Conflicts of Interest in Public Health Service-Funded Research

This training module focuses on new federal regulations regarding financial conflicts of interest that apply to research funded by the Public Health Service. The Public Health Service (PHS) comprises all agency divisions of the U.S. Department of Health and Human Services. These agencies include the National Institutes of Health (NIH) and others, such as the: Centers for Disease Control and Prevention (CDC) Food and Drug Administration (FDA) Health Resources and Services Administration (HRSA) Substance Abuse and Mental Health Services Administration (SAMHSA)

These new regulations were published in August They are located in Title 42, Part 50, Subpart F of the Code of Federal Regulations (CFR). For convenience in this training module, the regulations will be referred to collectively as “Subpart F”. Click on the image if you would like to view Subpart F in a new browser window. Regulations on COI in PHS-funded research Subpart

The purpose of Subpart F is to establish standards which help to ensure that the design, conduct, and reporting of research funded under PHS grants will be free from bias resulting from Investigator financial conflicts of interest. Subpart F: Applies to each institution that is applying for, or receives, PHS research funding, and to each Investigator participating in such research. Assigns a number of responsibilities to DePaul Investigators and to the University for upholding standards that promote research objectivity.

After completing this training module, you will be able to: Define a number of key terms used in Subpart F. Recognize when a “Significant Financial Interest” (SFI) exists, and correctly determine when and how to disclose an SFI. Explain the difference between an SFI and a Conflict of Interest (COI). Explain what happens after an SFI is disclosed. Distinguish between the responsibilities of the Investigator and those of the University when it comes to disclosing and addressing SFIs.

Key TermsDefinition ResearchA systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health. InvestigatorThe project director or principal investigator and any other person, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding. Institutional responsibilities An Investigator’s professional responsibilities on behalf of the University, which includes activities such as research, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards. Significant Financial Interest (SFI) Anything of monetary value that meets one of the Subpart F disclosure requirements and is related to the Investigator’s institutional responsibilities Financial Conflict of Interest (FCOI) A significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research. Manage Taking action to address a financial conflict of interest to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias. FCOI reportThe University’s report of a financial conflict of interest to a PHS Awarding Component. PHS Awarding Component The organizational unit of the PHS funding the research that is subject to Subpart F.

Let’s focus on the term “Significant Financial Interest” (SFI), which is the key to understanding your responsibilities, as an Investigator, under Subpart F. An SFI = Anything of monetary value + Meets one of the Subpart F disclosure requirements + Related to your institutional responsibilities

Anything of monetary value Includes things whose financial value may be difficult to ascertain, for example, a copyright or patent.

Meets one of the Subpart F disclosure requirements Publicly traded entities Non-publicly traded entities Intellectual property Travel Click on each shape for more information, and then click the arrow to move to the next topic.

Meets one of the Subpart F disclosure requirements Publicly traded entities Non-publicly traded entities Intellectual property Travel Disclosure requirement applies when You, your spouse, and/or your dependent children (in aggregate) receive remuneration from any publicly traded entity in the past 12 months, or you hold an equity interest in the entity that When aggregated (remuneration + value of the equity interest), exceeds $5,000. AND Reasonably appears to be related to your institutional responsibilities. Except for the following: Salary, royalties, or other remuneration paid to you by DePaul University. Income from mutual funds and retirement accounts where you do not directly control the investment decisions. Income from seminars, lectures, teaching, or advisory committee or review panel service received from a government agency, an institution of higher education, or an academic teaching hospital.

Meets one of the Subpart F disclosure requirements Publicly traded entities Non-publicly traded entities Intellectual property Travel Disclosure requirement applies when You, your spouse, and/or your dependent children 1. Received remuneration from any non-publicly traded entity in the past 12 months, that Exceeds $5,000 AND Reasonably appears to be related to your institutional responsibilities. OR 2. Hold any equity in a non-publicly traded entity that reasonably appears to be related to your institutional responsibilities. Except for the following: Salary, royalties, or other remuneration paid to you by DePaul University. Income from mutual funds and retirement accounts where you do not directly control the investment decisions. Income from seminars, lectures, teaching, or advisory committee or review panel service received from a government agency, an institution of higher education, or an academic teaching hospital.

Meets one of the Subpart F disclosure requirements Publicly traded entities Non-publicly traded entities Intellectual property Travel Disclosure requirement applies when You, your spouse, and/or your dependent children (in aggregate) have intellectual property rights (e.g., patents, copyrights) From which you receive income. AND That reasonably appear to be related to your institutional responsibilities

Meets one of the Subpart F disclosure requirements Publicly traded entities Non-publicly traded entities Intellectual property Travel Disclosure requirement applies when You have engaged in reimbursed or sponsored travel in the past 12 months that: When aggregated, exceeds $5,000. AND Reasonably appears to be related

Related to your institutional responsibilities These are your professional responsibilities on behalf of the University, which include activities such as: Research Teaching Professional practice Institutional committee memberships Service on panels such as Institutional Review Boards

Scenarios Let’s apply this information about SFIs to some scenarios. As a starting point, assume this is the case: After reviewing each of the following scenarios, indicate whether, under the circumstances, you have an SFI. You are doing PHS-supported research aimed at determining the effectiveness of a survey instrument that may help to identify expectant mothers who are at risk for developing postpartum depression in the first few months after childbirth.

Scenario 1 The survey has been developed by a publicly traded company from which you received $4,500 in consulting income for your input on the survey design. You are doing PHS-supported research aimed at determining the effectiveness of a survey instrument that may help to identify expectant mothers who are at risk for developing postpartum depression in the first few months after childbirth. Yes No Yes, this is an SFI. No, this is not an SFI.

Scenario 1 Yes No Yes, this is an SFI. No, this is not an SFI. You answered Yes. However, this is NOT an SFI. YES__Involves something of monetary value. NO__Does not meet one of the Subpart F disclosure requirements. (Remuneration was received from a publicly traded entity, but the $5,000 threshold was not met.) YES__Related to your institutional responsibilities since you are conducting research on this topic as a DePaul faculty member. The survey has been developed by a publicly traded company from which you received $4,500 in consulting income for your input on the survey design. You are doing PHS-supported research aimed at determining the effectiveness of a survey instrument that may help to identify expectant mothers who are at risk for developing postpartum depression in the first few months after childbirth.

Scenario 1 Yes No Yes, this is an SFI. No, this is not an SFI. The survey has been developed by a publicly traded company from which you received $4,500 in consulting income for your input on the survey design. You answered No. Correct, this is NOT an SFI. YES__Involves something of monetary value. NO__Does not meet one of the Subpart F disclosure requirements. (Remuneration was received from a publicly traded entity, but the $5,000 threshold was not met.) YES__Related to your institutional responsibilities since you are conducting research on this topic as a DePaul faculty member. You are doing PHS-supported research aimed at determining the effectiveness of a survey instrument that may help to identify expectant mothers who are at risk for developing postpartum depression in the first few months after childbirth.

Scenario 2 You and your spouse have formed a start-up company that will market the survey to health- care providers. You own 40% of the start-up company. The remaining equity is held by other investors. You and your spouse have formed a start-up company that will market the survey to health- care providers. You own 40% of the start-up company. The remaining equity is held by other investors. Yes No Yes, this is an SFI. No, this is not an SFI. You are doing PHS-supported research aimed at determining the effectiveness of a survey instrument that may help to identify expectant mothers who are at risk for developing postpartum depression in the first few months after childbirth.

Scenario 2 Yes No Yes, this is an SFI. No, this is not an SFI. You and your spouse have formed a start-up company that will market the survey to health- care providers. You own 40% of the start-up company. The remaining equity is held by other investors. You and your spouse have formed a start-up company that will market the survey to health- care providers. You own 40% of the start-up company. The remaining equity is held by other investors. Correct - This is an SFI. YES__Involves something of monetary value. YES__Meets one of the Subpart F disclosure requirements. (Equity interest at any level in a privately-held entity.) YES__Related to your institutional responsibilities. You are doing PHS-supported research aimed at determining the effectiveness of a survey instrument that may help to identify expectant mothers who are at risk for developing postpartum depression in the first few months after childbirth.

Scenario 2 Yes No Yes, this is an SFI. No, this is not an SFI. You and your spouse have formed a start-up company that will market the survey to health- care providers. You own 40% of the start-up company. The remaining equity is held by other investors. You and your spouse have formed a start-up company that will market the survey to health- care providers. You own 40% of the start-up company. The remaining equity is held by other investors. Not quite - This IS an SFI. YES__Involves something of monetary value. YES__Meets one of the Subpart F disclosure requirements. (Equity interest at any level in a privately-held entity.) YES__Related to your institutional responsibilities. You are doing PHS-supported research aimed at determining the effectiveness of a survey instrument that may help to identify expectant mothers who are at risk for developing postpartum depression in the first few months after childbirth.

Scenario 3 Your spouse developed the survey and holds the copyright to it. She has received $2,500 in royalty payments from the survey publisher over the past year. Your spouse developed the survey and holds the copyright to it. She has received $2,500 in royalty payments from the survey publisher over the past year. Yes No Yes, this is an SFI. No, this is not an SFI. You are doing PHS-supported research aimed at determining the effectiveness of a survey instrument that may help to identify expectant mothers who are at risk for developing postpartum depression in the first few months after childbirth.

Scenario 3 Yes No Yes, this is an SFI. No, this is not an SFI. Your spouse developed the survey and holds the copyright to it. She has received $2,500 in royalty payments from the survey publisher over the past year. Your spouse developed the survey and holds the copyright to it. She has received $2,500 in royalty payments from the survey publisher over the past year. Correct - This is an SFI. YES__Involves something of monetary value. YES__Meets one of the Subpart F disclosure requirements. (Intellectual property rights from which you receive income at any level.) YES__Related to your institutional responsibilities. You are doing PHS-supported research aimed at determining the effectiveness of a survey instrument that may help to identify expectant mothers who are at risk for developing postpartum depression in the first few months after childbirth.

Scenario 3 Yes No Yes, this is an SFI. No, this is not an SFI. Your spouse developed the survey and holds the copyright to it. She has received $2,500 in royalty payments from the survey publisher over the past year. Your spouse developed the survey and holds the copyright to it. She has received $2,500 in royalty payments from the survey publisher over the past year. Not quite - This IS an SFI. YES__Involves something of monetary value. YES__Meets one of the Subpart F disclosure requirements. (Intellectual property rights from which you receive income at any level.) YES__Related to your institutional responsibilities. You are doing PHS-supported research aimed at determining the effectiveness of a survey instrument that may help to identify expectant mothers who are at risk for developing postpartum depression in the first few months after childbirth.

Scenario 4 The company that publishes and markets the survey you are assessing paid for you, your spouse, and your three children to attend a week-long company convention in Hawaii four months ago. Yes No Yes, this is an SFI. No, this is not an SFI. You are doing PHS-supported research aimed at determining the effectiveness of a survey instrument that may help to identify expectant mothers who are at risk for developing postpartum depression in the first few months after childbirth.

Scenario 4 Yes No Yes, this is an SFI. No, this is not an SFI. The company that publishes and markets the survey you are assessing paid for you, your spouse, and your three children to attend a week-long company convention in Hawaii four months ago. Correct - This is an SFI. YES__Involves something of monetary value. YES__Meets one of the Subpart F disclosure requirements. (Sponsored travel; value likely exceeds the $5,000 threshold based on market costs for air fare, lodging, and food.) YES__Related to your institutional responsibilities. You are doing PHS-supported research aimed at determining the effectiveness of a survey instrument that may help to identify expectant mothers who are at risk for developing postpartum depression in the first few months after childbirth.

Scenario 4 Yes No Yes, this is an SFI. No, this is not an SFI. The company that publishes and markets the survey you are assessing paid for you, your spouse, and your three children to attend a week-long company convention in Hawaii four months ago. Not quite - This IS an SFI. YES__Involves something of monetary value. YES__Meets one of the Subpart F disclosure requirements. (Sponsored travel; value likely exceeds the $5,000 threshold based on market costs for air fare, lodging, and food.) YES__Related to your institutional responsibilities. You are doing PHS-supported research aimed at determining the effectiveness of a survey instrument that may help to identify expectant mothers who are at risk for developing postpartum depression in the first few months after childbirth.

The Connection between an SFI and a COI A conflict of interest (COI) exists when a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of a sponsored project. In short, a COI exists when the potential for bias introduced by an SFI is significant. Your responsibility as an Investigator is to disclose your SFIs so a determination as to whether a COI exists can be made.

When and How to Disclose When to DiscloseHow to Disclose At the point of proposal submission. At any of these times, complete the Screening and Certifications for Sponsored Projects Form provided to you by the Office of Research Services. During the annual Conflict of Interest screening for multi-year sponsored projects. Within 30 days when new SFIs develop.

What happens when a SFI is Disclosed? Designated University Official Conflict of Interest Committee Management Plan Monitoring Reporting (as required) Public Access Record Retention Disclosures of SFIs are forwarded to the Designated University Official (in this case, the Director of Grants Compliance & Award Management, who reports to the AVP for Research). If the SFI is significant enough to create a conflict of interest, the COI Committee will develop a management plan in consultation with you to help ensure that the research conducted is free from bias. The Conflict of Interest (COI) Committee reviews the disclosure to determine whether the SFI could directly and significantly affect your PHS- funded research. The University submits the various COI reports required by Subpart F to the PHS entity that issued that award. The Designated University Official coordinates monitoring of COI management plan in consultation with the COI Committee. Any requests from the public regarding Investigator COIs are addressed by the University within the time frames established by Subpart F. Records involving all actions under Subpart F are included in the award files, which are retained by ORS and by Restricted Accounting for the required three-year period.

Training Requirement In addition to making the required disclosures of SFIs, Investigators receiving or requesting PHS funding most also complete training focused on Subpart F before engaging in PHS-funded research. This training must be renewed every four years. The good news is that completion of this module fulfills this PHS-specific training requirement for now, and you are almost done.

Thank you for completing this training module. To register your completion of this module, please click the pen to send your identifying information. Thank you for completing this training module. To register your completion of this module, please click the pen to send your identifying information.