Grassley Calls for Immediate Action on Three HHS OIG Reports that Raise Concerns About NIH Research Oversight

Statement

On the heels of a hearing he chaired on the subject, Sen. Chuck Grassley (R-Iowa) released the following statement regarding three recently-released reports from the Health and Human Services Office of Inspector General (HHS OIG) that highlight significant concerns about the National Institutes of Health (NIH). Specifically, the reports raise flags about the lack of oversight of taxpayer-funded projects by NIH and the increasing threats of intellectual property theft of American taxpayer-funded research by foreign governments.

"Serious and ongoing threats to American taxpayer-funded research puts our nation at risk of falling behind competing countries. Our government and institutions must take all reasonable and necessary steps to protect the integrity of our research. They also must ensure that the intellectual property created in the U.S. does not fall victim to criminals or foreign agents.

"I appreciate the hard work of the Inspector General and staff. The findings of these Inspector General reports are alarming, to say the least. The problems identified need to be addressed immediately and aggressively. Processes need to be implemented to ensure proper vetting procedures are put in place and all relevant personnel must participate completely so that we know who is working on our taxpayer-funded projects. These issues are simply too important to take a relaxed approach and I urge NIH to move forward as quickly and efficiently as possible in implementing the recommendations."

HHS OIG released three reports detailing different reviews of NIH reviews. Some of Grassley's specific concerns include:

Peer Review
HHS OIG found that NIH's Center for Scientific Review (CSR), during its vetting of peer reviewer nominees, "gives little attention to foreign affiliation beyond requiring a justification for reviewers who are not based in North America." The OIG also notes in its report that NIH limits the sources it uses in vetting peer reviewers for "legal and moral controversies" to publicly reported information which is unlikely to reveal undisclosed foreign support.

Financial Conflicts of Interest
HHS OIG found that inconsistencies exist in NIH's efforts to oversee financial conflicts of interests, particularly "in the depth of its oversight reviews." The OIG cited that "staff differed in the level of scrutiny they applied to their review" and that NIH "lacks quality assurance processes in its review process." Specifically, NIH central management do not perform any systematic analyses or even ad-hoc check to determine whether staff accurately and consistently review reported financial conflicts of interest.

Most alarming, the OIG found that NIH was not able to identify financial conflicts of interests involving foreign interests because HHS regulations "do not require institutions to indicate whether an investigators financial conflicts of interest involves an entity" based outside of the U.S. Further, NIH doesn't currently have plans to move forward on any such requirement.

Reporting Sources of Research Support, Financial Interests and Affiliations
HHS OIG found that 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."

Of the 1,875 institutions that received NIH funding in fiscal year 2018 and were required to have financial conflict of interest policies, 1,013 did not have such policies posted on their websites.
Of the 90 institutions in the OIG's sample that had websites but did not have posted financial conflict of interest policies, 41 either did not have them or did not respond to the OIG's requests that they provide policies.
Of the 10 institutions in the OIG's sample that did not have websites, 3 did not have financial conflict of interest policies, and 1 did not respond to the OIG's request that it provide its policy.
The OIG also found that "not all NIH-funded investigators may be aware that they are required to disclose significant financial interests to their institutions." Some institutions even stated that they "were not aware of their responsibility to create and maintain financial conflict of interest policies." In addition, in FY 2018 NIH only performed reviews of three institutions relating to financial conflicts of interest policies, which is down from 28 in FY 2013.

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