Policy on Financial Conflict of Interest in Externally-Funded Research
This policy requires that Investigators disclose financial interests held by themselves, their spouse and/or dependent children that are both significant and related to their research that would reasonably appear to be affected by the research.
Purpose of Policy
Federal regulation establishes standards to insure that there is no reasonable expectation that the design, conduct or reporting of research under the Public Health Service (PHS) grants or cooperative agreements will be biased by any conflicting financial interest of an investigator.
The PHS requires that prior to spending any funds under an award, the Institution must report to the PHS Awarding Component the existence of any conflicting financial interest, and assure that the interest has been managed, reduced, or eliminated, within sixty days of that identification.
The University has adopted this Policy on Financial Interest in Research to apply to all externally sponsored research.
Who is Subject to This Policy
All Investigators involved in a sponsored project whether or not they have significant related financial interest(s) are required to complete a disclosure. If the investigator has no conflict, he or she simply states that in the disclosure. See the attached disclosure form.
Who is an "Investigator"
An Investigator is the Principal Investigator and any other member of the research team who is “responsible for the design, conduct, or reporting of research, including subcontractors, or collaborators.” The definition includes the investigator’s spouse and/or dependent children.
A post-doctoral associate, fellow or graduate student or consultant who meets the definition of Investigator would be subject to the regulation.
All investigators on a project must indicate whether or not they have a related significant financial interest as part of the grant application process.
Each investigator is responsible for disclosing his or her own financial interests; in addition, it is important that the Lead Principal Investigator identify all Investigators (as defined above) on his or her research project who need to submit disclosures.
This Policy for PHS Projects Applies to Subrecipients. If an Investigator, through the University, carries out PHS-funded research through a subrecipient, the University must take reasonable steps to ensure that any subrecipient Investigator complies with this policy by either requiring a financial disclosure form to be filled out at the proposal stage, which includes certification that the subrecipient has a policy in place that meets the PHS requirements or will incorporate, as part of a written agreement with the subrecipient, terms that certify the subrecipient has a financial conflicts of interest policy that meets the PHS requirements for disclosure and reporting.
What Financial Interest Must be Disclosed
This policy requires the disclosure of a significant and related financial interest that would reasonably appear to be affected by the research for which funding is sought.
What is a significant financial interest?
A significant financial interest is considered anything with a monetary value (for example salary or other payments for service, equity, or property rights) of $5,000 or more or which represent more than a 5% ownership interest during the past 12 months or anticipated during the next 12 months from disclosure.
This can include, but is not limited to:
- Salary or other payments for services (e.g., consulting fees or honoraria). Salary, royalties, or other remuneration from the University are not included.
- Equity interests, public or private, such as stocks, stock options or other ownership sources
- Intellectual property rights such as patents, copyrights, and royalties from those rights.
- Sponsored or reimbursed travel. This does not include travel that is reimbursed or sponsored by a government agency, an institution of higher education, academic teaching hospital or medical center, or a research institute affiliated with an institution of higher education.
This does not include:
- Income from seminars, lectures, or teaching engagements, or nonprofit entities;
- An equity investment that, when aggregated for the Investigator and the Investigator’s spouse and/or dependent children, does not exceed $5,000.
- Salary, royalties or other payments that, when aggregated for the Investigator and the Investigator’s spouse and/or dependent children do not exceed $5,000.
What is a related financial interest?
A related financial interest is anything that would appear, to a reasonable objective observer familiar with such issues, to actually or potentially affect or be affected by the research being undertaken.
Some possible examples include:
- The Investigator is carrying out a sponsored project, and the results of that project would be relevant to the development, manufacturing, or improvement of the products or services of the entity in which he or she has a financial interest.
- The Investigator has a financial interest in an entity which might manufacture or commercialize a drug, device, procedure, or any other product used in the sponsored project or that might result from the project.
- The Investigator has consulting income from an entity and the financial interests of that entity, or the Investigator’s financial interests related to consulting for that entity, would reasonably appear to be affected by the research.
- The Investigator has intellectual property interest on a patent, patent application or a copyright of software related to the research that is or may be assigned or licensed to an outside party.
- The Investigator’s financial interest is in the sponsor of the research.
- The entity in which the investigator has a financial interest is serving as a sub-awardee, subcontractor, or consortium member for the project.
When is Disclosure Required?
A disclosure should be submitted:
- Before a proposal is submitted
- The disclosure should be updated annually
- A new disclosure submitted within 30 days after new or significant financial interests are acquired.
How Do I Submit a Disclosure?
Financial Conflict of Interest disclosure forms must be submitted to the Office of Sponsored Programs, Kris Wolff, Director, Canisius Hall, first floor. They may also be scanned and emailed to email@example.com or faxed to 718-817-5575.
What Happens When I Disclose a Potential Significant and Related Financial Interest?
If your disclosure indicates that there is a significant financial interest related to a sponsored research project, you will be asked to submit additional information that will be reviewed by the Office of Sponsored Programs. If it is determined that the interest has the potential to directly and significantly affect the design, conduct, or reporting of research then the following conditions or restrictions may be used to manage, reduce or eliminate the conflict of interest.
The following list is illustrative, and is not intended to include all possible conditions or restrictions that might be used:
- Public disclosure of the significant financial interest on publications and in presentations, to your research team, and to the public via a publicly accessible at http://www.fordham.edu/osp, or upon a request, within 5 business days
- Monitoring of research or other activities by independent reviewers
- Modification of a research plan
- Disqualification from participation in all or a portion of the proposed project
- Divestiture of the Significant Financial Interest
- Severance of relationships that create actual or potential conflicts
What Information About a Conflict of Interest is Conveyed to the Research Sponsor?
The following is information about a conflict of interest being conveyed to the research sponsor:
- The PHS and agencies that have adopted the PHS rule require notification that a conflict has been identified and is being managed.
- NSF requires notification only of conflicts that cannot be resolved.
- The University will comply with the conflict of interest disclosure rules of other research sponsors.
What Training and Support Will Be Provided?
An online course offered through the Collaborative Institutional Training Initiative (CITI) will serve as the primary training mechanism to disseminate and explain Fordham’s Policy on Financial Conflicts of Interest in Research. Participants will be guided through an on-line training session, a quiz will be administered, and a certificate of completion that can be downloaded or printed out for proof of training will be available. Everyone involved in research will need to be trained initially, and retrained within four years. In addition, advanced training will be provided for certain populations of researchers based on need.
What Supporting Information and Resources are Available?
Additional information on this topic can be found at the following websites:
- Grants and Funding Policy, U.S. Department of Health and Human Services
- Rules and Regulations, U.S. Department of Health and Human Services