NIH has made strides in reviewing financial conflicts of interest in extramural research, but could do more
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Report in brief
- Contributor(s):
- United States. Department of Health and Human Services. Office of Inspector General. Office of Evaluation and Inspections, issuing body.
- Publication:
- [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2019
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Conflict of Interest Ethics, Research Research Financing, Government Government Regulation Mandatory Programs Humans United States National Institutes of Health (U.S.)
- Genre(s):
- Technical Report
- Abstract:
- Why OIG Did This Review. NIH awards more than 70 percent of its $37 billion budget to universities and other grantee institutions. Identifying and managing investigators' FCOIs is critical to safeguarding the integrity of NIH-funded research. In 2008, OIG identified serious gaps in 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 NIH to have robust oversight of institutions' management of these FCOIs. This report focuses on the need for thisrobust 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' FCOIs. It also provides--for the first time--information about the total number and types of FCOIs that institutions are reporting to NIH. In a separate review, OIG examined NIH's policies, procedures, and controls regarding institutions' reporting of investigators' FCOIs. How OIG Did This Review. We collected from NIH the number and type of FCOIs that institutions reported in FY 2018. We sent a questionnaire and conducted an interview with staff from NIH's Office of Extramural Research. We also reviewed guidance and training documents related to investigators' FCOIs. Finally, we interviewed staff at three NIH ICs regarding their procedures for reviewing FCOIs that institutions reported. What OIG Found. The National Institutes of Health (NIH) has made progress in overseeing financial conflicts of interest (FCOIs) that extramural grantee institutions (institutions) report for their research investigators. Over the last decade, NIH has strengthened its reporting requirements and developed an online system for collecting, reviewing, and storing FCOIs that institutions report. These changes have resulted in improvements in how NIH tracks and reviews FCOIs that institutions report. Because of its improved tracking, NIH is now able to provide the number and types of FCOIs that institutions report. Overall, 3 percent of NIH grants in fiscal year (FY) 2018 had $1 billion in funding during FY 2018, and institutions reported a total of 2,755 FCOIs. Although NIH has made substantial strides in reviewing each reported FCOI for completeness and compliance, as well as to ensure the reasonableness of institutions' management plans, we found inconsistencies in the depth of its oversight reviews. Across the three NIH Institutes and Centers (ICs) that we reviewed, staff differed in the level of scrutiny they applied to their FCOIs. Furthermore, NIH lacks quality assurance procedures in its review process. Specifically, NIH central management and the three ICs that we reviewed do not perform any systematic analyses or even ad-hoc checks to determine whether staff accurately and consistently review reported FCOIs, and OIG found a small number of inconsistencies in the FCOI data that institutions reported, which might highlight the need for more oversight of the review process. Lastly, NIH was unable to identify FCOIs involving foreign interests because U.S. Department of Health and Human Services' (HHS) regulations do not require institutions to indicate whether an investigator's FCOI involves an entity (e.g., a company, university, or government) that is based outside the United States. NIH has no plans to require institutions to designate--when reporting their investigators' FCOIs--whether those FCOIs involve foreign entities. Instead, NIH is collecting information regarding investigators' foreign associations through a clarification of its requirements for pre-award reporting. What OIG Recommends. NIH has taken many steps within the last decade to improve its tracking and review of investigators' FCOIs, and additional actions would further strengthen the consistency and rigor of its oversight process. We recommend that NIH (1) perform periodic quality assurance reviews of the FCOI 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 FCOI review process to address concerns regarding foreign threats. NIH concurred with both recommendations.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (27 pages))
- Illustrations:
- Illustrations
- NLM Unique ID:
- 101757721 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/101757721