NIH Extramural Clinical Research:

Internal Controls Are Key to Safeguarding Phase III Trials Against Misconduct

HEHS-96-117: Published: Jul 11, 1996. Publicly Released: Jul 11, 1996.

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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.

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.

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