As part of RIA’s continuing efforts to provide useful resources for Faculty, Academic Professionals and Professional Librarians, we compiled answers to the most frequently asked questions regarding the implementation of the federal regulations for grants and cooperative agreements and the Princeton COI Policy. The questions are arranged by topic. The purpose of the FAQs is to clarify issues that may arise and will assist individuals in the interpretation and requirements of the regulation and Princeton COI Policy.
- 1. Who should I contact with questions?
If you have related questions that have not been addressed here, please contact the following office for assistance: Research Integrity and Assurance Office Tel.: 609-258-3105 Email: email@example.com Web site: Research Integrity and Assurance Conflict of Interest.
- 2. How is the COI Policy interpreted and implemented?
An essential aspect of any conflict of interest policy is to prevent even the appearance of a conflict because the reputation of the University can be compromised by such an appearance. In other words, how would the transaction or behavior in question appear to the public if it were published on the front page of the local newspaper, or can the action be explained to a trustee, parent or student as in the best interests of the University? If you have questions about whether to disclose a financial interest you may email firstname.lastname@example.org or contact the Research Integrity and Assurance COI office at 609-258-3105. In general, it is better to over-report than fail to disclose something that may later prove embarrassing.
- 3. How are the COI disclosure forms reviewed?
All Conflict of Interest disclosure forms are reviewed initially by Princeton’s Research Integrity and Assurance Office to determine if there are any relationships that may pose a potential conflict of interest (i.e. conflict of commitment, or conflict of resources (personnel and/or space and/or equipment, and financial conflict of interest). If there are no disclosed potential conflicts, the form will be cleared as not posing a potential or actual issue. Sometimes, the information submitted is incomplete or needs to contain more information, and RIA staff may ask you to supplement or clarify your answer.
Depending on the type of potential conflict, RIA will then contact the appropriate Department associated with the potential conflict (i.e. commitment and nepotism will be forwarded to the Dean of Faculty’s Office, engagement of graduate students will be forwarded to the Dean of the Graduate School, etc.).
Disclosures that reach significant financial interest thresholds are further reviewed by the RIA staff and, when appropriate, a meeting is set up with the individual to better understand the relatedness and the potential of the significant financial interest to affect the design, conduct and reporting of the funded research. After that meeting, RIA will summarize their findings and make a recommendation to the Chair of the COIR Panel (Panel) regarding whether or not there is an FCOI. The Chair is empowered to make determinations of conflict of interest or financial conflict of interest. FCOIs are not inherently bad and do not indicate any wrongdoing. In fact, FCOIs often come as a result of successful business partnerships and hours of hard work, all of which are in line with the University’s mission and uphold the highest standards of integrity .
The Chair may choose to have certain issues evaluated by the Panel to make the final determination if a conflict is a financial conflict of interest and requires management. If the Chair or Panel determines that management is needed, the compliance staff will contact you to develop a plan appropriately tailored to the conflict. You will be required to sign the management plan and confirm that it is still applicable and remains in effect each year thereafter.
In certain cases, individuals may have to divest from their significant financial interest.
- 4. Are disclosure forms kept confidential?
Yes. Disclosure forms are kept confidential except where a disclosure is required by law or for an administrative purpose. Examples of an administrative purpose include a review by a conflict of interest committee or by grant administrators where a potential conflict relates to the grant. Disclosures that are taken to the COIR Panel will be shared with Panel members who are instructed about the sensitive nature of these documents and the requirement for confidentiality. Sometimes, a sponsor requires notice that a conflict is being managed and, as part of this, requires a description or summary of the management plan.
- 1. To whom does the disclosure process apply?
The disclosure process applies to the following individuals employed by Princeton University:
Any faculty member (regular and non-regular rank), principal investigator, independent investigator, academic professional (including postdoctoral research fellows), graduate and (possibly) undergraduate student and any other individual who is listed as “key personnel” on an award document. An investigator is the principal investigator or anyone (could be from list above) who is responsible for the design, conduct, or reporting of research. This list includes but is not limited to Academic Dean, Professor, Associate Professor, Assistant Professor, senior Lecturer, Lecturer, Instructor, Lecturer with continuing appointment, Lecturer with Rank of Professor (Emeritus faculty who are teaching are appointed to this rank), Senior Scholar (Emeritus faculty who are not teaching but performing research and serving as a Principal Investigator (PI) are appointed to this rank);
Certain Voting Faculty (FVO) through PeopleSoft HR feed; and
Certain individuals involved in research who are involved in hiring, evaluating, and managing employees at Princeton University; these staff groups have full time and part-time employees. They include but are not limited to 1) Research Regular (as in not visiting) including the following: Senior Scholar, Senior Research Scholar, Research Scholar, Associate Research Scholar, Postdoctoral Research Associate and Senior Research Assistant. 2) Technical Regular (as in not visiting) including the following: Senior Professional Specialist, Professional Specialist and Associate Professional Specialist. And 3) Librarian Regular (as in not visiting) including the following: Librarian III, Senior Librarian, Librarian and Associate Librarian;
All DOF appointees that are greater than 50% duty time regardless of whether they are responsible for the design, conduct or reporting of a research award.
- 2. As part of Conflict of Interest (COI) policy, what am I being asked to do?
You are being asked to do two things:
First, to comply with the Princeton University Conflict of Interest Policy and Conflict of Interest in Research Panel Charter , and other ethical standards of institutional importance to the University (e.g., financial conflict of interest, conflict of commitment, nepotism, conflict of resources and gift prohibition). If you are funded by the Public Health Service (PHS) you must comply with the National Institutes of Health Financial Conflict of Interest (FCOI) Federal Regulations ( NIH FCOI Regulations ).
Second, to submit an annual conflict of interest disclosure form within the prescribed deadline. For PHS-funded researchers, you must update your responses over the course of the year within 30 days of a reportable change. Examples of a reportable change include acquiring or discovering (e.g. through purchase, marriage, inheritance) a new financial interest including, but not limited to, an outside position, equity in a business, royalties or honoraria, or employing a member of your family as it relates to your institutional responsibilities.
- 3. How are family members of an employee covered and why?
Family members are covered in two different ways:
For financial conflict of interest, federal rules require the individual to report his/her own financial interests and those of any immediate family member, which is defined as a spouse, and/or dependent children. Under these rules, the concern is that the family members’ financial interests can affect an individual’s decisions related to objectivity in research, teaching, and other institutional responsibilities.
For nepotism, i.e., decisions affecting the employment of relatives, the definition of “family” is broader and includes a spouse, spousal equivalent, children, parents, brothers, sisters, step-parents, step-children, and step-brothers or sisters, and other persons living in the same household as that individual. There is a concern when an employee hires or has direct or indirect supervision of a family member, or where the employee can influence employment decisions affecting the employment of the family member, i.e., hiring, firing, setting hours and wages, evaluations, promotion, etc.
- 1. What disclosures are required?
The annual disclosure form includes questions that identify relationships that might affect your work for Princeton. Examples of areas that might be affected include how much time you spend working outside of the University (commitment). Another example is your ability to influence purchasing or recommending items for purchase on Princeton’s behalf. While many faculty and staff do not have all of these duties, most have at least one. The disclosure form requires providing information related to the following areas:
Whether you or a family member have a significant financial interest (SFI - explained below in Disclosures) that is related to, or overlaps with, your institutional responsibilities on behalf of Princeton or with a company that does business with Princeton;
Whether you or a family member serve on an outside entity’s board as a director, trustee, advisor, etc., or have a position with fiduciary obligations, including as a president, vice-president, treasurer, secretary, or other officer position;
Whether you are listed as an owner, inventor, contributor, or co-owner on any licensed or optioned intellectual property, including patents, provisional patents, copyrights, or trademarks;
Whether you are involved in any research that assesses a company's product, service, or intellectual property (e.g., something that could evolve into a product or new use for an existing product - whether or not you have any other relationship with the company or its competitors);
Whether you provide any advice to investors, including a hedge fund, venture capital firm, brokerage house, investment advisor, hedge fund manager, etc.;
Whether you have funding from an SBIR or STTR , i.e., types of federal awards provided directly to small businesses;
Whether any intermediary company receives money on your behalf, e.g., a consulting group that receives payment for your work (in which case you will be asked to identify the original funding entity);
Whether you employ or supervise a member of your family; and
Whether you engaged in government relations activities that Princeton must account for and report as lobbying activities to comply with federal (e.g., IRS) and state law.
- 2. What are some examples of a conflict of commitment?
A conflict of commitment exists when a non-Princeton obligation prevents an individual from spending the time required for his/her full-time commitment to the University. Some examples include:
- Membership by an individual on multiple scientific advisory or corporate boards, including committees, that could take that individual away from his/her job at the University to the extent that the employee's full-time job obligations to the University are not met;
- Employment by another entity that is intended to be part-time, but that interferes with full-time duties at the University even if unrelated to the missions of Princeton (i.e., owner/manager in a start-up company); and
- For faculty, the fundamental rule is that consulting should be limited to 1 day per week (a maximum of 36 days/year for full-time employees).
- 3. What are examples of a significant financial interest (SFI)?
Payments from an outside entity (i.e. a pharmaceutical company, a foreign university etc.) or anything of actual or potential monetary value owned by the employee or family member can be a significant financial interest if it meets the required thresholds and is related to one’s institutional responsibilities.
Significant financial interest thresholds include:
- Any current or pending ownership interest in a privately held entity;
- Any current or pending ownership interest of >$5,000 or more in a publicly traded entity that is related to their research or teaching activities;
- Any income amounting to >$5,000 per year per company/organization that is related to their research or teaching activities;
- Payments >$5,000 for services, including honoraria, consulting fees, lecture payments, etc. that are not otherwise excluded under the Policy (i.e. if it comes from a U.S. University, medical school, etc., See A9 below);
- A right of ownership in intellectual property (copyright, patent, trademark);
- Equity ownership (stock, stock option, security, or other ownership interest).
Princeton University only has to report these financial interests when they are related to the employee’s institutional responsibilities. Institutional responsibilities include activities like research, teaching, and administrative activities (like purchasing). We exclude hobbies or professional activities that do not relate to your work at Princeton. For example, if an English professor was also a professional antique automobile appraiser, the appraising would not be related to her role as an English professor.
- 4. Are there examples of financial interests that are exempt from the Conflict of Interest review process?
The following do not constitute financial interests of concern to this policy; therefore; do not need to be reported:
- Ownership of a share or shares in a mutual fund or retirement accounts that the individual does not directly control;
- Salary or other payment from Princeton University or another U.S. institute of higher education, from hospitals and medical centers, from research institutes, or from a branch of government, including federal, state, or local;
- Unlicensed intellectual property that does not generate income.
- 5. What are some examples of a financial conflict of interest (FCOI)?
An FCOI exists when there is an SFI that has the potential to directly and significantly affect the design, conduct or reporting of funded research, or the performance of duties and responsibilities on behalf of Princeton. Some examples include:
- An SFI that affects the investigator’s objectivity such that the design, conduct, and reporting of research performed is not free from bias;
- An SFI that affects the purchase of items like equipment, supplies, and services. For example, ownership by an administrator or a family member in a vendor or potential vendor that does or may do business with the University when the administrator has some control over the decision or recommendation of purchases from vendors offering the same services or products; and
- An SFI that affects what information the individual decides to include in an article or presentation.
- 6. What Factors/Guidelines are used to determine if an SFI is an FCOI?
The following factors are considered when determining whether an SFI should be considered 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 is not likely.
- 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 SFI in the company.
- Whether the goal of the research is to evaluate an invention linked to the SFI (such as where the SFI is a patent, or an interest in a company that has licensed the invention)
- W here the SFI is in a privately held company that could result in the researcher having influence over company decisions, or whether the research could have a significant impact on the company’s business or financial outlook.
- The number and nature of relationships the researcher has with an entity. Multiple entanglements can create a relationship with an outside entity that is stronger than the sum of the parts.
- Whether other scientific groups are independently pursuing similar questions.
- The magnitude of the SFI
- 7. When am I required to submit disclosure updates for newly acquired SFIs?
For PHS funded (or foundations that the follow the PHS COI regulations) DOF appointees, there is a 30-day updating requirement when a new SFI is acquired. For example, if you are the PI on a research project funded by the NIH or CDC, then this requirement will apply to you. Likewise, if you are a co-investigator, independent investigator, key person or a mentor/sponsor on an NIH or CDC funded research project then this requirement will likely apply to you. Non-PHS funded and non-funded DOF appointees must disclose an SFI either on an annual basis or as new reportable financial interests are obtained.
- 8. Do I have to report reimbursed or sponsored travel?
If you are an “investigator” on a U.S. Public Health Service (i.e., NIH, FDA, CDC, etc.) funded award (see A1 above), you must disclose reimbursed or sponsored travel related to your institutional responsibilities over the previous twelve-month period to Princeton no later than the time of application for funded research. You must also submit an updated disclosure of reimbursed or sponsored travel within 30 days of each occurrence.
Princeton University currently only requires reporting if PHS (or a component agency) is the sponsor.
You can report the sponsored or reimbursed travel at the following link: Princeton Conflict of Interest in Reporting System
- 9. What is sponsored travel?
Sponsored travel is travel that is paid directly by the sponsoring entity and is not reimbursed to the investigator. For example, a professional organization in Italy pays directly for your flight and hotel expenses when you attend the organization’s conference as an invited speaker. In most cases, the exact value of the sponsored travel is not known to you as the traveler. However, for reporting purposes, you can make a good faith estimation as to the approximate value of the travel.
- 10. Do I need to report all travel, even a reimbursed trip across town?
No, the PHS COI regulations allow institutions to set internal thresholds for reporting travel. At Princeton, the threshold has been set to $5,000 to align with the Significant Financial Interest threshold. Therefore, you only need to report travel that meets the following criteria:
- The aggregate value of the travel is greater than $5,000 from a single entity over a 12-month period; and
- The travel is related to your University institutional responsibilities and professional expertise.
Please note that if a company or organization sponsors or reimburses multiple small trips over the course of a year, each of which has a value of less than $5,000 but, when added up over a 12-month period exceed $5,000, then these trips have to be reported.
The $5,000 threshold does not mean that an investigator cannot have sponsored or reimbursed travel of more than $5,000. Rather, it means that any travel that exceeds this threshold must be reported.
- 11. Is there any type of travel that is excluded from the reporting requirement?
This disclosure requirement does not apply to:
- Any travel reimbursed, sponsored or paid for by a U.S. government agency, a U.S. higher education institution, a U.S. academic teaching hospital, medical center, or a U.S. research institute affiliated with a U.S. higher education institution; and
- Any travel reimbursement or payment of travel made by Princeton University
- 12. What gifts are acceptable, or are they all banned?
As long as an individual was not making financial or personnel decisions relative to the University that involved another entity, it might be acceptable to take a gift, so long as it is not too extravagant.
If the individual was somehow involved with influencing University spending as it relates to potential spend with another entity, it would be unethical to accept this gift
When in doubt, don’t accept it.
Gifts that could be allowed include:
- Accepting a meal from a potential contributor or donor to Princeton, when development activities are part of the employee’s job responsibilities;
Accepting a gift from a current or potential vendor that is unrelated to the employee’s job responsibilities, e.g., for an existing personal relationship.
- 1. What is a conflict of interest management plan?
1. What is a conflict of interest management plan?
A conflict of interest management plan documents the fact that your significant financial interest or use of resources results in an actual conflict, and it contains the terms for managing issues going forward. Management plans are common and required by regulators and sponsors. Provided below is a summary of terms that may be included in a management plan:
- Public disclosure of the financial interest, e.g., when publishing or presenting the results of the research;
- Informing other research team members regarding conflicts;
- Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias;
- Guidance for the engagement of students or academic professionals with the SFI entity or research that may affect the SFI
- Guidance for the appointment of visiting researchers from the SFI
- Guidance for the use of space and/or equipment by visiting researchers or for research that could affect the SFI
- Changing personnel or responsibilities, or removing personnel from all or some part of the project;
- Reducing or eliminating the financial interest (e.g., sale of an equity interest);
- Severing of relationships that create financial conflicts;
- Confirming the employee’s agreement to the management plan;
- Describing how the plan will be monitored to ensure compliance; and
- Other information as needed.
- 2. Is there a limit to the number of Visiting Researchers that can be appointed to a PIs lab from an entity in which the PI has a significant financial interest?
Yes with the following stipulations:
- No more than 2 visiting researchers will be allowed at any given time during any given calendar year.
- If a PI would like to have more than 2 visitors, a written request and justification must be submitted to RIA and approved by the Chair of the COIR Panel.
- The written request and justification will then be presented to the COIR Panel for informational purposes.
- Each visitor must be officially appointed and reappointed annually according to University Policy. Therefore, the PI will need approval from the Department Chair, followed by formal appointment by the Dean of the Faculty (DoF).
- Each visitor’s appointment shall be limited to one year and be focused on activities that benefit the PI’s research endeavors and the University’s teaching and research missions. At the end of each appointment, the PI may request to extend a visitor’s stay according to procedures listed in bullet point 4 above. Such an extension should not be regarded as routine, and requires that the PI articulate the ways in which the extended stay would further the University’s teaching and research mission.
- Am I required to complete a training program?
It depends. If you are an “investigator” (Principal Investigator, Independent Investigator, key personnel, consultant, etc.) and have the responsibility for the design, conduct and reporting of PHS (i.e., NIH, CDC, FDA, SAMHSA, etc.) funded research, then “YES” the federal rules require you to complete training prior to engaging in PHS-funded research and at least every four years, and immediately under the following circumstances:
- You are new to Princeton and qualify as an investigator
- You are found not to be in compliance with the COI Policy or your management plan
- Princeton changes the COI Policy in a manner that affects Investigator requirements
The required training program is available to all persons in a lead role on sponsored projects or programs, i.e. principal investigators, project leaders, core leaders, project directors, co-principal investigators, and PI fellows.
The link to the training program can be found here:
Follow the instructions for logging on and affiliating with Princeton University in order to ensure that you receive credit for successfully completing the FCOI course.
If you are not on a PHS funded research award, then you are not required to perform COI training.
- What happens if I forgot and submit my disclosure update late?
For those individuals funded by the PHS (i.e. NIH and CDC, etc.) a new SFI must be reported to the institution within 30 days of acquiring or discovering the interest. If you report a new SFI late, after the 30 days have passed, per the federal COI regulations, the institution may need to conduct a “retrospective review” if the SFI is determined to create an FCOI with your PHS-funded research. The purpose of the retrospective review is to determine whether any of your PHS-funded research, or portions thereof, conducted during the time period of the non-compliance, was biased in the design, conduct, or reporting of such research. Retrospective reviews are time consuming and burdensome to the institution as well as the investigator. The results of the retrospective review may also need to be reported to NIH.