IND is committed to ensuring that staff and others with designated research related responsibilities at the company are provided an open and productive environment in which to conduct research. A conflict of interest, which arises when a secondary objective could affect the performance of a person's primary mission, is a normal part of human existence. The potential for financial gain is one of many potential incentives that can lead to bias in a subjective activity. While IND encourages interaction with outside institutions and persons, the company also defines clear boundaries within which to operate to ensure that company research and participant care are performed in a manner that maintains the utmost in integrity and objectivity.
This policy applies to IND as a research institution having responsibilities under 42 CFR 50. This policy also applies to Investigators employed or otherwise contracted through IND.
Financial Interest: Anything of monetary value or potential monetary value that reasonably appears to be related to the IND Individual's duties and responsibilities, including, but not limited to:
The term does not include:
Financial Conflict of Interest ("FCOI"): A financial interest that could directly and significantly affect the design, conduct or reporting of PHS funded research.
A significant FCOI can exist in a variety of situations, including the following example:
FCOI is present in a situation in which a primary interest or responsibility is affected, perhaps unduly, by a secondary interest or responsibility. This means that a subjective component of a primary interest (e.g. research) is affected, or potentially affected, by a financial secondary interest, either ongoing (e.g. consulting) or where there is the potential for increased valuation (of stock or an option). Financial COI is present when the outcome of the research could affect future income or the value of an asset (including an option for equity).
Institution: Any domestic or foreign, public or private, entity or organization (excluding a Federal agency) that is applying for, or that receives, PHS research funding.
Investigator: Any person who is independently responsible for making decisions regarding PHS funded research. This would include both the Principal Investigator on a research study, and anyone else, regardless of title, who is responsible for the design, conduct, or reporting (i.e. key personnel) of research funded by the PHS. For any one individual, the policy includes a financial interest of any immediate family member (spouse or spousal equivalent, and dependent children) as if any financial interest of that family member were one of the individual. Investigators include both those currently working on PHS projects, and those who may in the future become associated with PHS projects.
PHS: Public Health Service of the U.S. Department of Health and Human Services, including the National Institutes of Health (NIH).
Policy and Process
Statement of Policy
It is the policy of IND that an Investigator is obligated to appropriately disclose any financial interest to IND, and if after review it is determined necessary by the company FCOI committee, the company is obligated to ensure the establishment of a management plan which has been developed, approved and implemented by the company, with commitment of compliance by the Investigator and all other involved parties per the company’s procedures.
All Investigators are required to complete a training on FCOI requirements at a minimum of every four years. This training requirement can be fulfilled by completion of the web training and receipt of the training certificate provided by the interactive training module located at the following web address: https://nexus.od.nih.gov/all/2018/12/03/new-financial-conflict-of-interest-training-module-available/
Identification of Potential Financial Conflicts of Interest
An Investigator will be required to report to the company her/his financial interests on an annual basis and at the time of a reportable change. The company reserves the right to request additional information, as deemed necessary.
Establishment of Financial Conflict of Interest Committee
A financial conflict of interest committee will be appointed by the Executive Director and the Board of Directors of the company and the committee will report to them.
Procedures for Evaluation of Potential Financial Conflicts of Interest
The FCOI committee will determine who is classified as an Investigator. Training on this policy and the annual disclosure requirements will be held annually.
Disclosure statements will be required of all Investigators of the company annually and when an Investigator identifies a new financial interest during the year. The committee will review all disclosure statements to determine if a significant FCOI exists. If the committee determines that a significant FCOI exists, the committee will develop a management plan for the FCOI, meet with the Investigator to review the plan and obtain the Investigator's acceptance of the plan. Annually, the FCOI committee will present the status of disclosures and management plans to Board of Directors. The FCOI committee will also be responsible for all required reporting of significant FCOI to NIH as required by the regulation.
Management of Financial Conflicts of Interest
The FCOI committee will oversee the implementation of the management plan, which may include the elimination of the financial conflict of interest, approval of a management plan or an alternative course of action.
This policy is intended to be consistent with federal and state laws and regulations. Where there is a discrepancy, the applicable federal or state law or regulation will take precedence.