COI Frequently Asked Questions

Reporting - General

1. Why do I need to submit a COI Reporting form?
2. When and where do I submit my COI Reporting form?
3. I submitted my annual COI Reporting form; do I need to submit updates at other times during the year?

Reporting - Annual Cycle

4. When and where do I submit my Annual COI Reporting form? 
5. What do I need to report on my Annual COI Reporting form?
6. 
I do not have any conflicts. Why do I still need to submit a COI Reporting form?

Reportable Interests

7. What do I have to disclose?
8. What is a Significant Financial Interest?
9. What does “related to my University responsibilities or professional expertise” mean?
10. Do I really need to report my spouse’s interests?
11. I hold stock in mutual funds. Do these need to be reported?
12. I hold stock as part of an investment portfolio. Do I need to report these stock holdings?
13. I provide expert legal testimony and services. Do I need to report these?
14. 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"?
15. 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?

16. I have written several books. Do I need to report royalties I receive for these publication?

17. I joined Brown during the last calendar year. The COI forms asks for income from non-Brown entities during the prior calendar year. Do I need to report salary from my prior institution/employer on the COI form?

Travel Reporting

18. Do I need to report travel?
19. What is sponsored travel?
20. Do I need to report all travel, even a reimbursed trip across town?
21. Do I need to report spousal travel?
22. What information is required for travel reporting?
23. 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?
24. Is there any type of travel that is excluded from the reporting requirement?

Conflict of Commitment - General

25. What is a conflict of commitment?
26. What constitutes “use” of Brown facilities or personnel for the benefit of a non-Brown entity, interest or activity?
27. A researcher in my lab brought back some chocolates for me from a trip. Can I accept it and do I need to report it?
28. My son is a current student at Brown. Do I need to report a birthday gift I received from him?
29. I serve of the board of my local nursing home, a non-profit. This is a volunteer, unpaid position. Do I need to report this?
30. What is the non-fraternization policy?
31. What is the purpose of the Non-Solicitation/Supervisory Conflict question?
32. One of my supervisees has asked me for a recommendation for a physical therapist. Can I recommend my spouse, who has a Physical Therapy practice?
33. My brother is a plumber and is independently engaged by various members of the Brown community who need plumbing services. Is this a problem? Do I need to report this?

Non-US Support Reporting

34. What kind of information do I need to report in response to the Non-U.S. Support question on the COI Reporting form?
35. What is the time-frame for reporting? For example, do I need to report Non-U.S. Support I received in 2018?
36. What does “not being administered through Brown University” mean?
37. I recently joined Brown University from a Non-U.S. university/research institute. Does my salary and grant funding from my prior institution need to be reported as Non-U.S. Support received during calendar year 2020?
38. I have foreign students working in my lab. Do I need to report this as Non-U.S. Support?
39. I will be affiliated with / working at a foreign institution during my sabbatical. Is this reportable in the COI form as Non-U.S. Support?
40. I have already reported income I received from a foreign entity as a financial interest on the COI Reporting form. Do I need to report it again as Non-U.S. Support?

Submitting Disclosure Updates

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

Review and Management

44. Who reviews the COI Reporting forms?
45. Who determines whether my interests could create a conflict of interest?
46. If I have a conflict of interest, does it mean I cannot work on certain research or other scholarly activities?
47. How are conflicts of interests managed?
48. Do I need to disclose conflicts?

COI Training

49. Who needs to complete COI training?
50. How do I complete COI training?

Hospital-based Faculty

51. 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

52. 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 Reporting form?

Brown University’s Conflict of Interest (COI) in Research Policy requires certain members of the Brown faculty and all Brown Investigators to complete a COI Reporting form annually.  The COI Reporting 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 COI Reporting form?

COI Reporting is conducted electronically via InfoEd. The annual COI cycle runs between the end of February and the end of March of every year. 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. At other times of year, submit a transactional COI Reporting form via InfoEd to report newly acquired interests.

3. I submitted my annual COI Reporting form; do I need to submit updates 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.

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Reporting - Annual Cycle

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

The annual COI cycle runs between the middle of February and the middle 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.

5. What do I need to report on my Annual COI Reporting form?

On the University’s annual COI Reporting 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 the definition of Significant Financial Interest, see question #8, keeping in mind that the annual form refers to the past calendar year, not the previous 12 months. You will also be asked additional questions about academic appointments, conflict of commitment, gifts, non-US support, and supervisory conflicts. 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. I do not have any interests or conflicts. Why do I still need to submit a COI Reporting 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. The Annual COI Reporting form documents these interests. If you have no interests, the Annual COI Reporting form serves as an affirmation that you do not have any reportable interests. 

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Reportable Interests

7. What do I have to disclose?

 On the University’s annual COI Reporting 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 #8 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. If you need specific advice, email [email protected].

8. 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, including start ups and LLCs;  

  • Income received directly from a company/organization (not through Brown University) from rights in intellectual property and interests (e.g., patents, copyrights),  as measured on a rolling 12‐month basis.

For the purposes of the Annual COI Reporting form, consider "rolling 12 month basis" to mean "in the past calendar year."

The following interests are excluded from this definition: 

  • Payments (including salary, travel, and intellectual property royalties) received from your employer, i.e. Brown University;
  • Income from investment vehicles, such as mutual funds and retirement accounts, as long as you do not directly control individual investment decisions (i.e. the purchase of specific stock); or
  • Income for seminars, lectures, or teaching engagements from a U.S. government agency, a U.S. institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.

9. 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.  

10. 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.

11. 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.

12. 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.

13. 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.

14. 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.

15. 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.

16. I have written several books. Do I need to report royalties I receive for these publications?

Faculty are generally not required to report royalties that are related to an academic publication. However, if the royalty payments you receive are either significant (e.g., related to a textbook) or are related to a non-academic publication, they should be reported. If you have reportable royalties, you can report them on the COI form in two ways. You can either report them as income from a particular publisher, if greater than $5,000.  Alternatively, you can report them as "income related to intellectual property rights and interests".

17. I joined Brown during the last calendar year. The COI form asks to report income from non-Brown entities during the prior calendar year. Do I need to report salary from my prior institution/employer on the COI form?

Any income from a non-Brown institution received during the prior calendar year is reportable if greater than $5,000, including salary and/or other remuneration from a prior employer. However, while reportable, salary/income from a prior employer rarely creates a conflict of interest. 

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Travel Reporting

18. 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

19. 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.

20. 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.

21. 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.

22. 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).

23. 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.

24. 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.

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Conflict of Commitment

25. What is a conflict of commitment?

The Brown University Conflict of Interest and Commitment Policy defines a Conflict of Commitment as occurring when outside activities interfere with an individual’s ability to meet University Responsibilities (see section 3, paragraph 3). On the COI Reporting Form, disclosure of certain information about your outside activities and relationships (see below FAQs for more details) is required to assess and manage potential conflicts of commitment.

26. What constitutes “use” of Brown facilities or personnel for the benefit of a non-Brown entity, interest or activity?

Use of Brown facilities or personnel by an outside entity is governed by the Conflict of Interest and Commitment Policy (see section 3.3). Per the policy, personal use of Brown computers and telephones must be infrequent and cannot incur additional expenses for the University. Similarly, Brown offices, email, printers, copiers, or research equipment should not be used for personal consulting or business activities. Likewise, Brown personnel should not be engaged in personal consulting or business activities. This applies, regardless of whether the consulting or business activities are for a for-profit or non-profit organization.

If you or a third, non-Brown party wants to use campus space, equipment, or personnel, you must contact your University Representative, in advance, to discuss the implementation of a facilities use agreement.

27. A researcher in my lab brought back some chocolates for me from a trip. Can I accept this gift and do I need to report it?

Yes, gifts received from a current student that have a value of $100 or less can be accepted but need to be reported on the University Gift Policy question in the Conflict of Commitment section of the COI Reporting form. Generally, gift giving should be discouraged. The Brown Conflict of Interest and Commitment Policy prohibits Brown faculty, students, and staff from accepting gifts and favors from a donor; current, prospective or former student or parent; or others with whom there is a potential or existing business or professional relationship, in most circumstances if valued at more than $100. See section 3.5 of the policy for details and exemptions.

28. My son is a current student at Brown. Do I need to report a birthday gift I received from him?

No, you do not need to report personal gifts, such as a birthday present, received from a family member or friend who also happens to be a donor; current, prospective or former student or parent; or someone with whom there is a potential or existing business or professional relationship.

29. I serve of the board of my local nursing home, a non-profit. This is a volunteer, unpaid position. Do I need to report this?

It depends. Are your university responsibilities related to nursing homes or elder care in general? For example, do you do research on aging? If so, then yes, this needs to be reported on the Board Services question in the Conflict of Commitment section of the COI Reporting form because it is related to your university responsibilities. If your university responsibilities are unrelated to nursing homes or elder care, then you do not need to report this. See question 7 for details on what constitutes “related” to your university responsibilities.

30. What is the non-fraternization policy?

Brown University’s Non-Fraternization Policy prohibits romantic or sexual relationships where there is supervision, direction, or control between the parties at Brown. Should such a relationship arise, it should be promptly reported so that the University can evaluate the situation and ensure that alternate supervisory or evaluative arrangements are in place to address any conflicts of interest. Contact the Senior Director of Employee and Labor Relations at [email protected] with questions. 

Please note that romantic or sexual relationships between faculty or staff and undergraduate students are expressly prohibited.

 31. What is the purpose of the Non-Solicitation/Supervisory Conflict question?

The relationships we have at work can be affected by other relationships outside work. These other relationships can, in some situations, create conflicts of interest, especially in supervisory relationships or in hierarchical relationships where one party is in a position to make decisions that affect the other party.

Acknowledging the potential for relationships outside work to create conflicts of interest at work, it is important that supervisors, to the extent possible, minimize the occurrence of such relationships. This includes refraining from recommending services that are provided by the supervisor’s family members to any direct supervisees.

Additionally, per Brown University’s Non-Solicitation Policy, all members of the Brown community are prohibited from engaging in sales or solicitations on university property, buildings, and facilities or using university resources or systems.

32. One of my supervisees has asked me for a recommendation for a physical therapist. Can I recommend my spouse, who has a Physical Therapy practice?

Generally, you should not recommend a family members’ services to any individual that you directly supervise because the business relationship they will have with your family member(s) could create a conflict of interest and could affect your work relationship with your supervisee.

33. My brother is a plumber and is independently engaged by various members of the Brown community who need plumbing services. Is this a problem? Do I need to report this?

It depends. Your brother might not know which of his clients work at Brown. To the extent that he does know, are any of them under your direct supervision? If yes, you should report it.

If none of his clients are under your supervision, then it does not need to be reported. If you are made aware of anyone under your supervision hiring your brother as their plumber, update your COI reporting form as soon as you know.

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Non-U.S. Support Reporting

34. What kind of information do I need to report in response to the Non-U.S. Support question on the COI Reporting form?
The Non-U.S. Support question on the COI Reporting form asks you to list any support, regardless of value, that you received or are receiving from a non-U.S. government or non-U.S. organization, including a company, organization, university, or research institute, that was/is not administered through Brown University.

Types of support that you must report include:

  • salary or other income, grants or other research awards;
  • laboratory space;
  • personnel support;
  • use of special equipment;
  • housing support or living allowances; and
  • travel support.

35. What is the time-frame for reporting? For example, do I need to report Non-U.S. Support I received in 2018?
Any Non-U.S. Support that is active must be reported on this year's COI form, regardlss of the year it was initially received.

If you reported the Non-U.S. Support you received in 2018 on a prior COI form in 2019 or 2020 and it is no longer active, you do not need to report it again in this year’s form.

If you received the Non-U.S. Support in 2018, it is no longer active, you did not report it in subsequent COI forms, but did include it as appropriate in grant or contract documents submitted to federal sponsors (i.e., as Other Support, Current & Pending, in your biosketch, in Progress Reports, etc.), then you do not need to report it in this year’s COI form. If you did not include it as appropriate in grant and contract documents submitted to federal sponsors, then you must report it now.

You must also report any Non-U.S. Support received during calendar year 2020, regardless of whether it is still active, and any Non-U.S. Support that you know that you will receive in calendar year 2021.

36. What does “not being administered through Brown University” mean?

You do not need to report in the COI form Non-U.S. Support that is administered through Brown because the University should already know about and have approved the non-U.S. support. For example, if you receive a research subcontract from a foreign university and the contract was administered through OSP or BMRA, such support would not need to be reported since Brown already knows about this research support.

37. I recently joined Brown University from a Non-U.S. university/research institute. Does my salary and grant funding from my prior institution need to be reported as Non-U.S. Support received during calendar year 2020?

No. You only need to report Non-U.S. Support that you receive while at Brown. During your previous employment, you were not yet at Brown; therefore, it does not need to be reported through the COI form in response to this question.

However, you may need to report it as a Significant Financial Interest in the first section of the COI Reporting form if the income was greater than $5,000 during the previous calendar year.

38. I have foreign students working in my lab. Do I need to report this as Non-U.S. Support?

Non-U.S. students or trainees who are funded by a Non-U.S. government or entity and who are supporting your research efforts are considered a form of Non-U.S. Support and should be included in response to this question on the COI form, with a few exceptions:

  • You do not need to report any undergraduate and graduate students who are enrolled as full-time students at Brown.
  • You do not need to report any trainees who are fully supported by Brown (e.g., through grant or start-up or departmental funds).

Additionally, any non-U.S. students or trainees who are in your lab or research group and who have been sponsored by Brown for a visitor visa (J1 or TN), do not need to be listed on your COI form as they are considered support that “has been administered” through Brown. These individuals must be disclosed when submitting grants or contracts to federal sponsors if they meet sponsor disclosure requirements. See here for more information regarding sponsor disclosure requirements.

39. I will be affiliated with / working at a foreign institution during my sabbatical. Is this reportable in the COI form as Non-U.S. Support?

It depends. If you are affiliating with a non-U.S. institution during your sabbatical without a formal appointment (e.g.,visiting, adjunct, associate appointments) or formal contract (e.g., teaching, research contracts), and that institution provides you with courtesy services, such as library access and a desk, that does not need to be reported. However, if you have an appointment or title and/or receive payments, research or living support, personnel support, lab space, access to research equipment, or travel support, then it needs to be reported. You will also want to ensure your relationship and activities during your sabbatical are conducted in compliance with Brown’s Outside Professional Activities for Faculty Policy.

40. I have already reported income I received from a foreign entity as a financial interest on the COI Reporting form. Do I need to report it again as Non-U.S. Support?

Yes. If it is reportable as per questions #32-#37 above, you should also report it as Non-U.S. Support.

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Submitting Disclosure Updates

41. 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.

42. 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).

43. 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.

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Review and Management

44. Who reviews the COI Reporting forms?

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

45. 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 COI Review Board (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 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.

46. 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 (see COI in Research Policy Section 3.5, Presumptively Prohibited Activities). 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.

47. How are conflicts of interests managed?

In cases where ORI and the COI Review Board 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.

Please contact Jules Blyth and Torrey Truszkowski at [email protected] for guidance and templates for these disclosures.

The management plan is signed by the conflicted investigator. Once a year, or more frequently when warranted, the Office of Research Integrity (ORI) will conduct a review 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. 

48. Do I need to disclose managed conflicts?

Yes, managed 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.

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COI Training

49. 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.

50. 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 Juliane Blyth.

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Hospital-based Faculty

51. 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. If the research project is PHS-funded, the faculty member will also need to complete Brown's COI Training.

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Outside Activities - General

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

It depends. Providing occasional consulting services or engaging in other outside professional activities that are conducted within the permissible time limit (an average of one day per week) don’t require prior permission from the divisional Dean or the Chair of your department.  However, more extensive outside activities must receive prior approval from the appropriate divisional Dean and could require a concomitant reduction in assigned University duties and compensation. See Brown's Policy on Outside Professional Activities for details and procedures.

In general, it is advisable to talk to and, if necessary, receive approval from your supervisor or chair prior to engaging in any long-term, on-going outside professional activity, such as joining an advisory board, consulting over a period of several months, or starting a company. 

Certain outside professional activities will also need to be reported on your COI Reporting form if they meet the reporting criteria and threshold. Click here for guidance on how outside activities should be conducted. 

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