Public FAQs
		NIH Staff FAQs

In order to address the increasing complexity of the financial interests held by biomedical researchers, the Public Health Service (PHS) and the Office of the Secretary of Health and Human Services (HHS) published a regulation establishing standards and procedures to be followed by Institutions that apply for research funding from PHS granting agencies, including the NIH (http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=/ecfrbrowse/Title42/42cfr50_main_02.tpl). The regulation is aimed at ensuring that the design, conduct, or reporting of research funded under grants and cooperative agreements will not be biased by any conflicting financial interest of the Investigators responsible for the research.  Similar regulatory requirements apply to Institutions performing research under PHS contracts (http://www.access.gpo.gov/nara/cfr/waisidx_07/45cfr94_07.html).

We have compiled answers to the most frequently asked questions regarding the implementation of this regulation by the NIH and hope these will clarify issues that may arise. The FAQs have been categorized for ease of reference.  For more information, please consult the NIH guide notice on the regulation (http://grants.nih.gov/grants/guide/notice-files/not95-179.html) and the Conflict of Interest Page of the Grants Policy and Guidance section of the Office of Extramural Research home page (http://grants.nih.gov/grants/policy/coi/index.htm).   Hereafter, “regulation or FCOI regulation” shall refer to that which applies to either grants or contracts.

  A. General Questions

1. What is the purpose of this regulation?
2. Who is covered by this regulation?
3. Does this regulation apply to all grants/research contracts awarded by the NIH?
4. Does the regulation apply to subgrantees, collaborators of grantees (e.g. consortia) or subcontractors?
5. What financial interests are covered by the regulation?
6. Who is required to disclose financial interests?
7. Who is considered an “Investigator” for this purpose?
8. Where can I find additional information?
9. Does the regulation apply to conference grants (R13 and U13 award mechanisms) in support of sponsored and directed international, national or regional meetings, conferences and workshops?
10. Does the regulation apply to an S06 (Minority Biomedical Research Support) or other “S” award mechanisms?

  B. Institution-Specific Questions

1. What does the regulation require of the Institution?
2. Which offices within an Institution should be involved in administering the regulation?
3. What are the responsibilities of the Institutional designated official(s)?
4. May an Institution have conflict of interest policies that go beyond the regulation; i.e., impose more stringent requirements than those in the regulation?
5. What information must be obtained from Investigators and when should it be collected?
6. What must the Institution report to the NIH and when should it be reported?
7. To whom should the FCOI report be sent and what should it include?
8. What about interests incurred during the award period subsequent to the initial expenditure of funds?
9. What are the responsibilities of the Institution for subrecipients (e.g. consortia) or subcontractors?
10. For how long must Institutions keep records of financial disclosures and any resulting actions?
11. What actions should be taken in the event that an Investigator has failed to comply with the Institution’s conflict of interest policy, resulting in a bias in the design, conduct, or reporting of the research funded by the NIH?
12. What about enforcement mechanisms and/or sanctions?
13. How can an Institution manage conflicting interests?
14. Can the NIH request more information about these matters?
15. What action(s) could be taken by the NIH as a result of its review of records and/or other information that may be available regarding such conflicting financial interests?

  C. Investigator-Specific Questions

1. Who is required to disclose financial interests?
2. Who is considered an “Investigator” for this purpose? Is it only the Principal Investigator?
3. I am a post-doctoral fellow receiving funding from the NIH. Does this regulation apply to me?
4. I am a graduate student working on research funded by the NIH. Am I subject to the requirements of the FCOI regulation?
5. I am a collaborator/contractor/subcontractor/subrecipient performing research funded by the NIH but am not employed directly by the Institution that received the award. Does this regulation apply to me?
6. Which financial interests do I need to disclose?
7. What about assets held by my spouse or children? Are they included?
8. Does this include salary paid me by my Institution as an Investigator?
9. To whom should I disclose my financial interests?
10. When should I disclose these interests to the Institution?
11. What happens if my financial situation changes during the award period?
12. I am an investigator in an NIH-supported clinical trial network. My network has developed a study-wide policy for the trial that requires me to disclose my Significant Financial Interests to my network’s steering committee/operations office on an annual basis. Do I need to disclose my Significant Financial Interests to my Institution as well?
13. I’ve heard there is a special requirement for clinical research? Is this true?
14. I have heard about changes in the conflict of interest regulation for Investigators employed at the NIH. Do these apply to me?
15. I have been asked to give a paid presentation at and participate in a review of a non-profit research Institution. Do I need to report the income I receive from these activities?
16. Am I required to disclose interests in mutual funds?
17. What about stock options?
18. What about “blind trusts”? Are those included in this regulation?
19. Is income from royalties included in this regulation?
20. Are foreign investments (e.g., shares in a foreign corporation) covered by the financial disclosure requirement?

  A. General Questions

1. What is the purpose of this regulation?
   This regulation promotes objectivity in research by establishing standards to ensure there is no reasonable expectation that the design, conduct, or reporting of research funded under NIH grants, cooperative agreements or contracts will be biased by any conflicting financial interest of an Investigator. This regulation is commonly referred to as the Financial Conflict of Interest (FCOI) regulation.
2. Who is covered by this regulation?
   The regulation is applicable to each Institution that applies for NIH grants or cooperative agreements for research or submits a proposal for a research contract whether in response to a solicitation or otherwise and, through implementation of the regulation by each Institution, to any Investigator participating in that research (see regulatory definition of Investigator, discussed in separate questions, below). An Institution is defined as any domestic or foreign, public or private, entity or organization (excluding a Federal agency).
3. Does this regulation apply to all grants/research contracts awarded by the NIH?
   No. This regulation does not apply to Phase I Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) program applications or awards.
   
   The regulation also does not apply to training and fellowship awards funded under the “T” and “F” award mechanisms and to Research Construction Programs funded under C06 and UC6 award mechanisms.
4. Does the regulation apply to subgrantees, collaborators of grantees (e.g. consortia) or subcontractors?
   Yes. The regulation is applicable to each Institution that applies for NIH grants or cooperative agreements for research or submits a proposal for a research contract whether in response to a solicitation or otherwise and, through the implementation of the regulation by each Institution, to each Investigator participating in such research. Accordingly, Institutions carrying out NIH-funded research through subrecipients (e.g., contractors, collaborators) or subcontractors must take reasonable steps to ensure that Investigators working for such entities comply with the regulation, either by requiring the Investigators to comply with the awardee Institution's policy or by requiring the entities to provide appropriate assurances to the awardee Institution. Subrecipients/subcontractors must report identified FCOIs to the awardee Institution; the awardee Institution must report to the NIH the existence of any conflicting interests arising from subrecipients/subcontractors and assure that the interest has been managed, reduced, or eliminated in accordance with the regulation.
5. What financial interests are covered by the regulation?
   All “Significant Financial Interests” (1) that would reasonably appear to be affected by the research for which funding is sought from the NIH; and (2) in entities whose financial interests would reasonably appear to be affected by the research need to be disclosed.

   A “Significant Financial Interest” is defined by the regulation as anything of monetary value, including but not limited to:

   • salary or other payments for services (e.g., consulting fees or honoraria);
   • equity interests (e.g., stocks, stock options or other ownership interests); 
   • intellectual property rights (e.g., patents, copyrights and royalties from such rights).

   The term does not include:

   • salary, royalties, or other remuneration from the Institution;
   • any ownership interests in the Institution, if the Institution is an applicant under the SBIR and STTR programs
   • income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities;
   • income from service on advisory committees or review panels for public or nonprofit entities;
   • an equity interest that, when aggregated for the Investigator and the Investigator’s spouse and dependent children, does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not represent more than a five percent ownership interest in any single entity;
   • salary, royalties or other payments that when aggregated for the Investigator and the Investigator’s spouse and dependent children over the next twelve months, are not expected to exceed $10,000.
6. Who is required to disclose financial interests?
   Under the regulation through its implementation by the Institution, Investigators are required to disclose to an official(s) designated by the Institution a listing of Significant Financial Interests (and those of his/her spouse and dependent children) that (1) would reasonably appear to be affected by the research for which NIH funding is sought, and (2) in entities whose financial interests would reasonably appear to be affected by the research.
7. Who is considered an “Investigator” for this purpose?
   An “Investigator” is defined as the Principal Investigator and any other person who is responsible for the design, conduct, or reporting of research funded by the NIH, or proposed for such funding, including subgrantees, contractors, or collaborators. The definition of Investigator includes the Investigator’s spouse and dependent children.
8. Where can I find additional information?
   More information specific to grants is available on the Conflict of Interest Page of the Grants Policy and Guidance section of the Office of Extramural Research home page (http://grants.nih.gov/grants/policy/coi/index.htm).
9. Does the regulation apply to conference grants (R13 and U13 award mechanisms) in support of sponsored and directed international, national or regional meetings, conferences and workshops?
   Yes. The regulation defines “Research” as “…any such activity for which research funding is available from a PHS Awarding Component through a grant or cooperative agreement…” A conference grant is a research grant mechanism. Therefore, like traditional research grants, conference grants should be routinely subject to review for Investigator financial conflict of interest.
10. Does the regulation apply to an S06 (Minority Biomedical Research Support) or other “S” award mechanisms?
    Yes. These award mechanisms are funded under NIH’s “Research-Related Programs”. Therefore, these types of grants should be routinely subject to review for Investigator financial conflict of interest.

  B. Institution-Specific Questions

1. What does the regulation require of the Institution?
   The regulation requires that each Institution maintain a written, enforced policy on conflict of interest that conforms with the following requirements:
   • Complies with the regulation;
   • Informs each Investigator of the Institution's policy as well as the regulation;
   • Informs each Investigator of his or her reporting responsibilities;
   • Provides adequate guidelines for enforcement mechanisms and sanctions where appropriate.
2. Which offices within an Institution should be involved in administering the regulation?
   An Institution may administer its policy through whichever office or structure it chooses, as long as the policy reaches all Investigators on projects funded by the NIH, and the requirements of the regulation are met. The Institution must designate an Institutional official(s) to solicit and review financial disclosure statements from each Investigator who is planning to participate in the research and provide the Institutional designated official(s) with guidelines consistent with the regulation to identify conflicting interests and take actions necessary to ensure that such conflicting interests will be managed, reduced, or eliminated.
3. What are the responsibilities of the Institutional designated official(s)?
   The Institution’s designated official(s) must review all financial disclosures; determine whether a financial conflict of interest exists; and, if so, determine what actions should be taken by the Institution to manage, reduce, or eliminate such conflict of interest. A conflict of interest exists when the designated official(s) reasonably determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of the research funded by the NIH.
4. May an Institution have conflict of interest policies that go beyond the regulation; i.e., impose more stringent requirements than those in the regulation?
   Yes, as long as the Institution’s policies meet the minimum requirements of the regulation and each Investigator is informed of the Institution’s policies; of the Investigator's disclosure responsibilities; and of the regulation. For example, if an Institution adopts a policy that includes more restrictive disclosure standards, the Institution must report identified financial conflict of interests to NIH in accordance with those standards. For example, if the Institution’s policy requires Investigators’ to report all of their Significant Financial Interests regardless of the value (i.e., no de minimis), then the Institution must report all identified Financial Conflict of Interests to NIH, not just those greater than $10,000.
5. What information must be obtained from Investigators and when should it be collected?
   By the time an application/proposal is submitted to the NIH, each Investigator planning to participate in the research must have submitted to the Institutional designated official(s) a listing of his/her known Significant Financial Interests (and those of his/her spouse and dependent children) 1) that would reasonably appear to be affected by the research for which funding is sought from the NIH and 2) in entities whose financial interests would reasonably appear to be affected by the research.
6. What must the Institution report to the NIH and when should it be reported?
   At the time of the application/proposal submission: The Institution must certify that it has a written and enforced administrative process to identify and manage, reduce, or eliminate conflicting interests with respect to all research projects for which funding is sought from the NIH.  By the time an application/proposal submission is submitted to the NIH, each Investigator who is planning to participate in the research must have submitted to the designated official a listing of her/her known Significant Financial Interests (and those of his/her spouse and dependent children) (1) that would reasonably appear to be affected by the research for which funding is sought from the NIH; and (2) in entities whose financial interests would reasonably appear to be affected by the research need to be disclosed.
   
   Prior to spending any funds under an award:  Prior to spending any funds under an award, the Institution must report to the NIH the existence of any conflicting financial interests and assure that the interest has been managed, reduced, or eliminated in accordance with the regulation. The regulation does not require the Institution to report to NIH officials the nature or other details of a reported FCOI; however, the Institution is required to make information available, upon request, to the NIH regarding all FCOIs identified by the Institution and how those interests have been managed, reduced, or eliminated to protect the research from bias.  Your Institution’s financial conflict of interest policy may have additional requirements (as noted above); therefore, please consult with the appropriate Institutional officials.
   
   Subsequent to the initial report: For any interest that the Institution identifies as conflicting subsequent to the Institution's initial report under the award, a report should be made and the conflicting interest managed, reduced, or eliminated, at least on an interim basis, within sixty days of that identification.
7. To whom should the FCOI report be sent and what should it include?
   For awarded grants and cooperative agreements, all FCOI reports must be submitted through the electronic Research Administration (eRA) Commons FCOI Module beginning July 1, 2009.  See NIH Guide for Grants and Contracts, Notice No. NOT-OD-09-072.  Refer to the FCOI User Guide for additional information.
   
   For awarded contracts, reports should be sent to the appropriate Director, Office of Acquisitions. (http://oamp.od.nih.gov/AcquisitionOffices/chief_cos1.asp).
   The Institution’s report should include the following information:
   
   • Contract number
   • Principal Investigator (PI) or contact PI if the contract is awarded under the multiple PI model;
   • Name of the Investigator (if different from the PI) with the FCOI; and
   • Distinguish which method was used to protect the involved NIH-funded research from bias (e.g., managed, reduced, or eliminated).
8. What about interests incurred during the award period subsequent to the initial expenditure of funds?
   All financial disclosures must be updated during the period of the award, either on an annual basis or as new reportable Significant Financial Interests are obtained. As stated above, for any interest that the Institution identifies as conflicting subsequent to the Institution's initial report under the award, a report should be made and the conflicting interest managed, reduced, or eliminated, at least on an interim basis, within sixty days of that identification.
9. What are the responsibilities of the Institution for subrecipients (e.g. consortia) or subcontractors?
   As stated above, Institutions carrying out NIH-funded research through subrecipients (e.g. subgrantees, contractors, or collaborators) or subcontractors must take reasonable steps to ensure that Investigators working for such entities comply with the regulation, either by requiring those Investigators to comply with the awardee Institution’s policy or by requiring the entities to provide assurances to the awardee Institution that will enable the awardee Institution to comply with the regulation. In addition, the awardee Institution is responsible for reporting to the NIH any conflicting interests it has identified, including those of its subrecipients/subcontractors, and assuring that the interest has been managed, reduced, or eliminated in accordance with the regulation.
10. For how long must Institutions keep records of financial disclosures and any resulting actions?
    The Institution is required to keep all records of all financial disclosures and all actions taken by the Institution with respect to each conflicting interest as follows:
    • For grants or cooperative agreements, - for at least three years from the date of submission of the final expenditures report or, where applicable, from other dates specified in 45 C.F.R. 74.53(b) for different situations
    • For research contracts - for three years after final payment or, where applicable, for the other time periods specified in 48 CFR part 4, subpart 4.7.
11. What actions should be taken in the event that an Investigator has failed to comply with the Institution’s conflict of interest policy, resulting in a bias in the design, conduct, or reporting of the research funded by the NIH?
    The Institution must promptly notify the NIH of the corrective action taken or to be taken. The NIH will consider the situation and, as necessary, take appropriate action, or refer the matter to the Institution for further action, which may include directions to the Institution on how to maintain appropriate objectivity in the funded project.
12. What about enforcement mechanisms and/or sanctions?
    Each Institution is required to establish adequate enforcement mechanisms and provide for sanctions where appropriate; however, the Institution may determine the nature of the enforcement mechanisms and sanctions.
13. How can an Institution manage conflicting interests?
    Examples of conditions or restrictions that might be imposed to manage conflicts of interest include, but are not limited to:
    • public disclosure of Significant Financial Interests;
    • monitoring of research by independent reviewers;
    • modification of the research plan;
    • disqualification from participation in all or a portion of the research funded by the NIH;
    • divestiture of Significant Financial Interests; or
    • severance of relationships that create actual or potential conflicts.
14. Can the NIH request more information about these matters?
    Yes. The NIH may at any time inquire into the Institutional procedures and actions regarding conflicting financial interests in research funded by the NIH, including a requirement for submission, or review on site, of all records pertinent to compliance with the regulation.
15. What action(s) could be taken by the NIH as a result of its review of records and/or other information that may be available regarding such conflicting financial interests?
    The NIH may decide that a particular conflict of interest will bias the objectivity of the research it funds to such an extent that further corrective action is needed or that the Institution has not managed, reduced, or eliminated the conflict of interest in accordance with the regulation. The NIH may determine that suspension of funding is necessary until the matter is resolved.

  C. Investigator-Specific Questions

Through the implementation of the regulation by each Institution, the regulation is applicable to the Investigator. The following information is based on the PHS regulation only. As discussed above, an Institution’s policy may be more restrictive than the requirements of the regulation. Therefore, please make sure you are familiar with the policies of your particular Institution, which may have additional requirements.

1. Who is required to disclose financial interests?
   Under the regulation, Investigators are required to disclose to official(s) designated by the Institution a listing of Significant Financial Interests (and those of his/her spouse and dependent children) (1) that would reasonably appear to be affected by the research for which NIH funding is sought, and (2) in entities whose financial interests would reasonably appear to be affected by the research.
2. Who is considered an “Investigator” for this purpose? Is it only the Principal Investigator?
   An “Investigator” is defined as the Principal Investigator and any other person who is responsible for the design, conduct, or reporting of research funded by the NIH, or proposed for such funding. The definition includes the Investigator’s spouse and dependent children.
3. I am a post-doctoral fellow receiving funding from the NIH. Does this regulation apply to me?
   The regulation is applicable to each Institution that applies for NIH grants or cooperative agreements for research or submits a proposal for a research contract whether in response to a solicitation or otherwise and, through the implementation of the regulation by each Institution, to each Investigator participating in such research. As noted above, an Investigator is defined as the Principal Investigator and any other person who is responsible for the design, conduct, or reporting of research funded by the NIH, or proposed for such funding. Thus, if a post-doctoral fellow meets the definition of an Investigator, he or she would be subject to the regulation if the NIH funding is for research. You should consult with your Institution’s designated official to ensure you comply with the appropriate requirements.
4. I am a graduate student working on research funded by the NIH. Am I subject to the requirements of the FCOI regulation?
   As stated above, the term "Investigator" is defined to encompass individuals "responsible for the design, conduct or reporting" of research funded by the NIH. You should confirm with your Institutional designated official whether you, as a graduate student, meet this definition.
5. I am a collaborator/contractor/subcontractor/subrecipient performing research funded by the NIH but am not employed directly by the Institution that received the award. Does this regulation apply to me?
   Yes, if you meet the definition of an “Investigator.” Please consult your Institution’s policy. If you meet the applicable definition, you may either need to report your Significant Financial Interests directly to the awardee Institution or your Institution may need to provide assurances to the awardee Institution that will enable the awardee Institution to comply with the regulation. The awardee Institution is responsible for reporting to the NIH any conflicting interests it has identified, including those of its subrecipients/subcontractors, and assuring that the interest has been managed, reduced, or eliminated in accordance with the regulation.
6. Which financial interests do I need to disclose?
   The regulation requires the disclosure of all “Significant Financial Interests” (1) that would reasonably appear to be affected by the research for which funding is sought from the NIH; and (2) in entities whose financial interests would reasonably appear to be affected by the research.

   A “Significant Financial Interest” is defined by the regulation as anything of monetary value, including but not limited to:

   • salary or other payments for services (e.g., consulting fees or honoraria);
   • equity interests (e.g., stocks, stock options or other ownership interests); 
   • intellectual property rights (e.g., patents, copyrights and royalties from such rights).

   The term does not include:

   • salary, royalties, or other remuneration from the Institution;
   • any ownership interests in the Institution, if the Institution is an applicant under the SBIR and STTR programs;
   • income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities;
   • income from service on advisory committees or review panels for public or nonprofit entities;
   • an equity interest that, when aggregated for the Investigator and the Investigator’s spouse and dependent children, does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not represent more than a five percent ownership interest in any single entity;
   • salary, royalties or other payments that when aggregated for the Investigator and the Investigator’s spouse and dependent children over the next twelve months, are not expected to exceed $10,000.

   As noted above, your Institution may have more stringent disclosure requirements. Please refer to your Institution’s conflict of interest policy and verify with your Institution its disclosure requirements.

7. What about assets held by my spouse or children? Are they included?
   Yes, please see the previous question. The calculation of interests that should be disclosed includes the aggregated holdings of the Investigator and his/her spouse and dependent children.
8. Does this include salary paid me by my Institution as an Investigator?
   No. Salary, royalties, or other remuneration from your Institution are not included.
9. To whom should I disclose my financial interests?
   Your Institution will designate an Institutional official(s) to solicit and review financial disclosure statements.
10. When should I disclose these interests to the Institution?
    Please refer to your Institution’s conflict of interest policy. In general, interests must be reported to the Institutional designated official(s) by the time an application is submitted to the NIH for funding, and at intervals thereafter to be determined by your Institution (either on a regular basis or as new reportable Significant Financial Interests are obtained – as detailed below).
11. What happens if my financial situation changes during the award period?
    You should immediately notify the appropriate Institutional officials so that any conflict resulting from your changed situation can be identified and reported, and appropriate measures taken to manage, reduce, or eliminate it.
12. I am an investigator in an NIH-supported clinical trial network. My network has developed a study-wide policy for the trial that requires me to disclose my Significant Financial Interests to my network’s steering committee/operations office on an annual basis. Do I need to disclose my Significant Financial Interests to my Institution as well?
    Reporting your Significant Financial Interests to a steering committee or other entity overseeing an NIH-supported clinical trial may not fulfill your responsibilities under your Institution’s FCOI policy. If you are an Investigator as previously defined in Question 2 above on an NIH-supported grant or contract then you may also need to disclose your Significant Financial Interests to your Institution in accordance with its FCOI policy. Please refer to your Institution’s policy (which may integrate network disclosures) and verify with your Institution your disclosure requirements and how they apply to your research.
13. I’ve heard there is a special requirement for clinical research? Is this true?
    Yes. In any case in which the HHS determines that an NIH-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with a conflicting interest that was not disclosed or managed as required by the regulation, the Institution must require the Investigator(s) involved to disclose the conflicting interest in each public presentation of the results of the research. Your Institution’s financial conflict of interest policy may have additional requirements so please consult the appropriate Institutional designated official(s).
14. I have heard about changes in the conflict of interest regulation for Investigators employed at the NIH. Do these apply to me?
    No. The regulation discussed here is distinct from the rules that apply to NIH employees.
15. I have been asked to give a paid presentation at and participate in a review of a non-profit research Institution. Do I need to report the income I receive from these activities?
    Under the regulation, the definition of Significant Financial Interests does not include income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities and income from service on advisory committees or review panels for public or nonprofit entities. However, your Institution may have a broader policy with additional requirements so please consult the appropriate Institutional designated official(s).
16. Am I required to disclose interests in mutual funds?
    Please refer to your Institution’s policy. An interest in a pooled fund such as a diversified mutual fund may be sufficiently remote that it would not reasonably be expected to create a conflict of interest for an Investigator funded by the NIH.
17. What about stock options?
    Please refer to your Institution’s policy. Stock option assets are to be reported by the time an application for funding is submitted, and then reported annually or as new stocks are obtained, in the same manner as all other assets. The documentation needed to determine the value of a stock option is defined by the Institution.
18. What about “blind trusts”? Are those included in this regulation?
    Please refer to your Institution’s policy. Institutions may determine that the research will not be affected by qualified blind trust assets not known to the Investigator that are managed by an independent fiduciary. Because such assets would not be known to an Investigator, they could not directly and significantly affect the design, conduct or reporting of the research. Of course, an Investigator is aware of the assets originally placed in the trust at the time of its formation and would be required to disclose any such assets that would reasonably appear to be affected by research funded by the NIH. Only new assets purchased with the proceeds from the original assets would be unknown to the Investigator.
19. Is income from royalties included in this regulation?
    If the royalties relate to patents owned by the university and licensed or potentially licensed through the university technology transfer office (i.e. they are not personally owned by the Investigator), they are considered remuneration from the applicant Institution and would not be considered a Significant Financial Interest of the Investigator. Income from royalties from other sources could be considered a Significant Financial Interest if the income fits the definition of a Significant Financial Interest.
20. Are foreign investments (e.g., shares in a foreign corporation) covered by the financial disclosure requirement?
    Yes, if the investments constitute Significant Financial Interests (1) that would reasonably appear to be affected by the NIH-funded research, and (2) in entities whose financial interests would reasonably appear to be affected by the NIH-funded research.

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