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Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is
Sought (42 CFR Part 50 Subpart F) applicable to grants and cooperative agreements (2011 Revised Regulations)
Initial Posting: September 30, 2011
Last Revised: October 22, 2015
The objectivity of research is of paramount importance and the basis for obtaining and maintaining public trust. To address the increasing complexities of the financial interests held by biomedical and behavioral researchers and the resulting interactions among Government, research Institutions, and the private sector, the Public Health Service (PHS) and the Office of the Secretary of the U.S. Department of Health and Human Services (HHS) published revised regulations on the Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought and Responsible Prospective Contractors (commonly known as the Financial Conflict of Interest (FCOI) regulations). These regulations establish new standards and clarify previously established standards to be followed by Institutions that apply for or receive research funding from PHS Awarding Components, including the National Institutes of Health (NIH), for grants, cooperative agreements, and research contracts. The 2011 revised regulations were written to increase accountability, add transparency, enhance regulatory compliance and effective Institutional management of Investigators’ financial conflicts of interest, and strengthen NIH’s compliance oversight. The primary goal is to promote objectivity by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under PHS grants, cooperative agreements and contracts will be free from bias resulting from Investigator financial conflicts of interest.
As part of NIH’s continuing efforts to provide useful resources for extramural recipients, we compiled answers to the most frequently asked questions regarding the implementation of the revised regulations for grants and cooperative agreements. The questions are arranged by topic, indicating to whom (Institution and/or Investigator) they pertain. The purpose of the FAQs is to clarify issues that may arise and will assist Institutions as they develop and/or revise an Institution’s FCOI policy that meets or exceeds the requirements of the regulation; the FAQs pertain only to grants and cooperative agreements. Questions regarding the applicability and/or compliance with the revised contract regulation provided at 45 CFR Part 94 should be directed to fcoicontracts@mail.nih.gov.
The 2011 revised regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research performed under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest. This regulation is commonly referred to as the Financial Conflict of Interest (FCOI) regulation. (http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf).
An Institution applying for or receiving NIH funding from a grant or cooperative agreement must be in compliance with all of the revised regulatory requirements no later than 365 days after publication of the regulation in the Federal Register, i.e., August 24, 2012, and immediately upon making the Institution’s Financial Conflict of Interest policy publicly accessible as described in 42 CFR part 50.604(a).
When the Institution posts its Financial Conflict of Interest policy (or, if the institution does not have a current presence on a publicly accessible Web site, makes the policy publicly accessible by written request), it signifies that the Institution applying for or receiving PHS funding from a grant or cooperative agreement that is covered by the 2011 revised regulation is in full compliance with all the regulatory requirements. The Institution must be in compliance with the 2011 revised regulation no later than August 24, 2012.
No. The revised regulation will apply to each grant or cooperative agreement with an issue date of the Notice of Award that is subsequent to the compliance dates of the Final Rule (including noncompeting continuations) no later than August 24, 2012 and immediately upon making its Financial Conflict of Interest policy publicly accessible. Through their policies, however, Institutions may choose to apply the revised regulations to all active PHS awards. For example, Institutions may choose, in their Financial Conflict of Interest policy, to implement the regulation on a single date for all PHS-funded awards rather than implementing the regulation sequentially on the specific award date of each individual project.
More information specific to grants and cooperative agreements is available on the Financial Conflict of Interest Web Page of the Grants Policy and Guidance section of the NIH Office of Extramural Research home page (http://grants.nih.gov/grants/policy/coi/index.htm.)
Yes, as long as the Institution’s policies meet the minimum requirements of the PHS regulation. The regulation states the Institution’s policy must inform each Investigator of the Institution’s policy on Financial Conflict of Interest; of the Investigator's Significant Financial Interest disclosure responsibilities; and of the PHS regulation. If an Institution adopts a policy that includes more restrictive disclosure thresholds than those in the 2011 revised regulation, the Institution must adhere to the requirements of the policy’s more restrictive standards. Institutions must report all identified FCOIs to the NIH, including any financial conflicts of interest identified in accordance with the Institution’s own more restrictive standards, in the time and manner specified in the regulation (see “Reporting” section for additional information).
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 managed or reported by the Institution as required by the regulation, the Institution must require the Investigator(s) involved to disclose the Financial Conflict of Interest in each public presentation of the results of the research and to request an addendum to previously published presentations. Institution’s Financial Conflict of Interest policy may have additional requirements.
Institutional policies must be followed regarding maintenance of records as long as they are in compliance with the PHS regulation. Under the regulation, the Institution is required to keep all records of all Investigator disclosures of financial interests and the Institution’s review of, or response to, such disclosure (whether or not a disclosure resulted in the Institution’s determination of a Financial Conflict of Interest), and all actions under the Institution’s policy or retrospective review, if applicable, as follows:
Records of financial disclosures and any resulting action must be maintained by the Institution 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. 75.361 (see FAQ A.11) for different situations.
NIH expects Institutions to retain records for each competitive segment as provided in the regulation.
The 2011 revised regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research performed under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest. This regulation is commonly referred to as the Financial Conflict of Interest (FCOI) regulation. (http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf).
No. The record retention requirements have not changed. However, with the implementation of the Uniform Guidance on December 26, 2014, recipients should review their institutional FCOI policy to determine if changes are needed. Policies may need to be updated to reflect 45 CFR Part 75.361 in place of 45 CFR Part 74.53(b) and 92.42(b).
An Institution may administer its policy through whichever office or structure it chooses as long as the policy is applicable to all Investigators and the policy meets all requirements of the regulation.
The Institution’s designated official(s) must review all financial disclosures by Investigators and determine whether any Significant Financial Interest is related to a NIH-funded research and a Financial Conflict of Interests exists by making a reasonable determination that the Significant Financial Interest: could be affected by the NIH-funded research or is in an entity whose financial interest could be affected by the research.
Yes. The institution’s designated official(s) may involve the Investigator to determine whether the Significant Financial Interest is related to the NIH-funded research. In accordance with the 2011 revised regulation, a Significant Financial Interest is related to the research when the Significant Financial Interest: could be affected by the NIH-funded research; or is in an entity whose financial interest could be affected by the research.
When an Investigator fails to comply with the Institution’s Financial Conflict of Interest policy or the management plan, the Institution shall within 120 days:
a) complete a retrospective review of the Investigator’s activities and the NIH-funded research project to determine any bias in the design, conduct or reporting of research;
b) document the retrospective review consistent with the regulation; and
c) document the Institution’s determination as to whether any NIH-funded research, or portion thereof, conducted during the period of time of the Investigator’s non-compliance with the Institution’s Financial Conflict of Interest policy or a Financial Conflict of Interest management plan, was biased in the design, conduct, or reporting of such research.
If bias is found, the Institution shall notify the NIH promptly and submit a mitigation report to the NIH that shall address the following:
impact of the bias on the research project and
the Institution’s plan of action or actions taken to eliminate or mitigate the effect of the bias.
Thereafter, the Institution shall submit FCOI reports annually, in accordance with the regulation. Depending on the nature of the Financial Conflict of Interest, an Institution may determine that additional interim measures are necessary with regard to the Investigator’s participation in the NIH-funded research project between the date that the Financial Conflict of Interest is identified and the completion of the Institution’s independent retrospective review, in accordance with 42 CFR 50.605(a)(3) and 42 CFR 50.605(b)(3).
In addition, if the NIH determines that one of its funded clinical research projects 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 Financial Conflict of Interest that was not managed or reported by the Institution, the Institution shall require the Investigator involved to disclose the Financial Conflict of Interest in each public presentation of the results of the research and to request an addendum to previously published presentations.
After NIH issues a grant or cooperative agreement award, “prior to the Institution's expenditure of any funds” is the period of time before an expense is recorded in the official records of the Institution.
The FCOI regulation (42 CFR Part 50 Subpart F) does not include a “fine structure” for noncompliance. However, Section 50.604 (j) requires Institutions to establish adequate enforcement mechanisms and provide for employee sanctions or other administrative actions to ensure Investigator compliance as appropriate. In addition, Section 50.506 permits NIH to take appropriate action or direct the Institution to take action to maintain appropriate objectivity in Public Health Service-funded research.
In addition, the NIH Grants Policy Statement (GPS) (https://grants.nih.gov/policy/nihgps/index.htm), which serves as a term and condition of all NIH awards, provides information in chapter 8.5 Special Award Conditions and Remedies for Noncompliance (Special Award Conditions and Enforcement Actions) on actions NIH may take in those situations when a grantee fails to comply with the terms and conditions of award.
Depending on the severity and duration of the noncompliance, NIH may to take one or more actions. For example, NIH may impose special conditions on a grant to allow the grantee to take corrective action. In addition, if a grantee has failed to materially comply with the terms and conditions of award, NIH may take action to wholly or partly suspend the grant, pending corrective action, or may terminate the grant. The regulatory procedures that pertains to suspension and termination are specified in 45 CFR parts 75.371.
The cost of implementing the amended regulations, including the cost to conduct a retrospective review, is an allowable cost that may be eligible for reimbursement as a Facilities and Administrative cost on Public Health Service supported grants and cooperative agreements.
Yes. As provided by NIH grants policy, Institutions may, at their own risk, incur preaward costs. However, the Institution must submit the FCOI report to the NIH through the eRA Commons FCOI Module prior to the Institution's expenditure of NIH funds authorized under the award, that is, after the Notice of Award is issued and before the specific amount is charged to an NIH award.
Yes. The prime Institution may expend funds issued under an NIH grant or cooperative agreement award to support activities conducted at the prime Institution,if a subaward agreement has not been executed. If the subrecipient policy applies to the subrecipient Investigators, once the subaward agreement is executed, it is expected that the subrecipient Institution will submit any FCOI report(s), if applicable, to the prime Institution for submission to the NIH prior to the subrecipient’s expenditure of funds. Therefore, the prime Institution may record expenses in the official records of the Institution for costs incurred at the prime Institution but not for costs incurred at the subrecipient Institution until the subaward agreement is executed and the FCOI report(s) for any subrecipient Investigator(s), if applicable, is submitted to the NIH.
To ensure consistency with the FCOI regulation, the foreign Institution’s FCOI policy should prescribe any regulatory de minimis threshold in U.S. currency.
Until a better solution becomes available, we recommend that institutions set up a rule within their email system to forward any "FCOI" related notifications that are sent to the assigned FCOI SO to another email account. If this action is taken, the Institution will ensure its receipt of email reminder notifications that are sent to the assigned FCOI SO when an annual FCOI report is due.
The regulation is applicable to each Institution that is applying for, or that receives, NIH research funding by means of a grant or cooperative agreement and, through the implementation of the regulation by the Institution, to each Investigator who is planning to participate in, or is participating in, such research. The regulation, however, does not apply to Phase I Small Business Innovative Research or Small Business Technology Transfer applications. For purposes of financial disclosure only, the regulation covers the Investigator’s spouse and dependent children. The regulation also applies to those few cases where an individual, rather than an Institution, is applying for or receives NIH research funding. However, in those cases, the NIH will make case-by-case determinations on the steps an Institution or an Investigator must take, consistent with the regulation, to provide a reasonable expectation that the design, conduct, and reporting of the research will be free from bias resulting from a Financial Conflict of Interest of the individual.
No. The regulation does not apply to Phase I Small Business Innovative Research (SBIR) Small Business Technology Transfer (STTR) applications. The regulation applies to research and includes any activity for which research funding is available from the NIH through a grant or cooperative agreement. The regulation explicitly applies to research authorized under the PHS Act or other statutory authority, such as a research grant, career development grant, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award.
Yes. The regulation defines “Research” as any such activity (described at 42 CFR 50.603) for which research funding is available from a PHS Awarding Component (e.g., NIH) through a grant or cooperative agreement. The definition of the term “Research” provides a non-exhaustive list of examples of the different types of NIH-funding mechanisms to which the regulation applies such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, Institutional training grant, program project, or research resources award. The only award programs that are excluded from the regulation are the Small Business Innovative Research (SBIR) and Small Business Technology Transfer Research (STTR) Phase I applications.
Yes. The regulation defines “Research” as any such activity (described at 42 CFR 50.603) for which research funding is available from a PHS Awarding Component (e.g., NIH) through a grant or cooperative agreement. The definition of the term “Research” provides a non-exhaustive list of examples of the different types of NIH-funding mechanisms to which the regulation applies such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, Institutional training grant, program project, or research resources award. The only award programs that are excluded from the regulation are the Small Business Innovative Research (SBIR) and Small Business Technology Transfer (STTR) Phase I applications.
Yes. The 2011 revised regulation is applicable to each Institution that applies for or receives NIH funding for research through grants or cooperative agreements and, through the implementation of the regulation by each Institution, to each Investigator planning to participate in, or participating in, such research. A subrecipient relationship is established when federal funds flow down from or through an awardee Institution to another individual or entity and the subrecipient will be conducting a substantive portion of the NIH-funded research project and is accountable to the awardee institution for programmatic outcomes and compliance matters. Accordingly, as a recipient of federal funds from an awardee Institution, the Financial Conflict of Interest regulation applies to subrecipients (e.g., subcontractors or consortium members). See 42 CFR 50.604 (c).
Yes. If you meet the definition of an “Investigator,” the PHS regulation applies to you. The awardee institution is required to incorporate as part of a written agreement with the subrecipient terms that establish whether the Financial Conflict of Interest policy of the awardee Institution or that of the subrecipient apply to the subrecipient’s Investigators. Please consult the appropriate Institutional official or the written agreement to determine which policy applies.
Yes. If you meet the definition of an “Investigator,” the PHS regulation applies to you. The regulation is applicable to each Institution that applies for or receives NIH grant awards or cooperative agreements for research and, through the implementation of the regulation by each Institution, to each Investigator who is planning to participate in, or is participating in such research. As noted above, an Investigator is defined as the project director or principal investigator and any other person, regardless of title or position, 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(s) to ensure you comply with the appropriate requirements.
Yes. If you meet the definition of an “Investigator,” the PHS regulation applies to you. As stated above, the term "Investigator" is defined to encompass individuals "responsible for the design, conduct or reporting" of research funded by the NIH. Be sure to confirm with your Institutional designated official(s) whether you, as a graduate student, meet this definition.
No. The Financial Conflict of Interest regulation discussed in this FAQ document (42 CFR Part 50 Subpart F) is distinct from the ethics rules that apply to NIH employees.
As noted in Section 50.602 of the regulation, the Final Rule applies to Institutions that apply for, or that receive Public Health Service (PHS) research funding by means of a grant or cooperative agreement. Section 50.603 defines “PHS”, “PHS Awarding Component” and “Research” as follows:
PHS means the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH).
PHS Awarding Component means the organizational unit of the PHS that funds the research that is subject to this subpart.
Researchmeans a systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. The term encompasses basic and applied research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug). As used in this subpart, the term includes any such activity for which research funding is available from a PHS Awarding Component through a grant or cooperative agreement, whether authorized under the PHS Act or other statutory authority, such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award.
Therefore, this regulation applies to institutions that receive Federal funding for research by a PHS Awarding Component. The NIH is a PHS Awarding Component. Institutions should contact the applicable PHS Awarding Component to determine whether the 2011 revised regulation applies to a PHS-funded award.
Yes. The regulation applies to any Institution (i.e., foreign or domestic) that applies for or that receives NIH research funding by means of a grant or cooperative agreement as either a prime awardee institution or a subrecipient institution.
Any Notice of Award (NoA) that has an issue date prior to August 24, 2012, is subject to the 1995 regulation. This also applies to projects extended without funds because even though the project period may be extended past August 24, 2012, the grant award was initially issued prior to August 24, 2012.
No. Pursuant to the final rule at 42 CFR 50.603, federal agencies are expressly excluded from the definition of "Institutions" subject to the FCOI regulation. (“Institution means any domestic or foreign, public or private, entity or organization (excluding a Federal agency) that is applying for, or that receives, PHS research funding.”) As is explained in the preamble to the final rule addressing that section (http://grants.nih.gov/grants/policy/coi/fcoi_final_rule.pdf see page 53261): "Federal agencies and their employees are subject to conflicts of interest requirements, including disclosure by employees and review by agencies, pursuant to Federal criminal statutes, the Ethics in Government Act as amended, and supplemental agency regulations. Accordingly, we have retained the exclusion of Federal agencies in this definition.”
PHS means the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including the NIH.
Institution means any domestic or foreign, public or private, entity or organization (excluding a Federal agency) that is applying for or that receives NIH research funding.
Entity means any domestic or foreign, public or private, organization (excluding a Federal agency) from which an Investigator (and spouse and dependent children) receives remuneration or in which any person has an ownership or equity interest.
Senior/Key Personnel means the Project Director/Principal Investigator (PD/PI) and any other person identified as senior/key personnel by the Institution in the grant application, progress report, or any other report submitted to the NIH by the Institution under the regulation.
No. “Investigator” means the project director or principal investigator 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), or proposed for such funding, which may include, for example, collaborators or consultants. Institutions should consider the role, rather than the title, of those involved in research and the degree of independence with which those individuals work. When the definition of investigator is limited to titles or designations (e.g., to principal investigators, key personnel, faculty) the risk is that an unidentified FCOI may compromise the research enterprise increases.
In addition, the Investigator’s spouse and dependent children have been eliminated from the definition of “Investigator” under the 2011 revised regulation; however, they are referenced in the definition of “Significant Financial Interest” because the Investigator must also disclose Significant Financial Interests of his/her spouse and dependent children. (see definition of Significant Financial Interest).
“Institutional responsibilities” are defined by the 2011 revised regulation as an Investigator’s professional responsibilities on behalf of the Institution, and as defined by the Institution in its policy on Financial Conflict of Interest, which may include, for example, activities such as research, research consultation, teaching, professional practice, Institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards. The Institution can include other professional responsibilities within the definition, as appropriate.
A Financial Conflict of Interest exists when the Institution, through its designated official(s), reasonably determines that an Investigator’s Significant Financial Interest is related to a NIH-funded research project and could directly and significantly affect the design, conduct or reporting of the NIH-funded research.
The regulation covers all financial interests that have monetary value, whether or not the value is readily ascertainable.
The 2011 revised regulation defines a “Significant Financial Interest” as follows:
“(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities:
(i) With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;
(ii) With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
(iii) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their institutional responsibilities; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education. The Institution’s FCOI policy will specify the details of this disclosure, which will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. In accordance with the Institution’s FCOI policy, the institutional official(s) will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research.
(3) The term significant financial interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights; any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization; income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles; income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education; or income from service on advisory committees or review panels for a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.”
The Institution may have more stringent financial disclosure requirements. Please refer to the Institution’s conflict of interest policy and confer with the Institution’s designated official(s) to determine the Institution’s disclosure requirements.
A new SFI is a different type or nature of SFI (e.g., royalty payment versus consulting fees) than what had previously been disclosed from the same source that meets or exceeds the threshold. In addition, a “new” SFI is also considered to be the same type or nature of SFI (e.g., royalty payment) from a different source (e.g., company A versus company B).
The definition of Significant Financial Interest under the 2011 revised regulation differs from the 1995 definition of Significant Financial Interest in a number of respects.
Institutional responsibilities:
Under the 2011 FCOI regulation,Significant Financial Interests that are subject to disclosure by an Investigator to an Institution are those that reasonably appear to be related to the Investigator’s ‘‘Institutional responsibilities,” as defined by the Institution. As a result, when read in conjunction with the revised Investigator disclosure requirements under 42 CFR 50.604, the revised Significant Financial Interest definition results in the disclosure by Investigators to Institutions of a wider array of interests on a more frequent basis. In addition to their own, Investigators are required to disclose the Significant Financial Interests of his/her spouse and dependent children.
Under the 1995 regulation, Investigators were required to disclose their Significant Financial Interests related to their PHS-funded research.
Monetary threshold:
The 2011 Significant Financial Interest definition lowers the de minimis threshold to $5,000 and, in some circumstances, eliminates the existing monetary thresholds for disclosure.
Under the 1995 FCOI regulation, a Significant Financial Interest did not include an equity interest that, when aggregated for the Investigator and the Investigator’s spouse and dependent children, met both of the following tests: Did not exceed $10,000 in value and did not represent more than a five percent (5%) ownership interest in any single entity. Similarly, a Significant Financial Interest did not include payments (e.g., salary) that, when aggregated for the Investigator and the Investigator’s spouse and dependent children over the next twelve months, were not expected to exceed $10,000.
The 2011 definition also differentiates between remuneration to the Investigator (and the Investigator’s spouse and dependent children) from a publicly traded entity and remuneration from a non-publicly traded entity. With regard to a publicly traded entity, a monetary threshold of $5,000 applies to the aggregated amount of any remuneration received from the entity in the twelve months preceding disclosure and the value of any equity interest as of the date of disclosure. With regard to a non-publicly traded entity, a Significant Financial Interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest).
Timing:
The revised Significant Financial Interest definition changes the timing for determining whether remuneration represents a Significant Financial Interest.
The 1995 regulation excluded aggregated payments (including salary and royalties) that were ‘‘not expected to exceed’’ the monetary threshold ‘‘over the next twelve months.’’
Under the 2011 definition, at issue is any remuneration received from an entity ‘‘in the twelve months preceding the disclosure and the value of any publicly traded equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000.”
Examples of payment for services:
The 1995 definition referenced as examples of payments for services receipt of consulting fees or honoraria.
The 2011 revised regulation adds ‘‘paid authorship’’ as an additional example of payment for services.
Royalties & Intellectual Property:
Under the 1995 regulation, royalties were subject to the $10,000 threshold if not received from the applicant institution.
Under the 2011 revised regulation, the preamble clarifies that a threshold of $5,000 applies to licensed intellectual property rights (e.g., patents, copyrights), royalties from such rights, and agreements to share in royalties related to licensed intellectual property rights (see page 53265.) However, intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights are still excluded from the Significant Financial Interest definition.
Reimbursed or Sponsored Travel:
Under the 1995 regulation, there was no specific requirement to disclose reimbursed or sponsored travel.
Under the 2011 revised regulation, and with the express exceptions noted therein, Investigators must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to the Investigator’s institutional responsibilities as prescribed by the Institution’s Financial Conflict of Interest (FCOI) policy (i.e., specify the details of the disclosure which will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration). The institutional official will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with PHS-funded research. This disclosure is addressed in the definition of “Significant Financial Interest,” (SFI) which makes it subject to the following considerations:
(1) Investigators who are planning to participate in PHS-funded research must disclose their SFIs over the previous twelve-month period to their Institution no later than at the time of application for PHS-funded research.
(2) Each Investigator who is participating in PHS-funded research must submit an updated disclosure of SFIs at least annually, in accordance with the specific time period prescribed by the Institution, during the period of award.
(3) Each Investigator who is participating in the PHS-funded research must submit an updated disclosure of SFIs within 30 days of discovering or acquiring a new SFI.
Exclusions:
The 2011 revised regulation modifiesthe types of interests that are specifically excluded from the Significant Financial Interest definition. The exclusions are:
salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution;
intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights
any ownership interests in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization
income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles;
income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an Institution of higher education as defined in 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education;
income from service on advisory committees or review panels for a federal, state, or local government agency, or an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.
Unlike in the 1995 Financial Conflict of Interest regulation, income from non-profit entities other than federal, state, or local government agencies, Institutions of higher education, academic teaching hospitals, medical centers, or research institutes that are affiliated with an Institution of higher education for the types of activities described above would be subject to the Significant Financial Interest definition.
In addition, the SBIR/STTR applicant exclusion under the 1995 regulation was broadened to include any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization (whether or not an SBIR/STTR applicant).
Under the 2011 revised regulation, Investigators (as defined by the regulation) who are planning to participate in, or are participating in, NIH-funded research, with the exception of Phase I SBIR/STTR applications, are required to disclose to the designated official(s) of the Institution a listing of Significant Financial Interests (and those of his/her spouse and dependent children) that reasonably appear to be related to the Investigator’s institutional responsibilities.
Under the 2011 revised regulation, Investigators are required to disclose their Significant Financial Interests (and those of the Investigator’s spouse and dependent children) that reasonably appear to be related to the Investigator’s institutional responsibilities:
(1) no later than at the time of application for NIH-funded research;
(2) within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new Significant Financial Interest; and
(3) at least annually, in accordance with the specific time period prescribed by the Institution, during the period of award.
Investigators have an ongoing obligation to disclose Significant Financial Interests throughout the awarded project period. Under the 2011 revised Financial Conflict of Interest regulation, Investigators must update financial disclosures of Significant Financial Interests to their Institutions within thirty (30) days of acquiring or discovering (e.g., through purchase, marriage, or inheritance) a new Significant Financial Interest. The Institution’s designated official(s) will have sixty (60) days to review the Significant Financial Interest disclosure, determine whether the Significant Financial Interest is related to NIH-funded research, determine whether a Financial Conflict of Interest exists, and if so, implement, on at least an interim basis, a management plan that shall specify the actions that have been, or will be, taken to manage the Financial Conflict of Interest. If a Financial Conflict of Interest exists, the Institution must submit an FCOI report to the NIH within this same 60-day period.
Yes. Please see the question on the definition of “Significant Financial Interests.” The financial interests that must be disclosed by the Investigator include the aggregated amounts or values of financial interests held by the Investigator and his/her spouse and dependent children.
Under the 2011 revised regulation, each Investigator who is participating in the NIH-funded research must submit to his/her Institution an updated disclosure of Significant Financial Interests within thirty (30) days of acquiring or discovering a new Significant Financial Interest or a Significant Financial Interest that was not disclosed timely.
Yes. The regulation requires Investigators to disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to the Investigator’s institutional responsibilities. The disclosure requirement also applies to the Investigator’s spouse and dependent children. However, the disclosure requirement does not apply to travel that is reimbursed or sponsored by the following:
a federal, state, or local government agency,
an Institution of higher education as defined at 20 U.S.C. 1001(a),
an academic teaching hospital,
a medical center, or
a research institute that is affiliated with an Institution of higher education.
It is important to check with your Institution’s FCOI policy since it will specify the details of this disclosure, which will include, at a minimum, the following:
purpose of the trip,
the identity of the sponsor/organizer,
the destination, and
the duration.
In addition, the Institution’s FCOI policy may also determine if additional information is needed, such as a determination or disclosure of monetary value, in order to determine whether the travel constitutes a Financial Conflict of Interest with the NIH-funded research or to limit the disclosure requirement to the de minimis threshold, as discussed in answers E.9. and E.24.
The Final Rule does not impose a general requirement to apply the de minimis threshold to all reimbursed or sponsored travel disclosure. However, Institutions may, within the discretion afforded by the Final Rule, impose the $5,000 de minimis threshold to reimbursed or sponsored travel disclosure in their institutional policies which specify the disclosure details. For example, consistent with the requirement for other types of financial interests within the regulatory definition of SFI, Institutions could apply the de minimis threshold when aggregated per entity.
The 2011 revised regulation requires disclosure of basic information about reimbursed or sponsored travel including, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination and the duration. As provided in the regulation, the Institutional official(s) will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research. The regulation does not specify the process to be used by Institutions for review of Investigator travel disclosures; however, the Institution is responsible for determining whether such travel constitutes a Financial Conflict of Interest with PHS-funded research. Travel to scientific meetings and to present Investigator’s research to colleagues and other interested parties is an integral part of the scientific research enterprise and affords many important opportunities for forging relationships and collaborations among researchers. The provisions in the revised regulations are not intended to discourage this type of travel but require the disclosure of the occurrence of any reimbursed or sponsored travel related to the Investigator’s institutional responsibilities provided the travel is not sponsored or reimbursed by those identified sources excluded in the Final Rule.
Your Institution will designate an Institutional official(s) to solicit and review financial disclosure statements. Please consult your Institution’s conflict of interest policy and procedures and/or your Institution’s designated official(s) for more information about the disclosure requirements and procedures at your Institution.
Please refer to your Institution’s conflict of interest policy. In accordance with the 2011 revised regulation, Significant Financial Interests must be disclosed to the Institutional designated official(s) by the time an application is submitted to the NIH for funding, within thirty (30) days of discovering or acquiring a new Significant Financial Interest, and on an annual basis at intervals thereafter to be determined by your Institution.
The 2011 revised regulation requires each Investigator who is participating in NIH-funded research to submit an updated disclosure of Significant Financial Interest to the Institution’s designated official(s) within thirty (30) days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new Significant Financial Interest. Be sure to check with your Institutional policy since the policy may have a more restrictive reporting requirement. The Institution’s designated official(s) are required to review the updated financial disclosure of Significant Financial Interest, determine whether the Significant Financial Interest is related to the NIH-funded research and, if so related, whether the Significant Financial Interest is a Financial Conflict of Interest and take appropriate action to manage any Financial Conflict of Interests and report such FCOI(s) to NIH.
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 Financial Conflict of Interest policy. If you are an Investigator as defined by the regulation under an NIH-supported grant award, then you must disclose your Significant Financial Interests to your Institution in accordance with its Financial Conflict of Interest policy. Please refer to your Institution’s policy (which may integrate network disclosures) and/or consult the appropriate Institutional designated official(s) to verify your Institution’s disclosure requirements and how they apply to your research.
No. The 2011 revised regulation states that income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education is excluded from the definition of Significant Financial Interest. Such income from all other sources is included in the definition of Significant Financial Interest and, accordingly, must be disclosed.
If the Investigator is supported by an NIH grant through the University (i.e., the University is the grantee), the Investigator must disclose the equity interest in the for-profit company to the University if the Significant Financial Interest is related to the Investigator’s institutional responsibilities.
Maybe. The 2011 revised regulation does not require the disclosure of income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles. Please refer to your Institution’s Financial Conflict of Interest policy for disclosure requirements for mutual funds since the Institutional policy may be more restrictive.
Please refer to your Institution’s Financial Conflict of Interest 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.
Maybe. Financial interests are defined as anything of monetary value, whether or not the value is readily ascertainable. Any financial interest that meets the definition of Significant Financial Interest under the regulation must be disclosed. Foreign investments are covered financial interests under the regulation, if the investments satisfy the definition of Significant Financial Interest. The Investigator must disclose Significant Financial Interests (and those of the Investigator’s spouse and dependent children). Disclosure requirements and the documentation needed to determine the value of foreign investments should be defined by the Institution’s Financial Conflict of Interest policy and procedures.
Please refer to your Institution’s Financial Conflict of Interest 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, an Institution might determine that 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 related to his/her institutional responsibilities. The Institution may determine that only new assets purchased with the proceeds from the original assets would be unknown to the Investigator.
It depends. Financial interests are defined as anything of monetary value, whether or not the value is readily ascertainable. Royalties are potentially subject to disclosure, as are other interests related to intellectual property. Royalties from and agreements to share in royalties related to intellectual property rights paid to an Investigator (or his/her spouse or dependent children) are covered by the regulation and are subject to the $5,000 threshold as described in the preamble (page 53265). If the royalties paid to the Investigator (or his/her spouse and dependent children) satisfy the definition of “Significant Financial Interest,” then they must be disclosed. However, if the royalties or agreement to share in royalties relate to intellectual property owned by the employing or appointing applicant or awardee Institution and are licensed or potentially licensed through the applicant or awardee Institution (i.e., they are not personally owned by the Investigator), they are considered remuneration from the Institution and would not be considered a Significant Financial Interest of the Investigator. Royalties received by the Investigator from the Institution would be excluded from the definition of Significant Financial Interest if the Investigator is currently employed or otherwise appointed by the Institution.
Unlicensed intellectual property that does not generate income is also excluded from the definition of Significant Financial Interest. Nonetheless, such interests have the potential to become significant and generate income, at which point they would become subject to the regulation. Disclosure requirements and the documentation needed to verify the value of royalties or agreements to share in royalties should be defined by the Institution’s Financial Conflict of Interest policy and procedures. (See definition of Significant Financial Interest).
Yes. In each case when the regulation refers to exclusions of Institutions of higher education as defined in 20 U.S.C. 1001(a) or a federal, state or local government agency, the reference is made to a United States (U.S.) Institution of higher education or a federal, state or local government agency within the U.S.
It depends. The requirement for an Investigator to disclose his/her significant financial interest (SFI) depends upon if the Investigator, at the subrecipient Institution, is a Public Health Service (PHS)-supported Investigator. If the subrecipient Investigator does not receive PHS funding, the Investigator would not be required to disclose his/her SFI to their Institution (e.g., University) unless it was a requirement of the Institution (e.g., University’s FCOI policy).
On the other hand, if the subrecipient Investigator is a PHS-funded Investigator, he/she must disclose his/her SFI in accordance with the 2011 Revised FCOI regulation.
No. Generally, the annual disclosure requirement will be sufficient to allow the Investigator to disclose updated information regarding any previously disclosed SFI (e.g., the updated value of a previously disclosed equity interest).
Yes.In recognition of the different needs and resources of the diverse Institutions funded by the PHS, the regulation seeks to maximize Institutions’ flexibility and minimize administrative burden by deferring to the Institutions’ FCOI policies to prescribe the details of the Investigator’s disclosure of sponsored or reimbursed travel and the protocol that Institutions should use to review Investigators’ sponsored or reimbursed travel disclosures, as long as such details and protocol are consistent with the regulation. The following are several illustrations of how the Institution may “prescribe the details of disclosure” in its FCOI policy:
a. Institutions may prescribe the timing of disclosures.
The 2011 revised regulation requires that Investigators submit an updated disclosure of SFIs at least annually, as prescribed by the Institution, during the period of award. Annual updated disclosures include any information that was not disclosed initially to the Institution or in a subsequent disclosure of SFIs. An updated SFI disclosure must be made within 30 days of discovering or acquiring the new SFI. However, the rule does not require that each SFI be disclosed individually. Thus, an Institution has flexibility to prescribe the timing of disclosures.
For example, an Institution could require Investigators to disclose their planned or anticipated reimbursed or sponsored travel in a prospective manner (e.g., over the next twelve months) at the time of the annual update of financial disclosures or at another time of the Institution’s choosing, with a requirement to update the details of the travel annually. Once the Investigator has disclosed planned sponsored or reimbursed travel in this manner, the Investigator would have met the regulatory requirement to disclose it and would not have to disclose it again “within 30 days” of the travel (assuming there were no changes to the threshold reporting details of purpose of the trip, identity of the sponsor/organizer, destination, and duration). It should be noted, however, that under such an Institutional policy, an Investigator would continue to be required to disclose a new source of travel (i.e., that was not anticipated and disclosed at the annual reporting) within 30 days, as required by the regulation.
b. Institutions may prescribe the details of review requirements in their FCOI policy.
Institutions are required to determine if Investigators’ reimbursed or sponsored travel constitutes an FCOI; however, Institutions have the discretion to determine which details of the sponsored or reimbursed travel, for example, source of funding, destination, duration of travel, etc., drive further institutional review. We note that the Preamble to the Final Rule states, “…depending on the source of funding and other circumstances (e.g., destination, duration) of specific travel, the Institution may consider whether that sponsored travel could affect the design, conduct, or reporting of PHS-funded research.”
For example, an Institution could determine that Investigator travel to participate in annual meetings of professional societies or Gordon Conferences, while requiring disclosure in accordance with the regulatory requirements, may not require further institutional review to determine if the travel constitutes a FCOI.
c. Institutions may prescribe the details of Investigator disclosure.
Institutions may prescribe the details of the disclosure of sponsored or reimbursed travel that are consistent with the requirements of the 2011 revised regulation. The 2011 revised regulation requires that such disclosure must include the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. Institutions have discretion under the 2011 revised regulation to prescribe what other details, if any, are appropriate to particular travel-related disclosures or categories of disclosures.
For example, Institutions may, within the discretion afforded by the Final Rule, impose the $5,000 de minimis threshold that is required for disclosure of other types of financial interests within the regulatory definition of SFI, Institutions could apply the de minimis threshold when aggregated per entity.
No. Since the payment for services is paid to the Institution, Investigator disclosure is not required. However, if payment for services is paid directly to the Investigator, the remuneration must be disclosed by the Investigator, no matter if the Investigator turns the money over to the Institution or if the money will be used to support the Investigator’s future research activities.
If the Investigator is supported by an NIH grant through a for-profit company (i.e., the for-profit company is the grantee), the Investigator would not need to disclose the equity interest to the for-profit company that is applying for, or that receives, NIH research funding because any ownership interest held by an Investigator in a commercial or for-profit organization is excluded from disclosure.
The answer to this question depends on which entity is applying for or receiving PHS-funded research.
University is the applicant/grantee: If the Investigator is supported by an NIH grant awarded to a University, the Investigator must disclose his/her Significant Financial Interest (SFI) (e.g., ownership interest or equity interest) to the University if the SFI is related to the Investigator’s institutional responsibilities.
For-profit Company is the applicant/grantee: If the Investigator is supported by an NIH grant awarded to a for-profit/commercial organization, the Investigator’s ownership interest in the company is not considered an SFI and is therefore exempt from disclosure.
Note that the Investigator’s disclosure of his/her equity interest in a for-profit/commercial organization is only excluded (i.e., not considered an SFI) in those cases where the for-profit/commercial organization is the Institution that is applying for, or that receives, NIH research funding.
Upon the receipt of income, the Investigator is required to disclose the aggregated value of income received in excess of $5,000 from the entity in the twelve months preceding the disclosure. Because this income is subject to the definition of “Significant Financial Interest,” the following disclosure considerations apply:
(1) Investigators who are planning to participate in PHS-funded research must disclose their SFIs over the previous twelve-month period to their Institution no later than at the time of application for PHS-funded research.
(2) Each Investigator who is participating in PHS-funded research must submit an updated disclosure of SFIs at least annually, in accordance with the specific time period prescribed by the Institution, during the period of award.
(3) Each Investigator who is participating in the PHS-funded research must submit an updated disclosure of SFIs within 30 days of discovering or acquiring a new SFI.
No. Since the nature of SFI and source of SFI is the same, the SFI is not considered “new”. At the time of the annual disclosure, the Investigator must disclose the current aggregated value of the SFIs received over the previous 12 months so that the Institution can determine if any changes to an existing management plan are warranted. Any annual FCOI report would need to provide the status of the existing FCOI and any changes to the management plan resulting from the increase in value. (Also refer to FAQ D.9.)
Yes, at the time of the annual disclosure, the Investigator must disclose the aggregated value of the royalty payments to the Institution because the income received from the same source in the previous year exceeds $5,000 and, therefore, represents a significant financial interest.
Yes. Investigators who are planning to participate in PHS-funded research must disclose their reimbursed or sponsored travel related to their institutional responsibilities over the previous twelve-month period to their Institution no later than at the time of application for PHS-funded research, in accordance with SFI disclosure requirements outlined in the 2011 revised regulation. Investigators must submit an updated disclosure of reimbursed or sponsored travel within 30 days of each occurrence.
Under the 2011 revised regulation, and with the express exceptions noted therein, Investigators must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to the Investigator’s institutional responsibilities as prescribed by the Institution’s Financial Conflict of Interest (FCOI) policy (i.e., specify the details of the disclosure which will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration). The institutional official will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with PHS-funded research.
In recognition of the different needs and resources of the diverse Institutions funded by the PHS, the regulation seeks to maximize Institutions’ flexibility and minimize administrative burden by deferring to the Institutions’ FCOI policies to prescribe the details of the Investigator’s disclosure of sponsored or reimbursed travel and the protocol that Institutions should use to review Investigators’ sponsored or reimbursed travel disclosures, as long as such details and protocol are consistent with the regulation. Please refer to FAQ E.24. for illustrations of how the Institution may “prescribe the details of disclosure” in its FCOI policy.
Yes. Investigators must disclose their significant financial interests (SFIs), including reimbursed or sponsored travel, no later than at the time of application over the previous twelve-month period (initial disclosure), which is also the same disclosure requirement that applies to all other SFIs. The initial disclosure of SFIs over the previous twelve-month period provides baseline information that allows Institutions to take into account whether Investigators have an ongoing financial relationship with an entity providing a payment or reimbursement or whether the payment or reimbursement was limited in duration. Once Investigators have made their initial disclosure, they are required to update their disclosures within 30 days of discovering or acquiring a new SFI and annually during the period of award. Disclosure requirements also apply to reimbursed or sponsored travel received by the Investigator’s spouse and dependent children that is related to the Investigator’s institutional responsibilities.
It depends. If the individual receiving the payment meets the definition of “Investigator” under the regulation, such payment could be considered a significant financial interest and should be disclosed.
Yes. The 2011 revised FCOI regulation states that the Institution's FCOI policy will specify the details of the disclosure of reimbursed or sponsored travel that is not excluded by the regulation.
No, if an up-to-date financial disclosure is on file at the Institution at the time an application is submitted to the NIH, a new financial disclosure is not required unless an Investigator needs to report a change to the SFI data from what was previously disclosed to the Institution. This was highlighted in the Preamble to the final rule which states that Investigators who have not previously disclosed their SFIs to the Institution's designated official(s) must do so no later than the time of application. Institutions may establish a process prior to the submission of an application for Investigators to verify the currency of their SFI data and provide the ability to make changes, when needed, to ensure that an up-to-date financial disclosure is on file at the time of application to promote compliance with the regulation.
How an Institution manages an Investigator’s conflicting financial interest is left to the Institution’s policies and procedures. Examples of conditions or restrictions that might be imposed to manage an Investigator’s Financial Conflict of Interest include, but are not limited to:
Public disclosure of financial conflicts of interests (e.g., when presenting or publishing the research; to staff members working on the project; to the Institution’s Institutional Review Board(s), Institutional Animal Care and Use Committee(s), etc;
For research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants;
Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the Financial Conflict of Interest;
Modification of the research plan;
Change of personnel or personnel responsibilities, or disqualifications of personnel from participation in all or a portion of the research;
Reduction or elimination of the financial interest (e.g., sale of an equity interest); or
Severance of relationships that create financial conflicts
Neither the Financial Conflict of Interest regulation nor the NIH prescribes a specific format for an Institution’s management plan. The regulation defines, however, key elements of the FCOI report and a description of the management plan is one of the key elements of the FCOI report. The regulation requires that the FCOI report contain a description of the key elements of the Institution’s management plan including the following:
(A) The role and principal duties of the conflicted Investigator in the research project;
(B) Conditions of the management plan;
(C) How the management plan is designed to safeguard objectivity in the research project;
(D) Confirmation of the Investigator’s agreement to the management plan;
(E) How the management plan will be monitored to ensure Investigator compliance; and
(F) Other information as needed.
Updated or annual FCOI reports must include the status of the management plan (i.e., whether the financial conflict is still being managed or explain why the financial conflict no longer exists) and a description of any changes to the management plan since the last FCOI report was submitted to the NIH.
Yes. The Institution is required to make its policy on Financial Conflict of Interest publicly available via a publicly accessible Web site. If the Institution does not have any current presence on a publicly accessible Web site (and only in those cases), the Institution shall make its written policy available to any requestor within five business days of a request. If, however, the Institution acquires a presence on a publicly accessible Web site during the time of the PHS award, the requirement to post the information on that Web site will apply within 30 calendar days.
When the Institution posts its Financial Conflict of Interest policy or otherwise makes the policy publicly accessible, it signifies that the Institution applying for or receiving PHS funding from a grant or cooperative agreement that is covered by the 2011 revised regulation is in full compliance with all the regulatory requirements. The Institution must be in compliance with the 2011 revised regulation no later than August 24, 2012.
Prior to the Institution’s expenditure of any funds under a NIH-funded research project, the Institution shall ensure public accessibility, via a publicly accessible Web site or written response within five business days of a request, of information concerning any Significant Financial Interest disclosed to the Institution that meets the following three criteria:
The Significant Financial Interest was disclosed and is still held by the senior/key personnel for the NIH-funded research project identified by the Institution in the grant application, progress report, or any other required report submitted to the NIH;
The Institution determines that the Significant Financial Interest is related to the NIH-funded research; and
The Institution determines that the Significant Financial Interest is a Financial Conflict of Interest.
The information that the Institution makes available via a publicly accessible Web site or written response shall include, at a minimum, the following:
Investigator’s name;
Investigator’s title and role with respect to the research project;
Name of the entity in which the Significant Financial Interest is held;
Nature of the Significant Financial Interest; and
Approximate dollar value of the Significant Financial Interest (dollar ranges are permissible: $0-$4,999; $5,000-$9,999; $10,000-$19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000) or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.
Institutions have inquired about the need to include a contact person’s name or provide a dedicated mailing address or email address where individuals can send in their written request for the information above. Although information beyond what is specified in the regulation is not required by NIH, Institutions may determine that designating a contact in this manner is a helpful step in satisfying their obligation to make the information publicly accessible.
The Institution’s response should be postmarked or dated (if replying by electronic means) within five business days of the receipt of the written request.
If the institution uses a publicly accessible Web site for making the information publicly accessible, the information shall be updated at least annually. In addition, the Institution shall update the Web site within sixty (60) days of the Institution’s receipt or identification of information concerning any additional Significant Financial Interests of the senior/key personnel for the NIH-funded research project that was not previously disclosed, or upon the disclosure of a Significant Financial Interest of senior/key personnel; or upon the disclosure of a Significant Financial Interest of senior/key personnel new to the NIH-funded research, if the Institution determines that the Significant Financial Interest is related to the NIH-funded research and is a Financial Conflict of Interest. The Web site shall note that the information provided is current as of the date listed and is subject to updates, on at least an annual basis and within 60 days of the Institution’s identification of a new Financial Conflict of Interest. If the Institution responds to written requests, the Institution will note in its written response that the information provided is current as of the date of the correspondence and is subject to updates, on at least an annual basis and within 60 days of the Institution’s identification of a new Financial Conflict of Interest, which should be requested subsequently by the requestor.
In all cases it is the prime Institution’s responsibility to make FCOI information publicly accessible. However, when the subrecipient Investigator is required to comply with the subrecipient’s FCOI policy, the subrecipient Institution will also make such information publicly accessible. Therefore, in these situations, the prime Institution may consider including the requirement for the subrecipient Institution to make FCOI information publicly available as part of the written subaward agreement.
For awarded grants and cooperative agreements, Institutions must submit all FCOI reports to the NIH through the electronic Research Administration (eRA) Commons FCOI Module. See NIH Guide for Grants and Contracts, Notice No. NOT-OD-09-072. Refer to the FCOI Module User Guide for additional information.
Until such time as the Institution implements the requirements of the 2011 revised regulation, Institutions must continue to comply with the 1995 regulation and report Investigator FCOIs to the NIH as required in the 1995 regulation.
Once the institution is required to be in full compliance with the regulatory requirements, the additional reporting requirements must be met. Therefore, if the eRA Commons FCOI Module is not updated by the time this occurs, the FCOI report should include an attachment that addresses the minimum elements of the FCOI report as stated below or as provided in 42 CFR 50.605(b)(3).
Initial Reports: Prior to the Institution’s expenditure of any funds under a NIH-funded research project, the Institution must provide to the NIH an FCOI report regarding any Investigator Significant Financial Interest found by the Institution to be a Financial Conflict of Interest in accordance with the regulation. The Institution must also provide an FCOI report whenever an Investigator does not timely disclose a Significant Financial Interest or whenever the Institution, for whatever reason, does not review a disclosed Significant Financial Interest and the Institution then determines that a Financial Conflict of Interest exists.
Submission of Initial FCOI reports during an Ongoing NIH-funded Research Project:
The Institution must submit an FCOI report within sixty (60) days after its determination that an FCOI exists for an Investigator who is newly participating in the project or for an existing Investigator who discloses a new Significant Financial Interest to the Institution during the period of award.
Whenever an Investigator does not disclose timely a previously existing Significant Financial Interest or the Institution fails to review a previously existing Significant Financial Interest during an ongoing NIH-funded project, the Institution’s designated official(s) shall, within sixty (60) days: review the Significant Financial Interest; determine whether it is related to the NIH-funded research; determine whether a Financial Conflict of Interest exists. If so, the Institution must implement, on at least an interim basis, a management plan that shall specify the actions that have been, or will be, taken to manage such Financial Conflict of Interest going forward and submit an FCOI report to the NIH.
In addition to the FCOI report, the Institution must, within 120 days of the Institution’s determination of noncompliance, complete a retrospective review of the Investigator’s research activities and the NIH-funded research project to determine whether any NIH-funded research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct or reporting of such research.
Based on the results of the retrospective review, if appropriate, update the previously submitted FCOI report, specifying the actions that will be taken to manage the Financial Conflict of Interest going forward.
If bias is found, notify the NIH promptly and submit a mitigation report that includes the key elements documented in the retrospective review and a description of the impact of the bias on the research project and the Institution’s plan of action or actions taken to eliminate or mitigate the effects of the bias. Thereafter the Institution will submit FCOI reports annually.
Annual FCOI Report: For any Financial Conflict of Interest previously reported by the Institution, the Institution shall provide an annual FCOI report that addresses the status of the financial interest and any changes to the management plan. Annual FCOI reports shall specify whether the Financial Conflict of Interest is still being managed or explain why the Financial Conflict of Interest no longer exists. Annual FCOI reports must be submitted to the NIH (e.g., through the eRA Commons for grants and cooperative agreements) for the duration of the project period (including extensions with or without funds) at the same time as when the Institution is required to submit the annual progress report (i.e., two months prior to the start date or 45 days prior to the start date of the noncompeting continuation award), including a multi-year funded progress report, or at the time of a project extension with or without funds (see FAQ H.35).
The annual FCOI report is submitted to NIH separately through the eRA Commons FCOI Module. In addition, please note that the annual FCOI report is not to be submitted as part of the annual progress report nor is it a grant closeout requirement.
No.In cases in which the Institution identifies a Financial Conflict of Interest and eliminates it prior to the expenditure of NIH-awarded funds, the Institution shall not submit an FCOI report to the NIH.
Yes. When a conflicting financial interest ceases to exist during the ongoing project period, the Institution should update the status of the Financial Conflict of Interest at the time of the next annual FCOI report submission deadline (i.e., at time of the submission of the annual progress report). The annual FCOI report shall address the status of the Financial Conflict of Interest and any changes to the management plan. The FCOI report shall specify whether the financial conflict is still being managed or include an explanation why the Financial Conflict of Interest no longer exists.
All FCOI reports must include sufficient information to enable the NIH to understand the nature and extent of the Financial Conflict of Interest and to assess the appropriateness of the Institution’s management plan. The regulation provides key elements that must be included in the FCOI report to NIH. These include but are not necessarily limited to the following:
Project number;
PD/PI or Contact PD/PI if a multiple PD/PI model is used;
Name of the Investigator with the Financial Conflict of Interest;
Name of the entity with which the Investigator has a Financial Conflict of Interest;
Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium);
Value of the financial interest (dollar ranges are permissible: $0-$4,999; $5,000- $9,999; $10,000-$19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000), or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value;
A description of how the financial interest relates to the NIH-funded research and why the Institution determined that the financial interest conflicts with such research;
A description of the key elements of the Institution’s management plan, including: (A) Role and principal duties of the conflicted Investigator in the research project; (B) Conditions of the management plan (C) How the management plan is designed to safeguard objectivity in the research project; (D) Confirmation of the Investigator’s agreement to the management plan; (E) How the management plan will be monitored to ensure Investigator compliance; and (F) Other information as needed.
See the “Management” section for the questions for guidance on the minimum requirements for the management plan.
NIH grant and cooperative agreement award recipients should continue to submit FCOI reports using the electronic Research Administration (eRA) Commons FCOI Module. Once the institution is required to be in full compliance with the regulatory requirements, the additional reporting requirements must be met. Therefore, if the eRA Commons FCOI Module is not updated by the time this occurs, the FCOI report should include an attachment that addresses the minimum elements of the FCOI report as stated above and provided in 42 CFR 50.605(b)(3).
Institutions are required to submit to the NIH an annual FCOI report that addresses the status of the Financial Conflict of Interest and any changes to the management plan for the duration of the NIH-funded research project. Annual FCOI reports are required to be submitted (i.e., through the eRA Commons FCOI Module for grants and cooperative agreements) for the duration of the project period (including extensions with or without funds). The annual FCOI report is due at the same time as when the Institution is required to submit the annual progress report (i.e., two months prior to the start date or 45 days prior to the start date of the noncompeting continuation award), including a multi-year funded progress report, or at the time of the extension (e.g., submission of an extension notification in the eRA Commons or submission of a NIH prior approval request, whichever is applicable.) (see FAQ H.35.). Please note that the annual FCOI report is not to be submitted as part of the annual progress report. The annual FCOI report is submitted to NIH separately through the eRA Commons FCOI Module. The Annual Report link will appear 75 days prior to the next type 5 budget period start date or anniversary date for a multi-year funded award. The Annual Report link will not appear if the Original Report is submitted on or after the annual progress report due date within the current budget period. See FAQs H.34 and 35 for Annual Report links applicable to grant extensions and FAQs H.39. and H.40. for Annual Report links applicable to Original Reports submitted on or after the progress report due date.
The disclosure requirements in the regulation speak to “the value of any remuneration received from the entity” in the twelve months preceding the disclosure and “the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000,” must be disclosed to the awardee Institution. Accordingly, the Institution will be required to report to the NIH the cumulative or aggregated value of each Significant Financial Interest that resulted in the determination of a Financial Conflict of Interest. The reported value of the financial interest will include permissible dollar ranges: $0-$4,999; $5,000-$9,999; $10,000-$19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000), or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.
NIH professional and scientific staff will evaluate the information received to determine whether an Institution’s actions are sufficient to manage the identified Financial Conflict of Interest given program’s knowledge about the NIH-funded project. NIH will utilize the information to monitor the Institution’s compliance with the regulation. NIH will follow-up when additional information is needed to complete NIH’s review and/or address specific questions.
Yes. The NIH may inquire at any time before, during, or after award into any Investigator disclosure of financial interests and the Institution’s review (including any retrospective review) of, and response to, such disclosure, regardless of whether the disclosure resulted in the Institution’s determination of a Financial Conflict of Interest, including a requirement to submit, or permit on site review of, all records pertinent to compliance with the regulation.
NIH professional and scientific staff will evaluate the information provided by the Institutions as specified in the regulation, as well as other information that may be requested from an Institution during the review process.
NIH may inquire at any time (i.e., before, during, or after award) into any Investigator disclosure of financial interests and the Institution’s review of, or response to, such disclosure, whether or not the disclosure resulted in the Institution’s determination of a Financial Conflict of Interest. An Institution is required to submit, or permit on site review of, all records pertinent to compliance with the regulation.
If NIH decides that a particular Financial Conflict of Interest will bias the objectivity of the PHS-funded research to such an extent that further corrective action is needed or that the Institution has not managed the Financial Conflict of Interest in accordance with the regulation, NIH may, consistent with the regulations and the NIH Grants Policy Statement (which is a term and condition of all NIH grant awards), determine that imposition of special award conditions under 45 CFR 75.207, or suspension of funding or other enforcement action under 45 CFR 75.371, is necessary until the matter is resolved.
Yes. A “new” FCOI report must be submitted to the NIH through the eRA Commons FCOI Module prior to the expenditure of any funds under a Renewal (Type 2) or Revision (Type 3) award. Annual FCOI reports are submitted at the same time as when the Institution is required to submit the annual progress report, including a multi-year funded progress report, or at the time of project extension (i.e., submission of an extension notification in the eRA Commons or submission of a NIH prior approval request, whichever is applicable [see FAQ H.35.]).
The Institution must submit a new FCOI report if any of the following elements of a previously submitted FCOI report changes:
Project Number
Name of Investigator with the FCOI
Name of the entity
Nature of the Significant Financial Interest
If the value of a reported SFI changes during the year, the Investigator should disclose the change to the Institution in his/her annual disclosure. Changes in the value of an SFI do not constitute a “new” FCOI report. The annual FCOI report will provide the status of the existing FCOI and any changes to the management plan that may result due to the increase in value.
The FCOI report for competing awards must be submitted prior to the expenditure of funds under the Notice of Award. FCOIs identified during the period of award must be submitted to NIH within 60 days of identification.
Although the 2011 revised FCOI regulation will apply to the award, an FCOI report is not required under the one-time FCOI reporting guidance until it is requested by the NIH. Normally the annual FCOI report is due at the same time as when the Institution submits the annual progress report. However, due to the timing of the implementation date, the next annual FCOI report is due at the same time as when the Institution is required to submit the annual progress report for the Fiscal Year 2013 award, if the FCOI still exists.
The FCOI report is not required under the one-time FCOI reporting guidance until requested by NIH staff. The FCOI report will be required at the same time as when the Institution submits the multi-year progress report beginning in Fiscal Year 2013. As an example, if the initial budget period start date for the multi-year funded grant was September 1, 2010, and the award provides three years of funding, the annual FCOI report is due either 45 or 60 days prior to September 1, as appropriate, which is the same time as when the Institution is required to submit the FY 2013 multi-year progress report.
Yes the information provided in these two data fields can be combined into one PDF file that is uploaded to either text box. However, since the FCOI Module requires that both fields be populated, the Institution will need to include narrative in the text box that does not have the uploaded PDF file or text to inform NIH staff that the required information has been combined into one response.
In all cases, when an FCOI report is submitted for the first time under the 2011 revised FCOI regulation, even if it was previously reported under the 1995 regulation, the FCOI report must be submitted as a “new” report so that the details of the identified FCOI are captured in eRA Commons FCOI Module. Therefore, the Institutional official should first choose “Initiate 2011 FCOI Report” and a new screen will appear as “Initiate New Report” in the eRA Commons FCOI Module. FCOI reports submitted each year thereafter will be submitted as an “Annual” FCOI report as provided under 42 CFR 50.605(b)(4) until the end of the current competitive segment or until the Institution reports that the FCOI no longer exists. The Annual FCOI report is an abbreviated report that addresses the status of a previously disclosed financial interest and any changes to the management plan, if applicable.
No. If the FCOI was reported under the 1995 regulation and it no longer exists on a project that has future years, an FCOI report is not required. However, NIH staff may request information on a previously submitted FCOI report. If this is the case, the Institution will provide the information through the eRA Commons as a text or an uploaded PDF document. See the FAQ H.4. for requirements applicable to the same situation when an FCOI is initially submitted under the 2011 revised regulation.
If an FCOI report is submitted in error, send an email to the Grants Manager identified on the latest issued Notice of Award to request that the Institute and/or Center (IC) take action to rescind the FCOI report (or FCOI record). Following the IC’s action, the status of the FCOI record will be marked as “Rescinded,” which will enable the Institution to submit a corrected report, as needed.
Revised FCOI reports are only needed following the completion of a Retrospective Review when the grantee needs to provide:
New FCOI information that results in a change to a previously submitted FCOI report (e.g., an increase in value of a previously reported significant financial interest (SFI), discovery of a new SFI, or changes to the management of the FCOI, etc.); or
A Mitigation Report if bias is found following completion of the Retrospective Review (See FAQ I.3.).
Grantees should not submit a Revised FCOI report to notify NIH that either the Retrospective Review has been completed or that bias is not found.
When the Original Report is submitted and the grantee indicates that the Retrospective Review is not completed, the system will allow the Institution to submit a Revised FCOI report up to 150 days after the Original Report's submission date.
The status of the FCOI report will change from “WIP” to “Submitted.” In addition, an email notification will be sent to the signing official who submitted the FCOI report indicating the receipt of the FCOI report.
The 2011 revised FCOI regulation at 42 CFR 50.605(b)(2) speaks to FCOI reporting stating that for FCOIs identified subsequent to the initial report, the Institution shall, within 60 days, provide an FCOI report and ensure that a management plan is in place. While 42 CFR 50.605(a)(2) speaks to FCOI management stating that for newly disclosed SFIs, the Institution shall within 60 days review the disclosure, determine its relatedness, determine if it is an FCOI, and, if so, implement a management plan. In both circumstances, however, the Institution is required to first identify the FCOI before it can be reported or managed. Therefore, the “clock starts ticking” upon the Institution’s identification of an FCOI.
No. Institutions must provide only the information required by the regulation which includes a description of the key elements of the Institution’s management plan, including and in this format: (A) Role and principal duties of the conflicted Investigator in the research project; (B) Conditions of the management plan; (C) How the management plan is designed to safeguard objectivity in the research project; (D) Confirmation of the Investigator’s agreement to the management plan; (E) How the management plan will be monitored to ensure Investigator compliance; and (F) Other information as needed.
To confirm the Investigator’s agreement to the management plan, the FCOI report may include a statement that a copy of the signed management plan is on file at the Institution or a statement that the Investigator has agreed to and signed the management plan, for example.
The annual FCOI report should be submitted under the current, active grant number since the FCOI Module will not allow for the submission of an FCOI report for a grant year that has not been awarded. For example, if an 05 year award is pending for a February 1 start date, the annual FCOI report should be submitted through the eRA Commons FCOI Module under the current 04 year grant number and at the same time as when the grantee is required to submit the annual progress report (i.e., 45 or 60 days prior to February 1).
The Annual FCOI Report Link for grants that were issued for less than 12 months in the last quarter of FY 12, may not be available in the Commons when the grantee is required to submit the Annual FCOI Report. If this is the case, the Annual Report Link will appear in the Commons after the scheduled eRA Commons release this coming July (scheduled release date is currently on July 19th) to address this problem. Therefore, for these affected grants only, the Annual FCOI Report will be accepted on or before September 30, 2013.
No. While NIH expects Institutions to obtain changes in the value of an SFI as part of the Institution’s annual disclosure requirements, this information is not required for submission as part of the Annual FCOI report. The Annual FCOI report requires Institutions to report on the status of the FCOI and whether there are any changes to the management plan, if applicable, which may or may not occur due to the increase in value of an SFI.
The grantee should report the change in status of the FCOI in the Annual Report. The Annual Report is due at the same time as when the Institution is required to submit the annual progress report, including a multi-year funded progress report, or at the time of the project extension (i.e., submission of an extension notification in the eRA Commons or submission of a NIH prior approval request, whichever is applicable.) (see FAQ H.35.).
No. As noted in Section 60.605(b)(2), for any significant financial interest that the Institution identifies as conflicting subsequent to the Institution’s initial FCOI report “during an ongoing” NIH-funded research project, the institution shall submit an FCOI report to the NIH within sixty days. Although the Institution has up to sixty days to report the identified FCOI to NIH, reports should be submitted during the ongoing project and not after the project period end date.
No. Annual FCOI reports are not required as part of the grant closeout requirements. The last submitted Annual Report will be required prior to the issuance of the last year noncompeting award within the project’s competitive segment unless the grant is extended via the Commons or through the issuance of a revised Notice of Award.
Yes. When an Investigator has multiple FCOIs with different entities, the grantee is required to submit one FCOI report per entity. The eRA Commons FCOI Module is designed to allow the grantee to enter multiple significant financial interests per entity within one FCOI report.
Yes, an Annual Report is required when the grant is extended via the eRA Commons; the Annual Report link will appear the day after the grant is extended. An email communication will alert the FCOI signing official that the grant has been extended and an Annual report is due.
Yes, an Annual Report is required for a grant that is extended by NIH. However, until NIH implements a change to the FCOI module, an Annual Report link will not be available in these cases. Therefore, NIH staff will generally send a request for information through the FCOI module asking the grantee to provide a status of the FCOI and any changes to the management plan, if applicable, prior to the issuance of the revised Notice of Award.
It depends.Corrections to some FCOI reports can be made without NIH taking action to rescind the Original Report which requires the grantee to submit a new report. Depending on the error, these are the options:
Errors in the following data fields can be corrected only by NIH rescinding the Original Report and requiring the grantee to submit a new report:
Grant Number,
Investigator Name with the conflict,
Entity Name, and
Subrecipient information
When these corrections are needed, the FCOI SO should contact the Grants Management Specialist/Officer identified on the latest Notice of Award to ask NIH to rescind the FCOI report.
Errors in the following data fields can be corrected by NIH sending the Institution a “Request for Additional Information,” which allows the grantee to make the correction and submit the corrected FCOI report:
Changes to previously reported significant financial interest data
Responses to the compliance questions (i.e., questions numbered 4, 5 or 6).
When these corrections are needed, the FCOI SO should send an email to the NIH Grants Management Specialist/Officer identified on the Notice of Award to explain the nature of the error and the need to make a correction.
The Annual Report link will appear 75 days prior to the next type 5 budget period or anniversary date for multi-year funded awards unless the Original Report is submitted on or after the progress report due date. See FAQs H.34 and 35 for Annual Report links applicable to grant extensions and FAQs H.39. and H.40. for Annual Report links applicable to Original Reports submitted on or after the progress report due date.
A system generated email notification will be sent to the FCOI SO when the Annual FCOI Report link becomes available in the FCOI Module (see FAQ H.36). In addition, the FCOI Module allows certain Commons users to search for Annual Reports in “Work-in-Progress” status as well as Original Reports with an Annual Report due. Refer to the FCOI User Guide under section “5.5 Searching Existing FCOI Reports (Notifications)” for more information.
Yes. The Annual FCOI Report link will appear the day after the Original FCOI Report is submitted. The Annual FCOI Report is due at the same time as when the current annual progress report is due or at the time of grant extension, whichever is applicable.
No. The next Annual FCOI report will be due at the same time as when the next annual progress report is due in the following fiscal year or at the time of grant extension, whichever is applicable.
If this error message is displayed under these circumstances, it means that the beginning date of the initial budget period of a new or renewal award (competing continuation award) has not begun; thus the grant year is not active. Therefore, the FCOI report must be submitted prior to the expenditure of funds anytime on or after the beginning date of the initial budget period of a new or renewal award.
No. Institutions are encouraged to provide only the information required by the regulation (see the information described in FAQ H.5.). Documents in NIH’s possession, including those submitted with FCOI reports, are subject to the Freedom of Information Act 5 U.S.C. 552.
No. The FCOI report should only include the information that is required by the regulation. Therefore, unless otherwise requested by the NIH Awarding Component, FCOI reports should not include copies of business plans, license agreements, equity agreements or similar documents. Documents in NIH’s possession, including those submitted within an FCOI report, are subject to the Freedom of Information Act 5 U.S.C. 552. Refer to the FAQ H.5 for information that is required for submission in FCOI reports.
It depends. The eRA Commons 4/16/2015 release created some Annual Report links and email notifications to FCOI SOs for grants that may not require an Annual FCOI Report. eRA is working to fix this problem to prevent it from happening in the future. As a result, to ensure proper reporting, before submitting an Annual Report, FCOI SOs should review the competitive segment for that particular FCOI ID number to ensure the competitive segment is still active. Also, please note that Annual FCOI reports should not be submitted for any FCOI report(s) that had been rescinded.
Annual FCOI reports are due for ongoing projects that had a previously reported FCOI under the particular FCOI ID#. Annual reports are due at the same time as when the grantee is required to submit to NIH the annual progress report, multi-year funded progress report, or at the time of grant extension.
If there is a question about whether an Annual Report is due, please contact the eRA Helpdesk at helpdesk@od.nih.gov with a “cc” to the FCOI Compliance inbox at FCOICompliance@mail.nih.gov.
No. The FCOI report should only include the information that is prescribed in the regulation (see 45 CFR 50.605[b][3] and 45 CFR 50.605[b]). Therefore, unless otherwise requested by the NIH Awarding Component, FCOI reports should not include copies of business plans, license agreements, equity agreements or similar documents. Documents in NIH’s possession, including those submitted within an FCOI report, are subject to the Freedom of Information Act 5 U.S.C. 552.
The recipient should report the FCOI report to the NIH after NIH issues the Notice of Award and prior to the recipient’s expenditure of funds under the type 7 award. If an FCOI is identified during the period of award, the recipient should submit the FCOI report to NIH within 60 days of identifying the conflict or at the time of grant extension, whichever is applicable.
The prime institution should submit an Annual FCOI Report, when due, to change the status of the FCOI from “Managed” to “No longer exists” with an explanation. This action will end the FCOI reporting requirements under the originally submitted FCOI report and/or FCOI ID number. If an FCOI is identified by the subrecipient institution, assuming that the subrecipient Investigator will be subject to the subrecipient institution's FCOI policy, the prime institution will initiate and submit a new (subrecipient) FCOI report in the eRA Commons FCOI Module.
When an FCOI is identified upon the issuance of a Notice of Award, the Original FCOI Report must be submitted prior to the expenditure of NIH funds. The FCOI Module will allow the submission of the FCOI report on or after the budget period start date. Therefore, if the Federal Award date precedes the budget period start date, the FCOI Signing Official must wait until the budget period begins to submit the report. It may be helpful to refer to FAQ B.8. regarding the recipient's ability to incur preaward costs prior to submitting the FCOI report to the NIH.
Whenever a Financial Conflict of Interest is not identified or managed in a timely manner, including:
Failure by the Investigator to disclose a Significant Financial Interest that is determined by the Institution to constitute a Financial Conflict of Interest;
Failure by the Institution to review or manage such a Financial Conflict of Interest; or
Failure by the Investigator to comply with a Financial Conflict of Interest management plan;
the Institution shall, within 120 days of the Institution’s determination of noncompliance, complete a “retrospective review” of the Investigator’s activities and the NIH-funded research project to determine whether any NIH-funded research, or portion thereof, conducted during the time period of the noncompliance was biased in the design, conduct, or reporting of such research.
The Institution shall document the retrospective review which must include at least the following key elements:
Project number;
Project title;
PD/PI or contact PD/PI if a multiple PD/PI model is used;
Name of the Investigator with the FCOI;
Name of the entity with which the Investigator has a financial conflict of interest
Reason(s) for the retrospective review;
Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed, etc.);
If bias is found, the Institution must notify NIH promptly and submit a mitigation report. If the FCOI was previously reported to the NIH, the mitigation report is submitted as a “Revised FCOI Report.” (see FAQ H.2.). The mitigation report must include, at a minimum, the key elements documented in the retrospective review above and a description of the impact of the bias on the research project and the Institution’s plan of action or actions taken to eliminate or mitigate the effect of the bias (i.e., impact on the research project, extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable). Thereafter, the Institution will submit FCOI reports annually as prescribed by the regulation.
No. When bias is not found following the completion of a Retrospective Review, the grantee should not submit a “Revised” FCOI report to notify NIH that either the Retrospective Review has been completed or that bias is not found. See FAQ H.22. for more information about when it is appropriate to submit a “Revised” FCOI report following the completion of a Retrospective Review.
The revised 2011 regulation does not apply to Phase I SBIR/STTR applications but the revised 2011 regulation does apply to Phase II SBIR/STTR applications/awards.
As defined in Section 50.603 Definitions, a “Significant Financial Interest” does not include “….any ownership interest in the [applicant or awardee] Institution held by the Investigator, if the Institution is a commercial or for-profit organization;…”. Therefore, the Investigator's equity interest is excluded from the disclosure requirement when the for-profit company is the Institution that is applying for, or that receives, the PHS research funding in which the Investigator is participating. (The 1995 regulation had a similar exclusion: “…Any ownership interests in the institution, if the institution is an applicant under the SBIR Program….”.)
As stated above, the regulation does not apply to applications and awards supported under the SBIR/STTR Phase I program and therefore would not be passed through to a subrecipient. Therefore, a University, for example, that is a subawardee under a Phase I SBIR/STTR award, is not required to make an FCOI determination as it relates to the subaward under the Phase I SBIR/STTR award.
The awardee Institution is responsible for ensuring any subrecipient’s compliance with the regulation and reporting identified financial conflicts of interests for subrecipient Investigators to the NIH. Awardee institutions must incorporate as part of a written agreement with a subrecipient terms that establish whether the Financial Conflict of Interest policy of the awardee Institution or that of the subrecipient will apply to subrecipient Investigators and include time periods to meet disclosure and/or Financial Conflict of Interest reporting requirements.
Subrecipient Institutions who rely on their Financial Conflict of Interest policy must report identified financial conflicts of interests to the awardee Institution in sufficient time to allow the awardee Institution to report the Financial Conflict of Interest to the NIH to meet its reporting obligations.
Subrecipient institutions that must comply with the awardee Institution’s policy must submit all Investigator disclosures of Significant Financial Interests to the awardee in sufficient time to allow the awardee to review, manage and report identified FCOIs to the NIH.
Awardee Institutions are responsible for monitoring subrecipient’s compliance with the Financial Conflict of Interest regulation, management plans, and for reporting all identified financial conflicts of interest to the NIH.
Yes. Each Investigator (as defined by the regulation), including subrecipient Investigator(s), must complete training prior to engaging in NIH-funded research and at least every four years, and immediately under the designated circumstances:
Institutional Financial Conflict of Interest policies change in a manner that affects Investigator requirements
An Investigator is new to an Institution
An Institution finds that an Investigator is not in compliance with the Institution’s Financial Conflict of Interest policy or management plan.
Institutions may utilize resources available on NIH’s Office of Extramural Research Financial Conflict of Interest Web page found at http://grants.nih.gov/grants/policy/coi/ to satisfy some of the training requirements. However, Institutions must also provide additional training regarding Investigator’s responsibilities for disclosure of Significant Financial Interests and of the Institution’s specific policy on financial conflicts of interests.
Institutions are expected to develop and implement their Financial Conflict of Interest policies during the 365-day implementation period provided in the 2011 revised regulation. Once the Institution implements and posts their Financial Conflict of Interest policy as required under the Final Rule, Investigators are expected to then complete required training prior to engaging in NIH-supported research or by the issue date of the Notice of Award issued subsequent to the Institution’s implementation date.
Yes. The implementation date can precede the date when all Investigators have been trained. If the implementation date falls on the 365th day (i.e., August 24, 2012), it is expected that all Investigators who are supported by the NIH will complete their training obligations prior to engaging in NIH-supported research or by the issue date of the Notice of Award issued subsequent to the Institution’s implementation date.
NIH expects Institutions to define “immediately” in the Institution’s Financial Conflict of Interest policy, which would establish a reasonable timeframe when Investigators must complete training under the prescribed circumstances. Although the regulation does not define a precise timeline, the expectation is that Institutions will make it a priority to ensure Investigators understand and comply with the requirements of the regulation and the Institution’s Financial Conflict of Interest policy, which reinforces the need for training to be handled expeditiously.
