Financial Conflict of Interest (FCOI)

 

The federal government, along with other sponsors, are committed to preserving the public’s trust that the research they support is conducted without bias and with the highest scientific and ethical standards. The federal regulations on promoting objectivity in research establishes the standards to provide a reasonable expectation that the design, conduct, and reporting of research will be free from bias resulting from investigators’ financial conflicts of interest.

A financial conflict of interest exists when the institution reasonably determines that an investigator’s significant financial interest could directly and significantly affect the design, conduct, or reporting of the funded research.

The requirements promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, or reporting of research funded will be free from bias resulting from any conflicting financial interest of an investigator.

An "investigator" is someone:

• Defined as the PD/PI 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.
• Although students are not considered 'investigators,' if they are submitting an application for a fellowship or another type of grant specifically suited for them, the same rules apply.

Each Institution shall maintain an up-to-date, written, enforced policy on financial conflicts of interest that complies with the regulation and makes the policy available via a publicly accessible Web site. 

When submitting a grant application, the signature of the Sponsored Program Associate (the Authorized Organization Representative (AOR)) certifies the applicant institution's compliance with the requirements of 42 CFR 50, Sub-part F, including that: 

1. There is in effect at the Institution an up-to-date, written and enforced administrative policy to identify and manage Financial Conflicts of Interest (FCOI) with respect to all research projects for which funding is sought or received;
2. The Institution shall promote and enforce Investigator compliance with the regulation's requirements including those pertaining to disclosure of Significant Financial Interests;
3. The Institution shall identify and manage FCOIs and provide initial and ongoing FCOI reports consistent with sponsors’ policy;
4. When requested, the Institution will promptly make information available to the sponsor relating to any Investigator disclosure of financial interests and the Institution's review of, and response to, such disclosure, whether or not the disclosure resulted in the Institution's determination of an FCOI;
5. The Institution shall fully comply with the requirements of the regulation. 

The above regulations apply to consortium as well. At the time of proposal, Sponsored Programs Administration will verify the collaborative institution has a policy in place. When they are unable to do so, they will request the PI send the collaborator an FCOI certification form. If the collaborative institution does not have a policy in effect at the time of proposal, but expects to at the time of award, they would indicate that on the form. At the Just-in-Time (JIT) phase for federal applications, the Project Associate will send a Sub-recipient follow-up form to confirm the policy was established. In extenuating circumstances where the consortium doesn't have a policy, we will allow them to fall under ours. The latter requires the collaborator to complete our training and follow all of Downstate COI policies, and for this instance, an exception request must be submitted and approved by Sponsored Programs Administration.

It is the responsibility of the PD/PI to identify Downstate “investigator’s” working on their project at the time of at the time of proposal on the Proposal Tracking/Signature Worksheet, in addition to the IRB/IACUC protocols respectively. For PD/PIs working on research not extramurally supported (institutional/department funds), the “investigators” must be identified at the time of protocol development to the IRB and IACUC.

It is also the responsibility of all investigators to complete COI training every four (4) years and complete an Annual FCOI disclosure. For each proposal, a Transactional disclosure is also required, either at the time of submission or any time prior to the award. Awards will not be setup without all these requirements in place. The disclosures must be completed in our COI software system.