters and who receives compensation, directly or indirectly, from the ISV for services is precluded from voting on matters pertaining to that member’s compensation.
- No voting member of the ISV Officers or Board or any ISV Committee, whose jurisdiction includes compensation matters and who receives compensation, directly or indirectly, from the ISV, either individually or collectively, is prohibited from providing information to any Committee regarding compensation.
Statement of Affirmation
- Each ISV Officer and staff member with Board–delegated powers shall sign a statement that affirms such person has received a copy of the conflict-of-interest policy, has read and understands the policy, has agreed to comply with the policy, understands the ISV is charitable and in order to maintain its federal tax exemption it must engage primarily in activities that accomplish one or more of its tax-exempt purposes.
To ensure the ISV operates in a manner consistent with charitable purposes and does not engage in activities that could jeopardize its tax-exempt status, periodic reviews shall be conducted. The periodic reviews shall, at a minimum, include the following subjects:
- Whether compensation arrangements and benefits are reasonable
- Whether partnerships, joint ventures, and arrangements with management organizations, if any, conform to the ISV’s written policies, are properly recorded, reflect reasonable investment or payments for goods and services, further charitable purposes, and do not result in inurement, impermissible private benefit, or in an excess benefit transaction.
Policies of the ISV, revised 18 July 2023
Financial Conflict of Interest (FCOI) Policy for the International Society for Vaccines (ISV)
Effective Date: 1 August 2023
1. Background, Purpose, and Scope of the ISV FCOI Policy
Effective September 16, 2022, the National Institutes of Health (NIH) of the Department of Health and Human Services (DHHS) has posted the resource, the NIH’s Guide Notice NOT-OD-22-210, to existing Public Health Service (PHS) regulations for promoting objectivity in research (42 CFR part 50 subpart F). These regulations are designed to encourage research integrity by requiring disclosure and management of any financial conflicts of interest (FCOI) of investigators who receive research funding from the NIH. To comply with the DHHS regulations and companion rules published by the National Science Foundation (NSF), the ISV has written its FCOI policy to accomplish the following:
- Informs all senior key personnel and investigators of the federal conflict of interest rules and their responsibilities under those rules,
- Mandates conflict of interest training for investigators before they engage in research under a federally funded grant and at prescribed intervals thereafter; training is provided through https://grants.nih.gov/grants/policy/coi/fcoi-training.htm
- Requires investigators applying for, or receiving, federal research funding to disclose any significant financial interests,
- Designates institutional officials who will review disclosure statements, identify any financial interests that could directly and significantly affects the design, conduct, or reporting of the funded research, and determine appropriate measures to manage or eliminate the conflicts of interest,
- Establishes mechanisms for ensuring compliance with the policy and any stipulated remedial measures, and imposes sanctions, as appropriate, for an investigator’s failure to comply, and,
- Requires institutional reporting to the funding agency of any conflict of interest, if mandated, and maintenance of related records for three years from the date of submission of final grant expense reports.
The ISV FCOI policy is intended to supplement the ISV’s general policy on conflicts of interest disclosure applicable to members of the ISV Board, and ISV administrative staff, which requires annual disclosure of personal financial interests and external commitments, irrespective of the receipt of grant funding from federal sources.
This policy affects only research funded by agencies of the PHS, and the NSF, particularly applied to the ISV R13 conference grant application 1R13AI179169-01, GRANT13770325. Since the rules issued by the US DHHS for PHS-sponsored research and the NSF are not identical, the ISV has chosen to confirm the policy to the PHS rules.
The ISV considers compliance with these rules fundamental to maintaining continued public trust in the integrity of research conducted at the ISV. Members of the ISV Board and Staff are encouraged to direct any questions concerning the rules of the ISV’s Officers (President, President-Elect, Past-President, Treasurer, Secretary, and Vice-Chair of the Board).
2. Persons Affected
The following have responsibility under this policy:
- All Investigators (defined below),
- ISV Departments responsible for administration of federal grants and reporting to federal sponsors, i.e. ,PHS and NSF,
- Departments involved in managing non-federal funding sources including any of the ISV’s commercial partners for business development and institutional advancement.
- ISV committees and staff responsible for implementation, assessment, management, and reporting of the COI disclosure processes,
- Family: an Investigators spouse, domestic partner, or dependent children including same-sex partners/spouses
- Equity Interest(s): stock, stock options, warrants, and other existing or continent ownership interests in a commercial entity.
- Financial Conflict of Interest (FCOI): a significant financial interest (defined below) that could directly and significantly affect the design, conduct, or reporting of PHS or NSF-funded research.
- Institutional Responsibilities: an Investigator’s professional responsibilities on behalf of the ISV and as defined by the ISV’s general COI policy, including, but not limited to, activities such as research, research consultation, teaching, administration, institutional committee memberships, and service on panels and review boards.
- Investigator: a project director, senior, key personal, or principal investigator and any other person, including collaborators and consultants, who are responsible for the design, conduct or reporting of research, including key personal, for which PHS or NSF funding is sought or obtained.
- Ethics Administrator: a person who has responsibilities defined in this policy and is the individual appointed by the ISV President as Research Integrity Officer under PHS policy.
- Research: a systematic investigation, study, or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health. The term encompasses basic and applied research and product development.
- Significant Financial Interest (SFI): any of the following items of monetary value received by an Investigator, alone or in combination with his or her Family and has not excluded in subsection 5 below) that appear reasonably related to the Investigator’s Institutional Responsibilities:
- payments, renumeration or anything of monetary value in or from a publicly traded entity where the aggregate value of the payments received during the 12-month period preceding the disclosure, or expected over the next 12-month period, when aggregated, exceeds $5,000, or the aggregate value as of the date of disclosure of any Equity Interest in the entity exceeds $5,000, as determined through reference to public prices or other reasonable measures of fair market value.
- payments or anything of monetary value from a non-publicly traded entity where the aggregate value of the payments received during the 12-month period preceding disclosure, or expected over the next 12-month period, exceeds $5,000,
- equity interests of any value in a non-publicly traded entity,
- payments received from an organization other than the ISV relating to intellectual property rights and interests including patents and copyrights,
- travel related to institutional responsibilities that is reimbursed or sponsored by an organization other than a US federal, state, or local government agency, a US institution of higher education, a US academic teaching hospital, a US medical center, or a US research institute that is affiliated with a US institution of higher education.
The NIH has specifically advised that Investigators, including subrecipient Investigators, must disclose all financial interests received from a foreign institute of higher education or the government of any other countries, including local, provincial, or equivalent governments of another country.
The term Significant Financial Interest (SF) does not include the following types of financial interests received by an Investigator:
- salary, royalties, or other remuneration paid by the ISV to the Investigator if the Instigator is currently employed or otherwise appointed by the ISV, including intellectual property assigned to the ISV and agreements to share in royalties related to such rights,
- income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in those vehicles,
- income from seminars, lectures, or teaching engagements sponsored by, and service on advisory committees or review panels for a US federal, state, or local government agency, a US institution of higher education, a US academic teaching hospital, a US medical center, or a US research institute that is affiliated with a US institution of higher education.
4. Policy Statement
Disclosure Requirements: Investigator(s), including any personal responsible for the design, conduct, or reporting of the funded research, must disclose any SFI at the following times:
- prior to submitting a funding proposal to any PHS agency or the NSF,
- annual during the period of the award
- within 30 days of discovering or acquiring any new SFI during the term of a grant, and
- within 30 days following reimbursement of travel expenses by a third party, or if travel costs are paid directly by the third party, within 30 days of the completion of the trip (travel costs required for disclosure described below). When disclosing an SFI that is reimbursed or sponsored travel, the Investigator must detail the purpose of the trip, the identify of the sponsor or organizer, the destination, duration, and monetary value.
- The ISV Officers will maintain disclosure forms to be completed by each Investigator, which will require the Investigator to disclose reportable SFIs, or certify that he or she has no such interests. Upon submission of a grant application, the Institute must certify that it has received the Investigator’s disclosure forms. Any real or perceived financial conflict of interest will be resolved under this policy, before PHS funds are expended. For all grant submissions subsequent to the initial application, or at least annually, Investigators must submit an updated statement of any changes that have occurred since submitting their most recent disclosure statement or certify that no changes have occurred. Additionally, at any time during the term of the grant, Investigators must submit an updated disclosure statement within 30 days of discovering or acquiring a new SFI.
Review and Implementation
The ISV COI Committee will comprise of the ISV Director of Operations, acting as the ISV Ethics Administrator, with the ISV President, and the ISV Secretary with responsibilities to review any SFI reported by an Investigator to determine if it is related to the Investigator’s PHS or NSF-funded research (this determination may involve discussions with the Investigator). If the ISV COI Committee determines that the SFI is related to the Investigator’s PHS or NSF-funded research, then the ISV Director of Operations, with the other ISV COI Committee Members and the Investigator, will develop a FCOI management plan for approval by the ISV President.
Examples of conditions or restrictions that might be imposed to manage FCOIs include, but are not limited to the following:
- public disclosure of SFIs for research projects involving human subjects, disclosures of the SFI directly to participants,
- monitoring of research by independent reviewers,
- modification of the research plan,
- change of personnel or personnel responsibilities on the project, or disqualification from participation in all or a portion of the research funded by the granting agency,
- divestiture of SFIs, or
- severance of relationships that create actual or potential FCOIs.
The aim of a management plan is to ensure open and timely dissemination of research results, protect trainees, and preserve the integrity of the research. The Investigator will be asked to acknowledge in writing that he or she understands and will comply with any conditions imposed by the ISV President for managing or eliminating a FCOI. Should he or she decline or fail to agree to these conditions, the ISV will take appropriate disciplinary action, including, without limitation, suspending the Investigator’s research and, with requisite approval of the NIH, designating a substitute Investigator.
If the ISV President reports an SFI, then the ISV COI Committee, less the participation of the ISV President and replaced with the ISV President-Elect, will be consulted to determine if the financial interest constitutes of potential FCOI. With concurrence of the ISV Officers, the ISV Secretary will implement measures to manage or eliminate any FCOI of the ISV President, consistent with PHS policy.
In all cases, the ISV COI Committee will monitor, on an ongoing basis until the completion of the impacted PSH or NSF funded research project, the Investigator’s compliance with the conditions mandated by the ISV President in any established management plan.
(This section is applicable to PHS-funded research only)
The PHS rules require the ISV to take reasonable steps to ensure that subcontractors or subrecipients to comply with the federal rules. Then the ISV carries out the PHS-funded research through a subrecipient, the ISV will incorporate, as part of a written agreement with the subrecipient, terms that require the subrecipient to maintain a FCOI policy that complies with federal requirements and establish that the subrecipient’s FCOI policy will apply to the subrecipient Investigators.
If the subrecipient’s policy will apply, the subrecipient must report any FCOIs to the ISV within 60 days of identification so that the ISV can report to the PHS in a timely manner (below description for reporting). Alternatively, if the ISV’s FCOI policy applies, then the agreement shall specify time period(s) for the subrecipient to submit all subrecipient Investigator disclosures of SFIs to the ISV. Time periods shall be sufficient to enable the ISV to comply with timely review, management, and reporting obligations under the federal rules as described below.
If the ISV is a subrecipient of PHS funds, then this policy will apply to the required FCOI review rather than the policy of the sub-awarding organization.
Public Access of Disclosed SFIs (applicable to PHS-funded research only)
Upon request, the ISV will make available to the public information concerning any SFI disclosed to the ISV that meets the following criteria: the disclosed SFI is still held by an Investigator of an active PHS-funded project, the ISV determines that the SFI is related to the PHS-funded research, and the ISV determines that the SFI is a FCOI.
The ISV will respond within 10 business days of receipt of a request for public disclosure, which may include disclosure in publications, presentations, or to research personnel working on the study. The response shall minimally include the following: the Investigator’s name, the Investigator’s title, the Investigator’s role with respect to the research project, the name of the entity in which the SFI is held, the nature of the SFI, and the approximate dollar value of the SFI, as set forth in the PHS rules, 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. The ISV will note in its written response that the information provided is current as of the date of correspondence and is subject to updates on an annual basis, or within 60 days of the identification of a new FCOI. The requester must ask for any such updates if he or she desires them. FCOI information will remain available for 3 years from the date the information was most recently updated.
Before the ISV’s expenditure of PHS grant funds, the organization will report to the PHS any FCOIs found by the ISV that have not be eliminated, and along with certain other details required by the PHS, will provide assurance that the FCOIU has been managed. NSF requires reporting of conflicts of interest only when the ISV is unable to satisfactorily mange, reduce, or eliminate a conflict of interest. The ISV may be required by law or by conditions imposed by a sponsor to report an FCOI and any failure to report an FCOI to the affected project sponsors. When FCOIs are identified during the term of the grant for an Investigator newly participating in the project, or the ISV identifies a new FCOI for an existing Investigator, the ISV will report such FCOIs to the POHS within 60 days of identification. The ISV will provide the PHS with the status of a reported FCOI and any changes to the management plan annually, if applicable, until the completion of the project. Each report to the PHS will include sufficient information to enable understanding the nature and extent of the FCOI and to assess the appropriateness of the management plan.
Required information includes the following:
- project number,
- name of the Principal Investigator of the funded research,
- name of the Investigator with the FCOI,
- name of the entity in which the Investigator has a FCOI,
- nature of the FCOI such as equity, consulting fees, travel reimbursement, speaking honoraria,
- value of the SFI in dollar amounts of $5,000 or a statement that the SFI if the value cannot be determined through reference to public prices or other reasonable measures of fair market value,
- description of the relationship of the SFI to the PHS-funded research and the basis for the ISV’s determination that the SFI conflicts with the research, and
- description of key elements of the ISV’s FCOI management plan including the role and principal duties of the conflicted Investigator in the research, the conditions of the management plan, description of how the management plan is designed to safeguard objectivity in the research project, description of how the management plan will be monitored to ensure compliance by the Investigator.
Adherent to the NIH issued notices that grantees must use eRA Commons module to submit FCOI reports, the Signing Official may submit retrospective FCOI reports disclosing new SFIs or changes to an ISV FCOI management plan up to 150 days after submitting a report.
Whenever the ISV identifies an SFI that was not disclosed in a timely manner by the Investigator, or for whatever reason was not reviewed in a timely manner by the ISV, then the ISV will determine whether the SFI constitutes a FCOI within 60 days thereafter and will implement an appropriate management plan. If the FCOI was not identified or was not managed in a timely manner such as when an Investigator failed to disclose a SFI that subsequently was found by the ISV to constitute a FCOI, or the ISV failed to review or manage such a new FCOI, or the Investigator failed to comply with the FCOI management plan after discovery of a SFI, then the ISV shall complete a retrospective review of the Investigator’s activities and the PHS-funded research project. The retrospective review must occur within 120 days of the ISV’s determination of noncompliance with the FCOI and the purpose is to determine whether any PHS-funded research that was conducted during the period of noncompliance was biased in the design, conduct, or reporting of such research.
The ISV will document the retrospective review, which documentation must include, but not be limited to, all of the following key elements:
- project number,
- project title,
- name of Principal Investigator
- name of the Investigator with the FCOI,
- name of the entity with which the Investigator has a FCOI,
- reasons for the retrospective review,
- detailed description of management of the retrospective review, and
- review findings and conclusions.
As appropriate, the ISV will update any previously submitted FCOI report with additional information describing how the FCOI will be managed going forward. If bias is found after a retrospective review, such as if the FCOI will have a material effect on the research, will affect the design, conduct or reporting of the research, then the ISV will notify the PHS and follow up with the mitigation report within 15 days. The mitigation report must include the key elements documented in the retrospective review and a description of the impact of the bias on the research project and the ISV’s plan of action to eliminate or mitigate the effect of the bias. The ISV will monitor the Investigator’s compliance with the management plan on an ongoing basis until completion of the PHS- or NSF-funded research project.
Enforcement and Sanctions for Noncompliance
If an Investigator fails to comply with the provisions of this FCOI policy or fails to comply with any conditions for managing or eliminating a FCOI as mandated by the ISV President, then the ISV President will discuss the violation with the Investigator and will attempt to remedy the violation informally. If the ISV President is unable to reach a resolution, then he or she will impose appropriate sanctions up to and including suspension or termination of the Investigator.
Before engaging in any research project, all Investigators must complete COI training on the Investigator’s obligations under this FCOI policy and must complete the training annually. Training must be completed immediately upon this FCOI policy being instated or revised to the extent that it affects Investigator’s obligations when an Investigator is new to the ISV or when the ISV COI Committee mandates refresher training such as when the ISV find an Investigator to have violated the FCOI policy or any applicable management plan.
The ISV will maintain records relating to all Investigator disclosures of SFI, any measures implemented to manage or eliminate FCOIs, and all actions related to a retrospective review if applicable for at least 3 years from the date of submission of the final grant expenditure report. Records may be maintained for longer periods of time where applicable unless any litigation, claim, audit, or other action involving the records is commenced before the end of the 3-year period, in which case, the records will be retained until completion of the action and resolution of all issues.
The ISV Disclosure of Conflicts of Interest Policies and Procedures for implementation and management, as applicable more broadly beyond Investigators to the ISV Officers, ISV Board, and ISV Staff.