Procedure 649: Financial Conflict of Interest – Sponsored Research
Date Adopted: June 7, 2022
A. Definition of Terms
For purposes of this policy, the following terms shall have the following meanings:
- “College” shall mean Ramapo College of New Jersey.
- “Animal Use Committee” shall mean the body that oversees and ensures the appropriate review of the use of vertebrate animals in teaching, testing, and research.
- “College General Counsel” shall mean the College’s General Counsel who serves as the chief legal officer as well as the Ethics Liaison Officer.
- “FCOI” or “Financial conflict of interest” shall mean any instance when an investigator’s significant financial interest could directly and significantly affect the design, conduct, or reporting of the research.
- “FCOI Committee” shall mean a committee convened by the Grants Director to evaluate financial conflict of interest. The members of the committee will include the Grants Director, the Investigator’s Dean, the Provost, a representative from the Institutional Review Board (if applicable), and a representative from the Animal Care and Use Committee (if applicable). The College General Counsel shall serve in an advisory capacity to the FCOI Committee.
- “Institutional Responsibilities” shall mean an Investigator’s professional responsibilities on behalf of the College, which may include for example, activities such as research, research consultation, teaching, professional practice, and institutional committee and panel memberships.
- “Institutional Review Board” (IRB) shall mean the College’s Institutional Review Board that assures the upholding of the highest ethical standards in research involving human subjects.
- “Investigator” shall mean the Project Director or Principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research including collaborators, consultants and sub awardees. For purposes of the regulatory requirements relating to financial interests, the term “Investigator” includes the Investigator’s family including spouse, dependent children and other individuals and relationships that may create, or may be perceived to create a conflict of interest.
- “Management plan (FCOI)” shall mean a written plan instituted by the College to manage, reduce, or eliminate to the fullest extent possible any financial conflict of interest.
- “NIH” shall mean the National Institutes of Health.
- “NSF” shall mean the National Science Foundation.
- “OGSP” shall mean the College’s Office of Grants and Sponsored Programs.
- “PHS” shall mean Public Health Service.
- “HHS” shall mean the United States Department of Health and Human Services, which oversees 11 operating divisions that offer competitive grants, including: the National Institutes of Health; the Health Resources and Services Administration; the Substance Abuse and Mental Health Services Administration, and eight (8) others.
- “SFI” or “significant financial interest” shall mean anything of monetary value that reasonably appears to be related to an Investigator’s institutional responsibilities. Additional guidance can be found in the NIH FCOI regulation and FAQs.
SFI may include:
- Salary or other payments for services (e.g., consulting fees, honoraria)
- Equity interests (e.g. stock, stock options, ownership interests)
- Intellectual property rights (e.g., patents, copyrights and royalties from such rights)
- Certain travel related to the sponsored research
SFI does not include:
- Salary, royalties, or other remuneration from the applicant institution
- Income from investment vehicles in which the Investigator does not directly control the investment decisions made in these vehicles
- Income from seminars, lectures, or teaching engagements
- Income from service on advisory committees or review panels
- “Sponsored research” shall mean activities funded by an external agency such as one of the divisions of the HHS, or the National Science Foundation.
OGSP has established the following process to train investigators on financial conflict of interest.
The OGSP will hold a financial conflict of interest information session with each Investigator before grant approvals are sought from the Dean and Provost. The OGSP will hold the session within two weeks of a grant proposal being submitted for Dean’s approval. Any Investigator recently hired to work on sponsored research will also be required to attend the FCOI information session. For Investigators whose research is funded, the information session will be held every four years.
Investigators will undergo training again when a change has been made to FCOI policy or procedures, or when the Investigator has been found to be noncompliant with an FCOI management plan or College FCOI policy.
The information session will train Investigators on the federal FCOI regulation, inform the Investigator of Ramapo College’s FCOI policy, the Investigator’s responsibility to disclose significant financial interests, and actions that may be taken when noncompliance is found.
The OGSP will indicate that an Investigator has completed the financial conflict of interest information session by checking the box on the grant approval form, which is completed before a proposal is submitted. The checked box indicates that the Investigator(s) and any applicable subawardees and contractors have completed a significant financial interest disclosure form.
C. Disclosure, Review, and Monitoring
During the grant period, existing Investigators or Investigators who are new participants to the research project must complete the significant financial interest disclosure form annually. The SFI disclosure form must also be completed within 30 days of any change in an SFI (e.g., through purchase, marriage, or inheritance), or within 30 days of discovery of an incidence of SFI.
The form will be reviewed by the Investigator’s Dean, the Institutional Review Board (as appropriate), the Institutional Animal Care and Use Committee (as appropriate), and the Director of the Office of Grants and Sponsored Programs (“OGSP Director”), in consultation with the College General Counsel.
If no significant financial interest is disclosed, no further action is required.
If a significant financial interest that is related to PHS-funded research is found to violate this policy, or that biases the design, conduct, or reporting of the sponsored research, the OGSP Director will take the following actions:
- Immediately inform the Investigator’s Dean, the Provost, and the College General Counsel, and begin gathering further information and supporting documentation from the Investigator and others as applicable. All such documentation and subsequent discussions will be confidential to the extent permitted by applicable law.
- The OGSP Director, Dean, and Provost, in consultation with the College General Counsel, will review the documentation and within 60 days determine if corrective action is necessary.
- The OGSP will notify the funding agency within 60 days if corrective action is necessary.
- Corrective action may include a FCOI management plan that specifies the actions to be taken to manage a financial conflict of interest. Compliance with any corrective actions/management plan will be under the direction of the Investigator’s Dean and the Provost.
- The Director of Grants will promptly notify the funding agency and submit a mitigation report that includes the impact of the bias on the research project and the plan to eliminate or mitigate the bias.
In the event the College identifies an SFI that was not disclosed or managed in a timely manner, the Director of Grants will complete a retrospective review (see section F.iii.).
D. Reporting to NIH
The OGSP Director will submit significant financial interest disclosure forms to the NIH:
- Prior to the expenditure of funds.
- Annually during the grant period.
- Within 60 days of the addition of a new Investigator.
- In the case of the discovery of a new financial conflict of interest, within 60 days of the creation of a FCOI management plan; when corrective action is implemented; and annually until the matter is resolved, or the grant period ends.
- Following a retrospective review to update a previously submitted report.
The College will notify the funding agency and take corrective action if an Investigator fails to comply with this policy or a FCOI management plan appears to have biased the design, conduct, or reporting of the research.
E. Maintenance of Records
All records of FCOI disclosure and the College’s review, response, and action related to the disclosure will be maintained in the OGSP. These records will be maintained for three (3) years from the date of submission of the final expenditures report, or where applicable, from other dates specified in 45 C.F.R. 75.361 (see FAQ A.11) for different situations.
F. Enforcement Mechanisms, Remedies, and Noncompliance
i. Corrective Actions
If a financial conflict of interest is found, actions will be taken to manage, reduce, or eliminate the conflict. These corrective actions will be determined by the FCOI Committee. Corrective actions may include:
- Public disclosure of the significant financial interest (e.g. when presenting or publishing research, to staff working on the project, to the College’s IRB or Animal Use Committee. etc.)
- Removal of an investigator from the portion of the research affected by the SFI
- Disclosure of the significant financial interest to research participants
- Appointment of an independent monitor capable of protecting the research from bias resulting from the FCOI
- Modification of the research plan
- Change of personnel or personnel responsibilities
- Reduction or elimination of the financial interest
- Severance of relationships that create financial conflicts
- Other actions as appropriate
If HHS determines that a clinical research project evaluating the safety or effectiveness of a drug, medical device, or treatment is managed by an Investigator in violation of this policy or related regulations, the Investigator will be required to 1) disclose the financial conflict of interest in each public presentation of the results of the research, and 2) request an addendum to previously published presentations.
The OGSP Director will notify the Investigator of the committee’s decision and of any corrective action, including a FCOI Management Plan.
ii. Appeal Process
If the Investigator does not agree with the committee’s corrective actions, the Investigator can appeal in writing to the OGSP Director within ten (10) days after receipt of notification. The appeal must describe why such conditions and restrictions are inappropriate. The OGSP Director will consult with the President to determine whether a modification is necessary, and their decision will be final.
iii. Retrospective Reviews
If FCOI is not identified or managed in a timely manner, the Director of Grants will convene the FCOI Committee and complete a retrospective review. Retrospective reviews will be completed within 120 days of the determination of non-compliance. The documentation for the retrospective review shall include:
- The funding agency project number and project title,
- Project PD/PI contact information,
- Name of the Investigator with the FCOI,
- Name of the entity with which the Investigator has an FCOI,
- Reason(s) for the retrospective review,
- Methodology used for the retrospective review,
- Findings of the review, and
- Conclusions of the review.
If bias is found, the Director of Grants will notify the funding agency and promptly submit a mitigation report. This report will include information from the retrospective review and FCOI management plan. The report will be submitted annually.
iv. FCOI Management Plan
The FCOI Committee may conduct factual inquiries, consultations, and recommendations as appropriate in order to formulate a financial conflict of interest management plan. The terms of the plan shall be consistent with all applicable legal and regulatory requirements, and the requirements of this policy.
The Management Plan will include at a minimum:
- The role and principal duties of the conflicted Investigator in the research project;
- Conditions of the Management Plan, which may include one or more of the actions described under section F.i. Corrective Actions above;
- How the Management Plan is designed to safeguard objectivity in the research project;
- Confirmation of the Investigator’s agreement to the Management Plan, and
- How the Management Plan will be monitored to insure Investigator compliance.
Before a research proposal is submitted, or a subaward agreement is issued, the College shall secure written assurance that the proposed subrecipient agrees to comply with all applicable PHS, NIH, and/or NSF policies on financial conflict of interest. If the proposed subrecipient has a publicly posted FCOI policy in compliance with PHS, NIH, and/or NSF policy, the subrecipient will provide a certification to the College that such FCOI policy complies with all applicable regulations. To the extent that the subrecipient does not have a compliant FCOI policy, the subrecipient will be required to comply with the College’s FCOI policy.
Subrecipients will be required to report FCOI to the College’s Director of Grants, prior to the expenditure of any funds, and within 45 days of discovering any FCOI. FCOI reported by a subrecipient Investigator will be reported to the PHS and/or NSF by the College on the subrecipient’s behalf.
H. Public Accessibility
Information concerning any FCOI related to an externally-funded research project that has been disclosed to the OGSP will be made publicly accessible. The OGSP web site will list the contact information where the public may request this information, and will respond to any request within five (5) business days. The response will include:
- The Investigator’s name, title, and role in the research project,
- The name of the entity giving rise to the SFI and FCOI,
- The nature of the FCOI, and
- The approximate dollar value of the FCOI.