describing some activities. Compared to the level of discussion and detail provided in extramural research annual reports, there is minimal information in the intramural research reports that would allow NIAID program officers to conduct meaningful oversight.
The summary information in the reports was not informative as to what was accomplished and how objectives were met. The NIH needs to reassess its requirements for annual intramural research reports in light of Principle 13 “Use Quality Information,” in GAO’s Standards for Internal Controls in the Federal Government (also known as “the Green Book”).[1] In the alternative, if annual progress reports are not a useful oversight tool, the NIH should devise a more effective way to track the progress and accomplishments of its intramural research programs.
Conclusion & Next Steps
The Committee continues to seek information on this matter and will continue to request documents and answers about what research has been conducted and how it has been overseen. HHS, the NIH, and NIAID have not been forthcoming about the details of the MPXV gene transfer research efforts. In addition to refusing to produce relevant documents, HHS, the NIH, and NIAID made misrepresentations that misled the Committee and attempted to conceal the fact that transfers from clade I to clade II had been proposed and approved.
The obstructive behavior by HHS and the NIH is unacceptable. However, Committee staff believe that NIAID bears the most responsibility for misleading the Committee. The NIH’s decentralized structure gives its institutes and centers a substantial level of autonomy in setting research priorities and managing grants, including approval and oversight of biosafety measures.[2] Further, the individuals with first-hand knowledge of events, subject matter expertise, and control of the documents related to the experiment are all employed by NIAID.
The Constitution assigns to Congress the power to legislate, including the implied authority to conduct oversight of federal government programs, including research impacting public health. Congress cannot discharge this duty of oversight if agencies, like NIAID, obstruct the collection of facts, analysis, and documents needed to assess policies to support critical research and to make sure it is conducted safely. The lack of transparency
- ↑ U.S. Gov’t Accountability Office, GAO-14-704G, Standards for Internal Controls in the Federal Government 59 (2014), https://www.gao.gov/assets/gao-14-704g.pdf.
- ↑ Cong. Research Serv., supra note 14.
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