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Conflict of Interest Policy for Officers of Instruction and Research For a PDF version of this policy statement, click here. I. BackgroundII. General Policy III. Definitions IV. Issues of Concern V. When is there a Conflict of Interest/Commitment? VI. Faculty/Researcher Responsibilities VII. Institutional Responsibilities VIII. Review of Disclosures IX. Procedures for Resolving Violations of Policy or Failure to Disclose X. Examples of Management of Conflicts of Interest XI. Generally Prohibited Conflicts of Interest for Brown University Faculty and Research Staff Engaged in Human Subjects Research XII. Generally Prohibited Business and Educational/Research Conflicts of Interest and Commitment XIII. Compliance with PHS and NSF Policies Governing Financial Conflict of Interest This policy addresses situations in which there might be a potential financial or personal conflict between a particular outside interest of a faculty member or member of the academic staff and the professional obligation that person owes to Brown University. Such situations are not unusual; they do not imply wrong-doing or inappropriate activities. Rather, research universities encourage interactions and the establishment of relationships between faculty and business and industry. The experience and knowledge gained through outside consulting and service on advisory committees is valued for its synergistic return to both research and student training. Commercialization of faculty inventions and discoveries through technology transfer brings the benefits of university research to the public good. Faculty often play an important role in successful commercialization efforts as scientific consultants and in continuing research development projects. However, in a university setting, these relationships can compromise, or be perceived as compromising important academic values, research integrity or the university mission. Universities and their faculty have an obligation to assure that all potential conflicts of interest are managed, minimized or eliminated, as appropriate. The identification and management of conflicts of interest attempts to address the tension between the benefits of outside activity and the primary responsibility of faculty and staff to their university duties and thereby to protect both individual faculty and the University. All faculty and key research personnel are required to assure compliance with the Brown University Conflict of Interest Policy. Key research personnel are those who have independent responsibility for the design, conduct or reporting of research. Although the Assurance and Disclosure processes are centered around financial conflicts of interest in research, scholarly and educational activities, other matters such as conflicts of commitment and outside professional activities which may conflict with or appear to conflict with institutional obligations are included under this policy. Activities which compete or may appear to compete with the business interests of the University are always a matter of disclosure under this policy. The Brown University policy on conflict of interest applies to all Brown faculty and senior research staff, including those employed by hospitals, faculty practice plans, or other clinical entities. All faculty must adhere to the University's Conflict of Interest and Disclosure policies. In addition, because of the special concerns regarding involvement of human subjects in research, all Brown faculty involved in human subjects research activities have particular disclosure requirements; these requirements are in addition to whatever disclosure requirements they may have to their employer if the employer is not Brown University. A potential conflict of interest generally arises when a university researcher has outside interests that are very close to his or her university research activities. The value of research lies in its objectivity or absence of bias in the research process. Researchers, in particular, must be committed to conducting themselves and their research activities in accordance with the highest standards of integrity. For researchers, a potential financial conflict of interest exists when an investigator's significant financial outside interest could lead an independent observer to reasonably question whether the design, conduct or reporting of research might be influenced by the possibility of personal gain. Faculty research-related conflicts of interest that are not appropriately disclosed, discussed and managed could compromise public confidence in the integrity of the University's commitment to its core values: • The commitment to educating students; • The commitment to academic freedom; • The commitment to advancing the range and depth of knowledge and understanding of the natural world and our human condition; • The commitment to the safety of patients under the care of University faculty and participants in research; • Them commitment to open and timely communication and dissemination of knowledge; and • The commitment to protecting both the appearance and the actual integrity and objectivity of research, instruction and public service An appointment as a full-time faculty member at Brown carries primary professional responsibility to the University, to its educational mission, and to its students. Full-time, regular faculty members are therefore not permitted to hold regular (tenured or tenure-track) positions elsewhere, except under special circumstances and only with the prior written permission of the Dean of the Faculty or the Dean of Medicine and Biological Sciences, as appropriate. Financial Conflict of Interest in Research refers to situations in which financial considerations may compromise, or have the appearance of compromising, an investigator’s professional judgment in designing, conducting or reporting research. The bias such conflicts may conceivably impart not only affects collection, analysis, and interpretation of data, but also other activities such as the hiring of staff, mentoring of students and junior faculty, procurement of materials, sharing of results, choice of protocol, involvement of human participants and the use of statistical methods. The definition of financial conflict of interest in research applies to all Brown faculty. Assurance (or Certification) means the annual process and form by which faculty and key research personnel acknowledge that they have read the Brown University Conflict of Interest Policy and are in compliance with certain specific disclosure requirements of the policy.Disclosure means the form and process by which faculty and any key personnel in research activities inform and describe to administrative officers of the University, the nature and extent of relationships related to their research that produce or may be perceived to produce personal financial benefits or of other activities which could be in conflict with the objectives of the University. Significant Financial Interest: financial interest means anything of monetary value, including but not limited to, salary or other payments or services (e.g. consulting fees or honoraria); equity interests (e.g. stocks, stock options or other ownership interests); intellectual property rights (e.g. patents, copyrights and royalties from such rights); and gifts. Such interests are "significant" if, for any one enterprise, the interest has a value of $10,000 or more or represents more than 5% ownership interest. For all faculty involved in human subjects research, however, the threshold is zero; that is, all financial interests must be disclosed. Investigator means the principal investigator and any other person who is responsible for the design, conduct, or reporting of research. For the purposes of relating to financial interests, “investigator” includes the Investigator’s spouse, domestic partner and/or dependent children. Conflict of Commitment means that a faculty member's outside professional and commercial interests interfere with or compromise his/her full time obligation to the University. University policy permits faculty members who are full-time University employees to devote not more than one day per normal work week, on average, to outside professional and commercial interests. It should be noted that the primary responsibility of regular faculty is the education of Brown students. Therefore, regular faculty members are not permitted to teach at other institutions during the academic year except under special circumstances and with the prior written permission of the Dean of the Faculty or the Dean of Medicine and Biological Sciences, as appropriate. Brown faculty who are not University employees are not subject to the Conflict of Commitment provision. The following section discusses a range of additional potential conflicts of interest pertinent to the research, educational and professional activities of faculty. Universities are accountable for the research they perform. An institution must ensure that the research conducted by its faculty, both on campus and in affiliated facilities, meets the highest standards of ethics and integrity, and promotes public health. The increasing collaboration between industry and research universities, the expectation that the universities can and should be involved in the economic development of their region and state, and the increasing interest of the faculty in participation in entrepreneurial endeavors have inevitably raised questions about the potential risks of academics' financial relationships with the private sector. Brown's Conflict of Interest Policy both affirms the University's own integrity and responds to federal requirements. In general, there is a predisposition to permit faculty, with appropriate disclosure and management practices, to maintain their outside professional and commercial relationships. Problems most often arise not from the particular conflicts, but rather from what is done with the conflict. In most cases, problems arise when the conflict is not disclosed, discussed, assessed and appropriately managed. However, there may be instances, such as research involving human subjects in clinical studies, where the relationships may be determined to be unmanageable. In those instances, faculty will be required by the University to either eliminate the relationship with the outside interest, or not participate in the proposed research activity. Technology Transfer and Financial Conflicts of Interest Conflicts of interest often arise at the intersection of two fundamental missions: to push the boundaries of knowledge and to transfer that knowledge to the private sector for the benefit of the public. With pro-active technology transfer comes increasingly close relationships between industry and university, which provide benefits but also increase the risk of academic research being compromised through either or both individual and institutional conflict of interest. There are, for example, significant personal financial advantages from outside consulting, patenting and licensing, stock options or other business interests. However, the perception that such incentives might harm research or educational integrity, or diminish the protection of human subjects, students or others whose work depends on the direction of the conflicted individual is sufficient to mandate that such conflicts be identified, then managed, mitigated or eliminated. Conflict with Educational/Research Obligations Consideration of personal gain related to activities outside the University must not influence the decisions or actions of individuals in carrying out their University responsibilities. Such outside activities conflict with obligations to the University when they involve excessive commitments of time, when they bias the nature and direction of scholarly research, or when they influence a faculty member’s decision or behavior with respect to teaching and student affairs, appointments and promotions of faculty, purchasing of equipment or medical devices, or other matters of interest to the University. The potential problems arising from conflicts between a faculty member’s obligations to the University and outside professional and commercial activities are numerous and sometimes subtle. A conflict may arise out of a single transaction and should be addressed whenever possible before that transaction is undertaken. Conflict with the Business Interests of the University Faculty may be privy to certain confidential business decision making within the University, such as selection of equipment, services, educational materials, procurement of consultants, and acquisition of information or management systems. Faculty who have an interest in an organization that either has Brown as a large customer or supports the individual’s University activities must disclose their relationships to administrative and academic officers who need to assure that any purchase decision is free from bias or self-interest. A faculty member who has a personal interest, or who has an immediate family member who has a personal interest, in an organization engaged in negotiation of a contract between the University and the organization should not generally participate in the contract negotiation attempt to influence the University’s decision in favor of their interest. Management, employment, consulting, or other contractual activities with, or ownership interest in, a business entity that competes with the University must be disclosed and is generally not permitted. Faculty engaged in federal research activities are prohibited from soliciting or accepting any gratuities, favors, or anything of monetary value from contractors or parties to subagreements that are paid through either direct or indirect federal funds awarded to the University. Some Specific Issues Requiring Particular Attention in Designing Management of Conflicts of Interest: A. Research. Maintaining objectivity in research is the personal responsibility of each scholar. Decisions concerning the nature and direction of research should be governed by its intellectual merits and the controls implicit in the scientific method and other scholarly modes of inquiry. A relationship or interest in outside commercial interests should not bias a faculty member's own research or his/her assessment of other faculty or students. Faculty are obliged to assure that their research results are not subject to influence by third parties that may have financial interests in the research outcomes. This is particularly significant if a company has been the sponsor of the research or if a company's product is involved in the research, directly or indirectly. B. Publication. Publication and presentation of the research results are the hallmark of academic freedom. Where financial relationships exist with the company, the investigator is expected to disclose relevant consulting or other affiliations in any publication or public presentation of the research. Faculty should not participate in nor accept sponsor conditions that preclude dissemination of research results or otherwise compromise academic freedom. C. Education of Students. From the education, research, financial, and career status perspectives, there are many occasions in which outside financial interests might compromise or create the perception of compromising the student-faculty relationship. At the same time, involvement of students in projects of commercial interest, practical benefits from corporate work experience or internships, and potential career opportunities may benefit students. It is incumbent upon faculty, and on any Conflict of Interest management plan, to assure that their advice and guidance should always be governed by the student's best interest and should not become entangled with the personal financial interests of faculty who are in positions of authority over the students. Occasions where faculty members' commercial interests could compromise the publication rights and research data derived from students' work should be explicitly avoided. D. Appointments and Promotions. Junior faculty and developing independent investigators must be assured that their evaluations are based on the merits of their scholarship and contribution to the University’s research and educational mission. Senior faculty and department chairs are required to exercise their recommendations and decisions concerning promotion and appointments in the absence of influence of benefit from personal commercial relationships. E. University Contribution. A faculty member’s outside professional and commercial interests cannot interfere or compromise his/her full time obligation to the University’s mission. Faculty must assure that their outside obligations are within the consulting privileges permitted under University policy, that their absence from campus does not preclude them from participation in the normal and productive interactions with colleagues and students in the affairs of the faculty member’s department and the University, and that no intellectual property rights of the University are breached by agreements between the individual faculty member and the outside corporation. University policy permits faculty members who are full-time employees of the University to devote not more than one day per normal work week, on average, to outside professional and commercial interests. F. Clinical Trials. Faculty involved in the design, conduct or reporting of clinical trials have a special obligation to avoid bias or the appearance of bias in the conduct of these studies. All faculty or other investigators, including those in the Medical School who conduct their clinical research outside the University but who publish or interact professionally as faculty of Brown University, will be subject to special oversight for financial relationships that are associated with clinical research. Of special interest are those clinical studies where the drug, device or procedure has been invented or discovered by the faculty member. Faculty must fully disclose to the Institutional Review Board (IRB) any financial relationship pertaining to any protocol under review. The IRB should be apprised of management practices that the University has defined for the disclosed relationship. The IRB shall determine what information relating to the disclosed financial relationship would be included in the informed consent form or other appropriate protections for human subjects. Investigators participating in any human subjects protocol who have any financial interest in a company sponsoring the study, a drug, device or procedure are required to disclose that interest to the University and the Institutional Review Board. G. Institutional Review Board. IRB members are required to disclose any financial relationship they have to companies sponsoring clinical research, or competing companies, products or other sensitive interests to the Chair of the IRB. The IRB shall determine if the conflicts present an occasion that could compromise the IRB’s deliberations. There can be no question that investigators involved in clinical research and the members of the IRB charged with reviewing protocols are using all appropriate controls to eliminate real or perceived financial interests that could harm subjects. H. Office/Laboratory Space and other Resources. Faculty members should not use the facilities and resources of the University for personal gain. Faculty members should reimburse the University for any administrative costs (e.g. secretarial/administrative assistance, phones, use of office equipment and computer services) used in the course of their consulting activities. Assuming the consulting activity does not interfere with University obligations and operations, use of the faculty member’s office is permissible. Use of University laboratory space by for-profit companies, especially those in which the faculty member has a financial interest, is permissible only under special conditions and requires prior written approval of the Chair, Dean of the Faculty or Dean of Medicine and Biological Sciences, and Provost. Approval is likely to be granted only in extraordinary circumstances and where the University is fully compensated for the use of the facilities and the research program is conducted in compliance with all University research policies. I. Hiring Family Members for University Business. Faculty and staff must not be in the position of hiring, supervising, directing, or setting the pay for one’s spouse, domestic partner, children and/or relatives. J. Service on Committees. Faculty members may be asked to serve on University committees charged with purchasing of equipment, systems, or educational materials where the faculty member or their families may have relationships with outside vendors, suppliers or contractors. Faculty members are not automatically disqualified from serving on committees when potential conflicts appear, but early and full disclosure to the Chair of the Committee and the administrative officer overseeing the procurement activity, is critical. In most circumstances, it should be possible for the faculty member to continue to serve on the committee, but some conflicts may be so obvious and severe that they are resolvable only if the faculty member resigns from the committee. V. When is there a Financial Conflict of Interest/Commitment that must be Disclosed In summary, financial interests known to a faculty member or researcher must be disclosed in any one of the following cases: a.Any financial interests related to human subjects research. b.If the interest would reasonably appear as one that could be affected by the research or is a financial interest in a commercial entity whose financial interests would reasonably appear to be affected by the research; c.If the financial interest has a value of $10,000 or more or represents more than 5% ownership interest; VI. Faculty/Researcher Responsibilities All faculty and key research personnel are required to assure compliance with the Brown University Conflict of Interest Policy. Although the Assurance and Disclosure processes are centered around financial conflicts of interest in research and scholarly activities, other matters such as conflicts of commitment and outside professional activities which may conflict with or appear to conflict with institutional obligations are included under this policy. Activities which compete or may appear to compete with the business interests of the University are always a matter of disclosure under this policy. Faculty are obligated under the Brown University Conflict of Interest Policy to complete an annual Assurance that they are in compliance with the University COI Policy. When the Assurance indicates that a Disclosure of potential financial conflicts of interest or outside professional and commercial activities is merited, affected faculty and researchers investigators are required to submit a Disclosure statement. Faculty Principal Investigators are responsible, for each proposed activity, for determining which nonfaculty staff, including students, fellows, technicians and off-campus collaborators, meet the definition of "investigator" according to the Federal agency definitions. These individuals will be required to assure compliance with the University's Conflict of Interest policy. In addition, faculty and other researchers and staff must disclose on an ad hoc basis any current situations which may raise questions of conflict of interest or conflict of commitment. Ad hoc disclosures are made according to the same procedures described in this policy and are to be made as soon as such situations become known to the individual. When the institutional review of the Disclosure indicates that additional management practices are necessary to permit the real or perceived conflicts to exist, faculty are required to follow the particular management practices described in a COI Management letter from the Office of the Provost. Financial Interests that do not have to be disclosed include:
VII. Institutional Responsibilities Brown is responsible for informing faculty about existing federal and institutional policies regarding disclosure and management of real and perceived conflicts of interest. The University satisfies its obligation to assure that financial conflicts of interest are not inappropriately compromising the mission of the University by assessing Disclosures and determining that the disclosed conflict has been reduced, managed or eliminated. Faculty are required under this policy to annually complete an Assurance of Compliance with the Brown University COI policy. If the Assurance indicates financial relationships that meet the threshold for Disclosure, the faculty/investigator will be asked to complete a supplemental questionnaire, a Disclosure Form. Disclosure Forms are reviewed by the Dean of the Faculty or the Dean of Medicine and Biological Sciences, as appropriate, who are asked to make recommendations to the Provost about the nature of the disclosed conflict and what management practices may be appropriate if the disclosed conflict is manageable. The Provost or his/her designee will establish a faculty committee for consultation on the management of conflicts, when appropriate. The Provost has final authority for compliance with the University Conflict of Interest Policy. The Provost may delegate this responsibility to the Vice President for Research. The Provost or the Provost’s designee responds to all Disclosures in writing to the individual, outlining all necessary management practices pertinent to the financial relationship or advising when a disclosed conflict cannot be managed; when disclosures pertain to human subjects research, a copy of the letter will be forwarded to the IRB. The Provost or the Provost’s designee is responsible for advising research sponsors of disclosures of significant financial interests when required under the sponsor’s regulations. IX. Procedures for Resolving Violations of Policy or Failure to Disclose Faculty may be subject to the ordinary disciplinary process of the University if they fail to fully and truthfully disclose conflict of interest situations or fail to comply with any stipulated plan for managing the disclosed conflict. They may be subject to additional penalties if the noncompliance falls under the regulations and policies of Federal agencies sponsoring research at Brown University. X. Examples of Management of Conflicts of Interest Full and open disclosure of all significant related business interests is considered by most to be the best management tool. Sometimes additional safeguards and even prohibition of certain types of financial relationships may be required. Examples of other possible conditions or restrictions are:
Certain conflicts are generally prohibited for faculty and associated investigators engaged in human subjects research. Other activities involving financial conflicts of interest or commitment may be permitted with appropriate oversight and management practices. The examples below include activities that need to be disclosed and managed for all faculty. Because human subjects research requires a higher level of scrutiny, these activities are prohibited for faculty and researchers engaged in human subjects research. Examples of conflicts that are generally prohibited for faculty and research staff engaged in human subjects research: A. Faculty members accepting research sponsorship from a company in which they (or family member) have a significant financial interest; B. Ownership interest by a faculty member in a business that is sponsoring his/her research; C. Involvement of research assistants in the outside professional activities of faculty members; D. Faculty members making clinical referrals to a business in which the faculty member of family member has financial interest other than Brown-affiliated institutions, e.g. hospitals, foundations, clinical laboratories, or practice plans; E. Faculty members publishing or presenting research results or expert commentary without simultaneously disclosing any financial relationship; F. Solicitation or acceptance of any gratuities, favors, or anything of monetary value from contractors or parties to subagreements that are paid through direct or indirect funds awarded to Brown University; G. Serving as a Principal Investigator on a federal grant/contract that involves the evaluation of products from companies in which the PI has a significant financial interest, excluding SBIR grants; Examples of conflicts that are generally prohibited: A. Receipt of remuneration from Brown and an outside source for identical services or activities; B. Authorizing a consulting agreement at Brown for one’s spouse or domestic partner; C. Authorizing University-paid travel for a spouse or domestic partner; D. Voting on the award of University business to a vendor in which one has a significant financial interest or by which one is employed; E. Solicitation for personal benefit of gratuities, favors or anything of monetary value from students, donors, vendors, or contractors of the University; F. Serving on an organization’s Board and authorizing a Brown donation to or purchase from that organization; G. Faculty and/or staff investing personally or owning stock in privately held business ventures of their subordinates or students; H. Faculty members signing contracts with corporations that forbid publication of research findings; I. Faculty members using staff time and laboratory space for consulting or other non-university purposes; J. Faculty members using students, staff or postdocs for purposes of potential or real financial gain if there is no educational purpose; K. Faculty use of confidential information acquired through the conduct of university business or research for personal gain. XIII. PHS and NSF Requirements Regarding Financial Disclosures and Agency Notification On July 11, 1995, the Public Health Service (PHS) at the Department of Health and Human Services (DHHS) published as 60 FR 35810, its final regulations governing financial conflicts of interest. At the same time the National Science Foundation (NSF) published technical changes to final guidelines (published June 28, 1994 as 59 FR 33308) to make them more consistent with the final DHHS rules (60 FR 35820). Brown University is obliged to incorporate the definitions and requirements of PHS and NSF into its policy and apply these agencies’ policies to any proposed or funded PHS and NSF projects. For those faculty and researchers whose pending or active research projects involve these sponsors, special attention to the added requirements is necessary. This section describes the federal agency requirements and alerts all University employees to the way Brown University will handle them. In addition, it informs faculty and staff of Brown’s requirement to notify agencies in the event a potential conflict is identified. PHS and NSF require that for each proposal that the PI certify that he or she has appropriately disclosed any significant financial interests related to that proposal. Before an award can be made, the University must determine how any potential conflict will be managed, reduced or eliminated. PHS and NSF have defined “significant financial interest” as follows: a financial interest is anything of monetary value, including but not limited to:
Such results become “significant” for PHS and NSF if, for any one enterprise, the interest has a value of $10,000 or more or represents more than 5% ownership interest. Note that this threshold applies to the individual or aggregated interest of the PI, spouse or domestic partner, and dependent children. The term “significant financial interest” does not include:
“Investigator” means the principal investigator and any other person who is responsible for the design, conduct, or reporting of research. For the purposes of relating to financial interests, “investigator” includes the Investigator’s spouse and dependent children. Reporting Requirements: For every proposal (including continuations and renewals) submitted to either PHS or NSF, the following additional questions must be answered by the PI:
[It may be helpful to keep in mind what these questions are asking: Would your financial interests appear to be affected by the activities being proposed? You might own a significant amount of IBM stock, and your proposal may include purchase of a new PC. Such a purchase would not likely affect the financial interests of either you or IBM. On the other hand, if you have the same dollars invested in a privately-held company, with only one product, and your proposal calls for purchase of that product or service from that company, then it might indeed appear that your interests could be affected.] Review of Disclosures: Any investigator who is required to assure compliance with PHS and NSF policies should follow the Brown University COI Policy, Assurance and, as needed, Disclosure with review as specific above. The Office of the Provost, consistent with University COI policy, shall determine management of any disclosed conflict pertaining to a PHS or NSF proposal or award. Agency Notification Brown University is obligated to notify the sponsoring PHS institute or agency if a potential conflict has been identified in regard to that proposal or award. The Public Health Service does not require, nor do they want, any explanation of the details of the potential conflict situation, unless specifically requested.The notification should be signed and transmitted by the Office of Research Administration. A copy of the notification must be kept with the project records. This notification requirement applies only to the Public Health Service, including the National Institutes of Health (NIH).
Revised November 3, 2006 |