Conflicts of Interest in Research for Public Health Services (PHS)

Policy: Financial Conflicts of Interest in Research for Public Health Services (PHS)
Effective Date: 11/01/12
Update: 12/03/19; 12/14/2020
Revision No. 3
Approval: Vice President for RIPS

Introduction

Northern Illinois University (NIU) strives for excellence in research. In order to reach this goal the public's trust is required. Maintaining public trust means ensuring NIU's research activities are not perceived as biased by financial and/or business relationships.

It is accepted NIU faculty members, and their families, may have financial relationships outside the university. NIU must be aware of these relationships to make sure there is no room for perceived bias in PHS funded research. If there is a possibility of perceived bias, a financial conflict of interest (FCOI) exists and it is NIU's responsibility to eliminate, reduce, or manage the FCOI.

This policy expands upon NIU’s Academic Conflicts of Interest (COI) Policy. It is applicable to all PHS funded investigators and is in accordance with 42 CFR 50, Subpart F, and 45 CFR 94.

NIU requires that any PHS sub-recipients at other institutions verify in writing their institution has a FCOI policy equal to or more stringent than NIU's policy. If the sub-recipient institution does not have a FCOI policy they must agree in writing to follow NIU's policy.

Definitions

“Financial Conflict of Interest” means a significant financial interest that is related to a research program or project and could directly and significantly affect the design, conduct or reporting of that research.

“Institutional Responsibilities” means the Investigator’s professional responsibilities on behalf of the university including, but not limited to, activities such as research, consultation, teaching, professional practice, institutional committee membership, and service on panels such as Institutional Review Boards or Data and Safety Monitoring boards.

“Investigator(s)” means the principal investigator/project director, co-principal investigator, and any other person who is responsible or involved in the design, conduct, or reporting of research, instructional or service activities funded, or proposed for funding, by an external sponsor. For the purposes of the requirement relating to financial interest, investigator includes spouses and dependent children.

“Research” means any systematic investigation designed to develop or contribute to generalizable knowledge. The term encompasses basic and applied research and product testing and development. It includes any activity for which research funding is available from a Public Health Service component that awards funds under grants, cooperative agreements, or otherwise.

"Significant Financial Interest" A financial interest consisting of one or more of the following interest of the Investigator (and/or those of the Investigator's spouse and/or dependent children) that reasonably appears to be related to the Investigator's institutional responsibilities:

1. Publicly traded entity
   • 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 the disclosure, when aggregated, exceeds $5,000.
   • Includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship, travel, reimbursement). Equity Interests include any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.
2. Non-publicly traded (private) entity
   • Remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or the Investigator (or the Investigator’s spouse of dependent children) holds any equity interest.
3. Intellectual property rights and interests (e.g., patents, copyrights,) upon receipt of any income related to such rights and interest in the past twelve months.
4. Any reimbursed or sponsored travel (i.e., that which is paid on behalf of the investigator so that the exact monetary value may not be readily available) related to their institutional responsibilities.

The term does not include the following:

1. Salary, royalties, or other remuneration from the University;
2. Income from seminars, lectures, or teaching engagements sponsored by a federal, state or local agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education;
3. Income from service on advisory committees or review panels for sponsored by a federal, state or local agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education;
4. Travel that is reimbursed or sponsored by a sponsored by a federal, state or local agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education;

Requirements

In accordance with Public Health Service (PHS) regulations (42 CFR 50) institutions receiving funds from any PHS agency must comply with the following requirements:

1. Investigators who are planning to participate in PHS-funded research must disclose their SFIs over the previous twelve-month period to their institution no later than at the time of the application for PHS-funded research.
2. Each investigator who is participating in PHS-funded research must submit an updated disclosure of SFIs at least annually, no later than January 15^th, during the period of award.
3. Each Investigator who is participating in the PHS funded research must submit an updated disclosure of SFIs within 30 days of discovering or acquiring a new SFI.
4. All PHS-funded investigators must complete FCOI training provided by Northern Illinois University prior to the expenditure of funds for any funded project. Thereafter training must be completed at least every four years and immediately under the designated circumstances:          
   • Institutional Financial Conflict of Interest policies change in a manner that affects Investigator requirements
   • An investigator is new to Northern Illinois University
   • Northern Illinois University finds that an Investigator is not in compliance with this Financial Conflict of Interest policy or a management plan.

Investigator Responsibilities

The principal investigator is responsible for:

1. Determining who meets the definition of investigator;
2. Ensuring and certifying that each investigator has disclosed his/her SFIs.
3. Ensuring and certifying that each investigator has completed the mandatory NIU sponsored training.
4. Complying with any management plan.

Institutional Responsibilities

The Office of Research Compliance, Integrity, and Safety (ORCIS) will collect and perform an initial review of all disclosed SFIs to determine if a FCOI exists. If a determination has been made that a FCOI does exist, the matter will be referred to the VPR for the final decision.

If a determination is made that there may be a potential or actual FCOI by the VPR, ORCIS will develop a management plan (see below) to address the FCOI.  This 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.

ORCIS will also report to the federal government funders if it believes an investigator’s significant financial interest could affect the research in accordance with 42 CFR 50, subpart F and 45 CFR 94.

Management Plan

When a Significant Financial Interest determined to constitute a Financial Conflict of Interest exists the RCRC may recommend a Conflict of Interest Management Plan.  The plan is developed after discussion by the RCRC and/or approval by the Institutional Review Board if human subjects are involved.  The following steps are required when implementing a management plan:

1. Signed Agreement The investigator signs an agreement accepting the plan. Final IRB approval of the study is contingent upon this signed agreement.
2. Assurance of Continued Compliance Whenever an institution implements a management plan pursuant to this subpart, the institution shall monitor Investigator compliance with management plan on an ongoing basis until the completion of the PHS-funded research project.
3. Notification of Changes The investigator is responsible for notifying the ORCIS and IRB of any changes, in a timely manner, of his/her financial interests or relationships, so it can be determined whether further management is necessary.

An investigator may appeal the recommendation to the IRB for research pertaining to human subjects, or to the VPR itself for non-human subjects research. An investigator dissatisfied with his/her appeal may submit his/her disagreement in writing to the Provost for final resolution.

Non-Compliance

Retrospective Review

Identification of untimely or any delayed disclosure of an SFI by an investigator requires the ORCIS’ review within 60 days of determination: if it’s related to PHS funded research, and if an FCOI exists.  Such a determination requires:

1. Implementation – at least in the interim – of a management plan that specifies the actions that have been and will be taken to manage the FCOI moving forward; and
2. Completion of a retrospective review of the Investigator’s activities and the PHS-funded research to determine whether any PHS funded research or a portion of it, conducted during the noncompliance period was biased in the design, conduct or reporting of such research within 120 days of the Investigator’s noncompliance. Such noncompliance may have occurred due to the Investigator’s failure to disclose an SFI which is deemed an FCOI, the institution's failure to review or manage said FCOI, or the Investigator’s failure to comply with a management plan.

Mitigation Report

As appropriate, the institution shall update the previously submitted FCOI report specifying the actions taken to manage the FCOI moving forward. If the institution determines there was bias it must notify the PHS awarding component promptly and submit a mitigation report to that component. The mitigation report must include:

1. The key elements documented in the retrospective review and a description of the impact of the bias on the research project and the institution’s actions/action plan to eliminate or mitigate the effect of the bias
2. Subsequently the institution will submit annual reports, as per the regulation. Depending on the nature of the FCOI the institution may decide that additional interim measures are necessary regarding the Investigator’s participation in the PHS-funded research project between the date of the FCOI or the Investigator’s noncompliance is determined and the completion of the institution’s retrospective review.

Records

Records of the Investigator’s significant financial interests and NIU’s review and management of the SFI, will be retained by the university for (i) three years from the date of submission of the final expenditures report (in the case of grants and cooperative agreements); or (ii) three years from the final payment (in the case of research contracts), or (iii) resolution of any government action involving the records, or (iv) as otherwise required by law.

Public Accessibility

Prior to any expenditure of funds from a PHS supported study, NIU will ensure the FCOI information will be accessible to the public providing for written responses to requests within 5 business days based, on the following criteria, within reason:

• The SFI was disclosed and is still held by the senior/key personnel defined in the regulation; and
• NIU determines that the SFI is related to PHS-funded research; and
• NIU determines that the SFI is a FCOI.

NIU must make the following information available in writing (or on its website):

• The investigator’s name, title and role regarding the research project;
• Name of the entity in which the SFI interest is held;
• Nature of the SFI; and
• Approximate dollar value of the SFI (dollar ranges are permissible) or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measure of fair market value.