COI Frequently Asked Questions

Reporting - General

1. Why do I need to submit a COI Assurance and/or Reporting form?
2. When and where do I submit my annual COI Assurance and Reporting form?
3. I submitted my annual Assurance form; do I need to submit updates or any other COI reporting forms at other times during the year?
4. I do not have any conflicts. Why do I still need to submit a COI Assurance form?

Reportable Interests

5. What do I have to disclose?
6. What is a Significant Financial Interest?
7. What does “related to my University responsibilities or professional expertise” mean?
8. Do I really need to report my spouse’s interests?
9. I hold stock in mutual funds. Do these need to be reported?
10. I hold stock as part of an investment portfolio. Do I need to report these stock holdings?
11. I provide expert legal testimony and services. Do I need to report these?
12. a) I am Editor of a journal that is published by a professional organization. I receive more than $5,000 per year. Do I have to report that?
        b) What is a "paid authorship"?
13. Last year, I founded a company. At this point in time, it is very much a paper company. It has no products, no employees and not even a website. It’s worth nothing. Is this a reportable interest?

Travel Reporting

14. Do I need to report travel?
15. What is sponsored travel?
16. Do I need to report all travel, even a reimbursed trip across town?
17. Do I need to report spousal travel?
18. What information is required for travel reporting?
19. A company invited me to give a talk in Japan. I received an honorarium of $7,000. The company also paid for my business class airfare, hotel and expenses. How do I report this? Is the travel reportable and if so, do I have to submit a separate travel report?
20. Is there any type of travel that is excluded from the reporting requirement?

Submitting Disclosure Updates

21. Am I required to submit disclosure updates for newly acquired Significant Financial Interests?
22. What is a “new” Significant Financial Interest (SFI)?
23. What happens if I forgot and submit my disclosure update late?

Review and Management

24. Who reviews the COI Assurance and Reporting forms?
25. Who determines whether my interests could create a conflict of interest?
26. If I have a conflict of interest, does it mean I cannot work on certain research or other scholarly activities?
27. How are conflicts of interests managed?
28. Do I need to disclose conflicts?

COI Training

29. Who needs to complete COI training?
30. How do I complete COI training?

Hospital-based Faculty

31. I am based at one of the affiliated hospitals but am on a grant that is administered through Brown. Who handles my COI disclosures?

Outside Activities - General

32. I want to provide consulting services to a company. Do I have to get permission from Brown University?

 

Reporting - General

1. Why do I need to submit a COI Assurance and/or Reporting form?

 Brown University’s Conflict of Interest (COI) Policy for Officers of Instruction and Research requires certain members of the Brown faculty and all Brown Investigators to complete a COI Assurance of Compliance form annually.  The COI Assurance form collects information related to Significant Financial Interests, Conflict of Commitment, supervisory conflicts, and gifts. 

Under the Public Health Service (PHS) regulations, an Investigator means the Project director or PI and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS (e.g., NIH). This may include, for example, postdoctoral fellows, collaborators or consultants.  It is the role, rather than the title, of the individuals involved in the research and the degree of independence with which those individuals work that should form the basis of a decision for whether someone qualifies as an “Investigator.”  When the definition of investigator is limited to titles or designations (e.g., to PIs, key personnel, faculty), the risk is that an unidentified FCOI may compromise the research enterprise, particularly if it results in late reporting and a subsequent retrospective review.

2. When and where do I submit my annual COI Assurance and Reporting form?

The annual COI cycle runs between the end of February and the end of March of every year. Annual reporting is conducted electronically via InfoEd. In February, when the annual cycle begins, Brown faculty and Investigators will receive an email with instructions and a link to the electronic COI system. The information collected on the form is for the previous calendar year (January through December), to align with the receipt of income forms/statements and preparation of taxes.

3. I submitted my annual Assurance form; do I need to submit updates or any other COI reporting forms at other times during the year?

 Unless you are an Investigator on a research project funded by the Public Health Service (PHS) or a foundation that follows the PHS COI regulations, there is no requirement to update your COI form throughout the year. However, even if you are not required to submit updates, it is advisable to update the COI reporting form whenever there is a significant change to already reported financial interests or if you acquire a new Significant Financial Interest. The information you submit as updates is carried over, and will pre-populate your next annual form. Thus, if you update frequently throughout the year, you will have no updates or just very minor updates to make on your next annual form.

4. I do not have any conflicts. Why do I still need to submit a COI Assurance form?

The determination regarding whether or not you have conflicts is not a self-determination, but is instead made by the institution. In many instances, the perception of conflict is a critical factor to consider. Perception, however, is seldom considered when one evaluates one’s own potential conflicts. Therefore, the institution does not ask whether you have “a conflict,” but rather, asks you to provide a list of your financial and other outside interests and then evaluates these against your University responsibilities (e.g., research, teaching) to determine if these interests create potential conflicts.

Reportable Interests

5. What do I have to disclose?

 On the University’s annual COI Assurance form, you will be asked to report Significant Financial Interests that you or your spouse or dependent child held during the past calendar year that are related to your University responsibilities and professional expertise. For a definition, see question #6 immediately below. You will also be asked additional questions about academic appointments, conflict of commitment, gifts, and supervising relatives. Please read the questions carefully. Some people will also have to report travel. Please click here for further details regarding travel reporting. Reading the questions carefully and, if necessary, clicking on any hyperlinks provided, should give you enough guidance on how to answer and what or how much information to provide. 

6. What is a Significant Financial Interest?

A “Significant Financial Interest” (SFI) is the receipt by you, your spouse, or your dependent children of any of the following, if related to your University responsibilities or professional expertise:  

  • Income that exceeds $5,000 from any outside entity, measured on a rolling 12‐month basis. This may be one payment from a particular company of more than $5,000, or multiple payments from the same company that, in the aggregate, exceed $5,000.  

  • Acquisition of equity in a public company that exceeds $5,000 in value;  

  • Aggregated income and equity/ownership interest from a public company that exceeds $5,000, as measured on a rolling 12‐month basis;  

  • ANY equity/ownership interest in a privately‐held company;  

  • Any income received from rights in intellectual property, as measured on a rolling 12‐month basis.

Excluded from this definition are payments (including travel) received from Brown University, and income from investment vehicles over which you do not exercise control, such as mutual funds and retirement accounts. Also excluded from this definition are payments received from any of the following entities, provided these payments are received for teaching engagements, lectures, seminars, or services on advisory committees or review panels:  

  • Government agencies  

  • US institutions of higher education and research institutes affiliated with them  

  • Academic teaching hospitals  

  • Medical centers  

7. What does “related to my University responsibilities or professional expertise” mean?

The term “University responsibilities” refers to any professional responsibilities that you undertake on behalf of Brown University, which may include, for example, research, research consultation, teaching, professional practice, Institutional committee memberships, and service on panels such as Institutional Review Boards or Purchasing Committees. Professional expertise refers to anything in your area of expertise with the caveat that it shouldn’t be applied too narrowly. This does not mean that this term broadly captures the entirety of one’s field, such as engineering, biology or political science. When evaluating what is related, instead consider aligning your analysis with the appropriate sub-field, such as electrical engineering, molecular biology or political theory.  

8. Do I really need to report my spouse’s interests?

 Yes, the interests of a spouse are reportable if they meet the reporting criteria and threshold. That is, if they are related to your (not his/her) University responsibilities and professional expertise, and if they are >$5,000 for the calendar year or 12 month period (whichever is being asked). For example, if you are a faculty member in the Department of Molecular Microbiology and Immunology and your spouse works for Thermo Fisher with salary and stock options, it may be reportable because it seems related to your University responsibilities and professional expertise. However, if you are faculty member in the Department of Music and your spouse works for Thermo Fisher with salary and stock options, it would be unrelated to your University responsibilities and thus would not be reportable.

9. I hold stock in mutual funds. Do these need to be reported?

No, these do not need to be reported because they are excluded from the definition of Significant Financial Interest. In general, any investment vehicle where you have no control over the acquisition of individual stock, are excluded from reporting.

10. I hold stock as part of an investment portfolio. Do I need to report these stock holdings?

It depends. If the investment portfolio is such that you have control over individual stock purchases – even if you rarely or never exercise it – then the stock holdings are reportable if they meet the reporting criteria and threshold: >$5,000 in value during the calendar year or 12 month period (whichever is being asked) and related to your University responsibilities and professional expertise.

11. I provide expert legal testimony and services. Do I need to report these?

Yes, expert legal testimony is reportable if it meets the reporting criteria and threshold: >$5,000 in value during the calendar year or 12 month period (whichever is being asked) and related to your University responsibilities and professional expertise. When reporting expert legal testimony, you should report it as income from the law firm or legal entity that paid or retained you. If you know that you provided this testimony on behalf of another company (e.g., a pharmaceutical company), please use the comment field on the disclosure page to provide this information.

12. a) I am Editor of a journal that is published by a professional organization. I receive more than $5,000 per year. Do I have to report that?

Yes, any income from journals and professional organizations that meets the reporting criteria and threshold (>$5,000 in value during the calendar year or 12 month period, whichever is being asked) is reportable because it is not excluded from the definition of Significant Financial Interest.

        b) What is a "paid authorship"?

Paid authorship means that a company, organization, foundation or individual pays you a pre-negotiated sum of money to write an article, book, report, etc. Typically, a paid authorship does not grant you any ownership interest in the copyright; in other words, the material you authored is owned by the entity or individual that paid you. 

Please note that advances from publisher are not considered "paid authorship". Advances are a form of royalties that are paid prior to publication.  After publication of the book, publishers usually deduct the advance from your royalty payments.

13. Last year, I founded a company. At this point in time, it is very much a paper company. It has no products, no employees and not even a website. It’s worth nothing. Is this a reportable interest?

 Yes, the definition of Significant Financial Interest includes ANY equity/ownership interest in a privately‐held company. Therefore, any ownership interest in a legal entity (whether it’s a corporation or an LLC) is reportable even if, at this point, the entity exists mainly on paper and has no assets.

Travel Reporting

14. Do I need to report travel?

The travel reporting requirement only applies to Investigators on research projects funded by PHS or foundations that follow the PHS COI regulations. If you are the PI on a research project funded by NIH or AHRQ, for example, then this requirement will apply to you. Likewise, if you are the PI on a research grant awarded by a foundation that follows the PHS COI regulations, this requirement will apply to you. If you are a co-investigator or a mentor/sponsor on an NIH or AHRQ funded research project then this requirement will likely apply to you. For more information, please click here

15. 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 Switzerland 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.

16. 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 Brown, 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 responsibilities and professional expertise.

Please note that if a company or organization, for example, 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.

17. Do I need to report spousal travel?

Yes, spousal travel is reportable if it 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 responsibilities and professional expertise.

The same is true of travel of any dependent children.

18. What information is required for travel reporting?

When reporting travel, you will need to provide:

  • the name of the company or organization that sponsored or reimbursed the travel;

  • the destination;

  • travel dates (departure and return dates); 

  • the approximate dollar value of the sponsored or reimbursed travel; and

  • the purpose of the trip (business purpose).

19. A company invited me to give a talk in Japan. I received an honorarium of $7,000. The company also paid for my business class airfare, hotel and expenses. How do I report this? Is the travel reportable and if so, do I have to submit a separate travel report?

Honoraria and travel can both be reported in the electronic reporting system, InfoEd. You should report the honorarium as a Significant Financial Interest on your COI reporting form. In addition, you will need to report the travel, which, given that you flew business class, will likely have a value of >$5,000, on the Travel Update Form.

20. 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 Brown University, another university college, department or unit, or travel covered by a sponsored research agreement managed through OSP or TVO.

Submitting Disclosure Updates

21. Am I required to submit disclosure updates for newly acquired Significant Financial Interests?

The 30-day updating requirement only applies to Investigators on research projects funded by PHS or foundations that follow the PHS COI regulations. If you are the PI on a research project funded by NIH or AHRQ, for example, then this requirement will apply to you. Likewise, if you are the PI on a research grant awarded by a foundation that follows the PHS COI regulations, this requirement will apply to you. If you are a co-investigator or a mentor/sponsor on an NIH or AHRQ funded research project then this requirement will likely apply to you.

22. What is a “new” Significant Financial Interest (SFI)?

An SFI is considered “new” if you have never previously reported it to the University. An SFI is also considered “new” if it is a different type of SFI (e.g., royalty payment vs. consulting fees) than what has previously been disclosed from the same source, OR is the same type or nature of SFI (e.g., royalty payment) but from a different source (e.g., company A versus company B).

23. What happens if I forgot and submit my disclosure update late?

A new Significant Financial Interest (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 a financial conflict of interest (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.

Review and Management

24. Who reviews the COI Assurance and Reporting forms?

All COI Assurance and Reporting forms are reviewed by ORI staff. Some reported interests may require further review by the COI Review Board (COIRB). Assurance forms with potential conflicts of commitment are referred to the Dean of Faculty for review. Please see COI Review and Management at Brown University for further details. 

25. Who determines whether my interests could create a conflict of interest?

The determination regarding whether an interest could create a conflict of interest is based on careful review by ORI and, if necessary, the COIRB. When reviewing interests, the ORI and the COIRB will look at a number of factors, such as the type and magnitude of the financial interest, the degree of overlap between the outside interest and University responsibilities, and whether the interest could affect the research or educational activity. Perception is also a factor that is considered in the analysis.

In general, a conflict of interest exists when an outside interest could compromise, or has the appearance of compromising, the professional judgment of a researcher or faculty member when designing, conducting, or reporting research, when teaching, and when carrying out general University duties and responsibilities. The existence of a conflict of interest does not imply any wrong-doing. Conflicts of interest are not in and of themselves unethical or impermissible. Indeed, they are often unavoidable, and in many cases can be appropriately managed or reduced to an acceptable level. However, faculty and researchers should be cognizant of the fact that any outside activity, interest, or interaction with an outside entity has the potential to create conflicts, whether real or perceived.  Recognition of potential conflicts, and sensitivity to how personal, financial, and other relationships can be perceived by others, are critical parts of managing conflicts.

26. If I have a conflict of interest, does it mean I cannot work on certain research or other scholarly activities?

No, having a conflict of interest does not prohibit you from engaging in research or other scholarly activities. In most instances, a conflict of interest can be appropriately managed so that you can, for example, continue to participate in a research activity while keeping your financial or outside interest. In some rare instances the conflict may be such that it cannot be appropriately managed. In such case, you may be asked to consider reducing or eliminating the financial interest rather than discontinue your participation in the research activity. In general, your outside activities and interests should not prevent you from carrying out your research activities, teaching, and other University duties and responsibilities.

27. How are conflicts of interests managed?

In cases where ORI and the COIRB recommend COI management, ORI, with guidance from COIRB and the Vice President for Research, will develop and implement a COI management plan. The management plan lists required and recommended management measures that are designed to mitigate the conflict of interest. Possible measures include but are not limited to:

  • disclosure of the financial interest in publications/presentations;

  • disclosure to all collaborators on the research projects

  • disclosure to students/trainees

  • disclosure to any study participants, if applicable.

The management plan is signed by the conflicted investigator and the Chair of the COIRB. Once a year, or more frequently when warranted, a COI management committee will meet with the investigator to monitor plan adherence and effectiveness, review the existing FCOI, and confirm management strategies. Please see COI Review and Management at Brown University for further details. 

28. Do I need to disclose conflicts?

Yes, conflicts should be disclosed in any relevant setting. For example, a conflict should be disclosed to any student, trainee or junior faculty you supervise; it should be disclosed in any publication and presentation that is related to the financial interest/conflict of interest, and it should be disclosed to board or committee members if it is relevant to an issue or item that is being discussed by the board/committee. In general, it is better to disclose than to not disclose. When disclosing, providing context is critical. Disclosure is a primary responsibility and should not be treated as an afterthought. In some instances, providing a written disclosure may be more efficacious than a verbal disclosure.

COI Training

29. Who needs to complete COI training?

As of August 24, 2012, Investigators on PHS funded research must complete FCOI training prior to engaging in PHS funded research. Investigators have to be re-trained every four years, and whenever there is a substantive change to the institution’s COI policy. The institution must also re-train any Investigator who has been found to not be in compliance with the regulations, Brown’s COI policy and/or a COI management plan.

30. How do I complete COI training?

Brown FCOI training is available online via the Traincaster system.

To take the training, click on the link and log into the system. If you need to take the FCOI training but have not been set up with an account in Traincaster, please contact Rebecca Haworth.

Hospital-based Faculty

31. I am based at one of the affiliated hospitals but am on a grant that is administered through Brown. Who handles my COI disclosures?

In general, hospital-based faculty members are employees of the hospital and are subject to the hospital’s policies, including COI policies. Their COI disclosures are, therefore, handled by their hospital compliance group. However, if a hospital-based faculty member is an Investigator on a grant that is administered through Brown, and there is no grant-specific subcontract with the faculty member’s employer, he/she will be subject to Brown’s COI policy for the work conducted on the Brown-administered research grant. When coming under Brown’s COI policy, the faculty member will be required to submit a transactional COI reporting form and will also be asked to submit an annual COI form for the duration of the grant. 

Outside Activities - General

32. I want to provide consulting services to a company. Do I have to get permission from Brown University?

No. There is no requirement that you receive permission from Brown prior to engaging in an outside activity. Similarly, Brown does not review or approve any written agreements or contracts you sign when engaging in your outside activity. However, it is advisable to talk to and, if necessary, receive approval from your supervisor or chair prior to engaging in the activity. Certain activities will need to be reported on your annual COI assurance form if they meet the reporting criteria and threshold. Click here for guidance on how outside activities should be conducted.