Financial Conflict of Interest
Standard Operating Procedure: Managing Financial Conflict of Interests (FCOI) related to research funded by Public Health Service in the US
PURPOSE & SCOPE
This Standard Operating Procedure (SOP) applies to research funded by US Public Health Service (PHS) grants where AstraZeneca or any entity in the AstraZeneca Group of Companies is the recipient. The aim is to prevent potential bias resulting from any Financial Conflict of Interest (FCOI) the researches may have.
The SOP defines the requirements and processes for disclosing FCOIs that apply to investigators or individuals participating in research funded PHS in the US; including by the National Institute of Health (NIH), where AstraZeneca is the recipient of such funding. It covers activities for setting up the financial disclosure (FD) process and to collect, reconcile and maintain FD information for all covered studies, including for FD reports and/or United States (US) Food & Drug Administration (FDA) submissions.
The disclosure requirements cover both AstraZeneca employees participating in covered research activities as well as individuals at third parties. Exemptions are:
§ The disclosure requirements set out in this SOP do not apply to employees of federal agencies in the US.
§ AstraZeneca employees are not required to disclose salaries or other remuneration received from AstraZeneca (where AstraZeneca is the grant recipient).
More information about the NIH requirements on disclosure of FCOIs can be found at: https://grants.nih.gov/grants/policy/coi/index.htm
PHS funded research
A financial conflict of interest (FCOI) exists when the FCOI Manager reasonably determines that an investigator's significant financial interest could directly and significantly affect the design, conduct, or reporting of the PHS-funded research.
The grant recipient’s designated official for managing the FCOI process related to a specific PHS grant. The Engagement Owner is accountable for ensuring that a FCOI Manager is appointed.
The Engagement Owner is the AstraZeneca Employee overall accountable for the grant and the research funded by the grant (for example the project lead). The Engagement Owner will appoint a FCOI Manager and ensure that they have the resources to manage the process.
In the context of the regulation, Institution refers to the entity or organization that is applying for or that receives PHS/NIH research funding. In the context of this SOP this refers to AstraZeneca (also referred to as the Company) as the recipient of such research funding.
An investigator is defined as the Principal Researcher and any other person, regardless of title or position who is responsible for the design, conduct, or reporting of research funded by PHS, or proposed for such funding which may include, for example, collaborators or consultants.
Public Health Service
Public Health Service (PHS) is any sub-agency of the Public Health Service or Department of Health and Human Services in the US.
A Significant Financial Interest (SFI) is 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.
An SFI exists if the value of any remuneration received from an entity (other than the Company) 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.
An SFI exists if an Investigator (or the Investigator’s spouse or dependent children) holds intellectual property rights and interests (e.g. patents, copyrights), from which they obtain an income.
Any organisation or individual that:
The FCOI Manager ensures that all Investigators are informed of the applicable regulation, this SOP and their disclosure responsibilities prior to engaging in covered research/activities.
All Investigators covered by the scope of this SOP are assigned FCOI training which needs to be completed
- prior to engaging in research relating to any PHS-funded grant and subsequently at least every 4 years;
- as deemed necessary by AstraZeneca due to regulatory changes
- immediately by any Investigator new to the Company
- immediately by any Investigator not in Compliance with this SOP
Where the research grant has been received from NIH, the training assigned to investigators will be the NIH Financial Conflict of Interest tutorial3.
DISCLOSURE, REVIEW, AND MONITORING
Each Investigator assigned by AstraZeneca is required to disclose SFIs (and those of the Investigator’s spouse, partner, and dependent children) related to the Investigator’s professional responsibilities on behalf of the Company that meet or exceed the regulatory definition of SFI.
SFIs have to be disclosed:
- No later than at the time of application for PHS-funded research
- At least annually during the period of award
- Within 30 days of discovery of a new SFI
The Engagement Owner will appoint a FCOI Manager who will
- Manage the FCOI process for the project/Research funded by the grant
- Ensure all Investigators receive information and training
- Review all disclosures to determine if an SFI of the Investigator (and those of the Investigator’s spouse and dependent children) related to an Investigator’s responsibilities exists.
- If, after the initial report has been submitted, any further interests are identified as conflicting , they will be reported by the Investigator to AstraZeneca within 30 days.
AstraZeneca will then report the SFI to the PHS organisation that has issued the award within 60 days.
- Each investigator must submit an updated disclosure of an SFI not less than annually.
AstraZeneca’s FCOI Management Plan requires monitoring of Investigator compliance throughout the project to completion.
If a PHS-funded project is conducted by an investigator with a conflict that was not disclosed or managed, AstraZeneca is required to disclose the conflict in each public presentation related to the results of the research.
The FCOI Manager is responsible for the reporting and disposition of matters involving disclosures of SFI in accordance with applicable federal requirements.
The following reports are required by the NIH:
- Initial report – Prior to AstraZeneca’s expenditure of any funds under a NIH-funded research project, AstraZeneca must provide to the NIH a FCOI report regarding any Investigator SFI found by the Company to be a financial conflict of interest in accordance with the regulation.
- During on-going NIH-funded research projects – AstraZeneca shall submit a FCOI report within 60 days after its determination that a new FCOI exists. If a FCOI was not disclosed timely, AstraZeneca shall submit a FCOI report to the NIH within 60 days of the discovery, as well as complete a retrospective review within 120 days of discovery of noncompliance. AstraZeneca shall submit a revised FCOI within 60 days for an Investigator who is newly participating in the project.
- Annual FCOI report – For any FCOI previously reported to the NIH, AstraZeneca shall provide an annual FCOI report addressing the status of the FCOI and any changes to its related plan.
- Updates – AstraZeneca will promptly submit an updated report following a retrospective review to update a previously submitted report, if applicable. AstraZeneca will complete and document retrospective reviews within 120 days of determination of noncompliance for SFIs not disclosed timely or previously reviewed or whenever an FCOI is not identified or managed in a timely manner in order to be consistent with regulation.
- Mitigation Report - AstraZeneca will promptly notify NIH if a bias is found with the design, conduct, or reporting of NIH-funded research and will submit a Mitigation Report and will immediately notify NIH if an Investigator fails to comply with AstraZeneca’s FCOI statement or the FCOI management plan appears to have biased the design, conduct, or reporting of the NIH-funded research. Corrective actions will be taken for noncompliance with these procedures and the FCOI management plan.
Records documenting activities and actions taken by AstraZeneca will be maintained for at least 3 years from the date of the final expenditures report submitted to the PHS.
REMEDIES FOR NONCOMPLIANCE
AstraZeneca will appoint an FCOI Manager to ensure Investigator compliance. This includes ensuring maintenance of processes, performing administrative actions, and providing for employee sanctions.
In any case in which the Department of Health and Human Services determines that the PHS-funded research 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 an FCOI that was not managed or reported as required by this regulation (42 CFR 50), AstraZeneca will:
- Disclose the FCOI in each public presentation of the results of the research;
- Submit an addendum to previous published presentations.
This SOP will be provided to each subrecipient (other than US federal agencies) of the PHS funding. Subrecipients are required to implement the SOP and associated processes prior to engaging in research relating to the PHS-funded grant. As such, the requirements of this SOP will be included in any agreement with subrecipients. If applicable, confirmation from the subrecipient that its FCOI policy statement complies with the regulation will be obtained. Subrecipients shall be required to report identified FCOIs for its Investigators in a timeframe that allows AstraZeneca to report identified FCOIs to the NIH as required by regulation.
AstraZeneca will make this SOP publicly available.
AstraZeneca will make available information concerning identified FCOIs held by senior/key personnel (as defined by regulation), publicly accessible prior to the expenditure of funds as follows:
- The information will contain the minimum elements as provided by regulation
- The information will be made available within 5 calendar days of a written request to the Engagement Owner
- The information will be available for three years.
- As required under 42 CFR Part 50, Subpart F for PHS grants and cooperative agreements (and 45 CFR Part 94 for contracts): https://www.govinfo.gov/content/pkg/FR-2011-08-25/pdf/2011-21633.pdf
- More information about the NIH requirements on disclosure of FCOIs can be found at: https://grants.nih.gov/grants/policy/coi/index.htm
- Link to the NIH tutorial: http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm.
- Data Privacy requirements related to non-US Investigators need to be assessed prior to them engaging in US PHS funded research; they may be required to provide consent for such disclosure prior to engaging with the covered research.