| Approved by: | The Board of Trustees | |
| History: | Issued -- February 15, 1996 | |
| Revised -- October 22, 2015 | ||
| Last Reviewed -- | ||
| Related Policies: | Compensation from External Consulting Policy; Conflict of Commitment Policy; Conflict of Interest Policy for Staff and Faculty | |
| Additional References: | Disclosure Form to Implement the CUA Policy on Conflicts of Interest; On Preventing Conflicts of Interest in Government Sponsored Research at Universities; Summary of Federal Laws Pertaining to Research; National Institutes of Health - Frequently Asked Questions Regarding Objectivity in Research; PHS regulations 42 CFR parts 50 and 94 | |
| Responsible Official: | Provost tel. (202) 319-5244 | |
| __________________________________________________________________________________ | ||
The need for public trust in university research is extremely important. The public must have faith in research, particularly research funded from outside entities, for the vast amount of research that is conducted affects the personal aspects of peoples' lives, such as their health, the environment, food, medicine, daily contact with equipment and consumer goods, the quality of life, etc. It is reasonable, therefore, that the University formulate policies and procedures that guide its institutional research effects and minimize any potential conflicts of interest.
Several federal agencies, including Health and Human Services and the National Science Foundation, have issued regulations requiring institutions receiving federal research money to establish written, implemented and enforced conflicts of interest policies as a prerequisite to such funding. The purpose of these regulations is to establish standards and procedures to be followed by the University so that the design, conduct, or reporting of research funded by the government will not be biased by any conflicting financial interest of those investigators responsible for the research.
The University seeks to promote the public trust in its research endeavors and comply with applicable federal regulations in order to guide University researchers in disclosing any potential conflicts when applying for funding from external funding entities.
To promote consistency and integrity in the University's conflict of interest processes, the following policy and procedures apply to all externally-funded research projects regardless of whether the external funding entity is public or private.
A. Financial Interest means anything of monetary value, whether or not the monetary value is readily ascertainable.
B. Principal Investigator means an individual, regardless of title, who is responsible for the design, conduct, reporting, or fiscal management of research funded or proposed for funding by an external entity. Principal Investigators may be employees of the University, and also may include consultants, subgurantees, subcontractors, or subrecipients not employed directly by the University.
C. Public Health Service (PHS) Funded Research means research funding from PHS Awarding Components, including the National Institutes of Health (NIH), for grants, cooperative agreements, and research contracts.
D. Research means a systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge in any academic discipline. The term also encompasses all studies conducted at the University including basic and applied research and product development.
E. Significant Financial Interest means:
1. A Financial Interest consisting of one or more of the following interests of the Principal Investigator (or those of the Principal Investigator's spouse and dependent children) that reasonably appears to be related to the Principal Investigator's University Responsibilities:
a. With regard to any publicly traded entity, a Significant Financial Interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;
b. With regard to any non-publicly traded entity, a Significant Financial Interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Principal Investigator (or the Principal Investigator's spouse or dependent children) holds any equity interest (e.g.,stock, stock option, or other ownership interest); or
c. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
2. 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 Principal Investigator if the Principal Investigator is currently employed or otherwise appointed by the University, including intellectual property rights assigned to the University 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 Principal Investigator does not directly control the investment decisions made in these vehicles; income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, an Institution of Higher Education (IHE) as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an IHE; or income from service on advisory committees or review panels for a Federal, state, or local government agency, an IHE as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an IHE.
F. Conflicts Coordinator means the Associate Provost for Research.
G. Financial Conflict of Interest (FCOI) means a situation where the University, through its Conflicts Coordinator, reasonably determines that a Principal Investigator's Significant Financial Interest is related to the externally-funded research and could directly and significantly affect the design, conduct or reporting of that research.
H. University Responsibilities mean a Principal Investigator's professional responsibilities on behalf of the University, and as defined by the University and in this policy, which may include, for example: activities such as research, research consultation, teaching, professional practice, University committee memberships, and service on panels such as Institutional review boards or Data and Safety Monitoring Boards.
It is the policy of the University that faculty and researchers who are Principal Investigators applying for or receiving research funding from any entity external to the University must disclose their Significant Financial Interests (and those of their spouse and dependent children) which might reasonably appear to be affected by such research. The purpose of this policy is to identify, manage, reduce or eliminate such conflicts which could directly and significantly affect the design, conduct or reporting of the externally-funded research.
IV. Disclosure Form to Implement CUA Policy on Conflict of Interest
Each Principal Investigator engaged in externally-funded research must submit to the Conflicts Coordinator a Disclosure Form to Implement the CUA Policy on Conflicts of Interest ("Disclosure Form") when submitting a proposal. The Disclosure Form requires the full and truthful reporting of "Significant Financial Interests" (as defined in this policy), as well as any other potential conflicts per the University's Conflict of Interest Policy for Staff and Faculty. The Disclosure Form is available as an attachment to this policy under Additional References (above), or from the Office of Sponsored Programs.
The Disclosure Form must be updated at least annually during the period of the award. The Disclosure Form must also be updated within 30 days if new reportable Significant Financial Interests are obtained.
Note that, in addition to the requirements of this policy, Principal Investigators also must complete the University's annual online Conflict of Interest Disclosure Statement and Questionnaire per the University's general Conflict of Interest Policy for Staff and Faculty.
V. Review of Written Disclosure of Conflicts of Interest
In order to obtain the external funding, the Conflicts Coordinator must certify, on behalf of the University, that any identified Financial Conflicts of Interest (FCOI) will be managed, reduced or eliminated prior to the University's expenditure of funds under the award.
The Conflicts Coordinator shall collect each Disclosure Form and record the receipt in the Office of Sponsored Programs (OSP). Failure of a Principal Investigator to complete and submit the Disclosure Form will prevent submission of the application in the case of PHS Funded Research. Failure of a Principal Investigator to complete and submit the Disclosure Form in a timely manner with respect to other externally-funded research may result in a delay or failure to receive the external funding. If a Disclosure Form is not received on the date the application is filed for external funding, the OSP shall first notify the Principal Investigator and, if necessary, the Dean, in order to secure the Form. Continued failure of a Principal Investigator to file a Disclosure Form may result in University withdrawal of the application.
Disclosure Forms shall be first reviewed by the Conflicts Coordinator, who shall make a determination whether the Principal Investigator has disclosed a Significant Financial Interest (a) that would appear to be affected by the research for which the external funding is sought and/or (b) in entities whose Financial Interests would reasonably appear to be affected by the research.
If the Conflicts Coordinator determines that a Significant Financial Interest constitutes an FCOI, then the Conflicts Coordinator shall meet with the Principal Investigator to develop a plan to manage, reduce or eliminate such conflict (a "Management Plan"). If the Principal Investigator and Conflicts Coordinator are unable to resolve the conflicts, the Conflicts Coordinator shall forward the matter to the Dean, who shall attempt to develop a Management Plan regarding the conflict. If no agreeable resolution is reached, the Dean shall forward the matter to the Provost, who shall make a final determination regarding the Management Plan.
The Conflicts Coordinator may be required to notify the external funding entity of the existence of a conflicting interest and to assure the entity that the interest will be managed, reduced or eliminated. External funding may be suspended until the conflict is managed, reduced or eliminated.
In all instances, the Conflicts Coordinator shall file and maintain Disclosure Forms, memos reflecting conflicts resolutions, Management Plans, and appeals determinations for a period of at least three years after the date of submission of the final expenditures report to the external entity awarding the research funds. These documents will be considered confidential information and will only be shared with University officials on a need to know basis.
VII. Subrecipient Requirements
If any part of a research project funded by a Public Health Service (PHS) Awarding Component (such as the National Institutes of Health (NIH)) will be carried out by a subrecipient, the subrecipient must certify to the Conflicts Coordinator that it has a conflict of interest policy that complies with the PHS regulations (42 CFR Parts 50 and 94) or that it agrees to be subject to and comply with this policy. All agreements with subrecipients of research funding must contain this requirement.
VIII. Reporting to the National Institutes of Health (NIH)
The University will send FCOI reports to NIH:
Prior to the expenditure of funds;
Within 60 days of identification for a Principal Investigator who is newly participating in the project;
Within 60 days for new, or newly identified FCOIs for existing Principal Investigators; or
For any FCOI previously reported (with regard to ongoing PHS funded research) an annual status report addressing the FCOI and any changes to the management plan.
IX. Retrospective Review in cases of Non-Compliance with PHS Regulations
In all instances of non-compliance with the PHS regulations (42 CFR parts 50 and 94), the University will conduct a retrospective review. Retrospective reviews will be completed and documented within 120 days of the University's determination of non-compliance.
In cases where bias is found, the University will notify the PHS Awarding Component promptly and submit a mitigation report. The report will address the impact of the bias on the research project and the actions that the University has taken, or will take, to eliminate or mitigate the effects of the bias.
In any case in which the Department of Health and Human Services determines that a clinical research project funded by a PHS Awarding Component, the purpose of which is to evaluate the safety or effectiveness of a drug, medical device, or treatment, has been designed, conducted, or reported by a Principal Investigator with an FCOI that was not managed or reported by the University as required by 42 CFR parts 50 and 94, the University shall require the Principal Investigator involved to:
Disclose the FCOI in each public presentation of the results of the research, and
Request an addendum to previously published presentations.
X. Public Accessibility of FCOIs Pertaining to PHS Awards
In the event that it is determined that a Principal Investigator (or another individual identified as senior/key personnel by the University in the grant application or in any other report submitted to PHS), holds an FCOI related to PHS-funded research, the University is required to make certain information regarding that FCOI publicly accessible.
XI. FCOI Training
Each Principal Investigator must complete FCOI training prior to engaging in research. Trainings must be completed at least every four years and immediately, if:
This policy changes in a manner that affects the requirements of Principal Investigators;
A Principal Investigator begins work on an externally-funded research project; or
The University finds a Principal Investigator non-compliant with this policy or a Management Plan.
Within 2 weeks of submitting a proposal, the Principal Investigator must submit to the Conflicts Coordinator documentation (such as a PDF of the completion screen) that the required FCOI training has been completed.
FCOI training is available online at https://www.citiprogram.org/Default.asp? Contact the Office of Sponsored Programs for assistance.
XII. Remedies for Non-compliance
In the event a Principal Investigator does not comply with this policy or a Management Plan and it is determined that the non-compliance appears to have biased the design, conduct, or reporting of the research, the University will implement disciplinary action and remedial measures to correct or minimize the effects of the non-compliance. In the event the non-compliance pertains to PHS-funded research the University is required to notify the PHS Awarding Component, and additional corrective action may be imposed.
XIII. Compliance with other Conflict Policies
In addition to the requirements of this research-specific policy, Principal Investigators must follow the requirements of the University's general Conflict of Interest Policy for Staff and Faculty, as well as the faculty Conflict of Commitment Policy and Compensation from External Consulting Policy.