Financial Conflict of Interest Policy for Grants (FCOI)

Policy Summary
Juniata College is required, by federal law (42 CFR Part 50 Subpart F), to comply with regulations pertaining to Financial Conflicts of Interest in government-funded research. As an institution that regularly competes for and receives federal funding for research, the College is required to have a written- and enforcement- policy on FCOI. The policy promotes objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under Public Health Service (PHS) and related components such as the National Institutes of Health (NIH) and Substance Abuse and Mental Health Services Administration (SAMHSA), as well as the National Science Foundation (NSF) grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest. The policy further provides a mechanism for all conflicts of interest for each award to be managed, reduced or eliminated prior to the expenditure of the award funds.

Definitions/Glossary
Disclosure of significant financial interests – an Investigator's disclosure of significant financial interests to an Institution.

Faculty institutional responsibilities – create educational policies to implement the academic program. Service to the student and the College including; teaching, academic advising, counseling in the faculty member's area of special competence, committee work, administrative duties such as departmental duties, research, writing, membership in professional societies, other means of professional self- improvement, and other responsibilities relating to the academic program as appropriate.

Financial conflict of interest (FCOI) – a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS/NSF-funded research.

FCOI report – an Institution's report of a financial conflict of interest to a PHS Awarding Component.

Financial interest – anything of monetary value, whether or not the value is readily ascertainable.

HHS – the United States Department of Health and Human Services, and any components of the Department to which the authority involved may be delegated.

Investigator – 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 PHS/NSF, or proposed for such funding, which may include, for example, collaborators or consultants.

Manage – taking action to address a financial conflict of interest, which can include reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.

NSF – the National Science Foundation.

PD/PI – a project director or principal investigator of a PHS/NSF-funded research project.

PHS – the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH). See https://www.hhs.gov/about/agencies/hhs-agencies-and-offices/index.html for a complete list of these organizations.

Research – a systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge relating broadly to scientific knowledge, including behavioral and social sciences research. The term encompasses basic and applied research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug). As used in this policy, the term includes any such activity for which research funding is available from a PHS Awarding Component or the NSF through a grant or cooperative agreement, whether authorized under the PHS Act, NSF Act or other statutory authority, such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award.

Senior/key personnel – the PD/PI and any other person identified as senior/key personnel by Juniata College in the grant application, progress report, or any other report submitted to the PHS/NSF by the College.

Significant financial interest –
College definition related to NIH funding 
(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator's spouse and dependent children) that reasonably appears to be related to the Investigator's institutional responsibilities:

(i) 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;

(ii) 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 Investigator (or the Investigator's spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or

(iii) Intellectual property rights and interests (e.g., patents, copyrights) in excess of $5,000, upon receipt of income related to such rights and interests.

(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel in excess of $5,000 received in the preceding 12 months (initial disclosure) related to the Investigators’ Juniata College responsibilities; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a Federal, state, or local government agency located in 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. Note: Reimbursed or sponsored travel from a foreign government, which includes local, provincial, or equivalent governments of another country or foreign institutions of higher education must be disclosed when such income is more than $5,000. The details of the disclosure will include, at minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.

(3) The term SFI does not include the following types of financial interests: salary, royalties, or other remuneration paid by the College to the Investigator if the Investigator is currently employed or otherwise appointed by the College, including intellectual property rights assigned to the College and agreements to share in royalties related to such rights; any interest in the College held by the Investigator, if the College is a commercial or for-profit organization; 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 located in 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; or income from any service on advisory committees or review panels for a Federal, state, or local government agency located in 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. Note: Income from seminars, lectures, or teaching engagements and from service on advisory committees or review panels received from a foreign government, which includes local, provincial, or equivalent governments of another country or foreign institutions of higher education must be disclosed when such income meets the threshold for disclosure (e.g., income more than $5,000).  See NIH’s FAQs E.36. and E.37. for more information.

NSF Definition
(1) A financial interest consisting of interests of the Investigator (and those of the Investigator's spouse and dependent children):
(i) that would reasonably appear to be affected by the research or educational activities funded or proposed for funding by NSF; or
(ii) in entities whose financial interests would reasonably appear to be affected by such activities.

(2) Significant financial interests can include 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 or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights).

(3) The term does not include:
(i) salary, royalties or other remuneration from the proposing organization;
(ii) any ownership interests in the organization, if the organization is an applicant under the Small Business Innovation Research Program (SBIR) or Small Business Technology Transfer Program (STTR);
(iii) income from seminars, lectures, or teaching engagements sponsored by public or non-profit entities;
(iv) income from service on advisory committees or review panels for public or nonprofit entities;
(v) an equity interest that, when aggregated for the investigator and the investigator’s spouse and dependent children, meets both of the following tests: does not exceed $5,000* 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
(vi) salary, royalties or other payments that, when aggregated for the investigator and the investigator’s spouse and dependent children, are not expected to exceed $5,000* during the prior twelve-month period.
*NOTE: Although current NSF regulations specify a higher threshold for SFI than PHS, Juniata College identifies $5,000 as the monetary threshold. Similarly, in non-publicly traded companies, PHS and Juniata identify any equity amount as the threshold.

Policy Applicability 
This policy applies to all people, regardless of title or position, who are responsible for the design, conduct, or reporting of research proposed for funding by the PHS /NSF, including collaborators or consultants. All Investigators applying for and working on PHS/NSF-funded research must disclose significant financial interests (SFIs) that are related to the Investigator’s institutional responsibilities and research. This procedure is mandated by 42 CFR Part 50 Subpart F— Promoting Objectivity in Research. This policy provides the structure to identify, evaluate and correct/remove apparent and potential financial conflicts of interest.

Policy
The Director of Grants and Foundation Relations will inform each Investigator of the Juniata College FCOI policy, the Investigator’s responsibilities regarding timely disclosure of significant financial interests, and federal regulations governing federally funded research prior to submitting an application to a federal funding agency. An electronic copy of the policy will be given to the Investigator, and it can also be found on the Juniata College website.

FCOI Training Procedures
All Investigators who plan to participate in or are participating in PHS/NSF-funded research must be informed of Juniata College’s FCOI policy, the Federal regulation 42 CFR Part 50.604(b), and the Investigator’s responsibility to disclose significant financial interests. All Investigators including subrecipient investigators must complete FCOI training, on NIH’s FCOI Training website, prior to the start of funded research and every four years thereafter. Investigators must also complete the Financial Interest Form: Screening Questions, according to the sponsor, with each grant application and submit it to the Grant Office. Training is also immediately required in cases where an Investigator is new to Juniata College and continues to serve as an Investigator in a funded project transferred from another institution to Juniata College or when Juniata has a policy change/update. The FCOI training tutorial can be found at: Office of Extramural Research, Financial Conflict of Interest Tutorial. Refresher training is required in the event an Investigator is not in compliance with Juniata College’s financial conflict of interest policy or management plan.

Training constitutes Investigators certifying by signature they have read and reviewed the Juniata College Financial Conflict of Interest Policy and submitting to the College a NIH FCOI training tutorial certificate of completion indicating the Investigator name and date of completion for the NIH’s “FCOI Training” on Regulation 42 CFR Part 50.604(b).

Investigator FCOI Disclosure Responsibilities
Investigators are required to disclose their foreign and domestic Significant Financial Interests (and those of the Investigator’s spouse and dependent children) related to the Investigator’s institutional responsibilities (e.g., research, research consultation, teaching, professional practice, etc.) that meet the regulatory definition of SFI, 42 CFR 50.603 and 50.604(e)(1)-(3):

1. no later than at the time of application for NIH-funded research. This should be done concurrently with the submission of the Juniata College internal grants and contracts electronic approval form;
2. within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new Significant Financial Interest; and
3. at least annually, in accordance with the specific project start and end date, during the period of award.

Investigators have an ongoing obligation to disclose Significant Financial Interests throughout the awarded project period. Investigators must update financial disclosures of Significant Financial Interests to their Institutions within thirty (30) days of acquiring or discovering (e.g., through purchase, marriage, or inheritance) a new Significant Financial Interest. The Director of Grants and Foundation Relations is the Institution’s designated official and will have sixty (60) days to review the Significant Financial Interest disclosure to determine whether the Significant Financial Interest is related to PHS/NIH/NSF-funded research, and along with an assigned ad hoc committee determine whether a Financial Conflict of Interest exists, and if so, implement, on at least an interim basis, a management plan with the Grants Compliance Coordinator that shall specify the actions that have been, or will be, taken to manage the Financial Conflict of Interest 42 CFR 

50.604(d).  If a Financial Conflict of Interest exists, the Institution must submit an FCOI report to the NIH within this same 60-day period.

Investigators must first complete and submit the Financial Interest Form: Screening Questions. If a significant financial interest is indicated, the Investigator must fill out the Financial Disclosure Form. An Investigator participating in any PHS/NIH/NSF-funded research must disclose SFIs annually by submitting an updated Financial Interest Form: Screening Questions and if a significant financial interest is apparent, the Financial Disclosure Form.

All federal, state, and local laws, and the guidelines, policies or regulations for specific grants and contracts must also be considered and met. Federal program specific forms must also be completed by faculty, staff and/or administrator involved in a particular grant or contract. Collaborators, sub-recipients and /or subcontractors from other institutions involved in projects of Juniata must also comply with the Financial Conflict of Interest policy or provide a certification that they are in compliance with the policies of their institutions.

Review and Monitoring Requirements
Juniata College’s Director of Grants and Foundation Relations will solicit and review the initial Financial Interest Form: Screening Questions and all Financial Disclosure Forms of SFIs of every Investigator (and those of the Investigators’ spouse and dependent children)  to determine whether an Investigator's SFI is related to PHS/NIH-funded research and, if so related, whether the SFI is an FCOI 42 CFR 50.604(f).

An SFI is related to PHS/NIH-funded research when the Institution through the Director of Grants and Foundation Relations, reasonably determines that the SFI: 

• could be affected by the PHS/NIH/NSF-funded research; or 
• is in an entity whose financial interest could be affected by the research.

An Investigator may be involved in making the determination of whether the SFI is related to PHS/NSF-funded research.

If the Director of Grants and Foundation Relations reasonably determines that the SFI is related to the PHS/NSF-funded research, an ad hoc committee will be appointed by the College to determine if an FCOI exists. An FCOI exists when the Director of Grants and Foundation Relations and the ad hoc committee reasonably determine that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS/NSF-funded research.

In the case an SFI is determined to be a FCOI, Juniata College will manage the FCOI at its discretion 42 CFR 50.605(a)(1). This may include full public disclosure of the FCOI (e.g., in presentations, publications, to research personnel working on the study, etc.), appointment of an independent monitor, modification of the research plan, removal of the Investigator from the PHS/NSF- funded research, etc.  See NIH’s FAQ F.1. for more strategies that may be imposed to manage an FCOI.

In NSF-funded research, if the reviewer(s) determines that imposing conditions or restrictions 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 reviewer(s) may allow the research to go forward without imposing such conditions or restrictions.

In the case a new Investigator begins to work on the PHS/NSF-funded research project or an existing Investigator discloses a new SFI, the Director of Grants and Foundation Relations shall within 60 days review the SFI disclosures, determine whether an FCOI exists, and, if so, implement a management plan that specifies the actions that have been and will be taken to manage the FCOI 42 CFR 50.605(a)(2).

In the case Juniata College identifies an SFI that was not disclosed timely by an Investigator or was not previously reviewed by Juniata College during an ongoing PHS/NSF- funded research project, the Director of Grants and Foundation Relations shall within 60 days review the SFI disclosures, determine whether an FCOI exists, and, if so, implement a management plan that specifies the actions that have been and will be taken to manage the FCOI going forward 42 CFR 50.605(a)(3)(i)-(iii). The Grants Compliance Coordinator will continually manage FCOIs records and reminders of all Investigators, including those of a subrecipient Investigator, if applicable, and monitor Investigator compliance with management plans until completion of the project 42 CFR 50.604(g) and 50.605(a)(4).

Reporting Requirements
PHS Requirements
Juniata College must send initial, annual, and revised FCOI reports, if applicable, including all required information defined in 42 CFR 50.604(h)(3) or NIH’s FAQ H.5., to the NIH via the eRA Commons FCOI Module for the Institution and its subrecipients, as follows 42 CFR 50.605(b):

1. Prior to the expenditure of funds
2. Within 60 days of identification for an Investigator who is newly participating in the project.
3. Within 60 days for new, or newly identified, FCOIs for existing Investigators.
4. At least annually, at the same time as Juniata College is required to submit the annual progress report, multi-year progress report, if applicable, or at time of extension). The annual report will provide the status of the FCOI and any changes to the management plan, if applicable, until completion of the project. FCOI reporting will end during the period of an award if a submitted annual FCOI report indicates that the FCOI “No Longer Exists.”
5. After a retrospective review to update a previously submitted report, if new information is discovered following completion of the review 42 CFR 50.605(a)(3)(iii).

Based on the results of a retrospective review, Juniata College must notify NIH promptly if bias is found with the design, conduct, or reporting of PHS-funded research and submit the required Mitigation Report. A Mitigation Report will be submitted to detail the action(s) taken to mitigate the effects of the bias in accordance with 42 CFR Part 50.605(a)(3)(iii). The Mitigation report includes the key elements of the retrospective review plus information to explain what action(s) have been or will be taken to mitigate the effects of the bias (i.e., a description of the impact of the bias on the research project and the College’s plan of action or actions taken to eliminate or mitigate the effect of the bias). Juniata College will report all elements (e.g., entity name, Investigator with the FCOI, nature of the SFI(s), value of the SFI(s), etc.) as required by 42 CFR Part 50.605(a)(3)(iii).

Juniata College must notify NIH promptly if any Investigator fails to comply with Juniata College’s FCOI policy or if an FCOI management plan appears to have biased the design, conduct, or reporting of the PHS-funded research 42 CFR 50.606(a). Juniata College will take corrective action for noncompliance with Juniata College’s FCOI policy or the management plan.

NSF Policy
In the case of NSF-funded research, if Juniata finds that it is unable to satisfactorily manage a conflict of interest and if it finds that research will proceed without the imposition of conditions or restrictions when a conflict of interest exists, the college will keep NSF’s Office of the General Counsel (OGC) appropriately informed.

Record Maintenance
The Grants Compliance Coordinator will maintain college records relating to all Investigator disclosures of financial interests and Juniata’s review of, and response to, such disclosures (whether or not a disclosure resulted in the Juniata's determination of a financial conflict of interest) and all actions under Juniata’s policy or retrospective review, if applicable; for at least three years from the date the final expenditures report is submitted to the NIH, or where applicable, from other dates specified in 45 CFR 75.361 for different situations. For NSF-funded projects, the records will be maintained for three years beyond the termination or completion of the grant to which they relate, or until the resolution of any NSF action involving those records, whichever is longer.

Enforcement Mechanisms and Remedies and Noncompliance
In the case an Investigator fails to comply with Juniata College’s FCOI policy or an FCOI management plan, employee sanctions or other administrative actions will be implemented 42 CFR 50.604(j). Sanctions may include restrictions on future submission of research proposals and other disciplinary actions up to and including dismissal in accordance with the faculty handbook. Members of the faculty have the right to appeal any sanction or disciplinary actions using the general grievance procedure outlined in the faculty handbook.

Juniata College will perform a retrospective review within 120 days of a determination of noncompliance when either an SFI is not disclosed timely or not previously reviewed or when an FCOI is not identified or managed in a timely manner 42 CFR 50.605(a)(3)(ii)(B), including:

1. Failure by the Investigator to disclose a significant financial interest that is determined by the College to constitute an FCOI.
2. Failure by the College to review or manage such a FCOI.
3. Failure by the Investigator to comply with the FCOI management plan.
4. The retrospective review will be documented and will include, at minimum 42CFR 50.605(a)(3)(ii)(B), the following:

1. 1. Project number
   2. Project title
   3. PD/PI and contact information
   4. Name of Investigator with the FCOI
   5. Name of the entity with which the Investigator has an FCOI
   6. Reasons for the retrospective review
   7. Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documentation reviewed)
   8. Findings of the review
   9. Conclusions of the review

In the case where a PHS-funded project includes clinical research to evaluate the safety or effectiveness of a drug, medical device or treatment has been designed, conducted, or reported by an Investigator with a FCOI that was not managed or reported by the College as required by 42 CFR 50.606(c), Juniata College will require the Investigator involved to 1) disclose the FCOI in each public presentation of the results of the research, and 2) request an addendum to previously published presentations.

Subrecipient Requirements

PHS Requirements
When applicable, Juniata College will comply with all subrecipient requirements according to 42 CFR 50.604(c) and NIH Grants Policy Statement 15.2.1. Juniata College will establish, via a written agreement, whether the subrecipient will follow Juniata College’s FCOI policy or the FCOI policy of the subrecipient 42 CFR 50.604©(1)(i)-(iii).

In the case of the latter:

1. Juniata College will obtain a certification from the subrecipient that its FCOI policy complies with the regulation.
2. Juniata College will include in the written subrecipient agreement a requirement for the subrecipient to report identified FCOIs for its Investigators in a time frame that allows the College to report identified FCOIs to the NIH as required by the regulation
3. Alternatively, Juniata College will include in the written subrecipient agreement a requirement to solicit and review subrecipient Investigator disclosures that enable the awardee Institution to identify, manage, and report identified FCOIs to the NIH.

NSF Requirements
If the organization carries out agency-funded research through subrecipients or collaborators, the organization must take reasonable steps to ensure that:

1. the entity has its own policies in place that meet the requirements of this policy; or
2. investigators working for such entities follow the policies of the primary organization.

Public Accessibility Requirements
Juniata College’s FCOI policy will be made publicly accessible on the Juniata College website by posting on the institution’s website 42 CFR 50.604(a) (also see NIH GPS 4.1.10). Information concerning identified FCOIs held by Investigator(s), as defined by the regulation, will be publicly accessible prior to the expenditure of funds. See FAQs in Section G.1. Public inquiries will be granted through a written email request to either the Director of Grants and Foundation Relations or the Grant Compliance Coordinator through email addresses posted prominently on the campus website, linked to the FCOI policy.

The publicly accessible information will:

1. Include the minimum elements as provided in the regulation.
2. Be made available within 5 business days of a written request.
3. Remain available for 3 years from the date the information was most recently updated.
4. The written response will contain a note that the correspondence is subject to updates, on at least the annual award date and within 60-days of the Institution's identification of a new financial conflict of interest, which should be requested subsequently by the requestor.

Date of Implementation
This procedure is effective the date of the last electronic approval signature from the Juniata College internal grants and contracts electronic approval form that must be submitted 72 hours prior to the time that a proposal is submitted to any external funding source.

Expiration or Review
This procedure and associated forms extend into perpetuity, unless:
1) Revised, in accordance with the procedures on revision.
2) Made obsolete by the implementation of a procedure that specifically supersedes this procedure.

Required Forms – to be posted

• Juniata College FCOI Policy review certification with signature
• Financial Interest Form: Screening questions

Additional PHS/NIH/NSF Required Forms – to be posted

• Juniata College Financial Disclosure Form (only if SFI exists)

Effective: 3/27/24