the Department of Health & Human Services’ Office of Inspector General reported.
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In highlighting the improvement in a September 2019 report, “NIH has made strides in reviewing financial conflicts of interest in extramural research, but could do more,” the OIG noted that, in the past 10 years, “NIH has strengthened its reporting requirements and developed an online system for collecting, reviewing, and storing financial conflicts of interest (FCOIs) that institutions report. These changes resulted in improvements in how NIH tracks and reviews FCOIs that institutions report.”
That being said, OIG also highlighted some ongoing issues with NIH’s FCOI oversight.
“Across the three NIH Institutes and Centers (ICs) that we reviewed, staff differed in the level of scrutiny they applied to their review of FCOIs,” the report states.
For example, the report notes that 15 of the 25 ICs have written procedures related to FCOI reviews and the documentation shared by the three ICs showed different levels of detail and instruction.
“Only one of the three guidance documents provided IC staff with specific criteria aimed at standardizing the review of FCOIs,” the report stated. Two of the three ICs also reported using external resources to aid in the review.
Review times also varied significantly, with two of the three ICs reporting that they spend generally 5-30 minutes per review, while the third said staff spends several hours on reviews.
The OIG also reported that “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.”
The report notes that there is a process in place to provide oversight of ICs’ review of reported FCOIs, but there is no longer sufficient staff to continue this oversight.
The “OER [Office of Extramural Research] now relies on IC staff to seek guidance when needed and does not conduct regular oversight of the ICs. Similarly, none of the three ICs we reviewed perform quality checks to ensure the thoroughness or consistency of review by program officials. Staff members from one IC stated that while they do not conduct quality checks, the IC provides new program officials more guidance during their first few reviews.”
The HHS watchdog also noted that NIH cannot identify whether FCOIs involve foreign entities even though investigators must disclose financial interests from foreign investments.
“The HHS regulations on FCOI do not require institutions to designate whether FCOIs involve foreign entities, and NIH reported that it has no plans to expand these regulations to include such a requirement,” the OIG reported.
The OIG recommended that NIH perform periodic quality assurance reviews of FCOI information to ensure adequacy of oversight and suggested it use “information regarding foreign affiliations and support that it collects during the pre-award process to decide whether to revise its FCOI review process to address concerns regarding foreign influence.”
SOURCE: Murrin S. Office of Inspector General. 2019 Sep 25. OEI-03-19-00150.