News & information from UB, New York's flagship university
Published October 15, 2014
The University at Buffalo is a proponent of transparency and protecting the public trust. For many years, UB and the State of New York have had programs, policies and practices in place to deal with conflict of interest. These policies and practices have been adjusted over time to make them more effective and to assure that they comply and comport with applicable laws, regulations and agency guidance.
The University at Buffalo has well-established policies and procedures for conducting research, disclosing potential conflicts of interest and working compliantly with industry. These safeguards help ensure that no UB faculty activity is unduly influenced by the industry and help assiduously avoid even the perception of a circumstance in which one’s personal interest or relationships might compromise education, research or integrity at the university.
All UB employees, including faculty physicians that practice in partner organizations, are subject to UB related policies pertaining to conflict of interest.
While all relationships involve differing priorities and interests, the concern is that the duality of interests can become or can create the perception of conflicts that compromise education, research, or the integrity of the field. While this duality has been recognized for many years, because of decreases in support for the educational and research missions of academic institutions from federal and other traditional funding agencies, academic departments increasingly look to other sources to support such vital functions.
All UB faculty are subject to UB conflict of interest policies, the SUNY Joint Commission on Public Ethics, and are required to make financial conflict of interest disclosures. Each faculty is required to complete an Annual Financial Disclosure form at the time of applying for funded research or prior to the release of grant funds, whichever occurs first, annually thereafter, and within 30 days of discovering or acquiring a new significant financial interest (SFI). UB carefully reviews these conflict of interest disclosures and effectively manages any conflict of interest cases and reports to appropriate federal agencies as needed.
In 1995, the University established an investigator conflict of interest policy requiring investigators to disclose their and their immediate family members significant obligations, significant financial interests that is related to their institutional responsibilities to provide the reasonable expectation that the design, conduct, or reporting of funded research by UB faculty, students, or staff will not be biased. In 2012, UB updated the Investigator Conflict of Interest Policy to fulfill the requirements of the revised Public Health Service policy that went into effect August 24, 2012
In 2012, the Jacobs School of Medicine and Biomedical Sciences at Unviersity at Buffalo established the Jacobs School of Medicine and Biomedical Sciences at University at Buffalo Conflict of Interest Disclosure policy to ensure that no activity of the SMBS and its members is unduly influenced by industry, and that we assiduously avoid even the perception of abridgment of the implicit trust (which is based both on reality and perception) the public places in us to practice in the best interests of our patients and with the greatest integrity. A revised policy is currently under review and will provide further provisions to mitigate conflict of interest.
Several significant changes have taken place in 2013 in the university's efforts to address the issue of conflicts of interest in research. UB established the Institutional Conflicts of Interest in Human Subjects Research Policy to protect the rights and welfare of human subject research participants and to ensure research integrity. All potential Institutional Conflicts of Interest in human subjects research require disclosure, evaluation, and management or elimination. A new UB Conflict of Interest in Research Committee (CIRC) was established in compliance with new federal regulations. The establishment of CIRC and other changes are reflected in the revised UB Investigator Conflict of Interest policy.
UB activities are also subject to SUNY RF’s Policy on Conflicts of Interest in Public Health Service Sponsored Programs and SUNY RF’s Conflict of Interest Policy. SUNY and RF Investigators may not have any interest or engage in any outside activity that results in an unmanaged Financial Conflict of Interest. To this end, SUNY and RF Investigators must disclose their interests and outside activities, and those of a related party, which may affect their independent and objective performance of their PHS-funded project(s). Financial Conflict of Interest shall be subject to management plans, and compliance with such management plans shall be monitored. In addition, Research Foundation Board Members, Officers, and Employees may not have any interest or engage in any outside activity that results in an unmanaged conflict of interest. To this end, Board Members, Officers, and Employees must disclose their interests and outside activities, and those of a Related Party, which may affect their ability to perform their duties with independence and objectivity. A conflict of interest must be managed so the conflict is reduced or eliminated, and compliance with conflict of interest management plans should be monitored where necessary.
UB encourages innovation by faculty and staff to fulfill our mission of delivering new knowledge and biotechnologies for public benefit. Transparency and Conflict of interest oversight contributes to our unquestioned commitment to safety in our programs and services, and to scientific objectivity as we develop potentially beneficial discoveries.
Universities are responsible for stimulating economic development and transferring discoveries to the private sector. Universities commercialize their technologies by licensing discoveries to established companies or to companies started by academic inventors.
Financial conflicts of interest are common in a modern research university, and to some extent, they are inevitable. Academic researchers and industry have a long history of collaborating, and these collaborations can provide mutual benefit by contributing to a university's research mission and helping to focus the research directions of industry. Industry/researcher collaboration is accomplished by personal consultation and/or sponsored research.
While all relationships involve differing priorities and interests, the concern is that the duality of interests can become or can create the perception of conflicts that compromise education, patient care, research, or the integrity of the field. While this duality has been recognized for many years, because of decreases in support for the educational and research missions of academic institutions from federal and other traditional funding agencies, school departments increasingly look to other sources to support such vital functions.
UB Sponsored Project Services (SPS) must review and approve all proposals prior to submission to an outside funding agency. Proposals may not be submitted directly to the funding source without the prior approval of SPS. The University at Buffalo (UB) reserves the right to decline awards resulting from unapproved proposals.
Although the Principal Investigator is responsible for the scientific conduct of the project, the legal agreement will be between The Research Foundation of SUNY and the sponsor. This contract binds the SUNY RF to perform specific tasks outlined in the contract Statement of Work as it was proposed and approved, and within the time frame set out in the contract, and to deliver the agreed-upon results to the sponsor by the end of the project. At SUNY Buffalo, a Principal Investigator is not authorized to enter into an agreement that would legally bind The Research Foundation to a sponsor. This is designed to protect both the Principal Investigator and the University
SPS accepts the industry awards on behalf of the Research Foundation, obtains Conflict of Interest approval, and authorizes Contracts Services (GCS) to establish an account to make the awarded funds available to the Principal Investigator for expenditure.
The Research Foundation of State University of New York, or RF as it is commonly known, was the first and is the largest of the University's fiscal agents. A private, nonprofit, educational corporation, RF was established in 1951 under a charter issued by the Board of Regents of the State of New York to accept and administer funds of all types from external sources for the benefit of SUNY. In 1977, the informal relationship which had existed between SUNY and RF was formalized in a contract between the two organizations. Since that time, administration of grant and contract funds in support of research, educational, and public service activities became RF's principal mission.
The Research Foundation of State University of New York, the largest university-connected research foundation in the world, enables discovery through strong, behind-the-scenes support of research education and public service. Under formal contract with the university, the Foundation administers more than 5,000 sponsored programs being conducted at the 29 state-operated campuses of State University of New York.
Sponsored activities are under way in almost every field, ranging from the arts to quantum physics, have a major impact on the quality of life in the state. SUNY researchers have pioneered nuclear magnetic resonance imaging, isolated the bacterium that causes Lyme disease, developed the first implantable heart pacemaker, and made hundreds of other innovative contributions. Today, the university ranks among the top ten research universities in the country in patenting new discoveries.
The Foundation employs more than 21,000 people around the state -- primarily on SUNY campuses -- to conduct research; deliver healthcare; train students, the disabled, and the unemployed; assist the New York State business community; and work in international development programs.
Overseeing the Foundation's operations is a Board of Directors composed of researchers, campus and university administrators, SUNY Trustees, and representatives of business and industry. The SUNY Chancellor serves as board chair ex officio.
UB has had a conflict of interest policy since 1995. The University at Buffalo revised its conflict of interest in research policy in 2012, in order to be in compliance with the revised federal regulations. The regulation places the responsibility for determining the existence of a financial conflict of interest in research on the institution rather than the investigator. Researchers must disclose all financial interests in outside entities, and then the Conflict of Interest in Research Office reviews the disclosures in the context of all sponsored research and Human Subjects Research applications.
The policy applies to all individuals involved in research at the University, regardless of job title, who contribute in a substantive way to the development, execution, and reporting of research.
Conflict of interest (COI) involves circumstances where an individual's professional actions or decisions at the University could be influenced by considerations of personal gain, usually of a financial nature, as a result of interests outside his/her University responsibilities. The central theme in addressing COI is transparency, and the first step is disclosure of the interest to the appropriate University administrative office.
Financial conflict of interest in research involves situations in which a researcher has a significant financial interest that may compromise, or have the appearance of compromising, professional judgment in the design, conduct, or reporting of research. A significant financial interest could include personal compensation from industry, equity interest or a management role in a company, or royalties generated from intellectual property rights.
Financial conflicts of interest are common in a modern research university, and to some extent, they are inevitable. Academic researchers and industry have a long history of collaborating, and these collaborations can provide mutual benefit by contributing to a university's research mission and helping to focus the research directions of industry. Industry/researcher collaboration is accomplished by personal consultation and/or sponsored research.
Also, universities are responsible for stimulating economic development and transferring discoveries to the private sector. Universities commercialize their technologies by licensing discoveries to established companies or to companies started by academic inventors.
All of these situations can create opportunities for researchers to receive financial rewards related to their research. With the opportunities come risks that the direction of research will be affected, the objectivity of the data will be compromised, and the interpretation of research results will be skewed. Researchers might not consider that their financial interest would pose these risks, but it can create that perception. This perception of bias can be as damaging to the researcher and the institution as actual bias.
At UB, we seek to address conflict of interest in research and to advise faculty and staff on how to mitigate, manage, or if necessary, eliminate those conflicts. We are committed to complying with federal regulations and University policies related to disclosure, review and management of financial interests.
The policy following federal guidelines considers an investigator as "a principal investigator or any other person, regardless of title or position, responsible for the design, conduct or reporting of sponsored projects." This definition would include co-investigators, sub-investigators, study coordinators and other individuals with an active role in the research project including individuals responsible for the consent process (recruiters, screeners, interviewers, consenters) and those responsible for collecting, entering and analyzing the research data.
UB has had a conflict of interest policy since 1995 in compliance with federal regulations. UB implemented conflict of interest policies in response to several factors including a desire to have strong ethical standards.
The UB Conflict of Interest Policy went into effect in 1995, and the more prescriptive UB SMBS Conflict of Interest Disclosure Policy was updated in 2012.
No. However, UB is conducting a review of our policies to ensure transparency, consistency, and efficiency and the Jacobs School of Medicine and Biological Medicine at University at Buffalo has revised the Jacobs School of Medicine and Biomedical Sciences at University at Buffalo Conflict of Interest Disclosure Policy.
Yes. Widespread national attention on the issue has prompted many academic medical centers to strengthen their policies. Here are some examples:
A conflict of interest in research exists when an investigator has a significant financial interest or a significant obligation to another organization that could potentially bias research. A common example is an investigator who is serving as a paid consultant to a company that is also sponsoring the investigator's research study.
A COI management plan must be drafted for any research project.
For each new, renewed, or updated research, the Conflict of Interest Review Committee (CIRC) receives a conflict of interest (COI) management plan prepared by the UB Conflict of Interest Officer in collaboration with the conflict of interest reviewer in the investigator's dean's office and with the investigator. This step follows UB policy and assures that the investigator's input is sought from the outset by someone familiar with the investigator's particular research culture.
CIRC will review the draft COI management plan or develop a management plan if needed. The CIRC approved COI management plan will, at a minimum, require the investigator to make full disclosure of their relationships with a research sponsor to their colleagues on a study, to research participants, and in any presentations or publications.
The Conflict of Interest (COI) management plan is an action plan that will reduce or eliminate an financial COI, prevent or mitigate the harm that could arise from the conflict, and to the extent possible, ensure that the design, conduct, and reporting of research or other activity is free of bias. At a minimum, the COI management plan will require the investigator to make full disclosure of their relationships with a research sponsor to their colleagues on a study, to research participants, and in any presentations or publications.
The Office of the Vice President for Research and Economic Development is responsible for Conflict of Interest (COI) in funded and human subjects research. The COI process involves the UB Conflict of Interest Officer and the UB Conflict of Interest in Research Committee (CIRC).
In 2013, UB established the new UB Conflict of Interest in Research Committee (CIRC) in compliance with new federal regulations. The establishment of CIRC and other changes are reflected in the revised UB Investigator Conflict of Interest policy.
CIRC is comprised of well-qualified, senior faculty from each of the twelve UB schools and colleges as well as the Research Institute on Addictions. These individuals have been recommended by their units and appointed by the Vice President for Research and Economic Development.
CIRC is chaired by Michael Detty, Chair, Chemistry, College of Arts and Sciences. Members include: William McDonnell, Associate Dean, Architecture and Planning; Anne Meyer, Associate Dean for Research, Dental Medicine; Gregory Fabiano, Associate Dean for Research; Graduate School of Education; Albert Titus, Chair, Biomedical & Electrical Engineering, Engineering and Applied Sciences; Errol Meidinger, Professor, Law; William Kross, Associate Dean for Research, Management; Mulchand Patel, Associate Dean for Research, Medicine and Biomedical Sciences; Davina Porock, Associate Dean for Research, Nursing; Joseph Balthasar, Associate Dean for Research, Pharmaceutical Sciences; John Wilson, Professor, Exercise & Nutrition Science, Public Health and Health Professions; Catherine Dulmus, Associate Dean for Research, Social Work; Kenneth Leonard, Director, Research Institute on Addictions. Ed Zablocki, COi Officer, provides administrative support to CIRC.
A conflict of interest in research exists when an investigator has a significant financial interest or a significant obligation to another organization that could potentially bias research. A common example is an investigator who is serving as a paid consultant to a company that is also sponsoring the investigator's research study. CIRC typically receives a draft conflict of interest (COI) management plan prepared by the conflict of interest reviewer in the investigator's dean's office in collaboration with the investigator. This step follows the policy and assures that the investigator's input is sought from the outset by someone familiar with the investigator's particular research culture.
CIRC will review the draft management plan or develop a management plan if needed. The CIRC approved COI management plan will, at a minimum, require the investigator to make full disclosure of their relationships with a research sponsor to their colleagues on a study, to research participants, and in any presentations or publications.
Any personnel, whether UB personnel or not (e.g. nurse at a HCP, research collaborator from another University), involved with funded research or with human subjects must submit full financial disclosure in compliance with UB and other related policies at least annually and at any time their relationship with a research sponsor changes. UB will accept a COI statement for personnel from another University from their University’s Conflict of Interest Officer. At a minimum, Personnel must make full disclosure of their relationships with a research sponsor to their colleagues on a study, to research participants, and in any presentations or publications.
The annual University deadline for disclosure of financial interests is in November. Public Health Service funded research (principally NIH) disclosures must be submitted by the time an application is submitted to the Public Health Service for funding, within thirty (30) days of discovering or acquiring a new Significant Financial Interest, and on an annual basis at intervals thereafter.
Disclosures must be updated when a project is up for renewal or updated with new personnel, at which time personnel are again reviewed for conflict of interest. If any of the new personnel are not on file, they are required to fill out a disclosure.
Financial disclosure statements should be submitted using the Osprey COI Risk Manager online financial disclosure system. The system forwards this disclosure to the UB Conflict of Interest Officer and those within the Dean’s office responsible for review of financial disclosure statements.
UB policy, consistent with the 2011 revised PHS regulation, requires each Investigator who is participating in NIH-funded research to submit an updated disclosure of Significant Financial Interest using COI Risk Manager within thirty (30) days of discovering or acquiring (e.g., through purchase, marriage, or inheritance).
The revised Public Health Service regulations require completion of a conflict of interest course by all investigators and key research personnel before grants can be submitted or funding released. This online conflict of interest mini-course was developed by the Collaborative Institutional Training Initiative (CITI) and is being used by all SUNY institutions.