The Department of Health and Human Services (HHS) Office of Inspector General (OIG) Sept. 27 released three reports on financial conflicts of interest (FCOI), foreign threats to the biomedical research enterprise, and the steps the National Institutes of Health (NIH) is taking to protect the integrity of NIH-funded research.
The NIH has become increasingly concerned about the sharing of confidential information from grant applications, diversion of intellectual property, and the lack of reporting of financial support by NIH-funded researchers from foreign governments [Washington Highlights, July 9].
The objective of the OIG study was to “determine whether NIH has policies, procedures, and other controls in place for helping to ensure that institutions report all sources of research support, financial interests, and affiliations.” The reports demonstrate that the NIH should take steps to strengthen the agency’s oversight of investigator’s financial conflicts of interest and vetting process for the peer review of grant applications to identify potential foreign threats.
Specifically, the reports include:
- The NIH has made strides in reviewing FCOIs in extramural research, but could do more.
The OIG recommends that the NIH perform quality assurance reviews of FCOI information and use the information about foreign affiliations obtained during the pre-award reporting process to make determinations about whether to revise its financial conflict review process.
- The NIH has limited policies, procedures, and controls in place for helping to ensure that institutions report all sources of research support, financial interests, and affiliations.
The OIG recommends that the NIH ensure that the 1,013 institutions identified as not having FCOI policies posted on their website, post those policies as required. Other recommendations include enhancing the NIH FCOI monitoring program, reviewing grantee websites to ensure FCOI policies are publicly accessible, and implementing procedures to ensure institutions have FCOI policies.
- Vetting peer reviewers at the NIH's Center for Scientific Review: strengths and limitations.
The OIG recommends that the NIH update its guidance on vetting peer reviewers to identify potential foreign affiliations that may impact research integrity and coordinate with the HHS Office of National Security to develop a process for identifying peer reviewer nominees that require additional vetting.
The AAMC is developing a series of issue briefs on foreign influence, focusing on government efforts to address the issue and the institutional response.
The OIG reports, AAMC’s briefs, and other resources can be found on the AAMC Conflicts of Interest and Transparency webpage.