Opportunities Exist To Strengthen NIH Grantees' Oversight of Investigators' Foreign Significant Financial Interests and Other Support

WHY WE DID THIS STUDY

In fiscal year (FY) 2020, NIH awarded $31 billion to grantee institutions (hereafter grantees) to support biomedical research. These grantees play key roles in protecting the integrity and security of U.S. biomedical research by requiring investigators to report (1) significant financial interests (hereafter financial interests) and (2) all sources of their other support (hereafter support), which includes all resources in support of and/or related to all of their research endeavors. This includes foreign financial interests and support. Failures by some investigators at these grantees to disclose substantial contributions of resources from foreign entities (including foreign governments) have raised concerns about threats to the integrity of NIH-supported research.

HOW WE DID THIS STUDY

To determine how grantees (1) ensure that investigators disclose all foreign financial interests and support and (2) review this information prior to reporting information to NIH, we administered online surveys to 773 grantees that (as of July 1, 2020) received NIH funding for FY 2020. We administered online surveys from October 2020 to January 2021. We received responses from 617 grantees.

WHAT WE FOUND

Noncompliance with Federal requirements. More than two-thirds of grantees failed to meet one or more requirements for investigators' disclosure of all foreign financial interests and support. These problems often involved requirements to disclose nonpublicly traded equity interests from foreign entities and to disclose in-kind resources, professional affiliations, or participation in a foreign "talents" program. Some grantees also were unsure about whether or how disclosure requirements applied to R13 grants, which specifically support conferences and scientific meetings. In addition, some grantees did not comply with Federal requirements to train investigators regarding disclosure of foreign financial interests. Further, 10 percent of grantees did not perform required reviews to determine whether investigators' foreign financial interests were conflicts that could bias their research.

Additional opportunities to strengthen oversight. In addition to having specific oversight requirements, grantees have general responsibilities for overseeing the disclosure and management of investigators' financial interests and support. We found that many grantees could strengthen their oversight practices to better ensure that all materials submitted to NIH are complete and accurate. At the same time, some grantees have implemented promising practices that—if more widely adopted—would strengthen oversight of foreign financial interests and support. These practices include:

• Providing written guidance and training regarding investigators' disclosures of foreign support. (Only a quarter of grantees reported providing this guidance and/or training.)
• Distinguishing whether the sources of investigators' financial interests or support were from a foreign entity. (Less than two thirds of grantees reported doing this.)
• Taking steps to validate investigators' reports or to identify financial interests and support that investigators failed to report. (Seventy-nine percent of grantees reported taking such steps.)

WHAT WE RECOMMEND

To address gaps in grantees' procedures regarding investigators' foreign financial interests and support, NIH should (1) ensure that grantees comply with Federal requirements to train investigators regarding disclosure of significant financial interests; (2) ensure that grantees conduct the required review of investigators' significant financial interests to determine whether conflicts exist; (3) specifically require grantees to provide trainings and to maintain a written policy regarding investigators' disclosure of other support; (4) modify its reporting mechanisms to require grantees to report whether investigators' significant financial interests and other support involve foreign entities; (5) conduct outreach to grantees with R13 conference grants to clarify requirements regarding the disclosure and review of investigators' significant financial interests and other support; (6) clarify whether and how grantees should verify investigators' significant financial interests and other support prior to submitting information to NIH; and (7) establish a method for grantees to share their best practices for identifying and reviewing investigators' foreign significant financial interests and other support. NIH concurred with all recommendations.