Public Health Services/National Institutes of Health Project Financial Conflict of Interest Procedure

Intent

This Procedure provides guidance to support compliance with the Public Health Services/National Institutes of Health (PHS/NIH) Financial Conflicts of Interest Policy. This Procedure explains the expectations of the management and disclosure of financial conflicts of interest of staff engaged in research under JCU auspices and are investigators on any PHS/NIH proposal or project.

This Procedure is separate and additional to the best practice guidance outlined in the JCU Disclosure of Interests and Management of Conflicts of Interest Procedure that supports the JCU Code for the Responsible Conduct of Research (Research Code).

Scope

This Procedure applies to any person identified as a senior or key personnel in a PHS/NIH grant application or progress report who directly or materially influences the research or who is responsible for the design, conduct, and reporting of such research, whether JCU is the Prime Awardee or a Sub-Awardee.

Definitions

Table of Contents

1. Financial Conflict of Interest disclosure
2. Institutional Responsibilities
3. Identifying and managing financial conflicts of interest
4. Record of management financial conflicts of interest
5. Researcher responsibilities
6. Training and education
7. Resolution of disputes
8. Non-Compliances PHS/NIH and Potential Breaches of the JCU Research Code
9. Further guidance and FAQ’s

Introduction

The PHS/NIH states it is committed to preserving the public’s trust in that the research supported is conducted without bias and with the highest scientific and ethical standards. Their Financial Conflict of Interest Policy is a regulation that promotes objectivity in research and establishes the standards to provide a reasonable expectation that the design, conduct and reporting of PHS/NIH research will be free from bias resulting from investigators’ financial conflict of interest (FCOI). Through its policies and procedures, JCU also seeks to ensure that any researcher engaged in PHS/NIH research complies with the expectations of the PHS/NIH Financial Conflict of Interest Policy.

JCU acknowledges the use of the University of Melbourne PHS/NIH Project Financial Conflict of Interest (FCOI) Requirements Guidance and that text in this Procedure is reproduced from this Guidance.

Procedure

1. Financial Conflict of Interest Disclosure

1.1 In compliance with this Procedure, JCU requires disclosure of all financial interests that are relevant or could appear to be relevant, to proposed or ongoing PHS/NIH research. In relation to the PHS/NIH Financial Conflict of Interest Policy a “Significant Financial Interest (SFI)” that requires disclosure includes:

• 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:
  • With regard to any publicly traded entity, a SFI 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, 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, 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;
  • With regard to any non-publicly traded entity, a SFI 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); and
  • Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
  • Interests relating to sponsored or reimbursed travel.

SFI does not include the following types of financial interests:

• salary, royalties, or other remuneration paid by the University 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;
• 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;
• income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an institution of higher education as defined at US Policy 20 U.S.C. 1001(a), an academic teaching hospital, a medical centre, or a research institute that is affiliated with an institution of higher education; or
• income from service on advisory committees or review panels for a federal, state, or local government agency, an institution of higher education as defined at US Policy 20 U.S.C. 1001(a), an academic teaching hospital, a medical centre, or a research institute that is affiliated with an institution of higher education.

2. Institutional Responsibilities

2.1 JCU requires disclosure of all financial interests that are relevant or could appear to be relevant, to proposed or ongoing research. These financial interests could be actual, perceived or a potential conflict of interest. In compliance with this Procedure, FCOIs must be disclosed and managed by the University in relation to PHS/NIH funded research. JCU undertakes to:

• Provide annual and ad hoc FCOI reports to PHS/NIH;
• Maintain central records relating to all Investigator disclosures of financial interests and review of and actions taken related to such disclosures for at least three years from the date of the final expenditures report is submitted to NIH, or, where applicable, from other dates specified in NIH policy;
• Prior to the expenditure of PHS/NIH funds provide details of FCOIs held by senior/key personnel within 5 days of a written request as long as the provision of information does not breach Australian privacy legislation;
• Address non-compliance in accordance with this Procedure;
• Take relevant corrective actions where appropriate;
• Receive, review and register changes to FCOIs;
• Develop and implement Institutional-level processes to comply with PHS/NIH policy;
• Report to NIH within 60 days of changes to FCOIs arising;
• Provide Institutional-level monitoring and assurance; and
• Record completion of training by all Investigators.

2.2 Heads of Work Unit (Designated Officials)

Under this Procedure, Heads of Work Unit are the Designated Officials that must review, determine and manage financial conflicts of interest of researchers under their supervision. Designated Officials must:

• Review disclosures of SFI and determine if a FCOI exists (refer to Identifying and Managing Financial Conflicts of Interest below);
• Manage FCOIs, including through the development and implementation of management plans and monitoring compliance (refer to 2.1 Management Plans), with Institutional oversight/escalation to JCU Research Integrity Office.
• Maintain records relating to all Investigator disclosures of financial interests and review of and actions taken related to such disclosures for at least three years from the date of the final expenditure report is submitted to NIH, or, where applicable, from other dates specified in NIH policy; and
• Comply with any other obligations under the PHS/NIH policy.

3. Identifying and managing financial conflicts of interest

3.1 Investigators (Principal Investigators and Investigators)

3.1.1 Having a FCOI does not, in itself, imply improper motivation or individual wrong doing, but once a FCOI is identified, appropriate measures must be taken to manage the particular conflict of interest and situation. The Head of Work Unit (Designated Official) must determine if the declared FCOI could reasonably be said to relate to PHS/NIH research by assessing whether the SFI:

3.1.2 Could be affected by the PHS/NIH research; or is in an entity whose financial interest could be affected by the PHS/NIH research.

3.1.3 If related to PHS/NIH research, whether the SFI could directly and significantly affect the design, conduct, or reporting of the PHS/NIH research.

3.2 If the SFI is determined to be both:

• related to the NIH research; and
• to affect the design, conduct or reporting of the PHS/NIH research,

it is a FCOI, and must be managed in accordance 3.1 Management Plans of this Procedure.

3.1.3 The Head of Work Unit may discuss the determination if the SFI is related to PHS/NIH research with the relevant Investigator, and also seek advice from the Research Integrity Office, but the final determination must be made by the Head of Work Unit.

3.2 Subcontractors and Subrecipients

3.2.1 If JCU is a prime awardee of a PHS/NIH project, the University must delegate   responsibility for compliance with the PHS/ NIH FCOI policy relating to identification, disclosure, determination and management of FCOIs to each sub-awardee/subcontractor, and will specify in any agreement all matters necessary to implement 42 CFR 50.604, including that the sub-awardee/subcontractor must:

• comply with the requirements of the NIH FCOI policy;
• submit all requisite details of FCOIs to JCU:
  • prior to the expenditure of funds; and
  • within 60 days of any subsequently identified FCOI;
• promptly notify the University of any management plan and suspected non-compliance; and
• provide a declaration that all FCOIs have been identified, disclosed and managed in accordance with NIH requirements.

3.3 Management Plans

3.3.1 At any time where a FCOI is determined, the Head of Work Unit (Designated Official) must develop and implement a management plan within 60 days of the FCOI being identified that specifies the actions that have been, and shall be, taken to manage such FCOI. Examples of conditions or restrictions that might be imposed to manage a FCOI include, but are not limited to:

• Public disclosure of FCOIs (e.g., when presenting or publishing the research, to other members of the project team, and where relevant to Human Research Ethics Committee and Animal Ethics Committees);
• For research projects involving human subjects research, disclosure of FCOIs 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 the FCOI;
• Modification of the research plan;
• Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;
• Reduction or elimination of the financial interest (e.g., sale of an equity interest); or
• Severance of relationships that create financial conflicts.

3.3.2 The Head of Work Unit must appropriately monitor compliance of the matter and ensure that management plan is followed until the completion of the relevant PHS/NIH project.

4. Record of management of financial conflict of interest

Principal Investigators, Investigators and Heads of Work Units (Designated Officials) must create, maintain and store records of financial disclosures, including the records of review, management plan and any other records relating to implementation of this Procedure:

• for at least 3 years following the submission of the final report to the NIH (or such other period as required under the NIH policy);
• in accordance with the University’s record-keeping policies; and
• in addition, the University through the Research Integrity Office will store and retain all relevant central records in accordance with NIH and University requirements.

5. Researcher responsibilities

5.1 JCU recognises that researchers may be financially conflicted and therefore requires a researcher to acknowledge the financial conflict and make disclosures as appropriate. Researchers must:

• Maintain records of activities that may be relevant to the assessment of whether a financial conflict of interest exists (e.g. consultancies; membership of boards of directors, advisory groups, or committees; or receipt or delegation to receive funds, services or equipment from outside bodies to support research activities.
• Disclose any financial interest in a timely fashion (i.e. as soon as it becomes apparent that the interest could constitute a potential, actual, or perceived conflict of interest).
• Update any disclosures of financial interest as circumstances change, and at least annually during the period where the research remains active

5.2 Researchers must ensure they observe and undertake the following actions in relation to PHS/NIH Financial Conflict of Interest Policy and this Procedure:

5.2.1 Principal Investigators

Comply with all Investigator Responsibilities specified in clause 5.2.2 including:

• Pre-award
  • complete the FCOI Screening Form with respect to all University Investigators and submit the FCOI Screening Form to RIC Compliance Officer at the pre-award stage.
• Post-award
  • confirm that the information disclosed in the FCOI Screening Form is still current and, if not, update the Form; and
  • ensure that all University Investigators involved in the PHS/NIH project are aware of, comply with and make any disclosures required under this Procedure, including completing the FCOI Disclosure Form for any SFIs identified in the FCOI Screening Form.

5.2.2 Investigators

• Prior to commencing any PHS/NIH funded research at the University, undertake FCOI training on the Investigator’s responsibilities regarding disclosure of SFIs as detailed in clause 6.
• Assist the University’s Principal Investigator to complete the University’s FCOI Screening Form at the pre-award stage;
• Disclose any and all identified SFIs (including those of the Investigator’s spouse/common law partner and dependent children) that reasonably appear to be related to the Investigator’s Institutional Responsibilities using the University’s FCOI Disclosure Form and submit to Head of Work Unit, copied to Research Integrity Office at the post-award stage:
  • prior to expenditure of PHS/NIH funding;
  • annually post-award;
  • within 30 days of a new SFIs arising during the course of an PHS/NIH project; and
  • within 30 days of new investigators joining the project;
• Assist with the development of a management plan for any identified SFI’s determined by the University to directly and significantly affect the design, conduct or reporting of the PHS/NIH project (FCOI);
• Comply with this Procedure, and with any management plan developed to manage any identified FCOI
• Assist with completing any reports that are required to be provided to the PHS/ NIH by the University by completion of any annual and revised FCOI reports to the NIH via the eRA Commons FCOI Module for the University and any of its subrecipients as applicable including but not limited to:
  • prior to expenditure of PHS/NIH funding;
  • within 60 days of identification for an Investigator who is newly participating in the project;
  • within 60 days for new, or newly identified FCOIs for existing Investigators
  • at least annually, with the annual progress report, the status of the FCOI and any changes to management plans if applicable to the completion of the project;
  • results of a retrospective review to update any previously submitted report or advise any new information discovered by the review; and
  • promptly notify the NIH if bias is found with the design conduct or reporting of PHS/NIH funded research and include actions taken to mitigate the effects of bias outlined in a mitigation report to the NIH.
• Comply with any other obligations under the PHS/NIH policy.

6. Training and Education

6.1 Researchers (Principal Investigators and Investigators) have an obligation to engage in the training and education provided by the University and PHS/NIH in regard to the PHS/NIH Financial Conflict of Interest Policy and the responsibilities and application of this Procedure including but not limited to:

6.1.1 Completion of training available through the NIH FCOI Online Tutorial prior to engaging in PHS/NIH funded research; This training must be completed:

• prior to engaging in research related to any PHS/NIH grant; and
• at least once every 4 years and

6.1.2 Immediately review and complete further training when:

• this Procedure or guidance relating to FCOI policies are revised in any manner that affects the requirements of the Investigators;
• when an Investigator is new to the University (even if the PHS/NIH funded research has already begun; and/or
• an Investigator is not in compliance with this Procedure or a management plan as determined by the Head of Work unit (Designated Official).

6.1.3 Must retain evidence (electronic copy of the certification of generated through the system) of the completion of the NIH on-line tutorial and provide this evidence to the Research Integrity Office.

7. Resolution of disputes

7.1 In the first instance, disputes over the identification or management of a FCOI involving JCU researcher/s must be mediated by the Head of Work Unit. If the dispute is unable to be resolved satisfactorily, the matter must be escalated to the Deputy Vice-Chancellor of the relevant Division.

7.2 If the dispute involves allegations of a potential breach of the Research Code and the PHS/NIH Financial Conflict of Interest Policy, refer to Clause 8 of this Procedure.

8. Non-compliance with the PHS/NIH Financial Conflicts of Interest Policy and Potential breaches of the JCU Research Code

8.1 Any concerns or complaints about potential breaches of the Research Code in relation to disclosure of financial interests and management of FCOI must be managed in accordance with the Managing and Investigating Potential Breaches of the JCU Code for the Responsible Conduct of Research Procedure. Examples of breaches of the Code that are related to disclosure and FCOI include, but are not limited to:

• Failure to disclose a relevant financial interest;
• Failing to abide by any decisions as to the management of a FCOI.

8.2 Specifically related to the requirements of this Procedure and the PHS/NIH Financial Conflicts of Interest Policy, in the event that an incidence of non-compliance or suspected non-compliance is identified, Investigators and the Head of Work Unit (Designated Official) must immediately:

• report the non-compliance or suspected non-compliance to Research Integrity office; and
• take all necessary steps to retrospectively comply with this Procedure relating to disclosure, determination and management of SFIs.

8.3 The Research Integrity Office will, within 120 days of notification or detection of any suspected non-compliance, review the Investigator's activities and the PHS/NIH project under its research integrity processes (Managing and Investigating Potential Breaches of the JCU Code for the Responsible Conduct of Research Procedure) in order to determine whether:

• a potential breach of this Procedure and the Research Code may have occurred; and
• whether any PHS/NIH research, or portion thereof, conducted during the time period of the non-compliance, was biased in the design, conduct, or reporting of such research.

Investigators must fully and promptly cooperate with this review.

8.4 Where the non-compliance relates to PHS/NIH research investigating the safety or effectiveness of a drug or device, the University may require the Investigators to disclose the FCOI in each public presentation and request an addendum to previously published outcomes relating to the research. Investigators must comply with this requirement.

8.5 Non-compliance with this Procedure, including failure to disclose SFIs or failure to comply with any management plan, may constitute a potential breach of the JCU Research Code. As a result of the processes and assessment of the non-compliance under the Managing and Investigating Potential Breaches of the JCU Code for the Responsible Conduct of Research Procedure, the University may take corrective actions in accordance with applicable University and NIH policies and procedures, including withholding access to NIH funds and/or suspending project activity.

9. Further Guidance and FAQ’s

Further guidance with regard to the NIH Financial Conflict of Interest Policy and access to frequently asked questions can be found at:

• https://grants.nih.gov/grants/policy/coi/index.htm
• https://grants.nih.gov/faqs#/financial-conflict-of-interest.htm

Related policy instruments

JCU Code for the Responsible Conduct of Research (Research Code)

Managing and Investigating Potential Breaches of the JCU Code for the Responsible Conduct of Research Procedure

Disclosure of Interest and Management of Conflicts of Interest Procedure

PHS/NIH Financial Conflict of Interest Policy

Schedules/Appendices

PHS/NIH Project Financial Conflicts of Interest Disclosure Form

Administration

NOTE:  Printed copies of this procedure are uncontrolled, and currency can only be assured at the time of printing.

Approval Details

Revision History