Compliance

Effective Date: January 1, 2021
Version 1.0
Summary/Scope

This Policy is made pursuant to the National Institutes of Health’s (NIH) requirements to implement a company FCOI policy in accordance with Federal Regulations for NIH funded projects. The purpose of the FCOI regulation is to promote 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) grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest.

References

42 CFR 50, Subpart F, “Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought.”

Definitions

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

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

Institution means any domestic or foreign, public or private, entity or organization (excluding a Federal agency) that is applying for, or that receives, PHS research funding (meaning PARC and/or SRI).

Investigator means the Project Director, Principal Investigator or any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding, which may include, for example, collaborators or consultants.

PHS means 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).

Significant financial interest means:

(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:

(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their institutional 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, an Institution of higher education 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 Institution of higher education. The Institution’s FCOI policy will specify the details of this disclosure, which will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. In accordance with the Institution’s FCOI policy, the institutional official(s) will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research.

(3) The term significant financial interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights; any ownership interest in the Institution held by the Investigator, if the Institution 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, an Institution of higher education 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 Institution of higher education; or income from service on advisory committees or review panels for a Federal, state, or local government agency, an Institution of higher education 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 Institution of higher education.

Functional Responsibilities

PARC NIH Contract Manager – The PARC Contract Manager (CM) will ensure that Investigators carry out their FCOI obligations as set forth in this policy.

Institutional Official – The PARC Director of Contract Management is the designated PARC FCOI institutional official(s), and has the following duties:

• Provide adequate guidelines consistent with the regulation for the designated institutional official(s) to determine whether an Investigator’s SFI is related to PHS-funded research and, if so related, whether the SFI is an FCOI
• Solicit and review disclosures of SFIs of the Investigator (and those of the Investigator’s spouse and dependent children) related to an Investigator’s institutional responsibilities;
• Establish a process to require the designated official(s), prior to Institution’s expenditure of funds, to:
  • Review all Investigator SFI disclosures
  • Determine if any SFIs relate to PHS-funded research
  • Determine if an FCOI exists (SFI that could directly and significantly affect the design, conduct, or reporting of the NIH-funded research)
  • Develop and implement management plans, as needed to manage FCOIs
• Microsoft Word – PARC FCOI Policy draft 6_11_2021 FINAL.docx
  • disclosures of SFIs, make determination of FCOIs,
    and implement a management plan when required for an Investigator who is new to participating in the research project or for an existing Investigator who discloses a new SFI.
  • disclosures of SFIs, make determination of FCOIs,
    and implement a management plan within sixty days whenever an Institution identifies an SFI that was not disclosed timely by an Investigator or not previously reviewed by the Institution.
  • and take such actions as necessary to manage FCOIs,
    including any financial conflicts of a subrecipient Investigator, if applicable, and monitor Investigator compliance with management plans until completion of the project.

Policy and Procedures

PARC is required to comply with the requirements of 42 CFR 50, Subpart F, “Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought.”
(FCOI Regulation), as implemented in the 2011 Final Rule for grants and cooperative agreements. FCOI requirements are aligned with 42 CFR Part 50 and the overarching goal for reporting is to promote and encourage transparency in order to avoid distorting NIH funding decisions.

The requirements under the 2011 revised regulation promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, or reporting of research funded under PHS grants or cooperative agreements will be free from bias by any conflicting financial interest of an Investigator

Investigator Obligations

Investigators planning to participate in the PHS-funded research disclose to the Institution’s designated official the Investigator’s significant financial interests (and those of the Investigator’s spouse and dependent children) using PARC’s SFI Form noted below, no later than the time of application for PHS-funded research.

Investigators are also required to submit an updated disclosure of significant financial interests annually from the date of project award and annually thereafter. Such disclosure shall include any information that was not disclosed initially to the Institution pursuant to paragraph, or in a subsequent disclosure of significant financial interests (e.g., any financial conflict of interest identified on a PHS-funded project that was transferred from another Institution) and shall

include updated information regarding any previously disclosed significant financial interest (e.g., the updated value of a previously disclosed equity interest).

Each Investigator participating in the PHS-funded research project must submit an updated disclosure of significant financial interests within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new significant financial interest.

Non-compliance to this Policy may result in disciplinary action, including termination of employment at PARC.

Reporting Requirements to the NIH

The PARC Institutional Official will send initial, annual, (i.e. ongoing) and revised FCOI reports, including all reporting elements required by the regulation, to the NIH for the Institution and its subrecipients (if applicable) as follows:

1. Prior to the expenditure of funds for a NIH project;
2. Within 60 days if the Investigator is new to a project;
3. Within 60 days for new, or newly identified, FCOIs for existing Investigators;
4. Annually as required to provide the status of the FCOI and any changes to the Management Plan, if applicable, until the completion of the project.
5. Following a retrospective review to update a previously submitted report, if appropriate.

In the event that bias is found with the design, conduct or reporting of NIH funded research, the PARC Institutional Official will promptly notify the NIH in writing and will include a Mitigation report in accordance with 42 CFR 50.605(a)(3)(iii).

The PARC Institutional Official shall maintain all FCOI related records for at least three years from the date the final expenditures report is submitted to NIH. Reference 42 CFR 50.604(i).

Requirements for Subrecipients

The Contract Manager shall ensure that any subrecipient(s) have a policy that meets the requirements of the applicable FCOI policy regulations, or whether the subrecipient shall adopt PARC’s FCOI policy. The determination shall be affirmed in the subrecipients certifications for the applicable project. Also, the CM shall ensure that the subrecipient agreement includes a term that requires the subrecipient to report identified FCOIs for its investigators in a time frame that allows PARC to report identified FCOIs to the NIH.

SFI Institutional Investigation Process

Upon receipt of a SFI report by an Investigator, the PARC Institutional Official will take the following actions:

• Review the SFI disclosure for completeness.
• Distribute the SFI disclosure to the PARC Head of Research, Head of Public Sector, and the applicable Lab Manager, and meet with them to review and discuss the SFI disclosure.
• If necessary, interview the Investigator to clarify and/or present finding.
• Meet with the PARC Head of Research, Head of Public Sector, and Lab Manager to present final determination.
• In the event of a FCOI finding, follow the NIH notification processes and take the appropriate mitigation actions.

Training:

Investigators are required to take the PARC training presentation prior to engaging in research related to any PHS funded grant, and additionally as follows:

(1) Every four years

(2) Immediately if:

Additional training may be taken at the following NIH site:
https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html

Forms/Resources/Other Regulations

• PARC SFI Disclosure Form
• PARC FCOI Training Presentation

NIH FCOI Website: https://grants.nih.gov/grants/policy/coi/index.htm

Other relevant HHS regulations:

Several other regulations and policies may apply to the primary CFR. They include, but are not necessarily limited to:

2 CFR part 376—Non-procurement debarment and suspension (HHS)

42 CFR part 50, subpart D—Public Health Service grant appeals procedure 45 CFR part 16—Procedures of the Departmental Grant Appeals Board

45 CFR part 75—Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards

45 CFR part 79—Program fraud civil remedies
[76 FR 53283, August 25, 2011, as amended at 81 FR 3006, Jan. 20, 2016]