SALK INSTITUTE FOR BIOLOGICAL STUDIES
Investigator Conflict of Interest Policy
TABLE OF CONTENTS
Section 1- Applicability: Who Must Comply with the Investigator Conflict of Interest Policy
Section 2- Definitions
Section 3- Purpose of the Investigator Conflict of Interest Policy
Section 4- Mandated Conflict of Interest Training for All Investigators
Section 5- What Constitutes a Significant Financial Interest••••

Publicly Traded Entity
Non-publicly Traded Entity
Intellectual Property Rights
Reimbursed or Sponsored Travel

Section 6-

Submitting and Updating Annual Disclosure Forms

Section 7-

Annual Disclosure Form Review by the Conflict of Interest Committee

Section 8-

Reducing or Eliminating the Financial Conflict of Interest

Section 9-

Reporting the Financial Conflict of Interest to the Funding Agency

Section 10- What Financial Conflict of Interest Information is Submitted to the Funding Agency
Section 11- Public Accessibility of the Institute’s Investigator Conflict of Interest Policy and Identified
Financial Conflict of Interests
Section 12- Continued Monitoring of the Financial Conflict of Interest and the Institute Compliance
Section 13- What Happens After the Financial Conflict of Interest is Reported to the Federal Agency
Section 14- Non-compliance and Enforcement
Section 15- Project Certification Form Submission
Section 16- Subrecipient Conflict of Interest Compliance
Section 17- Additional Resources
1.

APPLICABILITY: WHO MUST COMPLY WITH THE INVESTIGATOR CONFLICT OF INTEREST POLICYThis Investigator Conflict of Interest Policy (COI Policy) policy applies to all individuals who fit thedefinition of Investigator in Section 2 below, including, without limitation, faculty, post-doctoral fellows, andnon-faculty staff scientists, as well as individuals identified by the Institute as senior/key personnel in a grantapplication, progress report or any other report submitted to a federal funding agency. Subrecipients,
collaborators, visiting researchers consortium members, consultants or subcontractors may also be subject tothis policy if they are responsible for the design, conduct or reporting of Federally Funded Research or
Research that is proposed for federal funding.
2.

DEFINITIONS
1.

Conflict of Interest Committee (COI Committee) is an administrative committee comprised ofmembers of the administration and, in some cases, members of the faculty and/or others, that will
review Investigator disclosures of Significant Financial Interests (SFIs), determine whether aFinancial Conflict of Interest (FCOI) exists, and, if so, develop a Management plan for the-1-

Investigator to manage, reduce or eliminate the FCOI.
2.

Financial Conflict of Interest (FCOI) will be deemed to exist when the Institute’s COI
Committee reasonably determines that a Significant Financial Interest disclosed by theInvestigator could directly and significantly affect the design, conduct or reporting of Federally
Funded Research, with the exception of Research funded through Phase I support under the
Small Business Innovation Research (SBIR) and Small Business Technology Transfer (SBTT)
programs. Note: Phase II SBIR and STTR programs are not exempt like Phase I and are subject
to this policy.

3.

Federally Funded Research means any Research funded by a Public Health Service (PHS)awarding component, such as the National Institute of Health (NIH), National Science
Foundation (NSF), Department of Defense (DOD), Department of Energy (DOE) or other U.S.
federal agency.

4.

Investigator refers to the principal investigator or project director, and any other person,
regardless of title or position, who is responsible for the design, conduct or reporting of Federally
Funded Research or Research that is proposed for federal funding. Investigators include faculty,
post-doctoral fellows, graduate students, non-faculty scientific staff above the level of research
assistant, individuals identified by the Institute as senior/key personnel in a grant application,
progress report or any other report submitted to a federal funding agency, and also may include
Subrecipients, collaborators, visiting researchers consortium members, consultants or
subcontractors.

5.

Investigator’s Institutional Responsibilities means professional activities taking place on behalfof the Institute including, but not limited to, Research, Research consultation, teaching,institutional committee memberships and service on committees or panels such as Institutional
Review Boards or other monitoring boards.

6.

Management of an FCOI means taking action to address the FCOI, including by reducing or
eliminating the conflict so that the Institute can reasonably expect that the Investigator’s design,
conduct and reporting of Research will be free from bias.

7.

Management Plan is a written document approved by the COI Committee under which an
Investigator with an identified FCOI must take steps and follow guidelines, conditions and/or
restrictions to reduce or eliminate the conflict.

8.

Research means a systematic investigation designed to develop or contribute to generalizableknowledge relating broadly to public health or agriculture, and encompasses basic and applied
Research. Research includes any activity for which research funding is available regardless ofthe source, such as:

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Research grant
Career development award
Center grantIndividual fellowship award

9.

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Infrastructure award
Institutional training grant
Program project
Research resources award

Significant Financial Interest (SFI) means anything of monetary value that was received from anentity in the twelve (12) months preceding the disclosure, whether or not the value is readily
ascertainable, belonging to the Investigator, his or her spouse, and/or his or her dependent children,
alone or in combination, that reasonably appears to be related to the Investigator’s Institutional
Responsibilities.
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3.

10.

Small Business Innovation Research (SBIR) is an award designed to support projects from small
businesses having commercial viability.

11.

Small Business Technology Transfer (SBTT) is a program under the SBIR program designed tofoster technology innovation through cooperative efforts between small businesses and research
institutions.

12.

Subrecipient refers to an individual or entity that receives federal funds from or through the Institute,as an awardee institution, where the subrecipient will be conducting a substantive portion of theFederally Funded Research and who will be accountable to the awardee institution for, e.g.,
programmatic outcomes and compliance matters.

PURPOSE OF THE INVESTIGATOR CONFLICT OF INTEREST POLICYThe COI Policy implements and ensures compliance with the specific federal requirements set forth in the
United States Department of Health and Human Services’ 2011 Objectivity in Research Regulations (COI
Regulations), 42 CFR part 50 subpart F (grants) and 42 CFR part 94 (contracts). The COI Regulations establish
new standards and clarify previously established standards to be followed by institutions that apply for or receive
Research funding from the United States Public Health Service (PHS) Awarding Components, including the
National Institutes of Health (NIH), for grants, cooperative agreements, and research contracts.
Interactions between research institutions, government, the private sector, and industry help ensure therapid application of scientific discoveries and the efficient translation of Research findings. Although suchinteractions are encouraged in many forms, they have become increasingly complex and can lead to relationships
involving a Significant Financial Interest (SFI). A Financial Conflict of Interest (FCOI) exists when the Salk
Institute for Biological Studies (the Institute), through procedures described in this COI Policy, reasonably
determines that the Investigator’s SFI could affect the design, conduct or reporting of the Investigator’s Research.
An FCOI may arise even though no improper conduct or unethical behavior has occurred.
The Institute has the responsibility under the COI Regulations to manage Financial Conflicts of Interest
between an Investigator’s (and his/her spouse’s and dependent children’s) personal financial interests and his/her
Institutional Responsibilities. The Institute and its Investigators must identify, and then manage, reduce or
eliminate, FCOIs to strengthen accountability and transparency, promote Research objectivity, maintain the
integrity of Research findings, and ensure prudent stewardship of public funds.
Where more stringent requirements and regulations relating to conflict of interest of any funding agency orsponsor conflict with the Institute’s COI Policy, the requirements and regulations of that funding agency or sponsor
will take precedence.
4.

MANDATED CONFLICT OF INTEREST TRAINING FOR ALL INVESTIGATORSAll Investigators must be informed of the Institute’s COI Policy as well as their disclosure responsibilities
and other requirements of the COI Regulations. The COI Regulations require all Institute Investigators to complete
a COI training tutorial prior to engaging in Federally Funded Research and at least every four years thereafter. In
addition, training is required immediately under the following circumstances:
1.

The Institute’s COI Policy changes in a manner that affects Investigator requirements;

2.

An Investigator is a new Institute employee; and3.

An Investigator is non-compliant with the Institute’s COI Policy or management plan.

The Institute’s training program will be available on-line, on the Institute intranet. Each Investigator mustcertify his/her completion after each training session.
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5.

WHAT CONSTITUTES A SIGNIFICANT FINANCIAL INTEREST

An SFI is a financial interest consisting of one or more of the following interests of the Investigator (andthose of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’sInstitutional Responsibilities:
1.

With regard to any publicly traded entity, a SFI exists if the value of any remuneration received
from the entity in the twelve (12) 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.
• Remuneration includes salary and any payment for services not otherwise identified assalary such as consulting fees, honoraria and paid authorship.
• Equity interests include stocks, stock options, or other ownership interests, as determinedthrough reference to public prices or other reasonable measures of fair market value.

2.

With regard to any non-publicly traded entity, a SFI exists if the value of any remuneration
received from the entity in the twelve (12) 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.
• Equity interests include stocks, stock options, or other ownership interests including any
equity in a non-publically traded company.
• The Investigator must fully describe the nature of the equity interest including the numberof shares owned, voting rights, etc. if at the time of disclosure there is no reasonable basis
for assessing the fair market value or percentage interest in the non-publicly traded entity.

3.

Remuneration from intellectual property rights such as patents, copyrights and royalties fromsuch rights and agreements to share royalties related to intellectual property rights and interests, notreceived from the Institute.

4.

Travel. Investigators must disclose the occurrence of any reimbursed or sponsored travel (i.e.,
travel that is paid on behalf of the Investigator and not reimbursed to the Investigator so the exact
monetary value may not be readily ascertainable) that is related to their Institutional
Responsibilities and reimbursed or sponsored by any entity other than the Institute or a federal,state, or local government agency, an institution of higher education, an academic teaching
hospital, a medical center, or another research institute that is affiliated with an institution of higher
education including the Institute. The disclosure must include the following details:··

The purpose of the trip
The identity of the sponsor/organizer··

The destination of the trip
The time duration of the trip

The Institute will then determine if any travel requires further investigation, including
determination or disclosure of the monetary value in order to determine whether the travel
constitutes a FCOI.
An SFI does not include the following types of financial interests:
1.

Salary, royalties, or other remuneration received from the Institute if the Investigator is currently
employed or appointed by the Institute.

2.

Income from seminars, lectures, or teaching engagements sponsored by a federal, state or local
government agency, an institution of higher education, an academic teaching hospital, a medical
center or a research institute that is affiliated with an institution of higher education.

3.

Income from service on advisory committees or review panels for a federal, state or local
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government agency, an institution of higher education, an academic teaching hospital, a medical
center or a research institute that is affiliated with an institution of higher education.
4.

Travel expenses that are reimbursed or sponsored by the Institute or a federal, state or local
government agency, an Institution of higher education, an academic teaching hospital, a medical
center or another research institute that is affiliated with an institution of higher education.

5.

An equity interest that when aggregated for the Investigator and the immediate family, meets boththe following tests:• Does not exceed $5,000 in value as determined through reference to public prices or otherreasonable measures of fair market value.
• Does not represent more than a five (5) percent ownership interest in any single entity.

6.

Salary, royalties or other payments that when aggregated for the Investigator and the immediatefamily over the next twelve (12) months are not expected to exceed $5,000.

7.

Intellectual property rights assigned to the Institute and unlicensed intellectual property
that does not generate income.

8.

Agreements with the Institute to share in royalties related to such rights.

9.

Income from investment vehicles, such as mutual funds and retirement accounts, as long as theInvestigator does not directly control the investment decisions made in these vehicles.

Many scientific journals have implemented policies that require authors to declare competing financial
interests in relation to work published in those journals. Such requirements of third parties, including how financial
interests are defined, are distinct from the requirements in this policy relating to Federally Funded Research andshould not be used as guidance for the information an Investigator must disclose under this policy.
6.

SUBMITTING AND UPDATING ANNUAL DISCLOSURE FORMS

All individuals who fit the definition of Investigator in Section 2 above must submit an Annual Disclosure
Form at the beginning of their time at the Institute and each subsequent year thereafter. All Investigators are
required to complete a current, accurate Annual Disclosure Form that identifies and describes both existing and new
SFIs. Annual Disclosure Form must be submitted by way of a portal located on the Institute’s intranet by the yearly
December 1 deadline. In addition, Investigators have an ongoing obligation to promptly update their Annual
Disclosure Forms to accurately reflect any significant change in their external activities, SFIs, and internal
responsibilities as follows:
1.
2.
3.

No later than at the time of application for federally funded Research;Within thirty (30) days of discovering or acquiring a new SFI (including through purchase,marriage, or inheritance); andAt least annually in accordance with the December 1 deadline.

The Institute (i) may not submit any new grant applications to a federal agency for Research projects,and (ii) may not spend any federal funds in connection with Notices of Award for new or continuing
Federally Funded Research projects, until all Investigators identified to work on such projects havecompleted the training and submitted their disclosures as required by the COI Regulations and this policy.
7.

ANNUAL DISCLOSURE FORM REVIEW BY THE CONFLICT OF INTEREST COMMITTEEThe Institute’s COI Coordinator will initially review the Annual Disclosure Forms and may request further
information or clarification about an SFI. Prior to the expenditure of any Federal Funds, the COI Coordinator will
review all disclosures of SFIs and make a preliminary determination whether any SFI appears to relate to the
Research. If so, the matter will be immediately referred to the COI Committee for further review. The COI
Committee, will be comprised of approximately 3 or 4 Institute administrators, the faculty chair, and may include
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additional Institute faculty. One member of the Institute’s Office of Technology Development will serve on the
COI Committee. One member of the Institute’s Grants Administration or Research Development department willserve on the COI Committee. One member of the COI Committee will be an Institute Vice President. The
Institute’s General Counsel may serve on the COI Committee as a non-voting member whose role is to provide
legal advice to the Committee.
The administrative members of the COI Committee will initially review all disclosed SFIs to determine
whether any are related to the Investigator’s Research and, if so, whether the SFI may be an FCOI. The Committee
reviews and analyzes the specific circumstances of an SFI by taking into account such factors as the nature of theInvestigator’s relationship to an outside entity, the dollar value of that relationship, and the degree and nature of any
overlap between that relationship and the Investigator’s Research. The administrative members of the COI
Committee may, if warranted, involve the faculty chair, the Investigator, and/or other faculty members or advisors
in determining whether an SFI is related to the Research in question. An FCOI will be deemed to exist when thefull COI Committee reasonably determines that an SFI disclosed by an Investigator could directly and significantly
affect the design, conduct or reporting of the Investigator’s Research.
The steps set forth in this Section7 must be completed promptly following disclosure of an SFI in order toenable any FCOIs to be reported to the federal funding agency within the sixty (60) day deadline set forth in the
COI Regulations and Section 10 of this policy.
Where a documented SFI is deemed by the COI Committee not to constitute a current FCOI, the COI
Committee nevertheless may decide to manage the SFI and may institute guidelines for the Investigator to follow as
an interim measure.
8.

MANAGING, REDUCING OR ELIMINATING A FINANCIAL CONFLICT OF INTEREST

If an SFI is identified by the COI Committee as an FCOI, the COI Committee will develop a Management
Plan to manage, reduce or eliminate the conflict. The Management Plan will be set forth in a written document andmay require the Investigator to take certain steps and follow guidelines approved by the COI Committee.
Conditions or restrictions that might be imposed to manage the FCOI include, but are not limited to, the following:
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Disclosure of the FCOI to lab personnel and collaborators
Disclosure of the FCOI in publications, journals, and posters, etc.
Disclosure of the FCOI to audiences at conferences and seminars
Monitoring of Research, proposals and data by independent peer reviewers
Modification of the Research plan
Removal of an affected Investigator from participation in all or the portion of the Researchwhich is funded by the entity that would be affected by a SFI
Divestiture of an SFI by the affected Investigator
Limiting the dollar value of fees received and/or stock ownership
Severing of the relationship(s) that created the conflict

As appropriate, the COI Committee may meet with the Investigator and/or appoint an Institute official tomeet with the Investigator during the design and development of a Management Plan that will include mechanisms
appropriate for the specific situation. The COI Committee may, as necessary, query other Institute committees
and/or personnel to solicit alternate ideas for Management of the conflict.
A copy of the Management Plan will be sent by the COI Coordinator to the Investigator and to theInstitute’s President, who will have final authority to determine whether an FCOI exists and the appropriate plan for
managing the FCOI. The Investigator may appeal the COI Committee’s proposed Management Plan, or thefindings on which the plan is based, to the President within ten (10) calendar days of the date of the plan. The
President and/or the COI Committee may consult with members of the Institute Board of Trustees as needed6regarding the FCOI and its Management. After the Management Plan and its implementation schedule have been
finalized, the COI Coordinator will forward the final version to the Investigator. The Investigator will then review
and sign the plan to acknowledge his or her commitment to compliance.
9.

10.

REPORTING THE FINANCIAL CONFLICT OF INTEREST TO THE FUNDING AGENCY
1.

With regard to a new Federally Funded Research award, the COI Coordinator will disclose
through the eRA Commons FCOI Module required information about the identified FCOI before theInstitute spends any awarded funds. If the FCOI is eliminated prior to spending any funds, then no
FCOI report is required. In addition, the Institute may be required to submit an FCOI report for
FCOIs identified for subrecipient investigators, if applicable under Section 16 of this policy.

2.

With regard to an ongoing Federally Funded Research award, the COI Coordinator will disclose
through the eRA Commons FCOI Module information about the identified FCOI within sixty (60)days of the identification of the FCOI. For any SFI that is identified as an FCOI subsequent to theInstitute’s initial FCOI report during an ongoing Federally Funded Research project, the Instituteshall implement, within sixty (60) days, on at least an interim basis, a Management Plan that shallspecify the actions that have been and will be taken to manage the FCOI.

3.

With regard to a period of non-compliance during an ongoing Federally Funded Research
project, the Institute will within sixty (60) days of the Investigator’s delayed disclosure of an SFI,
determine if the SFI constitutes an FCOI. If the FCOI exists, the Institute will implement, on at leastan interim basis, a Management Plan that shall specify the actions that have been and/or will be taken
to reduce or eliminate the FCOI, and the COI Coordinator will submit the FCOI report through theeRA Commons FCOI Module. In addition to the FCOI report, the Institute will, within one-hundred
twenty (120) days of its determination of non-compliance, complete a retrospective review of theInvestigator’s activities, and the Research project to determine whether part or all of the Research
conducted during the period of non-compliance was biased in the design, conduct or reporting ofsuch Research. Based on the results of the retrospective review, if appropriate, the COI Coordinator
will update the previously submitted FCOI report, specifying the actions that will be taken to reduceor eliminate the FCOI.

4.

With regard to a new, non-federal award entity, the Institute may, if warranted, disclose to such
entity (e.g., corporation, educational institution, nonprofit entity, private foundation, trust or
individual donor) information about an identified FCOI before dispersing or spending any funds
and/or during the duration of the award.

5.

Annual FCOI follow-up reports will be provided by the COI Coordinator to the funding agency for
any FCOI previously reported by the Institute. The annual FCOI report will specify whether the
FCOI is still being managed, describe any changes to the Management Plan or explain why the FCOI
no longer exists. The Institute will provide annual FCOI reports to the funding agency for theduration of the project period, including extensions with or without funds, at the same time as theInstitute’s Grants Administration department submits the annual progress report or at the time of
project extension.

WHAT INFORMATION ABOUT AN IDENTIFIED FINANCIAL CONFLICT OF INTEREST IS SUBMITTED TO
THE FUNDING AGENCY
Information submitted to a federal funding agency about the identified FCOI shall include the following:··

Grant/contract number
Name of the principal investigator or project director
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Name of the Investigator with the FCOIThe name of the entity with which the Investigator has a FCOIStatement about whether the FCOI was managed, reduced or eliminated
The nature of the FCOI, i.e. equity, consulting fees, travel reimbursement,
honoraria
The value of the financial interest; $0-$4,999, $5,000-$9,999, $10,000-$19,000;
amounts between $20,000-$100,00 by increments of $20,000;
amounts above $100,000 by increments of $50,000
or a statement that a value cannot be readily determined through reference to public prices orreasonable measures of fair market value·
A description about how the FCOI relates to the Research and the basis for the Institute’s
determination that a SFI conflicts with such Research
A description of the key elements of the Institute’s Management Plan must also be submitted to thefunding agency including the following information:

11.

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•
•

Role and principal duties of the conflicted Investigator in the Research project
Conditions of the management plan
How the management plan is designed to safeguard objectivity in the Research project
Confirmation of the Investigator’s agreement to the management plan••

How the management plan will be monitored to facilitate Investigator compliance
Other information as needed

PUBLIC ACCESSIBILITY TO THE INSTITUTE’S INVESTIGATOR CONFLICT OF INTEREST POLICY AND
IDENTIFIED FINANCIAL CONFLICT OF INTERESTSThe Institute’s COI Policy will be publically accessible on its web site (www.salk.edu). In addition, incompliance with the COI Regulations, the Institute will make the following information about identified FCOIs
available by written response within five (5) days of a request:
•
•
•
•
•

The name of the Investigator
The title and role of the Investigator with respect to the Research project
Name of the entity in which the SFI is held
The nature of the SFI
Approximate value of the SFI as determined by dollar range from $0--$4,999;$5,000-$9,999; $10,000-$19,000;
amounts between $20,000-$100,00, by increments of $20,000;
amounts above $100,000, by increments of $50,000; ora statement that a value cannot be readily determined through reference to public prices orreasonable measures of fair market value

12. CONTINUED MONITORING OF THE FINANCIAL CONFLICT OF INTEREST AND THE INSTITUTE COMPLIANCE
The Institute will monitor the FCOI and Investigator compliance with the FCOI Management Plan until thecompletion of the Research project. As necessary, the COI Committee may require and develop a project specificmonitoring process, which may include appointing an Institute designated official to assist with monitoring the
FCOI and Investigator compliance. The COI Committee may modify an Investigator’s Management Plan at any
time.
813. WHAT HAPPENS AFTER THE FCOI IS REPORTED TO THE FEDERAL AGENCY
The federal agency will evaluate the FCOI information received through the eRA Commons FCOI Module
to determine if the Institute’s actions are sufficient to reduce or eliminate the identified FCOI. The federal agency
may request and review additional information before implementing, if needed, further corrective actions to ensure
research objectivity. If the federal agency decides that the particular FCOI will bias the objectivity of the funded
Research to such an extent that further corrective action is needed or that the Institute has not managed the FCOI in
accordance with the regulation, it may impose special award conditions, suspend funding or enforce other actions
until the matter is sufficiently resolved.
14. NON-COMPLIANCE AND ENFORCEMENTThe Institute is required to establish adequate enforcement mechanisms and provide for employee sanctions
and/or other administrative action, where appropriate, to address any failure by an Investigator to comply with the
COI Policy or a Management Plan. Violations of this policy may result in progressive disciplinary action.
An Investigator is non-compliant and in violation of the COI Policy if an Investigator fails to:1.

submit an Annual Disclosure Form or provide an update to the Annual Disclosure Form by thedeadlines established for such submissions;

2.

provide the COI Coordinator with written acknowledgement of a Management Plan; or3.

provide the COI Coordinator and/or COI Committee with requested documentation regarding
compliance with a Management Plan.

If an Investigator fails to comply with the Institute’s COI Policy or Management Plan, the Institute mustcomplete within one-hundred twenty (120) days of determining non-compliance a retrospective review of theInvestigator’s activities and Research projects, document the Institute’s determination as to whether the Federally
Funded Research or any portion thereof conducted prior to the identification and management of the FCOI wasbiased in the design, conduct or reporting of such Research.
If bias is found, the Institute must submit a mitigation report addressing the impact of the bias on the
Research project including the extent of the harm done, and any qualitative and quantitative date to support any
actual or future harm, analysis of whether the project is salvageable and the actions the Institute has taken, or will
take, to eliminate or mitigate the effect of the bias. Depending on the nature of the FCOI, the Institute may
determine that additional interim measures are necessary with regard to the Investigator’s participation in the
Research project between the date the FCOI is identified and the completion of the Institute’s retrospective review.
15.

PROJECT SPECIFIC CERTIFICATION FORM REQUIREDEach principal investigator or project director involved with a federal funding submission must submit a
COI Project Specific Certification Form to the Grants Administration department upon receipt of any Notice ofAward on a new or continuing project. The Project Specific Certification Form lists all anticipated Institute lab
personnel who are responsible for the design, conduct, or reporting of the proposed Research (Investigators) andcertifies that such Investigators are compliant with this policy. Information needed to complete the Project SpecificCertification Form includes:
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Name of the principal investigator
Application deadline
Funding opportunity announcement number
Funding entity or agency
Project title
Names of personnel, who will design, conduct or report on any of the proposed Research,
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including but not limited to non-Institute Investigators such as collaborators, sub-recipients,
contractors or subcontractors proposed to receive funding on the application
The Grants Administration department monitors the status of all grant submissions. Upon receipt of a
$5,000 or more award notice, the Project Specific Certification Form must be completed and submitted in order forthe award to be processed.
16.

SUBRECIPIENT CONFLICT OF INTEREST COMPLIANCE

If the Institute carries out Research through a subrecipient, the Institute, as the awardee institution, will takereasonable steps to ensure that any subrecipient Investigator complies with the federal FCOI regulations. The
Institute will incorporate as part of a written agreement with the subrecipient, terms that establish whether the FCOI
policy of the Institute or that of the subrecipient will apply to the subrecipient Investigators.
If the subrecipient’s FCOI policy applies to subrecipient Investigators, the subrecipient will certify as partof the agreement that they are in compliance with federal regulations and that their portion of the project is incompliance with their institutional policies on conflict of interest. If the subrecipient cannot provide thecertification, the agreement shall state that the subrecipient Investigators are subject to the Institute’s COI Policy fordisclosing SFIs that are directly related to the subrecipient’s work for the Institute. The Institute will, if applicable,
submit an FCOI report through the eRA Commons FCOI Module for any FCOIs identified for subrecipient
Investigators.
If the subrecipient’s COI policy applies to subrecipient Investigators, the agreement shall specify the time
period(s) for the subrecipeient to report all identified FCOIs to the Institute. Such time period(s) must be sufficient
to enable the Institute to provide timely FCOI reports, as necessary, through the eRA Commons FCOI Module.
If the institute’s FCOI policy applies to subrecipient Investigators, the agreement shall specify time periods
for the subrecipeient to submit all Investigator disclosures of SFIs to the Institute. Such time periods shall be
sufficient to enable the Institute to comply with its review, Management, and reporting obligations under the COI
Regulations. The Institute’s Grants Administration department will submit any FCOI reports for subrecipeint
Investigators through the eRA Commons FCOI Module.
17.

ADDITIONAL RESOURCES

NIH/HHS FCOI Policy and Guidance, including the 2011 Revised Regulations and FAQs can be found at:
http://grants.nih.gov/grants/policy/coifaq.htm.

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