Policies and Guidelines

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.

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. 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. 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, 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.

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 and, typically, appropriate financial support from the same persons or organizations.

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, 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 funding research at the University have a legitimate interest in ensuring that the design, conduct and reporting of such research will be free from bias resulting from an investigator’s financial conflicts of interest. Often these federal agencies have specific regulations requiring certain disclosure of financial interests by principal investigators and key personnel applying for and working on federally funded research. The reporting requirements of federally funded research may be different than those ordinarily required by the University. In those cases, the University will provide guidelines to assist Investigators in understanding their obligations as well as disclosure forms.

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 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, 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.

Because federal agencies have different COI requirements Princeton University’s guiding principles to report outside financial interests are divided into two categories: (1) those DOF Appointees who are PHS-funded and (2) those DOF Appointees who are non-PHS funded or are not funded:

Princeton University Policy on COI and The COI in Research (COIR) Panel (Panel) Charter requires all DOF appointees to abide by Federal Regulation 42 CFR Part 50 Subpart F – Promoting Objectivity in Research for defining and disclosing Significant Financial Interest(s).

PHS funding agencies include:

• Agency for Healthcare Research and Quality (AHRQ)
• Agency for Toxic Substances and Disease Registry (ATSDR)
• Centers for Disease Control and Prevention (CDC)
• Food and Drug Administration (FDA)
• Health Resources and Services Administration (HRSA)
• Indian Health Service (IHS)
• National Institutes of Health (NIH)*
• Substance Abuse and Mental Health Services Administration (SAMHSA)

* NIH funding encompasses 99% of Princeton’s PHS Funding

The Public Health Service (PHS) regulations (Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding is Sought, Title 42 CFR Part 50, Subpart F and Responsible Prospective Contractors Title 45 CFR Part 94) promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded by the PHS will be free from bias resulting from an investigator’s SFI.  For answers to frequently asked questions on COI regulations visit the NIH COI FAQ website or the Princeton FAQ for Conflict of Interest. 

Reporting Requirements for PHS-Funded DOF Appointees with Significant Financial Interests (SFI)

All PHS-funded investigators must report SFI(s) of themselves, their spouses, and dependent children that are in any way related to their institutional responsibilities on an annual basis and thereafter within 30 days of acquiring a new financial interest. For the purposes of these guidelines, Princeton University defines an investigator’s institutional responsibilities as a person’s professional responsibilities on behalf of the University including, but not limited to research and teaching activities both within and outside the University.  

The PHS Regulations Define an SFI 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 person’s institutional responsibilities:

• With regard to any publicly traded entity, an SFI 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 and travel (see guidelines below)); 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;
• With regard to any non-publicly traded entity, an SFI 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
• Intellectual property rights and interests (e.g., patents, copyrights) outside of Princeton University amounting to $5,000 or more per year per entity, upon receipt of income related to such rights and interests. 

Excluded from the definition of an SFI 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 the PHS regulations, all PHS-funded recipients are required to complete a COI disclosure form annually and thereafter within 30 days of acquisition of a new SFI. The regulations state that the institution must review all disclosed SFIs to determine if a Financial Conflict of Interest (FCOI) exists and if so, a management plan must be implemented. An FCOI exists “when the Institution, through its designated official(s), reasonably determines that an Investigator’s SFI is related to a PHS-funded research project and could directly and significantly affect the design, conduct or reporting of the PHS-funded research.” 

Once the appointee discloses an SFI, the person will then be asked to describe the relationship between the SFI and their institutional responsibilities.  Each response will then be reviewed by RIA, who may require additional discussions with the investigator. The final determination as to whether an SFI is an FCOI is made by the DFR or the COIR Panel. If the DFR or COIR Panel determines that an FCOI exists then several outcomes will happen: 1) The FCOI must be reported to the PHS sponsor; 2) A conflict of interest management plan must be implemented; and 3) Princeton will have to make certain information regarding the FCOI available to the public if requested (see below in Reporting Requirements).

When an FCOI is identified this does not imply any wrongdoing on any person’s part.  In fact, FCOI’s that are managed appropriately, are in line with Princeton’s entrepreneurial mission.  Such determinations and plans protect the reputation of the researcher and the University and maintain the integrity of the research process through disclosure of any potential conflicts. Examples of conditions or restrictions that might be imposed in a management plan include but are not limited to: 

• Public disclosure of the financial conflict of interest (e.g., when presenting or publishing the research and to lab personnel);
• For research involving human subjects research, disclosure of financial conflicts of interest directly to participants;
• Modification of the research plan;
• Reduction or elimination of the financial interest.

PHS-funded DOF Appointees’ Training Requirements

The PHS regulations require mandatory investigator training regarding FCOI prior to engaging in PHS-funded research and at least every four years thereafter. 

Princeton, in conjunction with the Collaborative Institutional Training Initiative (CITI), has developed a web-based training module in order to comply with this requirement. All PHS-funded recipients (Principal Investigators (PIs) and Independent Investigators, or key personnel described on the award application) need to complete the initial training and then every four years thereafter. Additionally, as required by the regulations, PIs must notify RIA if there are others working on any PHS-funded research projects that, regardless of title or position, are responsible for the design, conduct or reporting of the research. This may include, Co-Principal Investigator, key personnel, post-doctoral fellows, students, professional research staff, collaborators or consultants. All such personnel will also be required to complete the training.

PHS-funded DOF Appointees’ Travel Reporting Requirements

The PHS regulations require each investigator to 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) by an outside entity other than Princeton and related to the investigator’s institutional responsibilities within thirty (30) days of the travel. Note that travel includes transportation, living accommodations, and food. 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.

Princeton University has set a de minimis threshold of $5,000 or greater from a single entity over the previous 12-months to initiate a travel disclosure. The regulations also require, the disclosure of the purpose of the trip, the identity of the sponsor/organizer, the destination and the duration of the trip.  NIH Travel Disclosure forms are available through the web based Princeton COI Reporting System. Each disclosure will thereafter be reviewed by RIA for a recommendation to the DFR as to whether the disclosed travel constitutes an FCOI. The DFR will decide if the information needs to be reviewed by the COIR Panel. The DFR or the COIR Panel makes the final FCOI determination.

FCOI Non-Compliance for PHS-funded DOF Appointees

If an SFI is not reported to RIA within 30 days and that SFI is determined to be an FCOI, this becomes a noncompliance issue, and a Retrospective Review must be completed within 120 days. In a Retrospective Review, a researcher’s peers examine the Investigator’s activities, the SFI and the PHS-funded research project to determine whether the funded research, conducted during the time of noncompliance was biased in the design, conduct or reporting of such research. Princeton is required to document the Retrospective Review through a national database, which may be discoverable via the Freedom of Information Act.

PHS-funded DOF Appointees’ Reporting Requirements for SFIs that are determined to be FCOIs

All FCOIs must be reported through the federally-managed Electronic Research Administration (eRA) Commons web based system. Princeton is required to make a public disclosure of such information including but not limited to the name of the investigator, the conflicted company, and the amount of the financial interest through either a website or by written request within 5 days of the request.  Princeton University will 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 request.

All Non-PHS funded DOF appointees and all other Faculty, Academic Professional and Professional Librarians, are subjected to the same PHS Federal Regulation requirements for reporting Significant Financial Interests with the following exceptions:

1. There is no travel reporting requirement
2. There is no mandated training requirement for FCOI
3. Federal reporting of an FCOI is only required for those funded by the National Science Foundation

Non-PHS-funded DOF Appointees’ and all other Faculty, Academic Professionals and Professional Librarians Reporting Requirements for Significant Financial Interests (SFI)

All Non-PHS funded and all other Faculty, Professional Researchers and Librarians must report SFIs for themselves, their spouses, and dependent children that are in any way related to their institutional responsibilities on an annual basis.  For the purposes of these guidelines, Princeton University defines an investigator’s institutional responsibilities as a person’s professional responsibilities on behalf of the University including, but not limited to research and teaching activities both within and outside the University. Additionally, as required by University Policy, PIs must notify RIA if there are others working on any funded research projects that, regardless of title or position, are responsible for the design, conduct or reporting of the research. This may include, Co-PI, key personnel, post-doctoral fellows, students, professional research staff, collaborators or consultants. 

University Policy defines an SFI for non-PHS-funded researchers and all other Faculty, Academic Professionals and Professional Librarians as:

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

• With regard to any publicly traded entity, an SFI 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;
• With regard to any non-publicly traded entity, an SFI 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
• Intellectual property rights and interests (e.g., patents, copyrights) outside of Princeton University amounting to $5,000 or more per year per entity upon receipt of income related to such rights and interests. 

Excluded from the definition of an SFI 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 Federal Regulations, Princeton University COI Policy and the COIR Panel Charter, non-PHS funded DOF appointees and all other Faculty, Academic Professionals and Professional Librarians are required to complete a COI disclosure form annually and thereafter within 30 days of acquisition of a new SFI. Federal regulations and University COI Policy state that the Institution must review all disclosed SFIs to determine if an FCOI exists and if so a management plan must be implemented. Under Federal regulations, University COI Policy, and the COIR Panel Charter, an FCOI exists when the Institution, through its designated official(s), reasonably determines that a DOF appointees’ SFI is related to their institutional responsibilities and could directly and significantly affect the design, conduct or reporting of their research and/or teaching activities.

Once the appointee discloses an SFI, the person will then be asked to describe the relationship between the SFI and their institutional responsibilities.  Each response will then be reviewed by RIA and may include additional discussions with the person.  The final determination as to whether an SFI is an FCOI is made by the DFR or the COIR Panel. If it is determined that an FCOI exists then a couple of outcomes will happen: 1) Princeton may have to report the FCOI to the funding sponsor; and/or 2) Princeton will have to implement a COI management plan.

The Following Factors will be Considered in the Determination as to Whether an SFI Represents an FCOI:

Each SFI disclosure is handled on a case-by-case basis. Once the relationship is disclosed as an SFI the following criteria will be used to determine whether the SFI rises to the level of an FCOI:

• Whether the research is of a basic or fundamental nature directed at understanding basic scientific processes.
• Whether the degree of replication and verification of research results is such that immediate commercialization or clinical application is not likely
• Whether the SFI is in a privately held company, where the SFI could result in the researcher having influence over the company’s decisions.
• Where the SFI is the sponsor of the research.
• Whether the research could have a significant impact on a company’s business or financial outlook.
• Whether one of the goals of the research is to validate or invalidate a particular approach or methodology that could affect the value of the company.
• The magnitude of the SFI.
• Whether the goal of the project is a comparative evaluation of a technology on which an investigator has an SFI
• Whether the entity is licensing Princeton’s intellectual property derived from the research.
• The number and nature of the relationships a DOF appointee has with the entity. For example, Material Transfer Agreements, visitors from the entity, family members with equity interest in the entity, use of Princeton University space or equipment by the entity.
• Whether the DOF appointee holds an ongoing managerial position (e.g., CEO, Director, President or VP) at the entity.
• Whether other scientific groups are independently pursuing similar questions

After evaluating the information provided by the DOF appointee in light of the criteria above, if the determination of an FCOI is made, possible options for mitigation may include: (1) implement a management plan to mitigate the potential for conflict or bias; or (2) eliminate aspects of the interrelationship; 3) reduce or eliminate the SFI; or 4) the funding may be denied.

When an FCOI is identified this does not imply any wrongdoing on any person’s part.  In fact, FCOI’s that are managed appropriately, are in line with Princeton’s entrepreneurial mission.  Such determinations and plans protect the reputation of the researcher and the University and maintain the integrity of the research process through disclosure of any potential conflicts.  Examples of conditions or restrictions that might be imposed in a Management Plan include but are not limited to: 

• Public disclosure of the financial conflict of interest (e.g., when presenting or publishing the research and to lab personnel);
• For research involving human subjects research, disclosure of financial conflicts of interest directly to participants;
• Modification of the research plan;
• Reduction or elimination of the financial interest.

Training Requirements for Non-PHS-funded DOF Appointees’ and all other Faculty, Academic Professionals and Librarians

Currently there are no University or Federal requirements for COI training for non-PHS funded individuals and all other Faculty, Academic Professionals and Professional Librarians. Only PHS-funded researchers have a mandated training requirement.

Travel Reporting Requirements for Non-PHS funded DOF Appointees’ and all other Faculty, Academic Professionals and Librarians

Currently there are no University or Federal requirements for travel reporting for non-PHS funded individuals and all other Faculty, Academic Professionals and Professional Librarians, although travel amounts should be added in to the overall total when reporting an SFI from a particular entity if that travel was considered part of the remuneration package from the outside financial interest.  Note that travel includes transportation, living accommodations, and food.   

FCOI Non-Compliance for Non-PHS funded researchers and all other Faculty, Academic Professionals and Librarians

If an annual disclosure form that contains disclosures of SFI(s) is not reported to RIA during the annual disclosure period by any Faculty, Academic Professional or Professional Librarian, then annual merit salary increases may be withheld.

Federal Non-PHS-funded DOF Appointees’ and all other Faculty, Academic Professionals and Librarians Reporting Requirements for SFIs Which are Determined to be FCOIs

The National Science Foundation requires that the Institution must include arrangements tor keeping the NSF’s Office of the General Counsel appropriately informed if the institution finds that it is unable to satisfactorily manage a Conflict of Interest.

The Following Factors will be Considered in the Determination as to Whether an SFI Represents an FCOI:

Each SFI disclosure is handled on a case-by-case basis. Once the relationship is disclosed as an SFI the following criteria will be used to determine whether the SFI rises to the level of an FCOI:

• Whether the research is of a basic or fundamental nature directed at understanding basic scientific processes. 
• Whether the degree of replication and verification of research results is such that immediate commercialization or clinical application is not likely
• Whether the SFI is in a privately held company, where the SFI could result in the researcher having influence over the company’s decisions.
• Where the SFI is the sponsor of the research.
• Whether the research could have a significant impact on a company’s business or financial outlook.
• Whether one of the goals of the research is to validate or invalidate a particular approach or methodology that could affect the value of the company.
• The magnitude of the SFI.
• Whether the goal of the project is a comparative evaluation of a technology on which an investigator has an SFI 
• Whether the entity is licensing Princeton’s intellectual property derived from the research.
• The number and nature of the relationships a DOF appointee has with the entity. For example, Material Transfer Agreements, visitors from the entity, family members with equity interest in the entity, use of Princeton University space or equipment by the entity.
• Whether the DOF appointee holds an ongoing managerial position (e.g., CEO, Director, President or VP) at the entity. 
• Whether other scientific groups are independently pursuing similar questions

After evaluating the information provided by the DOF appointee in light of the criteria above, if the determination of an FCOI is made, possible options for mitigation may include: (1) implement a management plan to mitigate the potential for conflict or bias; or (2) eliminate aspects of the interrelationship; 3) reduce or eliminate the SFI; or 4) the funding may be denied.

When an FCOI is identified this does not imply any wrongdoing on any person’s part.  In fact, FCOI’s that are managed appropriately, are in line with Princeton’s entrepreneurial mission.  Such determinations and plans protect the reputation of the researcher and the University and maintain the integrity of the research process through disclosure of any potential conflicts. Examples of conditions or restrictions that might be imposed in a management plan include but are not limited to: 

• Public disclosure of the FCOI (e.g., when presenting or publishing the research and to lab personnel);
• For research involving human subjects research, disclosure of financial conflicts of interest directly to participants;
• Modification of the research plan;
• Reduction or elimination of the financial interest.

Document Summary:

This document establishes guidelines for investigators who are consulting AND receiving research funds or a gift from the same entity. Compensated consulting that rises to a level of significance defined below as a Significant Financial Interest (SFI), and receiving research funds from the same entity should be disclosed as an SFI on the Annual Disclosure form in Part G: Significant Financial Interests Relating to Your Research or Teaching Activities.  Once disclosed, the information will be evaluated on a case by case basis by the Dean for Research (DFR) or the Conflict of Interest in Research Panel (COIR Panel), to determine whether the SFI constitutes a financial conflict of interest (FCOI).  If the DFR or the COIR Panel determines that the SFI is an FCOI, there are three possible outcomes: 1) a management plan is implemented; 2) aspects of the relationship between the investigator and the entity are eliminated; or 3) the funding may be denied.

Scope:

This guideline applies to all Dean of the Faculty (DOF) appointees, regardless of funding source, who meet the monetary threshold for significant financial interest (SFI) received from consulting practices as defined below and are also receiving research funds from the same entity.

Regulatory Background:

Princeton University follows the Public Health Service (PHS) Federal Regulation 42 CFR Part 50, Subpart F, “Promoting Objectivity in Research” to define monetary thresholds used to identify SFI in cases where such interests relate to an individual’s institutional responsibilities.

Princeton University’s Rules and Procedures of the Faculty state: “The risk of conflict of interest, or serious appearance of conflict, can arise when a University investigator (or his/her spouse or dependent children) has an SFI in an external enterprise engaged in activities closely related to the investigator's line of University research.  It is the policy of the University to require faculty to complete an annual disclosure form designed to identify any potential conflicts of interest arising from SFIs so that they may be appropriately managed.”*

Responsibilities:

Institution: Ensures the submission of disclosures of SFIs by all DOF appointees (Faculty, Academic Professionals, and Professional Librarians) during the annual disclosure period, and reviews the disclosures for potential conflicts of interest (COI). 

Investigator: Complies with Federal regulations and Princeton Policy on conflict of interest by submitting an annual disclosure form that includes SFI disclosures related to his/her institutional responsibilities. PHS-funded investigators must disclose annually, and in addition within 30 days of acquiring a new SFI that is related to their institutional responsibilities.

Chair of the COIR Panel and the COIR Panel: The Chair of the COIR Panel is the Dean for Research (DFR).  The DFR reviews SFIs that are related to institutional responsibilities and makes determinations of Financial Conflict of Interest (FCOI) or defers this determination to the COIR Panel.

Departmental Chairs: Ensure that annual disclosure forms are returned in a timely manner.  In addition to the Panel review of annual disclosures, Department Chairs should review annual disclosure forms submitted by their department members and address any conflict of interest concerns with Research Integrity and Assurance (RIA).  In addition to the general review of the form, Department Chairs should also review the use of space, equipment, students and Academic Professionals when the use relates to any SFI.  Finally, the Department Chair consults, if necessary, with the Dean of the Faculty (DOF) and/or RIA on any special circumstances regarding consulting and the potential for COI. **

Definitions:

Consulting - Professional activity related to the person's field or discipline, where a fee-for-service or equivalent relationship with a third party exists.  When consulting, a person agrees to use his or her professional capabilities to further the agenda of a third party, in return for an immediate or prospective gain.

Significant Financial Interest (SFI) – In general, this refers to a financial interest for a DOF appointee (and/or his or her spouse or dependent children) that is related to his/her institutional responsibilities.  If the monetary value received by the individual exceeds $5,000 over a period of a year, and/or the person receives any ownership interest (stocks or stock options) from a privately held entity, and/or the person receives any ownership interest (stocks or stock options) from a publicly-traded entity that is worth over $5,000, this is deemed significant. In the context of this document, if the above monetary thresholds are met and result from consulting activities and, in addition, the entity for which the DOF appointee consults also funds his/her research activities either through a research award or a gift, then the consulting activity and the research funding should be disclosed as an SFI on the annual disclosure form. For PHS-funded individuals, the SFI must be reported within 30 days of acquiring it.

Institutional Responsibilities – A DOF appointee’s responsibilities on behalf of the University including, but not limited to, research and teaching activities both within and outside the University.

Financial Conflict of Interest (FCOI) - Exists when the DFR or the COIR Panel reasonably determine that an SFI related to a DOF appointee’s research activities could directly and significantly affect the design, conduct, or reporting of research.

The existence of a financial conflict of interest does not imply wrongdoing and does not mean that a researcher may not retain his or her financial interest nor undertake the affected research. Often Princeton can work with the person to manage a financial conflict of interest or the appearance of a conflict so that the research can continue in a way that minimizes the possibility of bias in, and preserves the objectivity of, the research. Proper management of a conflict depends on full and prompt disclosure.

Guidelines:

Consulting and receiving research funds from the same entity should be disclosed as a Significant Financial Interest (SFI) on the Annual Disclosure form in Part G: Significant Financial Interests Relating to Your Research or Teaching Activities.

Members of the University who pursue external consulting must take care that the agreements that define these activities 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.* Financial gain must be incidental to the research:  the prospect of such gain cannot be allowed to govern the selection and conduct of research projects.

FCOI Determination:

Each SFI disclosure is handled on a case-by-case basis. Once the relationship is disclosed as an SFI (in this case when the consulting remuneration threshold is met and is from an entity that is also funding the research via awards or gifts) the following criteria will be used to determine whether the SFI rises to the level of an FCOI:

• Whether the research is of a basic or fundamental nature.
• Whether the research could have a significant impact on a company’s business or financial outlook.
• Whether one of the goals of the research is to validate or invalidate a particular approach or methodology that could affect the value of the company.
• The magnitude of the consulting fees.
• Whether the funded research from the company that the DOF appointee is consulting for is related to the appointee’s federally funded research.
• Whether the entity that the DOF appointee is consulting for licenses Princeton’s intellectual property derived from the DOF appointee’s research.
• Whether the DOF appointee also has equity interest in the company that he/she is consulting for.
• Whether the DOF appointee who is consulting for, and being funded by, the entity also has other connections or interrelationships with the entity (i.e. Material Transfer Agreements, visitors from the entity, family members with equity interest in the entity, use of Princeton University space or equipment by the entity).
• Whether the DOF appointee holds a managerial position (e.g., CEO, Director, President or VP) at the entity for which they consult and from which he/she receives research funding.

After evaluating the information provided by the DOF appointee in light of the criteria above, if the determination of an FCOI is made, possible options for mitigation may include: (1) implement a management plan to mitigate the potential for conflict or bias; or (2) eliminate aspects of the interrelationship; or 3) the funding may be denied.

Other considerations:

In the case when a DOF appointee is consulting and receiving funding from the same entity, consulting agreements with the entity should carefully delineate and separate university responsibilities from consulting responsibilities. Specifically, the scope of the consulting services should be distinguished from the scope of research commitments at Princeton University.

When a DOF appointee is consulting for and being funded by the same entity, he/she may not use University resources or personnel, including students, academic professionals, facilities and equipment for consulting-related activities, except in a purely incidental way. In conducting research funded by an entity for whom the DOF appointee also consults, the same rules concerning the use of University resources apply as they would for any other research activity. In particular, inappropriate use of University resources includes the following:

• A faculty member assigning tasks to students, staff, or postdoctoral scholars for purposes of potential or real financial gain to the faculty member and/or his or her spouse or dependent children rather than the advancement of the scholarly field or the students' educational needs.
• Involvement of the faculty member's students or staff in his or her outside consulting or business activities without prior review and approval by the Department Chair.
• Granting the external entities with whom one consults and receives funding or gifts access to Princeton University resources, personnel or services for purposes outside the University's missions. 

Intellectual property (IP) resulting from a DOF appointee’s research, including any research done in collaboration with the entity for which a DOF appointee is consulting and from which he/she is receiving funding, is to be disclosed to Princeton’s Office of Technology Licensing (OTL) as required by the University’s Patent Policy and contractual obligations. The IP will be pursued in accordance with University Patent Policy.***

Princeton is under no obligation to license any intellectual property resulting from a DOF appointee’s research to the entity that a DOF appointee is consulting for and being funded by, unless there is a previously approved research agreement that specifies the licensing terms of the intellectual property.

The University must retain full rights concerning the timing and content of publications, including publications resulting from any research done in collaboration with the entity for which a DOF appointee is consulting and from which he/she is receiving funding.

A DOF appointee may not publish articles or other forms of scholarly communication under their own names in the course of their outside professional activities that are written in whole or material part by employees of the outside entity (i.e., “ghost written”).  This is of particular relevance in cases where the DOF appointee receives funding and consults for the same company.

All significant consulting contracts (e.g. if the monetary value received by the individual exceeds $5,000 over a period of a year, and/or the person receives any ownership interest (stocks or stock options) from a privately held entity, and/or the person receives any ownership interest (stocks or stock options) from a publicly-traded entity that is worth over $5,000) that are put into place with an entity that is also funding or gifting a DOF appointee’s research should be reported to the COIR Panel  for review and possible mitigation.

References:

Public Health Service Federal Regulation 42 CFR Part 50, Subpart F, “Promoting Objectivity in Research”
*Rules and Procedures of the Faculty, Chapter 5:I – Conflicts of Interest in Research
** Guidebook for Department Chairs and Managers, Outside Professional Activities and Conflicts of Interest
*** Princeton University Patent Policy

Princeton University is a leading academic research institution that welcomes interest in our discoveries from entrepreneurs, industry and potential collaborators.  We encourage the creative and innovative process through a number of programs including the provision of incubators, accelerators, start-up support and entrepreneurial education.  Funding for such interests, especially during initiation, is often challenging. While encouraging innovation, Princeton must also maintain its status as a premier research and education institution.

During initiation, funding may come from many possible sources, including industry, venture capital, private foundations and even the government.  When funding comes from private sources in which owners or investors may have personal or vested interests in the research outcome, potential conflicts of interest exist.        

This document establishes guidelines for Dean of the Faculty (DOF) appointees (Faculty, Academic Professionals and Professional Librarians) who would like to receive research funds or gifts into their Princeton University laboratory, office, or department from a privately held company in which they also own equity interest. Any equity ownership interest in a privately owned company is deemed significant and should be disclosed as a significant financial interest (SFI) either on the annual disclosure form in Part G: Significant Financial Interests Relating to Your Institutional Responsibilities if it is related to the investigator’s institutional responsibilities of research, teaching and/or service, or on the Conflict of Interest (COI) update form. Requests to receive funding or gifts from such entities must be approved by the Dean for Research (DFR) or the Conflict of Interest in Research Panel (Panel) prior to accepting those funds/gifts. 

History:

Historically, Princeton University supported a 5% practice for requests to fund research, either via a sponsored contract or a gift, into a person’s University laboratory.  Such funding requests would typically be initiated either through the Office of Research and Project Administration (ORPA), in the case of a funded award or contract, or through Corporate Engagement and Foundation Relations (CEFR), in the case of a gift.  Under this paradigm, in general, if a person owned greater than 5% equity in a company, they were not allowed to fund research into their lab from that company.  The new guidelines will replace the 5% practice funding paradigm. The new guidelines are not intended to be a scoresheet: each case will be considered on its own merits and the decision to allow funding (or not) will be based upon the totality of the circumstances, which will include background information on the company, the research, and the investigator’s current source(s) of funding.

Regulatory Background:

Federal COI regulations and Princeton COI policy are designed to ensure research integrity by assuring that outside influences do not affect the design, conduct or reporting of research or interfere with one’s institutional responsibilities.  To avoid undue influence, federal regulations and University policy require DOF appointees to disclose SFIs and/or potential conflicts of interest.  Princeton University must identify and manage any relationship that may affect an appointees’ abilities to perform their institutional responsibilities, which include their ability to perform teaching, research, or service.  In addition, the research must not be overly influenced by external factors (obligations, financial interests, etc.) that could impact the design, conduct or reporting of funded research or teaching activities. 

Princeton University follows the Public Health Service (PHS) Federal Regulation 42 CFR Part 50, Subpart F*, “Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought” to define thresholds used to identify an SFI in cases where such interests relate to an individual’s institutional responsibilities.

Princeton University’s Rules and Procedures of the Faculty state: “The risk of conflict of interest, or serious appearance of conflict, can arise when a University investigator (or his/her spouse or dependent children) has an SFI in an external enterprise engaged in activities closely related to the investigator's line of University research.  It is the policy of the University to require faculty to complete an annual disclosure form designed to identify any potential conflicts of interest arising from SFIs so that they may be appropriately managed.”**

Although the University supports and helps to manage potential conflicts, the Rules and Procedures (Chapter V, Part I – Conflicts of Interest in Research** and the Policy Library (Conflict of Interest in Sponsored Research***) clearly state the following:

“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. “

“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.”

“An individual should not undertake or orient any research within the University with the purpose of serving the needs or interests of an external individual or organization, except in connection with projects financed by the same individual or organization and approved by the University.”

For more in depth background and other policy or regulatory information please see either the COIR Panel Charter or the University COI Policy and Research Integrity and Assurance (RIA) COI Guidelines

Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) are programs that encourage domestic small businesses to engage in Federal Research/Research and Development (R/R&D) that has the potential for commercialization. Through a competitive awards-based programs, SBIR and STTR enable small businesses to explore their technological potential and provides the incentive to profit from its commercialization. By including qualified small businesses in the nation's R&D arena, high-tech innovation is stimulated and the United States gains entrepreneurial spirit as it meets its specific research and development needs. At this time, both Phase I SBIR and STTR awards are not subject to financial conflict of interest regulations.

Basic Principles:

Members of the University who own equity interest in a company and would like to receive research funding or a gift from the same entity must take care that the agreements that define these activities 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.  Financial gain must be incidental to the research and the prospect of such gain cannot be allowed to govern the selection and conduct of research projects.

When a DOF appointee has equity interest and is being funded by the same entity, they may not use University resources or personnel, including students, academic professionals, facilities and/or equipment for company-related activities, except for the research collaboration that is being funded by the entity.  In conducting research funded by an entity for whom the DOF appointee also has equity interest, the same rules concerning the use of University resources apply as they would for any other research activity. In particular, inappropriate use of University resources includes the following:

• A DOF appointee assigning tasks to students, staff, or postdoctoral scholars for purposes of potential or real financial gain to the faculty member and/or his or her spouse or dependent children rather than the advancement of the scholarly field or the students' educational needs.
   
• Involvement of the DOF appointee’s students or staff in his or her outside company or business activities without prior review and approval by the Department Chair and the DOF.
   
• Granting the external entities with whom the DOF appointee has equity interest and receives funding or gifts access to Princeton University resources, personnel or services for purposes outside the University's missions. 

Guidelines Affecting Determination:

The determination as to whether Princeton University will accept research funding or a gift into a researcher’s lab from a company in which the researcher has an equity interest will be based upon the following guidance:

1. The justification for the request for research funding from the company in which the DOF appointee has equity interest.
    
2. The proposed research should satisfy minimum scholarly standards (i.e. be publishable in a peer reviewed journal) and there should be no restrictions on publication. Reasonable restrictions may be imposed by a company to delay publications for 60 to 90 days in order to allow for IP documentation.
    
3. The proposed funding should not support contract research (i.e. research with strict pre-determined deliverables).
    
4. The potential for the significant financial interest (SFI, in this case equity interest) to constitute a Financial Conflict of Interest (FCOI).  In general, clear separation between any federally-funded research and the company’s platform will be a favorable factor when considering whether to approve funds/gifts.
    
5. The proposed funding should not be a significant fraction of the PI’s annual sponsored research expenditures.  Although a strict numerical criterion is arbitrary, a reasonable guideline is that if the proposed funding exceeds 30% of the researcher’s overall sponsored research funding, this may be viewed as inconsistent with an otherwise active lab that is pursuing and being awarded other extramural funding awards and contracts.
    
6. The percent equity interest that the investigator owns in the company should be considered in light of the value of the company.  In general, investigators that own less than 30% of a company will be considered more favorably than those for whom the equity owned establishes controlling interest of a company.
    
7. The amount of the requested gift or fund and the likelihood that additional funds or gifts will be requested in the future.  An exception to this would be an SBIR or STTR award.
    
8. The number and degree of competing conflicts of commitment between the outside entity and the PI’s institutional responsibilities/commitments. 
    
9. The extent that 3^rd parties, who may provide the funding, may also be involved in the entity’s leadership, structure or organization, either directly or through relationship or nepotism.  This consideration is designed to prevent pass-through or 3^rd party funding opportunities in which individuals directly or peripherally involved with the startup company may have additional equity or financial interests in entities associated with the new company, resulting in a financial benefit to the individual (3^rd party) if such funding or gifting is allowed.
    
10. The extent and degree of additional connections between the PI and the company that would provide the funding. Examples of other connections (besides ownership interest) that may exist include, but are not limited to, Material Transfer Agreements, consulting arrangements, service on scientific advisory boards, paid honoraria, visitors from the entity and/or potential use of Princeton University personnel, space or equipment.  In general, the fewer interconnections, the more likely the funding may be approved.
     
11. The extent and degree of additional disclosed SFIs involving other companies that either fund the PI’s lab or involve payment for other services, for example through board membership or consulting.  In general, these funding requests should be limited to no more than 2 per year at the same time without a written approval from the DFR or DOF.  In the case of multiple SFIs there could be a potential conflict of commitment that needs to be addressed.

Special considerations for new start-up companies when determining whether to approve funding or a gift into an investigator’s lab:

Special consideration may be granted to PIs with new start-up companies, so called shell companies that are in the very early stages of developing strategies to obtain outside funding through grants, gifts, or other investors.  Such consideration will be granted to labs still performing basic, fundamental or proof-of-concept research to support their start-up.  Typically, such start-ups have a limited number of partners, are within the first year or two of creation and may not have physical space to perform independent research.

References:

*Public Health Service Federal Regulation 42 CFR Part 50, Subpart F, “Promoting Objectivity in Research”
**Rules and Procedures of the Faculty, Chapter 5, Part I – Conflicts of Interest in Research
*** Conflict of Interest in Sponsored Research Policy
**** Princeton University Patent Policy