NIH Has Made Strides in Reviewing Financial Conflicts of Interest in Extramural Research, But Could Do More

WHY WE DID THIS STUDY

NIH awards more than 70 percent of its $37 billion budget to universities and other extramural grantee institutions (institutions). Identifying and managing investigators' financial conflicts of interest (financial conflicts) is critical to safeguarding the integrity of NIH-funded research. In 2008, OIG identified serious gaps in NIH's oversight of investigators' financial conflicts. 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 report focuses on the need for robust oversight, follows up on OIG's prior work, and seeks to determine whether NIH has addressed the gaps that OIG previously identified in the oversight of investigators' financial conflicts. It also provides-for the first time-information about the total number and types of financial conflicts that institutions are reporting to NIH.

HOW WE DID THIS STUDY

We collected from NIH the number and type of financial conflicts that institutions reported in fiscal year (FY) 2018. We sent a questionnaire and conducted an interview with staff from NIH's Office of Extramural Research (OER). We also reviewed guidance and training documents related to investigators' financial conflicts. Finally, we interviewed staff at three NIH Institutes and Centers (ICs) regarding their procedures for reviewing the financial conflicts that institutions reported.

WHAT WE FOUND

Over the last decade, NIH has strengthened its reporting requirements and developed an online system for collecting, reviewing, and storing the financial conflicts that institutions report. Overall, 3 percent of NIH grants in FY 2018 had investigators with financial conflicts. These grants received $1 billion in funding during FY 2018, and institutions reported a total of 2,755 financial conflicts. Although NIH has made substantial strides in reviewing the financial conflicts that institutions report, we found inconsistencies in the depth of its oversight reviews. Across the three ICs that we reviewed, staff differed in the level of scrutiny they applied to their review of financial conflicts. Furthermore, NIH lacks quality assurance procedures in its review process. Lastly, NIH cannot identify-and does not plan to identify-whether investigators' financial conflicts involve foreign interests, but is identifying foreign affiliations through a clarification of its requirements for pre-award reporting.

WHAT WE RECOMMEND

We recommend that NIH (1) perform periodic quality assurance reviews of the financial-conflict information in its online system to ensure the adequacy of its oversight, and (2) use information regarding foreign affiliations and support that it collects during the pre-award reporting process to decide whether to revise its financial-conflict review process to address concerns regarding foreign threats. NIH concurred with both recommendations.