Policy Owner: Vice President of Academic Affairs
VP/Mission Area/ Cabinet Member: Academic Affairs
Policy Submitter: Katie Morford
Effective Date: April 28, 2020
Affected Constituents: Faculty, Staff
Contact Information: alee4@css.edu, 218-723-6072
I. Background
According to federal regulations (42 CFR Part 50, Subpart F; 45 CFR Part 94), The College of St. Scholastica (CSS) is responsible for ensuring that there is no bias in the design, conduct, and reporting of research funded by federal grants or cooperative agreements because of Investigator financial conflict of interest.
II. Purpose
This policy ensures that CSS will be compliant with the provisions of the 2011 Public Health Service Regulations (42 CFR Part 50, Subpart F), National Science Foundation Grantee Standards, and 45 CFR Part 94. It provides direction to faculty and staff for reviewing and disclosing any potential or actual conflict of interest.
III. Definitions
Significant Financial Interest: Significant financial interest includes any of the following:
- Any payments or equity interests in the 12 months preceding the disclosure that, when aggregated, exceed $5,000 in remuneration and/or in equity interest in any publicly traded entity.
- $5,000 in remuneration or any equity interest in a non-publicly traded entity that might affect the Investigator or the research.
- Reimbursed or sponsored travel, such as a conference trip paid for by a corporate sponsor.
Significant financial interest is not:
- Income from seminars, lectures, or teaching, and service on advisory or review panels for government agencies, institutions of higher education, academic teaching hospitals, medical centers, or research institutes affiliated with an institution of higher education.
- 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.
Investigator: An Investigator is the project director or Principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the Public Health Service or National Science Foundation, or proposed for such funding, which may include, for example, collaborators or consultants. This includes all senior and key personnel.
Institutional Official: The College of St. Scholastica’s Institutional Official is the Vice President for Academic Affairs.
IV. Policy
Applicability
This policy applies to the Investigators (faculty or staff) responsible for the design, conduct, or reporting of Public Health Service federally funded research projects, which includes the National Institutes of Health and the Health Resources and Services Administration; and National Science Foundation federally funded grant projects. This policy also applies to the spouses and dependent children of Investigators. This policy also applies to subrecipient Investigators, unless those Investigators are covered under an institutional Financial Conflict of Interest policy that meets the 2011 Public Health Service Regulations (42 CFR Part 50, Subpart F), National Science Foundation Grantee Standards, and 45 CFR Part 94.
Informing Investigators
The Foundation and Government Relations is responsible for informing potential Investigators of this policy, including applicable federal regulation and the Investigator’s disclosure requirements, and obtaining a signed disclosure form prior to the submission of an application for funds.
Foundation & Government Relations is responsible for notifying Investigators of active grants of their need to review the policy, including applicable federal regulation and the Investigator’s disclosure requirements. This notification will be completed via email on an annual basis.
Requirements
All Investigators must review this policy prior to submitting an application for Public Health Service or National Science Foundation federal funding and at least annually after receiving such federal funding. Investigators must disclose all significant financial interests to the College. Investigators must affirm via signature that they understand and will comply with this policy. Failure to comply with this policy may result in disciplinary action up to and including termination. The disclosures of all Investigators must be reviewed and any management plans approved prior to the expenditure of federal funds at the beginning of a project.
Disclosures from Investigators
Investigators must disclose any significant financial interests by completing the Financial Conflict of Interest Disclosure Form, available from Foundation and Government Relations. Investigators must disclose significant financial interest: (1) no later than at the time of application, (2) at least annually during the award period, (3) within 30 days of discovering or acquiring a new significant financial interest.
Foundation and Government Relations is responsible for securing a signed disclosure from all Investigators prior to proposal submission. The proposal will not be submitted unless all Investigators have complied with this requirement.
The Grants Management Specialist will be responsible for monitoring the completion of annual disclosures and forwarding the names of any non-compliers to the Institutional Official 30 days after the initial notification. The Institutional Official will contact Human Resources regarding disciplinary action if non-compliance is ongoing beyond 30 days.
Individual Investigators are responsible for notifying Foundation and Government Relations and completing a disclosure within 30 days of discovering or acquiring a new significant financial interest. Disclosures will be reviewed annually and as needed when proposals are submitted, new Investigators join CSS, and when Investigators discover and disclose a new significant financial interest.
The Vice President of Academic Affairs is the Institutional Official designated to determine if any significant financial interest could directly and significantly affect the design, conduct, or reporting of the federally funded project, thus indicating a financial conflict of interest. If the significant financial interest is determined to be a financial conflict of interest, the Institutional Official will determine the steps needed to manage, reduce, or eliminate the conflict of interest.
Foundation and Government Relations will provide initial review and recommendations regarding the existence of a financial conflict of interest and appropriate management steps.
Disclosures to Funding Agencies
The College will disclose financial conflicts of interest to the appropriate federal agency prior to the expenditure of funds, annually during the award period, and within 60 days of discovering or acquiring a new significant financial interest. Foundation and Government Relations will be responsible for providing such disclosure based on the Institutional Official’s review of disclosures submitted prior to the expenditure of funds, new Investigators joining a project, newly identified financial conflicts of interest, annually, and following a retrospective review.
These reports will include the project number, Principal Investigator contact information, the name of the Investigator with a financial conflict of interest, the entity with which the Investigator has a financial conflict of interest, the nature of the interest, the value of the financial interest, description of how the financial interest relates to the project and the justification for CSS’s determination that the significant financial interest constitutes a financial conflict of interest, a description of the management plan, and other information as needed.
Public Disclosures
This policy will be publicly available on the CSS website. Additionally, Investigators who are determined to have a financial conflict of interest related to Public Health Service-funded research will have their financial conflict of interest information posted on a CSS webpage. This information will include the Investigator name, Investigator title, Investigator role, financial
conflict of interest entity, nature of interest, approximate dollar value, and date of financial conflict of interest review. This posting list will be updated annually and within 60 days of a newly identified financial conflict of interest by the Grants Management Specialist. The postings will remain listed for three years from the date of last financial conflict of interest update
Training
Investigators must complete financial conflict of interest training prior to starting a new grant- funded project, at least every four years, and immediately if: (1) CSS revises its Financial Conflict of Interest Policy in a way that impacts Investigator requirements, (2) An Investigator is new to CSS, or (3) An Investigator is not in compliance with the policy or a management plan. Training must be completed within 30 days of any of these instances.
Training will be offered via the Collaborative Institutional Training Initiative (CITI) Conflict of Interest Training module. Instructions for the training will be provided during proposal preparation, annually in policy reminder emails, and upon request. The Director of Institutional Research will be responsible for providing financial conflict of interest training completion records to the Grants Management Specialist upon request.
Subawards
Subawards made by CSS must incorporate language that establishes an applicable financial conflict of interest policy, whether that be requiring subrecipients to follow CSS’s conflict of interest policy or their own institutional conflict of interest policy. The Grants Management Specialist is responsible for incorporating this language into subawards.
Such language will indicate if CSS has obtained certification that a subrecipient financial conflict of interest policy complies with applicable regulations or a requirement that the subrecipient provide disclosures to be evaluated according to CSS policy. Additionally, language included in a subaward will include a requirement for the subrecipient to report identified financial conflict of interest in a timeframe that allows CSS time to report identified financial conflict of interest to the federal awarding agency in an appropriate manner.
Records
Financial conflict of interest records will be maintained by Foundation and Government Relations for at least three years from the date of submission of final expense reporting for a federally funded project or longer if any of the conditions outlined in 45 CFR 74.53(b) and 92.42(b) apply. The College will make records available upon request to federal agencies.
Review of Noncompliance
The College will respond to noncompliance by completing and documenting a retrospective review of the Investigator’s activities and the federally funded project to determine if there was bias in the design, conduct, or reporting. This review will be completed by the Foundation and Government Relations within 30 days and reviewed by the Institutional Official within 60 days of the discovery of noncompliance.
The appropriate federal agency will be notified within the 60-day timeframe, including the submission of a mitigation report and all information required by regulation, as appropriate. These reports will include the project number, Principal Investigator contact information, the name of the Investigator with financial conflict of interest, the entity with which the Investigator has a financial conflict of interest, the nature of the interest, the value of the financial interest, description of how the financial interest relates to the project and the justification for CSS’s determination that the significant financial interest constitutes a financial conflict of interest, a description of the management plan, and other information as needed.
Management Plans
If required, management plans must be prepared by the Investigator, approved by Foundation and Government Relations and approved by the Institutional Official. Management plans must include the role and duties of the conflicted Investigator, conditions of the plan, how the plan design will safeguard objectivity in project design, confirmation of the Investigator’s agreement to follow the plan, and how the plan will be monitored to ensure Investigator compliance.
The Grants Management Specialist will be responsible for monitoring management plans and notify the Institutional Official of failures to comply with a financial conflict of interest management plan or appearance of bias in the design, conduct, or reporting of the project. If such issues are found, the Institutional Official will direct Foundation and Government Relations to notify the relevant federal agency promptly and be responsible for directing appropriate corrective action.
Retrospective Review
CSS will complete and document a retrospective review within 120 days of the Institution’s determination of noncompliance for significant financial interest or whenever a financial conflict of interest is not identified or managed in a timely manner. These reviews will be conducted by Foundation and Government Relations at the direction of the Institutional Official in accordance with relevant regulations.
Clinical Research
Any case where Public Health Service-funded research projects involve clinical research for the purpose of evaluating the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted or reported by an Investigator with an financial conflict of interest that was not managed or reported by CSS as required by regulation, CSS shall require the Investigator to disclose financial conflict of interest in each public presentation of the research results and to request an addendum to previously published research.