HHS OIG Identifies Opportunities to Strengthen NIH Grantees’ Oversight of Investigators’ Foreign Financial Interests

In June 2022, the United States Department of Health and Human Services Office of Inspector General (HHS OIG) released a new report, Opportunities Exist To Strengthen NIH Grantees’ Oversight of Investigators’ Foreign Significant Financial Interests and Other Support. National Institutes of Health (NIH) grantees are responsible for ensuring that investigators who conduct NIH-funded research disclose any required types of foreign financial interests and support, as well as reviewing the disclosures and reporting them (as necessary) to NIH. When grantees do not comply with the requirements, not only does it hinder grantees’ and NIH’s ability to conduct effective oversight, it also might leave NIH-funded research vulnerable to foreign influence.

Noncompliance

In conducting the review, HHS OIG found that more than 2/3 of grantees did not meet one or more requirements for investigators’ disclosure of all foreign financial interests and support. According to the review, these problems typically 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. There also seemed to be confusion and uncertainty around whether or how the disclosure requirements applied to R13 grants, which support conferences and scientific meetings.

The report also found that some grantees did not comply with Federal requirements to train investigators regarding their disclosure of foreign financial interests and 10% of grantees did not perform required reviews to determine whether investigators’ foreign financial interests were conflicts that could bias their research.

Strengthen Oversight

HHS OIG noted that in addition to specific oversight requirements, grantees also have general responsibilities for overseeing the disclosure and management of investigators’ financial interests and support. While some grantees have implemented practices that have increased oversight, by and large, grantees’ oversight practices could be better strengthened to ensure all materials submitted to NIH are complete and accurate.

Some of the practices that some grantees have put in place include: provide written guidance and training regarding investigators’ disclosures of foreign support, distinguish between whether the sources of investigators’ financial interests or support were from a foreign entity, and take steps to validate investigators’ reports and/or identify financial interests and support that investigators failed to report.

HHS OIG Recommendations

HHS made seven recommendations to NIH for the agency to address gaps in grantees’ procedures regarding investigators’ foreign financial interests and support.

(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

(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.