US Public Health Service Funded Research Procedure

1. Purpose

1.1 The US Public Health Service Funded Research Procedure (the procedure) sets out the requirements for managing financial conflicts of interest and research misconduct 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 supports compliance with 2 United States federal regulations: 

1. 42 CFR Part 50, Subpart F — Promoting Objectivity in Research (financial conflicts of interest)
2. 42 CFR Part 93 — Public Health Service Policies on Research Misconduct.

1.3 This procedure should be read in conjunction with the Research Policy, the Research Management Procedure (SharePoint) and the Conflicts of Interest Disclosure Policy.

2. Scope

2.1 This procedure applies to all people who are planning to participate in, or are participating in, PHS-funded research.

2.2 Investigator is a regulatory term used in 42 CFR Part 50, Subpart F and includes all people responsible for the design, conduct or reporting of PHS-funded research, regardless of title or position. This includes UTS staff, students and affiliates, as well as collaborators and consultants, who meet this definition. The Research Policy uses the terms researchers and lead chief investigator (lead CI); this procedure uses the term investigator to reflect the terminology in 42 CFR Part 50, Subpart F.

2.3 The disclosure requirements in this procedure extend to the significant financial interests of the investigator's spouse and dependent children.

3. Principles

3.1 The principles outlined in the Research Policy apply to this procedure.

3.2 UTS is committed to ensuring that the design, conduct and reporting of PHS-funded research is free from bias resulting from investigator financial conflicts of interest.

3.3 UTS affirms its commitment to research integrity in line with the Australian Code for the Responsible Conduct of Research (the Australian Code). Research misconduct, including fabrication, falsification or plagiarism, is inconsistent with UTS values and the responsible conduct of research.

3.4 The requirements in this procedure are in addition to UTS's requirements relating to conflicts of interest under the Conflicts of Interest Disclosure Policy.

4. Procedure statements

Who must disclose significant financial interests

4.1 The PHS requires institutions and investigators to comply with the requirements of 42 CFR Part 50, Subpart F, including the disclosure of significant financial interests (SFIs) (refer Definitions) that may constitute financial conflicts of interest.

4.2 Investigators must disclose their SFIs, and those of their spouse and dependent children, that reasonably appear to be related to their institutional responsibilities.

4.3 Investigators must disclose SFIs: 

1. at the time of application for PHS-funded research, before expenditure of any funds
2. at least annually during the period of all PHS-funded projects
3. within 30 days of acquiring or discovering any new SFI (for example, through purchase, marriage or inheritance), and
4. within 30 days of joining an ongoing PHS-funded project (for new investigators).

What must be disclosed

4.4 Investigators must disclose any SFI that meets the thresholds specified in the definition of significant financial interest (refer Definitions). This includes: 

1. remuneration exceeding $5000 from a single entity in the 12 months preceding the disclosure
2. equity interest exceeding $5000 in value, or representing more than 5 per cent ownership, in any publicly traded entity
3. any equity interest in a non-publicly traded entity, regardless of value
4. reimbursed or sponsored travel exceeding $5000 in the 12 months preceding the disclosure where the travel is related to the investigator's institutional responsibilities. This means travel paid for or reimbursed by an external entity, not by UTS.

4.5 The following are excluded from SFI disclosure requirements: 

1. salary, royalties or other remuneration paid by UTS to the investigator
2. intellectual property rights assigned to UTS and agreements to share in royalties related to such rights
3. income from investment vehicles such as mutual funds and retirement accounts, where the investigator does not directly control investment decisions
4. income from seminars, lectures or teaching engagements sponsored by government agencies (including Australian, United States or any other national government agencies), higher education institutions, academic teaching hospitals, medical centres or affiliated research institutes, and
5. income from service on advisory committees or review panels for the entities listed in statement 4.5(d).

How to disclose a SFI

4.6 Investigators must disclose SFIs using the Declaration of interest form. The disclosure must include: 

1. the investigator's name
2. the name of the entity with which the SFI is held
3. the nature of the SFI (for example, equity, consulting fees, travel reimbursement, honoraria)
4. for travel-related disclosures, the purpose of the trip, the destination and the sponsor or organiser
5. the value or approximate value of the SFI
6. a description of how the SFI relates to the investigator's institutional responsibilities, and
7. sufficient project details to enable identification and reporting (for example, NIH grant number, PHS awarding component, project title and ResearchMaster project IDs).

4.7 The completed Declaration of interest form must be submitted to the People Unit in line with the Conflicts of Interest Disclosure Policy. The investigator (or supervisor or lead CI) must also provide a copy of the form to the Research Office.

Review and determination

4.8 The Research Office, in consultation with the investigator's supervisor, will: 

1. review all disclosures of SFIs received under this procedure
2. determine whether any SFI relates to PHS-funded research, and
3. determine whether a financial conflict of interest (FCOI) exists.

4.9 For disclosures made before expenditure of funds, the review and determination must be completed before expenditure.

4.10 For investigators newly added to an ongoing PHS-funded project, or for newly disclosed SFIs during an ongoing project, the review and determination must be completed within 60 days of disclosure.

FCOI management plans

4.11 If an FCOI is found to exist, the investigator and their supervisor must develop and implement an FCOI management plan in line with the Conflicts of Interest Disclosure Policy. The Research Office will provide advice and oversight to ensure the plan meets PHS-specific compliance and reporting requirements. The management plan must specify: 

1. the role and principal duties of the investigator in the research project
2. conditions or restrictions imposed to manage the FCOI (refer statement 4.12)
3. how the plan will safeguard objectivity in the research project
4. confirmation of the investigator's agreement to the plan
5. how the plan will be monitored, and by whom, to ensure investigator compliance, including the frequency of institutional oversight reviews and any provision for audits, and
6. any other information required to manage the FCOI.

4.12 Examples of conditions or restrictions that may be imposed to manage an FCOI include: 

1. public disclosure of the FCOI when presenting or publishing the research
2. for research involving human subjects, disclosure of the FCOI directly to research participants, and in presentations and publications
3. appointment of an independent monitor to protect the design, conduct and reporting of the research against bias
4. modification of the research project
5. change of staff, or staff responsibilities, or removal from participation in all or a portion of the research
6. reduction or elimination of the SFI (for example, sale of an equity interest), and
7. severance of relationships that create financial conflicts.

4.13 Management plans must be reviewed and updated as circumstances change. The Research Office must maintain an FCOI management log for each PHS-funded project.

FCOIs in clinical research

4.14 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: 

1. disclose the FCOI in each public presentation of the results of the research, and
2. request an addendum to previously published presentations.

Reporting to PHS and NIH

4.15 If an FCOI is identified, the Research Office must submit an FCOI report to the NIH via eRA Commons. Reports must be submitted: 

1. before the expenditure of funds for FCOIs identified before a project commences
2. within 60 days of identification for new or newly identified FCOIs, and
3. annually, in conjunction with the project progress report.

4.16 FCOI reports must include the: 

1. grant number
2. name of the project director or principal investigator
3. name of the investigator with the FCOI
4. name of the entity with which the FCOI is held
5. nature of the FCOI
6. value of the FCOI (using regulatory value ranges)
7. description of how the FCOI relates to the PHS-funded research, and
8. key elements of the management plan.

Subrecipient compliance

4.17 When UTS engages subrecipients for a portion of PHS-funded research, a written agreement must be put in place to specify: 

1. whether UTS’s or the subrecipient’s FCOI policy will apply to the subrecipient's investigators
2. if the subrecipient's policy applies, certification that the policy complies with 42 CFR Part 50, Subpart F, and
3. the timeline for the subrecipient to report identified FCOIs to UTS.

4.18 Where UTS is the prime recipient of PHS-funded research, UTS is responsible for:

1. monitoring subrecipient compliance with this procedure or the subrecipient's certified FCOI policy, and
2. reporting all identified FCOIs to the PHS awarding component.

Training requirements

4.19 Investigators must complete the NIH FCOI online tutorial (available at NIH: FCOI Training). Training must be completed: 

1. before engaging in PHS-funded research
2. at least once every 4 years
3. immediately if this procedure is revised in a manner that affects investigator requirements
4. immediately if the investigator is new to UTS, and
5. immediately if an investigator is found to be not compliant with this procedure or their FCOI management plan.

4.20 On completion of training, investigators must submit their FCOI training certificate to the Research Office.

Non-compliance

4.21 If an SFI was not disclosed in a timely manner, or was not previously reviewed during an ongoing PHS-funded project, the Research Office must within 60 days: 

1. review the SFI
2. determine whether it is related to PHS-funded research
3. determine whether an FCOI exists, and
4. if an FCOI exists, ensure the investigator and supervisor immediately develop a management plan on at least an interim basis in parallel with the retrospective review required under statement 4.22.

4.22 If it is determined that an FCOI exists in relation to an SFI that was not disclosed or reviewed in a timely manner, the Research Office must complete a retrospective review within 120 days. The retrospective review must document: 

1. the project number
2. the project title
3. the name of the investigator with the FCOI
4. the name of the entity with which the FCOI is held
5. the reason for the retrospective review
6. a detailed methodology used for the review
7. findings of the review, and
8. conclusions regarding the impact of the FCOI on the research.

4.23 If bias is found during a retrospective review, the Research Office must notify the PHS awarding component and submit a mitigation report. The mitigation report must include: 

1. key elements documented in the retrospective review
2. a description of the impact of the bias on the research project, and
3. the plan of action to eliminate or mitigate the effects of the bias.

Breaches

4.24 If an investigator fails to comply with this procedure, the Research Office must immediately notify the PHS awarding component of the corrective action taken or to be taken.

4.25 Non-compliance will result initially in re-training. Further non-compliance will result in disciplinary action in accordance with the Code of Conduct and the Conflicts of Interest Disclosure Policy.

4.26 The PHS awarding component may take its own action as it deems appropriate, which may include suspension of funding or requiring UTS to take further action to maintain the objectivity of the research.

Research misconduct

4.27 The Deputy Vice-Chancellor (Research) is the designated official responsible for receiving allegations of research misconduct involving PHS-funded research. Allegations must be reported to the Research Office to comply with 42 CFR Part 93.

4.28 The Research Office must notify the United States Office of Research Integrity (ORI) when an allegation of research misconduct involving PHS funds is received. Notification is required immediately under 42 CFR section 93.305(g) where special circumstances exist, and in all other cases where an investigation is warranted under 42 CFR sections 93.307 and 93.309.

4.29 The Research Office will work with ORI, or other appropriate offices of the United States Department of Health and Human Services, to ensure UTS's response to allegations is consistent with 42 CFR Part 93. Following an investigation, the Research Office must submit reports to ORI that describes: 

1. the process followed in conducting the investigation
2. the evidence on which the conclusions of the investigation are based, and
3. if a finding of research misconduct is made, the actions taken.

4.30 Research misconduct involving PHS-funded research will be managed in line with the guidelines for research integrity breaches, the Research Policy and the Code of Conduct as appropriate. 

4.31 The Research Office must submit an annual report to ORI by 30 April each year covering allegations of research misconduct received during the previous calendar year.

4.32 Lead CIs must ensure that investigators on their PHS-funded projects are informed of the procedures for reporting allegations of research misconduct.

Publicly available information 

4.33 Before expenditure of funds under a PHS-funded research project, UTS must ensure public accessibility of information concerning any identified FCOI that meets all 3 of the following criteria:

1. the SFI was disclosed and is still held by the senior or key staff on the project
2. UTS has determined that the SFI is related to the PHS-funded research, and
3. UTS has determined that the SFI constitutes an FCOI.

4.34 UTS must make information concerning identified FCOIs available in response to written requests within 5 business days. The following information will be disclosed, the: 

1. investigator's name
2. investigator's title and role with respect to the research project
3. name of the entity with which the FCOI is held
4. nature of the SFI, and
5. approximate dollar value of the SFI (ranges are permitted) or a statement that the value cannot be readily determined.

4.35 Where UTS uses a publicly accessible website to meet this obligation, UTS must:

1. update the website at least annually
2. update the website within 60 days of identifying any new FCOI, or any new SFI related to PHS-funded research that constitutes an FCOI, and
3. ensure that the website notes that the information is current as of the date listed and is subject to updates on at least an annual basis and within 60 days of UTS identifying a new FCOI.

Records management 

4.36 Records of FCOI disclosures, UTS's review of and response to such disclosures, and any resulting actions must be maintained for 3 years from the date of submission of the final expenditure report. Records must be maintained in line with the Records Management Policy.

4.37 Records relating to research misconduct proceedings involving PHS-funded research must be maintained in accordance with the Records Management Policy and ORI requirements.

4.38 Disclosures must be recorded against the relevant project in ResearchMaster (MyProjects) in line with the Research Management Procedure (SharePoint).

5. Roles and responsibilities

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. 

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

5.3 Implementation and governance roles:

The Research Office is responsible for: 

1. promoting awareness of this procedure within the university
2. reviewing PHS-related disclosures and determining whether FCOIs exist
3. submitting FCOI reports to NIH via eRA Commons
4. responding to requests for FCOI information
5. tracking investigator training compliance, in conjunction with annual compliance reviews
6. managing subrecipient compliance
7. receiving allegations of research misconduct involving PHS-funded research
8. notifying ORI and submitting investigation reports as required, and
9. submitting annual reports to ORI.

Investigators are responsible for: 

1. disclosing SFIs in accordance with this procedure
2. completing required FCOI training
3. complying with FCOI management plans, and
4. reporting allegations of research misconduct.

Lead chief investigators are responsible for: 

1. ensuring all investigators on their project are aware of this procedure
2. ensuring all investigators have completed required training before engaging in PHS-funded research
3. working with investigators to develop an FCOI management plan
4. ensuring investigators are informed of procedures for reporting allegations of research misconduct, and
5. monitoring investigator compliance with FCOI management plans.

Supervisors are responsible for: 

1. developing and implementing FCOI management plans with investigators
2. monitoring investigator compliance with FCOI management plans, and
3. supporting investigators to meet their disclosure and training obligations under this procedure. 

Associate deans (research) are responsible for: 

1. promoting awareness of this procedure within their faculty, and
2. supporting compliance with FCOI management plans.

The People Unit is responsible for maintaining the central register of conflicts of interest declarations in line with the Conflicts of Interest Disclosure Policy. 

6. Definitions

The following definitions apply for this procedure. The definitions in the Research Policy also apply. Definitions in the singular also include the plural meaning of the word.

Affiliate is defined in the Code of Conduct.

Bias means undue influence on the design, conduct or reporting of the research resulting from the identified financial conflict of interest.

Fabrication means making up data or results and recording or reporting them.

Falsification means manipulating research materials, equipment or processes, or changing or omitting data or results so that the research is not accurately represented in the research record.

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 Conflicts of Interest Disclosure Policy for definition of conflict of interest.

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

Institution, for the purpose of this procedure, means any domestic or foreign, public or private, entity or organisation (excluding a federal agency) that is applying for, or that receives, PHS research funding. UTS is the institution in this procedure.

Institutional responsibility means an investigator's professional responsibilities on behalf of UTS, which include activities such as research, research consultation, teaching, professional practice, institutional committee memberships and service on panels, including human research ethics committees or data and safety monitoring boards.

Investigator means the project director, principal investigator, lead chief investigator or any other person, regardless of title or position, who is responsible, or proposed to be responsible, for the design, conduct or reporting of PHS-funded research. This includes collaborators and consultants.

Lead chief investigator is defined in the Research Policy.

PHS means the Public Health Service of the United States Department of Health and Human Services, and any components of the PHS to which authority may be delegated, including the National Institutes of Health (NIH).

Plagiarism means the appropriation of another person's ideas, processes, results or words without giving appropriate credit.

Research is defined in the Research Policy. For PHS-funded projects, the term includes any 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.

Research misconduct means fabrication, falsification or plagiarism in proposing, performing, reviewing or reporting research. Research misconduct does not include honest error or differences of opinion.

Significant financial interest (SFI) means 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 appears to be related to the investigator's institutional responsibilities: 

1. with regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the 12 months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5000. Remuneration includes salary and any payment for services not otherwise identified as salary (for example, consulting fees, honoraria, 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
2. 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 12 months preceding the disclosure, when aggregated, exceeds $5000, or when the investigator (or the investigator's spouse or dependent children) holds any equity interest
3. intellectual property rights and interests (for example, patents and copyrights), on receipt of income related to such rights and interests, and
4. reimbursed or sponsored travel related to the investigator's institutional responsibilities that exceeds $5000 in the 12 months preceding disclosure. This excludes travel reimbursed or sponsored by government agencies, higher education institutions, academic teaching hospitals, medical centres or research institutes affiliated with higher education institutions.

Significant financial interest does not include: 

1. salary, royalties or other remuneration paid by UTS
2. intellectual property rights assigned to UTS and agreements to share in royalties related to such rights
3. any ownership interest in UTS
4. income from investment vehicles such as mutual funds and retirement accounts, as long as the investigator does not directly control the investment decisions
5. income from seminars, lectures or teaching engagements sponsored by government agencies, higher education institutions, academic teaching hospitals, medical centres or research institutes affiliated with higher education institutions, and
6. income from service on advisory committees or review panels for the entities listed in the preceding paragraph.

Staff is defined in the Code of Conduct.

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

Supervisor is defined in the Code of Conduct.