US Public Health Service Financial Conflicts of Interest Disclosure Procedure

1. Purpose

1.1 This procedure sets out the requirements for disclosing financial conflicts of interest for research projects funded by the United States Public Health Service (PHS), including those provided by the National Institutes of Health (NIH). 

1.2 This procedure should be read in conjunction with the Research Management Procedure (SharePoint).

2. Scope

2.1 This procedure applies to all those under the scope of the Research Policy (the policy) who are planning to participate in or are participating in funded research from the PHS (through the NIH).

3. Principles

3.1 The principles outlined in the policy apply to this procedure.

4. Procedure statements

Who is required to disclose financial conflicts of interest

4.1 The NIH requires institutions and investigators to comply with the requirements of 42 CFR Part 50, subpart F Promoting Objectivity in Research (hereafter the regulation), including the disclosure of financial conflicts of interest (FCOI) (as defined in Definitions).

4.2 Any UTS researcher who meets the definition of a PHS-funded investigator (hereafter investigator) must disclose their significant financial interests (SFIs) (as defined in Definitions) to the Research Office. This must be done by:

• using the conflict of interest disclosure statement (available at Conflicts of interest (Staff Connect)) to disclose SFIs at least on an annual basis during the period of all PHS-funded projects
• notifying the Research Office within 30 days of acquiring or discovering (for example, through purchase, marriage or inheritance) any new SFIs
• taking part in FCOI training at least once every four years (refer statement 4.16).

4.3 New investigators joining an ongoing PHS-funded project must disclose any SFIs within 30 days of joining the project.

How to disclose SFIs

4.4 The disclosure statement (available at Conflicts of interest (Staff Connect)) at a minimum must include:

• name of the entity with which the investigator has an FCOI
• nature of FCOI (for example, equity, consulting fees, travel reimbursement, honoraria)
• for SFI disclosures related to sponsored or reimbursed travel, the purpose of the trip and the name of the entity
• value (or approximate) of the SFI if the interest is one whose value cannot be readily determined, and
• if needed, the Research Office may request supporting documentation (for example, a copy of any applicable agreement) to determine whether an FCOI exists.

4.5 Disclosures will be managed by the Research Office who will review the disclosure, determine whether the SFI is related to PHS-funded research and determine whether an FCOI exists.

Managing an FCOI

4.6 If an FCOI is found to exist, the Research Office must:

• submit an FCOI report (through eRA Commons at eRA) to the NIH or PHS-agency within 60 days of disclosure
• conduct a retrospective review of SFIs for the PHS-funded investigator within 120 days, and
• develop an FCOI management plan and maintain an FCOI management log.

FCOI management plan 

4.7 An FCOI management plan will be used to manage a potential or actual FCOI. At a minimum, the management plan will include:

• the role and principal duties of the investigator
• conditions and/or restrictions of the plan (refer statement 4.8)
• how the plan will safeguard objectivity in the research project
• confirmation of the investigator’s agreement to the plan
• how the plan will be monitored to ensure investigator compliance
• any ongoing changes to the plan, and
• any other information as needed.

4.8 Examples of conditions or restrictions that might be imposed to manage an investigator’s FCOI include, but are not limited to:

• public disclosure of FCOIs (for example, when presenting or publishing the research)
• for research projects involving human subjects, disclosure of an FCOI directly to participants
• appointment of an independent monitor capable of taking measures to protect the design, conduct and reporting of the research against bias resulting from an FCOI
• modification of the research project plan
• change of staff or staff responsibilities, or disqualifications of staff from participation in all or a portion of the research
• reduction or elimination of the financial interest (for example, sale of an equity interest)
• severance of relationships that create financial conflicts.

FCOIs and clinical research

4.9 If the NIH determines that an NIH-administered clinical research project to evaluate the safety or effectiveness of a drug, medical device or treatment has been designed, conducted or reported by an investigator with an FCOI that was not managed or reported, the investigator must disclose the FCOI in each public presentation of the results of the research and request an addendum to previously published presentations. 

Non-compliance and mitigation reporting 

4.10 If an investigator fails to comply, or the FCOI was not managed or reported as required, and there appears to be a conflict with the PHS-funded research, the Research Office must immediately notify the PHS-agency of the corrective action taken or to be taken. 

4.11 The Research Office must prepare a mitigation report, as applicable, for submission to the PHS-agency and comply with any requirements for a retrospective review. At a minimum, the mitigation report will include:

• key elements documented in the retrospective review
• description of the impact of the conflict with the research project
• plan of action(s) to eliminate or mitigate the FCOI
• submission of FCOI reports annually.

4.12 The PHS agency may take its own action as it deems appropriate, which may include suspension of funding, or require UTS to take further action to maintain the objectivity of the research.

4.13 Non-compliance will result initially in re-training, then in disciplinary action if there are further occurrences, in accordance with the Code of Conduct.

Subrecipient compliance 

4.14 When working with subrecipients for a portion of PHS-funded research, a written agreement must be put in place to clarify:

• which organisation’s (UTS or subrecipient) FCOI policy or procedures will be followed. If the subrecipient chooses to use its institutional FCOI policy, the subrecipient must provide certification that its FCOI policy complies with the regulation, and
• in either case, the timeline for disclosure and reporting.

4.15 In the case that UTS is the prime recipient of PHS-funded research, UTS is responsible for monitoring subrecipient’s compliance with this procedure and the regulation, and for reporting all identified FCOI.

FCOI training requirements

4.16 Investigators must complete the NIH: FCOI training. Training must be completed:

• before taking part in any PHS-funded research
• at least once every four years, and
• if an investigator (or other relevant staff member) is found to be not compliant with the PHS FCOI requirement.

4.17 On completion of the training, investigators must submit the FCOI certification to the Research Office.

4.18 Relevant UTS research staff will receive training on this procedure.

Retention of records

4.19 Records of FCOI disclosures and UTS's review of, and response to, such disclosures and any resulting action must be maintained for three years from the date of submission of the final expenditures report. Records must be maintained in line with the Records Management Policy.

4.20 Any disclosures must be recorded against the relevant project in ResearchMaster (MyProjects) in line with the Research Management Procedure (SharePoint).

Public accessibility of FCOIs

4.21 Before expenditure of funds, UTS must make certain information concerning FCOIs available by written request, in line with the regulation. UTS will make the information available within five business days on receipt of a request, and the information will remain available for three years.

5. Procedure owner and contact

5.1 Procedure owner: The Deputy Vice-Chancellor (Research) is responsible for enforcement of and compliance with this procedure, ensuring that its principles and statements are observed. The Deputy Vice-Chancellor (Research) is also responsible for the approval of associated university-level procedures, guidelines and user guides.

5.2 Procedure contact: The Director, Research Office is the primary contact for advice on implementing, administering and monitoring compliance with this procedure.

6. Definitions

The following definitions apply for this procedure (refer section 50.603 Definitions, Electronic Code of Federal Regulations). The definitions in the Research Policy also apply. Definitions in the singular include the plural meaning of the word.

A 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. Refer also Code of Conduct for definition of conflicts of interest.

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

Institution means any entity or organisation, inside or outside the United States, public or private that is applying for or that receives NIH research funding. UTS is the institution for the purpose of this procedure.

Investigator means the UTS research project leader, 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 the PHS (NIH), or proposed for such funding, which may include, for example, collaborators or consultants. 

PHS means the Public Health Service of the United States 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).

Research is defined in the Research Policy. For PHS-funded projects, the term includes any such activity for which research funding is available from a PHS awarding component through a grant or cooperative agreement, whether authorised under the United States or other statutory authority, such as a research grant, career development award, centre grant, individual fellowship award, infrastructure award, institutional training grant, program project or research resources award.

Staff (for the purpose of this procedure and referred to as senior/key personnel in the regulation) means the investigator and any other UTS senior and/or key staff identified in the grant application, progress report or any other report submitted to the PHS by UTS under the regulation.

Subrecipient means a non-federal entity that receives a subaward from UTS to carry out part of a US federal award, but does not include an individual that is a beneficiary of such award. The subaward may be provided through a form of legal agreement that UTS considers a contract.

Significant financial interest (SFI) is the value of remuneration received by the UTS investigator, or their spouse or dependent children, that reasonably appears to be related to their responsibilities exceeding $5000 from one entity (in the 12 months preceding the disclosure and the value of any equity interest in the entity at the date of disclosure, when aggregated). 

For the purposes of this definition, this includes:

• salary or other payments for services (for example, consulting fees or honoraria) for services not otherwise identified as salary received in the 12 months preceding disclosure
• equity interests (for example, stocks, stock options or other ownership interests) as determined through reference to public prices or other reasonable measure of fair market value
• income from intellectual property rights and interests (for example, patents, copyrights) on receipt of income related to such rights and interests
• externally funded reimbursed or sponsored travel when aggregated exceeds $5000 in the 12 months preceding the disclosures (the costs are paid on behalf of the investigator and as such the exact monetary value may not be readily available) and related to their UTS responsibilities, however is not funded by UTS.

The following are not SFIs:

• salary, royalties, stock options or other remuneration paid by UTS to the investigator if the investigator is currently employed or otherwise appointed by the university, including intellectual property rights assigned to the university and agreements to share in royalties related to such rights, and income from investment vehicles, such as mutual funds and retirement accounts, as long as the investigator does not directly control the investment decisions, and
• income from seminars, lectures and teaching engagements at other institutions (refer Outside Work Policy).