Deeper than the Headlines: The NIH and the Potential for Financial Conflicts of Interests

In the healthcare research world, the National Institute of Health (NIH) awards more than 70 percent of its $37 billion budget to universities and other grantee institutions. That’s a lot of money, and there is a lot of effort that goes into safeguarding the integrity of the money NIH grants for research purposes.

Some of the major steps that go into safeguarding those funds include identifying and managing investigators’ financial conflicts of interest (FCOIs). And it just so happens that the OIG recently published a report summarizing their findings of a review they performed on the NIH activities surrounding FCOI.

In 2008, the OIG identified serious gaps in the NIH’s oversight of investigators’ FCOIs. More recently, failures by some investigators to disclose substantial contributions of resources from other organizations—including foreign governments—have raised new concerns about threats to research integrity. This failure highlights 1) The need for institutions to accurately identify and report investigators’ FCOIs, and 2.) The need for the NIH to have robust oversight of institutions’ management of these FCOIs.

This report focuses on the need for robust oversight. It follows up on the OIG’s prior work and seeks to determine whether the NIH has addressed the gaps that the OIG previously identified in the oversight of investigators’ FCOIs. It also provides, for the first time, information about the total number and types of FCOIs that institutions are reporting to the NIH. In a separate review, the OIG examined the NIH’s policies, procedures, and controls regarding institutions’ reporting of investigators’ FCOIs.

In order to perform the review, the OIG collected the total number and type of FCOIs that institutions reported in FY 2018. Then the OIG sent a questionnaire and conducted an interview with staff from the NIH’s Office of Extramural Research. The OIG also reviewed guidance and training documents related to investigators’ FCOIs. Finally, they interviewed staff at three NIH Institutes and Centers regarding their procedures for reviewing FCOIs that institutions reported. What they found was illuminating.

The Findings

In contrast to what the OIG found in their 2008 report (i.e., that the NIH was unable to provide the number or types of FCOIs associated with its extramural grants) the NIH is now able to provide the total number of FCOIs that institutions report, and a detailed count of the types of significant financial interests associated with these FCOIs.

The NIH now requires institutions to submit FCOI reports electronically, instead of through paper submissions to the awarding Institutes and Centers. To streamline and track the reporting of FCOIs, the NIH implemented an online reporting, tracking, and monitoring system: the electronic Research Administration Commons FCOI Module. In addition to streamlining the process that institutions use to report FCOIs, the FCOI Module also has made FCOI information readily available for the NIH to review. The FCOI Module provides NIH staff with the ability to access, review, and perform searches of reported FCOIs.

The NIH has improved its process for reviewing investigators’ FCOIs. Following publication of the OIG’s 2008 report, the NIH developed written guidance that outlines the responsibilities for staff reviewing FCOIs, as well as the actions that staff should take once an institution submits an FCOI report in the FCOI Module. The NIH now has a process to review each reported FCOI for completeness and compliance and to ensure the reasonableness of institutions’ management plans.

For 87 percent of FCOIs reported in FY 2018, program officials completed their reviews within 30 days, meeting the recommended timeline established for reviewers. However, for 13 percent of reported FCOIs, the NIH staff completed their reviews after 30 days, with the longest period of review lasting 260 days.

The NIH was unable to provide OIG with the number of FCOIs reported in FY 2018 that involved a significant financial interest in a foreign entity (e.g., the investigator with the FCOI was conducting research in the United States but had a significant financial interest in a foreign entity). Although the NIH released a notice in March 2018 to remind the NIH extramural research community that investigators must disclose all financial interests received from a foreign institution of higher education or the government of another country, the NIH has no mechanism within the FCOI Module to identify foreign entities.

In July of 2019, the NIH released a notice that clarifies its policy regarding other support, including foreign affiliations. Specifically, the NIH clarifies that institutions are required to provide information during the pre-award process about investigators’ other active and pending support, regardless of whether or not that support has monetary value, from all foreign and domestic entities. The NIH believes that collecting information regarding an investigator’s foreign interests is most appropriately captured as part of the pre-award reporting process rather than as part of the FCOI reporting process.

OIG Conclusions and Recommendations

Congress and the NIH have raised concerns about threats to research integrity, including foreign threats. The OIG found that, overall, the NIH has made progress in overseeing extramural investigators’ FCOIs but has made no changes to its FCOI review process in light of recent concerns about foreign threats.

The OIG recommends that NIH should perform periodic quality assurance reviews of information in the FCOI module to ensure the adequacy of oversight regarding FCOIs. They also recommend the NIH use information regarding foreign affiliations that it collects during the pre-award process to decide whether to revise its FCOI review process in order to address concerns regarding foreign influence.

Is your organization involved in any NIH-funded research? My recommendation would be to read the full report to better understand how the NIH will handle submissions and the awarding of grants moving forward. You can find a copy of the report here.