They’re Here! NIH’s New FCOI Regulations And What To Look For

After all of the webinars, articles and presentations, we are now only two days away from the new NIH regulations on Financial Conflicts of Interest taking full effect.  As a reminder, these regulations apply to each Notice of Award received from the Public Health Service (PHS) of the DHHS and any related unit, most notably NIH.

The full text of the policy can be found on NIH’s always-informative website, but we thought it would be helpful to address a few of the more significant changes that may directly affect Research Administration personnel.  (Note that the PHS regulations are the minimum standards required; an Institution’s own policies can be more strict if it so chooses.)

Definition of Significant Financial Interest

A “significant financial interest” (SFI) is a financial interest held by the PI or his immediate family (spouse and dependent children) that may reasonably be interpreted to be related to the PI’s responsibilities for his or her Institution.  Such SFI disclosures must be made annually by a PI, and cover any possible conflicts within the previous twelve-month period.

Perhaps the most important change in the FCOI policies is the lowering of the threshold for a SFI to a flat $5,000 total of both compensation (e.g. salary) and equity value (e.g. shares).  In the event that a PI has any equity interest in a non-publicly traded company or business, this will qualify as a SFI, regardless of the dollar amount.  Additionally, remuneration from non-profit entities other than institutions of higher learning is no longer exempt from being included in calculations.

Travel Reimbursements

Investigators must now disclose any sponsored or reimbursed travel that could be reasonably interpreted to be related to their Institutional duties.  Such disclosures must state the destination, duration, purpose of the trip and the name of the sponsor.  However, travel that has been reimbursed by a U.S. government agency (federal, state or local), or by a domestic institution of higher education, is exempt from this requirement.

Investigator Training

Prior to engaging in any research funded by a PHS entity, a PI will be required to complete training with respect to both PHS and Institutional FCOI policies, as well as to better understand his/her individual responsibilities.  Subsequently, PIs receiving PHS funding must receive Institutional training every four years, or immediately if (1) his/her Institution amends its own FCOI procedures; (2) the PI is new to the Institution; or (3) his/her Institution finds the PI to be non-compliant.

Subrecipient Monitoring

In addition to increased requirements for Institutional personnel, greater regulations have also been implemented for any subrecipients to PHS awards.  First, there must be written agreement as to whether the sub will follow its own FCOI regulations or that of the Institution.  If the former, the sub must certify in the agreement that its own policies are in line with the PHS regulations, and specify time periods wherein the sub will report all identified FCOI to the Institution.  If the latter, the parties will agree on the time parameters within which the sub will provide the parent Institution with information regarding possible FCOI, which shall be sufficient to allow Institution to determine if any actions by sub PIs should be disclosed.  Regardless, the Institution is responsible for reporting all identified FCOI of its subs using the newly revamped eRA Commons Module.

Reimbursement of Costs of Implementation

While NIH acknowledges that the new regulations will be onerous, especially as they relate to general Institutional responsibilities, they do note the following:

 

“The cost of implementing the amended regulations is an allowable cost eligible for reimbursement as a Facilities and Administrative cost on PHS-supported grants, cooperative agreements and contracts. This generally offsets the cost burdens of implementation.”

 

(http://www.gpo.gov/fdsys/pkg/FR-2010-05-21/html/2010-11885.htm)