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Selected NIH Institutes Met Requirements for Documenting Peer Review But Could Do More To Track and Explain Funding Decisions

WHY WE DID THIS STUDY

Congress, NIH, and Federal intelligence agencies have raised concerns about the integrity of U.S. medical research. In August 2018, the NIH Director stated that the risks to the integrity of peer review were increasing. Subsequently, Congress provided the Office of Inspector General with $5 million for oversight of NIH.

Peer review is how NIH uses scientific experts to evaluate grant applications for funding. This study assesses the extent to which select NIH institutes and centers (ICs) met NIH's basic requirements for documenting first-level peer review when evaluating applications for extramural research grants and the extent to which ICs made funding decisions not strictly limited to the scores from that review (i.e., the extent of funding of grant applications out of rank order). NIH's peer review process is central to its upholding its values of transparency, impartiality, and fairness, among others. Because of this, it is important to ensure that the process works as intended.

HOW WE DID THIS STUDY

We reviewed documentation for a representative sample of extramural grants funded by six ICs in fiscal year (FY) 2018. For those grants, we assessed NIH's compliance with selected aspects of its peer review process. We did so by reviewing summary statements, documentation of NIH's followup to resolve peer reviewer concerns, and justifications for funding grants out of rank order. We also reviewed the Department of Health and Human Services' (HHS's) grant policy and NIH policies and NIH's written responses to our questions.

WHAT WE FOUND

For the six ICs we reviewed, NIH met its basic requirements for documenting first-level peer review. It also followed up with applicants, as required, to resolve concerns about protections for human subjects and animals. However, ICs' documentation to justify funding grants out of rank order often appeared to fall short of the requirements in HHS's Grants Policy Administration Manual, and the documentation of reasoning for those funding decisions was missing in 37 out of 109 grants in our sample. A failure to document these justifications reduces transparency and can raise questions about undue influence.

WHAT WE RECOMMEND

Without better insight into where and why funding out of rank order is happening, the integrity of NIH's peer review process could come under question We recommend that NIH centrally track and monitor data on funding out of rank order and update its policy and guidance to reflect the latest HHS grants policy on justifying funding out of rank order. NIH concurred with both recommendations.