Financial Conflicts of Interest in Externally Sponsored Research
Policy number: 10.7
Policy section: Research
Revised Date: January 17, 2025
1. Definitions
Definitions of capitalized terms used herein are set forth in Appendix A.
2. Policy Statement
It is the policy of the University to ensure that research is conducted in accordance with applicable standards of federal, state, and local government agencies and other external sponsors. Persons subject to this policy must comply with those standards, to the extent applicable, and with any additional requirements imposed by this policy or other applicable University Policies and obligations. Nothing in this policy shall be read to preclude the University from taking actions to comply with federal, state, and local laws and regulations and to protect the integrity of University research and the University’s reputation.
3. Purpose
To address potential risks that financial conflicts of interest in research entail and to help the University maintain the highest level of integrity in its research endeavors, this policy was developed for the purpose of:
- Establishing clear guidelines for identifying and addressing perceived, potential, and actual financial conflicts of interest in externally sponsored research to which faculty, staff and students engage.
- Protecting externally funded investigators and the University from the appearance of bias in the creation, analysis, interpretation, and publication of data.
- Protecting human participants who participate in externally funded research from risk and providing information which can be used in reaching decisions about entering or remaining in research protocols.
Excellence and integrity in research are integral parts of the University’s mission. In support of these important goals, the University encourages and supports innovative and effective scholarship, research, and teaching in all fields. In recent years, corporations and other organizations have played an important role in research at universities as industry partners. Productive and positive interaction between University personnel and industry can benefit research and advance the University’s mission to translate discoveries for the public good. Personal financial interests, however, may give rise to conflicts of interest, which, unless appropriately addressed, may in fact or appearance compromise the objectivity of, and public trust in, University research.
4. Scope of this Policy
- This policy applies to all Investigators, regardless of title. Each Investigator must make the disclosures required under this policy with respect to himself or herself and with respect to his or her spouse (or domestic partner), dependent children, and household members.
- Investigators engaged in government-sponsored and other externally-sponsored research must comply with all requirements imposed by the laws and regulations governing those sponsors, and must consult with the Office of Research and Innovation for guidance.
5. Financial Conflict of Interest and Significant Financial Interests
For purposes of this policy, a Financial Conflict of Interest exists when the University reasonably determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of externally funded research. Disclosure of additional types of financial interests may be required to comply with requirements of specific federal sponsors. Specific sponsors may define Significant Financial Interest more broadly; see Appendices B through E of this document for additional sponsor-specific requirements.
6. Department Administrative Rules, Procedures, and Guidelines
The Financial Conflict of Interest in Research Committee (“Committee”), is chaired by the Associate Vice Provost for Research and consists of the University Controller, the Director of Internal Audit, the Director of Research Integrity and Compliance and two (2) faculty members appointed by the Associate Vice Provost for Research. The Committee members are the Institutional Officials responsible for the review of the Investigator’s potential financial conflicts of interest and the other powers and responsibilities prescribed to it in this policy.
- Review of Externally-Funded Research Awards. Any Investigator must disclose to the Office of Research and Innovation any Significant Financial Interest before submission of an application for funding. The Office of Research and Innovation determines if such interest reasonably could appear to directly and significantly affect the externally funded project. The Office of Research and Innovation, as an agent of the University, will take steps either to manage, reduce, or to eliminate financial conflict of interest before funds are spent.
This Policy applies to ongoing and future externally funded activities, research grants, project or programs, but not to past transactions or past research grants. The latter are subject to applicable University policies in place at the time these activities were undertaken. If an individual is also a member of and has duties and responsibilities to another institute or agency that conflicts with University Policies, the most restrictive of the conflicting policies will prevail.
The Office of Research and Innovation, or its designee, will obtain assurance from sub-recipients (subcontractors and subgrantees) who are compliant with current financial conflict of interest regulations and University Policies. - Coordination with the Institutional Compliance Board or Committees. Relationships between the Institutional Compliance Board or Committees shall be carried out in a transparent manner and all disclosures must be made as required. The Institutional Compliance Board or Committees, the Financial Conflicts of Interest in Research Committee, and the Council on Conflict of Interest and Commitment will share no fewer than two members who will coordinate review of Financial Conflict of Interest disclosures and Conflict of Commitment disclosures.
- Commitments of Institutional Compliance Board or Committee Members. No regular or alternate member of an Institutional Compliance Board or Committee may participate in the initial review or renewal of any research project in which the member has a Financial Conflict of Interest, except to provide information as requested. It is the responsibility of each voting member or alternate member to disclose any Significant Financial Interest in a study submitted to an Institutional Compliance Board or Committee and recuse themselves from deliberations and voting. University staff whose job status or compensation is affected by the research that is reviewed by the committees must recuse themselves from any meeting at which such a protocol is reviewed.
7. Disclosure
- Initial Disclosure. Investigators have the primary responsibility for disclosing Financial Conflicts of Interest. Investigators are required to make full disclosure of their Significant Financial Interests no later than the date of submission of any research proposal. Disclosures should provide sufficient detail to conduct an accurate and objective evaluation and must be completed for each externally funded research project in accordance with established procedure. Investigators must promptly provide any other requested information to the Institutional Official. Investigators must complete a disclosure from the Office of Research and Innovation’s Financial Conflict of Interest online system before funds will be released. Investigators engaged in government-funded research may be subject to additional disclosure obligations and must consult with the Office of Research Compliance to identify and address those additional obligations.
- Annual Disclosure. Disclosures must be updated by Investigators annually during the period of the award. The annual disclosures shall include any Significant Financial Interest not previously disclosed and will include updates to any previously reported Significant Financial Interest. A fixed annual disclosure schedule is utilized by the University. All Investigators will be notified at the beginning of each calendar year to submit an Annual Disclosure for each externally funded research project.
- Updated Disclosures. Each Investigator is also responsible for submitting updated disclosures within the time frames and in accordance with the standards specified by sponsor rules and regulations. For federally funded projects, disclosure updates must be submitted within 30 days of discovering or acquiring a new Significant Financial Interest.
- Disclosure by Additional University Personnel. An Investigator who is added to an externally funded project after a project has been initially started must submit a disclosure form reporting any Significant Financial Interests in the manner set forth herein. Such disclosure forms shall be submitted annually to the Office of Research and Innovation Financial Conflict of Interest online system updated as specified herein.
8. Review of Disclosures
- The Office of Research and Innovation will review each Financial Conflict of Interest disclosure submission and other pertinent information and shall determine whether a potential Financial Conflict of Interest exists within five (5) working days of receipt.
- If the Office of Research and Innovation identifies a potential Financial Conflict of Interest, the matter will be referred to the Committee. Within ten (10) working days of receiving a notice of a potential Financial Conflict of Interest (or within a longer period as approved by the Institutional Official), the Financial Conflict of Interest disclosure and any additional documentation will be assessed and a formal determination will be issued by the Committee to the Investigator. The formal determination may include information that no further action is required, involve a request for additional information, or require a management plan. If the Committee identifies and deems a potential Financial Conflict of Interest to be a Financial Conflict of Interest, the Committee or its designee will develop and implement a management plan that specifies the actions that have been, and will be, taken to mitigate the Financial Conflict of Interest. If the matter involves federally funded research, the review will proceed in accordance with applicable federal regulations. See Appendices B through E for additional information pertinent to common funding agencies.
9. Management of Actual or Apparent Conflicts of Interest
- If the Committee identifies an actual or apparent Financial Conflict of Interest, the Institutional Official will outline what conditions are required to eliminate or reduce the conflict of interest. The Committee will develop and implement a management plan that identifies proposed actions to be taken to manage the conflict of interest, such as elimination or reduction of an external interest, posting of a public disclosure of Financial Conflict of Interest in publications and presentations, disclosure to human subject participants, informing other research team members, appointment of an independent third party to monitor research, severance of the relationships that create the Financial Conflict of Interest, or changing personnel or personnel roles in the research.
- Determination of the existence of a conflict of interest and the means identified for eliminating or managing the conflict will be communicated through the Financial Conflict of Interest electronic system to the affected Investigator and other appropriate personnel. When applicable, the appropriate manager responsible for grant and contract administration will also be notified of pertinent facts needed for grant administration and regulatory compliance.
- The Committee will monitor Investigator compliance with any management plan implemented pursuant to this Section on an ongoing basis until completion of the sponsored research project.
10. Appeal of Committee Determinations
If the Investigator is dissatisfied with the determination as to the existence of a Financial Conflict of Interest or an associated management plan, the Investigator may, within ten (10) calendar days of such determination or implementation of the management plan, appeal to the Vice Provost for Research and Chief Innovation Officer. After such review, the Vice Provost for Research and Chief Innovation Officer will make a decision after consultation with the Chair of the Faculty Senate Ethics and Tenure Committee, which shall be final. During the pendency of any appeal, the Investigator is required to comply with any management plan developed and implemented by the Committee.
11. Responsibility and Non-Compliance
The Institutional Official and the Office of Research and Innovation are responsible for articulating and enforcing the Disclosure of Financial Interest and Management of Financial Conflict of Interest. Research Integrity and Compliance is responsible for monitoring the Financial Conflict of Interest status, disclosures, and training profiles of faculty and staff.
In the event of an Investigator’s failure to comply with this Policy, the Institutional Official may suspend all relevant activities or take other disciplinary action until the matter is resolved or other action deemed appropriate by the Institutional Official is implemented. An Institutional Official’s decision to impose sanctions on an Investigator because of failure to comply with this Policy, or failure to comply with the decision of the Institutional Official will be described in written explanation of the decision of the investigator.
12. Report to Sponsors
The University will make reports to appropriate government agencies and other external sponsors to the extent required by, and in accordance with, its funding agreement with the sponsor and applicable law and regulation.
13. Record Retention
Financial Conflict of Interest disclosures, records of actions taken by the University with respect to each Financial Conflict of Interest, and other records of actions under this policy will be maintained by the Office of Research and Innovation for a period of no less than three (3) years from the end of the project period or the date of final payment under the project, whichever is later. If an external sponsor requires a longer record retention period such longer retention period will apply to projects sponsored by that external sponsor.
Records related to any litigation, claim, or audit will be retained until all litigation, claim, or audit findings involving the records have been resolved and any final action taken. In the event of an action by the external sponsor, records generated under this policy will be maintained by the Office of Research and Innovation until such time as the action by the external sponsor is resolved. If the University is notified in writing by an external federal sponsor, cognizant agency for audit, oversight agency for audit, cognizant agency for indirect costs, or pass-through entity to extend the retention period, such records shall be retained for the time period specified in the notice. Records for real property and equipment acquired with Federal funds must be retained for three (3) years after final disposition of such property or equipment. Upon authorized request of a sponsoring agency, disclosure documents and related records pertaining to the specific sponsored project will be made available to appropriate officials.
14. Research Misconduct
All persons subject to this policy are expected to comply fully and promptly with applicable requirements. Failure to make required disclosures; deliberate filing of incomplete, erroneous, or misleading disclosure forms; failure to comply with prescribed management plans; and other violations of this policy may constitute research misconduct as defined by University Policy 10.6, Standards for Addressing Research Misconduct, and will be referred to the Institutional Official for evaluation under that policy.
15. Applicable Regulations and Guidelines
This policy applies to all research projects receiving external funding. Federal requirements are in addition to other University provisions.
- University Policy 1.3, Conflict of Interest
- University Policy 10.1, Sponsored Research and Activities
- University Policy 10.6, Standards for Addressing Research Misconduct
- University Policy 1.3.2 Conflict of Commitment
- 42 CFR 50 Subpart F and 45 CFR 94
- Public Health Service Policy
- NSF Proposal & Award Policies & Procedures Guide Part II, Chapter IX, Section A
- NIH Policy Statement, section 4.1.10 Financial Conflict of Interest
- 51²è¹Ý HRPP Policy 301, section 3.8
16. Sponsor-Specific Requirements
The Office of Research and Innovation is authorized to prepare, administer, and modify supplemental sponsor-specific appendices to this Policy. Investigators are advised to consult sponsor-specific appendices following this document for additional guidance and compliance requirements for the federal sponsors that require additional supplementation.
Appendix A: Definitions
“Equity Interest” means any stock, stock option, or other ownership interest.
“Financial Conflict of Interest” means the situation that arises when the University reasonably determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of externally funded research.
“Institutional Compliance Board or Committee” means the Institutional Review Board, the Institutional Animal Care and Use Committee, and the Institutional Biosafety Committee.
“Institutional Official” means the Financial Conflict of Interest in Research Committee or other University employees designated by the Provost.
“Institutional Responsibilities” means an Investigator's professional responsibilities on behalf of the Institution, including research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.
“Investigator” means faculty, staff, and other members of the University, regardless of title, who are responsible for the design, conduct, oversight, or reporting of research at the University under grants or contracts funded by a federal, state, or local government agency or other external sponsor, or negotiation of research agreements or externally funded educational activities.
"Policy” means the Financial Conflicts of Interest in Externally Sponsored Research Policy.
"Remuneration” means salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship).
“Significant Financial Interest” means:
- One or more of the following interests of an Investigator (and those of the Investigator’s spouse or domestic partner, or any dependent children):
- Income that exceeds $5,000 from any outside entity, in the twelve months preceding the disclosure.This may be one payment from a particular company of more than $5,000 or multiples payments from the same company that in the aggregate exceed $5,000 and are received within the previous 12 months.
- Remuneration and/or Equity Interest in a publicly traded company that exceeds $5,000 in value.
- Remuneration that exceeds $5,000 from a privately held company
- Any Equity Interest in a privately held company, regardless of value.
- An income that exceeds $5,000 from rights in intellectual property (e.g., patents, copyrights), royalties from such rights, and agreements to share in royalties related to such intellectual property rights, received in the twelve months prior preceding the disclosure;
- All reimbursed and “sponsored” travel that exceeds $5,000 from a single entity, as measured on a rolling 12-month basis.
- Any foreign financial interest that exceeds $5,000, including income from seminars, lectures, or teaching engagements, service on advisory committees or review panels, and reimbursed or sponsored travel received from any foreign entity, including foreign institutions of higher education or the government of another country.
- The term Significant Financial Interest does not include the following types of financial interests:
- salary, royalties, or other remuneration paid by the University to the Investigator (including intellectual property rights assigned to the University and agreements to share in royalties related to such rights) if the Investigator currently is employed or otherwise appointed by the University;
- 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 of the United States; or a United States Institution of Higher Education, an academic teaching hospital, a medical center, or a research institute that is affiliated with a United States Institution of Higher Education; or
- income from service on advisory committees or review panels for a federal, state or local government agency of the United States; a United States Institution of Higher Education; an academic teaching hospital, a medical center, or a research institute that is affiliated with a United States Institution of Higher Education.
“United States Institution of Higher Education” means an educational institution as defined by 20 U.S.C. § 1001(a).
“University” means 51²è¹Ý and its subsidiaries and affiliates.
“University Policies” means, for the purposes of this policy, all University Policies included in the University Policy Manual and all other procedures, guidelines, and requirements of the Office of Research and Graduate Studies and the Office of Grant and Contract Accounting included in the Research Handbook, and the procedures, guidelines and requirements of all University colleges, schools, departments, centers, institutes, and divisions.
Appendix B: Specific Requirements for PHS Research Funding
The following agencies are a part of PHS: Agency for Health Care Research & Quality (AHRQ), Agency for Toxic Substances and Disease Registry (ATSDR), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), Health Resources and Services Administration (HRSA), Indian Health Service (IHS), National Institutes of Health (NIH), and Substance Abuse and Mental Health Services Administration (SAMHSA). Accordingly, these specific requirements apply to research funded by any of these PHS agencies.
1. Training Requirements
An Investigator receiving PHS funds must participate in training regarding (1) this Policy, (2) this Appendix, and (3) the PHS regulations before engaging in research related to any PHS-funded activity and at least every four years thereafter, and immediately when any of the following circumstances apply:
- The University revises this Appendix in any manner that affects the requirements of an Investigator (training will be completed in the manner and within the time frame specified in communications announcing such changes);
- An Investigator is new to the University; or
- An Investigator is not in compliance with the Policy, this Appendix, or a Financial Conflict of Interest management plan, as determined by the University.
The University will track training for all PHS-funded researchers.
2. Subcontractor/Consultant Disclosures
For any PHS award to the University carried out through a subrecipient, the University and the subrecipient will establish whether the conflict guidelines of the University or that of the subrecipient will apply to the subrecipient’s Investigator. Where the conflict policy of the subrecipient will apply to the subrecipient’s Investigator, the subrecipient will certify that its policy complies with the PHS regulations. In all cases, the subrecipient agreement will include time periods to meet the University’s disclosure and/or Financial Conflict of Interest reporting requirements to PHS.
3. Reporting to PHS Components
Prior to expenditure of any funds under a PHS-funded project, the University will provide to the appropriate prime or PHS awarding component a Financial Conflict of Interest report regarding any Investigator’s Significant Financial Interest that the University deems to be a Financial Conflict of Interest and the corresponding management plan.
For any Significant Financial Interest that the University identifies as a Financial Conflict of Interest subsequent to the initial Financial Conflict of Interest report during an ongoing PHS-funded research project (e.g., upon the participation of an Investigator who is new to the research project), the University will provide, within sixty (60) days, a Financial Conflict of Interest report regarding any Investigator’s Significant Financial Interest that the University deems to be a Financial Conflict of Interest and the corresponding management plan.
The Office of Research and Innovation staff will make these reports to the appropriate prime or PHS awarding component and include the following:
- Project number;
- PI/PD name;
- Name of the Investigator with the conflict;
- Name of the entity related to the conflict;
- Nature of the financial interest, e.g., equity, consulting income, travel reimbursement, etc.;
- Value of the financial interest in 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 if the interest is one whose value cannot be readily determined through reference to public information, a statement to that effect;
- A description of the financial interest related to the funded research and the determination of why such financial interest is a conflict;
- A description of the key elements of the management plan.
- Annual report. For every Financial Conflict of Interest previously reported by the University to PHS with regard to an ongoing PHS-funded research project, the University will submit an annual report to PHS that addresses the status of the Financial Conflict of Interest and any changes to the management plan.
- Late certification or review.Whenever the University identifies a Significant Financial Interest that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed during an ongoing PHS- funded research project, the University will, within sixty (60) days, review the Significant Financial Interest, determine whether it is related to PHS-funded research, and determine whether a Financial Conflict of Interest exists; and, if so, implement, on at least an interim basis, a management plan that specifies the actions that have been, and will be, taken to manage such Financial Conflict of Interest going forward.
- Retrospective review.If the University determines that a Financial Conflict of Interest was not identified or managed in a timely manner, including, but not limited to, an Investigator’s failure to disclose a financial conflict of interest, or, for whatever reason, was not previously reviewed by the Committee during an ongoing PHS-funded research project (e.g., was not timely reviewed or reported by a subrecipient), the Committee will determine whether a Financial Conflict of Interest exists within sixty (60) days.
In addition, 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 University to constitute a Financial Conflict of Interest; failure by the University to review or manage such a Financial Conflict of Interest; or failure by an Investigator to comply with a management plan, an advisory committee appointed by the Institutional Official will, within 120 days, complete a retrospective review of the Investigator’s activities and the sponsored project to determine whether the activities conducted during the period of non-compliance were biased in the design, conduct or reporting of the research or activities.
Documentation of the retrospective review shall include the project number, project title, principal Investigator, name of the Investigator with the Financial Conflict of Interest, name of entity with which the Investigator has the 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), and findings and conclusions of the review.
If appropriate, the Office of Research and Innovation will update any previously submitted Financial Conflict of Interest report to the sponsor, specifying actions that will be taken to manage the Financial Conflict of Interest going forward. This retrospective review will be completed in the manner and time frame established in the regulations.
If bias is found, the institution will promptly notify PHS and submit a mitigation report. The mitigation report will identify key elements documented in the retrospective review, a description of the impact of the bias on the research project and the plan of action to eliminate or mitigate the effect of the bias.
Depending on the nature of the Financial Conflict of Interest, the University may impose interim measures with regard to the Investigator’s participation in the research project between the date that the Financial Conflict of Interest or the Investigator's noncompliance is determined and the completion of the University’s retrospective review.
- Management plan.If a management plan is established for a PHS-funded project, the University will report details of the management plan to the PHS. The following key elements of the management plan must be included in the report:
- Role and principal duties of the conflicted Investigator;
- Conditions of the management plan;
- How the management is designed to safeguard objectivity of the research;
- Confirmation of the Investigator’s agreement to the management plan;
- How the management plan will be monitored to ensure Investigator compliance; and
- Other information as needed.
No expenditure of funds under any PHS-funded research project will be permitted until the Investigator has complied with the obligations of the Policy and this Appendix and agrees to comply with any management plan.
4. Disciplinary Action
If an Investigator fails to comply with this policy or a Financial Conflict of Interest management plan and that failure appears to have biased the design, conduct, or reporting of the PHS-funded research, the University will promptly notify PHS of the corrective action taken or to be taken. If required, the Office of Research and Innovation will promptly notify any other sponsor of the action to be taken.
If the Department of Health and Human Services determines that a Public Health Service-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 Financial Conflict of Interest that was not managed or reported by the University, the University will 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.
5. Public Disclosure of Financial Conflicts of Interest
Upon request, the University will make information available to the Department of Health and Human Services (DHHS) regarding all conflicting research financial interests and how those interests have been managed, reduced or eliminated.
The Office of Research and Innovation shall identify one office address as the recipient address for public requests for information under the DHHS regulation and this policy and shall take the necessary action to provide this address to the public, including prominently posting this information on the campus website. In accordance with DHHS regulations.
Prior to the expenditure of funds, the University will respond to any requestor within five business days of the request, information concerning any Significant Financial Interest that meets the following criteria:
- The Significant Financial Interest was disclosed and is still held by the senior and key personnel, meaning the project director or principal investigator of a PHS-funded research project and any other person identified as senior/key personnel by the University in the grant application, progress report, or any other report submitted to the PHS by the University;
- A determination has been made that the Significant Financial Interest is related to federally-funded research; and
- A determination has been made that the Significant Financial Interest is a Financial Conflict of Interest.
If a written response is required, the response will include the following:
- The Investigator's name;
- The Investigator's title and role with respect to the research project;
- The name of the entity in which the significant financial interest is held;
- The nature of the significant financial interest; and
- Value of the financial interest in 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 if the interest is one whose value cannot be readily determined through reference to public information, a statement to that effect;
Annual disclosure forms, ad hoc disclosure forms, and management plans including determinations of Financial Conflicts of Interest are public records open to public inspection, under federal and state laws. Written responses to requestors will be maintained for at least three years from the date that the information was most recently updated.
The University will confirm with the Investigator that the information provided is current as of the date of the correspondence and note the same in its written response to the requestor, and the University will also note in its written response that the information is subject to updates, on at least an annual basis and within sixty (60) days of the University’s identification of a new Financial Conflict of Interest, which should be requested subsequently by the requestor.
Information concerning the Significant Financial Interest will remain available, for responses to written requests, for at least three years from the date that the information was most recently updated.
6. References
Appendix C: Specific Requirements for U.S. Department of Energy (“DOE”) Research Funding
1. Disclosure Process and Review
For purposes of DOE-funded research, an Investigator’s Significant Financial Interest is related to the Investigator’s research activity when the Office of Research and Innovation reasonably determines that the Significant Financial Interest could be affected by the Investigator’s research activity, could affect the research activity, is in an entity whose financial interest could affect the research activity, or is in an entity whose financial interest could be affected by the Investigator’s research activity. A Financial Conflict of Interest exists for DOE-funded research when the Office of Research and Innovation reasonably determines that the Significant Financial Interest could directly and significantly affect the purpose, design, conduct, or reporting of the Investigator’s research activity.
2. Definitions
For purposes of DOE-funded research:
- “Financial Conflict of Interest” means a situation in which an Investigator or the Investigator’s spouse or dependent children has a significant financial interest or financial relationship that could directly and significantly affect the design, conduct, reporting or funding of a project.
- “Investigator” means the principal investigator and any other person, regardless of title or position, who is responsible for the purpose, design, conduct, or reporting of a project funded by DOE or proposed for funding by DOE. DOE program offices have the discretion to expand the definition to include any person who participates in the purpose, design, conduct, or reporting of a project funded by DOE or proposed for funding by DOE. Such expansion will be specified in the applicable funding opportunity announcement and/or terms and conditions of the financial assistance award.
- “Key Personnel” means the Investigator; any other person who significantly influences the design, conduct, or reporting of a project funded under a DOE award; and any other person identified as senior or key personnel by the University in the application for financial assistance, approved budget, progress report, or any other report submitted to the DOE by the University under this Policy.
- “Significant Financial Interest” is one or more of the following interests of the Investigator, the Investigator’s spouse and dependent children that reasonably appears to be related to the Investigator’s institutional responsibilities:
- With regard to any non-publicly traded entity, a Significant Financial Interest exists if the value of any Remuneration not otherwise disclosed as current, pending, or other support, 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/domestic partner or dependent children) holds any Equity Interest.
- 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 thedisclosure and the value of any Equity Interest in the entity as of the date of disclosure (as determined through reference to public prices or other reasonable measures of fair market value), when aggregated, exceeds $5,000.
- For purposes of DOE-funded research, Significant Financial Interest includes any reimbursed or sponsored travel regardless of value (i.e., that which is reimbursed to or paid on behalf of the Investigator, the Investigator’s spouse/domestic partner or dependent children) related to the Investigator’s Institutional responsibilities that is not otherwise disclosed in current and pending or other support disclosures. Disclosure of reimbursed or sponsored travel should be made by submitting a disclosure profile update within 30 days of the travel.This disclosure requirement does not apply to travel that is reimbursed or sponsored by a Federal, state, or local government agency of the United States; a domestic institution of higher education; or a domestic research institute that is affiliated with a domestic institution of higher education.
- For purposes of DOE-funded research, with regard to intellectual property rights and interests (e.g., patents, copyrights), a Significant Financial Interest exists upon receipt of income, regardless of value, related to such rights and interests.
- DOE-funded researchers must submit a Certification statement regarding the truthfulness of their Significant Financial Interest disclosures and acknowledgement of their responsibility to update disclosures during the award period performance should circumstances change which affect previous responses.
A Significant Financial Interest does not include the following types of financial interests:
- Salary, royalties, or other remuneration paid by the University to the Investigator if the Investigator is currently employed or otherwise appointed by the University, including intellectual property rights assigned to the non-Federal entity and agreements to share in royalties related to such rights;
- 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 of the United States, a domestic institution of higher education, or a domestic research institute that is affiliated with a domestic institution of higher education; or
- Income from service on advisory committees or review panels for a Federal, state, or local government agency of the United States, a domestic institution of higher education, or a domestic research institute that is affiliated with a domestic institution of higher education
3. Training Requirements
An Investigator receiving DOE funds must participate in training about this Policy, this Appendix, and DOE policies and guidelines before engaging in research related to any DOE-funded activity and at least every four years thereafter, and immediately when any of the following circumstances apply:
- The University revises this Appendix in any manner that affects the requirements of Investigator (training will be completed in the manner and within the time frame specified in communications announcing such changes);
- An Investigator is new to the University; or
- An Investigator is not in compliance with the Policy, this Appendix, or a Financial Conflict of Interest management plan, as determined by the University.
The University will track training for all DOE-funded researchers.
4. Subcontractor/Consultant Disclosures
For any DOE award to the University carried out through or with the assistance of one or more subrecipients, the written agreement between the University and the subrecipient will establish whether the conflict guidelines of the University or that of the subrecipient will apply to the subrecipient’s Investigator.
Where the conflict policy of the subrecipient will apply to the subrecipient’s Investigator, the subrecipient will certify as part of its subaward agreement that its policy complies with the relevant sponsor regulations and policies, and the subrecipient shall make such policy available via a publicly accessible website. If the subrecipient does not have any current presence on a publicly accessible website, the subrecipient shall make its written policy available to any requestor within five business days of a request. In all cases, the subrecipient agreement will include time periods to meet the University’s disclosure and/or Financial Conflict of Interest reporting requirements to DOE.
If a subrecipient does not have DOE-compliant policies, the University’s Policy will apply to the subrecipient. The Office of Research and Innovation will work with an Investigator during the proposal, new award, and ongoing reporting stages of such awards to complete the necessary requirements and disclosures. The subaward agreement must specify time period(s) for the subrecipient to submit all Investigator disclosures of significant financial interests to the recipient non-Federal entity. Such time period(s) shall be sufficient to enable the recipient non-Federal entity to comply timely with its review, management, and reporting obligations under this DOE Interim COI Policy.
All Financial Conflict of Interest reports relating to Financial Conflict of Interest of a subrecipient Investigator must be submitted prior to the expenditure of funds and within sixty days of any subsequently identified Financial Conflict of Interest.
5. Reporting to DOE Program Offices
Prior to expenditure of any funds under a DOE-funded project, the University will provide to the appropriate prime or DOE program office a Financial Conflict of Interest report (containing all elements that DOE guidelines and policies require) regarding any Investigator’s unmanaged or unmanageable Significant Financial Interest that the University finds to be a Financial Conflict of Interest. If required by a DOE program office through language in a funding opportunity announcement or term and condition of award, the University will provide to the DOE program office a list of any Investigator’s Significant Financial Interest found by the University to be conflicting and addressed by a management plan. The University shall, upon DOE’s request, provide to DOE Financial Conflict of Interest reports and supporting documentation about any Significant Financial Interest that the University finds to be conflicting, regardless of whether the conflict has been managed, mitigated, or eliminated.
For any Significant Financial Interest that the University identifies as a Financial Conflict of Interest subsequent to the initial Financial Conflict of Interest report during an ongoing DOE-funded research project (e.g., upon the participation of an Investigator who is new to the research project), the University will, within sixty (60) days, review the disclosure; determine whether it is related to the project funded under the DOE award; 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, and will be, taken to manage such financial conflict of interest.
The University will also submit to DOE, within sixty (60) days, a Financial Conflict of Interest report regarding the Investigator’s Significant Financial Interest found to be a Financial Conflict of Interest. Where the DOE program office requires the University to include only unmanaged or unmanageable Financial Conflicts of Interest in the report, the Financial Conflict of Interest report must include only those Financial Conflicts of Interest that the University determines to be unmanageable. Where the DOE program office requires the University to include all Investigator Financial Conflicts of Interest, including managed and unmanaged Financial Conflicts of Interest, in the Financial Conflict of Interest report, the University must ensure that it has implemented a management plan in accordance with this Appendix and DOE guidelines and policies.
The Office of Research and Innovation staff will make these reports to the appropriate prime or DOE program office and include the following:
- Project number;
- Principal Investigator / Principal Director name;
- Name of the Investigator with the conflict;
- Name of the entity related to the conflict;
- Nature of the financial interest, e.g., equity, consulting income, travel reimbursement, etc. and/or applicable external relationships or activities;
- Value of the financial interest in 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 if the interest is one whose value cannot be readily determined through reference to public information, a statement to that effect;
- A description of the financial interest related to the funded research and why the University determined there is a conflict;
- A description of the key elements of the University’s management plan (to be included in Financial Conflict of Interest reports submitted to DOE only where the DOE program office requires the University to include all Investigator Financial Conflicts of Interest, including managed and unmanaged Financial Conflicts of Interest).
- Management plans. If a DOE program office requires the University to include all Investigator Financial Conflicts of Interest – including managed and unmanaged/unmanageable Financial Conflicts of Interest – in the Financial Conflict of Interest Report, the University will report details of the management plan to the DOE. The following key elements of the management plan must be included in the report:
- Role and principal duties of the conflicted Investigator;
- Conditions of the management plan;
- How the management is designed to safeguard objectivity of the research;
- Confirmation of the Investigator’s agreement to the management plan;
- How the management plan will be monitored to ensure Investigator compliance; and
- Other information as needed.
- Annual report.For every Financial Conflict of Interest previously reported to DOE with regard to an ongoing DOE-funded research project, the University will submit an annual report to DOE that addresses the status of the Financial Conflict of Interest and any changes to the management plan. The annual Financial Conflict of Interest report shall specify whether the Financial Conflict of Interest is still being managed or if it remains unmanaged or unmanageable. Alternatively, the annual Financial Conflict of Interest report shall explain why the Financial Conflict of Interest no longer exists.
- Routine Financial Conflict of Interest submissions to DOE.In addition to the annual Financial Conflict of Interest report, the DOE may require the University to routinely submit all or some Investigator disclosures of financial interests. Circumstances when DOE may require the University to submit all or some Investigator disclosures include:
- As part of monitoring the University’s compliance with DOE conflict of interest policies;
- Bankruptcy;
- Other legal winding down;
- Acquisition of the University by a foreign entity, where “acquisition” includes a foreign entity obtaining a controlling interest in the University; or
- As otherwise required by 2 CFR Part 200.
An Investigator or any other party who receives a request from the DOE to submit Investigator disclosures shall promptly notify the Sponsored Projects Administration.
- Late certification or review.Whenever the University identifies a Significant Financial Interest that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed by the University during an ongoing DOE- funded research project, the University will, within sixty (60) days, review the Significant Financial Interest, determine whether it is related to DOE-funded research, and determine whether a Financial Conflict of Interest exists; and, if so, implement, on at least an interim basis, a management plan that specifies the actions that have been, and will be, taken to manage such Financial Conflict of Interest going forward.
- Retrospective review.In the event the University determines that a Financial Conflict of Interest is not identified or managed in a timely manner, including, for example, failure by an Investigator to comply with the disclosure requirements; failure by the University 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 University will, within one-hundred and twenty (120) days of the University’s determination of noncompliance, complete a retrospective review of the Investigator’s research activities to determine whether any DOE-funded research was biased in the purpose, design, conduct or reporting of the research.
- Retrospective review report. The University must document the retrospective review and such documentation shall include, but not necessarily be limited to, all of the following key elements:
- DOE award number;
- Project title;
- Principal Investigator or contact Principal Investigator if a multiple Principal Investigator 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;
- 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);
- Findings of the review; and
- Conclusions of the review.
- Updates resulting from retrospective review.Based on the results of the retrospective review, if appropriate, the University shall update the previously submitted Financial Conflict of Interest report, specifying the actions that will be taken to manage the financial conflict of interest going forward. If bias is found during the review, the University will notify the sponsorpromptly and submit a mitigation report to the sponsor. The mitigation report will include, at a minimum, the key elements documented in the retrospective review and a description of the impact of the bias on the research project and the University’s plan of action taken to eliminate or mitigate the effect of the bias (e.g., impact on the research project, extent of harm done, analysis of whether the research project is salvageable). Thereafter, the University will submit Financial Conflict of Interest reports annually as prescribed by applicable DOE guidelines and policy, and more frequently as required by DOE program offices through language in funding opportunity announcements or term and conditions of award.
No expenditure of funds under any DOE-funded research project will be permitted until the Investigator has complied with the obligations of this Policy and this Appendix and agrees to comply with any management plan.
6. Public Disclosure of Financial Conflicts of Interest
Prior to the expenditure of any funds under a DOE-funded research project, the University will ensure public accessibility via a publicly accessible website or by written response to any requestor within five (5) business days of a request of information concerning any Significant Financial Interest disclosed to the University that meets the following three criteria:
- The Significant Financial Interest was disclosed and is still held by the Investigator;
- The University has determined that the Significant Financial Interest is related to the DOE-funded research; and
- The University has determined that the Significant Financial Interest is a Financial Conflict of Interest.
The information that the University will release includes:
- Investigator’s name;
- An Investigator’ title, and role with respect to the research;
- Name of the entity in which the Significant Financial Interest is held;
- Nature of the Significant Financial Interest (stock, income, etc.);
- The approximate dollar value of the Significant Financial Interest in 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 if the interest is one whose value cannot be readily determined through reference to public information, a statement to that effect.
The University will confirm with the Investigator that the information provided is current as of the date of the correspondence and note the same in its written response to the requestor, and the University will also note in its written response that the information is subject to updates, on at least an annual basis and within sixty (60) days of the University’s identification of a new Financial Conflict of Interest, which should be requested subsequently by the requestor.
Information concerning the Significant Financial Interest will remain available for responses to written requests for at least three years from the date that the information was most recently updated.
7. Record Keeping Requirements
Records related to research, disclosures of Significant Financial Interests and the University’s reviews of and responses to such disclosures, and financial conflicts of interest and related management plans will be maintained for three years, dates specified in the individual award terms and conditions, or such other date as is required by law.
8. References
Appendix D: Specific Requirements for NSF Research Funding
1. Definitions
“Significant Financial Interest” means, for purposes of National Science Foundation (NSF) funded research, anything of monetary value, including, but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interest (e.g., stocks, stock options, private equity, or other ownership interests); venture or other capital financing, and intellectual property rights (e.g., patents, copyrights, and royalties from such rights).
Significant Financial Interest does not include:
- Salary, royalties or other remuneration from the University;
- Income from seminars, lectures, or teaching engagements sponsored by public or non-profit entities;
- Income from service on advisory committees or review panels for public or nonprofit entities;
- An equity interest that, when aggregated for the Investigator and the Investigator’s spouse and dependent children, that does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value and does not represent more than a 5% ownership interest in any single entity; or
- Salary, royalties, or other payments that, when aggregated for the Investigator and the Investigator’s spouse and dependent children, are not expected to exceed $10,000 during the prior twelve-month period.
2. Review of Financial Conflicts of Interest
A Financial Conflict of Interest exists when the University reasonably determines that a significant financial interest could directly and significantly affect the design, conduct, or reporting of NSF-funded research or educational activities.
If the University determines that imposing a management plan would be either ineffective or inequitable, and that the potential negative impacts that may arise from a significant financial interest are outweighed by interests of scientific progress, technology transfer, or the public health and welfare, then the University may allow the research to go forward without imposing a management plan.
3. Reporting Financial Conflicts of Interest
The University will inform NSF’s Office of the General Counsel (OGC) if the University finds that it is unable to satisfactorily manage a Financial Conflict of Interest and if the University allows the research to proceed without the imposition of a management plan.
4. References
Appendix E: Specific Requirements for U.S. National Aeronautics and Space Administration (“NASA”) Research Funding
1. Definitions
“Significant Financial Interest” means, for purposes of NASA funded research, anything of monetary value, including, but not limited to, salary or other payments for services not otherwise identified as salary (e.g., consulting fees or honoraria); equity interest (e.g., stocks, stock options, private equity, or other ownership interests); venture or other capital financing, and intellectual property rights (e.g., patents, copyrights, and royalties from such rights).
Significant Financial Interest does not include:
- Salary, royalties or other remuneration from the University to an Investigator currently employed by the institution;
- Income from seminars, lectures, or teaching engagements sponsored by public or non-profit entities;
- Income from service on advisory committees or review panels for public or nonprofit entities;
- An equity interest that, when aggregated for the Investigator and the Investigator’s spouse and dependent children, that does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value and does not represent more than a 5% ownership interest in any single entity; or
- Salary, royalties, or other payments that, when aggregated for the Investigator and the Investigator’s spouse and dependent children, are not expected to exceed $10,000 during the prior twelve-month period.
2. Subcontractor/Consultant Disclosures
For any NASA grants and cooperative agreements that the University carries out through a subrecipient under a subaward to another institution, the University will ensure (1) subaward recipients have their own policies in place that meet the requirements of NASA’s conflict of interest policy, or (2) an Investigator working for subaward recipients follow the University’s conflict guidelines.
3. Reporting to NASA Program Offices
Prior to the University’s expenditure of any funds under a NASA-funded grant or cooperative agreement, the University will provide to the appropriate NASA office a Financial Conflict of Interest report (containing all elements that NASA guidelines and policies require, such as award number, name of Investigator, nature of the Significant Financial Interest, etc.) regarding any Investigator’s Significant Financial Interest that the University finds to be a Financial Conflict of Interest and that the University cannot satisfactorily manage, reduce, or eliminate.
For any Financial Conflict of Interest subsequent to the initial Financial Conflict of Interest report during an ongoing NASA-funded grant or cooperative agreement (e.g., upon the participation of an Investigator who is new to the research project), if the University cannot manage, reduce, or eliminate the conflict, the University will provide, within sixty (60) days, a Financial Conflict of Interest report to the appropriate NASA office containing all elements that the relevant regulations and policies require, such as award number, name of Investigator, nature of the Significant Financial Interest, etc.
No expenditure of funds under any NASA-funded grant or cooperative agreement will be permitted until the Investigator has complied with the obligations of this Policy and this Appendix and agrees to comply with any management plan.
4. References
Revised: January 17, 2025
Adopted: August 21, 2012