According to NIH, these institutes and grantee institutions know the nature and objectives of the trials and are therefore in the best position to develop monitoring procedures to ensure safety and data integrity. Fiscal Oversight Policies and Controls Are Consistent Among Institutes and Grantees

Although each institute independently oversees the clinical trials it sponsors, the controls established to prevent and detect fiscal misconduct were consistent among the institutes in our review. The control procedures must conform with federal requirements and policies on the expenditure of federal funds. Independent auditors review grantee compliance annually in a required financial audit. Controls That Protect Trial Data Integrity Are Not Always Consistently Applied

Clinical trials have controls that safeguard against scientific misconduct, including direct data verification to ensure data integrity. One control designed to safeguard trials against scientific misconduct is the use of clinical monitors to review trial data. Furthermore, NIH has not adopted its internal committee’s recommendations to develop agencywide guidance on quality assurance measures and data monitoring procedures for institutes to use in managing clinical trials. NIH Conducts Limited Central Oversight and Monitoring of Phase III Clinical Trials

Even though NIH’s Office of Extramural Research is responsible for centralized activities concerning oversight of extramural research, such as developing policy on the review, funding, and management of clinical trials, it has limited knowledge of and data on the Phase III clinical trials NIH funds and the performance of individual institutes and grantees. NIH has decided not to adopt any of the committee’s recommendations agencywide. ORI monitors compliance with this requirement. This applies also to all NIH-sponsored research. The data coordinating centers we visited differed in how they were funded.
Why GAO Did This Study

Pursuant to a congressional request, GAO reviewed the National Institutes of Health's (NIH) oversight of the clinical trials it sponsors, focusing on NIH internal controls to prevent misuse of federal funds and safeguard the integrity of clinical trial data.

What GAO Found

GAO found that: (1) individual NIH institutes and grantee institutions oversee and monitor NIH-funded Phase III clinical trials; (2) internal controls to guard against fiscal misconduct in extramural research must comply with regulations and policies on federal funds expenditures and be consistently applied; (3) independent auditors review grantees' compliance with these internal control regulations during annual audits; (4) NIH imposes sanctions on offending grantees when scientific misconduct occurs; (5) internal controls to guard against scientific misconduct and ensure participants' safety are generally consistent, but they vary slightly among trials due to differences in the sponsoring institute's management philosophy and past experience, the trial's size, nature, and complexity, and the way the trial is funded; (6) NIH institutes and grantees use clinical monitors and data coordinating centers to ensure data integrity, but these controls are not consistently applied; (7) one institute provides direct funding for certain data verification functions which ensures prompt reporting of data concerns and potential misconduct to NIH, but this is not an agencywide policy for multisite trials; (8) central NIH oversight and monitoring of clinical trials is limited; and (9) NIH has not adopted on an agencywide basis, any of its study committee's recommendations to improve clinical trial oversight because it believes agencywide monitoring policies are inappropriate.