Financial Conflict of Interest in Research: Frequently Asked Questions
1. I already signed a 'Conflict of Interest with Fordham' disclosure form every year; how is this different?
Many people receive a disclosure form from the Office of Internal Audit based on conflict of interest with their employment with Fordham University, the purpose of which is to "ensure that the name, reputation, and integrity of the University are not compromised." This policy remains in effect. The purpose of the FCOI in Research policy is to "ensure that there is no reasonable expectation that the design, conduct or reporting of research... will be biased by any conflicting financial interest of an investigator." The original conflict of interest policy ensures the integrity of Fordham; the new policy ensures the integrity of Fordham research. While they are related, one does not replace the other.
2. What is covered under the definition of "Research"?
"Fordham research," for purposes of this policy, is research conducted in the course of an appointment with the university and/or using university resources, funded by federal and non-federal sources through contracts, subcontracts, grants, clinical trials, training grants, fellowships, or other forms of external funding.
3. Is this policy retroactive? Does it apply to grants that I got before August 24, 2012?
No. The FCOI policy is only for new and continuing (non-competing renewal) grants with a start date of August 24, 2012, and beyond.
4. What is a Financial Conflict of Interest (FCOI) related to research?
A financial conflict of interest occurs when research personnel have a financial self-interest that might interfere or appear to interfere with his or her professional duties on a research project. While such situations do not imply that the activities are inappropriate or unethical, if they could bias or create a reasonable perception by a neutral observer of bias in the research with the intersecting financial interests, they must be reported.
5. How do you determine whether a significant financial interest in an outside entity could be in conflict with my research project(s)?
The determination of whether activities are related to a reporter's Fordham research duties can be complicated and must be done on a case-by-case basis. However, Cornell University has come up with the following general considerations which we think will be a helpful starting point for our own reviews:
- Entity is a sponsor, subcontractor, or supplier or lessor of goods, materials, proprietary information, services, or facilities for your Fordham research duties.
- Entity makes use of your Fordham research or scholarly work either directly or indirectly. Making use of your Fordham research indirectly, for example, maybe when you are paid to provide expert testimony, to act as a witness or provide an opinion, which is derived from your Fordham duties.
- Entity is a member of an industry, trade, or advocacy group that directly funds your research or funds a sponsor of your Fordham research.
- Entity manufactures, commercializes, or is developing a product that is being used, evaluated, or further developed by your Fordham research.
- Entity will receive materials, data, or other information from your Fordham research.
- Entity is a competitor of a sponsor of your Fordham research.
- Entity refers human participants for your Fordham research.
- Entity has some other relationship not described above that could be related to or could be affected by your Fordham research.
6. How will the reported information be reviewed?
The review process is summarized below:
- Investigator fills out the Financial Conflict of Interest in Research disclosure form and submits it to the Office of Sponsored Programs (OSP).
- If the answer to question 5 is "I have no Significant Financial Interest as that term is defined in the Policy", the investigator is not required to do anything further until or unless there is an event that triggers an action (see item 6 in Fordham's Policy).
- If the answer to question 5 is "I do have Significant Financial Interest(s) to report", then further review of the information is required. After gathering all the necessary information, which may include conversations with the investigator, Legal Counsel, the IRB and IACUC, OSP will perform the initial review.
- As warranted by the findings of the initial review, the process may continue in the following manner: OSP forwards information, with comments, to the Chief Research Officer (CRO); if necessary, CRO forwards information to the Provost's office; if necessary, Provost will request a final review/decision by the Director of Internal Audit. Confidentiality will be maintained at all times, and information will only be shared with those with a need to know based on a role in the analysis of the conflict.
7. Who will make determinations for management plans and how will they be communicated to the investigators?
Based on the above process, if it is determined that a Significant Financial Interest needs to be managed in order for the investigator to continue with a research project, the plan will be drafted by the above-listed individuals on a case-by-case basis, possibly with input from the investigator. Investigator will be notified via email with a request for confirmation of receipt within a certain number of days.
8. What happens if I don't complete the Financial Conflict of Interest in Research disclosure form, or I don't take the training?
FCOI disclosures must be made 1) before a proposal is submitted, 2) as annual updates and 3) within 30 days of acquiring a new or significant financial conflict of interest. Everyone involved in research must take an initial FCOI training before grant monies can be expended, and update this training, at a minimum, every four years.
Failure to complete the Financial Conflicts of Interest form or the FCOI training may restrict the submittal of proposals for new funding to which you may be a party. Additionally, grant accounts you already hold will normally be frozen until you have fulfilled your obligations.
9. Who can I contact with specific questions regarding my unique situation?
For questions about the FCOI in Research policy, procedures or the review process, please contact Kris Wolff, Director, Office of Sponsored Programs 718-817-4086.