Clinical Research System Policy

Conflict of Interest Policy Applicable to a Subaward Issued Under a Public Health Services Prime Award

Submitted by: Chris Schulze
Approved by: Tim Jones, DO

Purpose

The federal Public Health Service (PHS) has adopted regulations (42 CFR Part 50 Subpart F and 45 CFR Part 94) on Promoting Objectivity in Research. These regulations describe the actions an individual and an organization must take in order to promote objectivity in research.

Policy

The regulations require that investigators submitting applications for funding on behalf of a subrecipient, where the prime sponsor is PHS (e.g., funding from the National Institutes of Health, the Food and Drug Administration, the Centers for Disease Control), prior to the submission of the subaward application to the PHS Grantee organization, disclose to Cox Medical Centers any significant financial interests related to their institutional responsibilities at Cox Medical Centers. 

Scope

The regulations apply to all PHS funded grants, cooperative agreements, research contracts (but not Phase 1 Small Business Innovation Research or Small Business Technology Transfer program grants) and subawards where the originating sponsor is PHS.

Definitions

PHS Grantee is the organization that receives a prime award directly from PHS and under that prime award the PHS Grantee issues a subaward to a subrecipient. This policy may also be used for those subawards under a non-PHS sponsor adopting the PHS Promoting Objectivity in Research regulations. 

Institutional responsibilities means an Investigator’s professional activities on behalf of Cox Medical Centers; administration, research or clinical care. 

Investigator means 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 a subaward, or proposed for such funding, which may include, collaborators or consultants. Cox Medical Center’s Principal Investigator/Project Director, upon consideration of the individual’s role and degree of independence in carrying out the work, will determine who is responsible for the design, conduct, or reporting of the research.

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 appear to be related to the Investigator’s institutional responsibilities on behalf of Cox Medical Centers.

a. 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 for the investigator, investigator’s spouse and dependent children, 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, honor aria, 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; 

b. 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 

c. With regard to intellectual property rights and interests (e.g., patents, copyrights), a significant financial interest exists upon receipt of income of greater than $5,000 related to such rights and interests. 

d. Third party reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and/or the Investigator’s spouse/dependent children) of greater than $5,000 that is related to the Investigator’s institutional responsibilities (i.e., administrative, teaching, research, or clinical activities) must be disclosed to (Insert Name of Your Organization). The details of this disclosure will include at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination and the duration. This disclosure requirement excludes travel paid for by (Insert Name of Your Organization) and does not apply to travel that is reimbursed or sponsored by an U.S. federal, state, or local government agency, an U.S. 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. 

a. Salary, royalties, or other remuneration paid by Cox Medical Centers to the Investigator if the Investigator is currently employed or otherwise appointed by Cox Medical Centers, including intellectual property rights assigned to the Cox Medical Centers and agreements to share in royalties related to such rights; 

b. 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; 

c. Income from seminars, lectures, or teaching engagements sponsored by an U.S. 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 

d. Income from service on advisory committees or review panels for an U.S. 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. 

Review by Cox Medical Center’s Designated Officials

Cox Medical Centers’ designated officials are the Institutional Official and Human Protections Administrator as listed on the federal wide assurance. The designated officials may invite consultation, as appropriate, on to assist with review at their discretion. 

The designated officials will conduct reviews of disclosures. The designated officials will review any SFI that has been identified in a disclosure; these interests will be compared to each research subaward funded under a PHS prime award on which the Investigator is identified as responsible for the design, conduct, or reporting of the research to determine if the SFI is related to the award and, if so, whether the SFI creates a Financial Conflict of Interest (FCOI) related to that research subaward. 

Guidelines for Determining “Relatedness” and Financial Conflict of Interest 

The designated officials will determine whether an Investigator’s SFI is related to the research under a subaward supported by a PHS prime award and, if so, whether the SFI is a financial conflict of interest. An Investigator’s SFI is related to the research under the subaward when the designated officials reasonably determines that the SFI: could be affected by the research conducted under the subaward; or is in an entity whose financial interest could be affected by the research. The designated officials may involve the Investigator in the determination of whether a SFI is related to the research supported by the subaward. 

A financial conflict of interest exists when the designated officials reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS-funded research. 

In determining if an Investigator’s SFI is related to the research under a subaward supported by a PHS prime award, and if so, whether the relationship creates a FCOI, the designated officials consider the role of the Investigator and the opportunity (if any), to bias the results, the nature of the research being proposed and the value of the SFI in relation to the size and value of the entity. In addition, the designated official may also consider the following factors: 

a. Whether the research is of a basic or fundamental nature directed at understanding basic scientific processes; or 

b. Whether the degree of replication and verification of research results is such that immediate commercialization or clinical application is not likely; or 

c. Whether the goal of the research is to evaluate an invention linked to the SFI (such as where the SFI is a patent, or an interest in a company that has licensed the invention); or 

d. Where the research involves human subjects, whether there are double blind conditions or the involvement of a data and safety monitoring board; or 

e. Where the SFI is in a privately held company, whether the researcher’s SFI could result in the researcher having influence over company decisions, or whether the research could have a significant impact on the company’s business or financial outlook (excluding Phase I SBIRs and STTRs); or 

f. The magnitude of the SFIs (e.g., the amount of consulting, or the percentage or value of equity); or 

g. Where the SFI is in the sponsor of the research, and the sponsor is a licensee of the Discloser’s technology, the amount of commercialization payments received by the Investigator from that technology, both currently or in the future; or 

h. The number and nature of relationships an Investigator has with an entity. Multiple entanglements can create a relationship with an outside entity that is stronger than the sum of the parts; or 

i. Whether the goal of the research is to validate or invalidate a particular approach or methodology that could affect the value of the SFI; or 

j. Whether other scientific groups are independently pursuing similar questions; or 

k. Whether sufficient external review of the research conducted and the reporting of research results exist to mitigate undue bias; or 

l. Whether the goal of the project is a comparative evaluation of a technology in which an Investigator has a SFI; or 

m. Whether the project involves a subaward to an entity in which the Investigator has a SFI. 

Management of Significant Financial Interests that Pose Financial Conflict(s) of Interest 

If a conflict of interest exists, the designated officials will determine by what means – such as the individual’s recusal from decisions affecting the conflicting entity, abstention from the external activity, modification of the activity and/or monitoring of the activity by a subcommittee – the conflict should be avoided or managed in order to mitigate undue bias. In making those determinations, the designated officials will be guided by the principles discussed in this Policy the designated officials will also take into consideration whether the Investigator’s ongoing role is necessary to continue advancing the research, based upon the factors such as the uniqueness of his or her expertise and qualifications. 

Examples of conditions that might be imposed to manage a financial conflict of interest include, but are not limited to: 

a. Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research); 

b. For research projects involving human subjects research, disclosure of financial conflicts of interest directly to human participants; 

c. Appointment of an independent monitor capable of taking measures to protect the design, conduct and reporting of the research against bias resulting from the financial conflict of interest; 

d. Modification of the research plan; 

e. Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research; 

f. Reduction or elimination of the financial interest (e.g., sale of an equity interest); 

g. Severance of relationships that create financial conflicts; 

h. For research projects involving human subjects research, use of a data and safety monitoring board; 

i. Double-blind conditions; 

j. Provisions to conduct the work simultaneously at multiple sites; 

k. Written disclosure of the conflict to all individuals working on the research project; 

l. Annual reports on the research progress to the designated officials. 

No expenditures on a subaward supported by a PHS prime award will be permitted until the Investigator has complied with the Disclosure requirements of this Policy and has agreed, in writing, to comply with any plans determined by the designated officials necessary to manage the Conflict of Interest. The designated officials will communicate, in writing, with the PHS Grantee to notify it of the existence and the nature of a Financial Conflict of Interest and whether the conflict has been managed, reduced, or eliminated. No expenditures can be incurred until the PHS Grantee has reported the FCOI to PHS. The PHS Grantee will notify Cox Medical Center when it may incur expenditures. 

The designated officials will keep a record of Investigator disclosures of financial interests and the designated official’s review of, and response to, such disclosure and all actions under this policy. Such records will be maintained and kept for at least three years from the date the final expenditures report is submitted and in accordance with the terms and conditions of the subaward and relevant PHS Regulations. 

Public Accessibility to Information Related to Financial Conflicts of Interest 

Prior to the expenditure of any funds under a subaward funded by a PHS prime award, Cox Medical Centers will ensure public accessibility, via a publicly accessible website or by written response to any requestor within five business days of a request, of information concerning any SFI disclosed that meets the following three criteria: 

a. The Significant Financial Interest was disclosed and is still held by the senior/key personnel. Senior/key personnel are the PD/PI and any other person identified as senior key personnel Cox Medical Centers in the subaward application to the PHS Grantee, progress report or any other report submitted to the PHS Grantee; 

b. Cox Medical Centers has determined that the Significant Financial Interest is related to the research funded through a subaward; and 

c. Cox Medical Centers has determined that the Significant Financial Interest is a financial conflict of interest. 

a. The Investigator’s name; 

b. The Investigator’s title and role with respect to the research project; 

c. The name of the entity in which the Significant Financial Interest is held;

d. The nature of the Significant Financial Interest; and The approximate dollar value of the Significant Financial Interest in the following ranges: $0-$4,999; $5,000-9,999; $10,000 - $19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000), or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value. 

If Cox Medical Centers responds to written requests for the purposes of public accessibility, it will ascertain from the Investigator that the information provided is current as of the date of the correspondence, and will note in its written response that the information is subject to updates, on at least an annual basis and within 60 days of the Cox Medical Centers’s identification of a new financial conflict of interest, which should be requested subsequently by the requestor. 

Information concerning the Significant Financial Interests of an individual, as limited by this Policy, will remain available, for responses to written requests or for posting via Cox Medical Center’s publicly accessible website for at least three years from the date that the information was most recently updated. 

Reporting of Financial Conflicts of Interest 

Prior to the expenditure of any funds under a subaward funded by a PHS prime award, Cox Medical Centers will provide to the PHS Grantee a FCOI report compliant with PHS regulations regarding any Investigator’s Significant Financial Interest found to be conflicting and will ensure that the Investigator has agreed to and implemented the corresponding management plan. Cox Medical Centers cannot incur expenditures until it has received notification to do so from the PHS Grantee. 

While the subaward is ongoing (including any extensions with or without funds), Cox Medical Centers will provide to the PHS Grantee an annual FCOI report that addresses the status of the FCOI and any changes in the management plan. 

For any Significant Financial Interest that is identified as conflicting subsequent to an initial FCOI report during an ongoing PHS-funded research project (e.g., upon the participation of an Investigator who is new to the research project), Cox Medical Centers will provide to the PHS Grantee, within forty five days, an FCOI report regarding the financial conflict of interest and ensure that Cox Medical Centers has implemented a management plan and the Investigator has agreed to the relevant management plan. 

Training Requirements 

Each Investigator must complete training on Cox Medical Centers’ Conflict of Interest Policy Applicable to A Subaward Issued Under A Public Health Services Prime Award prior to engaging in research related to any PHS-funded subaward and at least every four years, and immediately (as defined below) when any of the following circumstances apply: 

a. Cox Medical Centers revises this Policy, or procedures related to this Policy, in any manner that affects the requirements of Investigators (training is to be completed within the timeframe specified in communications announcing such changes); 

b. An Investigator is new to Cox Medical Centers research under a subaward issued under a PHS prime award (training is to be completed prior to his/her participation in the research); or 

c. Cox Medical Centers finds that an Investigator is not in compliance with this Policy or a management plan issued under this Policy (training is to be completed within 30 days in the manner specified by the designated officials). 

Failure to Comply with Cox Medical Centers’ Conflict of Interest Policy Applicable to Public Health Service Funded Subaward 

When a FCOI is not identified or managed in a timely manner, including, for example, because the underlying Significant Financial Interest is not disclosed timely by an Investigator or, because a FCOI was not timely reviewed or reported by a second tier subrecipient or by Cox Medical Centers; or because an investigator failed to comply with a management plan; then Cox Medical Centers will within 90 days: 

a. Complete a retrospective review of the Investigator’s activities and the research project to determine any bias in the design, conduct or reporting of research; 

b. Document the retrospective review consistent with the regulation; 

c. Document Cox Medical Centers’s determination as to whether any research, or portion thereof, conducted during the period of time of the Investigator’s non-compliance with this Policy or a Financial Conflict of Interest management plan, was biased in the design, conduct, or reporting of such research; and 

d. Notify the PHS Grantee in writing. 

a. Impact of the bias on the research project and 

b. Cox Medical Centers’ plan of action or actions taken to eliminate or mitigate the effect of the bias. 

Clinical Research 

If the PHS Grantee determines that one of its funded clinical research projects whose purpose is to evaluate the safety or effectiveness of a drug, medical device or treatment has been designed, conducted or reported by an Investigator with a Financial Conflict of Interest that was not managed or reported by Cox Medical Centers, shall require the Investigator involved to disclose the Financial Conflict of Interest in each public presentation of the results of the research and to request an addendum to previously published presentations. 

Failure to Comply with This Policy 

No expenditures of funds on a subaward supported by a PHS prime award will be permitted unless the Investigator has complied with the Disclosure requirements of this Policy and has agreed, in writing, to comply with any designated official-approved FCOI management plan. 

Any failure by an individual to adhere to this Policy may be cause for disciplinary action, including, in severe cases, termination, and termination of the subaward by the PHS Grantee. 

Disclaimer: Each subrecipient is legally required to independently assess the adequacy of its COI policy for purposes of compliance with legal requirements, including compliance with the PHS financial conflict of interest regulations, and with other federal, state, local and institutional requirements. This model policy is provided as a tool to assist in drafting the subrecipient’s own policy. No representation is made that this model policy complies with any organization’s particular legal requirements. Prior to finalizing or implementing this Policy, consult with appropriate legal counsel to determine its legal sufficiency. 

REFERENCES: 
42 CFR Part 50 Subpart F and 45 CFR Part 94

FORMS: 
Conflict of Interest evaluation form for PHS funded research