Investigators are required to disclose all Significant Financial Interests and provide updates to disclosed information as needed, complete the annual disclosure form even if they have no financial interests to report, and complete all required training and education. If acting as the PI/PD, Investigator will provide a list of individuals who meet the definition of “Investigator” and any other requested information within the required disclosure timeline. Reports of financial conflicts of interest shall be submitted to Immunicom within the requested disclosure timeline. Any interests that arise or are eliminated subsequent to the initial report must be reported to Immunicom within 30 days of such an event.
The NIH Financial Conflict of Interest tutorial was designed by the National Institutes of Health (NIH) to provide education on what constitutes financial conflict of interest. This course is required for any individual meeting the definition of Investigator. As of September 2021, the course is accessible at:
Upon completion of the training, the certificate of completion must be submitted to Immunicom’s Institutional Official (or designee) for record retention.
Each Investigator must complete training on this Policy, the investigator’s responsibilities regarding disclosure and the PHS regulations prior to engaging in research funded by PHS, and at least every four (4) years thereafter. They must also complete training within a reasonable period of time as determined by the Institutional Official in the event that this Policy is substantively amended in a manner that affects the requirements of Investigators, if the investigator is new to the institution, or if it is determined that the Investigator has not complied with this policy or with a management plan related to their activities.
Financial Conflict of Interest (FCOI) Review and Management
If a disclosure form reveals a Significant Financial Interest, it will be reviewed promptly by the Institutional Official or designee for a determination of whether it constitutes a Financial Conflict of Interest. An FCOI exists when Immunicom reasonably determines that a SFI could directly and significantly affect the design, conduct or reporting of PHS- or NIH-funded research.
If a Financial Conflict of Interest exists, the Institutional Official will take action to manage the financial conflict of interest, including the reduction or elimination of the conflict, as appropriate. If the Institutional Official determines that there is a Financial Conflict of Interest that can be managed, he or she will develop and implement a written management plan. The affected Investigator must formally agree to the proposed management strategies and sign the written management plan before any related PHS-sponsored research goes forward. The plan must ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.
The Institutional Official will periodically review the ongoing activity, monitor the conduct of the activity (including use of students and postdoctoral appointees), to ensure open and timely dissemination of the research results, and to otherwise oversee compliance with the management plan.
General Reporting Requirements
Immunicom‘s designated Institutional Official will review all disclosures and evaluate whether they contain any FCOI. If no FCOI is found, the disclosure forms will be kept on file. If an FCOI is identified, the disclosure of the FCOI will be reported through the eRA Commons FCOI module. If any interests are identified as conflicting subsequent to the initial report, they must be reported to Immunicom within 30 days. Immunicom will then report it to the PHS awarding component that has issued the award within 60 days. Each Investigator must submit an updated disclosure of an SFI not less than annually.
In the event of non-compliance with reporting and/or management of a financial conflict of interest involving a PHS-sponsored clinical research project whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment as required by this Policy, the investigator must disclose the financial conflicts of interest in each public presentation of the results of the affected PHS-sponsored research and request an addendum to previously published presentations.
Immunicom will provide to the PHS Awarding Component an FCOI report as outlined in the regulations:
Initial Report: Prior to expenditure of any funds under the NIH- or PHS-funded research project, Immunicom will provide a FCOI report regarding any SFI found to be a FCOI. Immunicom will also provide a FCOI report within 60 calendar days from the date of a new SFI disclosure determined to be a FCOI, a new Investigator with an identified FCOI becomes engaged in the project, or when Immunicom identifies a FCOI not previously disclosed. The report will include information mandated by PHS guidelines, including Grant/Contract Number and its Principal Investigator, the Name of Investigator with the FCOI, the nature of the FCOI and its value (or relevant description in cases where value cannot be readily defined), a description of how FCOI relates to PHS-funded research and the basis for the determination that the financial interest conflicts with such research, and key elements of the FCOI action plan.
Annual updates will be submitted to the PHS Awarding Component for the duration of the research project, describing the status of the FCOI, and, as necessary, updates to the action plan or justification that an FCOI no longer exists.
Records Management and Confidentiality
The Institutional Official will retain all disclosure forms, conflict management plans, and related documents for a period of three years from the date the final expenditure report is submitted to the PHS or to the prime PHS awardee, unless any litigation, claim, financial management review, or audit is started before the expiration of the three year period; in which case the records shall be retained until all litigation, claims or audit findings involving the records have been resolved and final action taken.
To the extent permitted by law, all disclosure forms, conflict management plans, and related information will be confidential. However, the Institution may be required to make such information available to the PHS Awarding Component and/or HHS, to a requestor of information concerning financial conflict of interest related to PHS funding, or to additional entities as required. If the Institution is requested to provide disclosure forms, conflict management plans, and related information to an outside entity, the Investigator will be informed of this disclosure.
Financial and other information disclosed in compliance with this policy will be disclosed only on a need-to-know basis as required to perform appropriate review and evaluation required by the policy, except in the case of required public accessibility of identified financial conflicts of interest held by senior/key personnel.
Non-Compliance and Penalties
In the event of an Investigator’s failure to comply with this Policy, the Institutional official may suspend all relevant activities or take other disciplinary action until the matter is resolved or other action deemed appropriate by the Institutional official is implemented.
An Institutional Official’s decision to impose sanctions on an Investigator because of failure to comply with this Policy, or failure to comply with the decision of the Institutional official, will be described in a written explanation of the decision to the investigator, and, where applicable, the IRB, and will notify the individual of the right to appeal the decision.
If an investigator fails to comply with this FCOI policy, within 120 days, Immunicom will perform a retrospective review of the Investigator’s activities. If the Institutional Official determines that a Financial Conflict of Interest was not identified or managed in a timely manner, including but not limited to an Investigator’s failure to disclose a Significant Financial Interest that is determined to be a Financial Conflict of Interest, or failure by an Investigator to materially comply with a management plan for a Financial Conflict of Interest, the Institutional Official and designees will complete a retrospective review of the Investigator’s activities and the PHS-sponsored research to determine whether the research conducted during the period of non-compliance was biased in the design, conduct or reporting of the research.
Documentation of the retrospective review shall include the project number, project title, PI, name of Investigator with the Financial Conflict of Interest, name of the entity with which the Investigator has the Financial Conflict of Interest, reason(s) for the retrospective review, detailed methodology used for the retrospective review, and findings and conclusions of the review.
The Institutional official will update any previously submitted report to the PHS relating to the research, specifying the actions that will be taken to manage the Financial Conflict of Interest going forward. This retrospective review will be completed in the manner and within the time frame established in PHS regulations. If bias is found, the institution will promptly notify the PHS Awarding Component and submit a mitigation report in accordance with the PHS regulations. The mitigation report will identify elements documented in the retrospective review, a description of the impact of the bias on the research project and the plan of action to eliminate or mitigate the effect of the bias. In extreme cases of bias, the Investigator may lose the right to work on the project or receive any future NIH funding.
Public availability of FCOI procedure and information
Prior to the expenditure of funds, Immunicom will publish on a publicly-accessible website, or respond to any requestor within five business days of the request, information concerning any Significant Financial Interest that meets the following criteria: