Policies and Guidelines

Conflict of Interest in Research Policy

Research activity in the University is dedicated to the advancement, preservation and dissemination of knowledge.

Research activity in the University is dedicated to the advancement, preservation and dissemination of knowledge; instruction of undergraduate, graduate and postdoctoral students; advancement of the public interest and public welfare. Research dedicated to these ends may incidentally generate financial benefits to individual investigators and to the University, for example, through patents and licensing. This is to be welcomed. However, the prospect of such gain cannot be allowed to govern the selection and conduct of research projects. Choices concerning the nature and orientation of research must be based on University values, which include intellectual importance, educational merit and public benefit. It is thoroughly consistent with these values, indeed it is both necessary and desirable, for the University to seek outside support from government, industry, foundation and private sponsors. Sponsored projects should reflect a coincidence of research interests on the part of sponsors and University.

Primary commitment must be devoted to the University.

Outside professional, financial and entrepreneurial activities of individual faculty and staff can contribute to University goals and provide valuable public and personal benefits as well. Primary commitment must however be devoted to the University. External interests and activities have to be ordered so as to minimize any risk of conflict with University objectives and values. It is not possible to lay down a precise and comprehensive set of rules on conflict of interest, even when the focus is narrowed to the research side of University life. A representative set of markers is nevertheless provided below. A Review Panel on Conflict of Interest in Research is established to monitor and deal with issues of conflict. Faculty and staff are counted on, in the first instance, to monitor their own activities. Whenever they perceive that the question of conflict might arise, they are expected to disclose the relevant facts to the Panel as a basis for guidance, possible adjustments and expeditious resolution. These matters are described below.

Student participation in research is a central educational goal of the University

Student participation in research is a central educational goal of the University. The selection and involvement of students must therefore at all times be governed primarily by consideration of the students' own educational goals as well as the legitimate needs and objectives of the research project. Faculty and staff must at all times scrupulously avoid providing research guidance and facilities to students with the dominant aim of serving their own outside professional, financial and/or entrepreneurial activities and objectives.

Open communication of research findings is an important University value.

Open communication of research findings is an important University value. Outside sponsorship or other associations should not be a basis for inhibiting the publication or sharing of information. In the case of sponsored research, University researchers must retain full rights concerning the timing and content of publications, apart from those safeguards established by the University to protect privacy, proprietary information and patentable inventions.

Research data and materials owned by or in the custody of the University

Research data and materials owned by or in the custody of the University, if they are to be made available externally, must be made generally available. In no case can the transfer of data or materials be made for reasons of personal gain, except in accordance with University policy on patents and copyright.

The University does not accept research sponsorship predicated on the finding of predetermined research results.

The University does not accept research sponsorship predicated on the finding of predetermined research results.

Except in the most incidental of ways

Except in the most incidental of ways, members of the University community should not use University research or administrative facilities to pursue personal business or commercial consulting activities.

Research within the University may not be undertaken or oriented with the purpose of serving the interests of outside persons or organizations unless there is University approval

Research within the University may not be undertaken or oriented with the purpose of serving the interests of outside persons or organizations unless there is University approval and, typically, appropriate financial support from the same persons or organizations.

Members of the University who enter into external consulting or other agreements

Members of the University who enter into external consulting or other agreements must take care that these are not in conflict with the provisions of Princeton's patent policy, its obligations under any sponsored grant or contract, or any other policies of the University.

The risk of conflict of interest, or serious appearance of conflict

The risk of conflict of interest, or serious appearance of conflict, can arise when a University investigator (or immediate relative or household member) has significant financial interests in an external enterprise engaged in activities closely related to the investigator's line of University research. Counted as "significant" are paid consultantships, paid service on an advisory board, substantial equity holdings in or royalty income from the enterprise, etc. By no means does the existence of such interests necessarily imply conflict. Nevertheless, where there are such interests, the investigator is obligated to provide full and current disclosure to the Review Panel. In exercising their judgment, members of the University are urged to tilt toward disclosure rather than nondisclosure in cases where they are unsure whether or not their outside financial interests rise to the level of "significant."

Federal agencies and other sponsors have a legitimate interest in knowing of any significant financial interests

Federal agencies and other sponsors have a legitimate interest in knowing of any significant financial interests that investigators may have in areas closely related to that of the product being sponsored; a legitimate interest also in the identity of other organization, if any, that may be involved in sponsorship of the project. The University requires compliance with reasonable requests for such information.

A Review Panel on Conflict of Interest in Research

A Review Panel on Conflict of Interest in Research is established as a committee reporting to the Dean for Research. The Panel is charged with receiving and analyzing disclosure material; proposing to the investigator suitable adjustments in project arrangements when these are deemed necessary to remove, minimize, or manage conflict of interest; and developing policy recommendations on conflict for consideration by the URB or other appropriate University bodies. The Panel consists of ten members: the Dean for Research as Chair, Dean of the Faculty, Dean of the Graduate School, Dean of the School of Engineering and Applied Science, the Director of Research Integrity and Assurance, General Counsel, and the Director of the Office of Technology Licensing, ex officio; a minimum of three other tenured members of the Faculty, one from Division I or II, and two from Divisions III and/or IV, all three appointed by the Chair of the Panel for staggered, renewable, three year terms.

Every University researcher is obligated to make appropriate disclosure

Every University researcher is obligated to make appropriate disclosure when, in the investigator's judgment and in the spirit of the Guidelines and general University standards, there is a risk of conflict of interest or serious appearance of conflict. What is called for in such cases is full and current disclosure of all interests that bear on the particular instance of conflict. Wider disclosure of personal interests beyond that is not sought.

Where external sponsorship of research is involved

Where external sponsorship of research is involved, there can be extra sensitivities concerning the potential for conflict of interest and, especially in the case of government sponsorship, conformity with agency regulations. For these reasons, the Review Panel reviews the annual conflict of interest disclosure statements from investigators involved in sponsored research.

Guidelines

NIH has announced revised regulations on conflicts of interest in research (the Final Rule on Financial Conflict of Interest Regulations) that amends the Public Health Service (PHS) regulations on  Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding is Sought (42 CFR Part 50, Subpart F) and Management and reporting of financial conflicts of interest for contractors (45 CFR Part 94.5). The new regulations go into effective no later than August 24, 2012. For answers to frequently asked questions on the new regulations visit the NIH FAQ website.   

In response to the revised financial conflicts of interest regulations (“Rules”) promulgated by the Public Health Service last year, Princeton has modified the procedures for reporting financial conflicts of interest for all faculty who are recipients of funding from the Public Health Service (PHS) including AHRQ, ATSDR, CDC, FDA, HRSA, IHS, NIH, and SAMHSA.     The guidelines below provide information on how the Rules will impact reporting obligations with respect to outside financial interests.

Training

The revised regulations require mandatory investigator training regarding financial conflicts of interest in research at least every four years. All faculty who are recipients of funding from the Public Health Service (PHS) including AHRQ, ATSDR, CDC, FDA, HRSA, IHS, NIH, and SAMHSA are required to take the training at least every four years.  

Princeton, in conjunction with CITI, has developed a web-based training module in order to comply with this requirement. All PHS funding recipients (PIs) will need to complete the training prior to August 23, 2012 and then every four years thereafter. Additionally, as required by the regulations, we are asking you to notify us if there are others working on any of your PHS funded research projects that, regardless of title or position, are responsible for the design, conduct or reporting of the research. All such personnel will also be required to complete the training.

New Reporting Requirements For Significant Financial Interests

All investigators must report significant financial interests of themselves, their spouses, and dependent children that are in any way related to their institutional responsibilities (e.g., teaching, research, administrative) on an annual basis and thereafter within 30 days of acquiring a new financial interest.

For the limited purposes of compliance with the Rules, Princeton defines an investigator’s institutional responsibilities as research, teaching/education, outreach, and administrative activities, both within and outside the university, in the disciplinary field of an individual’s academic unit that would commonly accept and review such activities in assessing the individual’s annual institutional contributions and accomplishments. Personal consulting, service on corporate boards and other activities conducted under the Outside Professional Activities policy are explicitly excluded from the definition of institutional responsibility. The Rules define a Significant Financial Interest as:

A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities:

(i) With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000.  For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;

(ii) With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or

(iii) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests. 

 Expressly excluded from the definition of a significant financial interests are:

  • salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution;
  • intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights
  • any ownership interests in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization
  • 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 these vehicles;
  • income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an Institution of higher education as defined in 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education;
  • income from service on advisory committees or review panels for a federal, state, or local government agency, or an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.

In order to comply with this aspect of the Rules, all PHS funding recipients will be required to complete a COI questionnaire specifically related to these new definitions of significant financial interests by the PHS prior to August 23rd and thereafter within 30 days of any change. The Rules state that the Institution must review all disclosed significant financial interests to determine if a Financial Conflict of Interest (“FCOI”) exists and a management plan must therefore be implemented. Under the Rules, a Financial Conflict of Interest exists “when the Institution, through its designated official(s), reasonably determines that an Investigator’s Significant Financial Interest is related to a NIH-funded research project and could directly and significantly affect the design, conduct or reporting of the NIH-funded research.” 

Investigators will therefore be asked to provide their opinion as to whether any of their disclosed significant financial interests could directly and significantly affect the design, conduct or reporting of the NIH-funded research. Each response will thereafter be reviewed by a member of the Review Panel on Conflict of Interest in Research and may include additional discussions with the investigator.  If it is determined that a FCOI exists then several things will happen: 1) Princeton will have to report each occurrence to the sponsor; 2) Princeton will have to implement a conflict of interest management plan; and 3) Princeton will have to make certain information regarding the FCOI available to the public (see below).

Travel Reporting

The Rules require that starting August 23rd, each investigator must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the investigator and not reimbursed to the investigator so that the exact monetary value may not be readily available), related to the investigator’s institutional responsibilities and within thirty (30) days of the travel.  However, the disclosure requirement does not apply to travel that is reimbursed or sponsored by the following:

  • a federal, state, or local government agency,
  • an Institution of higher education as defined at 20 U.S.C. 1001(a) (which does not include foreign academic institutions),
  • an academic teaching hospital,
  • a medical center, or
  • a research institute that is affiliated with an Institution of higher education.

The Rules do not provide a de minimis threshold for the disclosure of reimbursed or sponsored travel.  However, they require the disclosure of the purpose of the trip, the identity of the sponsor/organizer, the destination and the duration but not including the dollar amount. Princeton will have a web-based system for reporting this travel and will notify you when it is online.   Each disclosure will thereafter be reviewed for a determination of whether a FCOI exists by a member of the Review Panel on Conflict of Interest in Research.

Public Accessibility of Certain Information Regarding All FCOIs

For all those investigators that are deemed to have a FCOI, Princeton is required to make public disclosure of such information including the name of the investigator, the conflicted company, and the amount of the financial interest through either a website or by written request.  Princeton University intends to respond in writing on a case-by-case basis to requests for this information and will not maintain a website to report such interests.   Affected faculty will be notified in advance of the release of this information in response to any such requests