USA Financial Conflicts of Interest Policy

1. Introduction

1.1 The University of Southampton (‘the University’) recognises the importance of undertaking our research responsibly and in accordance with the highest standards of ethics, integrity, openness, and accountability. 

1.2 This USA Financial Conflicts of Interest Policy (‘the Policy’) is a sub-policy to the University Conflicts of Interest Policy and has been developed to ensure that we comply with the USA Code of Federal Regulations (CFR), Title 42, Part 50, Subpart F – Promoting Objectivity in Research. 

1.3 The Policy’s aims are:

1.3.1To promote a culture of transparency and accountability in the conduct of the University’s research, preserve public trust in our research, and contribute to a strong reputation.

1.3.2 To promote objectivity in research by establishing standards and processes 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 financial conflicts of interest of the Investigator.

2. Policy Scope

2.1 This Policy applies to all University of Southampton staff and individuals working for or with the University (please see 2.4.1 and 2.4.2) who are:

2.1.1 Applying for, or in receipt of, funding from the Public Health Services (PHS) of the United States Department of Health and Human Services (HHS); AND

2.1.2 To all Investigators (please see 2.4.3) who are responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding.

2.2 PHS component organisations include, but are not limited to:

2.2.1 National Institutes of Health (NIH).

2.2.2 Centres for Disease Control and Prevention (CDC).

2.2.3 Food and Drug Administration (FDA).

2.2.4 Agency for Healthcare Research and Quality (AHRQ). 

2.2.5 Substance Abuse and Mental Health Services Administration (SAMHSA).

2.2.6 Agency for Toxic Substances and Disease Registry (ATSDR). 

2.2.7 Health Resources and Services Administration (HRSA).

2.2.8 Indian Health Service (IHS).

2.3 This Policy may also apply to University of Southampton staff and individuals working for or with the University (please see 2.4.1 and 2.4.2) who are applying for, or in receipt of, funding from other USA based funders, if they are following the requirements of the USA Code of Federal Regulations Title 42, Part 50, Subpart F – Promoting Objectivity in Research. 

2.4 For the purpose of this Policy:

2.4.1 Staff means University employees (whether full or part-time).

2.4.2 Individuals working for or with the University includes, but is not limited to:

• Individuals with visitor status.
• Consultants and contractors.
• Casual workers including those appointed via UniWorkforce and agency workers.
• Volunteers.
• Honorary staff and Emeritus Professors/Fellows.

2.4.3 Investigator means the project director or Principal Investigator (PI) and any other person (e.g., collaborator or consultant), 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.

3. Definitions

3.1 Designated University Official means the relevant Faculty’s Associate Dean Research (ADR).

3.2 Financial Conflict of Interest (FCOI) means a Significant Financial Interest (SFI) that could directly and significantly affect the design, conduct, or reporting of PHS-funded research. For the purpose of research funded by PHS, it includes the Investigator’s spouse and dependent children.

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

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

3.5 University responsibilities means an Investigator's professional responsibilities on behalf of the University, which may include the following activities: research, research consultation, teaching, professional practice, University committee and panel memberships.

3.6 PHS means the Public Health Service of the USA 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).

3.7 Research means a systematic investigation, study or experiment designed to develop or contribute to generalisable knowledge and encompasses basic and applied research (e.g., a published article or a book) or product development (e.g., a diagnostic test or drug) and is funded by PHS through a grant or cooperative agreement.

3.8 Significant Financial Interest(SFI) means a financial interest consisting of one or more of the following interests of the Investigator (and the Investigator’s spouse and dependent children) that reasonably appears to be related the Investigator’s University responsibilities: 

3.8.1 With regard to any publicly traded entity, a SFI exists if the value of any remuneration (please see 3.8.1.1) received from the entity in the 12 months preceding the disclosure and the value of any equity interest (please see 3.8.1.2) in the entity as of the date of disclosure, when aggregated, exceeds $US 5,000 (depending on the currency conversion around/over £4,000).

3.8.1.1 Renumeration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship).

3.8.1.2 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. 

3.8.2 With regard to any non-publicly traded entity, a SFI exists if the value of any remuneration (please see 3.8.1.1) received from the entity in the 12 months preceding the disclosure, when aggregated, exceeds $US 5,000 (depending on the currency conversion around/over £4,000), or when the Investigator (or the Investigator's spouse or dependent children) holds any equity interest (please see 3.8.1.2).

3.8.3 Intellectual property rights and interests (e.g., patents, copyrights) upon receipt of income related to such rights and interests. 

3.8.4 Reimbursed or sponsored travel (i.e., which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact value may not be available) related to University responsibilities.

3.8.5 The following financial interests are excluded from being classed as SFIs:

3.8.5.1 Travel that is reimbursed or sponsored by a Federal, state, or local government agency, a higher education institution (HEI), an academic teaching hospital, a medical centre, or a research institute that is affiliated with an HEI.

3.8.5.2 Salary, royalties or other remuneration paid to the Investigator by the University including:

• Intellectual property rights assigned to the University and agreements to share the royalties related to such rights.
• income from investment vehicles (e.g., mutual funds and retirement accounts) as long as the Investigator does not directly control the investment decision made in these vehicles.
• Income from seminars, lectures or teaching engagements sponsored by a Federal, state, or local government agency, a higher education institution (HEI), an academic teaching hospital, a medical centre, or a research institute that is affiliated with an HEI.
• Income from service on advisory committees or review panels for a Federal, state, or local government agency, a higher education institution (HEI), an academic teaching hospital, a medical centre, or a research institute that is affiliated with an HEI.

4. Roles and resposibilities 

4.1 Principal Investigators (PIs)

4.1.1All Principal Investigators (PIs) involved in research funded by, or where funding application has been submitted to the Public Health Services (PHS) of the United States Department of Health and Human Services (HHS), are responsible for: 

• Determining who within the research team meets the definition of an Investigator as per 2.4.3.
• Following the procedure in section 5 and ensuring that all those who meet the definition of an Investigator are informed about and adhere to the requirements of this Policy. 

4.2 Investigators

 4.2.1 All Investigators (please see 2.4.3), as determined by the PI, are responsible for

• Completing mandatory FCOI Training.
• Completing the USA Significant Financial Interest Disclosure Form and submitting it for evaluation to the Associate Dean Research (ADR) of a relevant Faculty.
• Where required, adhering to an agreed Financial Conflict of Interest Management Plan to manage an identified FCOI, and to inform the ADR about any changes of circumstances.
• Providing copies of all documents relevant in the context of this Policy to Finance so that they can be stored together with the funding documents.

4.3Associate Deans Research (ADRs) - Designated University Officials

4.3.1 Associate Deans Research are responsible for:

• Receiving and reviewing the USA Significant Financial Interest Disclosure Forms.
• Determining whether any of the SFIs are i) related to PHS-funded research, and ii) constitute a FCOI. 
• Where required, developing and monitoring of a Financial Conflict of Interest Management Plan.
• Notifying the Research Integrity and Compliance Office (RICO) promptly when a FCOI has been identified. 

4.4Research Integrity and Compliance Office (RICO)  

4.4.1 The Research Integrity and Compliance Office is responsible for:

• Ensuring that this Policy reflects the requirements the USA Code of Federal Regulations Title 42, Part 50, Subpart F – Promoting Objectivity in Research, is publicly available, and is updated in line with any subsequent changes.
• Ensuring that an up-to-date version of this Policy is maintained on the eRA Commons Institution Profile (IPF) Module.
• Maintaining and keeping up-to-date the administrative process to underpin this Policy and its requirements. 
• Providing initial and ongoing reports to the PHS awarding bodies in relation to all identified FCOIs, and any other FCOI related information. 

4.5 Heads of Service 

4.5.1 Heads of Service (Deans of Faculties and Directors of Professional Services) are responsible for:

• Ensuring that all staff and individuals working for or with the University within their Faculty or Professional Service are aware of this Policy and its requirements.
• Leading on implementation of this Policy in their Faculty or Professional Service, to create a culture of reflection and declaration of SFIs. 

5. Financial Conflict of Interest Procedure

5.1 Mandatory Financial Conflict of Interest (FCOI) Training

5.1.1 All Investigators (please see 2.4.3), as determined by the Primary Investigator, must complete the online FCOI Training:

5.1.1.1 Prior to engaging in PHS funder research.

5.1.1.2 Every 4 years thereafter.

5.1.1.3 If found to be non-compliant with the requirements of this Policy. 

5.1.2 The Certificate of Completion of the FCOI Training must be provided to Finance so that it can be stored together with the funding documents. 

5.2Disclosure of Significant Financial Interests (SFIs)

5.2.1All Investigators (please see 2.4.3), as determined by the Primary Investigator, must disclose their SFIs (and those of their spouse and dependent children) that reasonably appear to be related to their University responsibilities by completing and signing the USA Significant Financial Interest Disclosure Form whether they have any SFIs or not:

5.2.1.1 At the time of application for PHS funded research.

5.2.1.2 At least annually during the period of award. 

5.2.1.3 Within 30 days of discovering or acquiring a new SFI (e.g., through purchase, marriage, or inheritance).

5.2.2 Once completed, the USA Significant Financial Interest Disclosure Form must be submitted for evaluation to the Associate Dean Research (ADR) of the relevant Faculty, who will act as the Designated University Official.

5.2.2.1 Where the ADR has an interest in any of the matters disclosed, the USA Significant Financial Interest Disclosure Form should be evaluated by a person at the next higher level of authority. 

5.2.3 The Associate Dean Research/Designated University Official is responsible for:

5.2.3.1 Reviewing the USA Significant Financial Interest Disclosure Form before expenditure of any PHS funds, and within 60 days when the PHS-funded research project is ongoing, and determining whether:

• Any of the SFIs of an Investigator (and their spouse and dependent children) are related to PHS-funded research.
• A FCOI exists (i.e., a SFI could directly and significantly affect the design, conduct, or reporting of the PHS-funded research).  

5.2.3.2 Where relevant, seeking confidential advice from more senior colleagues and/or relevant Professional Services teams.

5.2.3.3 Where a FCOI exists, i) notifying the Research Integrity and Compliance Office (RICO) and ii) developing, overseeing the implementation, and monitoring of a Financial Conflict of Interest Management Plan (please see 5.3) until completion of the research project.

5.2.4  The completed and signed USA Significant Financial Interest Disclosure Form must be provided to Finance so that it can be stored together with the funding documents. 

5.2.5 Where a SFI was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed by the University during an ongoing PHS-funded research project, the ADR must review it within 60 days and where a FCOI is identified, develop, and implement the Financial Conflict of Interest Management Plan.

5.3 Management of Financial Conflict of Interest (FCOI)

5.3.1 Where a FCOI is identified, a Financial Conflict of Interest Management Plan must be developed and implemented. Depending on the seriousness of the FCOI, one or more of the following conflict management strategies should be adopted:

5.3.1.1 Public disclosure of a FCOI (e.g., when presenting or publishing the research; to staff members working on the project; to relevant Research Ethics Committees).

5.3.1.2 For research projects involving human participants, disclosure of FCOIs directly to participants. 

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

5.3.1.4 Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the FCOI.

5.3.1.5 Modification of the research plan.

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

5.3.1.7 Severance of relationships that create a FCOI.

5.3.1.8 Any other appropriate financial conflict management approach.

5.3.2  Once agreed and completed, the Financial Conflict of Interest Management Plan must be signed by both the Investigator and the Associate Dean Research.

5.3.3  It is the responsibility of the Investigator to comply with actions agreed in the Financial Conflict of Interest Management Plan and to inform the Associate Dean Research about any changes of circumstances. 

5.3.4  The Associate Dean Research is responsible for monitoring the Investigator’s compliance with the Financial Conflict of Interest Management Plan until the completion of the PHS-funded project.

5.3.5  The Associate Dean Research must inform the Research Integrity and Compliance Office (RICO) by emailing: researchintegrity@soton.ac.uk as soon as possible after it is determined that a FCOI exists, and provide copies of the USA Significant Financial Interest Disclosure Form and the Financial Conflict of Interest Management Plan. 

5.3.6  The Research Integrity and Compliance Office will report appropriately all identified FCOIs to the PHS awarding bodies.

5.4  Retrospective Review of a Financial Conflict of Interest (FCOI)

5.4.1  Where a FCOI is not identified or managed in a timely manner, the University will, within 120 days of the determination of the non-compliance, complete a Retrospective Review of the Investigator’s activities and the PHS-funded research project, to determine whether any PHS-funded research conducted during the period of non-compliance, was biased in the design, conduct, or reporting of such research.

5.4.1.1 The University will prepare the Financial Conflict of Interest Retrospective Review Report, which shall include the following information: 

• Project number.
• Project title.
• PI name and contact details. 
• Name of the Investigator with the FCOI. 
• Name of the entity with which the Investigator has a financial conflict of interest.
• Reason(s) for the Retrospective Review. 
• Detailed methodology used for the Retrospective Review (e.g., methodology of the review process, composition of the review panel, documents reviewed). 
• Review findings. 
• Review conclusions.

5.4.1.2 Where appropriate, the University will update any previously submitted FCOI reports and specify the actions that will be taken to manage the FCOI going forward.

5.4.1.3 Where bias is found, the University will notify the PHS awarding body promptly and submit a Mitigation Report which must include:

• Key elements documented in the Retrospective Review Report.
• Description of the impact of the bias on the research project.
• University’s plan of action or actions taken to eliminate or mitigate the effect of the bias (e.g., impact on the research project; extent of harm done, any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable).

5.4.1.4 Following the submission of the Mitigation Report, the University will submit FCOI reports annually. 

5.4.1.5 Depending on the nature of the FCOI, the University may determine that additional interim measures are necessary with regard to the Investigator's participation in the PHS-funded research between the date that the FCOI or the Investigator's non-compliance is determined and the completion of the Retrospective Review.

5.5 PHS-funded Research carried out via a Subrecipient 

5.5.1 Where PHS-funded research is carried out via a subrecipient (e.g., a subcontractor or collaborators), the University will establish a written agreement with the subrecipient to;

• Determine whether the subrecipient will follow the University Policy or comply with its own FCOI policy. 
• Obtain written assurance that the subrecipient’s FCOI policy complies with the USA Code of Federal Regulations, Title 42, part 50, Subpart F.
• Ensure compliance with this Policy if the subrecipient does not have an appropriate compliant policy.
• Specify time periods for the subrecipient to submit USA Significant Financial Interest Disclosure Forms for review, or report all identified FCOIs to the University, so that they can be reported to the PHS are required under this Policy. 
• Ensure that suitable FCOI reporting in line with this Policy is carried out in relation to the subrecipient. 

5.6  Public Accessibility and Maintenance of Records 

5.6.1 The University will make available information regarding SFIs (whether or not they resulted in the FCOIs), or any other information collected under this Policy, promptly upon request, to the HHS.

5.6.2 The University will provide within 5 working days a written response to anybody requesting information on any SFIs disclosed that meet the following 3 criteria:

• The SFI was disclosed and is still held by the Investigator.
• The University has determined that the SFI is related to the PHS-funded research.   
• The University has determined that the SFI constitutes a FCOI. 

5.6.2.1 The information that the University will provide in its written response within 5 working days, will include, at a minimum, the following information: 

• Investigator's name.
• Investigator's title and role with respect to the research project.
• Name of the entity in which the SFI is held.
• Nature of the SFI.
• Approximate dollar value of the SFI (the following dollar ranges are permissible: $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

• 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.

5.6.2.2  The University will note in its written response that the information provided is current as of the date of the correspondence and is subject to updates, on at least an annual basis and within 60 days of the University's identification of a new FCOI, which should be requested subsequently by the requestor. 

5.6.3 The University will maintain records of all information and documents required under this Policy for at least 3 years from the date the information was most recently updated, the final expenditures report is submitted to the PHS, or longer according to the individual circumstances of the research project.      

5.7  Reporting of Financial Conflict of Interest (FCOI)     

5.7.1 The University will submit appropriate FCOI reports to the PHS awarding bodies. This may include, but is not limited to:

5.7.1.1 Prior to expenditure of funds, the University will report all identified FCOIs, where the FCOI has been not eliminated. 

5.7.1.2  During ongoing PHS-funded research, the University will report within 60 days all identified FCOIs (e.g., when research is joined by a new Investigator).

5.7.1.3 For ongoing PHS-funded research, where a FCOI was identified and reported, the University will submit an annual FCOI report that address the status of the FCOI and any changes to the Financial Conflict of Interest Management Plan for the duration of the PHS-funded research project (including extensions with or without funds). The annual FCOI report shall specify whether the FCOI is still managed or why it no longer exists and will be submitted in the time and manner specified by the PHS awarding body.

5.7.1.4  Where bias was found as a result of the Retrospective Review (please see 5.4), the University will submit promptly a Mitigation Report. 

5.7.2  Any FCOI Report will include sufficient information to enable PHS awarding body to understand the nature and extent of the FCOI and assess the appropriateness of the Financial Conflict of Interest Management Plan. The FCOI Report will include as a minimum the following information: 

• Project number.
• Project title. 
• PI name and contact details. 
• Name of the Investigator with the FCOI. 
• Name of the entity with which the Investigator has a FCOI.
• Nature of the FCOI (e.g., equity, consulting fee, travel reimbursement, honorarium).
• Dollar value of FCOI (the following dollar ranges are permissible: $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

• 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.
• Description of how the FCOI relates to the PHS-funded research and why it was determined that it conflicts with such research. 
• Description of the key elements of the Financial Conflict of Interest Management Plan including: 
  •  Role and principal duties of the conflicted Investigator in the research project.
  • Conditions of the Financial Conflict of Interest Management Plan.
  • How the Financial Conflict of Interest Management Plan safeguards the objectivity of a research project. 
  • Confirmation of the Investigator's agreement to the Financial Conflict of Interest Management Plan.
  • How the Financial Conflict of Interest Management Plan will be monitored to ensure Investigator’s compliance.
  • Any other relevant information as required.  

5.7.3  If an Investigator fails to comply with this Policy, or the agreed Financial Conflict of Interest Management Plan, and bias is found in design, conduct, or reporting of the PHS-funded research, the University will ensure that appropriate corrective actions are taken and reported to the PHS awarding body. 

5.7.4  The University will take any necessary actions as directed by the PHS awarding body or HHS. 

6. Data Protection and Confidentiality 

6.1 The University is committed to processing all personal data in compliance with data protection legislation. Access to personal data is restricted to those who require it to comply with the requirements of this Policy. Further information on data protection can be found in the University Privacy Notice. 

6.2 All information shared with the relevant parties under this Policy must be kept confidential as far as possible. However, the University may be required to share such information with the PHS awarding body and/or HHS, and with others requesting such records (please see 5.6.2). Where the University is required to share any information with the third parties, the Investigator will be informed of the disclosure. 

7. Raising a Concern

 7.1 Any concerns about non-compliance with the requirements of this Policy must be reported to the Research Integrity and Compliance Office by emailing: researchintegrity@soton.ac.uk 

8. Failure to Comply with the Policy

8.1 Non-compliance with the requirements of this Policy is treated seriously by the University and will result in appropriate action being taken. 

8.1.1Any breaches of this Policy by a member of staff may result in disciplinary action under the University’s relevant procedures, up to and including summary dismissal. 

8.1.2Any breaches of this Policy by an individual working for or with the University may result in termination of their engagement with the University. 

8.2  Where non-compliance with the requirements of this Policy has been identified, the University will implement relevant corrective actions. 

9. Policy Review

9.1 This Policy will be reviewed following any changes to the USA Code of Federal Regulations, Title 42, Part 50, Subpart F – Promoting Objectivity in Research, or at least once every 3 years.

10. Version Control