This procedure has been adopted from the University of Adelaide and adapted to meet Adelaide University requirements in preparation for day 1 operations. A new procedure will be developed in the first half of 2026 in accordance with the Adelaide University Policy Framework.
1. Overview
This procedure defines the compliance requirements for research conducted with funding from any agency of US Public Health Services (PHS), including National Institutes of Health (NIH), and any other research funding sources which have adopted US PHS Financial Conflict of Interest (FCOI) Regulations (42 C.F.R. Part 50 and 45 C.F.R. Part 94). In this Procedure, these various sources of research funding are collectively referred to as PHS.
All Investigators who are applying for and/or have been awarded PHS funding or who are participating in a PHS-funded research project, whether directly or through a subaward/subcontract, must comply with this Procedure.
This is in addition to compliance with all applicable Adelaide University policies and procedures.
2. Purpose
2.1
To clarify the disclosure requirements regarding the reporting of domestic and foreign Significant Financial Interests (SFI) by Investigators that are related to their Institutional Responsibilities (e.g., research, research consultation, teaching, clinical, etc.).
2.2
To outline the process by which a Designated Official at Adelaide University (“the University”) confirms whether the Investigator’s disclosed SFI is related to PHS-funded research and constitutes a financial conflict of interest (FCOI) applicable to PHS-funded projects.
2.3
To set out the responsibility of the University for managing and reporting FCOIs to PHS, for informing Investigators of the FCOI Procedure, and for ensuring Subrecipient compliance.
2.4
To promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under PHS will be free from bias resulting from investigator FCOI.
3. Procedure
3.1 Reporting by Investigators
3.1.1 Who must disclose:
all investigators who meet the definition of “Investigator” and who are:
- applying for and/or receiving PHS funding, or
- participating in a PHS-funded research project
whether directly or through subcontract, must disclose, in writing, to the Designated Official at the University, all SFIs that they, their spouse and dependent children have, at the following times:
3.1.2 Initial disclosure:
- must be made at or before the time of application for PHS-funded research;
- must include all SFIs in the 12 months preceding the disclosure or as of the date of disclosure, as noted in the significant financial interest definition.
3.1.3 Ongoing disclosure:
- within 30 days of discovering or acquiring assets, for example a purchase, acquiring assets through marriage or inheritance, a new SFI, and
- on an annual basis, during the term of the PHS-funded research, disclosure of:
- all SFIs received in the 12 months preceding the disclosure that were not previously reported; and
- updated information regarding any previously disclosed SFI.
3.1.4 New to the University:
All investigators who are new to the University and are applying for and/or receiving PHS funding or who are participating in a PHS-funded research project must make the initial disclosure and ongoing disclosures as noted above.
3.1.5 Steps to Disclose Significant Financial Interests (SFI) to the University
To disclose Significant Financial Interests to the University:
- The Investigator, and (as applicable) their spouse and dependent children, must complete the appropriate Disclosure and Consent Form(s) for SFI and return it to the Designated Official.
- The Designated Official(s) must report the FCOI to the PHS for any of its Investigators or its subrecipients. FCOI information is made available to the public only for those FCOIs identified for Senior/Key personnel.
4. Assessment and Record-Keeping by Designated Official(s)
4.1
The Designated Official(s) must review all disclosures of SFIs from Investigators, including Subrecipient Investigators*, within the timeframes noted below in 4.2., and determine whether:
* When a Subrecipient Investigator has a compliant FCOI policy, their institution manages their own FCOI oversight.
4.1.1
the SFI is related to PHS funding; and an investigator’s SFI is related to PHS research when the Designated Official (s) reasonably determine that the SFI:
- could be affected by the PHS-funded research; or
- relates to an entity whose financial interest could be affected by the research.
The Designated Official(s) may involve the Investigator in the Designated Official’s determination of whether a SFI is related to the PHS-funded research.
4.1.2
whether each SFI is a FCOI.
- A FCOI exists when the University, through its Designated Official, reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS- funded research.
4.2
The review and determination noted in 4.1 above must be conducted by the Designated Official(s) at the following times:
4.2.1
prior to the University’s expenditure of any funds under PHS-funded research project;
4.2.2
within sixty (60) days, whenever, in the course of an ongoing PHS-funded project, an Investigator or Subrecipient Investigator, who is a new participant in the project, discloses a SFI or an existing Investigator or Subrecipient Investigator discloses a new SFI to the University; and
4.2.3
within sixty (60) days whenever the University identifies a SFI that:
- was not disclosed in a timely manner by an Investigator or Subrecipient Investigator; or
- for whatever reason, was not previously reviewed by the University during an ongoing PHS- funded research project.
4.3
Record-keeping: The Designated Official(s), on behalf of the University, must maintain records relating to all Investigator Disclosures of SFIs and the University’s review of, and response to, such disclosures (whether or not a disclosure resulted in the University’s determination of a FCOI) and all actions under the University’s policy or retrospective review related to the SFI and/or FCOI, if applicable, for at least three (3) years from the date the final expenditures report is submitted to PHS, the date of final payment or, where applicable, from other time periods specified in 45 CFR 75.361 for different situations.
5. Management and Reporting of FCOI
5.1
If the Designated Official(s) determine through their review pursuant to 4.1. Above that there is a FCOI, the Designated Official(s) must prepare a FCOI management plan to manage the FCOI. Key elements of the management plan include:
- role and principal duties of the conflicted Investigator in the research project;
- conditions of the management plan;
- how the management plan is designed to safeguard objectivity in the research project;
5.1.1
confirmation of the Investigator’s agreement to the management plan; and
5.1.2
how the management plan will be monitored to ensure Investigator compliance.
The Designated Official(s) may include additional elements into any management plan that ensure that the FCOI is properly managed.
Examples of conditions or restrictions that might be imposed to manage a FCOI:
- public disclosure of FCOI (e.g., when presenting or publishing research, to research personnel working on the study, to the Institution Review Board, to the Animal Committee, Data Safety and Monitoring Board, etc.);
- for research projects involving humans, disclosure of FCOI directly to the participants;
- appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from a 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 FCOI.
5.2
The Investigator is required to comply with the management plan prescribed by the Designated Official(s).
5.3
On behalf of the University, the Designated Official must monitor compliance with the management plan on an ongoing basis until the completion of the project.
5.4
Reporting requirements to PHS: The University, through its Designated Official, must provide initial and ongoing FCOI reports to PHS as applicable:
5.4.1
after the award is granted but prior to the University’s expenditure of any funds under a PHS-funded research project;
5.4.2
annually at the same time as the annual progress report is due:
For any FCOI previously reported by the University, the report must address the status of the FCOI and any changes to the management plan for the duration of the PHS-funded research project. The annual FCOI report must specify whether the financial conflict is still being managed or explain why the FCOI no longer exists.
5.4.3
in the time and manner specified by PHS for any other FCOI reports for the duration of project period (including extensions with or without funds).
5.4.4
Subrecipients: The University must provide FCOI reports to PHS regarding all FCOIs of all Subrecipient Investigators prior to the expenditure of funds and within 60 days of any subsequently identified FCOI.
FCOI reports by the University must include sufficient information to enable PHS to understand the nature and extent of the financial conflict, and to assess the appropriateness of the University’s management plan. Each FCOI report prepared by the Designated Official on behalf of the University must contain:
- grant number;
- project director/principal investigator or contact project director/principal investigator if a multiple project director/principal investigator model is used;
- name of Investigator with the FCOI;
- name of the entity with which the Investigator has a FCOI;
- nature of FCOI (e.g., equity, consulting fees, travel reimbursement, honoraria);
- value of the financial interest per year:
- US$0 - US$4,999;
- US$5,000 - US$9,999;
- US$10,000-US$19,999;
- amounts between US$20,000 - US$100,000 by increments of US$20,000;
- amounts above US$100,000 by increments of US$50,000; or
- a statement that a value cannot be readily determined
- a description of how the financial interest relates to PHS-funded research and the basis for the University’s determination that the financial interest conflicts with such research; and
- key elements of the University’s management plan.
6. Other University and Investigator Responsibilities: Training, Subcontracting and Public Accessibility of Information
6.1
Training: The University provides training with respect to the requirements of this Procedure, the Investigator’s responsibilities regarding the disclosure of SFIs and the PHS regulations. The mandatory training consists of the completion of the NIH Tutorial found at: http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm
https://grants.nih.gov/grants/policy/coi/fcoi-training.htm
Each Investigator must complete the Training as follows:
- prior to engaging in PHS-funded research,
- at least every four years, and
- immediately when any of the following circumstances apply:
- the University revises its financial conflict of interest policies
- an Investigator is new to the University
- the University finds that an Investigator is not in compliance with the University’s financial conflict of interest policy or management plan.
Adelaide University must notify the Investigator when:
- there is no need to report IP Royalty or reimbursement of travel under US$5,000
- outlining responsibilities of disclosure, steps and process
- providing links to NIH FCOI regulations
- providing a link to the University FCOI procedure located on the Adelaide University website
6.2
Subcontracting: If the University carries out the PHS-funded research through a Subrecipient, the University must take reasonable steps to ensure that any Subrecipient Investigator complies with this Procedure:
6.2.1
incorporate as part of the written agreement with the Subrecipient, terms that establish whether this Procedure or the Subrecipient’s policy will apply to the Subrecipient’s Investigators.
6.2.2
if the Subrecipient’s Investigators must comply with the Subrecipient’s financial conflicts of interest policy, the University shall obtain from the Subrecipient a certification that its policy complies with the PHS Regulations.
6.2.3
if the Subrecipient’s Investigators must comply with this Procedure, the University must obtain a written agreement specifying time periods for the Subrecipient to submit all Investigator disclosures of SFIs to the University. Such time periods shall be sufficient to enable the University to comply in a timely fashion with its review, management and reporting obligations under this procedure.
6.3
Public Accessibility of Information
6.3.1
the University shall maintain an up-to-date, written, enforced policy (and associated procedures) on financial conflicts of interest, that complies with PHS regulations and make such policy available via a publicly accessible website.
6.3.2
after an award has been granted, but prior to the University’s expenditure of any funds under a PHS- funded research project, the University shall make available, via a publicly accessible website, the information listed in 6.3.3. concerning any SFI that meets the following criteria:
- SFI was disclosed and is still held by the investigator who has been identified by the University as senior/key personnel for the NIH-funded research project in the grant application, contract proposal, contract, progress report, or other required report submitted to the NIH;
- the University determines that the SFI is related to the NIH-funded research; and
- the University determines that the SFI is an FCOI.
6.3.3
the University must post on the publicly accessible website or make available in response to written requests the following minimum information:
- investigator’s name,
- investigator’s position with respect to the research project,
- nature of the SFI,
- approximate dollar value of the SFI:
- US$0 - US$4,999;
- US$5,000 - US$9,999;
- US$10,000 - US$19,999;
- amounts between US$20,000 - US$100,000 by increments of US$20,000;
- amounts above US$100,000 by increments of US$50,000 or
- a statement that a value cannot be readily determined;
- the entity with which the investigator has a FCOI, to enhance transparency and accountability.
6.3.4
the University shall update the above-noted information within 60 days when there are changes to the information and, at a minimum, shall update the above-noted information annually.
6.3.5
the above-noted information, as updated, shall remain available for responses to written requests or for posting via the University’s publicly accessible website for at least three (3) years from the date that the information was most recently updated.
7. Non-Compliance Constitutes Misconduct
7.1
What is required when there is non-compliance?
Whenever an FCOI is not identified or managed in a timely manner, including:
- Failure by the Investigator to disclose a Significant Financial Interest that is determined by the Institution to constitute a Financial Conflict of Interest;
- Failure by the Institution to review or manage such a Financial Conflict of Interest; or
- Failure by the Investigator to comply with a Financial Conflict of Interest management plan;
The University must conduct a Retrospective Review within 120 days of determining non-compliance.
7.2
Non-compliance constitutes misconduct. In the event of non-compliance, the University may initiate actions under applicable collective and other agreements or University Policy.
7.3
Retrospective Review and Mitigation: Whenever the University identifies a SFI that was not disclosed in a timely fashion by an Investigator or, for whatever reason, was not previously reviewed by the institution during an ongoing PHS-funded project (including but not limited to when the SFI was not reviewed in a timely fashion or reported by a Subrecipient):
Step 1: the designated official shall, within sixty (60) days determine whether:
- the disclosures relate to PHS funding; and an Investigator’s SFI is related to PHS-funded research when the Designated Official reasonably determines that the SFI:
- could be affected by the PHS-funded research; or
- is an entity whose financial interest could be affected by the research.
The Designated Official may involve the Investigator in the Designated Official’s determination of whether a SFI is related to the PHS-funded research.
Step 2: If the Designated Official determines that a FCOI exists, the Designated Official must implement, on at least an interim basis, a management plan that shall specify the actions that have been and will be taken to manage and enforce the actions for the FCOI going forward and determine if additional monitoring is required.
Step 3: Within 120 days of the University’s determination of non-compliance, the University shall complete a retrospective review of the Investigator’s activities and the PHS-funded project to determine whether any PHS-funded research, or portion thereof, conducted during the time period of the non-compliance, was biased in the design, conduct, or reporting of such research.
Step 4: The University is required to document the retrospective review; such documentation shall include, but not necessarily be limited to, all of the following key elements:
- project number;
- project title;
- principal investigator or contact principal investigator if a multiple principal investigator model is used;
- name of the Investigator with the FCOI;
- name of the entity with which the Investigator has a FCOI;
- 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);
- findings of the review; and
- conclusions of the review.
Step 5: Based on the results of the retrospective review, if appropriate, the University shall update the previously submitted FCOI report, specifying the actions that will be taken to manage the FCOI going forward. If bias is found, the University is required to notify PHS promptly and submit a mitigation report to PHS. The mitigation report must include, at a minimum, the key elements cited in Step 4 above and a description of the impact of the bias on the project and the University’s plan of action or actions taken to eliminate or mitigate the effect of the bias (including, but not limited to: impact on the project; extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the project is salvageable).
The University will, thereafter, submit FCOI reports annually as specified in Part 3 of this Procedure.
7.4
In any case in which the PHS determines that a PHS-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with a FCOI that was not managed or reported by the University as required by the regulations, the University must not only require the Investigator involved to disclose the FCOI in each public presentation of the results of the research, but also to request an addendum to previously published presentations.
7.5
Pursuant to US Regulations, on the basis of its review of records or other information that may be available, PHS may decide that a particular FCOI will bias the objectivity of the PHS-funded project to such an extent that further corrective action is needed or that the University has not managed the FCOI in accordance with this procedure, the PHS may determine that issuance of a Stop Work Order by the contracting officer or other enforcement action is necessary until the matter is resolved.
8. Definitions used in our procedure
Designated Official means person(s) designated by the University to oversee the solicitation and review disclosures of Significant Financial Interest (SFI) from each Investigator and any Senior/key personnel who are planning to participate in, or who are participating in PHS funded research.
Disclosure means an Investigator’s disclosure of SFIs to the University.
Financial Conflict of Interest (FCOI) means a SFI that could directly and significantly affect the design, conduct, or reporting of PHS funded research.
Institutional Responsibilities means an Investigator’s professional responsibilities on behalf of the University, the responsibilities of the Investigator pursuant to the policies, procedures and rules of the University, and (as applicable) any other responsibilities outlined in the Investigator’s job description, employment agreement or appointment letter with the University. This includes, (as applicable), activities such as research, teaching, professional practice, institutional committee memberships and service on panels such as the Research Ethics Boards and others.
Investigator means the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of PHS-funded research, or proposed for such funding, which may include, for example, collaborators or consultants.
Manage means taking action to address a FCOI, which can include reducing or eliminating the FCOI, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.
PHS means the Public Health Service of the U.S. 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).
PHS FCOI Regulations mean the US Regulations 42 C.F.R. Part 50 and 45 C.F.R. Part 94, as they may be amended from time to time.
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 appear to be related to the Investigator’s Institutional Responsibilities:
- With regard to any publicly traded entity, a Significant Financial Interest 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 US$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 Significant Financial Interest exists if the value of any remuneration received from the entity in the twelve months preceding the Disclosure, when aggregated, exceeds US$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); or
- Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests exceeding US$5,000.
- For the purposes of making a Disclosure, Investigators also must disclose the occurrence of any reimbursed or sponsored travel exceeding US$5,000 (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their Institutional Responsibilities; provided, however, that this Disclosure requirement does not apply to travel that is reimbursed or sponsored by a US Federal, State or local government agency, a US institution of higher education, or an academic teaching hospital, a medical centre, or a research institute that is affiliated with a US institution of higher education. This Disclosure will include, at a minimum; the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.
- The University’s Designated Official(s) will determine if further information is needed, including a determination or Disclosure of monetary value, in order to assess whether the travel constitutes a FCOI with the PHS-funded research.
Exclusions the term Significant Financial Interest 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 US Federal, State or local government agency, a US institution of higher education, or an academic teaching hospital, a medical centre, or a research institute that is affiliated with a US institution of higher education; or
- income from service on advisory committees or review panels for a US Federal, State or local government agency, a US institution of higher education, or an academic teaching hospital, a medical centre, or a research institute that is affiliated with a US institution of higher education.
Subrecipient means a third-party organisation (subcontractor or sub-awardee) that receives funding from a prime awardee (i.e. AU) to collaborate in carrying out an externally- funded research project. Monies and responsibilities are passed down to a Subrecipient through a subaward or subcontract that outlines the scope of work, budget and laws and regulations that the Subrecipient must adhere to.
Subrecipient Investigator means the Project Director/Principal Investigator of the subaward and any other individual at the subrecipient institution who is planning to participate in, or who is participating in any research funded by the PHS through a subaward or subcontract between the University and a Subrecipient that is responsible for the design, conduct or reporting of PHS-funded research.
9. How our procedure is governed
This procedure is categorised, approved and owned in line with the governance structure of Adelaide University and the offices and officers listed below.
| Parent policy | Conflicts of Interest Policy |
|---|---|
| Policy category | Council |
| Policy owner | Vice Chancellor and President |
| Procedure owner | Deputy Vice Chancellor - Research & Innovation |
| Procedure category | Academic |
| Approving authority | Vice Chancellor |
| Responsible officer | Executive Director, Research Services |
| Effective from | 4 March 2026 |
| Review date | 1 year from the effective date |
| Enquiries | Interim Central Policy Unit/[Central Policy Unit] |
| Replaced documents | None |
10. Legislation and other documents related to our procedure
Refer to the Delegation Policy for all delegations at Adelaide University.
11. History of changes
| Date approved | To section/clauses | Description of change |
|---|---|---|
04 March 2026 GGOV4370PRO | N/A | New adopted procedure |